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  • Evaluation of the peri-strut low intensity area following sirolimus- and paclitaxel-eluting stents implantation: Insights from an optical coherence tomography study in humans INTERNATIONAL JOURNAL OF CARDIOLOGY Otake, H., Shite, J., Ikeno, F., Shinke, T., Teramoto, T., Miyoshi, N., Ako, J., Honda, Y., Fitzgerald, P. J., Hirata, K. 2012; 157 (1): 38-42

    Abstract

    Recent pathological studies have demonstrated that peri-strut low intensity area (PLIA) seen on optical coherence tomography (OCT) imaging represents the presence of fibrinogen and/or extracellular matrix. We sought to assess the clinical prevalence of PLIA and its relation to neointimal proliferation after the implantation of sirolimus- (SES) and paclitaxel-eluting stents (PES) in humans.Seventy patients underwent 6-months follow-up OCT after SES (43 stents) or PES (37 stents) implantation. PLIA was defined as a region around stent struts with homogenous lower intensity than surrounding tissue on OCT images without signal attenuation. The incidence of stent struts with PLIA (+PLIA struts) was calculated as the number of +PLIA struts/number of all struts (%).PES showed a higher incidence of stents with PLIA than SES (86% vs. 58%; p=0.005) with a higher prevalence of +PLIA struts (27.8±21.9% vs. 10.9±11.0%; p=0.0008). SES with PLIA showed a significantly greater neointimal thickness (NIT) than SES without PLIA (p=0.02), while PES showed a similar tendency (p=0.19). In a detailed strut basis analysis, average NIT on +PLIA struts were significantly greater than that on -PLIA struts in both SES and PES. In addition, average NIT was positively correlated with the prevalence of +PLIA struts (SES: Rho=0.73; p<0.0001, PES: Rho=0.58, p=0.0005) in both stents.The prevalence of PLIA was significantly higher in PES than in SES. The presence and extent of PLIA might be associated with intimal thickening after 1st-generation DES implantation.

    View details for DOI 10.1016/j.ijcard.2010.11.006

    View details for Web of Science ID 000303206800015

    View details for PubMedID 21168926

  • Impact of Donor-Transmitted Atherosclerosis on Early Cardiac Allograft Vasculopathy: New Findings by Three-Dimensional Intravascular Ultrasound Analysis TRANSPLANTATION Yamasaki, M., Sakurai, R., Hirohata, A., Honda, Y., Bonneau, H. N., Luikart, H., Yock, P. G., Fitzgerald, P. J., Yeung, A. C., Valantine, H. A., Fearon, W. F. 2011; 91 (12): 1406-1411

    Abstract

    The influence of donor-transmitted coronary atherosclerosis (DA) on plaque progression during the first year after cardiac transplantation (Tx) is unknown.Serial 3-dimensional intravascular ultrasound (IVUS) studies were performed within 8 weeks (baseline; BL) and at 1 year after Tx in 38 recipients. On the basis of maximum intimal thickness (MIT) at BL, recipients were divided into DA group (DA+; MIT?0.5 mm, n=23) or non-DA group (DA-; MIT<0.5 mm, n=15). Plaque, lumen, and vessel volume indexes were calculated by volume/measured length (mm/mm) in the left anterior descending artery. Univariate and multivariate regression analyses were attempted to reveal clinical predictors of change in coronary dimensions.During the first year after Tx, plaque volume index increased significantly in DA+ group, but did not change in DA- Group (DA+, 3.0±1.5 to 4.1±1.5 mm/mm, P<0.0001: DA-, 1.2±0.4 to 1.3±0.5 mm/mm, P=0.53). In both groups vessel volume index decreased significantly (DA+, 16.3±3.6 to 14.6±3.3 mm/mm, P=0.003: DA-, 13.5±4.1 to 12.0±3.3 mm/mm, P=0.01), as did lumen volume index (DA+, 13.2±3.1 to 10.5±2.7 mm/mm, P<0.0001: DA-, 12.2±3.7 to 10.7±3.0 mm/mm, P=0.004). Univariate and multivariate regression analyses revealed that DA was one of the strongest predictors for plaque progression.DA was associated with significant plaque progression during the first year after Tx, and in conjunction with negative remodeling, may be an important determinant of cardiac allograft vasculopathy.

    View details for DOI 10.1097/TP.0b013e31821ab91b

    View details for Web of Science ID 000291430500019

    View details for PubMedID 21512436

  • Clinical Evaluation of the Resolute Zotarolimus-Eluting Coronary Stent System in the Treatment of De Novo Lesions in Native Coronary Arteries The RESOLUTE US Clinical Trial JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY Yeung, A. C., Leon, M. B., Jain, A., Tolleson, T. R., Spriggs, D. J., Laurin, B. T., Popma, J. J., Fitzgerald, P. J., Cutlip, D. E., Massaro, J. M., Mauri, L. 2011; 57 (17): 1778-1783

    Abstract

    The RESOLUTE US (R-US) trial is a prospective, observational study designed to evaluate the clinical effectiveness of the Resolute zotarolimus-eluting stent (R-ZES) in a U.S. population.The R-ZES releases zotarolimus over a 6-month period in order to achieve optimal clinical effectiveness and safety.The R-US trial recruited patients with de novo native coronary lesions suitable for 1- or 2-vessel treatment with stents from 2.25 to 4.0 mm in diameter. In the main analysis cohort (2.5- to 3.5-mm stents and single-lesion treatment), the primary endpoint was 12-month target lesion failure (TLF) defined as the composite of cardiac death, myocardial infarction (MI), and clinically-driven target lesion revascularization (TLR), compared with data from Endeavor zotarolimus-eluting stent (E-ZES) trials, adjusting for baseline covariates through propensity scores.Overall, 1,402 patients were enrolled with a mean reference vessel diameter of 2.59 ± 0.47 mm and diabetes prevalence of 34.4%. In the main analysis cohort, TLF was 3.7% at 12 months compared with historical E-ZES results (TLF = 6.5%). The R-ZES met the 3.3% margin of noninferiority (rate difference = -2.8%, upper 1-sided 95% confidence interval: -1.3%, p < 0.001). The overall TLF rate was 4.7%, and rates of cardiac death, MI, and TLR were 0.7%, 1.4%, and 2.8%, respectively. The 12-month rate of stent thrombosis was 0.1%.The R-ZES achieved a very low rate of clinical restenosis while maintaining low rates of important clinical safety events such as death, MI, and stent thrombosis at 1-year follow-up. (The Medtronic RESOLUTE US Clinical Trial [R-US]; NCT00726453).

    View details for DOI 10.1016/j.jacc.2011.03.005

    View details for Web of Science ID 000289715600009

    View details for PubMedID 21470813

  • Intravascular Ultrasound Results From the NEVO ResElution-I Trial A Randomized, Blinded Comparison of Sirolimus-Eluting NEVO Stents With Paclitaxel-Eluting Taxus Liberte Stents in De Novo Native Coronary Artery Lesions CIRCULATION-CARDIOVASCULAR INTERVENTIONS Otake, H., Honda, Y., Courtney, B. K., Shimohama, T., Ako, J., Waseda, K., Macours, N., Rogers, C., Popma, J. J., Abizaid, A., Ormiston, J. A., Spaulding, C., Cohen, S. A., Fitzgerald, P. J. 2011; 4 (2): 146-U69

    Abstract

    The NEVO sirolimus-eluting stent (NEVO SES) is a novel cobalt-chromium stent combining sirolimus release from reservoirs with bioabsorbable polymer to reduce spatial and temporal polymer exposure. The aim of this study was to assess the arterial response to the NEVO SES in a randomized, blinded comparison versus the surface-coated TAXUS Liberte paclitaxel-eluting stent (TAXUS Liberté PES) in human native coronary lesions using intravascular ultrasound (IVUS).The NEVO ResElution-I IVUS substudy enrolled 100 patients (1:1 randomization). In addition to standard IVUS variables, uniformity of neointimal distribution within stents was evaluated in 3 dimensions by computing mean neointimal thickness within 12 equally spaced radial sectors on every 1-mm cross section along the stented segment. The NEVO SES showed significantly less neointimal proliferation (neointimal obstruction: 5.5±11.0% versus 11.5±9.7%, P=0.02), resulting in less late lumen area loss and smaller maximum cross-sectional narrowing at 6 months. The absolute variability of neointima distribution, assessed by the standard deviation of neointimal thickness within each stent, was significantly reduced with the NEVO SES compared with the TAXUS Liberté PES(0.04±0.04 mm versus 0.10±0.07 mm, P<0.0001). TAXUS Liberté PES showed significantly greater positive vessel remodeling than the NEVO SES (?vessel volume index: 1.30±1.36 mm(3)/mm versus 0.36±0.63 mm(3)/mm, respectively, P=0.003).The NEVO SES with focal release of sirolimus from reservoirs achieved significantly greater and more consistent suppression of neointimal hyperplasia than the surface-coated TAXUS Liberté PES. This was associated with less positive remodeling and no increased morphological or morphometric abnormalities surrounding the stent or at the stent margins.URL: http://www.clinicaltrials.gov. Unique identifier: NCT00714883.

    View details for DOI 10.1161/CIRCINTERVENTIONS.110.957175

    View details for Web of Science ID 000289673600012

    View details for PubMedID 21386089

  • Stent-Assisted Below-the-Ankle Angioplasty for Limb Salvage JOURNAL OF ENDOVASCULAR THERAPY Kawarada, O., Yokoi, Y., Higashimori, A., Waratani, N., Waseda, K., Honda, Y., Fitzgerald, P. J. 2011; 18 (1): 32-42

    Abstract

    To report the clinical outcome of stent-assisted below-the-ankle angioplasty for limb salvage in the setting of critical limb ischemia (CLI).A retrospective single-center study was conducted of 40 critical ischemic limbs in 31 patients (mean age 67 ± 8 years, range 46-94) undergoing below-the-ankle stent-assisted angioplasty between April 2006 and April 2009. Coronary bare metal stents were implanted in cases of failed balloon angioplasty due to significant recoil, flow-limiting dissection, abrupt closure, or repeat early reocclusion.Technical success was 93% (37 limbs), with 3 failures to cross the occlusive lesions. Acute or subacute occlusion was evident in 9 (23%) limbs. The number of runoff vessels increased significantly (p < 0.001) from 0.6 ± 0.8 to 1.8 ± 0.8. During a clinical follow-up of 19.3 ± 11.4 months (range 1-48), the number of repeat interventions for limb salvage was 2.2 ± 1.6 (range 1-9), and a total of 1.6 ± 0.9 stents (range 1-3) were implanted in 8 dorsalis pedis arteries. Acute or subacute stent thrombosis after stenting was observed in 2 of these, and symptomatic in-stent restenosis was detected in 4, which were all treated by repeat intervention. At 6, 12, and 24 months, the freedom from repeat intervention was 39.6%, 39.6%, and 35.2%, respectively. Amputation-free survival was 80.0%, 69.7%, and 62.7%, and limb salvage was 94.7%, 91.4%, and 82.1% at the same time points. Patient survival rates were 77.4%, 71.0%, and 71.0%, respectively. During a mean follow-up of 13.4 ± 12.7 months (range 1-31 months) in 7 of the 8 stented arteries, all examined stents were deformed: stent compression was evident in 5 and stent fracture in 5. However, 7 limbs undergoing dorsalis pedis artery stenting showed complete wound healing; 1 limb had a resistant wound in the heel.Stent-assisted below-the-ankle angioplasty produced a satisfactory clinical outcome but with the need for repeat intervention. Thus, further refinement in endovascular technology is mandatory to reduce the need for repeat interventions and to resolve stent deformity issues.

    View details for Web of Science ID 000287071700005

    View details for PubMedID 21314346

  • Six-Month Results of the NEVO RES-ELUTION I (NEVO RES-I) Trial A Randomized, Multicenter Comparison of the NEVO Sirolimus-Eluting Coronary Stent With the TAXUS Liberte Paclitaxel-Eluting Stent in De Novo Native Coronary Artery Lesions CIRCULATION-CARDIOVASCULAR INTERVENTIONS Ormiston, J. A., Abizaid, A., Spertus, J., Fajadet, J., Mauri, L., Schofer, J., Verheye, S., Dens, J., Thuesen, L., Dubois, C., Hoffmann, R., Wijns, W., Fitzgerald, P. J., Popma, J. J., Macours, N., Cebrian, A., Stoll, H., Rogers, C., Spaulding, C. 2010; 3 (6): 556-564

    Abstract

    Drug-eluting stents reduce restenosis and reintervention rates but are complicated by stent thrombosis, which may be related to polymer coating. The NEVO sirolimus-eluting coronary stent (NEVO SES) is designed to improve long-term percutaneous coronary intervention safety by combining sirolimus release from reservoirs with bioabsorbable polymer to reduce spatial and temporal polymer exposure.NEVO ResElution-I was a prospective randomized study in 394 patients with coronary artery disease comparing the NEVO SES with the TAXUS Liberté paclitaxel-eluting coronary stent (TAXUS Liberté PES) stent. The primary end point was in-stent angiographic late loss at 6 months. Six months after percutaneous coronary intervention (PCI), the primary end point favored NEVO SES (0.13±0.31 mm versus 0.36±0.48 mm, P<0.001 for noninferiority and superiority). The study was not powered for clinical end points and showed no significant difference for NEVO SES versus TAXUS Liberté PES: death: 0.5 versus 1.6%, P=0.36; myocardial infarction: 2.0 versus 2.6%, P=0.75; target lesion revascularization: 1.5 versus 3.2%, P=0.33; major adverse cardiac events: 4.0 versus 7.4%, P=0.19. No stent thrombosis was observed with NEVO SES, whereas 2 cases occurred in TAXUS Liberté PES. Intravascular ultrasound showed lower percent volume obstruction for NEVO SES (5.5±11% versus 11.5±9.7%, P=0.016).This trial proved the superiority of NEVO SES over TAXUS Liberté PES for the primary angiographic end point of in-stent late loss. No stent thrombosis occurred in the NEVO SES group.URL: http://www.clinicaltrials.gov. Unique identifier: NCT00606333.

    View details for DOI 10.1161/CIRCINTERVENTIONS.110.946426

    View details for Web of Science ID 000285296100009

    View details for PubMedID 21062998

  • Awareness of Anatomical Variations for Infrapopliteral Intervention CATHETERIZATION AND CARDIOVASCULAR INTERVENTIONS Kawarada, O., Yokoi, Y., Honda, Y., Fitzgerald, P. J. 2010; 76 (6): 888-894

    Abstract

    With the tremendous advancement and accumulated expertise of endovascular techniques, infrapopliteal intervention is emerging as an alternative therapeutic option to distal bypass surgery for limb salvage in the setting of critical limb ischemia (CLI). However, though much attention has been given to infrapopliteal intervention, the importance of identifying preprocedural infrapopliteal variants remains underappreciated. Becoming more aware of these anatomical variants will translate to increased clinical effectiveness for the patient with infrapopliteal artery disease. Therefore, this review will highlight the fundamental aspects of infrapopliteal variant anatomy for the catheter-based treatment of CLI patients with symptomatic infrapopliteal artery disease.

    View details for DOI 10.1002/ccd.22673

    View details for Web of Science ID 000284676100022

    View details for PubMedID 20578165

  • Neointimal hyperplasia in a thin-strut cobalt-chromium stent: Insights from detailed 3-D intravascular ultrasound analysis INTERNATIONAL JOURNAL OF CARDIOLOGY Otake, H., Ako, J., Waseda, K., Sakurai, R., Hirohata, A., Kaneda, H., Hasegawa, T., Honda, Y., Fitzgerald, P. J. 2010; 145 (1): 125-126

    Abstract

    The effect of current generation cobalt-chromium stents on neointimal proliferation has not been fully elucidated. IVUS images of 137 patients treated with a single thin-strut cobalt-chromium stent (Driver: DRI, n=74) or stainless steel stent (Multilink plus: ML, n=63) were selected. Although % neointima volume (neointimal volume divided by stent volume) were comparable, DRI showed significantly smaller maximum %cross-sectional narrowing (%CSN: neointimal area divided by stent area) (P=0.006) with significantly less %CSN>60 (percent stent length with %CSN>60%) than ML (P=0.04). In conclusion, the amount of neointimal hyperplasia after DRI implantation was comparable to that after ML. However, current generation cobalt-chromium DRI may show less and shorter severe narrowing than the stainless steel ML.

    View details for DOI 10.1016/j.ijcard.2009.06.038

    View details for Web of Science ID 000283727000070

    View details for PubMedID 19619904

  • Comparison of Vascular Response to Zotarolimus-Eluting Stent vs Paclitaxel-Eluting Stent Implantation - Pooled IVUS Results From the ZoMaxx I and II Trials CIRCULATION JOURNAL Waseda, K., Hasegawa, T., Ako, J., Honda, Y., Grube, E., Whitbourn, R., Ormiston, J., O'Shaughnessy, C. D., Henry, T. D., Overlie, P., Schwartz, L. B., Sudhir, K., Chevalier, B., Gray, W. A., Yeung, A. C., Fitzgerald, P. J. 2010; 74 (11): 2334-2339

    Abstract

    The ZoMaxx I and II trials were randomized controlled studies of the zotarolimus-eluting, phosphorylcholine-coated, TriMaxx stent for the treatment of de novo coronary lesions. The aim of this study was to compare the vessel response between zotarolimus- (ZES) and paclitaxel-eluting stents (PES) using intravascular ultrasound (IVUS).Data were obtained from the ZoMaxx I and II trials, in which a standard IVUS parameter was available in 263 cases (baseline and 9-months follow up). Neointima-free frame ratio was calculated as the number of frames without IVUS-detectable neointima divided by the total number of frames within the stent. While an increase in vessel and plaque was observed in PES from baseline to follow up, there was no significant change in ZES. At follow up, % neointimal obstruction was significantly higher (15.4 ± 8.8% vs 11.3 ± 9.7%), and minimum lumen area at follow up was significantly smaller in ZES compared to PES. However, the incidence of IVUS-defined restenosis (maximum cross-sectional narrowing >60%) was similar in the 2 groups (3.2% vs 6.7%). Neointima-free frame ratio was significantly lower in ZES. There were 5 cases of late incomplete stent apposition in PES and none in ZES.These IVUS results demonstrate a similar incidence of severe narrowing between these 2 DES. There was a moderate increase in neointimal hyperplasia that was associated with a greater extent of neointimal coverage in ZES compared with PES.

    View details for DOI 10.1253/circj.CJ-09-0850

    View details for Web of Science ID 000283623200018

    View details for PubMedID 20890052

  • Short- and Mid-Term Intravascular Ultrasound Analysis of the New Zotarolimus-Eluting Stent With Durable Polymer - Results From the RESOLUTE Trial - CIRCULATION JOURNAL Waseda, K., Ako, J., Yamasaki, M., Koizumi, T., Ormiston, J., Worthley, S. G., Whitbourn, R. J., Walters, D. L., Honda, Y., Meredith, I. T., Fitzgerald, P. J. 2010; 74 (10): 2097-2102

    Abstract

    The Resolute stent is a newly developed system with a bio-histocompatible polymer that allows programmed drug delivery up to 180 days. The aim of this intravascular ultrasound (IVUS) analysis was to evaluate the short- (4 months) and mid-term (9 months) efficacy using the Resolute stent.Data were derived from the RESOLUTE trial, a prospective, multicenter, non-randomized, single-arm study to treat de novo native coronary artery lesions. This trial included 2 cohorts with different follow-up periods, and all enrollment patients in this trial received IVUS study. Follow-up IVUS was available in 24 patients (4-month group) and 88 patients (9-month group). Neointimal obstruction (%) was defined as neointimal volume divided by stent volume. Cross-sectional narrowing (CSN, %) was defined as neointimal area divided by stent area. No significant differences in vessel, lumen and stent volume at post-procedure were observed within stented segments between the 4- and 9-month follow-up groups. Although neointimal volume and % neointimal obstruction showed no significant difference between the 2 groups (% neointimal obstruction: 2.2 ± 2.5 vs 3.7 ± 4.0%, P=0.09), maximum CSN was significantly larger in the 9-month group. There were 7 cases of late incomplete stent apposition.These IVUS results showed minimum growth of neointimal proliferation by the Resolute stent throughout the stented segment up to 9 months follow up.?

    View details for DOI 10.1253/circj.CJ-10-0063

    View details for Web of Science ID 000282562300015

    View details for PubMedID 20689221

  • Incidence of diffuse and focal chronic stent recoil after implantation of current generation bare-metal and drug-eluting stents INTERNATIONAL JOURNAL OF CARDIOLOGY Koo, B., Waseda, K., Ako, J., Hasegawa, T., Shimohama, T., Nakatani, D., Otake, H., Yamasaki, M., Sakurai, R., Tsujino, I., Honda, Y., Fitzgerald, P. J. 2010; 144 (1): 132-134

    View details for DOI 10.1016/j.ijcard.2008.12.117

    View details for Web of Science ID 000282679000054

    View details for PubMedID 19171393

  • Comparison of Everolimus- Versus Paclitaxel-Eluting Stents Implanted in Patients With Diabetes Mellitus as Evaluated by Three-Dimensional Intravascular Ultrasound Analysis AMERICAN JOURNAL OF CARDIOLOGY Otake, H., Ako, J., Yamasaki, M., Tsujino, I., Shimohama, T., Hasegawa, T., Sakurai, R., Waseda, K., Honda, Y., Sood, P., Sudhir, K., Stone, G. W., Fitzgerald, P. J. 2010; 106 (4): 492-497

    Abstract

    Previous reports have shown the advantage of paclitaxel compared to limus-derivative drugs for the treatment of diabetics. A total of 109 diabetics (115 lesions) treated with everolimus-eluting stents (EESs, n = 58) or paclitaxel-eluting stents (PESs, n = 55) undergoing 8 to 9 months of follow-up 3-dimensional intravascular ultrasound examinations were enrolled. In addition to the standard intravascular ultrasound parameters, the percentage of neointimal volume (neointimal volume/stent volume) and maximum percentage of cross-sectional narrowing (neointimal area/stent area) was calculated. EESs showed a lower percentage of neointimal volume (7.2 +/- 7.1% vs 11.7 +/- 11.0%; p = 0.01) and maximum percentage of cross-sectional narrowing (22.5 +/- 16.3% vs 29.4 +/- 19.2%; p = 0.04) than PESs. One case of severe narrowing (lesions with maximum percentage of cross-sectional narrowing >60%) in the EES group developed and 6 cases in the PESs group (p = 0.05). The EESs showed no serial changes for vessel or peri-stent plaque during the follow-up period, and PESs showed significant increases in vessel and peri-stent plaque. PESs showed significantly greater peri-stent plaque increase, with a tendency toward greater vessel enlargement than EESs. Late acquired incomplete stent apposition was observed in 2 PES cases. The major adverse cardiac event rate was comparable < or =2 years. In conclusion, EESs showed greater neointimal suppression without significant vessel expansion than PESs in diabetic patients. In this small cohort, no significant differences were observed in the major adverse cardiac event rate < or =2 years.

    View details for DOI 10.1016/j.amjcard.2010.03.059

    View details for Web of Science ID 000281174500007

    View details for PubMedID 20691306

  • Vascular responses to the multiple overlapped paclitaxel-eluting stents for the treatment of bare-metal in-stent restenotic lesions: angiographic and intravascular ultrasound analysis from the TAXUS-V ISR trial. Cardiovascular revascularization medicine : including molecular interventions Koizumi, T., Fitzgerald, P. J., Honda, Y., Ellis, S. G., Kent, K., Martin, S. L., Brown, C. L., Masud, A. R., Patterson, J. B., Greenberg, J., Friedman, M., Uchida, T., Stone, G. W. 2010; 11 (3): 140-148

    Abstract

    Although effective coverage of coronary diffuse in-stent restenosis (ISR) lesions has warranted the use of multiple drug-eluting stents, the vessel response to paclitaxel-eluting stent (PES) overlap is not fully understood.In the TAXUS-V ISR, i.e., comparing PES versus brachytherapy for the treatment of bare-metal ISR, angiographic analyses at 9-month follow-up were available in 184 ISR lesions treated with PES.In-stent late loss in entire stented segment of multiple PES (n=50) was 0.45+/-0.48 mm, whereas that of single PES (n=134) was 0.3+/-0.47 mm, P=.06. No aneurysm was observed at overlapping PES segments at 9 months. Stent thrombosis up to 9 months was observed in one in each group (single PES, 0.7% vs. multiple PES, 1.8%; P=.47). In a subset of 30 patients, volumetric intravascular ultrasound analysis demonstrated that in-stent net volume obstruction was 12.3+/-12.4 in single PES (n=20) and 14.9+/-9.8 in multiple PES (n=10), P=.60. The changes of vessel and lumen at the overlapping PES segment were similar to those of the adjacent 5-mm segments (Deltaminimum lumen area, mm(2): -1.2+/-1.0, -1.1+/-1.1, -0.8+/-0.9, P=.48; Deltavessel volume, mm(3)/mm: -0.2+/-1.4, 0.1+/-1.7, 0.3+/-1.3, P=.37; proximal, overlap, distal segment, respectively). There was no late incomplete stent apposition at overlapping PES segments.No in vivo evidence of adverse local vessel response at the site of overlapping PES for the treatment of bare-metal ISR has been demonstrated.

    View details for DOI 10.1016/j.carrev.2009.07.004

    View details for PubMedID 20599163

  • SPIRIT III JAPAN Versus SPIRIT III USA: A Comparative Intravascular Ultrasound Analysis of the Everolimus-Eluting Stent AMERICAN JOURNAL OF CARDIOLOGY Shimohama, T., Ako, J., Yamasaki, M., Otake, H., Tsujino, I., Hasegawa, T., Nakatani, D., Sakurai, R., Chang, H., Kusano, H., Waseda, K., Honda, Y., Stone, G. W., Saito, S., Fitzgerald, P. J., Sudhir, K. 2010; 106 (1): 13-17

    Abstract

    The aim of this study was to evaluate the vascular response after everolimus-eluting stent (EES) implantation in the SPIRIT III Japan Registry (JAPAN) compared to EES implantation in the SPIRIT III United States (USA) trial using serial intravascular ultrasound (IVUS) analysis. Data were obtained from the JAPAN and the randomized EES arm of the USA trial. Serial (postprocedure and 8-month follow-up) IVUS analysis was available in 199 lesions (JAPAN 82, USA 117) of 183 patients (JAPAN 73, USA 110). Although no difference was observed in vessel size in the reference segment between the 2 groups, postprocedure minimum lumen area and stent volume index were significantly greater in the JAPAN arm (minimum lumen area 5.8 +/- 2.2 vs 5.1 +/- 1.5 mm(2), p = 0.03; stent volume index 7.0 +/- 2.4 vs 6.3 +/- 1.7 mm(3)/mm, p = 0.03). Postprocedure incomplete stent apposition (ISA) was less frequently observed in the JAPAN arm (15.9% vs 33.3%, p = 0.006), possibly related to higher maximum balloon pressure and/or more postdilatation without excess tissue prolapse or edge dissection. In the JAPAN arm, percent neointimal obstruction and maximum percent cross-sectional narrowing were significantly lower at 8-month follow-up (percent neointimal obstruction 3.5 +/- 4.2% vs 6.8 +/- 6.4%, p = 0.0004). Late acquired ISA was infrequent in the 2 arms. In conclusion, comparative IVUS analysis between the JAPAN and USA arms showed more optimal stent deployment in the JAPAN arm as evidenced by the lower incidence of postprocedure ISA and larger minimum lumen area after the procedure. Moreover, there was less neointimal hyperplasia in patients with EES implants from the JAPAN arm compared to the USA arm.

    View details for DOI 10.1016/j.amjcard.2010.02.008

    View details for Web of Science ID 000279659700003

    View details for PubMedID 20609640

  • Mechanism of lumen gain with a novel rotational aspiration atherectomy system for peripheral arterial disease: examination by intravascular ultrasound. Cardiovascular revascularization medicine : including molecular interventions Hassan, A. H., Ako, J., Waseda, K., Honda, Y., Zeller, T., Leon, M. B., Fitzgerald, P. J. 2010; 11 (3): 155-158

    Abstract

    The purpose of this study was to evaluate the mechanism of luminal gain with a novel atheroablation system (Pathway PV) for the treatment of peripheral artery disease using intravascular ultrasound (IVUS).The atherectomy system is a rotational atherectomy device, which employs expandable rotating blades with ports that allow flushing and aspiration of the plaque material or thrombus. In this first-in-man clinical study, IVUS analysis was available in 6 patients with lower limb ischemia treated with this device. The treatment results were assessed using IVUS at pre and post atherectomy. Lumen beyond burr size (LBB) was defined as lumen gain divided by the estimated burr area determined by the burr-size.IVUS analysis was available in six patients (superficial femoral artery n=3, popliteal artery n=2, posterior tibial artery n=1). Atheroablation achieved a significant increase in lumen area (LA) (preintervention 3.9+/-0.4, postatheroablation 8.0+/-1.7 mm(2), P<.05), and significant reduction in plaque area (27.5+/-4.0, 23.7+/-3.1 mm(2), P=.001), while there was no change in the vessel area (31.3+/-4.2, 32.1+/-2.8 mm(2), P=.4). LBB was 57.4+/-51.3%.This novel rotational aspiration atherectomy device achieved significant luminal gain by debulking in the absence of vessel stretching. The LA was greater than burr-sized lumen expectancy at cross-sections along the treated segments, suggesting a complimentary role of aspiration in luminal gain in atherosclerotic peripheral artery lesions.

    View details for DOI 10.1016/j.carrev.2009.05.001

    View details for PubMedID 20599165

  • Vascular Response to Overlapping Everolimus-Eluting Stents - Comparison With Paclitaxel-Eluting Stents CIRCULATION JOURNAL Otake, H., Honda, Y., Yamasaki, M., Tsujino, I., Shimohama, T., Sakurai, R., Hasegawa, T., Waseda, K., Ako, J., Fitzgerald, P. J. 2010; 74 (5): 1023-1025

    Abstract

    Overlapping drug-eluting stents might be associated with an adverse vessel response because of increased drug/polymer toxicity and lesion rigidity.Lesions treated with overlapping everolimus- (EES=36) or paclitaxel-eluting stents (PES=38) were analyzed for 8-9-months by 3-dimensional intravascular ultrasound. EES were associated with significantly greater neointimal suppression in the single-strut regions than PES, with a similar trend in the overlap region. PES had significant vessel expansion in all regions, whereas there were no changes with EES. Neither stent fracture nor late incomplete stent apposition (LISA) in the overlap region was observed.Overlapping EES appears to be effective without vessel expansion, stent fracture or LISA for up to 8-9 months.

    View details for DOI 10.1253/circj.CJ-10-0052

    View details for Web of Science ID 000277226100033

    View details for PubMedID 20424338

  • Anatomic and Functional Evaluation of Bifurcation Lesions Undergoing Percutaneous Coronary Intervention CIRCULATION-CARDIOVASCULAR INTERVENTIONS Koo, B., Waseda, K., Kang, H., Kim, H., Nam, C., Hur, S., Kim, J., Choi, D., Jang, Y., Hahn, J., Gwon, H., Yoon, M., Tahk, S., Chung, W., Cho, Y., Choi, D., Hasegawa, T., Kataoka, T., Oh, S. J., Honda, Y., Fitzgerald, P. J., Fearon, W. F. 2010; 3 (2): 113-119

    Abstract

    We sought to investigate the mechanism of geometric changes after main branch (MB) stent implantation and to identify the predictors of functionally significant "jailed" side branch (SB) lesions.Seventy-seven patients with bifurcation lesions were prospectively enrolled from 8 centers. MB intravascular ultrasound was performed before and after MB stent implantation, and fractional flow reserve was measured in the jailed SB. The vessel volume index of both the proximal and distal MB was increased after stent implantation. The plaque volume index decreased in the proximal MB (9.1+/-3.0 to 8.4+/-2.4 mm(3)/mm, P=0.001), implicating plaque shift, but not in the distal MB (5.4+/-1.8 to 5.3+/-1.7 mm(3)/mm, P=0.227), implicating carina shifting to account for the change in vessel size (N=56). The mean SB fractional flow reserve was 0.71+/-0.20 (N=68) and 43% of the lesions were functionally significant. Binary logistic-regression analysis revealed that preintervention % diameter stenosis of the SB (odds ratio=1.05; 95% CI, 1.01 to 1.09) and the MB minimum lumen diameter located distal to the SB ostium (odds ratio=3.86; 95% CI, 1.03 to 14.43) were independent predictors of functionally significant SB jailing. In patients with > or =75% stenosis and Thrombolysis In Myocardial Infarction grade 3 flow in the SB, no difference in post-stent angiographic and intravascular ultrasound parameters was found between SB lesions with and without functional significance.Both plaque shift from the MB and carina shift contribute to the creation/aggravation of an SB ostial lesion after MB stent implantation. Anatomic evaluation does not reliably predict the functional significance of a jailed SB stenosis.

    View details for DOI 10.1161/CIRCINTERVENTIONS.109.887406

    View details for Web of Science ID 000276873400005

    View details for PubMedID 20407111

  • Endovascular detection and removal of radiographic contrast. Cardiovascular revascularization medicine : including molecular interventions Hassan, A. H., Luna, J., Davidson, C. J., Fitzgerald, P. J. 2010; 11 (2): 114-115

    View details for DOI 10.1016/j.carrev.2009.03.003

    View details for PubMedID 20347803

  • Sirolimus-eluting stent implantation in small coronary arteries: A three dimensional intravascular ultrasound study from the SIRIUS trial INTERNATIONAL JOURNAL OF CARDIOLOGY Kaneda, H., Ako, J., Terashima, M., Morino, Y., Honda, Y., Yock, P. G., Leon, M. B., Moses, J. W., Fitzgerald, P. J. 2010; 138 (2): 126-130

    Abstract

    To assess the efficacy of the sirolimus-eluting stent when implanted in smaller caliber vessels using three-dimensional intravascular ultrasound (IVUS) analysis.One hundred and twenty-three patients (69 sirolimus-coated Bx Velocity and 54 control) who underwent successful three-dimensional IVUS at follow up comprised this IVUS substudy from the SIRIUS (SIRolImUS-coated Bx Velocity stent in the treatment of patients with de novo coronary artery lesions) population. To evaluate the impact of vessel size, 2 groups were created using QCA reference vessel diameter (RVD; large vessel group: RVD>/=2.75 mm and small vessel group: RVD<2.75 mm).Sirolimus-eluting stents significantly reduced neointimal hyperplasia by the same relative magnitude within the stent in small vessels as well as in large vessels. Although sirolimus-eluting stents had favorable effects on lumen area at stent edges in larger vessels, the effect was less in smaller vessels, especially at the proximal edge. IVUS-detected adverse vessel response, such as late-acquired incomplete apposition, did not increase in smaller vessels even with relatively higher dose exposure.Sirolimus-eluting stents showed inhibition of neointimal hyperplasia in small vessels compared to bare metal stents with no increase of vascular complications.

    View details for DOI 10.1016/j.ijcard.2008.08.006

    View details for Web of Science ID 000273613300004

    View details for PubMedID 18804877

  • Stent Expansion as a Mechanical Parameter to Predict Late Stent Patency Back to the Basics JACC-CARDIOVASCULAR INTERVENTIONS Honda, Y., Fitzgerald, P. J. 2009; 2 (12): 1276-1278

    View details for DOI 10.1016/j.jcin.2009.10.013

    View details for Web of Science ID 000275914400015

    View details for PubMedID 20129556

  • Preprocedural Inflammation Does Not Affect Neointimal Hyperplasia following Everolimus-Eluting Stent Implantation JOURNAL OF INVASIVE CARDIOLOGY Nakatani, D., Ako, J., Yamasaki, M., Shimohama, T., Hasegawa, T., Otake, H., Waseda, K., Tsujino, I., Sakurai, R., Koo, B., Chang, H., Yock, P. G., Sudhir, K., Pierson, W., Stone, G. W., Saito, S., Honda, Y., Fitzgerald, P. J. 2009; 21 (12): 613-617

    Abstract

    Preprocedual C-reactive protein (CRP) has been reported to correlate with in-stent restenosis following bare-metal stent implantation. The aim of this study was to investigate the impact of preprocedural inflammation on neointimal hyperplasia assessed by intravascular ultrasound (IVUS) following everolimus-eluting stent (EES) implantation.We identified 134 patients meeting the following criteria: 1) patients treated with EES; 2) those with stable or unstable angina; and 3) patients available for high-sensitivity (hs)-CRP before the procedure and volumetric IVUS analysis at follow up. We divided the patients into two groups on the basis of hs-CRP levels (< 3 or > or = 3 mg/L) before the procedure and compared IVUS parameters. Volume index (volume/length) was calculated for vessel (VVI), plaque (PVI), neointima (NIV), stent (SVI), and lumen (LVI). Percent neointimal volume (%NIV) was calculated as (NIV/SVI) x 100. Cross-sectional narrowing (CSN) was defined as neointimal area divided by stent area (%).There was no significant difference in VVI, PVI, or LVI at either baseline or 8-month follow up between the two groups. At 8-month follow up, there was also no significant difference in %NIV (4.93 +/- 5.66% vs. 4.98 +/- 5.25% p = 0.959) and maximum %CSN (16.81 +/- 13.62% vs. 18.14 +/- 13.91%; p = 0.608) as well as VVI, PVI, and LVI between the two groups. Furthermore, hs-CRP did not correlate with %NIV (r = 0.044; p = 0.610) and maximum %CSN (r = 0.086, p = 0.321) at follow up. There was no significant difference in incidence of late-acquired incomplete stent apposition between the two groups (1.2% vs. 0%; p = 0.512).Our results suggest that preprocedural inflammation does not affect neointimal hyperplasia following EES implantation.

    View details for Web of Science ID 000284807300002

    View details for PubMedID 19966361

  • Late-acquired incomplete stent apposition: morphologic characterization. Cardiovascular revascularization medicine : including molecular interventions Hur, S., Ako, J., Honda, Y., Sudhir, K., Fitzgerald, P. J. 2009; 10 (4): 236-246

    Abstract

    Incomplete stent apposition (ISA) is a lack of contact between stents and the underlying vessel wall, best described by intravascular ultrasound (IVUS). Late acquired incomplete apposition, defined as complete stent apposition at the time of procedure but ISA at follow-up, is an unusual IVUS finding reported in intracoronary brachytherapy, bare-metal stent (BMS), and drug-eluting stent (DES) implantation. Late-acquired ISA is observed relatively more frequently with DES implantation compared with BMS implantation. Possible mechanisms of this phenomenon include focal/extensive vascular remodeling and dissolution of thrombus. While there are conflicting reports regarding the possible impact of this IVUS finding on clinical outcomes, recent reports of DES have suggested its possible association with late adverse cardiac events including late stent thrombosis. In this paper, we review the incidence, location, underlying pathology, and possible clinical sequelae of late-acquired ISA, primarily focusing on that of DES.

    View details for DOI 10.1016/j.carrev.2009.02.002

    View details for PubMedID 19815171

  • Intravascular Ultrasound Results From the ENDEAVOR IV Trial Randomized Comparison Between Zotarolimus- and Paclitaxel-Eluting Stents in Patients With Coronary Artery Disease JACC-CARDIOVASCULAR INTERVENTIONS Waseda, K., Miyazawa, A., Ako, J., Hasegawa, T., Tsujino, I., Sakurai, R., Yock, P. G., Honda, Y., Kandzari, D. E., Leon, M. B., Fitzgerald, P. J. 2009; 2 (8): 779-784

    Abstract

    The aim of this study was to compare the vessel response between zotarolimus-eluting stents (ZES) and paclitaxel-eluting stents (PES) using intravascular ultrasound.The ENDEAVOR IV (Randomized Comparison of Zotarolimus- and Paclitaxel-Eluting Stents in Patients With Coronary Artery Disease) trial was a randomized controlled study of zotarolimus-eluting, phosphorylcholine-coated, cobalt-alloy stents for the treatment of de novo coronary lesions compared with using PES for the same treatment.Data were obtained from patients with serial (baseline and 8-months follow-up) intravascular ultrasound analysis available (n = 198). Volumetric analysis was performed for vessel, lumen, plaque, stent, and neointima. Cross-sectional narrowing (given as percentage) was defined as neointimal area divided by stent area. Neointima-free frame ratio was calculated as the number of frames without intravascular ultrasound-detectable neointima divided by the total number of frames within the stent. Subsegment analysis was performed at every matched 1-mm subsegment throughout the stent.At follow-up, the ZES group showed significantly greater percentage of neointimal obstruction (16.6 +/- 12.0% vs. 9.9 +/- 8.9%, p < 0.01) and maximum cross-sectional narrowing (31.8 +/- 16.1% vs. 25.2 +/- 14.9%, p < 0.01) with smaller minimum lumen area than the PES group did. However, the incidence of maximum cross-sectional narrowing >50% was similar in the 2 groups. Neointima-free frame ratio was significantly lower in the ZES group. In overall analysis, whereas the PES group showed positive remodeling during follow-up (13.7 +/- 4.2 mm(3)/mm to 14.3 +/- 4.3 mm(3)/mm), the ZES group showed no significant difference (12.7 +/- 3.6 mm(3)/mm to 12.9 +/- 3.5 mm(3)/mm). In subsegment analysis, significant focal positive vessel remodeling was observed in 5% of ZES and 25% of PES cases (p < 0.05).There were different global and focal vessel responses for ZES and PES. Both drug-eluting stents showed a similar incidence of lesions with severe narrowing despite ZES having a moderate increase in neointimal hyperplasia compared with neointimal hyperplasia in PES. There was a relatively lower neointima-free frame ratio in ZES, suggesting a greater extent of neointimal coverage. (The ENDEAVOR IV Clinical Trial: A Trial of a Coronary Stent System in Coronary Artery Lesions; NCT00217269).

    View details for DOI 10.1016/j.jcin.2009.05.015

    View details for Web of Science ID 000278971500011

    View details for PubMedID 19695548

  • A Novel Technique for Endovascular Detection and Removal of Radiographic Contrast during Angiography JOURNAL OF INVASIVE CARDIOLOGY Chang, H., Hassan, A. H., Kim, Y. L., Lloyd, L. J., Koo, B., Ako, J., Honda, Y., Davidson, C. J., Fitzgerald, P. J. 2009; 21 (7): 314-318

    Abstract

    This study aims at in-vitro validation of the principles of endovascular detection of contrast medium and assessing the feasibility of in-vivo detection and removal of contrast during angiography.Contrast-induced nephropathy is a growing concern in current percutaneous interventions with increasing lesion complexity and patient comorbidity. To address this clinical problem, a novel method of endovascular detection and automatic removal of contrast has been developed, and is comprised of a catheter-based system with a reflectance-type optical sensor.Blood samples were obtained from ovine subjects to characterize the optical response of blood by measuring the reflectance spectrum at varying levels of hematocrit diluted by a contrast agent. The results from the in-vitro test were implemented into an in-vivo system. An aspiration catheter equipped with a fiberoptic sensor was inserted into the coronary sinus (CS) of 5 canines. Contrast was administered through the coronary artery and reflectance signals were recorded at the CS. The removal rate was analyzed through 20 specimen collections.A proportional relationship was found between hematocrit and reflectance intensity in in-vitro test. Upon in-vivo detection of contrast, the sensor signal showed a 79.5 +/- 9.9% (n = 33) drop from the pre-injection baseline. This was highly reproducible and beyond the noise level of baseline, (2.5 +/- 0.9%), enabling automatic activation of the aspiration system. The signal duration was 12.2 +/- 3.7 seconds. The removal rate of contrast was 59.3 +/- 11%.The present study validated the principles of endovascular contrast detection and demonstrated the feasibility of an in-vivo, catheter-based removal of contrast using reflectance technology.

    View details for Web of Science ID 000284806800005

    View details for PubMedID 19571339

  • Distribution pattern of neointimal hyperplasia following sirolimus-eluting stent implantation assessed by 3-dimensional intravascular ultrasound INTERNATIONAL JOURNAL OF CARDIOLOGY Kaneda, H., Ako, J., Terashima, M., Waseda, K., Yock, P. G., Fitzgerald, P. J. 2009; 135 (2): 243-245

    Abstract

    Sirolimus-eluting stents (SES) have been shown to reduce intimal hyperplasia (IH) within the stent. Although angiographic studies have suggested focal distribution of IH, these data are limited by its spatial resolution and the minimal amount of IH. Therefore, the exact distribution pattern of SES IH remains unclear. Ninety-six SIRIUS trial patients who underwent SES (51) or bare metal stent (45) implantation and three-dimensional IVUS at 8 months follow-up were enrolled. Neointimal area (stent-lumen area) was obtained at every 0.5-mm interval throughout the stented segment. The length of each stent with IVUS-detectable neointima was determined and divided by the stented length in each case to normalize the data. Even with IVUS, IH was detectable in very limited SES stented segments (median 8% of total stented length) compared to the diffuse nature of IH within BMS with only 5 stented lesions having segments free from IH. In 25% (13 of 51) of patients, no IH was detectable within whole SES stented segments. In conclusion, SES has reduced not only the total amount of IH, but also limited the distribution. These data suggest that local conditions (heterogeneity of biological responses of particular plaques, pharmacokinetics, or their combination) may play a role in IH following SES implantation.

    View details for DOI 10.1016/j.ijcard.2008.01.054

    View details for Web of Science ID 000266884600020

    View details for PubMedID 18571251

  • Intraoperative Fluorescence Imaging System for On-Site Assessment of Off-Pump Coronary Artery Bypass Graft JACC-CARDIOVASCULAR IMAGING Waseda, K., Ako, J., Hasegawa, T., Shimada, Y., Ikeno, F., Ishikawa, T., Demura, Y., Hatada, K., Yock, P. G., Honda, Y., Fitzgerald, P. J., Takahashi, M. 2009; 2 (5): 604-612

    Abstract

    The aim of this study was to evaluate the intraoperative fluorescence imaging (IFI) system in the real-time assessment of graft patency during off-pump coronary artery bypass graft.Intraoperative fluorescence imaging is an intraoperative angiography-like imaging modality using fluorescent indocyanine green excited with laser light. Recently, assessment of graft patency using the IFI system was introduced into clinical use. The feasibility and efficacy of IFI technology in off-pump coronary artery bypass graft has not been systematically compared with other conventional diagnostic modalities.Patients undergoing off-pump coronary artery bypass graft received IFI analysis, intraoperative transit time flowmetry, and postoperative X-ray angiography. In off-line IFI analysis, the graft washout was classified based on the number of heartbeats required for indocyanine green washout: fast washout (15 beats).A total of 507 grafts in 137 patients received IFI analysis. Of all the IFI analyses, 379 (75%) grafts were visualized clearly up to the distal anastomosis. With regard to anastomosis location, anterior location was associated with a higher percentage of fully analyzable images (90%). More than 80% of images were analyzable, irrespective of graft type. Six grafts with acceptable transit time flowmetry results were diagnosed with graft failure by IFI, which required on-site graft revision. All revised grafts' patency was confirmed by post-operative X-ray angiography. Conversely, 21 grafts with unsatisfactory transit time flowmetry results demonstrated acceptable patency with IFI. Graft revision was considered unnecessary in these grafts, and 20 grafts (95%) were patent by post-operative X-ray angiography. Compared with slow washout, fast washout was associated with a higher preoperative ejection fraction, use of internal mammary artery grafts, and anterior anastomosis location.The IFI system enables on-site assessment of graft patency, providing both morphologic and functional information. This technique may help reduce procedure-related, early graft failures in off-pump bypass patients.

    View details for DOI 10.1016/j.jcmg.2008.12.028

    View details for Web of Science ID 000287653200013

    View details for PubMedID 19442948

  • Whole blood reflectance for assessment of hematologic condition and detection of angiographic contrast media APPLIED OPTICS Chang, H., Kim, Y. L., Hassan, A., Fitzgerald, P. J. 2009; 48 (13): 2435-2443

    Abstract

    We present simple whole blood reflectance analyses in the range 500-900 nm, using intact whole blood to simultaneously quantify hematocrit and oxygen saturation from a single spectral reading. We applied these results for the development of an intravascular catheter-based reflectance sensing system to detect and remove contrast media injected during angiography so as to reduce the risk of complications associated with the injected contrast media. We further tested the practicality of the optical detection of angiographic contrast media in a pilot animal study in vivo. We successfully demonstrated the feasibility of real-time in vivo contrast detection and removal during angiography. Our simple method for the detection and removal of angiographic contrast media will facilitate the development of intravascular optical sensing systems.

    View details for Web of Science ID 000266260000004

    View details for PubMedID 19412200

  • A Randomized Controlled Trial of Angiography Versus Intravascular Ultrasound-Directed Bare-Metal Coronary Stent Placement (The AVID Trial) CIRCULATION-CARDIOVASCULAR INTERVENTIONS Russo, R. J., Silva, P. D., Teirstein, P. S., Attubato, M. J., Davidson, C. J., DeFranco, A. C., Fitzgerald, P. J., Goldberg, S. L., Hermiller, J. B., Leon, M. B., Ling, F. S., Lucisano, J. E., Schatz, R. A., Wong, S. C., Weissman, N. J., Zientek, D. M. 2009; 2 (2): 113-U56

    Abstract

    AVID (Angiography Versus Intravascular ultrasound-Directed stent placement) is a multicenter, randomized controlled trial designed to assess the effect of intravascular ultrasound (IVUS)-directed stent placement on the 12-month rate of target lesion revascularization (TLR).After elective coronary stent placement and an optimal angiographic result (<10% stenosis), 800 patients were randomized to Angiography- or IVUS-directed therapy. Blinded IVUS was performed in the Angiography group without further therapy. In the IVUS group, IVUS criteria for optimal stent placement (<10% area stenosis, apposition, and absence of dissection) were applied. Final minimum stent area was 6.90+/-2.43 mm(2) in the Angiography group and 7.55+/-2.82 mm(2) in the IVUS group (P=0.001). In the IVUS group, only 37% with inadequate expansion (<90%) received further therapy. The 12-month TLR rate was 12.0% in the Angiography group and 8.1% in the IVUS group (P=0.08, 95% confidence level [CI], [-8.3% to 0.5%]). When vessels with a distal reference diameter <2.5 mm by core laboratory angiography measurement were excluded from analysis, the 12-month TLR rate was 10.1% in the Angiography group and 4.3% in the IVUS group (P=0.01, 95% CI, [-10.6% to -1.2%]). With a pre-stent angiographic stenosis of > or =70%, the TLR rate was lower in the IVUS group compared with the Angiography group (3.1% versus 14.2%; P=0.002; 95% CI, [-18.4% to -4.2%]).IVUS-directed bare-metal stent placement results in larger acute stent dimensions without an increase in complications and a significantly lower 12-month TLR rate for vessels > or =2.5 mm by angiography and for vessels with high-grade pre-stent stenosis. However, for the entire sample analyzed on an intention-to-treat basis, IVUS-directed bare-metal stent placement does not significantly reduce the 12-month TLR rate when compared with stent placement guided by angiography alone. In addition, IVUS evaluation of adequate stent expansion is underutilized by experienced operators.

    View details for DOI 10.1161/CIRCINTERVENTIONS.108.778647

    View details for Web of Science ID 000276051600006

    View details for PubMedID 20031704

  • Analysis of Left Main Coronary Artery Bifurcation Lesions Treated With Biolimus-Eluting DEVAX AXXESS Plus Nitinol Self-Expanding Stent: Intravascular Ultrasound Results of the AXXENT Trial CATHETERIZATION AND CARDIOVASCULAR INTERVENTIONS Hasegawa, T., Ako, J., Koo, B., Miyazawa, A., Sakurai, R., Chang, H., Dens, J., Verheye, S., Grube, E., Honda, Y., Fitzgerald, P. J. 2009; 73 (1): 34-41

    Abstract

    To assess the efficacy of the AXXESS stent on the treatment of left main coronary artery (LMCA) bifurcation lesions using IVUS.The treatment of LMCA bifurcation lesions remains challenging even with the use of drug-eluting stents. The AXXESS system is a biolimus A9-eluting self-expanding stent, dedicated to the treatment of bifurcation lesions.Data were obtained from the AXXENT trial, a prospective, single-arm, multicenter study designed to evaluate the efficacy of the AXXESS stent on the treatment of LMCA bifurcation lesions. IVUS was available in 26 cases at 6-months follow-up. Volumetric and cross-sectional analyses within the AXXESS stent, and cross-sectional analyses at the ostia of left anterior descending (LAD) and left circumflex coronary arteries (LCX) were performed.Within the AXXESS stent, percent neointimal volume obstruction was (3.0 +/- 4.1)% with a minimal lumen area of 10.3 +/- 2.6 mm(2). AXXESS stent volume showed an 12.4% increase at follow-up compared with postprocedure (P = 0.04). Lumen area was significantly smaller in the LCX ostium compared with the LAD ostium at follow-up (3.6 +/- 1.3 mm(2) vs. 5.5 +/- 2.0 mm(2), P = 0.0112). There was greater neointimal formation in the LCX ostium compared with the LAD ostium (1.37 +/- 1.20 mm(2) vs. 0.30 +/- 0.36 mm(2), P = 0.0003).The AXXESS stent in the LMCA showed enlargement through 6-months follow-up and significant neointimal suppression. Greater neointimal formation and relatively inadequate stent expansion may contribute to luminal narrowing in the LCX ostium.

    View details for DOI 10.1002/ccd.21765

    View details for Web of Science ID 000262119700006

    View details for PubMedID 19089934

  • Intravascular Ultrasound Analysis of Small-Vessel Lesions Treated with Novel Ultra-Low Profile, Guidewire-Based Self-Expanding Stent System JOURNAL OF INVASIVE CARDIOLOGY Koo, B., Yamasaki, M., Ako, J., Waseda, K., Honda, Y., Fitzgerald, P. J., Abizaid, A., Whitbourn, R. J. 2008; 20 (12): 647-650

    Abstract

    This study was performed to evaluate the long-term vascular response of the first series of patients treated by a novel ultra-low profile, guidewire-based self-expanding stent system (Sparrow stent) using serial intravascular ultrasound (IVUS).The long-term vascular response and stent geometry change after self-expanding stent implantation are not known.The CARE 1 trial was a single-arm feasibility study of the Sparrow stent in patients with small-vessel disease. Twenty patients were included in this prospective IVUS study, and serial volumetric IVUS analysis was performed after stent implantation and at 6- and 12-months follow up.Serial volumetric IVUS analysis was available in 13 cases between post-procedure and 6- month follow up and in 6 cases between 6- and 12-month follow up. At 6-month follow up, % neointimal volume was 34 +/- 9%. Stent volume index was increased by 13% , negating part of the luminal loss due to neointimal hyperplasia. There was no correlation between % neointimal volume index and % change in stent volume index (p = 0.7). No additional change occurred in any IVUS parameter between 6 and 12 months after stent implantation.In this small feasibility study, the use of a novel guidewire-based self-expanding stent was associated with the same degree of neointimal response as that seen with conventional bare-metal stents. Through serial analyses, the IVUS parameters of both the stent and the vessel remained unchanged beyond 6 months after stent implantation.

    View details for Web of Science ID 000207739500007

    View details for PubMedID 19057028

  • Serial angiographic and intravascular ultrasound analysis of late stent strut fracture of sirolimus-eluting stents in native coronary arteries INTERNATIONAL JOURNAL OF CARDIOLOGY Yamada, K. P., Koizumi, T., Yamaguchi, H., Kaneda, H., Bonneau, H. N., Honda, Y., Fitzgerald, P. J. 2008; 130 (2): 255-259

    Abstract

    Stent fracture in sirolimus-eluting stents (SES) has been reported to be associated with late adverse events. However, a suitable method to diagnose stent fracture is not fully elucidated.One hundred and two consecutive SES implantations were performed in 83 lesions in 56 patients and underwent serial angiography with intravascular ultrasound (IVUS) at baseline and at 6 months follow-up. Angiographic stent strut fracture was defined as stent bending with separation of stent struts. Angiographic hinge movement was defined as stent shaft deviation without separation of stent struts. IVUS stent strut dissociation was defined as the disappearance of stent struts in more than one cross-sectional image which were previously visualized at baseline.By angiography, no cases of stent fracture were detected at 6 months. One case of angiographic hinge movement was found at 12 months. However, three instances of stent fracture were detected by IVUS at 6 months. One case of stent fracture showed a patent lumen area at 6 months but subsequently developed late stent restenosis at 12 months. The other two cases were associated with in-stent restenosis at 6 months.Compared to angiography, IVUS can more reliably detect stent fracture during follow-up evaluation.

    View details for DOI 10.1016/j.ijcard.2007.08.082

    View details for Web of Science ID 000260757600021

    View details for PubMedID 18096257

  • Evaluation of vessel response to percutaneous coronary intervention REVISTA ESPANOLA DE CARDIOLOGIA Fitzgerald, P. J., Otake, H. 2008; 61 (10): 1001-1006

    View details for Web of Science ID 000259574100001

    View details for PubMedID 18817674

  • Two-Year Intravascular Ultrasound Observations in Diabetic Patients Treated with Single and Double Dose Sirolimus-Eluting Stents: Results of the Double Dose Diabetes (3D) Study JOURNAL OF INVASIVE CARDIOLOGY Hur, S., Ako, J., Shimada, Y., Tsujino, I., Hassan, A. H., Abizaid, A., Shiran, A., Lewis, B. S., Guagliumi, G., Cohen, S. A., Honda, Y., Fitzgerald, P. J., Eduardo Sousa, J. 2008; 20 (8): 411-416

    Abstract

    Diabetes has been reported as an independent predictor of restenosis after drug-eluting stent implantation. The purpose of this study was to assess the long-term impact of increased drug dose in sirolimus-eluting stents (SES) on neointimal hyperplasia (NIH) in diabetic patients using volumetric intravascular ultrasound analysis.The 3D trial is a multicenter, prospective, randomized, feasibility study of double-dose (280 microg/cm2) or conventional single-dose (140 microg/cm2) SES for the treatment of de novo coronary lesions in diabetic patients. To evaluate long-term efficacy, complete serial volumetric analyses (baseline, 6-month and 2-year follow up) were performed in 39 diabetic patients (17 single-dose, 22 double-dose). Each volume was divided by stent length to acquire volume index, expressed as mm3/mm. Percent neointimal volume was calculated as (neointimal volume/stent volume) x 100 at follow up.Volumetric analysis showed similar results over time between the 2 stent groups (p = NS for all). At 2-year follow up, minimal increases in NIH area and percent NIH were observed in both groups, which translated into a decrease in lumen volume index compared to baseline (p < 0.05 for all). No late-acquired incomplete stent apposition was observed in either group.The current single dose of sirolimus in SES is effective in inhibiting NIH in diabetic patients up to 2 years. In this patient subset, double-dose SES did not confer additional NIH suppression at 2-year follow up compared to conventional single-dose SES.

    View details for Web of Science ID 000207739100009

    View details for PubMedID 18688066

  • Thoracoscopic ligation versus coil occlusion for patent ductus arteriosus: A matched cohort study of outcomes and cost SURGICAL ENDOSCOPY AND OTHER INTERVENTIONAL TECHNIQUES Dutta, S., Mihailovic, A., Benson, L., Kantor, P. F., Fitzgerald, P. G., Walton, J. M., Langer, J. C., Cameron, B. H. 2008; 22 (7): 1643-1648

    Abstract

    Coil occlusion (CO) and video-assisted thoracoscopic surgery (VATS) have both emerged as minimal access therapies for patent ductus arteriosus (PDA). These techniques have not previously been statistically compared.Twenty-four consecutive children undergoing VATS for PDA were each retrospectively matched by PDA diameter and child weight to two children undergoing CO (total 48) during the same time period. The two modalities were compared with respect to outcome and cost. Statistical analysis was performed using a Student's t-test and Mantel-Haenszel relative risk. Cost analysis from an institutional perspective was used to compare resource consumption.Mean PDA diameter was 3.6 +/- 1.2 mm in both groups. Mean age and weight for VATS and CO children were 2.7 and 2.9 yrs and 13.2 and 13.1 kg, respectively. Mean surgical times were 94 +/- 34 min for VATS and 50 +/- 23 min for CO (p < 0.0001). Mean length of stay was 1.6 +/- 0.2 days for VATS and 0.6 +/- 0.2 days for CO (Mantel-Haenszel RR (95% CI) = 0.15 [0.07, 0.29], p < 0.0001). Mean fluoroscopy time with CO was 13 +/- 7 min. No VATS or CO children required conversion to open surgical ligation. Two children in each arm (8% VATS, 4% CO) required indefinite antibiotic endarteritis prophylaxis for a persistent shunt. The cost per child was C$ 4282.80 (Canadian dollars) for VATS and C$ 3958.08 for CO.VATS is as efficacious for PDA closure as CO but requires longer surgical times and lengths of stay. Costs for each procedure are similar.

    View details for DOI 10.1007/s00464-007-9674-1

    View details for Web of Science ID 000256530000019

    View details for PubMedID 18027029

  • Novel guidewire-based stent-delivery system: Examination by intravascular ultrasound CATHETERIZATION AND CARDIOVASCULAR INTERVENTIONS Yamasaki, M., Ako, J., Honda, Y., Hassan, A., Koo, B., Abizaid, A., Fitzgerald, P., Whitbourn, R. 2008; 72 (1): 47-51

    Abstract

    This report describes the first-in-man experience with a novel 0.014-in. guidewire-based, self-expanding stent delivery system designed for small or tortuous coronary arteries that may be difficult to access with conventional stent-delivery systems.

    View details for DOI 10.1002/ccd.21562

    View details for Web of Science ID 000257306300010

    View details for PubMedID 18412249

  • Frontiers in intravascular Imaging technologies CIRCULATION Honda, Y., Fitzgerald, P. J. 2008; 117 (15): 2024-2037
  • Effect of lumen narrowing within sirolimus-eluting stents on proximal and distal vessel segments CIRCULATION JOURNAL Waseda, K., Ako, J., Kaneda, H., Miyazawa, A., Shimada, Y., Morino, Y., Honda, Y., Fitzgerald, P. J. 2008; 72 (4): 534-537

    Abstract

    Flow dynamics and shear stress may influence downstream vessel segments. The aim of this study was to investigate the potential impact of lumen narrowing within sirolimus-eluting stents (SES) on vessel response at adjacent reference sites.In 135 patients after SES implantation, minimal lumen area (MLA) within the stent and average lumen area at distal or proximal adjacent reference segments (5 mm) were obtained at baseline and follow up. In the smaller in-stent MLA group (MLA <3 mm(2)), lumen area decreased significantly at the distal reference compared with the larger in-stent MLA group (MLA >or=3 mm(2)), although no significant difference was seen at the proximal reference.In-stent lumen patency may influence vascular responses at adjacent reference segments after SES implantation.

    View details for Web of Science ID 000254468800005

    View details for PubMedID 18362421

  • In Vivo Comparison Between Optical Coherence Tomography and Intravascular Ultrasound for Detecting Small Degrees of In-Stent Neointima After Stent Implantation JACC-CARDIOVASCULAR INTERVENTIONS Suzuki, Y., Ikeno, F., Koizumi, T., Tio, F., Yeung, A. C., Yock, P. G., Fitzgerald, P. J., Fearon, W. F. 2008; 1 (2): 168-173

    Abstract

    The purpose of this study was to evaluate optical coherence tomography (OCT) for detecting small degrees of in-stent neointima (ISN) after stent implantation compared with intravascular ultrasound (IVUS).The importance of detecting neointimal coverage of stent struts has grown with the appreciation of the increased risk for late stent thrombosis after drug-eluting stent (DES) implantation. Intravascular ultrasound, the current standard for evaluating the status of DES, lacks the resolution to detect the initial neointimal coverage. Optical coherence tomography has greater resolution but has not yet been compared with IVUS in vivo with histological correlation for validation.Intravascular ultrasound and OCT were performed with motorized pullback imaging in 6 pigs across 33 stents, 1 month after implantation. Each pig was euthanized, and histological measurements of vessel, stent, and lumen dimensions were performed in 3 sections of each stent. A small degree of ISN was defined as occupying <30% of the stent area measured with histology. The IVUS, OCT, and histological assessment of ISN were compared in matched cross-sections of the stents with a small degree of ISN.Eleven stents had a small degree of ISN (average ISN area: 1.26 +/- 0.46 mm(2), and percent area obstruction: 21.4 +/- 5.2%). Compared with histology, the diagnostic accuracy of OCT (area under the receiver operating characteristic curve [AUC] = 0.967, 95% confidence interval [CI] 0.914 to 1.019) was higher than that of IVUS (AUC = 0.781, 95% CI 0.621 to 0.838).Optical coherence tomography detects smaller degrees of ISN more accurately than IVUS and might be a useful method for identifying neointimal coverage of stent struts after DES implantation.

    View details for DOI 10.1016/j.jcin.2007.12.007

    View details for Web of Science ID 000207586100011

    View details for PubMedID 19463295

  • Coronary risk factors and coronary atheroma burden at severely narrowing segments INTERNATIONAL JOURNAL OF CARDIOLOGY Kaneda, H., Kataoka, T., Ako, J., Honda, Y., Yock, P. G., Fitzgerald, P. J. 2008; 124 (1): 124-126

    Abstract

    While only few data exist correlating cardiovascular risk factors with volumetric measurements of coronary atheroma burden in patients with coronary artery disease, a recent report using intravascular ultrasound (IVUS) demonstrated independent predictors of atherosclerotic burden in a native coronary artery with relatively mild narrowing (20-50% diameter stenosis by visual estimation). The purpose of this study was to examine whether cardiovascular risk factors can predict atherosclerotic burden at severely narrowing segments (>50% diameter stenosis).Patients who met the criteria (high-quality, automated pull-back IVUS images of severely narrowing segments prior to intervention) were identified from the IVUS database of the Cardiovascular Core Analysis Laboratory at Stanford University. Using commercially available planimetry software, lumen and vessel inside external elastic membrane areas were manually traced at every 0.5-mm interval in diseased segments. Using Simpson's method, vessel, lumen, and plaque (vessel minus lumen) volumes were calculated, and average area was calculated as volume data divided by length. Percent plaque volume was computed as plaque volume divided by vessel volume. Multiple linear regression analysis with backward selection was used to determine the risk factors for atherosclerotic burden.For percent plaque volume, diabetes or hypertension were predictors of more severe disease. For average plaque area, male gender or diabetes were predictors of more severe disease. These variables were also independent predictors in multivariate regression models.Male gender, hypertension, and diabetes are also strong independent predictors of atherosclerotic burden in coronary disease patients, though analyzed segments and disease severity were different.

    View details for DOI 10.1016/j.ijcard.2006.11.194

    View details for Web of Science ID 000253546900022

    View details for PubMedID 17350700

  • Predictive value of the index of microcirculatory resistance in patients with ST-segment elevation myocardial infarction JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY Fearon, W. F., Shah, M., Ng, M., Brinton, T., Wilson, A., Trernmel, J. A., Schnittger, I., Lee, D. P., Vagelos, R. H., Fitzgerald, P. J., Yock, P. G., Yeung, A. C. 2008; 51 (5): 560-565

    Abstract

    The objective of this study is to evaluate the predictive value of the index of microcirculatory resistance (IMR) in patients undergoing primary percutaneous coronary intervention (PCI) for ST-segment elevation myocardial infarction (STEMI).Despite adequate epicardial artery reperfusion, a number of patients with STEMI have a poor prognosis because of microvascular damage. Assessing the status of the microvasculature in this setting remains challenging.In 29 patients after primary PCI for STEMI, IMR was measured with a pressure sensor/thermistor-tipped guidewire. The Thrombolysis In Myocardial Infarction (TIMI) myocardial perfusion grade, TIMI frame count, coronary flow reserve, and ST-segment resolution were also recorded.The IMR correlated significantly with the peak creatinine kinase (CK) (R = 0.61, p = 0.0005) while the other measures of microvascular dysfunction did not. In patients with an IMR greater than the median value of 32 U, the peak CK was significantly higher compared with those having values 32 U compared with

    View details for DOI 10.1016/j.jacc.2007.08.062

    View details for Web of Science ID 000252908600007

    View details for PubMedID 18237685

  • Intraoperative assessment of coronary grafts with fluorescent angiography. Heart Waseda, K., Fitzgerald, P. J., Takahashi, M. 2008; 94 (1): 64-?

    View details for PubMedID 18083950

  • Comparison of vascular response to zotarolimus-eluting stent versus sirolimus-eluting stent: Intravascular ultrasound results from ENDEAVOR III AMERICAN HEART JOURNAL Miyazawa, A., Ako, J., Hongo, Y., Hur, S., Tsujino, I., Courtney, B. K., Hassan, A. H., Kandzari, D. E., Honda, Y., Fitzgerald, P. J. 2008; 155 (1): 108-113

    Abstract

    The purpose of this study was to investigate the vascular response of zotarolimus-eluting stent (ZES) and sirolimus-eluting stent (SES) using serial intravascular ultrasound (IVUS).Data were obtained from the Endeavor Drug-Eluting Coronary Stent System Versus the Center Siromlimus-Eluting Coronary Stent System in De Novo Native Coronary Artery Lesions (ENDEAVOR) III trial, a randomized study comparing ZES and SES for the treatment of de novo native coronary artery lesions. Serial (baseline and 8-month follow-up) IVUS was available in 258 patients (190 ZES, 68 SES).At 8 months, ZES had greater percentage of neointimal volume index (ZES 1.1 +/- 0.8 mm3/mm vs SES 0.2 +/- 0.1 mm3/mm, P < .01), resulting in smaller lumen volume index (6.0 +/- 2.0 mm3/mm vs 7.0 +/- 2.1 mm3/mm, P < .05). Zotarolimus-eluting stents showed larger IVUS-detectable neointimal coverage over stent surface (50.2% vs 10.5%, P < .01) and greater mean neointimal thickness (0.19 +/- 0.07 mm vs 0.10 +/- 0.06 mm, P < .01). Zotarolimus-eluting stents had a significantly lower incidence of late-acquired incomplete stent apposition.Zotarolimus-eluting stent is associated with a significantly greater amount of neointimal hyperplasia compared with SES. This amount of hyperplasia in ZES is distributed throughout the stent at 8-month follow-up.

    View details for DOI 10.1016/j.ahj.2007.08.008

    View details for Web of Science ID 000251732400017

    View details for PubMedID 18082499

  • Characterization of late incomplete stent apposition: a comparison among bare-metal stents, intracoronary radiation and sirolimus-eluting stents. journal of invasive cardiology Miyazawa, A., Tsujino, I., Ako, J., Shimada, Y., Courtney, B. K., Sakurai, R., Nakamura, M., Okura, H., Waseda, K., Honda, Y., Fitzgerald, P. J. 2007; 19 (12): 515-518

    Abstract

    Late incomplete stent apposition (LISA) develops following implantation of conventional bare-metal stents (BMS) or drug-eluting stents, or after adjunctive intracoronary radiation (IR). However, no study has systematically compared the morphology of LISA seen with various treatment modalities.To compare the morphometric features of LISA accompanying BMS, IR or sirolimus-eluting stents (SES) using serial intravascular ultrasound (IVUS).A query of Stanford University's IVUS database of the Cardiovascular Core Analysis Laboratory was performed to identify LISA cases. Dedicated software programs were used for volumetric IVUS analyses.In 30 LISA cases (12 BMS, 6 IR and 12 SES), there was no intertreatment difference in the degree of LISA (lumen area minus stent area at follow up). Serial analyses of LISA segments showed that vessel area of SES and IR showed significant increase at follow up as compared with post procedure, while there was no significant change in plaque area. In contrast, the BMS group showed no increase in vessel area, whereas plaque area revealed significant reduction. Eight of 12 BMS cases were treated by directional atherectomy before stenting; however, there was no difference in the area change between patients with or without pre-stent atherectomy. Post-procedure plaque thickness beneath the stent struts of LISA was thinner for SES as compared with BMS.Plaque reduction primarily contributes to LISA after BMS, whereas vessel expansion is the predominant factor in LISA development for IR and SES. Thus, the mechanism of LISA may vary among different interventional treatments.

    View details for PubMedID 18180522

  • Analysis of bifurcation lesions treated with novel drug-eluting dedicated bifurcation stent system: Intravascular ultrasound results of the AXXESS PLUS trial CATHETERIZATION AND CARDIOVASCULAR INTERVENTIONS Miyazawa, A., Ako, J., Hassan, A., Hasegawa, T., Abizaid, A., Verheye, S., McClean, D., Neumann, F. J., Grube, E., Honda, Y., Fitzgerald, P. J. 2007; 70 (7): 952-957

    Abstract

    The aim of this intravascular ultrasound (IVUS) study was to assess the efficacy of the AXXESS Plus stent system for the treatment of bifurcation coronary lesions.The AXXESS Plus is a novel bifurcation drug-eluting stent, comprised of a self-expanding flare-shaped stent platform and bioabsorbable polymer coating that releases Biolimus A9.Data were obtained from the AXXESS PLUS trial, a prospective, multicenter, nonrandomized, single-arm study to evaluate safety and efficacy. Six-month follow-up IVUS analysis was available in 49 cases. Volumetric analysis using Simpson's method within the AXXESS stent, and cross-sectional analysis at the ostium of main branch and/or side branch was performed. Impact of bifurcation angle on stent expansion at the carina was also evaluated. Results: Within the AXXESS stent, neointimal volume obstruction percentage was 2.3% +/- 2.2%, with a minimum lumen area of 7.9 +/- 2.6 mm(2). Lumen area was 5.2 +/- 1.7 mm(2) at main branch ostium, and 4.0 +/- 1.5 mm(2) at side branch ostium. In two cases, incomplete stent apposition was observed at the proximal edge of the AXXESS stent. In one case, a gap between the AXXESS stent and an additional stent was observed. Greater bifurcation angle inversely correlated with smaller stent area at side branch ostium (r = -0.54, P = 0.03) but not at main branch ostium (r = -0.2, P = 0.29).This novel self-expanding, drug-eluting bifurcation stent demonstrated effective lesion coverage along with significant neointimal suppression equivalent to current generation balloon-expandable drug-eluting stent technology.

    View details for DOI 10.1002/ccd.21269

    View details for Web of Science ID 000251442900009

    View details for PubMedID 18044777

  • Determinants of lumen loss between years 1 and 2 after cardiac transplantation TRANSPLANTATION Sakurai, R., Yamasaki, M., Nakamura, M., Hirohata, A., Honda, Y., Bonneau, H. N., Luikart, H., Yock, P. G., Fitzgerald, P. J., Yeung, A. C., Valantine, H. A., Fearon, W. F. 2007; 84 (9): 1097-1102

    Abstract

    We previously reported that negative remodeling, not plaque progression, correlated with lumen loss during the first year after cardiac transplantation and that cytomegalovirus antibody seropositivity correlated with increased negative remodeling and greater lumen loss. Whether these findings persist between years 1 and 2 after transplantation is unknown.Serial 3-dimensional intravascular ultrasound analysis in the left anterior descending coronary artery was performed in 30 cardiac transplant recipients at year 1 and 2 after transplantation. Vessel, lumen, and plaque area were determined at 0.5-mm axial intervals in the first 50 mm of the left anterior descending coronary artery, and volumes were computed using Simpson's method. Univariate and multivariate regression analyses were performed to identify clinical predictors of change in coronary dimensions.Although mean vessel area did not change (13.6+/-3.4 to 13.4+/-3.3 mm/mm(3), P=0.45), mean plaque area increased (3.4+/-2.3 to 3.8+/-2.2 mm/mm(3), P=0.012), resulting in significant mean lumen area loss (10.3+/-2.5 to 9.6+/-2.3 mm/mm(3), P=0.016). However, the degree of luminal change strongly correlated with the degree of change in vessel size (R=0.81, P<0.0001), but not with change in plaque amount (R=-0.19, P=0.32). In fact, in 57% of the patients who demonstrated lumen loss, negative remodeling contributed more to lumen loss than did plaque progression. Diabetes at 2 years was the only significant independent clinical predictor of plaque progression and lumen loss.Despite significant plaque progression, negative remodeling correlated with coronary lumen loss between years 1 and 2 after cardiac transplantation.

    View details for DOI 10.1097/01.tp.0000285987.27033.65

    View details for Web of Science ID 000251030600006

    View details for PubMedID 17998863

  • Intravascular ultrasound findings in ENDEAVOR II and ENDEAVOR III AMERICAN JOURNAL OF CARDIOLOGY Sakurai, R., Bonneau, H. N., Honda, Y., Fitzgerald, P. J. 2007; 100 (8B): 71M-76M

    Abstract

    The results of 2 randomized controlled trials of the Endeavor zotarolimus-eluting stent (ZES; Medtronic Vascular, Santa Rosa, CA) were recently reported: ENDEAVOR II, in which the Endeavor stent was compared with the Driver bare metal stent (BMS; Medtronic Vascular), and ENDEAVOR III, in which the Endeavor stent was compared with the first-generation Cypher sirolimus-eluting stent (SES; Cordis Corporation, Miami Lakes, FL). To examine in detail the vascular responses to the Endeavor stent, serial intravascular ultrasound (IVUS) analyses were performed in subsets of patients in the 2 trials at baseline and 8-month follow-up. The investigators report results for various IVUS parameters and compare those with published results for the first-generation SES and paclitaxel-eluting stent (PES). The ZES demonstrated significantly improved effectiveness and equivalent safety compared with the BMS in ENDEAVOR II. Although the ZES seems to be slightly less effective at inhibiting intimal hyperplasia than the SES and PES, early results are indicative of an acceptable safety profile. This finding may be due in part to the relatively complete and uniform neointimal coverage associated with the ZES.

    View details for DOI 10.1016/j.amjcard.2007.08.025

    View details for Web of Science ID 000250759000010

    View details for PubMedID 17950835

  • Design criteria for the ideal drug-eluting Stent AMERICAN JOURNAL OF CARDIOLOGY Ako, J., Bonneau, H. N., Honda, Y., Fitzgerald, P. J. 2007; 100 (8B): 3M-9M

    Abstract

    The deployment of drug-eluting stents (DESs) is an integral treatment option for patients with coronary artery disease. Although the development and testing of the first-generation DESs focused to a considerable degree on efficacy parameters, including restenosis, recent concerns over late clinical events have prompted a refinement of the design criteria for succeeding generations of these devices. This review assesses design criteria for the ideal DES from 3 complementary perspectives: deliverability, efficacy, and safety. Most new investigational balloon-expandable DES systems have lowered crossing profiles by thinning stent struts using a cobalt chromium alloy, while investigational self-expanding DESs often use nitinol as the platform material. Stents designed to be fully biodegradable are also being developed, with deliverability and performance to be determined in future clinical trials. Refinements in bifurcation-dedicated stents will secure branch accessibility to offer better deliverability in complex lesion morphologies. Experimentation in stent design is already realizing multiple-lesion stenting and the in situ customization of stent length. Rather than simply targeting further reductions in restenosis rates, efforts to improve efficacy are shifting toward a lesion-specific approach, including the design of stents dedicated to bifurcation lesions. Another future direction is a disease-specific approach, or an approach using DESs as local drug-delivery devices. The identification of long-term safety issues with the first-generation DESs has reignited clinical interest in the development of stents that are more biologically based, including fully biodegradable stents and stents using biomimetic and biodegradable polymers. Important performance criteria for future DES agents include more cell-type specificity, broader safety margins, and greater facility at promoting endothelialization and healing.

    View details for DOI 10.1016/j.amjcard.2007.08.016

    View details for Web of Science ID 000250759000002

    View details for PubMedID 17950830

  • Detailed intravascular ultrasound analysis of Zotarolimus-eluting phosphorylcholine-coated cobalt-chromium alloy stent in de Novo Coronary lesions (results from the ENDEAVOR II trial) AMERICAN JOURNAL OF CARDIOLOGY Sakurai, R., Hongo, Y., Yamasaki, M., Honda, Y., Bonneau, H. N., Yock, P. G., Cutlip, D., Popma, J. J., Zimetbaum, P., Fajadet, J., Kuntz, R. E., Wijns, W., Fitzgerald, P. J. 2007; 100 (5): 818-823

    Abstract

    Zotarolimus-eluting phosphorylcholine-coated cobalt-chromium alloy Driver stents (ZES) demonstrated significant reductions in target lesion revascularization rate with few apparent adverse events compared with bare metal stents (BMS; uncoated Driver stents) in a prospective, multicenter, double-blind, randomized controlled trial in de novo coronary lesions. The aim of this study was to examine detailed vascular responses to ZES compared with BMS using serial intravascular ultrasound analysis. A total of 343 patients (ZES n = 178, BMS n = 165) were enrolled in this formal, prespecified intravascular ultrasound substudy of the Randomized Controlled Trial to Evaluate the Safety and Efficacy of the Medtronic AVE Zotarolimus-Eluting Driver Coronary Stent in de Novo Native Coronary Artery Lesions (ENDEAVOR II), a prospective, multicenter, double-blind, randomized controlled trial to compare ZES and BMS in de novo native coronary artery lesions. Quantitative and qualitative intravascular ultrasound analyses were performed postprocedurally and at 8-month follow-up in stented and reference segments. ZES showed significantly less neointima, with a larger lumen than BMS at 8 months (percentage neointimal volume 17.6 +/- 10.1% vs 29.4 +/- 17.2%, p <0.0001; maximum percentage neointimal area 32.9 +/- 13.0% vs 47.6 +/- 18.6%, p <0.0001; minimum luminal area 4.9 +/- 1.6 vs 4.0 +/- 1.7 mm(2), p <0.0001) and no unfavorable edge effect. In the 18-mm single stents, ZES showed evenly inhibited neointima compared with BMS. Neither persistent stent-edge dissection nor late-acquired incomplete stent apposition was observed in either group. In conclusion, ZES showed evenly inhibited neointima with no apparent adverse vascular response in stented and reference segments at 8 months compared with BMS.

    View details for DOI 10.1016/j.amjcard.2007.04.016

    View details for Web of Science ID 000249226100013

    View details for PubMedID 17719326

  • Neointimal progression and luminal narrowing in sirolimus-eluting stent treatment for bare metal in-stent restenosis: A quantitative intravascular ultrasound analysis AMERICAN HEART JOURNAL Sakurai, R., Ako, J., Hassan, A. H., Bonneau, H. N., Neumann, F., Desmet, W., Holmes, D. R., Yock, P. G., Fitzgerald, P. J., Honda, Y. 2007; 154 (2): 361-365

    Abstract

    Recurrent restenosis may occur after drug-eluting stent implantation for in-stent restenosis (ISR) of bare metal stents (BMSs), especially in areas involving drug-eluting stent gaps.To investigate the details of neointimal progression and luminal narrowing after the treatment of ISR using sirolimus-eluting stents (SESs), serial intravascular ultrasound analysis was performed in 65 patients with ISR at postintervention and at 6-month follow-up. The total stented segment was categorized into 3 compartments: new SES (N), new SES and old BMS overlap (N/O), and old BMS (O). In each of the 190 compartments, serial intravascular ultrasound parameters were analyzed at the cross section of the maximum change in neointimal area (delta neointimal area) from postintervention to follow-up or the minimum lumen area at follow-up if delta neointimal area was 0. Minimum lumen area in each compartment was also investigated serially.At postintervention, lumen area was the smallest in compartment N/O (N 5.8 +/- 1.5, N/O 5.1 +/- 1.3, O 6.0 +/- 1.4 mm2, P = .005). Not only the average of maximum delta neointimal area (N 0.2 +/- 0.4, N/O 0.2 +/- 0.4, O 0.8 +/- 1.0 mm2, P < .0001) but also the frequency of minimum lumen area decreasing from > or = 4.0 mm2 at postintervention to < 4.0 mm2 at follow-up (N 4.0%, N/O 5.1%, O 23.5%, P = .012) was the largest in compartment O.Neointimal progression and consequent luminal narrowing tend to occur where BMS is uncovered with SES in treatment of ISR, even in the absence of an obvious stenosis at postintervention.

    View details for DOI 10.1016/j.ahj.2007.04.023

    View details for Web of Science ID 000248511000025

    View details for PubMedID 17643589

  • The risks and benefits of drug-eluting stents. The American heart hospital journal Shimohama, T., Honda, Y., Fitzgerald, P. J. 2007; 5 (3): 146-150

    View details for PubMedID 17673855

  • Comparison of nonuniform strut distribution between two drug-eluting stent platforms. journal of invasive cardiology Hasegawa, T., Ako, J., Ikeno, F., Waseda, K., Suzuki, Y., Honda, Y., Fitzgerald, P. J. 2007; 19 (6): 244-246

    Abstract

    To compare the difference of strut distribution between two clinically available drug-eluting stent platforms (Bx Velocity and Express II stents) using intravascular ultrasound (IVUS).Nonuniform strut distribution (NSD) has been shown to be associated with increased intimal hyperplasia after drug-eluting stent implantation.IVUS imaging was performed on Bx Velocity (n = 6) and Express II stents (n = 6) after inflation pressures of 10, 16, and 26 atm in a bench test model. Percent NSD was defined as the length of segments with NSD (interstrut angle > 90 degrees) divided by stent length. NSD was also assessed in postprocedure IVUS images in 53 clinical cases (32 Cypher, 21 Taxus) using 3-dimensional IVUS analysis.Frequency of NSD segment and %NSD were lower in Bx Velocity stents than in Express II stents at the inflation pressures of 16 and 26 atm (%NSD: 16 atm, 0% vs. 13.8 +/- 9.4%; p < 0.005; 26 atm, 1.1 +/- 2.6% vs. 19.9 +/- 6.9% p < 0.0001). In postprocedural images from clinical cases, the frequency of NSD segment and %NSD were lower in Cypher stents than in Taxus stents (%NSD: 0.5 +/- 1.6 vs. 6.8 +/- 7.2; p < 0.0001).NSD segment was observed less in Bx Velocity stents than in Express II stents.

    View details for PubMedID 17541122

  • Changes in coronary anatomy and physiology after heart transplantation AMERICAN JOURNAL OF CARDIOLOGY Hirohata, A., Nakamura, M., Waseda, K., Honda, Y., Lee, D. P., Vagelos, R. H., Hunt, S. A., Valantine, H. A., Yock, P. G., Fitzgerald, P. J., Yeung, A. C., Fearon, W. F. 2007; 99 (11): 1603-1607

    Abstract

    Cardiac allograft vasculopathy (CAV) is a progressive process involving the epicardial and microvascular coronary systems. The timing of the development of abnormalities in these 2 compartments and the correlation between changes in physiology and anatomy are undefined. The invasive evaluation of coronary artery anatomy and physiology with intravascular ultrasound, fractional flow reserve, coronary flow reserve, and the index of microcirculatory resistance (IMR) was performed in the left anterior descending coronary artery during 151 angiographic evaluations of asymptomatic heart transplant recipients from 0 to >5 years after heart transplantation (HT). There was no angiographic evidence of significant CAV, but during the first year after HT, fractional flow reserve decreased significantly (0.89 +/- 0.06 vs 0.85 +/- 0.07, p = 0.001), and percentage plaque volume derived by intravascular ultrasound increased significantly (15.6 +/- 7.7% to 22.5 +/- 12.3%, p = 0.0002), resulting in a significant inverse correlation between epicardial physiology and anatomy (r = -0.58, p <0.0001). The IMR was lower in these patients compared with those > or =2 years after HT (24.1 +/- 14.3 vs 29.4 +/- 18.8 units, p = 0.05), suggesting later spread of CAV to the microvasculature. As the IMR increased, fractional flow reserve increased (0.86 +/- 0.06 to 0.90 +/- 0.06, p = 0.0035 comparing recipients with IMRs < or =20 to those with IMRs > or =40), despite no difference in percentage plaque volume (21.0 +/- 11.2% vs 20.5 +/- 10.5%, p = NS). In conclusion, early after HT, anatomic and physiologic evidence of epicardial CAV was found. Later after HT, the physiologic effect of epicardial CAV may be less, because of increased microvascular dysfunction.

    View details for DOI 10.1016/j.amjcard.2007.01.039

    View details for Web of Science ID 000247121700024

    View details for PubMedID 17531589

  • Serial intravascular ultrasonic study of outcomes of coronary culprit lesions with plaque rupture following bare metal stent implantation in patients with angina pectoris AMERICAN JOURNAL OF CARDIOLOGY Hur, S., Hassan, A. H., Rekhi, R., Ako, J., Shimada, Y., Nakamura, M., Yamasaki, M., Bonneau, H. N., Sudhir, K., Yock, P. G., Honda, Y., Fitzgerald, P. J. 2007; 99 (10): 1394-1398

    Abstract

    Coronary culprit lesions with plaque rupture (PR) have been treated with different coronary interventions. However, it is unknown whether the presence of PR affects the restenotic process after coronary intervention. One hundred forty-two patients undergoing coronary bare metal stent implantation were enrolled in the present retrospective analysis. Case selection was based on availability of intravascular ultrasound (IVUS) and quantitative coronary angiographic examinations at baseline (before and after intervention) and at follow-up. Serial comparative analyses included qualitative and quantitative features of the culprit lesion and reference segments. PR was defined as an intraplaque cavity in communication with the lumen in the presence of a residual, disrupted cap. Patients were categorized according to the presence/absence of PR. Pre-interventional IVUS detected PR in 54 patients (38%). Baseline patient demographics were similar between the +PR and -PR groups. Quantitative IVUS analysis showed higher rates of positive remodeling and larger vessel and plaque areas in the +PR compared with -PR lesions (p <0.001 for all). At follow-up (7.2 +/- 2.6 months), no statistically significant difference was observed between the 2 groups in quantitative coronary angiographic or IVUS measurements. In conclusion, culprit lesions with PR exhibited larger plaque mass and higher rates of positive remodeling at preintervention IVUS examination. However, when treated with bare metal stents, the absence/presence of preintervention PR was not found to affect the rate or severity of in-stent restenosis in these culprit lesions.

    View details for DOI 10.1016/j.amjcard.2006.12.067

    View details for Web of Science ID 000246715900010

    View details for PubMedID 17493467

  • Drug delivery via nano-, micro and macroporous coronary stent surfaces EXPERT OPINION ON DRUG DELIVERY Tsujino, I., Ako, J., Honda, Y., Fitzgerald, P. J. 2007; 4 (3): 287-295

    Abstract

    Drug-eluting stents (DESs) have revolutionized the treatment of occlusive coronary artery disease via marked reduction of in-stent restenosis. One critical feature for successful DESs is the sustained release of drugs, which is achieved using a polymer coating in the present generation of DESs. However, recent studies have raised a concern that polymers may trigger allergic reactions and/or prolonged inflammation in some patients. These untoward reactions may eventually lead to undesirable clinical events, including stent thrombosis and sudden cardiac death. A new drug delivery technology, using a porous stent surface, may offer desirable drug elution properties without the use of polymers, and may translate into an improved safety profile for the next-generation DESs.

    View details for DOI 10.1517/17425247.4.3.287

    View details for Web of Science ID 000252856900008

    View details for PubMedID 17489655

  • Comparison of vessel response following sirolimus-eluting stent implantation as assessed by serial 3-D intravascular ultrasound study. journal of invasive cardiology Waseda, K., Ako, J., Shimada, Y., Morino, Y., Tsujino, I., Hongo, Y., Sudhir, K., Yock, P. G., Fitzgerald, P. J., Honda, Y. 2007; 19 (4): 171-173

    Abstract

    Recent sirolimus-eluting stent (SES) studies have suggested higher rates of restenosis in non-left anterior descending (LAD) artery lesions. The aim of this study was to evaluate differential vessel response (LAD versus non-LAD) to SES implantation using serial intravascular ultrasound (IVUS). A total of 94 patients who underwent SES implantation and serial (post-PCI and 8 months) 3-dimensional IVUS were enrolled from our database. Volumetric analysis was performed throughout the stent as well as the adjacent reference segment (up to 5 mm). Volume index (volume/length) was calculated for vessel (VVI), lumen (LVI), and plaque (PVI). Cross-sectional narrowing (CSN) was defined as neointimal area divided by stent area (%). With respect to the in-stent segment, VVI, PVI, and LVI at post-PCI were not significantly different between the LAD (n = 41) and non-LAD (n = 53) lesions. At follow up, however, maximum CSN was significantly greater in the non-LAD lesions (18.3 +/- 15.2% versus 12.2 +/- 10.0%; p = 0.029). At the proximal reference segment, the non-LAD lesions showed a significantly greater LVI decrease than the LAD lesions (p <0.05), primarily due to mild vessel shrinkage observed in the non-LAD lesions. There were no significant differences at the distal reference segment between the LAD and non-LAD lesions. This detailed IVUS analysis suggests that there are minimal differences in the vessel responses following SES implantation. These findings may have potential implications for mechanical and pharmacokinetic properties of next-generation drug-eluting stent technology.

    View details for PubMedID 17404402

  • Impact of gender on neointimal hyperplasia following coronary artery stenting AMERICAN JOURNAL OF CARDIOLOGY Kaneda, H., Ako, J., Kataoka, T., Takahashi, T., Terashima, M., Waseda, K., Miyazawa, A., Hassan, A. H., Honda, Y., Yock, P. G., Fitzgerald, P. J. 2007; 99 (4): 491-493

    Abstract

    Whether gender affects long-term outcomes after bare metal stent implantation remains controversial. The aim of this study was to examine the impact of gender on neointimal hyperplasia in a large cohort of patients after stent implantation using 3-dimensional intravascular ultrasound. Lumen and stent areas were manually traced at 0.5-mm intervals throughout the stented segment. Using Simpson's method, lumen, stent, and neointimal (stent - lumen) volumes were calculated and standardized by stent length. Women were older, presented more often with hyperlipidemia or hypertension, and had smaller reference vessel diameter and mean stent area, compared with men. Although neointimal hyperplasia and neointimal thickness in women were similar to that in men, the percentage of neointimal hyperplasia (neointimal area divided by stent area) was higher in women due to the smaller stent area. After adjusting for stent area, the percentage of neointimal hyperplasia did not differ by gender. In conclusion, the results of this study indicate that neointimal hyperplasia after bare metal stent implantation in women is similar to that seen in men. Despite the similarity in outcome, there are several gender-specific differences in baseline characteristics.

    View details for DOI 10.1016/j.amjcard.2006.09.094

    View details for Web of Science ID 000244514500014

    View details for PubMedID 17293191

  • Comparison of the efficacy of direct coronary stenting with sirolimus-eluting stents versus stenting with predilation by intravascular ultrasound imaging (from the DIRECT trial) AMERICAN JOURNAL OF CARDIOLOGY Hirohata, A., Morino, Y., Ako, J., Sakurai, R., Buchbinder, M., Caputo, R. P., Karas, S. P., Mishkel, G. J., Mooney, M. R., O'Shaughnessy, C. D., Raizner, A. E., Wilensky, R. L., Williams, D. O., Wong, S., Yock, P. G., Honda, Y., Moses, J. W., Fitzgerald, P. J. 2006; 98 (11): 1464-1467

    Abstract

    A direct coronary stenting technique using drug-eluting stents may decrease drug-eluting stent efficacy due to possible damage to the surface coating of the stent. The DIRECT is a multicenter, prospective, nonrandomized trial designed to evaluate the direct stenting strategy for the sirolimus-eluting Bx-Velocity stent compared with the historical control (SIRIUS trial, stenting with predilation). Volumetric and cross-sectional intravascular ultrasound analyses at 8-month follow-up were performed in 115 patients (DIRECT n= 64, control n = 51). Patient and lesion characteristics were comparable between groups. The DIRECT group achieved an equivalent uniform expansion index, defined as minimum stent area/maximum stent area x 100, compared with the control group (65.9 +/- 11.7 vs 63.1 +/- 12.7, p = NS). At 8-month follow-up, vessel, stent, lumen, and neointimal volume index (volume in cubic millimeters/length in millimeters) and percent neointimal volume were similar between the DIRECT and control groups (vessel volume index 13.9 +/- 4.40 vs 15.0 +/- 3.83; stent volume index 6.83 +/- 2.02 vs 6.94 +/- 2.04; lumen volume index 6.71 +/- 2.04 vs 6.81 +/- 2.07; neointimal volume index 0.14 +/- 0.24 vs 0.16 +/- 0.23; percent neointimal volume 3.73 +/- 6.97 vs 3.14 +/- 5.32, p = NS for all). In addition, in-stent neointimal hyperplasia distribution was significantly smaller near the distal stent edge (0.22 vs 0.098 mm(3)/mm, p = 0.01 for an average neointimal volume index within 3 mm from the distal stent edge). In conclusion, direct coronary stenting with the sirolimus-eluting Bx-Velocity stent is equally effective in terms of uniform stent expansion and long-term quantitative intravascular ultrasound results compared with conventional stenting using predilation. This strategy appears to be associated with less neointimal hyperplasia near the distal stent edge.

    View details for DOI 10.1016/j.amjcard.2006.06.046

    View details for Web of Science ID 000242595300010

    View details for PubMedID 17126651

  • Predictors of recurrent in-stent restenosis after beta-radiation: An analysis from the START 40/20 trial. Journal of interventional cardiology Kaneda, H., Honda, Y., Morino, Y., Lansky, A. J., Yock, P. G., Bonan, R., Fitzgerald, P. J. 2006; 19 (5): 376-380

    Abstract

    The purpose of this study was to identify potential predictors, including clinical, procedural, angiographic, and intravascular ultrasound (IVUS) parameters, for recurrent in-stent restenosis (ISR) following beta-radiation 90Strontium/Yttrium (90Sr/Y) in a large multicenter trial.Although adjunct brachytherapy reduces recurrent ISR after primary catheter-based intervention, recurrence of stenosis after brachytherapy still occurs.We analyzed 185 IVUS cohort patients in the STent And Restenosis Therapy (START) 40/20 trial where a 40-mm, 90Sr/Y, radioactive source train was exclusively used for treatment of ISR to be treatable with a 20-mm balloon.Thirty-nine patients underwent target lesion revascularization. Preliminary univariate analysis showed that age, smoking, balloon/artery ratio, geographic miss, minimum lumen diameter, and diameter stenosis at baseline were associated with target lesion revascularization, while none of IVUS variables were (minimum lumen area, minimum stent area, or residual plaque burden). The multivariate logistic regression analysis showed that younger age, lower balloon/artery ratio, and presence of geographic miss were independent predictors of target lesion revascularization.Even with adjunct beta-radiation therapy, initial mechanical optimization, such as appropriate balloon sizing and positioning, may be critical for the prevention of recurrent ISR.

    View details for PubMedID 17020560

  • Axial plaque redistribution after coronary stent deployment. journal of invasive cardiology Hirohata, A., Honda, Y., Fitzgerald, P. 2006; 18 (8): E225-6

    Abstract

    We report a case of axial plaque redistribution after coronary stent deployment assessed by intravascular ultrasound (IVUS) as well as coronary angiography. A 72-year-old male with a history of hypertension, hyperlipidemia and a nuclear stress test demonstrating anterior and lateral ischemia was admitted for cardiac catheterization. Coronary angiography and IVUS examination revealed eccentric stenoses in the left anterior descending artery (LAD) and the left circumflex artery (LCx), just before the bifurcation of the first obtuse marginal branch. After successful LAD stent placement, the LCx was also stented, jailing the obtuse marginal branch. Immediately after dilatation, however, the coronary angiogram showed a new significant stenosis at the distal adjacent segment. IVUS examination after administration of nitroglycerin revealed a secondary critical lesion that was not observed before the interventional procedure. A significant plaque increase at the new lesion site presumably resulted from axial plaque redistribution (extrusion from the stented segment, otherwise known as plaque shift). After additional stenting, the patient had an uneventful course.

    View details for PubMedID 16877793

  • Intravascular ultrasonic analysis of atherosclerotic vessel remodeling and plaque distribution of stenotic left anterior descending coronary arterial bifurcation lesions upstream and downstream of the side branch AMERICAN JOURNAL OF CARDIOLOGY Shimada, Y., Courtney, B. K., Nakamura, M., Hongo, Y., Sonoda, S., Hassan, A. H., Yock, P. G., Honda, Y., Fitzgerald, P. J. 2006; 98 (2): 193-196

    Abstract

    Bifurcation lesions remain a challenging lesion subset, even in the era of drug-eluting stents. The aim of this study was to investigate the longitudinal remodeling pattern and cross-sectional plaque location of bifurcation lesions. Seventy-four preintervention intravascular ultrasound studies of left anterior descending bifurcation lesions were analyzed, in which the lesion was located proximal (type A, n=32) or distal (type B, n=42) to the side branch. Vessel area and plaque area at the lesion (VAlesion and PAlesion) and at the reference site (VAreference and PAreference) were measured. The remodeling ratio was defined as VAlesion/VAreference, and the vessel compensation ratio was defined as (VAlesion-VAreference)/(PAlesion-PAreference). The geometric center of the lumen at the lesion site was identified, and the lesion site was divided into circumferential equal arcs to compare the cross-sectional distribution of percentage plaque area (100x[PAlesion/VAlesion]) between the 2 groups. The remodeling ratio (1.03+/-0.15 vs 0.94+/-0.14, p=0.01) and the vessel compensation ratio (0.0+/-0.36 vs -0.37+/-0.61, p<0.01) were significantly greater in type A than in type B lesions. The circumferential distribution pattern of percentage plaque area was significantly different between the groups (analysis of variance p<0.005), with greater percentage plaque area for the vessel wall opposite from the side branch in type B lesions (46.3+/-18.0% vs 54.6+/-15.4%, type A vs type B lesions, p<0.05). In conclusion, these results suggest that a major side branch may affect longitudinal lesion remodeling as well as the circumferential location of atherosclerotic plaque.

    View details for DOI 10.1016/j.amjcard.2006.01.073

    View details for Web of Science ID 000239185300011

    View details for PubMedID 16828591

  • Safety of beta radiation exposure to the non-target segment: an intravascular ultrasound dosimetric analysis. journal of invasive cardiology Kaneda, H., Honda, Y., Morino, Y., Fox, T., Crocker, I., Lansky, A. J., Yock, P. G., Bonan, R., Fitzgerald, P. J. 2006; 18 (7): 309-312

    Abstract

    The use of longer radioactive seed trains to avoid geographic miss may lead to greater radiation exposure to distal vasculature due to the natural tapering of coronary arteries. The aim of this study was to use IVUS-based dosimetric analysis to evaluate the effect of beta-radiation on angiographically normal, noninjured distal segments.We analyzed 17 in-stent restenosis cases (stent length: 20 +/- 8 mm) treated with a 40 mm 90Sr/Y source train. The prescribed dose was 18.4 Gy (reference less than or equal to 3.3 mm) or 23 Gy (reference > 3.3 mm) at 2 mm from the source. Noninjured, but fully radiated, distal reference sites were determined by angiography. Based upon the three-dimensional vessel contours obtained at baseline, the minimum dose delivered to 90% of plaque volume (Dv90) was determined. Vessel, plaque and lumen volumes and Dv90 were computed in every 2 mm subsegment (n = 52).On average, no significant serial change was observed in plaque area (5.0 +/- 2.5 mm3/mm post-treatment to 5.6 +/- 3.1 mm3/mm at 8-month follow up; p = 0.09), vessel area (10.2 +/- 3.7 to 10.3 +/- 4.0 mm3/mm; p = 0.84), or lumen area (5.2 +/- 2.0 to 4.7 +/- 1.8 mm3/mm; p = 0.19). Subsegment analysis, however, revealed a wide range of dose distribution, with a significant positive correlation between Dv90 and plaque increase (p = 0.008), as well as vessel change (p < 0.001), representing dose-dependent positive vessel remodeling following beta radiation. Consequently, no significant relationship was observed between Dv90 and lumen change.Detailed IVUS-based dosimetric analysis demonstrated that beta radiation promoted positive remodeling, preventing lumen loss despite a mild increase in plaque mass on angiographically normal, noninjured distal segments.

    View details for PubMedID 16816435

  • Discordant changes in epicardial and microvascular coronary physiology after cardiac transplantation: Physiologic investigation for transplant arteriopathy II (PITA II) study JOURNAL OF HEART AND LUNG TRANSPLANTATION Fearon, W. F., Hirohata, A., Nakamura, M., Luikart, H., Lee, D. P., Vagelos, R. H., Hunt, S. A., Valantine, H. A., Fitzgerald, P. J., Yock, P. G., Yeung, A. C. 2006; 25 (7): 765-771

    Abstract

    Investigating changes in coronary physiology that occur after cardiac transplantation has been challenging. Simultaneous and independent assessment of the epicardial artery by measuring fractional flow reserve (FFR) and of the microvasculature by calculating the index of microvascular resistance (IMR) with a single coronary pressure wire may be useful.Twenty-five asymptomatic patients with normal coronary angiograms underwent FFR, thermodilution-derived IMR and coronary flow reserve (CFR) and intravascular ultrasound (IVUS) evaluation soon after cardiac transplantation and 1 year later.FFR significantly worsened (0.90 +/- 0.05 at baseline to 0.85 +/- 0.06 at 1 year, p = 0.004). FFR correlated strongly with percent plaque volume as measured by IVUS (r = -0.58, p < 0.0001). IMR improved significantly (29.2 +/- 15.9 at baseline to 19.3 +/- 7.6 units at 1 year, p = 0.007). CFR increased, but not significantly (2.6 +/- 1.4 at baseline to 3.2 +/- 1.2 at 1 year, p = not significant). Diabetes and donor heart ischemic time independently predicted baseline IMR. Treatment with rapamycin independently predicted FFR at 1 year.New coronary physiologic measures, FFR and IMR, show that epicardial artery physiology worsens and correlates with anatomic changes, whereas microvascular physiology improves during the first year after cardiac transplantation. CFR, the traditional method for evaluating coronary circulatory physiology, did not identify these changes.

    View details for DOI 10.1016/j.healun.2006.03.003

    View details for Web of Science ID 000239019700003

    View details for PubMedID 16818118

  • Influence of plaque calcium on neointimal hyperplasia following bare metal and drug-eluting stent implantation CATHETERIZATION AND CARDIOVASCULAR INTERVENTIONS Shimada, Y., Kataoka, T., Courtney, B. K., Morino, Y., Bonneau, H. N., Yock, P. G., Grube, E., Honda, Y., Fitzgerald, P. J. 2006; 67 (6): 866-869

    Abstract

    To examine the influence of vessel wall calcium on neointimal hyperplasia (NIH) following bare metal stent (BMS) and drug-eluting stent (DES) implantation.While procedural complications with coronary stenting in calcified lesions are well reported, little is known about subsequent NIH on plaque calcium following either BMS or DES implantation.In the Study to COmpare REstenosis Rate between QueST and QuaDDS-QP2 (SCORE) trial, 6 months follow-up volumetric intravascular ultrasound data were available for 41 lesions (BMS, 19; DES, 22). NIH thicknesses on superficial, deep, and noncalcified plaque were calculated at every 0.5 mm intervals over the stented segment. Calcified and less-calcified cross-sections were defined as those containing arcs of plaque calcium > or = 90 degrees and < 90 degrees , respectively.In BMS, mean NIH thickness on both superficial (0.24 +/- 0.23 mm) and deep calcium (0.25 +/- 0.21 mm) was significantly smaller than that of noncalcified plaque (0.31 +/- 0.22 mm) (P < 0.0005). NIH area was significantly smaller in calcified cross-sections compared to less-calcified cross-sections (2.1 +/- 1.2 mm2 vs. 3.1 +/- 1.9 mm2, P < 0.0001). While in contrast, in DES, mean NIH thickness was similar, irrespective of the presence or location of calcium (0.03 +/- 0.05 mm vs. 0.03 +/- 0.06 mm vs. 0.03 +/- 0.05 mm, superficial vs. deep vs. noncalcified plaque, P = NS). NIH area was also similar between calcified and less-calcified cross-sections (0.3 +/- 0.6 mm2 vs. 0.3 +/- 0.6 mm2, P = NS).These results suggest that while plaque calcium may influence NIH following BMS implantation, NIH suppression using DES does not appear to be affected by the presence or location of calcium.

    View details for DOI 10.1002/ccd.20708

    View details for Web of Science ID 000238082300005

    View details for PubMedID 16649232

  • Novel stent system for bifurcation lesions: Examination by intravascular ultrasound CATHETERIZATION AND CARDIOVASCULAR INTERVENTIONS Miyazawa, A., Webster, M. W., Fitzgerald, P. J., Ormiston, J. A. 2006; 67 (6): 900-903

    Abstract

    Bifurcation disease represents a mechanical and biological challenge for definitive interventional treatment. This case report discusses an experience with a novel stent system designed for the treatment of bifurcation lesions.

    View details for DOI 10.1002/ccd.20719

    View details for Web of Science ID 000238082300010

    View details for PubMedID 16649244

  • Long-term histopathologic and IVUS evaluations of a novel coiled sheet stent in porcine carotid arteries CARDIOVASCULAR AND INTERVENTIONAL RADIOLOGY Kaneda, H., Ikeno, F., Lyons, J., Rezaee, M., Yeung, A. C., Fitzgerald, P. J. 2006; 29 (3): 413-419

    Abstract

    Carotid angioplasty with stent placement has been proposed as an alternative method for revascularization of carotid artery stenosis. A novel stent with a laser-cut, rolled sheet of Nitinol (EndoTex Interventional Systems, Inc., Cupertino, CA) has been developed to customize treatment of stenotic lesions in carotid arteries utilizing a single stent, designed to adapt to multiple diameters and to tapered or nontapered configurations. The purpose of this study is to evaluate the conformability and vascular response to a novel stent in a chronic porcine carotid model using serial three-dimensional intravascular ultrasound (IVUS) analysis as well as histological examination. Ten Yucatan pigs underwent stent implantation in both normal carotid arteries with adjunctive balloon angioplasty. Three-dimensional IVUS analysis was performed before stent implantation, after adjunctive balloon angioplasty, and at follow-up [1 month (n = 6), 3 months (n = 6), or 6 months (n = 8)]. Histological examination (injury score, percent plaque obstruction, and qualitative analysis) was also performed. All stents were successfully deployed and well apposed in different sized vessels (lumen area range: 19-30 mm(2)). Volumetric IVUS analysis showed no significant difference between the lumen areas before stent implantation and after adjunctive balloon angioplasty and no stent area change at each follow-up point compared to immediately postprocedure. Histological examination revealed minimal injury and neointimal hyperplasia at each follow-up point. In the chronic porcine carotid model, the novel stent system demonstrated good conformability, resulting in minimal vessel injury and neointimal formation.

    View details for DOI 10.1007/s00270-005-0137-6

    View details for Web of Science ID 000236751300014

    View details for PubMedID 16502176

  • Location of focal vasospasm provoked by ergonovine maleate within coronary arteries in patients with vasospastic angina pectoris AMERICAN JOURNAL OF CARDIOLOGY Koizumi, T., Yokoyama, M., Namikawa, S., Kuriyama, N., Nameki, M., Nakayama, T., Kaneda, H., Sudhir, K., Yock, P. G., Komiyama, N., Fitzgerald, P. J. 2006; 97 (9): 1322-1325

    Abstract

    This study examined whether coronary focal vasospasm occurs in a nonuniform distribution within the coronary tree and whether a longitudinal plaque distribution pattern is present in patients with vasospastic angina using 3-dimensional intravascular ultrasound analysis. Of 121 patients with clinically suspected angina without fixed stenosis in the coronary arteries, vasospasm was provoked in 82 patients with 92 lesions (42 focal, 50 diffuse) by intravenous ergonovine maleate injection. Most focal vasospasms occurred in the proximal third of the coronary arteries (proximal 28, mid 8, distal 6, p <0.01), corresponding to the historical high-risk zones for acute coronary occlusion. More plaque burden also existed in the proximal third of the coronary arteries in patients with focal vasospasm.

    View details for DOI 10.1016/j.amjcard.2005.11.073

    View details for Web of Science ID 000237483100012

    View details for PubMedID 16635604

  • Latent plaque rupture in a patient undergoing stenting for acute coronary syndrome and diffuse coronary disease: A case report and review of literature CATHETERIZATION AND CARDIOVASCULAR INTERVENTIONS Koizumi, T., Wilson, A. M., Clark, D. A., Fitzgerald, P. J. 2006; 67 (2): 241-245

    Abstract

    Secondary prevention of plaque rupture following percutaneous coronary intervention in patients with acute coronary syndrome is not well studied. This case report describes a 53-year-old man who experienced plaque rupture between two previously successfully implanted stents in the right coronary artery, as documented during the 3rd intervention using intravascular ultrasound.

    View details for DOI 10.1002/ccd.20596

    View details for Web of Science ID 000235145100011

    View details for PubMedID 16400671

  • Heterogeneity of neointimal distribution of in-stent restenosis in patients with diabetes mellitus AMERICAN JOURNAL OF CARDIOLOGY Kaneda, H., Ako, J., Kataoka, T., Takahashi, T., Terashima, M., Waseda, K., Miyazawa, A., Hassan, A., Honda, Y., Yock, P. G., Fitzgerald, P. J. 2006; 97 (3): 340-342

    Abstract

    Diabetes mellitus is an independent predictor of restenosis after percutaneous coronary intervention. The pattern of restenosis after bare metal stent implantation in diabetic patients was examined with 3-dimensional intravascular ultrasound analysis. Lumen and stent were manually traced at every 0.5-mm interval in stented segments. Using Simpson's method, stent, luminal, and neointimal (stent minus lumen) volumes were calculated and average area was calculated as volume data divided by length. To measure the cross-sectional and longitudinal severities of luminal encroachment by the neointima, percent neointimal area (neointimal area divided by stent area) and neointimal hyperplasia 50 (IH50) (defined as percent stent length with percent neointimal area >50%) were calculated. In 278 patients (68 with diabetes and 210 without diabetes), there was a significantly higher percentage of maximal percent neointimal area with significantly longer percent stent length that was severely encroached by the neointima in diabetic patients. Diabetic patients showed a more heterogenous pattern of the neointima after bare metal stenting, resulting in longer high-grade obstruction segments. This may have important implications for stent design and pharmacokinetic properties of next-generation drug-eluting technology for this complex patient subset.

    View details for DOI 10.1016/j.amjcard.2005.08.067

    View details for Web of Science ID 000235265400009

    View details for PubMedID 16442392

  • Selective renal arterial infusion of fenoldopam for the prevention of contrast-induced nephropathy. Journal of interventional cardiology Ng, M. K., Tremmel, J., Fitzgerald, P. J., Fearon, W. F. 2006; 19 (1): 75-79

    Abstract

    Contrast-induced nephropathy (CIN) remains an important complication of angiographic procedures, particularly among patients with significant renal impairment. To date, vasodilator therapies such as fenoldopam have failed to prevent CIN, possibly because significant hypotension as a result of systemic infusion has limited the ability to deliver adequate drug levels to the renal vasculature. We present a case of averted CIN after multivessel coronary intervention in a diabetic patient with severe renal insufficiency, potentially due to bilateral renal arterial infusion of fenoldopam. Our subsequent experience with intrarenal fenoldopam in nine additional procedures in eight other high risk patients resulted in one case of asymptomatic transient CIN. Further studies are warranted to evaluate the efficacy of intrarenal administration of vasodilator therapies such as fenoldopam for the prevention of CIN.

    View details for PubMedID 16483344

  • Acute and long-term outcomes of the novel side access (SLK-View (TM)) stent for bifurcation coronary lesions: A multicenter nonrandomized feasibility study CATHETERIZATION AND CARDIOVASCULAR INTERVENTIONS Ikeno, F., Kim, Y. H., Luna, J., Condado, J. A., Colombo, A., Grube, E., Fitzgerald, P. J., Park, S. J., Yeung, A. C. 2006; 67 (2): 198-206

    Abstract

    To evaluate technical feasibility and procedural safety of SLK-View stent for treating bifurcation lesions.Percutaneous treatment of coronary bifurcation lesions represents a technical challenge. Several stenting techniques and dedicated devices have proven unsuccessful, with high rates of side branch occlusion at index procedure and follow-up.Eighty one patients with 84 de novo coronary artery lesions involving a major side branch underwent SLK-View (Advanced Stent Technologies, Inc., Pleasanton, CA) stent implantation with subsequent kissing balloon post dilatation. SLK-View stent is a new scaffolding device incorporating a side aperture that allows access to the side-branch of a bifurcation after deployment of the stent in main vessel. All patients underwent angiographic follow-up at 6 months. Procedural, in-hospital, and 6-month follow-up outcomes were examined.The lesions were located in left main (n = 11), left anterior descending (n = 50), left circumflex (n = 8), right coronary artery (n = 7), and 1 ramus intermedius. The most frequent lesions (44.1%) were true bifurcations. Successful stent delivery to bifurcation was accomplished in 82/84 of the cases (97.6%). Technical success was obtained in 99 and 94% of main vessel and side branches, respectively. Stenting in side-branch was performed in 21 lesions (25%). Side-branches were accessed effectively in 100% of bifurcations postprocedurally. Binary restenosis rate at 6-month follow-up was 28.3% and 37.7% for main vessel and side-branch, respectively. TLR rate at 6-month follow-up was 21% and CABG rate of 6%.In this consecutive multicenter series of patients with coronary bifurcation lesions, this novel side-branch access stent proved feasible, with a high procedural success rate, while maintaining side-branch access.

    View details for DOI 10.1002/ccd.20556

    View details for Web of Science ID 000235145100005

    View details for PubMedID 16404749

  • Transient left ventricular dysfunction under severe stress: Brain-heart relationship revisited AMERICAN JOURNAL OF MEDICINE Ako, J., Sudhir, K., Farouque, H. M., Honda, Y., Fitzgerald, P. J. 2006; 119 (1): 10-17

    Abstract

    Transient left ventricular dysfunction in patients under emotional or physical stress, also known as tako-tsubo-like left ventricular dysfunction, has been recently been recognized as a distinct clinical entity. The aims of this review are to define this phenomenon and to explore its similarities to the left ventricular dysfunction seen in patients with acute brain injury.MEDLINE database, bibliographies of each citation for relevant articles, and consultation with clinical experts were used to examine the clinical picture of tako-tsubo-like left ventricular dysfunction.We identified case series and a systematic review that report on patients with this syndrome. This phenomenon occurs predominantly in female patients, presenting with a variety of ST-T segment changes and mildly elevated cardiac enzymes that mimic an acute coronary syndrome. The left ventricular dysfunction, typically showing a hyperkinetic basal region and an akinetic apical half of the ventricle, occurs in the absence of obstructed epicardial coronary arteries. The ventricular dysfunction usually resolves within weeks with a generally favorable prognosis. This phenomenon has similarities to that seen in patients with acute brain injury with regard to clinical presentation, pathology, and its reversible nature.Transient left ventricular dysfunction occurs in the absence of obstructive epicardial coronary artery disease. In its broadest sense, this phenomenon may encompass a range of disorders including left ventricular dysfunction after central nervous system injury.

    View details for DOI 10.1016/j.amjmed.2005.08.022

    View details for Web of Science ID 000234912000005

    View details for PubMedID 16431176

  • Impact of asymmetric stent expansion on neointimal hyperplasia following sirolimus-eluting stent implantation AMERICAN JOURNAL OF CARDIOLOGY Kaneda, H., Ako, J., Honda, Y., Terashima, M., Morino, Y., Yock, P. G., Popma, J. J., Leon, M. B., Moses, J. W., Fitzgerald, P. J. 2005; 96 (10): 1404-1407

    Abstract

    To assess whether asymmetric stent expansion affects suppression of neointimal hyperplasia after sirolimus-eluting stent implantation, 64 patients in the SIRolImUS-coated Bx Velocity stent trial who underwent single 18-mm stent implantation and 3-dimensional intravascular ultrasonography at 8-month follow-up were enrolled. To assess the longitudinal stent asymmetric expansion, 2 cross sections with a maximal/minimal stent area were chosen in each patient. To assess for tomographic stent asymmetric expansion, stent eccentricity was determined by dividing the minimum stent diameter by the maximum stent diameter. At the 2 cross sections with a maximal/minimal stent area, a sirolimus-eluting stent reduced neointimal hyperplasia significantly with no interaction between the treatment and stent areas. A sirolimus-eluting stent also significantly reduced neointimal hyperplasia in the concentric and eccentric stent groups.

    View details for DOI 10.1016/j.amjcard.2005.07.044

    View details for Web of Science ID 000233509900012

    View details for PubMedID 16275187

  • Predictors of edge stenosis following sirolimus-eluting stent deployment (A quantitative intravascular ultrasound analysis from the SIRIUS trial) AMERICAN JOURNAL OF CARDIOLOGY Sakurai, R., Ako, J., Morino, Y., Sonoda, S., Kaneda, H., Terashima, M., Hassan, A. H., Leon, M. B., Moses, J. W., Popma, J. J., Bonneau, H. N., Yock, P. G., Fitzgerald, P. J., Honda, Y. 2005; 96 (9): 1251-1253

    Abstract

    To study the interaction of the sirolimus-eluting stent and vessel margins, we analyzed the intravascular ultrasound parameters in 317 edges of 167 stents having 18 edge stenoses at 8 months of follow-up from the SIRIUS trial. Of the baseline parameters, a larger reference percentage of plaque area and a larger edge stent area/reference minimum lumen area were associated with edge stenosis in the sirolimus-eluting stent cohort compared with the incidence of edge stenosis in the bare metal stent cohort. Thus, full lesion coverage and matching the stented segment properly to the adjacent segment using intravascular ultrasound guidance may improve sirolimus-eluting stent implantation efficacy further.

    View details for DOI 10.1016/j.amjcard.2005.06.066

    View details for Web of Science ID 000233343500015

    View details for PubMedID 16253592

  • Impact of intravascular ultrasound lesion characteristics on neointimal hyperplasia following sirolimus-eluting stent implantation AMERICAN JOURNAL OF CARDIOLOGY Kaneda, H., Koizumi, T., Ako, J., Terashima, M., Morino, Y., Honda, Y., Yock, P. G., Leon, M. B., Moses, J. W., Fitzgerald, P. J. 2005; 96 (9): 1237-1241

    Abstract

    The effect of lesion characteristics on neointimal hyperplasia after sirolimus-eluting stent implantation was examined in 45 patients who underwent successful preinterventional intravascular ultrasound. There were no differences in neointimal hyperplasia between the moderate/severe calcified lesion group (calcium arc >120 degrees ) and the non/mild calcified lesion group or between the positive vessel remodeling group (external elastic membrane area at the minimal lumen area site larger than that at the proximal reference site) and negative vessel remodeling group. No correlation between preinterventional plaque burden and neointimal hyperplasia was found. In patients who have coronary artery disease, sirolimus-eluting stents continue to demonstrate striking suppression of neointimal proliferation, irrespective of lesion characteristics previously associated with greater restenotic risk.

    View details for DOI 10.1016/j.amjcard.2005.06.063

    View details for Web of Science ID 000233343500012

    View details for PubMedID 16253589

  • Late incomplete stent apposition after sirolimus-eluting stent implantation - A serial intravascular ultrasound analysis JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY Ako, J., Morino, Y., Honda, Y., Hassan, A., Sonoda, S., Yock, P. G., Leon, M. B., Moses, J. W., Bonneau, H. N., Fitzgerald, P. J. 2005; 46 (6): 1002-1005

    Abstract

    We sought to identify the frequency of incomplete stent apposition (ISA) in sirolimus-eluting stents (SES) and clarify its findings and clinical sequelae.Late-acquired ISA has been reported in bare-metal stents (BMS) and brachytherapy and recently in drug-eluting stents. However, the characteristics of late ISA in SES have not been clarified.From the SIRIUS trial, a randomized, multicenter study comparing SES and BMS, serial qualitative intravascular ultrasound (IVUS; at stent implantation and eight-month follow-up) was available in 141 patients (BMS: n = 61; SES: n = 80). The IVUS images were reviewed for the presence of ISA.Incomplete stent apposition at follow-up was observed in 19 patients (BMS: n = 6 [9.8%]; SES: n = 13 [16.3%]; p = NS). Among these, 12 had ISA after intervention and at follow-up (persistent ISA). Late-acquired ISA was seen in the remaining seven cases, all from the SES group (BMS: n = 0; SES: n = 7 [8.7%]; p < 0.05). In late-acquired ISA, there was an increase in external elastic membrane area (after intervention: 16.2 +/- 2.7 m2; follow-up: 18.9 +/- 3.6 mm2; p < 0.05). The location of stent-vessel wall separation was primarily at the stent edges in persistent ISA cases, whereas late-acquired ISA in SES occurred mostly in the mid portion of the stent. There were no negative clinical events reported for any ISA cases at 12-month clinical follow-up.Late ISA was observed in 8.7% of patients after SES implantation. There were no negative clinical events associated with this IVUS finding at 12-month clinical follow-up; however, careful long-term follow-up will be necessary.

    View details for DOI 10.1016/j.jacc.2005.05.068

    View details for Web of Science ID 000231991600009

    View details for PubMedID 16168282

  • Effect of lumen narrowing within coronary stents on proximal and distal vessel segments following bare metal stent implantation AMERICAN JOURNAL OF CARDIOLOGY Kaneda, H., Ako, J., Kataoka, T., Miyazawa, A., Terashima, M., Ikeno, F., Sonoda, S., SHIMADA, Y., Morino, Y., Honda, Y., Yock, P. G., Fitzgerald, P. J. 2005; 96 (3): 376-378

    Abstract

    Adjacent reference vessel response to smaller lumens at stented segments was examined with 3-dimensional intravascular ultrasound analysis. In 128 patients after bare metal stent implantation, minimal lumen area (MLA) within the stent and average lumen area at distal/proximal adjacent reference segments (5 mm) were obtained at baseline and follow-up. In the smaller in-stent MLA group (MLA <3 mm2), lumen area decreased significantly at the distal edge compared with the larger in-stent MLA group (MLA > or =3 mm2), although no significant difference was seen at the proximal edge. In-stent lumen patency may influence vascular responses at adjacent reference segments after bare metal stent implantation.

    View details for DOI 10.1016/j.amjcard.2005.03.079

    View details for Web of Science ID 000231057000011

    View details for PubMedID 16054461

  • Impact of different definitions on the interpretation of coronary remodeling determined by intravascular ultrasound CATHETERIZATION AND CARDIOVASCULAR INTERVENTIONS Hibi, K., Ward, M. R., Honda, Y., Suzuki, T., Jeremias, A., Okura, H., Hassan, A. H., Maehara, A., Yeung, A. C., Pasterkamp, G., Fitzgerald, P. J., Yock, P. G. 2005; 65 (2): 233-239

    Abstract

    The objective of this study was to compare the categorizations and determinants related to remodeling by the three definitions commonly used. Several morphological and intravascular ultrasound (IVUS) studies have demonstrated the fundamental importance of arterial remodeling in atherosclerosis. However, lack of consensus on how to define remodeling has led to conflicting analyses of factors that influence this process. Analysis of pre-interventional IVUS images of 514 lesions in native coronary arteries was performed. Arterial remodeling was defined as outward by definition 1, when [cross-sectional area (CSA) of the external elastic membrane (EEM) at the lesion site (EEM(lesion))]/[EEM CSA either at the proximal (EEM(prox ref)) or distal (EEM(distal ref)) reference site with the least amount of plaque] was > 1.05, intermediate when this ratio was between 0.95 and 1.05, and inward when < 0.95. Remodeling was defined as outward by definition 2 when EEM(lesion) > both EEM(prox ref) and EEM(distal ref), inward when EEM(lesion) < both EEM(prox ref) and EEM(distal ref), and intermediate when EEM(lesion) was intermediate between EEM(prox ref) and EEM(distal ref). By definition 3, vessel remodeling was defined as outward when EEM(lesion) > (EEM(prox ref) + EEM(distal ref))/2 and intermediate/inward when EEM(lesion) < or = (EEM(prox ref) + EEM(distal ref))/2. The frequency of outward remodeling was significantly higher by definitions 1 and 3 than by definition 2, whereas a higher frequency of inward remodeling was observed in definition 1, resulting in significantly different remodeling distributions between the three definitions (P < 0.0001). By multivariate logistic analysis, the only clinical determinants related to outward remodeling was younger age, and only by definition 3. IVUS determinants varied significantly between the three definitions. The only consistent determinants among the three definitions were smaller lumen CSA at the reference site and larger plaque + media CSA at the lesion site. This study demonstrates the significant impact of different remodeling definitions on the incidence and determinants of remodeling patterns. The marked variability in categorization of remodeling underscores the importance of developing a standard methodology.

    View details for DOI 10.1002/ccd.20366

    View details for Web of Science ID 000229557600015

    View details for PubMedID 15812811

  • Impact of final Stent dimensions on long-term results following sirolimus-eluting stent implantation - Serial intravascular ultrasound analysis from the SIRIUS trial JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY Sonoda, S., Morino, Y., Ako, J., Terashima, M., Hassan, A. H., Bonneau, H. N., Leon, M. B., Moses, J. W., Yock, P. G., Honda, Y., Kuntz, R. E., Fitzgerald, P. J. 2004; 43 (11): 1959-1963

    Abstract

    We assessed the predictive value of minimum stent area (MSA) for long-term patency of sirolimus-eluting stents (SES) implantation compared to bare metal stents (BMS).Although MSA is a consistent predictor of in-stent restenosis, its predictive value in BMS is still limited because of biologic variability in the restenosis process.From the SIRolImUS (SIRIUS) trial, 122 cases (SES: 72; BMS: 50) with complete serial intravascular ultrasound (IVUS) (baseline and 8-month follow-up) were analyzed. Postprocedure MSA and follow-up minimum lumen area (MLA) were obtained. Based on previous physiologic studies, adequate stent patency at follow-up was defined as MLA >4 mm(2).In both groups, a significant positive correlation was observed between baseline MSA and follow-up MLA (SES: p < 0.0001, BMS: p < 0.0001). However, SES showed higher correlation than BMS (0.8 vs. 0.65) with a higher regression coefficient (0.92 vs. 0.59). The sensitivity and specificity curves identified different optimal thresholds of MSA to predict adequate follow-up MLA: 5 mm(2) for SES and 6.5 mm(2) for BMS. The positive predictive values with these cutoff points were 90% and 56%, respectively.In this SIRIUS IVUS substudy, SES reduced both biologic variability and restenosis, resulting in increased predictability of long-term stent patency with postprocedure MSA. In addition, SES had a considerably lower optimal MSA threshold compared to BMS.

    View details for DOI 10.1016/j./jacc.2004.01.044

    View details for Web of Science ID 000221715800006

    View details for PubMedID 15172398

  • Validation of a thermographic guidewire for endoluminal mapping of atherosclerotic disease: An in vitro study CATHETERIZATION AND CARDIOVASCULAR INTERVENTIONS Courtney, B. K., Nakamura, M., Tsugita, R., Lilly, R., Basisht, R., Grube, E., Honda, Y., Yock, P. G., Fitzgerald, P. J. 2004; 62 (2): 221-229

    Abstract

    Temperature heterogeneity along the inner surface of an artery may be a surrogate marker of impending plaque rupture and has been associated with an increased likelihood of future coronary events. Initial studies using catheter-based thermographic devices have demonstrated that the changes in temperature are subtle, while the effects of coronary flow on measured temperature have not yet been examined. A novel guidewire-based system (ThermoCoil, Imetrx) designed to measure surface temperature in coronary arteries was used to study the effects of heat source intensity and flow on measured temperature. An in vitro model of a focal, eccentric, heat-generating lesion demonstrated that a guidewire-based system can detect changes in surface temperature with a precision of less than 0.08 degrees C. In this model, temperature measurements increased linearly with source temperature and decreased with increases in flow by an exponent of -0.33 (P < 0.001 for both). Flow rates and heat source properties can significantly influence the measurement and interpretation of thermographic data. The incorporation of 2D thermographic images may contribute further to the characterization of metabolically active plaques likely to cause acute coronary syndromes.

    View details for DOI 10.1002/ccd.10750

    View details for Web of Science ID 000221856000016

    View details for PubMedID 15170716

  • Microvascular resistance is not influenced by epicardial coronary artery stenosis severity - Experimental validation CIRCULATION Fearon, W. F., Aarnoudse, W., Pijls, N. H., De Bruyne, B., Balsam, L. B., Cooke, D. T., Robbins, R. C., Fitzgerald, P. J., Yeung, A. C., Yock, P. G. 2004; 109 (19): 2269-2272

    Abstract

    The effect of epicardial artery stenosis on myocardial microvascular resistance remains controversial. Recruitable collateral flow, which may affect resistance, was not incorporated into previous measurements.In an open-chest pig model, distal coronary pressure was measured with a pressure wire, and the apparent minimal microvascular resistance was calculated during peak hyperemia as pressure divided by flow, measured either with a flow probe around the coronary artery (R(micro app)) or with a novel thermodilution technique (apparent index of microcirculatory resistance [IMR(app)]). These apparent resistances were compared with the actual R(micro) and IMR after the coronary wedge pressure and collateral flow were incorporated into the calculation. Measurements were made at baseline (no stenosis) and after creation of moderate and severe epicardial artery stenoses. In 6 pigs, 189 measurements of R(micro) and IMR were made under the various epicardial artery conditions. Without consideration of collateral flow, R(micro app) (0.43+/-0.12 to 0.46+/-0.10 to 0.51+/-0.11 mm Hg/mL per minute) and IMR(app) (14+/-4 to 17+/-7 to 20+/-10 U) increased progressively and significantly with increasing epicardial artery stenosis (P<0.001 for both). With the incorporation of collateral flow, neither R(micro) nor IMR increased as a result of increasing epicardial artery stenosis.After collateral flow is taken into account, the minimum achievable microvascular resistance is not affected by increasing epicardial artery stenosis.

    View details for DOI 10.1161/01.CIR.0000128669.99355.CB

    View details for Web of Science ID 000221477800004

    View details for PubMedID 15136503

  • Pseudo-candy wrapper: bifocal radial artery graft spasm following stent implantation. journal of invasive cardiology Kaneda, H., Nakamura, M., Fitzgerald, P. J. 2004; 16 (4): 201-203

    Abstract

    We encountered a case of intractable radial artery graft spasm after stent implantation which was partially responsive to nominal nitroglycerin therapy. We report this case with intravascular ultrasound imaging at the radial artery spasm site.

    View details for PubMedID 15152147

  • Evaluation of high-pressure retrograde coronary venous delivery of FGF-2 protein CATHETERIZATION AND CARDIOVASCULAR INTERVENTIONS Fearon, W. F., Ikeno, F., Bailey, L. R., Hiatt, B. L., Herity, N. A., Carter, A. J., Fitzgerald, P. J., Rezaee, M., Yeung, A. C., Yock, P. G. 2004; 61 (3): 422-428

    Abstract

    Delivery of angiogenic factors to ischemic myocardium remains a practical challenge. We evaluated the efficiency and efficacy of delivery of fibroblast growth factor-2 (FGF-2) protein via high-pressure retrograde injection into the anterior interventricular vein (AIV) in a porcine model of chronic myocardial ischemia. Labeled FGF-2 protein was delivered to the myocardium of three pigs via the AIV and the left anterior descending (LAD) coronary artery in three others. At 1 hr, the amount of protein in the left ventricle and the LAD region was quantified. Copper stents were implanted in the LAD of 25 pigs, resulting in chronic myocardial ischemia. At 4 weeks, microsphere-derived myocardial blood flow was assessed at rest and during pacing. In eight pigs (AIV FGF), FGF-2 protein (6 microg/kg) was delivered via high-pressure retrograde injection into the AIV. Six pigs (intracoronary FGF) received the same amount of FGF-2 by intracoronary delivery. Five pigs (AIV saline) received a placebo injection into the AIV and six pigs (control) served as controls. Four weeks later, myocardial blood flow was reassessed. At 1 hr, significantly more FGF remained in the left ventricle (1.3 vs. 0.82 microg; P < 0.04) and in the LAD region (1.2 vs. 0.64 microg; P = 0.03) after AIV compared to intracoronary delivery. Four weeks after treatment, resting LAD blood flow (normalized to right ventricular flow) improved slightly in the AIV FGF and intracoronary FGF arms (1.32-1.37 for both; P = 0.11), while it decreased significantly in the AIV saline (1.32-1.23; P = 0.02) and the control arms (1.32-1.19; P = 0.0004). Pacing LAD blood flow decreased significantly in the control arm (1.30-1.23; P < 0.05), but did not change significantly in the other three arms. High-pressure retrograde injection into the AIV may represent an efficient and effective means for delivering angiogenic factors to ischemic myocardium.

    View details for DOI 10.1002/ccd.10790

    View details for Web of Science ID 000220022500027

    View details for PubMedID 14988909

  • Late incomplete stent apposition and focal vessel expansion after bare metal stenting AMERICAN JOURNAL OF CARDIOLOGY Nakamura, M., Kataoka, T., Honda, Y., Bonneau, H. N., Hibi, K., Kitamura, K., Tamai, H., Aizawa, T., Yock, P. G., Fitzgerald, P. J. 2003; 92 (10): 1217-1219

    Abstract

    Late incomplete stent apposition was observed in 2.4% of the 412 stented segments studied by serial intravascular ultrasound analyses. Most of these phenomena and all late vessel expansions with incomplete stent apposition developed in vessels in which lesions were treated by atherectomy before stenting, suggesting a potential association between mechanical injury from debulking and these phenomena.

    View details for Web of Science ID 000186638600019

    View details for PubMedID 14609603

  • Comparison of coronary thermodilution and Doppler velocity for assessing coronary flow reserve CIRCULATION Fearon, W. F., Farouque, H. M., Balsam, L. B., Cooke, D. T., Robbins, R. C., Fitzgerald, P. J., Yeung, A. C., Yock, P. G. 2003; 108 (18): 2198-2200

    Abstract

    Thermodilution coronary flow reserve (CFRthermo) is a new technique for invasively measuring coronary flow reserve (CFR) with a coronary pressure wire and is based on the ability of the pressure transducer to also measure temperature changes. Whether CFRthermo correlates well enough with absolute flow-derived CFR (CFRflow) to replace Doppler wire-derived CFR (CFRDoppler) remains unclear.In an open-chest pig model, CFRthermo was measured in the left anterior descending (LAD) artery and compared with CFRDoppler and CFRflow, measured with an external flow probe placed around the LAD. In 9 pigs, CFR was measured simultaneously by all 3 means in the normal LAD and after creation of an epicardial LAD stenosis. To determine the added effect of microvascular disease, measurements of flow reserve were also performed after disruption of the coronary microcirculation with embolized microspheres. Intracoronary papaverine (20 mg) was used to induce hyperemia. In a total of 61 paired measurements, CFRthermo correlated strongly with the reference standard CFRflow (r=0.85, P<0.001). CFRDoppler correlated less well with CFRflow (r=0.72, P<0.001). Bland-Altman analysis showed a closer agreement between CFRthermo and CFRflow.CFRthermo correlates better with CFRflow than does CFRDoppler.

    View details for DOI 10.1161/01.CIR.0000099521.31396.9D

    View details for Web of Science ID 000186340900005

    View details for PubMedID 14568891

  • Simultaneous assessment of fractional and coronary flow reserves in cardiac transplant recipients - Physiologic investigation for transplant arteriopathy (PITA study) CIRCULATION Fearon, W. F., Nakamura, M., Lee, D. P., Rezaee, M., Vagelos, R. H., Hunt, S. A., Fitzgerald, P. J., Yock, P. G., Yeung, A. C. 2003; 108 (13): 1605-1610

    Abstract

    The utility of measuring fractional flow reserve (FFR) to assess cardiac transplant arteriopathy has not been evaluated. Measuring coronary flow reserve (CFR) as well as FFR could add information about the microcirculation, but until recently, this has required two coronary wires. We evaluated a new method for simultaneously measuring FFR and CFR with a single wire to investigate transplant arteriopathy.In 53 cases of asymptomatic cardiac transplant recipients without angiographically significant coronary disease, FFR and thermodilution-derived CFR (CFRthermo) were measured simultaneously with the same coronary pressure wire in the left anterior descending artery and compared with volumetric intravascular ultrasound (IVUS) imaging. The average FFR was 0.88+/-0.07; in 75% of cases, the FFR was less than the normal threshold of 0.94; and in 15% of cases, the FFR was < or =0.80, the upper boundary of the gray zone of the ischemic threshold. There was a significant inverse correlation between FFR and IVUS-derived measures of plaque burden, including percent plaque volume (r=0.55, P<0.0001). The average CFRthermo was 2.5+/-1.2; in 47% of cases, CFRthermo was < or =2.0. In 14%, the FFR was normal (> or =0.94) and the CFR was abnormal (<2.0), suggesting predominant microcirculatory dysfunction.FFR correlates with IVUS findings and is abnormal in a significant proportion of asymptomatic cardiac transplant patients with normal angiograms. Simultaneous measurement of CFR with the same pressure wire, with the use of a novel coronary thermodilution technique, is feasible and adds information to the physiological evaluation of these patients.

    View details for DOI 10.1161/01.CIR.0000091116.84926.6F

    View details for Web of Science ID 000185624500027

    View details for PubMedID 12963639

  • Late incomplete apposition with excessive remodeling of the stented coronary artery following intravascular brachytherapy AMERICAN JOURNAL OF CARDIOLOGY Okura, H., Lee, D. P., Lo, S., Yeung, A. C., Honda, Y., Waksman, R., Kaluza, G. L., Ali, N. M., Bonneau, H. N., Yock, P. G., Raizner, A. E., Mintz, G. S., Fitzgerald, P. J. 2003; 92 (5): 587-590

    Abstract

    Intravascular brachytherapy may cause "exaggerated" vessel remodeling with late incomplete apposition in segments that have little disease, which are exposed to higher radiation doses. The long-term clinical impact of this finding is unclear.

    View details for DOI 10.1016/S0002-9149(03)00728-8

    View details for Web of Science ID 000185060700017

    View details for PubMedID 12943881

  • Novel index for invasively assessing the coronary microcirculation CIRCULATION Fearon, W. F., Balsam, L. B., Farouque, H. M., Robbins, R. C., Fitzgerald, P. J., Yock, P. G., Yeung, A. C. 2003; 107 (25): 3129-3132

    Abstract

    A relatively simple, invasive method for quantitatively assessing the status of the coronary microcirculation independent of the epicardial artery is lacking.By using a coronary pressure wire and modified software, it is possible to calculate the mean transit time of room-temperature saline injected down a coronary artery. The inverse of the hyperemic mean transit time has been shown to correlate with absolute flow. We hypothesize that distal coronary pressure divided by the inverse of the hyperemic mean transit time provides an index of microcirculatory resistance (IMR) that will correlate with true microcirculatory resistance (TMR), defined as the distal left anterior descending (LAD) pressure divided by hyperemic flow, measured with an external ultrasonic flow probe. A total of 61 measurements were made in 9 Yorkshire swine at baseline and after disruption of the coronary microcirculation, both with and without an epicardial LAD stenosis. The mean IMR (16.9+/-6.5 U to 25.9+/-14.4 U, P=0.002) and TMR (0.51+/-0.14 to 0.79+/-0.32 mm Hg x mL(-1) x min(-1), P=0.0001), as well as the % change in IMR (147+/-66%) and TMR (159+/-105%, P=NS versus IMR % change), increased significantly and to a similar degree after disruption of the microcirculation. These changes were independent of the status of the epicardial artery. There was a significant correlation between mean IMR and TMR values, as well as between the % change in IMR and % change in TMR.Measuring IMR may provide a simple, quantitative, invasive assessment of the coronary microcirculation.

    View details for DOI 10.1161/01.CIR.0000080700.98607.D1

    View details for Web of Science ID 000183887100004

    View details for PubMedID 12821539

  • Treatment by mycophenolate mofetil of advanced graft vascular disease in non-human primate recipients of orthotopic aortic allografts AMERICAN JOURNAL OF TRANSPLANTATION Klupp, J., Dambrin, C., Hibi, K., Luna, J., Suzuki, T., Hausen, B., Birsan, T., van Gelder, T., Fitzgerald, P. J., Berry, G., Morris, R. E. 2003; 3 (7): 817-829

    Abstract

    Failure to control chronic graft dysfunction [e.g. graft vascular disease (GVD)] is the primary cause of immunologic graft failure. This is the first study of mycophenolate mofetil (MMF) for the treatment of GVD in non-human primate recipients of aortic allografts. Abdominal aortic allografts were exchanged between mixed leukocyte reaction (MLR) -mismatched, blood-group-compatible cynomolgus monkeys. Six control recipients were untreated. Individualized treatment with frequent dose adjustments of MMF insured that treatment was close to the maximum tolerated dose (mean 99.2 mg/kg/day). Immune-mediated injury proceeded unhindered until day 45, after which MMF treatment began. Changes in intimal volume (IV) were quantified by intravascular ultrasound (IVUS) and compared to histology on day 105. Serial IVUS measurements of IV (mm(3)) in controls showed progressive GVD. In four out of six animals, MMF was well tolerated, thus enabling optimum treatment; in all these animals, IV was significantly less than in the control animals (p = 0.02). In the two remaining animals, high doses were not tolerated; at day 105, there was no significant difference in IV between them and the controls. We found a significant correlation between the mean MMF tolerated dose and the inhibition of progression of IV (r = -0.88, p = 0.015). When high MMF doses were tolerated, MMF slowed progression of GVD.

    View details for Web of Science ID 000184032600007

    View details for PubMedID 12814473

  • Sirolimus (rapamycin) monotherapy prevents graft vascular disease in nonhuman primate recipients of orthotopic aortic allografts CIRCULATION Dambrin, C., Klupp, J., Birsan, T., Luna, J., Suzuki, T., Lam, T., Stahr, P., Hausen, B., Christians, U., Fitzgerald, P., Berry, G., Morris, R. 2003; 107 (18): 2369-2374

    Abstract

    Delayed treatment with sirolimus (SRL) halts progression of graft vascular disease (GVD) in nonhuman primate (NHP) aortic allograft recipients. In this study, we investigated whether SRL monotherapy prevents the development of GVD.Pairs of 3-cm infrarenal aortic segments were exchanged between mixed lymphocyte reaction-mismatched, blood group-compatible NHPs (n=12). Six NHPs were untreated controls, and 6 were treated orally with SRL starting on the day of transplantation. Follow-up was 105 days. SRL doses were adjusted individually by assessing SRL blood concentrations, immune function, and clinical status. The severity of GVD was determined every 3 weeks by intravascular ultrasound, which quantified intimal area (IA) and intimal volume (IV) for the middle 1-cm graft segments. The mean+/-SEM SRL plasma levels were 14.5+/-9 ng/mL. In grafts from treated NHPs, IA and IV values on days 63, 84, and 105 were significantly lower than for controls (P<0.05 to P<0.001). On day 105, in the grafts from SRL-treated NHPs compared with grafts from controls, values (mean+/-SEM) were IA, 2.9+/-0.9 versus 5.5+/-0.7 mm2, P<0.001 and IV, 29.6+/-4.6 versus 55.2+/-2.8 mm3, P<0.001; IA and IV values for grafts from SRL-treated NHPs did not increase significantly between days 21 and 105.We show that SRL monotherapy prevented GVD in NHP aortic allograft recipients, suggesting the value of SRL for controlling GVD in clinical transplantation.

    View details for DOI 10.1161/01.CIR.0000065576.80196.A4

    View details for Web of Science ID 000182807000028

    View details for PubMedID 12719285

  • Effect of a change in gender on coronary arterial size - A longitudinal intravascular ultrasound study in transplanted hearts JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY Herity, N. A., Lo, S., Lee, D. P., Ward, M. R., Filardo, S. D., Yock, P. G., Fitzgerald, P. J., Hunt, S. A., Yeung, A. C. 2003; 41 (9): 1539-1546

    Abstract

    We sought to document whether a physiologic change in gender has any effect on coronary arterial size.The coronary arteries are smaller in women, even after correction for body surface area (BSA). These differences may contribute to adverse clinical outcomes after coronary artery bypass graft surgery and myocardial infarction in women. In male and female transsexuals, pharmacologic doses of estrogens and androgens significantly influence vascular diameter. Thus, gender differences in the coronary vasculature may be a reflection of the hormonal environment.In 86 patients who had undergone orthotopic heart transplantation, serial intravascular ultrasound studies of the proximal left anterior descending coronary artery (LAD) were analyzed. Changes in vessel area (VA) over the first or second post-transplant year were recorded, and comparisons were made between donor hearts that were transplanted in a patient of the same gender and those that were transplanted in a patient of the opposite gender.Vessel area of the proximal LAD increased over time in all patient groups. In hearts transplanted within the same gender and in male donor hearts transplanted to female recipients, the change was small and not significant. However, in hearts transplanted from female donors to male recipients, there was a substantial and highly significant increase in LAD VA (median 16.13 to 17.88 mm(2); p = 0.01). This increase was not explained by confounding due to changes in BSA or left ventricular wall thickness.This pattern of arterial remodeling early after heart transplantation supports a link between host gender and coronary arterial size.

    View details for DOI 10.1016/S0735-1097(03)00246-8

    View details for Web of Science ID 000182631800019

    View details for PubMedID 12742295

  • Taxol-based eluting stents from theory to human validation: clinical and intravascular ultrasound observations. journal of invasive cardiology Sonoda, S., Honda, Y., Kataoka, T., Bonneau, H. N., Sudhir, K., Yock, P. G., Mintz, G. S., Fitzgerald, P. J. 2003; 15 (3): 109-114

    Abstract

    Treatment with antiproliferative drugs via coated stents appears to be a promising approach to both mechanically remodel target lesions and biologically reduce neointimal hyperplasia. Drug-eluting stents can maximize local drug effects and minimize the potential for systemic toxic effects. The purpose of this review is to describe the effects of a lipophilic microtubular inhibitor, paclitaxel, a strong antiproliferative agent under clinical investigation, and to define the vascular response to taxol-based eluting stents by intravascular ultrasound.

    View details for PubMedID 12612382

  • Relationship between neointimal regrowth and mechanism of acute lumen gain during the treatment of in-stent restenosis with or without supplementary intravascular radiation CATHETERIZATION AND CARDIOVASCULAR INTERVENTIONS Morino, Y., Limpijankit, T., Honda, Y., Somrantin, M., Waksman, R., Bonneau, H. N., Yock, P. G., Mintz, G. S., Fitzgerald, P. J. 2003; 58 (2): 162-167

    Abstract

    We investigated whether neointimal regrowth is related to the mechanism of acute lumen gain during the treatment of in-stent restenosis (ISR) lesions both with and without adjunct intravascular brachytherapy. From the WRIST (Washington Radiation for In-Stent Restenosis Trial) cohort, 54 ISR patients ((192)Ir, 29; placebo, 25) were treated with nonrepeat stenting percutaneous interventions (excimer laser, rotational atherectomy, and/or balloon angioplasty) prior to (192)Ir or placebo therapy. Using Simpson's method, serial volumetric intravascular ultrasound (IVUS) analyses (pre- and posttreatment and 6-month follow-up) were analyzed to obtain stent, lumen, and intimal hyperplasia (IH) volumes that were then adjusted for stent length to create stent, lumen, and IH volume indexes. In the placebo group, the acute reduction of neointima (1.6 +/- 1.4 mm(3)/mm) was counteracted by intimal regrowth (2.1 +/- 1.7 mm(3)/mm). The amount of intimal regrowth correlated directly with the intimal reduction due to the intervention (r = 0.76; P < 0.001), but not with the amount of additional stent expansion. In the (192)Ir-treated group, intimal regrowth was significantly less than in the placebo group (-0.3 +/- 0.1 vs. 2.1 +/- 1.7 mm(3)/mm; P < 0.001) despite a similar initial intimal reduction (1.3 +/- 0.9 vs. 1.6 +/- 1.4 mm(3)/mm; P = NS). No correlation was found between intimal reduction at the time of the procedure and intimal regrowth in the (192)Ir group. In this study, neointimal regrowth following treatment of ISR lesions correlates directly with the extent of acute intimal volume reduction, but not with the extent of additional stent expansion. This relation is not seen in ISR segments treated with radiation, where intimal regrowth is substantially inhibited.

    View details for DOI 10.1002/ccd.10405

    View details for Web of Science ID 000182814600005

    View details for PubMedID 12552537

  • Impact of deep vessel wall injury on acute response and remodeling of coronary artery segments after cutting balloon angioplasty AMERICAN JOURNAL OF CARDIOLOGY Nakamura, M., Yock, P. G., Kataoka, T., Bonneau, H. N., Suzuki, T., Yamaguchi, T., Honda, Y., Fitzgerald, P. J. 2003; 91 (1): 6-11

    Abstract

    Deep vessel wall injury is believed to affect vessel dimension following coronary intervention. The cutting balloon is designed to treat coronary artery stenoses with dilatation and surgical incisions, thereby reducing excess vessel injury. This study examines the effect of deep vessel wall injury on acute and late coronary arterial response after cutting balloon angioplasty. Serial volumetric intravascular ultrasound (IVUS) analyses were performed in 63 lesions treated with cutting balloon angioplasty alone. Before intervention, the longitudinal range of the lesion segment that included the smallest lumen area (LA) was determined as LA <4 mm(2) and/or LA stenosis >60%. The exact corresponding site at postintervention and follow-up was aligned using peri- and intravascular landmarks. Average vessel area (VA), plaque area (PA), and LA were measured. Lesion segments were categorized as with or without deep vessel wall injury, which was defined as the presence of plaque/vessel wall fracture extending to the sonolucent (medial) layer. Before intervention, the lesion vessel size of deep injury group was smaller than that of the nondeep injury group (p <0.05 for average VA and PA), whereas average lesion LA, lesion length, and reference vessel size did not differ. Immediately after cutting balloon angioplasty, the deep injury group showed a significant increase in VA (p <0.0001) and a lesser decrease in PA (p <0.01) compared with the nondeep injury group. During follow-up, the increase of VA tended to be greater in the deep injury group than in the nondeep injury group (p = 0.06), whereas the change of PA did not differ. Consequently, LA decrease was less in the deep injury group than in the nondeep injury group (p <0.05). From these results, it is suggested that deep vessel wall injury tends to occur in lesions with relatively small size and such lesions show favorable vessel response after cutting balloon angioplasty.

    View details for Web of Science ID 000180201000002

    View details for PubMedID 12505563

  • Mechanisms of acute lumen gain following cutting balloon angioplasty in calcified and noncalcified lesions: An intravascular ultrasound study CATHETERIZATION AND CARDIOVASCULAR INTERVENTIONS Okura, M., Hayase, M., Shimodozono, S., Kobayashi, T., Sano, K., Matsushita, T., Kondo, T., Kijima, M., Nishikawa, H., Kurogane, H., Aizawa, T., Hosokawa, H., Suzuki, T., Yamaguchi, T., Bonneau, H. N., Yock, P. G., Fitzgerald, P. J. 2002; 57 (4): 429-436

    Abstract

    Several studies have shown that mechanisms for lumen enlargement following conventional balloon angioplasty (BA) consist of plaque reduction and vessel expansion. To assess the mechanisms of lumen enlargement after Cutting Balloon (CB) angioplasty, intravascular ultrasound images were analyzed in 180 lesions (89 CB and 91 BA). External elastic membrane (EEM) cross-sectional area (CSA), lumen CSA, and plaque plus media (P+M) CSA were measured before and after angioplasty. In the CB group, lower balloon pressure was utilized (P < 0.0001). DeltaP+M CSA was significantly larger (P = 0.02) and deltalumen CSA showed a trend toward being larger (P = 0.07) compared to BA group. For noncalcified lesions, CB resulted in a larger deltaP+M CSA (P < 0.05) and a smaller deltaEEM CSA (P = 0.10) than BA. For calcified lesions, deltalumen CSA was significantly larger in the CB group (P < 0.05) without significant differences in deltaEEM CSA and deltaP+M CSA. Dissections complicated with calcified lesions were associated with larger deltalumen CSA for the CB group. In conclusion, for noncalcified lesions, CB achieves similar luminal dimensions with larger plaque reduction and less vessel expansion compared to BA. On the other hand, for calcified lesions, the CB achieves larger lumen gain, especially in lesions with evidence of dissections.

    View details for DOI 10.1002/ccd.10344

    View details for Web of Science ID 000182814400002

    View details for PubMedID 12455075

  • Efficacy and feasibility of helixcision for debulking neointimal hyperplasia for in-stent restenosis CATHETERIZATION AND CARDIOVASCULAR INTERVENTIONS Nakamura, M., Fitzgerald, P. J., Ikeno, F., Honda, Y., Sousa, J. E., Abizaid, A., de Brito, F. S., Tofte, A., Grube, E., Patterson, G. R., Yock, P. G., Yeung, A. C., Carter, A. J. 2002; 57 (4): 460-466

    Abstract

    The Helixcision system is a novel 6 Fr-compatible catheter designed to debulk tissue for in-stent restenosis lesions. The purpose of this study was to determine the efficacy and feasibility of this new system for removing neointimal hyperplasia. A total of 32 in-stent restenosis lesions in 32 patients were treated with helixcision followed by balloon angioplasty. Debulking efficacy was assessed with serial baseline intravascular ultrasound (IVUS) in a subset of 18 lesions. To investigate longitudinal efficacy, 3D analysis was also performed in 12 lesions with automated pullback to calculate average cross-sectional areas across the stent. Prior to procedure, the angiographic reference diameter was 2.60 +/- 0.46 mm. Immediately after procedure, minimum lumen diameter improved from 0.84 +/- 0.33 to 2.19 +/- 0.41 mm (P < 0.0001). IVUS showed a significant reduction of intimal area (IA) after helixcision (from 4.95 +/- 2.04 to 2.88 +/- 1.48 mm(2); P < 0.001). Adjunctive balloon angioplasty further improved lumen area (LA) mainly by stent expansion rather than IA reduction at the site of minimum lumen area. The degrees of IA reduction and LA improvement were closely similar in volumetric analysis. Thirty-day and 6-month clinical follow-up were available in 97% (n = 31) and 72% (n = 23) of the enrolled patients, respectively. At 30-day follow-up, no major adverse cardiac event was reported except for periprocedural CK elevation in two patients (6%). Target legion revascularization within 6 months was performed in six patients (26%). Preliminary results of helixcision indicate that this system is safe and feasible for the treatment of in-stent restenosis. The concordant results between 2D and 3D IVUS analyses suggest that this unique technology can achieve uniform longitudinal debulking throughout the stent. The long-term outcomes appeared to be favorable, considering the relatively diffuse lesion morphology.

    View details for DOI 10.1002/ccd.10352

    View details for Web of Science ID 000182814400006

    View details for PubMedID 12455079

  • Quantitative and spatial relation of baseline atherosclerotic plaque burden and subsequent in-stent neointimal proliferation as determined by intravascular ultrasound AMERICAN JOURNAL OF CARDIOLOGY Hibi, K., Suzuki, T., Honda, Y., Hayase, M., Bonneau, H. N., Yock, P. G., Yeung, A. C., Fitzgerald, P. J. 2002; 90 (10): 1164-?

    View details for Web of Science ID 000179262600027

    View details for PubMedID 12423727

  • Delivered dose and vascular response after beta-radiation for in-stent restenosis - Retrospective dosimetry and volumetric intravascular ultrasound analysis CIRCULATION Morino, Y., Kaneda, H., Fox, T., Takagi, A., Hassan, A. H., Bonan, R., Crocker, I., Lansky, A. J., Laskey, W. K., Suntharalingam, M., Bonneau, H. N., Yock, P. G., Honda, Y., Fitzgerald, P. J. 2002; 106 (18): 2334-2339

    Abstract

    Observations from previous intracoronary radiation therapy trials noted a considerable discrepancy between the prescribed radiation dose and the dose actually delivered. The aims of this study were to investigate the effect of actual delivered dose on vascular changes and to test the appropriateness of the current dose prescription.Serial volumetric intravascular ultrasound (IVUS) analysis was performed in 30 in-stent restenosis cases treated with a 40-mm (90)Sr/Y source train. The fixed dose was prescribed at 2 mm from the centerline of the source train (18.4 Gy at 2 mm for reference diameter < or =3.35 mm and 23 Gy for diameter > or =3.36 mm). Only stent segments with full radiation coverage and device injury were enrolled and divided into 2-mm-long subsegments (n=202). D(S90)EEM (the minimum dose absorbed by 90% of the external elastic membrane surface) was calculated as the delivered dose corresponding to each segment, assuming that the radiation catheter occupied the same position in the vessel as the IVUS catheter. Mean D(S90)EEM of 23.5+/-5.82 Gy (range 12.3 to 41.7 Gy) was delivered to these subsegments. Overall, intimal hyperplasia volume remained constant from postintervention to follow-up (2.23+/-1.10 to 2.32+/-1.09 mm3/m; P=NS). Regression analysis revealed there was no correlation between delivered dose intensity and changes in intimal hyperplasia volume. No particular dose-dependent complications were appreciated in this delivered dose range.The current dose-prescription protocol of (90)Sr/Y radiation to native in-stent restenosis lesions may provide substantial inhibition of neointimal reproliferation regardless of the actual delivered dose intensity.

    View details for DOI 10.1161/01.CIR.0000036367.17043.03

    View details for Web of Science ID 000179046600017

    View details for PubMedID 12403663

  • 7-hexanoyltaxol-eluting stent for prevention of neointimal growth - An intravascular ultrasound analysis from the study to COmpare REstenosis rate between QueST and QuaDS-QP2 (SCORE) CIRCULATION Kataoka, T., Grube, E., Honda, Y., Morino, Y., Hur, S. H., Bonneau, H. N., Colombo, A., Di Mario, C., Guagliumi, G., Hauptmann, K. E., Pitney, M. R., Lansky, A. J., Stertzer, S. H., Yock, P. G., Fitzgerald, P. J. 2002; 106 (14): 1788-1793

    Abstract

    Inhibition of neointimal tissue growth has been demonstrated in preliminary human feasibility studies with a stent-based polymer sleeve delivering 7-hexanoyltaxol. The Study to COmpare REstenosis rate between QueST and QuaDS-QP2 (SCORE) trial is a human, randomized, multicenter trial comparing 7-hexanoyltaxol (QP2)-eluting stents (qDES) with bare metal stents (BMS) in the treatment of de novo coronary lesions. The purpose of this substudy was to evaluate the acute expansion property and long-term neointimal responses of qDES compared with BMS as assessed by intravascular ultrasound (IVUS).A total of 122 (qDES 66, BMS 56) patients were enrolled into the IVUS substudy. All IVUS images (immediately after the procedure and at 6-month follow-up) were analyzed at an independent core laboratory in a blind manner. At baseline, qDES achieved stent expansion similar to BMS. At follow-up, qDES showed reduced neointimal growth by 70% at the tightest cross section and by 68% over the stented segment (P<0.0001 for both), resulting in a significantly larger lumen in qDES than in BMS. Unlike intracoronary brachytherapy, there was no evidence of negative edge effects, unhealed dissections, or late stent-vessel wall malapposition over the stented and adjacent references segments in either group.Detailed IVUS analysis revealed that qDES had comparable acute mechanical and superior long-term biological effects to BMS. Although the long-term benefits and limitations of this technology require further investigation, the reduction in neointimal thickenings demonstrated that local delivery of 7-hexanoyltaxol through polymer sleeves augments conventional mechanical treatment of atherosclerotic disease.

    View details for Web of Science ID 000178385700012

    View details for PubMedID 12356631

  • New catheter-based technology for the treatment of restenosis. Journal of interventional cardiology Kataoka, T., Honda, Y., Bonneau, H. N., Yock, P. G., Fitzgerald, P. J. 2002; 15 (5): 371-379

    Abstract

    Catheter-based vascular interventions have been in development worldwide for several decades, leading to remarkable progress in device technology. Mechanical interventional devices, such as angioplasty balloons, atherectomy devices, and stents, were invented and have contributed greatly to the treatment of atherosclerotic vascular stenosis. However, mechanical approaches do not effectively prevent subsequent intimal growth. Recently, several biological approaches, including radiation therapy and drug-eluting stents, have shown striking inhibition of intimal growth. These significant results are likely to change the treatment strategy in the field of interventional cardiology. Furthermore, additional catheter-based technologies for vascular interventions are presently being evaluated. These latest technologies designed to prevent intimal proliferation include intravascular sonotherapy, cryotherapy, photoangioplasty, and soft X ray. To date, intravascular sonotherapy has proven its efficacy in animal studies and safety in human studies. Cryotherapy, the application of cold thermal energy during angioplasty, enhances the acute effects of conventional dilation while decreasing the likelihood of restenosis. Photoangioplasty has a unique property based on its selective mechanism of action to treat atheromatous plaque. Soft X ray systems provide convenient device handling and well-controlled radiation dose. Some of these technologies may play an important role in vascular interventions in the near future.

    View details for PubMedID 12440180

  • Impact of deep vessel wall injury and vessel stretching on subsequent arterial remodeling after balloon angioplasty: A serial intravascular ultrasound study AMERICAN HEART JOURNAL Okura, H., Shimodozono, S., Hayase, M., Bonneau, H. N., Yock, P. G., Fitzgerald, P. J. 2002; 144 (2): 323-328

    Abstract

    Arterial remodeling has been shown to be responsible for lumen narrowing after nonstent interventions.To examine the impact of deep vessel wall injury (DI) after balloon angioplasty on the subsequent vessel remodeling process, we performed serial intravascular ultrasound (IVUS) analysis in 47 native coronary artery lesions that underwent balloon angioplasty. An IVUS study was performed before and after balloon angioplasty and repeated at follow-up. Vessel and lumen area were measured at the narrowest site before intervention. Plaque area was calculated as vessel area minus lumen area. DI was defined as the presence of plaque/vessel wall fracture deep in the medial layer (sonolucent zone by IVUS) after angioplasty.After angioplasty, DI was present in 18 (38%, DI group) and absent in 29 (62%, non-DI group) of lesions. During follow-up, changes in vessel area in the DI group were significantly larger than in the non-DI group (P =.007). There were no significant differences in changes in plaque area. A trend toward greater late lumen loss was observed in the non-DI group (P =.05). In the DI group, changes in lumen area correlated better with changes in vessel area (r = 0.81, P <.0001) than with changes in plaque area (r = 0.32, P =.20). However, in the non-DI group, changes in lumen area correlated with changes in plaque area (r = -0.55, P =.002), but not with changes in vessel area (r = 0.30, P =.11).Deep vessel wall injury after balloon angioplasty is associated with the magnitude of the subsequent vessel remodeling process. The differences in the remodeling process may have implications regarding adjunctive therapies to prevent restenosis after balloon angioplasty.

    View details for DOI 10.1067/mhj.2002.122282

    View details for Web of Science ID 000177501400022

    View details for PubMedID 12177652

  • Impact of vessel curvature on the accuracy of three-dimensional intravascular ultrasound: Validation by phantoms and coronary segments JOURNAL OF THE AMERICAN SOCIETY OF ECHOCARDIOGRAPHY Stahr, P., Voigtlander, T., Rupprecht, H. J., Aschenbrucker, P., Mamtimin, H., Brennecke, R., Otto, M., Fitzgerald, P. J., Meyer, J. 2002; 15 (8): 823-830

    Abstract

    Three-dimensional intravascular ultrasound (IVUS) is used for volumetric assessment of arteriosclerotic plaque burden and restenotic tissue at follow-up after coronary interventions. However, the accuracy of these measurements, especially in tortuous vessels, is unclear.A commercially available electrocardiogram (ECG)-gated 3-dimensional-IVUS system was tested in volume-validated straight and curved hydrocolloid phantoms and in volume-validated coronary specimens. Catheter withdrawal (30 MHz, 3.2F) was triggered using standardized ECG source with 0.2-mm step intervals per cardiac cycle simulation.On the basis of automated phantom volume measurements, IVUS overestimated true phantom volume (relative error = [measured V - true V]/true V x 100) by a median of 0.9%, 0.25%, and 1.96% for straight, mildly curved, and severely curved segments, respectively. The true volume of the coronary specimens was overestimated by a median of 5.79%.A median percentage deviation of 3-dimensional-IVUS-measured volumes from the true volumes of less than 10% in phantoms and coronary artery segments can be achieved.

    View details for DOI 10.1067/mje.2002.120700

    View details for Web of Science ID 000177431800010

    View details for PubMedID 12174352

  • Discrimination of early/intermediate and advanced/complicated coronary plaque types by radiofrequency intravascular ultrasound analysis AMERICAN JOURNAL OF CARDIOLOGY Stahr, P. M., Hofflinghaus, T., Voigtlander, T., Courtney, B. K., Victor, A., Otto, M., Yock, P. G., Brennecke, R., Fitzgerald, P. J. 2002; 90 (1): 19-23

    Abstract

    Radiofrequency intravascular ultrasound (IVUS-RF) analysis, as an extension of conventional IVUS imaging, may provide more accurate plaque discrimination. Thirty-two autopsy atherosclerotic coronary arteries were investigated. Corresponding sectors in different plaques were matched by histologic and RF analysis. Histologic analysis utilized the American Heart Association plaque classification. The backscattered ultrasound RF signal was analyzed by fast-Fourier transform, providing the underlying frequency components of its power spectrum. The normalized backscattered signal power (in decibels [dB]) for frequencies between 15.3 and 40.3 MHz was then measured for plaque discrimination. Advanced/complicated plaque types showed a higher signal power at all frequencies than early/intermediate lesion types (p <0.001 to p = 0.005). Discrimination of advanced/complicated lesion types was best at 15.3 MHz, with a cut-off point of 2.5 dB (sensitivity 93%, specificity 79%), and second best at 17.6 MHz (sensitivity 87%, specificity 71%, cut-off point 1.9 dB). With conventional IVUS, plaque discrimination was weaker; the best sensitivity for diagnosing early/intermediate lesion types was reached for "soft plaque" (sensitivity 63%, specificity 73%). Compared with conventional IVUS, IVUS-RF can discriminate between advanced/complicated and early/intermediate coronary atherosclerotic lesions with relatively high sensitivity and specificity in vitro.

    View details for Web of Science ID 000176635000005

    View details for PubMedID 12088773

  • Late vascular response to repeat stenting for in-stent restenosis with and without radiation - An intravascular ultrasound volumetric analysis CIRCULATION Morino, Y., Limpijankit, T., Honda, Y., Lansky, A. J., Waksman, R., Bonneau, H. N., Yock, P. G., Mintz, G. S., Fitzgerald, P. J. 2002; 105 (21): 2465-2468

    Abstract

    Re-stenting of in-stent restenosis (ISR) improves acute angiographic results. Methods and Results- Volumetric intravascular ultrasound analysis was performed in 70 ISR lesions that received either placebo (n=36) or (192)Ir radiation (n=34). ISR lesions treated by re-stenting were divided into 3 groups: old stent not re-stented (A), old/new stent overlap (B), and new stent only (C). ISR lesions treated without re-stenting were categorized as D. In placebo patients, postintervention lumen volume index (LVI) was significantly greater in re-stented segments B and C than in non-re-stented segment A (P<0.05).At follow-up, however, LVI was similar in all 4 segments secondary to the increased intimal hyperplasia (IH) reaccumulation within the re-stented segments. In patients treated with (192)Ir radiation, LVI was maintained from baseline to follow-up only in non-re-stented segments A and D. Conversely, there was a significant decrease in LVI in re-stented segments B and C (P<0.05). Qualitatively, 79% of patients in the irradiated group had stent struts with undetectable neointimal versus only 27% in the placebo group (P<0.001). Coefficient of variation of IH reaccumulation was greater in re-stented segments of (192)Ir patients (B=57.3% and C=58.9%) than in re-stented segments in placebo patients (B=27.3% and C 26.8%) and non-re-stented segments in irradiated patients.Additional lumen gain from re-stenting ISR lesions is counteracted by exaggerated neointimal proliferation in placebo patients. Maximum effectiveness and safety of radiation can be achieved for ISR lesions when treated without re-stenting. Thus, regardless of supplementary intravascular brachytherapy, repeat stenting strategies provided little long-term advantage.

    View details for DOI 10.1161/01.CIR.0000018949.39445.40

    View details for Web of Science ID 000175927500011

    View details for PubMedID 12034650

  • Effect of local delivery of L-arginine on in-stent restenosis in humans AMERICAN JOURNAL OF CARDIOLOGY Suzuki, T., Hayase, M., Hibi, K., Hosokawa, H., Yokoya, K., Fitzgerald, P. J., Yock, P. G., Cooke, J. P., Suzuki, T., Yeung, A. C. 2002; 89 (4): 363-367

    Abstract

    To determine whether intramural administration of L-arginine reduces intimal thickening after optimal Palmaz-Schatz stent deployment in humans, 50 patients with native coronary artery disease who received a single Palmaz-Schatz stent were enrolled in this pilot study. Patients were randomized into 2 treatment groups: an L-arginine group (n = 25) and a saline group (n = 25). After stent deployment, L-arginine (600 mg/6 ml) or saline (6 ml) was locally delivered via the Dispatch catheter (Scimed) over 15 minutes. Serial angiography and intravascular ultrasound examinations (motorized pull-back at 0.5 mm/s) were performed before and after the procedure, and at 6-month follow-up. Measurements of stent area, lumen area, and neointimal area were computed within the stents at 1-mm intervals, by technicians who were blinded to the treatment assignment. Using Simpson's rule, stent, plaque, and lumen volumes, neointimal volume within the stent, and percent neointimal volume were measured before and after the procedure, and at 6-month follow-up. The 6-month volume data in quantitative coronary ultrasound showed that neointimal volume in the L-arginine group was significantly less than in the saline group (25 vs 39 mm(3); p = 0.049). Similarly, percent neointimal volume was significantly less in the L-arginine group at 6-month follow-up (17 +/- 13% vs 27 +/- 21%; p = 0.048). Thus, these results showed that local delivery of L-arginine reduces in-stent neointimal hyperplasia in humans, indicating that this approach may be a novel strategy to prevent in-stent restenosis.

    View details for Web of Science ID 000173816400001

    View details for PubMedID 11835911

  • Predictors and outcomes of stent thrombosis - An intravascular ultrasound registry EUROPEAN HEART JOURNAL Uren, N. G., Schwarzacher, S. P., Metz, J. A., Lee, D. R., Honda, Y., Yeung, A. C., Fitzgerald, P. J., Yock, P. G. 2002; 23 (2): 124-132

    Abstract

    To investigate whether intravascular ultrasound provides additional information regarding the prediction of stent thrombosis, a retrospective multicentre registry was designed to enrol patients with stent thrombosis following stent deployment under ultrasound guidance.A total of 53 patients were enrolled (mean age 61+/-9 years) with stable angina (43%), unstable angina (36%), and post-infarct angina (21%) who underwent intracoronary stenting. The majority had balloon angioplasty alone prior to stenting (94%) with 6% also undergoing rotational atherectomy. The indication for stenting was elective (53%), suboptimal result (32%) and bailout (15%). There were 1.6+/-0.8 stents/artery with 87% undergoing high-pressure dilatation (> or =14 atmospheres). The minimum stent area was 7.7+/-2.8 mm(2)with a mean stent expansion of 81.5+/-21.9%. Overall, 94% of cases demonstrated one abnormal ultrasound finding (stent under-expansion, malapposition, inflow/outflow disease, dissection, or thrombus). Angiography demonstrated an abnormality in only 32% of cases (chi-square=30.0, P<0.001). Stent thrombosis occurred at 132+/-125 h after deployment. Myocardial infarction occurred in 67% and there was an overall mortality of 15%.On comparison with angiography, the vast majority of stents associated with subsequent thrombosis have at least one abnormal feature by intravascular ultrasound at the time of stent deployment.

    View details for DOI 10.1053/euhj.2001.2707

    View details for Web of Science ID 000173390100009

    View details for PubMedID 11785994

  • Effects of transducer position on backscattered intensity in coronary arteries ULTRASOUND IN MEDICINE AND BIOLOGY Courtney, B. K., Robertson, A. L., Maehara, A., Luna, J., Kitamura, K., Morino, Y., Achalu, R., Kirti, S., Yock, P. G., Fitzgerald, P. J. 2002; 28 (1): 81-91

    Abstract

    Acute myocardial infarction is a frequent cause of sudden death, and is typically initiated by the rupture of coronary artery plaques. The likelihood and severity of rupture are influenced by the plaque structures and components. Radiofrequency (RF) intravascular ultrasound (US) (IVUS-RF) measurements extend current IVUS imaging techniques and may eventually enable the in vivo identification of these features. However, IVUS-RF measurements are affected by the transducer's instantaneous position in the vessel. Specifically, backscattered intensity (BI) decreases as either the distance between the tissue and the transducer increases, or as the beam's angle of incidence on the tissue increases. IVUS-RF data were acquired from seven disease-free coronary arteries in vitro. The 0-dB level for BI was defined as the peak intensity of the reflection from a stainless-steel flat reflector at each distance. The baseline BI measured in adventitial tissue was -32.5 dB (at 0 degrees, 0 mm) with angle and distance dependencies of -0.172 dB/ degrees and -3.37 dB/mm. In contrast, the BI from combined intima and media was -38.2 dB with dependencies of -0.111 dB/ degrees and -4.46 dB/mm (p < 0.05 for all three parameters). Acknowledging and compensating for these effects may allow IVUS-RF to develop into a rapidly deployable tool for the clinical detection of vulnerable plaques and to monitor coronary artery disease progression and regression.

    View details for Web of Science ID 000174317900009

    View details for PubMedID 11879955

  • Intravascular ultrasound and quantitative coronary angiography CATHETERIZATION AND CARDIOVASCULAR INTERVENTIONS Takahashi, T., Honda, Y., Russo, R. J., Fitzgerald, P. J. 2002; 55 (1): 118-128

    View details for Web of Science ID 000172956000024

    View details for PubMedID 11793508

  • Impact of pre-interventional arterial remodeling on subsequent vessel behavior after balloon angioplasty: A serial intravascular ultrasound study JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY Okura, H., Hayase, M., Shimodozono, S., Bonneau, H. N., Yock, P. G., Fitzgerald, P. J. 2001; 38 (7): 2001-2005

    Abstract

    The purpose of this study was to assess the impact of pre-intervention arterial remodeling on subsequent vessel behavior following balloon angioplasty.Positive arterial remodeling before intervention has been shown to have a negative impact on the clinical outcome after nonstented coronary interventional procedures. However, the mechanism of interventions in coronary vessel geometry over time is less well characterized.Serial (pre-, post- and follow-up) intravascular ultrasound analysis was performed in 46 native coronary lesions. Positive remodeling (PR) was defined as vessel area (VA) at the target lesion greater than that of average reference segments. Intermediate or negative remodeling (IR/NR) was defined as VA at the target lesion less than or equal to that of average reference segment. Remodeling index was defined as VA at the target lesion site divided by that of average references.Pre-interventional PR and IR/NR were present in 21 (46%) and 25 (54%) of 46 patients, respectively. At follow-up, the change in plaque area was similar between the two groups (1.3 +/- 2.1 vs. 1.2 +/- 2.1 mm(2), p = 0.840). Lesions with PR showed a significantly smaller change in VA than those with IR/NR (-0.2 +/- 2.5 vs. 1.4 +/- 2.3 mm(2), p = 0.03). As a result, late lumen loss was significantly larger in lesions whose pre-intervention configuration exhibited PR (-1.5 +/- 1.8 vs. 0.2 +/- 1.6 mm(2), p = 0.002).Lesions with PR appear to have less capacity to compensate for further plaque growth after balloon angioplasty and thus show a proportional increase in late lumen loss. This may in part explain the less favorable clinical outcomes of positively remodeled lesions.

    View details for Web of Science ID 000172458000035

    View details for PubMedID 11738307

  • Efficacy of postdeployment balloon dilatation for current generation stents as assessed by intravascular ultrasound AMERICAN JOURNAL OF CARDIOLOGY Hur, S. H., Kitamura, K., Morino, Y., Honda, Y., Jones, M., Korr, K. S., Reen, B., Cooper, C. J., Niess, G. S., Christie, L., Corey, W., Messenger, J., Yock, P. G., Cummins, F., Fitzgerald, P. J. 2001; 88 (10): 1114-1119

    Abstract

    Adjunctive balloon dilatation strategy has been shown to improve optimal stent deployment. As improvements in current stent designs evolve, less adjunctive balloon dilatation may be needed. However, few data currently exist to support this practice. We evaluated 88 native coronary lesions treated with single stent implantation (Nir, Tristar or S670). Serial intravascular ultrasound was performed after successful stent deployment and again after adjunctive balloon dilatation. To investigate further the precise expansion characteristics of the stents, serial volumetric intravascular ultrasound analyses were performed in 40 patients with automated pullback. After adjunctive balloon dilatation, minimal stent area increased significantly, from 6.4 +/- 2.1 to 7.4 +/- 2.2 mm(2) (p <0.001). Volumetric analysis showed a corresponding increase in stent volume index (6.6 +/- 1.8 to 7.5 +/- 2.0 mm(3)/mm, p <0.001). In the analysis of cross sections at 0.5-mm axial intervals, the percentage of cross sections, where stent area was > or =80% of the average reference lumen area, increased from 51% to 78% (p <0.001). Similarly, the percentage of cross sections, where stent area was > or =90% of the average reference lumen area, increased from 29% to 56% (p <0.001) with postdilatation. Postdeployment high- pressure balloon dilatation improved minimal stent area and volumetric expansion throughout the stented segment.

    View details for Web of Science ID 000172412300006

    View details for PubMedID 11703954

  • The renaissance of directional coronary atherectomy: a second look from the inside. journal of invasive cardiology Honda, Y., Fitzgerald, P. J. 2001; 13 (11): 748-751

    View details for PubMedID 11689719

  • Fractional flow reserve compared with intravascular ultrasound guidance for optimizing stent deployment CIRCULATION Fearon, W. F., Luna, J., Samady, H., Powers, E. R., Feldman, T., Dib, N., Tuzcu, E. M., Cleman, M. W., Chou, T. M., Cohen, D. J., Ragosta, M., Takagi, A., Jeremias, A., Fitzgerald, P. J., Yeung, A. C., Kern, M. J., Yock, P. G. 2001; 104 (16): 1917-1922

    Abstract

    Determination of fractional flow reserve (FFR) has been proposed as a means to assess stent deployment. In this prospective, multicenter trial, we evaluate the use of FFR to optimize stenting by comparing it with standard intravascular ultrasound (IVUS) criteria.Eighty-four stable patients with isolated coronary lesions underwent coronary stent deployment starting at 10 atm and increased serially by 2 atm until the FFR was >/=0.94 or 16 atm was achieved. IVUS was then performed. FFR was measured with a coronary pressure wire with intracoronary adenosine to induce hyperemia. The diagnostic characteristics of an FFR <0.94 to predict suboptimal stent expansion by IVUS, defined in both absolute and relative terms, were calculated. Over a range of IVUS criteria, the highest sensitivity, specificity, and predictive accuracy of FFR were 80%, 30%, and 42%, respectively. Receiver operator characteristic analysis defined an optimal FFR cut point at >/=0.96; at this threshold, the sensitivity, specificity, and predictive accuracy of FFR were 75%, 58%, and 62%, respectively (P=0.03 for comparison of predictive accuracy, P=0.01 for concordance between FFR and IVUS). The negative predictive value was 88%. Significantly better diagnostic performance was achieved in a subgroup that received higher doses (>30 microgram) of intracoronary adenosine during pressure measurements, suggesting that FFR might be overestimated in the other group.A fractional flow reserve <0.96, measured after stent deployment, predicts a suboptimal result based on validated intravascular ultrasound criteria; however, an FFR >/=0.96 does not reliably predict an optimal stent result. Higher doses of intracoronary adenosine than previously used to measure FFR improve these results.

    View details for Web of Science ID 000171828700011

    View details for PubMedID 11602494

  • An optimal diagnostic threshold for minimal stent area to predict target lesion revascularization following stent implantation in native coronary lesions AMERICAN JOURNAL OF CARDIOLOGY Morino, Y., Honda, Y., Okura, H., Oshima, A., Hayase, M., Bonneau, H. N., Kuntz, R. E., Yock, P. G., Fitzgerald, P. J. 2001; 88 (3): 301-?

    View details for Web of Science ID 000170090500020

    View details for PubMedID 11472713

  • Novel drug-delivery stent - Intravascular ultrasound observations from the first human experience with the QP2-eluting polymer stent system CIRCULATION Honda, Y., Grube, E., de la Fuente, L. M., Yock, P. G., Stertzer, S. H., Fitzgerald, P. J. 2001; 104 (4): 380-383

    Abstract

    The aim of this study was to use serial intravascular ultrasound (IVUS) to evaluate the long-term effect of stent-based 7-hexanoyltaxol (QP2, a taxane analogue) delivery on neointimal tissue growth within the stent and on vessel dimensions at the adjacent reference segments.Serial IVUS analyses (immediately after intervention and at follow-up at 8.3 months) were performed in 15 native coronary lesions treated with the QuaDS-QP2 stent. IVUS measurements were performed at 8 cross-sections in each target segment (4 cross-sections within the stent and 2 cross-sections in each reference segment). At baseline, no significant plaque protrusion or thrombus was detected in the target segment. Mild incomplete stent apposition and edge dissection were observed in one and two cases, respectively. Percent expansion of the stent (minimum stent area/average reference lumen area) was 96.0+/-21.7%. At follow-up, mean neointimal area within the stent was 1.2+/-1.3 mm(2), and mean cross-sectional narrowing (neointimal area/stent area) was 13.6+/-14.9%. At the vessel segments immediately adjacent to the stent, a significant increase in plaque area (1.9+/-2.6 mm(2), P=0.001) was observed, but vessel area remained unchanged. However, no patients showed clinically significant in-stent or edge restenosis (diameter stenosis >/=50%) during the follow-up period.The first human experience with the new drug-delivery stent showed a minimal amount of neointimal proliferation in the stented segment. Late lumen loss at the reference sites adjacent to the stent was acceptable and predominantly due to plaque proliferation.

    View details for Web of Science ID 000170116200003

    View details for PubMedID 11468196

  • Vascular brachytherapy: what have we learned from intravascular ultrasound? journal of invasive cardiology Morino, Y., Bonneau, H. N., Fitzgerald, P. J. 2001; 13 (5): 409-416

    Abstract

    With the advent of intravascular brachytherapy (IVBT), a striking reduction in the rate of restenosis has been observed. The use of intravascular ultrasound (IVUS) during IVBT trials has shown many aspects and relevant pathophysiologic mechanisms following this practical therapy. Specifically, IVUS quantitative assessments have demonstrated a drastic inhibition of both neointimal formation and negative remodeling to be the predominant vascular response to IVBT. Moreover, IVBT has shown promise for challenging high-risk restenosis cases, such as patients with diabetes mellitus and smaller caliber target vessels. However, unexpected radiation-induced complications have also been discovered, as more patients have been treated for a broad class of lesion subsets. Edge effect, induced by catheter-based radiation, was seen to be due to geographic miss of the radiation source, advocating a new concept known as "radiation edge". Furthermore, late thrombosis, which is known to be strongly associated with new stent implantation following IVBT, may be avoided with novel antiplatelet agents. Two additional complications, whose clinical significance remains unclear, are unhealed dissection and late stent malapposition featured by IVUS qualitative assessment. Unhealed dissection was observed in half of radiated dissections and late stent malapposition has been seen for all radiation sources in a small percentage of cases at 6-12 months follow-up. Radiation sources, dosimetry, and delivery methods continue to improve and should ultimately translate to more effective treatment for the patient with atherosclerotic coronary disease.

    View details for PubMedID 11385159

  • Impact of peri-stent remodeling on restenosis - A volumetric intravascular ultrasound study CIRCULATION Nakamura, M., Yock, P. G., Bonneau, H. N., Kitamura, K., Aizawa, T., Tamai, H., Fitzgerald, P. J., Honda, Y. 2001; 103 (17): 2130-2132

    Abstract

    Vessel remodeling is an important mechanism of late lumen loss after nonstent coronary interventions. However, its impact on in-stent restenosis has not been systematically investigated.Serial volumetric intravascular ultrasound analyses (poststent and follow-up) were performed in 55 lesions treated with a balloon-expandable stent (ACS MultiLink) using standard stent deployment techniques. The vessel volume (VV), lumen volume (LV), and volume bordered by the stent (SV) were measured using Simpson's method. The volume of plaque and neointima outside the stent (peri-stent volume, PSV) and volume of neointima within the stent (intrastent volume) were also measured. The change of each parameter during the follow-up period (follow-up minus poststent) was calculated and then divided by SV to normalize these values (designated as percent change [%]). As expected, %PSV directly correlated with %VV (P<0.0001, r=0.935), with no significant SV. A highly significant inverse correlation was seen between %PSV and the percent change of intrastent volume (P<0.0001, r=0.517). Consequently, %LV significantly correlated with peri-stent remodeling, as measured by %VV (P<0.0001, r=0.602).Positive remodeling of the vessel exterior to a coronary stent occurs to a variable degree after stent implantation. There is a distinct trade-off between positive remodeling and in-stent hyperplasia: in segments in which the degree of peri-stent remodeling is less, intrastent neointimal proliferation is greater and accompanied by more significant late lumen loss.

    View details for Web of Science ID 000168583700002

    View details for PubMedID 11331251

  • Intravascular sonotherapy decreases neointimal hyperplasia after stent implantation in swine CIRCULATION Fitzgerald, P. J., Takagi, A., Moore, P., Hayase, M., Kolodgie, F. D., Corl, D., Nassi, M., Virmani, R., Yock, P. 2001; 103 (14): 1828-1831

    Abstract

    Intimal hyperplasia and subsequent in-stent restenosis remain a major limitation after stent implantation. In vitro cell culture studies show that low-frequency, noncavitational ultrasound energy may impact smooth muscle cell proliferation. Accordingly, we assessed the efficacy of intravascular sonotherapy treatment on intimal hyperplasia in a swine stent model.After balloon injury, biliary stents (Johnson & Johnson) were implanted in the femoral arteries of 14 swine. A total of 48 stented sites were randomized to sonotherapy or sham treatment using a custom-built, 8-French catheter intravascular sonotherapy system (URX, PharmaSonics Inc). After stent deployment, ultrasound energy (700 KHz) was applied to the treatment group for up to 5 minutes. Smooth muscle cell proliferation was assessed using bromodeoxyuridine histology preparation (BrdU) at 7 days in 28 stented sites. At 28 days, the neointimal thickness and the ratio of neointimal/stent area (percent stenosis) was calculated by histomorphometric quantification in 20 stented sites. At 7 days, percent of BrdU staining was significantly reduced in the sonotherapy group compared with the sham group (24.1+/-7.0% versus 31.2+/-3.0%, P<0.05). At 28 days, percent stenosis was significantly less in the sonotherapy group than in the sham group (36+/-24% versus 44+/-27%, P<0.05), and the mean neointimal thickness in the sonotherapy group was less than in the sham group (417+/-461 micrometer versus 643+/-869 micrometer, P=0.06).In this swine peripheral model, intravascular sonotherapy seemed to decelerate cellular proliferation and decrease in-stent hyperplasia. Therefore, intravascular sonotherapy may be an effective form of nonionizing energy to reduce in-stent restenosis.

    View details for Web of Science ID 000168122300010

    View details for PubMedID 11294798

  • Long-term vessel response to a self-expanding coronary stent: A serial volumetric intravascular ultrasound analysis from the ASSURE trial JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY Kobayashi, Y., Honda, Y., Christie, L. G., Teirstein, P. S., Bailey, S. R., Brown, C. L., Matthews, R. V., De Franco, A. C., Schwartz, R. S., Goldberg, S., Popma, J. J., Yock, P. G., Fitzgerald, P. J. 2001; 37 (5): 1329-1334

    Abstract

    We sought to investigate the in vivo mechanical properties of a new self-expanding coronary stent (RADIUS) and, particularly, the subsequent vessel response over time.Preclinical studies have suggested that self-expanding stents may produce less vessel wall injury at initial deployment, leading to larger follow-up lumens than with balloon-expandable stents. However, the influence of the chronic stimulus from self-expanding stents on the vessel wall remains unknown.Sixty-two patients were randomly assigned to either the RADIUS self-expanding stent group (n = 32) or the Palmaz-Schatz balloon-expandable stent group (n = 30). Intravascular ultrasound was performed after stent deployment and at six-month follow-up.At follow-up, the RADIUS stents had increased 23.6% in overall volume, while the Palmaz-Schatz stents had remained unchanged. Due to the greater mean neointimal area (3.0 +/- 1.7 mm2 vs. 1.9 +/- 1.2 mm2, p = 0.02) in the RADIUS group, no significant difference in net late lumen loss was observed between the two groups. On the other hand, analysis at the peristent margins demonstrated that mean late loss was significantly smaller in the RADIUS group than it was in the Palmaz-Schatz group (0.1 +/- 2.1 mm2 vs. 1.9 +/- 2.4 mm2, p = 0.02).Serial volumetric IVUS revealed that the RADIUS stents continued to enlarge during the follow-up period. In this stent implantation protocol, this expansion was accompanied by a greater amount of neointima than the Palmaz-Schatz stents, resulting in similar late lumen loss in both configurations. In the peristent margins, however, late lumen loss was minimized with the RADIUS stents.

    View details for Web of Science ID 000167901700027

    View details for PubMedID 11300443

  • Preintervention arterial remodeling affects clinical outcome following stenting: An intravascular ultrasound study JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY Okura, H., Morino, Y., Oshima, A., Hayase, M., Ward, M. R., Popma, J. J., Kuntz, R. E., Bonneau, H. N., Yock, P. G., Fitzgerald, P. J. 2001; 37 (4): 1031-1035

    Abstract

    The study was done to elucidate the relationship between baseline arterial remodeling and clinical outcome following stenting.The impact of preintervention arterial remodeling on subsequent vessel response and clinical outcome has been reported following nonstent coronary interventions. However, in stented segments, the impact of preintervention remodeling on clinical outcome has not been clarified.Preintervention remodeling was assessed in 108 native coronary lesions by using intravascular ultrasound (IVUS). Positive remodeling (PR) was defined as vessel area (VA) at the target lesion greater than that of average reference segments. Intermediate or negative remodeling (IR/NR) was defined as VA at the target lesion less than or equal to that of average reference segment. Remodeling index expressed as a continuous variable was defined as VA at the target lesion site divided by that of average reference segments.Positive remodeling was present in 59 (55%) and IR/NR in 49 (45%) lesions. Although final minimal stent areas were similar (7.76 +/- 1.80 vs. 8.09 +/- 1.90 mm2, p = 0.36), target vessel revascularization (TVR) rate at nine-month follow-up was significantly higher in the PR group (22.0% vs. 4.1%, p = 0.01). By multivariate logistic regression analysis, higher remodeling index was the only independent predictor of TVR (p = 0.02).Lesions with PR before intervention appear to have a worse clinical outcome following IVUS-guided stenting. Intravascular ultrasound imaging before stenting may be helpful to stratify lesions at high risk for accelerated intimal proliferation.

    View details for Web of Science ID 000167515700010

    View details for PubMedID 11263604

  • The influence of plaque orientation (pericardial or myocardial) on coronary arterial remodeling ATHEROSCLEROSIS Ward, M. R., Jeremias, A., Hibi, K., Herity, N. A., Lo, S. T., Filardo, S. D., Lee, D. P., Fitzgerald, P. J., Yeung, A. C. 2001; 154 (1): 179-183

    Abstract

    Many systemic, regional and lesion factors have been identified which may influence arterial remodeling, but little is known about the importance of extravascular resistance to vessel enlargement. As myocardial systolic splinting may significantly affect vessel expansion the effect of plaque orientation on arterial remodeling in eccentric coronary atherosclerotic lesions was examined.Using intravascular ultrasound imaging to obtain cross-sectional vessel area (VA), plaque area (PA) and lumen area (LA), remodeling in eccentric left anterior descending coronary artery lesions was compared which predominantly involved the pericardial or free arc (P, n=25) and the myocardial side (M, n=40) of the vessel wall. Normalized vessel area (NVA, VA(lesion)/VA(reference)) was compared as a continuous and categorical variable (positive>1.05, intermediate 0.95-1.05, negative<0.95) as well as remodeling index (RI, VA(lesion)-VA(reference)/PA(lesion)-PA(reference)).The two groups were well matched for clinical and lesion characteristics known to affect remodeling. Reference segments areas were similar in the two groups; while lesion LA was also similar, in the pericardial group there was significantly greater lesion PA (P 12.78+/-0.72, M 10.26+/-0.50 mm(2), P<0.05) and VA (P 15.71+/-0.90, M 12.82+/-0.57 mm(2), P<0.05) demonstrating enhanced compensatory remodeling. Outward remodeling was significantly greater in P than in M by both NVA (P 1.03+/-0.03, M 0.86+/-0.03, P<0.01) and RI (P 0.02+/-0.07, M -1.10+/-0.32, P<0.01). Positive, intermediate and negative remodeling occurred in nine, nine and seven lesions in P and in four, ten and 26 lesions in M (P<0.01).Remodeling compensates more for plaque growth in eccentric coronary lesions which are surrounded by the pericardium than those surrounded by the myocardium. Extravascular resistance appears to influence arterial remodeling.

    View details for Web of Science ID 000166116000022

    View details for PubMedID 11137098

  • Impact of plaque burden on subsequent intimal proliferation and remodeling of the stented coronary arteries following intracoronary beta-radiation therapy. Cardiovascular radiation medicine Okura, H., Lee, D. P., Yeung, A. C., Oesterle, S. N., Waksman, R., Kaluza, G. L., Ali, N. M., Yock, P. G., Raizner, A. E., Fitzgerald, P. J. 2001; 2 (1): 57

    View details for PubMedID 11068273

  • Longitudinal plaque redistribution during stent expansion AMERICAN JOURNAL OF CARDIOLOGY Maehara, A., Takagi, A., Okura, H., Hassan, A. H., Bonneau, H. N., Honda, Y., Yock, P. G., Fitzgerald, P. J. 2000; 86 (10): 1069-1072

    Abstract

    The purpose of this study was to clarify the 3-dimensional behavior of plaque during coronary stent expansion. Serial intravascular ultrasound (IVUS) studies, preintervention, and poststenting were evaluated in 32 patients treated with a single-balloon expandable tubular stent. External elastic membrane (EEM), lumen, stent, and plaque + media cross-sectional area were measured at 1-mm intervals through the entire stent as well as proximal and distal reference segments 5 mm from the stent edge. Volumetric calculations were based on Simpson's rule. Overall, the plaque + media volume through the entire lesion did not change during stent expansion (218 +/- 51 vs 217 +/- 47 mm3, p = 0.69). However, EEM and lumen volume increased significantly (EEM volume, 391 +/- 84 vs 448 +/- 87 mm3 [p < 0.0001]; lumen volume, 173 +/- 52 vs 231 +/- 54 mm3 [p < 0.0001]). The change in lumen volume correlated strongly with the change in EEM volume (r = 0.85, p < 0.0001), but poorly with the change in plaque + media volume (r = 0.37, p = 0.03). Plaque + media volume decreased in the midstent zone (59 +/- 14 vs 53 +/- 11 mm3, p = 0.0005), and increased in the distal stent zone (40 +/- 11 vs 44 +/- 9 mm3, p = 0.003), but did not change in either the proximal stent zone or reference segments. The mechanism of stent expansion is a combination of vessel stretch and plaque redistribution, translating disease accumulation from the midstent zone to the distal stent zone.

    View details for Web of Science ID 000165185500003

    View details for PubMedID 11074201

  • Selective regional myocardial infiltration by the percutaneous coronary venous route: A novel technique for local drug delivery CATHETERIZATION AND CARDIOVASCULAR INTERVENTIONS Herity, N. A., Lo, S. T., Oei, F., Lee, D. P., Ward, M. R., Filardo, S. D., Hassan, A., Suzuki, T., Rezaee, M., Carter, A. J., Yock, P. G., Yeung, A. C., Fitzgerald, P. J. 2000; 51 (3): 358-363

    Abstract

    Recent advances in the treatment of heart disease, in particular cardiovascular gene therapy and therapeutic angiogenesis, highlight the need for efficient and practical local delivery methods for the heart. We assessed the feasibility of percutaneous selective coronary venous cannulation and injection as a novel approach to local myocardial drug delivery. In anesthetized swine, the coronary sinus was cannulated percutaneously and a balloon-tipped catheter advanced to the anterior interventricular vein (AIV) or middle cardiac vein (MCV). During balloon occlusion, venous injection of radiographic contrast caused regional infiltration of targeted myocardial regions. Complete AIV occlusion had no impact on LAD flow parameters. Videodensitometric analysis following venous injection showed that radiographic contrast persisted for at least 30 min. Selective regional myocardial infiltration is feasible by this approach, targeting selected myocardial beds, including the apex, anterior wall, septum, and inferoposterior wall. This novel technique has potential application for local myocardial drug or growth factor delivery. Cathet. Cardiovasc. Intervent. 51:358-363, 2000.

    View details for Web of Science ID 000165141100027

    View details for PubMedID 11066126

  • Feasibility of a novel blood noise reduction algorithm to enhance reproducibility of ultra-high-frequency intravascular ultrasound images CIRCULATION Hibi, K., Takagi, A., Zhang, X. M., Teo, T. J., Bonneau, H. N., Yock, P. G., Fitzgerald, P. J. 2000; 102 (14): 1657-1663

    Abstract

    Ultra-high-frequency (40- to 50-MHz) intravascular ultrasound (IVUS) improves image quality compared with conventional 20- to 30-MHz IVUS. However, as the frequency of IVUS increases, high-intensity backscatter from blood components may cause visual difficulties in discrimination between the lumen and arterial wall structure. The purpose of this study was to evaluate the effect of a novel blood noise reduction algorithm (BNR) on quantitative coronary ultrasound measurements.IVUS studies using a 40-MHz transducer were performed in 35 patients with coronary artery disease. A total of 620 gray-scale images (310 pairs) were processed with and without the BNR, and lumen cross-sectional area (CSA) was determined by 2 independent observers. With the BNR, the intraobserver and interobserver correlation coefficients for lumen CSA were significantly improved (0.85 to 0.99 and 0.80 to 0.98, respectively). In the 270 images (135 pairs) in which vessel wall measurements were possible, the BNR significantly improved the intraobserver and interobserver correlation coefficients for plaque plus media CSA (0.83 to 0.99 and 0.76 to 0.97, respectively), whereas no influence was observed for external elastic membrane CSA (1.00 to 1.00 and 0.99 to 0.99, respectively).This study demonstrates the feasibility of this novel algorithm to reduce blood noise, thereby enabling accurate lumen border delineation and providing reproducible measurements of both the lumen and plaque plus media CSAs. Incorporating a digital BNR may serve as an important adjunct to ultra-high-frequency IVUS imaging for improving accurate quantitative evaluation of vessel dimensions.

    View details for Web of Science ID 000089593000012

    View details for PubMedID 11015344

  • Adequacy of intracoronary versus intravenous adenosine-induced maximal coronary hyperemia for fractional flow reserve measurements AMERICAN HEART JOURNAL Jeremias, A., Whitbourn, R. J., Filardo, S. D., Fitzgerald, P. J., Cohen, D. J., Tuzcu, M., Anderson, W. D., Abizaid, A. A., Mintz, G. S., Yeung, A. C., Kern, M. J., Yock, P. G. 2000; 140 (4): 651-657

    Abstract

    Fractional flow reserve (FFR) is a measure of coronary stenosis severity that is based on pressure measurements obtained at maximal hyperemia. The most widely used pharmacologic stimulus for maximal coronary hyperemia is adenosine, administered either as a continuous intravenous (IV) infusion or intracoronary (IC) bolus. IV adenosine has more side effects and is more costly than IC adenosine but has a more stable and prolonged hyperemic effect.We compared the efficacy of IC and IV adenosine administration for the measurement of FFR in a multicenter trial. Fifty-two patients with 60 lesions underwent determination of FFR with both IV and IC adenosine. IV adenosine was administered as a continuous infusion at a rate of 140 microgram/kg per minute until a steady state hyperemia was achieved. IC adenosine boluses were administered at a dose of 15 to 20 microgram in the right and 18 to 24 microgram in the left coronary artery. FFR was calculated as the ratio of the distal coronary pressure (from pressure guide wire) to the aortic pressure (guide catheter) at maximal hyperemia.A total of 26 left anterior descending, 23 right, 9 left circumflex, and 3 left main coronary arteries were evaluated. Mean percent stenosis for both groups was 55.8% +/- 23.6% (range 0% to 95%), and mean FFR was 0.78 +/- 0.15 (range 0.41 to 0.98). There was a strong and linear correlation between FFR measurements with IV and IC adenosine (R = 0.978, y = 0. 032 + 0.964x, P <.001). The agreement between the 2 sets of measurements was also high, with a mean difference in FFR of -0.004 +/- 0.03. However, a small random scatter in both directions of FFR measurements was noted with 5 lesions (8.3%) where FFR with IC adenosine was higher by 0.05 or more compared with IV infusions, suggesting a suboptimal hyperemic response in these patients. Changes in heart rate and blood pressure were significantly higher with IV adenosine. Two patients with IV, but none with IC adenosine, had severe side effects (bronchospasm and severe nausea).These results suggest that IC adenosine is equivalent to IV infusion for the determination of FFR in the majority of patients. However, in a small percentage of cases, coronary hyperemia was suboptimal with IC adenosine.

    View details for Web of Science ID 000089692600016

    View details for PubMedID 11011341

  • Tissue characterization of atherosclerotic plaques by intravascular ultrasound radiofrequency signal analysis: An in vitro study of human coronary arteries AMERICAN HEART JOURNAL Komiyama, N., Berry, G. J., Kolz, M. L., Oshima, A., Metz, J. A., Preuss, P., Brisken, A. F., Moore, M. P., Yock, P. G., Fitzgerald, P. J. 2000; 140 (4): 565-574

    Abstract

    Conventional gray-scale images of intravascular ultrasound (IVUS) cannot accurately differentiate histologic subtypes of sonolucent coronary plaques with or without a lipid core.We analyzed radiofrequency signals obtained in vitro from 24 regions of interest (ROI) of noncalcified (sonolucent) plaques in 10 atherosclerotic coronary artery specimens pressure-fixed by formalin. Radiofrequency signals were sampled with a 30-MHz IVUS catheter and digitized at 500 MHz in 8-bit resolution. The ROIs were histologically categorized into 12 plaques with a lipid core and 12 plaques without it. Integrated backscatter and statistical parameters of the radiofrequency envelope (mean/SD ratio [MSR], skewness, and kurtosis) within the ROI were calculated offline, and their ability to detect a lipid core was compared with visual analysis of the IVUS video images. In the group with lipid cores, percent area of a lipid core in each ROI was measured in a digitized histologic image by a computerized planimeter.Sensitivity and specificity of MSR, skewness, and kurtosis for lipid core detection were substantially greater than visual video image analysis (83.3% and 91.7%, 100% and 91.7%, 100% and 91.7% vs 53.3% and 71.7%). Furthermore, the parameters of integrated backscatter, MSR, skewness, and kurtosis were significantly correlated to percent of core area (r = -0.64, -0.73, 0.78, and 0.63, respectively; P<.05).Compared with IVUS video images, the parameters of radiofrequency signal analysis may be used to aid in more accurate detection and quantitative evaluation of a lipid core, which is one of the major factors of a vulnerable coronary plaque.

    View details for Web of Science ID 000089692600005

    View details for PubMedID 11011329

  • Spatial orientation of atherosclerotic plaque in non-branching coronary artery segments ATHEROSCLEROSIS Jeremias, A., Huegel, H., Lee, D. P., Hassan, A., Wolf, A., Yeung, A. C., Yock, P. G., Fitzgerald, P. J. 2000; 152 (1): 209-215

    Abstract

    It has been postulated that atherosclerotic plaque deposition is spatially related to regions of low shear in non-branching vessel segments. Intravascular ultrasound (IVUS) allows precise spatial orientation of coronary artery plaque formation in humans. The objective of this study was to test the hypothesis that coronary plaques have a higher prevalence on the myocardial side in regions that encounter low surface shear stress. IVUS allows the determination of the inner versus the outer curve of the vessel based on vascular and perivascular landmarks. We studied 30 consecutive patients pre-intervention using IVUS and measured vessel area, lumen area and plaque area (vessel-lumen area) during a motorized pullback at 1 mm intervals. Vessel segments near a side branch (within two times the diameter of the vessel) were excluded from analysis because of flow disturbances. All plaques were classified as concentric or eccentric and all eccentric plaques were further divided with respect to their spatial orientation in the vessel into quadrants: myocardial (inner curve, lower shear stress), epicardial (outer curve, higher shear stress) and lateral (two quadrants intermediate). A total of 613 cross-sections were analyzed in 14 left anterior descending, six left circumflex, and ten right coronary arteries. Plaque distribution was found to be concentric in 321 (52.4%) and eccentric in 292 (47.6%) cross sections. Of all eccentric plaques, 184 cross sections were oriented toward the myocardial side (62.6%) compared to only 54 toward the epicardial side (17.3%) and 54 in the 2 lateral quadrants (19.5%, P<0.001). No difference in plaque area (6.75+/-2.70 vs. 6.76+/-2.60 mm(2)), vessel area (15.28+/-4.73 vs. 15.35+/-4.40 mm(2)), or plaque thickness (1.26+/-0.37 vs. 1.25+/-0.43 mm) was noted between myocardial or epicardial plaques. These results suggest that atherosclerotic plaques develop more frequently on the myocardial side of the vessel wall, which may relate to lower shear stress. However, plaque size is similar on the epicardial and myocardial side.

    View details for Web of Science ID 000089447700025

    View details for PubMedID 10996357

  • Coronary artery compliance and adaptive vessel remodelling in patients with stable and unstable coronary artery disease HEART Jeremias, A., Spies, C., Herity, N. A., Pomerantsev, E., Yock, P. G., Fitzgerald, P. J., Yeung, A. C. 2000; 84 (3): 314-319

    Abstract

    To test the hypothesis that patients with unstable coronary syndromes show accentuated compensatory vessel enlargement compared with patients with stable angina, and that this may in part be related to increased coronary artery distensibility.In 23 patients with unstable coronary syndromes (10 with non-Q wave myocardial infarction and 13 with unstable angina), the culprit lesion was investigated by intravascular ultrasound before intervention. The vessel cross sectional area (VA), lumen area (LA), and plaque area (VA minus LA) were measured at end diastole and end systole at the lesion site and at the proximal and distal reference segments. Similar measurements were made in 23 patients with stable angina admitted during the same period and matched for age, sex, and target vessel. Calculations were made of remodelling index (VA at lesion site / VA at reference site), distensibility index ([(delta A/A)/delta P] x 10(3), where delta A is the luminal area change in systole and diastole and delta P the difference in systolic and diastolic blood pressure measured at the tip of the guiding catheter during a cardiac cycle), and stiffness index beta ([ln(P(sys)/P(dias))]/(delta D/D), where P(sys) is systolic pressure, P(dias) is diastolic pressure, and delta D is the difference between systolic and diastolic lumen diameters). Positive remodelling was defined as when the VA at the lesion was > 1.05 times larger than at the proximal reference site, and negative remodelling when the VA at the lesion was < 0.95 of the reference site.Mean (SD) LA at the lesion site was similar in both groups (4.03 (1.8) v 4.01 (1. 93) mm(2)), while plaque area was larger in the unstable group (13. 29 (4.04) v 8.34 (3.6) mm(2), p < 0.001). Remodelling index was greater in the unstable group (1.14 (0.18) v 0.83 (0.15), p < 0.001). Positive remodelling was observed in 15 patients in the unstable group (65%) but in only two (9%) in the stable group (p < 0.001). Negative remodelling occurred only in two patients with unstable symptoms (9%) but in 17 (74%) with stable symptoms. At the proximal reference segment, the difference in LA between systole and diastole was 0.99 (0.66) mm(2) in the unstable group and 0.39 (0.3) mm(2) in the stable group (p < 0.001), and the calculated coronary artery distensibility was 3.09 (2.69) and 0.94 (0.83) per mm Hg in unstable and stable patients, respectively (p < 0.001). The stiffness index beta was lower in patients with unstable angina (1.95 (0.94) v 3.1 (0.96), p < 0.001).Compensatory vessel enlargement occurs to a greater degree in patients with unstable than with stable coronary syndromes, and is associated with increased coronary artery distensibility.

    View details for Web of Science ID 000089145800020

    View details for PubMedID 10956298

  • Final results of the Can Routine Ultrasound Influence Stent Expansion (CRUISE) study CIRCULATION Fitzgerald, P. J., Oshima, A., Hayase, M., Metz, J. A., Bailey, S. R., Baim, D. S., Cleman, M. W., DEUTSCH, E., Diver, D. J., Leon, M. B., Moses, J. W., Oesterle, S. N., Overlie, P. A., Pepine, C. J., Safian, R. D., Shani, J., Simonton, C. A., Smalling, R. W., Teirstein, P. S., Zidar, J. P., Yeung, A. C., Kuntz, R. E., Yock, P. G. 2000; 102 (5): 523-530

    Abstract

    Intravascular ultrasound (IVUS) can assess stent geometry more accurately than angiography. Several studies have demonstrated that the degree of stent expansion as measured by IVUS directly correlated to clinical outcome. However, it is unclear if routine ultrasound guidance of stent implantation improves clinical outcome as compared with angiographic guidance alone.The CRUISE (Can Routine Ultrasound Influence Stent Expansion) study, a multicenter study IVUS substudy of the Stent Anti-thrombotic Regimen Study, was designed to assess the impact of IVUS on stent deployment in the high-pressure era. Nine centers were prospectively assigned to stent deployment with the use of ultrasound guidance and 7 centers to angiographic guidance alone with documentary (blinded) IVUS at the conclusion of the procedure. A total of 525 patients were enrolled with completed quantitative coronary angiography, quantitative coronary ultrasound, and clinical events adjudicated at 9 months for 499 patients. The IVUS-guided group had a larger minimal lumen diameter (2.9+/-0.4 versus 2.7+/-0. 5 mm, P<0.001) by quantitative coronary angiography and a larger minimal stent area (7.78+/-1.72 versus 7.06+/-2.13 mm(2), P<0.001) by quantitative coronary ultrasound. Target vessel revascularization, defined as clinically driven repeat interventional or surgical therapy of the index vessel at 9 month-follow-up, occurred significantly less frequently in the IVUS-guided group (8.5% versus 15.3%, P<0.05; relative reduction of 44%).These data suggest that ultrasound guidance of stent implantation may result in more effective stent expansion compared with angiographic guidance alone.

    View details for Web of Science ID 000088486200010

    View details for PubMedID 10920064

  • Automated contour detection for high-frequency intravascular ultrasound imaging: A technique with blood noise reduction for edge enhancement ULTRASOUND IN MEDICINE AND BIOLOGY Takagi, A., Hibi, K., Zhang, X. M., Teo, T. J., Bonneau, H. N., Yock, P. G., Fitzgerald, P. J. 2000; 26 (6): 1033-1041

    Abstract

    Automated edge detection may standardize measurements among observers, providing for rapid assessment of intravascular ultrasound (IVUS) images. However, with high frequency images, enhanced blood signals make it difficult to define and trace the lumen borders. Accordingly, we evaluated a fully automated contour analysis facilitated with a blood noise reduction algorithm (BNR) for 40-MHz IVUS images in human coronary arteries of 27 patients. This algorithm is based on the principle that blood echo speckles have higher temporal and spatial variations than the arterial wall. A total of 193 paired lumen areas and 78 external elastic membrane (EEM) areas were measured and compared. Automated measurements showed good agreement with manual tracings for lumen and EEM area, with high correlation coefficients (0.945 and 0.950, respectively) and small variability (0.4 +/- 14.4% and 0.6 +/- 9.7%, respectively). This preliminary finding suggests that automated contour detection facilitated with BNR appeared to be a feasible and reliable technique for area measurements in 40-MHz IVUS imaging.

    View details for Web of Science ID 000089463900009

    View details for PubMedID 10996703

  • Review of closed dressings after laser resurfacing DERMATOLOGIC SURGERY Newman, J. P., Fitzgerald, P., Koch, R. J. 2000; 26 (6): 562-571

    Abstract

    Laser skin resurfacing has become an accepted technique for the treatment of facial rhytides and associated solar skin damage. Achieving a successful result is directly related to proper postoperative wound care during the reepithelialization process. There are open and closed approaches to the treatment of the post-laser resurfacing patient with distinct advantages and disadvantages.To review the most commonly used closed dressings after facial laser skin resurfacing and compare their advantages and disadvantages. To compare clinical findings with a group of patients treated exclusively with an open technique.Review of composite foams, polymer film, polymer mesh, and hydrogel products and prospective observations of clinical outcomes of patients treated with each dressing category after facial laser skin resurfacing. We perform a retrospective chart review of a group of patients treated exclusively with an open technique comparing crust formation, comfort, and pruritus with the prospective group of patients treated with closed dressings.The closed dressings available today each have unique structural configurations and adhesive properties intended to maintain an occlusive wound environment. Patient acceptance of these dressings was favorable, with improved comfort compared to the open dressing group. Complications of bacterial infections and contact dermatitis were not observed when closed dressings were used with a protocol for dressing changes performed at 48 hours. Rates of reepithelialization did not vary according to dressing category. Crust formation and postoperative pruritus occurred less frequently when closed occlusive dressings were worn by patients.When used properly, these dressings improve patient comfort, simplify their postoperative wound care, and do not increase the risk of infection or contact dermatitis. Overall satisfaction was highest with perforated mesh and polymer dressings for full-face wounds.

    View details for Web of Science ID 000087401300014

    View details for PubMedID 10848938

  • Determinants of coronary remodeling in transplant coronary disease - A simultaneous intravascular ultrasound and Doppler flow study CIRCULATION Schwarzacher, S. P., Uren, N. G., Ward, M. R., Schwarzkopf, A., Giannetti, N., Hunt, S., Fitzgerald, P. J., Oesterle, S. N., Yeung, A. C. 2000; 101 (12): 1384-1389

    Abstract

    Coronary remodeling plays a significant role in lumen loss in transplant allograft vasculopathy (TxCAD), but the determinants of remodeling are unknown. We assessed the relationship between remodeling and plaque topography, coronary compliance, and blood flow in TxCAD.One artery in each of 27 transplant patients was investigated with simultaneous intravascular ultrasound and coronary flow measurements (basal and hyperemic by Doppler flow wire). At 4 to 8 different cross sections (mean 5.1+/-1. 2), plaque topography (concentric or eccentric) was determined, and total vessel area, lumen area, and intimal/medial area (IMA) were measured. Mean remodeling ratio (vessel area/IMA) in eccentric lesions (E, n=28) was significantly larger than that in concentric lesions (C, n=70) (E 5.87+/-0.93 versus C 3.58+/-0.62; P<0.001), despite similar IMA (E 3.89+/-0.68 versus C 3.90+/-0.41; P=NS) and distribution of imaged segments. Remodeling ratio was consistently larger in eccentric lesions in all 3 vessel segments when analyzed separately, and mean remodeling ratio for each artery was larger in vessels with predominantly eccentric lesions. Coronary compliance ([Delta lumen area/diastolic lumen area]/Delta mean arterial pressure x 10(3)) was also significantly greater in eccentric lesions versus concentric lesions (proximal 1.00+/-0.39 versus 0.22+/-0.04; mid 0.71+/-0.17 versus 0.21+/-0.10; distal 0.43+/-0.13 versus 0. 01+/-0.08; all P<0.01). Coronary flow reserve was also significantly higher in coronary arteries with primarily eccentric lesions (E 2. 49+/-0.64 versus C 1.87+/-0.28; P<0.01).Vessel remodeling in transplant vasculopathy is significantly greater in eccentric lesions than in concentric lesions, possibly due to greater coronary compliance and resistive vessel function.

    View details for Web of Science ID 000086143700014

    View details for PubMedID 10736281

  • Acute myocardial infarction and vascular remodeling AMERICAN JOURNAL OF CARDIOLOGY Filardo, S. D., Schwarzacher, S. P., Lo, S. T., Herity, N. A., Lee, D. P., Huegel, H., Mullen, W. L., Fitzgerald, P. J., Ward, M. R., Yeung, A. C. 2000; 85 (6): 760-?

    Abstract

    We used intravascular ultrasound to show that outward remodeling predominates in lesions responsible for acute myocardial infarction, whereas negative remodeling is far more prevalent in lesions responsible for chronic stable angina. The total cholesterol:high-density lipoprotein ratio was also strongly correlated with outward remodeling.

    View details for Web of Science ID 000085838000018

    View details for PubMedID 12000055

  • Accentuated remodeling on the upstream side of atherosclerotic lesions AMERICAN JOURNAL OF CARDIOLOGY Ward, M. R., Jeremias, A., Huegel, H., Fitzgerald, P. J., Yeung, A. C. 2000; 85 (5): 523-526

    Abstract

    Although it has been postulated that atherosclerotic stenotic lesions cannot remodel in response to altered flow, evidence to support or refute this hypothesis has been elusive. In vitro models have shown that accelerated endothelial shear stress occurs on the upstream side of stenoses, while turbulent lower shear stress is seen on the downstream side. We therefore compared vascular remodeling at paired sites 2 mm upstream and 2 mm downstream of the site of minimal lumen area in 25 atherosclerotic lesions in 23 patients using intravascular ultrasound. Remodeling was compared by 2 methods: normalized vessel area (vessel area(lesion)/vessel(reference) and remodeling index (change in vessel area/change in plaque area from reference). Normalized vessel area was significantly greater upstream than downstream (1.21+/-0.06 vs. 1.12+/-0.09; p<0.05), despite similar plaque burden (8.84+/-0.81 vs. 8.42+/-0.85 mm2) resulting in larger lumen area (8.15+/-1.02 vs. 6.10+/-0.88 mm2; p<0.05). Remodeling index was also significantly higher upstream than downstream (0.67+/-0.20 vs. 0.12+/-0.24, respectively, p<0.05). Accentuation of remodeling on the upstream side was significantly correlated (r = 0.54, p = 0.01) with the mean degree of shear acceleration expected by stenosis severity. Impaired remodeling on the downstream side may partly explain stenosis propagation down a vessel.

    View details for Web of Science ID 000085650900001

    View details for PubMedID 11078260

  • Comparison of coronary stent expansion by intravascular ultrasonic imaging in younger versus older patients with diabetes mellitus AMERICAN JOURNAL OF CARDIOLOGY Gilutz, H., Russo, R. J., Tsameret, I., Fitzgerald, P. J., Yock, P. G. 2000; 85 (5): 559-562

    Abstract

    The poor long-term outcome in young diabetic patients receiving stents is not well understood. The purpose of this study was to characterize the pastprocedural results of stent placement in diabetic patients using intravascular ultrasound to identify factors that might be associated with poor clinical outcome. The acute dimensions from intravascular ultrasound studies after stent deployment at 5 sites were measured from 39 coronary segments from patients with diabetes mellitus (DM) and 161 segments from nondiabetic patients (non-DM). Within these 2 groups, segments were subgrouped into young (y) and old (o) in reference to the mean study age of 64 years, forming 4 groups: yDM (n = 20), y non-DM (n = 65), oDM (n = 19), and o non-DM (n = 96). Results are reported as mean +/- 1 SD. Diabetic patients had smaller mean lumen area within the treated segment than o non-DM (8.37+/-2.59 vs. 9.11+/-3.35 mm2, p<0.01). These differences were more pronounced at the distal reference vessel lumen of yDM than y non-DM (7.6+/-2.3 vs. 10.3+/-4.5 mm2, p<0.003), and were associated with greater percent plaque area in the distal reference vessel (43.4+/-13% vs. 34.1+/-11.2%, p<0.003). In young diabetic patients undergoing elective stent placement, underexpansion of the stented segment is common, which may contribute to the relatively poor long-term outcome in these patients. We suggest that when stenting is the procedure of choice in this subgroup of high-risk patients, special attention should be given to optimizing lumen dimensions.

    View details for Web of Science ID 000085650900008

    View details for PubMedID 11078267

  • Effects of intravenous and intracoronary adenosine 5 '-triphosphate as compared with adenosine on coronary flow and pressure dynamics CIRCULATION Jeremias, A., Filardo, S. D., Whitbourn, R. J., Kernoff, R. S., Yeung, A. C., Fitzgerald, P. J., Yock, P. G. 2000; 101 (3): 318-323

    Abstract

    Measurements of Doppler derived coronary flow reserve (CFR) and pressure derived fractional flow reserve (FFR) for coronary stenosis assessment depend on the induction of maximal hyperemia. Adenosine is the most widely used pharmacological agent but is expensive and poorly tolerated by some patients.The objective of this study was to test the equivalency of adenosine 5'-triphosphate (ATP) to adenosine in their ability to cause maximal hyperemia as compared with the hyperemic response of complete coronary occlusion in 6 canines. Intracoronary administration of either ATP or adenosine resulted in a significant increase in CFR (2.79+/-0.64 and 2.22+/-0.7 for 10 microgram versus 4. 65+/-1.22 and 4.25+/-0.78 for 100 microgram for ATP and adenosine, respectively, P for trend <0.001) but not reaching the level of coronary occlusion (6.35+/-2.26). Additionally, FFR and CFR were measured in 35 different stenoses using ATP, adenosine, and coronary occlusion. There was an excellent linear correlation between ATP and adenosine for both CFR (R=0.934, P<0.001) and FFR (R=0.985, P<0.001). However, hyperemia with either ATP or adenosine was less than postocclusion hyperemia, resulting in significantly different reserve measurements (CFR: 1.93+/-0.66 and 2.08+/-0.81 versus 2.35+/-0.97, P<0.001; FFR: 0.62+/-0.24 and 0.63+/-0.23 versus 0.58+/-0.2, P<0.001).1) Step up in dosage of ATP and adenosine beyond currently recommended clinical doses resulted in a significant increase in coronary hyperemia; 2) ATP was equivalent to adenosine for both CFR and FFR; and 3) complete coronary occlusion yielded a better hyperemic response than either drug, indicating that maximal hyperemia was not achieved by either pharmacological stimulus.

    View details for Web of Science ID 000084957100031

    View details for PubMedID 10645929

  • Feasibility of in vivo intravascular ultrasound tissue characterization in the detection of early vascular transplant rejection CIRCULATION Jeremias, A., Kolz, M. L., Ikonen, T. S., Gummert, J. F., Oshima, A., Hayase, M., Honda, Y., Komiyama, N., Berry, G. J., Morris, R. E., Yock, P. G., Fitzgerald, P. J. 1999; 100 (21): 2127-2130

    Abstract

    Unprocessed ultrasound radiofrequency (RF) signal analysis has been shown to distinguish different tissue structures more reliably than gray-scale interpretation of conventional ultrasound images.The objective of this study was to test the feasibility of in vivo intravascular ultrasound (IVUS) RF signal analysis in an animal model of allograft rejection. Six cynomolgus monkeys underwent transplantation of 3-cm aortic allograft segments distal to the renal arteries from immunologically mismatched donors. IVUS imaging with a 30-MHz system was performed 84 to 105 days after the operation. RF signals were acquired from cross sections of the recipient and the allograft aortas in real time with a digitizer at 500 MHz with 8-bit resolution. Sixty-five cross sections and 68 regions of interest (31 in host aorta and 37 in allograft) were analyzed in the adventitial layer with a total number of 8568 vectors processed. For each region of interest, a weighted-average attenuation was calculated on the basis of the attenuation and length for each individual vector. Histological examination was performed at every cross section imaged by IVUS. When the gray-scale images of conventional IVUS scored by an independent observer were compared, no distinction between adventitia of the native aorta and allograft was possible. Analysis of the average RF backscatter power also showed no significant difference (70.32+/-3.55 versus 70.72+/-3.38 dB). However, the average attenuation of allografts was significantly lower than that of the host aortas (2.64+/-1.38 versus 4.02+/-1.16 dB/mm, P<0.001). Histology demonstrated a marked adventitial inflammatory response in all allografts, with no inflammation observed in the host aortas.In vivo IVUS tissue characterization can be performed during routine imaging. In this model of transplant vasculopathy, RF attenuation measurements were more sensitive than visual or quantitative gray-scale analysis.

    View details for Web of Science ID 000083945000005

    View details for PubMedID 10571969

  • Intravascular ultrasound volumetric assessment of intimal hyperplasia in stents treated with intracoronary radiation AMERICAN JOURNAL OF CARDIOLOGY Limpijankit, T., Waksman, P., Yock, P. G., Fitzgerald, P. J. 1999; 84 (7): 850-?

    Abstract

    Iridium-192 (gamma)-radiation is effective in preventing recurrent in-stent restenosis by reducing neointimal hyperplasia as illustrated by intravascular ultrasound study and plaque area-length plot. This analytic technique will further our understanding of vessel behavior to radiant energy source both inside and outside the stented coronary artery segments.

    View details for Web of Science ID 000082833300017

    View details for PubMedID 10513786

  • Ultrasound logic: The value of intracoronary imaging for the interventionist CATHETERIZATION AND CARDIOVASCULAR INTERVENTIONS Oesterle, S. N., Limpijankit, T., Yeung, A. C., Stertzer, S., Pomerantsev, E., Yock, P. G., Fitzgerald, P. J. 1999; 47 (4): 475-490

    View details for Web of Science ID 000081733400019

    View details for PubMedID 10470481

  • Delayed radionecrosis of the larynx AMERICAN JOURNAL OF OTOLARYNGOLOGY Fitzgerald, P. J., Koch, R. J. 1999; 20 (4): 245-249

    Abstract

    Radiation has been used to treat carcinoma of the larynx for more than 70 years. Radionecrosis is a well-known complication of this modality when treating head and neck neoplasms. It has been described in the temporal bone, midface, mandible, and larynx. Laryngeal radionecrosis is manifested clinically by dysphagia, odynophagia, respiratory obstruction, hoarseness, and recurrent aspiration. The vast majority of patients who develop laryngeal radionecrosis present with these symptoms within 1 year of treatment; however, delayed presentations have been reported up to 25 years after radiotherapy. We present, in a retrospective case analysis, an unusual case of laryngeal radionecrosis in a patient who presented more than 50 years after treatment with radiotherapy for carcinoma of the larynx. The cases of delayed laryngeal necrosis in the literature are presented. This represents the longest interval between treatment and presentation in the literature. The details of the presentation, clinical course, and diagnostic imaging are discussed. The pathogenesis, clinical features, and treatment options for this rare complication are reviewed. Early stage (Chandler I and II) laryngeal radionecrosis may be treated conservatively and often observed. Late stage (Chandler III and IV) cases are medical emergencies, occasionally resulting in significant morbidity or mortality. Aggressive diagnostic and treatment measures must be implemented in these cases to improve outcome. This case represents the longest interval between initial treatment and presentation of osteoradionecrosis in the literature. A structured diagnostic and therapeutic approach is essential in managing this difficult problem.

    View details for Web of Science ID 000081541000009

    View details for PubMedID 10442778

  • The progression of thrombus in an ex-vivo shunt model evaluated by intravascular ultrasound radiofrequency analysis ULTRASOUND IN MEDICINE AND BIOLOGY Komiyama, N., Chronos, N. A., Uren, N. G., Moore, M. P., Kelly, A. B., Harker, L. A., Hanson, S. R., Metz, J. A., Yock, P. G., Fitzgerald, P. J. 1999; 25 (4): 561-566

    Abstract

    We tested the ability of ultrasound radiofrequency (RF) signal analysis to characterize thrombus accumulation in a Dacron graft incorporated into the exteriorized arteriovenous shunt in 3 baboons with constant blood flow for 60 min. Thrombus formation was quantified by sequential measurements of 111Indium-labeled platelet deposition. RF signals were acquired every 15 min at 2 sites in the graft, using a 2.9 Fr intravascular ultrasound catheter-based transducer (30 MHz) and digitized at 250 MHz in 8-bit resolution. Regions of interest were placed within a 0.5-mm perimeter adjacent to the graft wall. Integrated backscatter increased significantly (p < 0.001) with increasing platelet deposition. However, mean-to-standard deviation ratio of the RF envelope showed no significant change and the distribution pattern of the RF probability function remained constant and consistent with a Rayleigh scattering process. These results provide a basis for using RF analysis to monitor the time-course of thrombus formation.

    View details for Web of Science ID 000080191900009

    View details for PubMedID 10386731

  • Impact of residual plaque burden on clinical outcomes of coronary interventions CATHETERIZATION AND CARDIOVASCULAR INTERVENTIONS Honda, Y., Yock, P. G., Fitzgerald, P. J. 1999; 46 (3): 265-276

    Abstract

    In this study, we summarize the role of residual plaque burden, as determined by intravascular ultrasound, on the development of restenosis following percutaneus coronary interventions. Several clinical trials have shown that the amount of residual plaque is a consistent and independent predictor of subsequent restenosis. The impact of residual plaque burden on late lumen loss is particularly augmented by negative vessel remodeling that is commonly seen after balloon angioplasty and atherectomy. However, early evidence suggests that the importance of plaque burden also applies in the context of stenting. The cotreatment of debulking may further improve the long-term outcome of stenting by maximizing an acute lumen gain with less vessel stretching, preventing stent edge problems and possibly reducing the cell source involved in the intimal hyperplastic process. Evaluation of residual plaque burden with on-line intravascular ultrasound could lead to definitive therapies via risk stratification of the treated segments.

    View details for Web of Science ID 000079175800003

    View details for PubMedID 10348121

  • Spontaneous postpartum coronary dissection CIRCULATION Lee, F. H., Yeung, A. C., Fowler, M. B., Fitzgerald, P. J. 1999; 99 (5): 721-721

    View details for Web of Science ID 000078473000020

    View details for PubMedID 9950672

  • Acute coronary closure after stenting: a lesson from intravascular ultrasound. International journal of cardiovascular interventions Kobayashi, Y., Amaro, M., Fitzgerald, P. J. 1999; 2 (1): 51-54

    Abstract

    Intravascular ultrasound (IVUS) is an imaging modality more sensitive for defining suboptimal stent deployment issues compared with conventional angiographic imaging. We report on a patient with unstable angina who underwent stent deployment using IVUS guidance. Despite an acceptable angiographic result, intrastent thrombus, incomplete expansion and an edge/marginal dissection were seen by IVUS examination. Both the incomplete expansion and the intrastent thrombus were successfully treated. The dissection, however, was not treated in the catheterization laboratory. This mechanical injury pattern at the stent edge led to vessel occlusion 4 h post-procedure.

    View details for PubMedID 12623387

  • New Approaches and Conduits: In Situ Venous Arterialization and Coronary Artery Bypass. Current interventional cardiology reports Fitzgerald, P. J., Hayase, M., Yeung, A. C., Virmani, R., Robbins, R. C., Burkhoff, D., Makower, J., Yock, P. G., Oesterle, S. N. 1999; 1 (2): 127-137

    View details for PubMedID 11096617

  • A new large-animal model for research of graft vascular disease TRANSPLANTATION PROCEEDINGS Gummert, J. F., Ikonen, T., Briffa, N., Honda, Y., Hayase, M., Perlroth, J., Kobayashi, Y., Hausen, B., Barlow, C., Billingham, M. E., Fitzgerald, P., Yock, P. G., Robbins, R. C., Morris, R. E. 1998; 30 (8): 4023-4023

    View details for Web of Science ID 000077593000033

    View details for PubMedID 9865284

  • Coronary stents: In vitro aspects of an angiographic and ultrasound quantification with in vivo correlation. Circulation Pomerantsev, E. V., Kobayashi, Y., Fitzgerald, P. J., Grube, E., Sanders, W. J., Alderman, E. L., Oesterle, S. N., Yock, P. G., Stertzer, S. H. 1998; 98 (15): 1495-1503

    Abstract

    The validity of quantitative coronary angiography (QCA) after stent placement has been questioned because the optical density of a metallic stent, added to the density of a contrast-filled lumen, could affect border definition. METHODS andWe deployed 3.0- and 4.0-mm Palmaz-Schatz, Wiktor, Multilink, NIR, and InStent stents in precision-cast phantoms. Central lumens of 2.0 mm were created. There was no difference between the "true" diameters of any stented lumen by both QCA and quantitative ultrasonic (QCU) measurement poststenting. QCA systematic error (SE) varied from 0.01 for the Wiktor stents to 0.14 mm for the Palmaz-Schatz stents; the random error (RE) was 0.03 to 0.14 mm. QCU SE varied from 0.05 to 0.11 mm, and RE ranged from 0.01 to 0.07 mm. At the next stage, 4.0-mm Wiktor and Palmaz-Schatz stents were deployed into the phantom lumens; 1.5-, 2.0-, 2.5- and 3.0-mm lumens were created inside the stents. QCA and QCU measurements of 1.5- to 2.5-mm residual lumens were overestimated by 0.1 to 0.3 mm. In the 3. 0-mm residual lumen within the Wiktor stent, QCA underestimated the luminal size by -0.1 mm. There was no QCA inaccuracy for a 3.0-mm lumen within the Palmaz-Schatz stent. In patients, in 25 stented segments in both the Palmaz-Schatz and Wiktor groups, there was no difference between QCA and QCU diameters.QCU is sufficiently precise for the assessment of the coronary lumen after stenting. QCA can be used as an accurate method of poststent assessment, except when a very mild recurrence within a highly opaque stent is measured. In that instance, QCA may underestimate the luminal diameter.

    View details for PubMedID 9769302

  • The stent decade: 1987 to 1997 AMERICAN HEART JOURNAL Oesterle, S. N., Whitbourn, R., Fitzgerald, P. J., Yeung, A. C., Stertzer, S. H., Dake, M. D., Yock, P. G., Virmani, R. 1998; 136 (4): 578-599

    Abstract

    In January 1997, experts from the United States, Europe, and Japan gathered at Stanford University to review their collective experience with intracoronary and noncoronary stenting and to identify and prioritize issues requiring further clinical investigation. This report summarizes the discussions that took place during this stent summit. Knowledge of stent-tissue interaction from animal and human pathologic specimens was reviewed in the context of evolving stent designs. The relative merits of coil and slotted tubular stent designs were discussed. Stent deployment routines, including self-expansion, balloon expansion, and high-pressure delivery were debated. The potential for covered stents and coated stents was explored. Problems surrounding the routine deployment of stents were identified: small vessel disease, long lesions, bifurcation stenoses, vein graft disease, ostial disease, left main stenoses, and intrastent restenosis. The value of intravascular ultrasound, as an adjunct to stenting, was explored and debated. An algorithm for "provisional stenting" based on ultrasound criteria was developed. Noncoronary stenting of the aorta, iliacs, and carotids were discussed. Clinical applications that may lead to randomized clinical trials were identified.

    View details for Web of Science ID 000076316800005

    View details for PubMedID 9778060

  • Enhancement of spatial orientation of intravascular ultrasound images with side holes in guiding catheters AMERICAN HEART JOURNAL Schwarzacher, S. P., Fitzgerald, P. J., Metz, J. A., Yeung, A. C., Oesterle, S. N., Belef, M., Kernoff, R. S., Yock, P. G. 1998; 135 (6): 1063-1066

    Abstract

    Intravascular ultrasound (IVUS) images are typically viewed and recorded in an arbitrary rotational orientation. This study was performed to validate a new method for improved orientation of sonographic vascular cross-sections.We have tested a simple technique for rotational indexing of IVUS in cases in which guiding catheters with side holes are used. Although guiding catheters are opaque to ultrasonography, the side holes transmit the beam and therefore can be easily identified. The orientation of the side holes, which is characteristic for each make of guiding catheter, can be used to determine the anatomically appropriate rotational orientation of the IVUS image. In this study images of four commercially available side-hole guiding catheters were viewed in vitro to confirm the visibility of the side holes and to characterize their orientation for purposes of rotational orientation of images. Feasibility tests of rotational orientation based on side holes were then performed in canine coronary arteries (n = 3) and in six human coronary arteries. Three serial imaging runs in each clinical case yielded a mean variability in rotational orientation of 7.5 +/- 1.5 degrees.Validation testing of the side-hole technique demonstrates the potential for consistent and anatomically appropriate orientation of intravascular ultrasound images.

    View details for Web of Science ID 000074109300018

    View details for PubMedID 9630112

  • Intravascular ultrasound: State of the art and future directions AMERICAN JOURNAL OF CARDIOLOGY Yock, P. G., Fitzgerald, P. J. 1998; 81 (7A): 27E-32E

    Abstract

    A variety of new devices in the field of intravascular ultrasound imaging are being designed and tested. Mechanical intravascular ultrasound (IVUS) devices with rotating transducers have been developed that allow transducer pullback with integrated longitudinal 2-dimensional displays. Recent advances in the area of imaging include (1) solid-state systems that combine ultrasound with balloon and stent placement; (2) combined imaging atherectomy devices; (3) imaging cores or guidewires; (4) forward-looking devices; (5) 3-dimensional reconstruction techniques; (6) high-frequency imaging; and (7) improved methods for characterizing tissue. Other promising approaches include magnetic resonance imaging, thermography, and optical coherence tomography. An important goal for long-term technologic improvement is visualization of lipid accumulations and fibrous caps during their early stages of development.

    View details for Web of Science ID 000073005600007

    View details for PubMedID 9551592

  • New developments in intravascular ultrasound. Vascular medicine Oshima, A., ITCHHAPORIA, D., Fitzgerald, P. 1998; 3 (4): 281-290

    Abstract

    Intravascular ultrasound (IVUS) is a dynamic imaging modality that provides real-time in vivo visualization of atherosclerosis and other vascular pathology. The tomographic image presentation of IVUS permits detailed assessment of plaque morphology and its corresponding responses to interventional therapy. IVUS studies have confirmed vascular remodeling in vivo, have proposed a high-pressure stent implantation strategy and have shown two key mechanisms of restenosis after angioplasty: plaque proliferation and vessel shrinkage (negative remodeling). IVUS also provides accurate quantitative information regarding lumen size, vessel size and plaque burden. These observations, essential to achieving improved outcomes, have drastically changed the understanding of atherosclerotic artery disease and interventional procedures. IVUS has matured into an essential complement to daily peripheral and coronary interventional practice and is routinely incorporated as part of the interventional arsenal in the catheterization laboratory. A variety of new imaging techniques are currently being designed and tested. These include combined therapeutic devices, further miniaturization, 3-D applications and tissue characterization. These techniques may evolve to provide increased favorable clinical outcomes and more accurate information of vessel geometry and plaque composition.

    View details for PubMedID 10102669

  • Orientation of intracoronary ultrasonography: Looking beyond the artery JOURNAL OF THE AMERICAN SOCIETY OF ECHOCARDIOGRAPHY Fitzgerald, P. J., Yock, C., Yock, P. G. 1998; 11 (1): 13-19

    Abstract

    Over the past 5 years intravascular ultrasound imaging has achieved many technical advancements both in catheter design and image quality. In addition to improved image quality that provides clear display of the endovascular structure, efficient signal penetration permits the viewing of structures beyond the artery by highlighting the perivascular structures. These perivascular landmarks, which are unique within a particular coronary segment, help provide both axial and spatial orientation during multiple imaging runs throughout a coronary artery. Orientation on the basis of veins and pericardium assists the operator to appreciate the full three-dimensional view of a particular coronary segment. This article describes several of the common perivascular structures that may be viewed from different arteries routinely imaged during coronary procedures.

    View details for Web of Science ID 000071772900004

    View details for PubMedID 9487465

  • Coronary AVE micro stents: Serial quantitative angiography and histology in a canine model CATHETERIZATION AND CARDIOVASCULAR DIAGNOSIS Pomerantsev, E. V., Kim, C., Kernoff, R. S., Oesterle, S. N., Yeung, A., Fitzgerald, P. J., Virmani, R., Yock, P. G., Stertzer, S. H. 1997; 41 (2): 213-224

    Abstract

    The AVE Micro Stent (AVE Inc., Santa Rosa, CA) is composed of helically welded 3 mm long, zigzag crowns with stent lengths from 6 to 39 mm and diameters from 2.5 to 4.5 mm. Quantitative coronary angiography and histologic analyses of acute and chronic implantation were obtained in 52 stented coronary segments of 18 dogs. Three hearts with 8 stented coronary segments were harvested after 24 hr, 3 hearts with 9 stented segments were harvested after 2 weeks, 6 hearts with 15 stented segments were harvested at 8 weeks, and 6 hearts with 20 stented segments were harvested at 24 weeks post-deployment. There were no procedural complications, deaths, or acute vessel closures. The average lumen diameter of the stented segment was largest at 2 weeks (3.3 +/- 0.3 mm). The smallest average diameters were observed at 8 weeks after the stent deployment (2.7 +/- 0.4, P < 0.05) with an increase again at 24 weeks (2.9 +/- 0.6). The pre-explant percent of stenosis was <30% in all animals. Histologically, a peak of inflammation was visible at 2 weeks; however, the extent of luminal narrowing reached its peak at 8 weeks and the lumen dimension increased somewhat at 24 weeks. The degree of intimal thickening remained relatively constant throughout the different time points (<200 microm). Overall, these data suggest that constrictive remodeling within the stented segment occurs at 8 weeks in this animal model. The later increase of the stented segment dimensions as well as higher net gain at 24 weeks compared to 8 weeks after deployment suggests that this constriction is a transitory phenomenon.

    View details for Web of Science ID A1997XC51700023

    View details for PubMedID 9184299

  • Clinical use of intravascular ultrasound. Seminars in interventional cardiology : SIIC Schwarzacher, S. P., Fitzgerald, P. J., Yock, P. G. 1997; 2 (1): 1-9

    Abstract

    Intravascular ultrasound has dramatically changed our view of atherosclerotic disease and has helped to define mechanisms of therapeutic interventions, providing a new rationale for selection of appropriate devices. Currently, this technology is used for sizing and orientation of commonly performed interventions such as balloon angioplasty and directional atherectomy. The information from intravascular ultrasound has also led to a dramatic change in the deployment algorithm of stents. Further improvements in catheter design and the findings from clinical trials utilizing intravascular ultrasound will help define a practical role for this new technology.

    View details for PubMedID 9546978

  • Intravascular ultrasound: basic interpretation. Cardiology clinics Metz, J. A., Yock, P. G., Fitzgerald, P. J. 1997; 15 (1): 1-15

    Abstract

    IVUS provides a new gold standard for visualization and measurement of coronary artery disease. Morphologic and morphometric observations by IVUS are in general considerably more detailed and accurate than those obtained by angiography. IVUS has led to new insights into the pathophysiology of coronary plaque accumulation with respect to adaptive vessel responses (remodeling) and their exhaustion (de-remodeling, shrinkage). Further technologic refinements need to focus on issues such as improvement in resolution and miniaturization of IVUS catheters to enhance the applicability of this imaging technique.

    View details for PubMedID 9085748

  • Vessel tearing at the edge of intracoronary stents detected with intravascular ultrasound imaging CATHETERIZATION AND CARDIOVASCULAR DIAGNOSIS Schwarzacher, S. P., Metz, J. A., Yock, P. G., Fitzgerald, P. J. 1997; 40 (2): 152-155

    Abstract

    Stent deployment strategies have changed significantly in the past 2 yr, with "high-pressure" balloon inflations postdilatation being performed in the large majority of cases. There is currently little information about the effects of high pressure on the geometry of stent expansion and on the adjacent areas of the vessel wall. Intravascular ultrasound (IVUS) imaging is well-suited to investigate these issues, since it provides information not only about stent expansion and apposition but also about adjacent vessel-wall morphology at transition points such as the articulation site of the stent and the the stent borders. We report on the results of a cohort of 30 consecutive stent cases which were systematically examined by IVUS following high-pressure inflation. All deployments were deemed successful by angiographic inspection. However, in 6 cases, intimal disruptions or "edge tears" were noted at the stent borders by IVUS. In 5 cases, edge tears were seen to occur at the distal border, whereas in one case edge tears were seen at both the proximal and distal edges of the stent. No angiographic and sonographic parameters were different except percent plaque area at the stent margins, which was significantly higher (53 +/- 11%) in the lesions with edge tears, compared to 40 +/- 10% plaque area in the group without evidence of pocket flaps (P = 0.007). This experience suggests that intimal disruptions or "edge tears" are a relatively common occurrence following high-pressure stent deployment, and may be related to the extent of marginal dissections.

    View details for Web of Science ID A1997WF28200006

    View details for PubMedID 9047054

  • Impact of curve distortion errors on intravascular ultrasound measurements and three-dimensional reconstructions AMERICAN JOURNAL OF CARDIOLOGY Schwarzacher, S. P., Honda, Y., Metz, J. A., Asvar, C. A., Fitzgerald, P. J., Yock, P. G. 1997; 79 (3): 384-?

    Abstract

    Intravascular ultrasound distortion errors and longitudinal reconstructions are primarily determined by the angle of curvature. The error in commonly encountered angles is relatively small.

    View details for Web of Science ID A1997WG53700029

    View details for PubMedID 9036768

  • High-speed rotational atherectomy: Six-month serial quantitative coronary angiographic follow-up AMERICAN HEART JOURNAL Stertzer, S. H., Pomerantsev, E. V., Fitzgerald, P. J., Yock, P. G., Yeung, A. C., Shaw, R. E., Walton, A. S., Singer, A. H., Sanders, W. J., Oesterle, S. N. 1996; 131 (4): 639-648

    Abstract

    One hundred twenty-three patients treated with high-speed rotational atherectomy (HSRA) were restudied 6.9 +/- 1.2 months later. At the follow-up, the number of focal concentric lesions increased from 32.2 percent to 63.0 percent, p<0.01, with decrease of type C lesions from 54.8 percent to 30.8 percent, p<0.05. Comparison of the degree of the net gain (NG) showed more severe baseline lesions in the high-gain group (NG >20 percent) compared with the moderate-gain group (20 percent > NG > 0 percent) and to the loss group (minimal luminal diameter [MLD] 0.8 +/- 0.4 mm vs 1.0 +/ 0.4 mm, p<0.05; and 1.2 +/- 0.5 mm; p<0.01, respectively). Highest initial gain (36.5 percent +/- 26.2 percent vs 24.5 percent +/- 18.1 percent; p<0.015; and 19.0 percent +/- 23.2 percent; p<0.001) as well as lowest late loss (1.8 percent +/- 21.7 percent vs 14.0 percent +/-18.4 percent; p<0.01 and 28.1 percent +/- 25.0 percent; p<0.01) were found in the high NG group. A higher interaction between burr and atheroma resulted in the lowest restenosis rate of 6 percent.

    View details for Web of Science ID A1996UE42100002

    View details for PubMedID 8721633

  • Ultrasound-guided atherectomy: The vision for the future? CORONARY ARTERY DISEASE Yock, P. G., Yock, C. A., Fitzgerald, P. J. 1996; 7 (4): 299-303

    View details for Web of Science ID A1996VA98800006

    View details for PubMedID 8853582

  • Validation of Automated Border Detection in Intravascular Ultrasound Images. Echocardiography (Mount Kisco, N.Y.) Hausmann, D., Friedrich, G., Soni, B., Daniel, W. G., Fitzgerald, P. J., Yock, P. G. 1996; 13 (6): 599-608

    Abstract

    Intravascular ultrasound (IVUS) imaging provides cross-sectional views of the vessel lumen; however, lumen measurements still rely on operator-dependent border delineation and time-consuming lumen tracings. We tested a new system for automated lumen border detection in IVUS images based on acoustic quantification of blood and vessel wall. In 10 rabbits, 29 segments of the aorta were imaged in vivo using a 2.9-Fr IVUS catheter. IVUS images were obtained during motorized pullbacks of aortic segments of 18 mm length. Automated measurements of lumen dimensions were compared to automated measurements of a second pullback through the same segment, lumen measurements derived from visual border tracings in IVUS images, and to quantitative angiography. The automated system showed good reproducibility: Correlations for repeated measurements of lumen area, maximal and minimal lumen diameters were r = 0.97, r = 0.91, and r = 0.93, respectively. Automated measurements also correlated well to visual image analysis (lumen area, r = 0.97; maximal lumen diameter, r = 0.89; minimal lumen diameter, r = 0.89) and to angiographic measurements (lumen area, r = 0.93; lumen diameter, r = 0.95). In 12% of the images, the automated system overestimated lumen dimensions because of weak wall signals in the presence of echolucent structures next to the wall. Signal artifacts from the IVUS catheter itself or strong blood backscatter resulted in lumen underestimation in 6% of the images. Over- and underestimation of lumen by the border detection system were often associated with eccentric catheter position. Thus, lumen measurements in vivo IVUS images can be performed using an automated border detection system based on acoustic quantification of blood and vessel wall. The system allows reproducible and accurate measurements of lumen area and diameters. (ECHOCARDIOGRAPHY, Volume 13, November 1996)

    View details for PubMedID 11442974

  • Effects of technique modification on immediate results of high speed rotational atherectomy in 710 procedures on 656 patients CATHETERIZATION AND CARDIOVASCULAR DIAGNOSIS Stertzer, S. H., Pomerantsev, E. V., Fitzgerald, P. J., Shaw, R. E., Walton, A. S., Singer, A. H., Yeung, A., Yock, P. G., Oesterle, S. N. 1995; 36 (4): 304-310

    Abstract

    Seven hundred ten high speed rotational atherectomy (HSRA) procedures were performed in a single consecutive series of 656 patients. Stand alone HSRA was performed in 253 patients (35%). HSRA with adjunctive low pressure (< or = 2 ATM) balloon angioplasty (LP BA) was performed in 221 patients (31%), and HSRA with adjunctive high pressure (> or = 4 ATM) balloon angioplasty (HP BA) was performed in 236 patients (34%). Prognostically unfavorable Type B2 and C lesions dominated the study group (74.7%). Procedural success rate was 96%. Emergency coronary artery bypass surgery was performed in 1.4% of cases, Q wave myocardial infarction occurred in 3.4% and death, related to procedure, was consequent in 0.5% of cases. Incidence of flow limiting dissections was 3.1%, distal spasm was 5.3%, and "no reflow" phenomenon was 1.8%. The recent technique modifications included continuous advancer/guiding catheter infusion of the nitroglycerin-verapamil mixture, limitation of duration of lesion engagement by the burr, stepwise increase in the burr size, decrease of rotational speed, and strict control of rpm drop during lesion ablation. Evolution of the interventional technique involved trends towards decrease of the use of HP BA in conjunction with steady increase in the percentage of SA and LP BA procedures over time. These technique changes resulted in complete absence of "no reflow" in 1994, as well as a generalized decrease in overall coronary vascular reactivity from all burr passes.

    View details for Web of Science ID A1995TM65600002

    View details for PubMedID 8719378

  • DETECTION OF CORONARY ATHEROSCLEROSIS IN YOUNG-ADULT HEARTS USING INTRAVASCULAR ULTRASOUND CIRCULATION STGOAR, F. G., Pinto, F. J., Alderman, E. L., Fitzgerald, P. J., Stinson, E. B., Billingham, M. E., Popp, R. L. 1992; 86 (3): 756-763

    Abstract

    Coronary atherosclerosis has been demonstrated in young adults by postmortem pathology. Angiographic evaluation of coronary disease in young adults is limited by ethical issues and the insensitivity of angiography for detecting early pathology. Catheter-based intracoronary ultrasound has proven useful both in detecting and quantitating coronary disease, but the ultrasound appearance of young, angiographically normal, coronary arteries has not been well defined.Twenty-five subjects were examined with intracoronary ultrasound within 1 month of cardiac transplantation. Mean age of the donor hearts was 28 years (range, 14-43 years). Measurements of an index of intimal thickening were obtained at four left anterior descending coronary artery sites in each patient. All study patients had angiographically normal coronary arteries. Ultrasound in 14 subjects demonstrated a three-layered appearance of the coronary vessel wall with a mean intimal index of 0.16 +/- 0.07. The other 10 subjects, including all donors under the age of 25 years, had coronary vessel wall layers too thin to be imaged separately at the 30-MHz sound frequency. Five subjects had ultrasound evidence of focal intimal thickening greater than 500 microns. The donors of these hearts each had risk factors for coronary artery disease. Two subjects died within 5 weeks of their ultrasound study. Histological measurements of the vessel wall layers were similar to the corresponding ultrasound values.This study provides a reference for the intravascular ultrasound appearance of young adult coronary arteries and confirms pathology findings that young subjects with angiographically normal vessels have a range of coronary intimal thickening, which includes occasional evidence of focal, early atheromatous lesions.

    View details for Web of Science ID A1992JM27000006

    View details for PubMedID 1516187

  • INTRAVASCULAR ULTRASOUND IMAGING OF ANGIOGRAPHICALLY NORMAL CORONARY-ARTERIES - AN INVIVO COMPARISON WITH QUANTITATIVE ANGIOGRAPHY JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY STGOAR, F. G., Pinto, F. J., Alderman, E. L., Fitzgerald, P. J., Stadius, M. L., Popp, R. L. 1991; 18 (4): 952-958

    Abstract

    Intravascular ultrasound, a new technique for real-time two-dimensional visualization of arteries and veins, delineates vessel wall morphology and measures luminal dimensions. This imaging method has been validated with in vitro systems and in peripheral vessels, but there are few in vivo coronary artery studies. Twenty cardiac transplant recipients with no angiographic coronary artery disease were scanned with a 30-MHz intravascular ultrasound catheter from the left main coronary ostium to the mid-left anterior descending coronary artery. Simultaneous angiographic measurements were performed at 76 sites. Ultrasound end-diastolic diameters in two perpendicular axes were 3.8 +/- 0.9 and 3.9 +/- 0.6 mm, respectively, and mean diameter derived from an area determined by planimetry was 3.9 +/- 0.9 mm. Angiographic coronary artery diameters measured with a computer-assisted edge detection system perpendicular to the long axis of the vessel and to the long axis of the catheter were 3.4 +/- 0.8 and 3.6 +/- 0.8 mm, respectively. Luminal diameters measured with the two imaging systems correlated closely, with an r value of 0.86 when ultrasound was compared with the angiographic diameter measured perpendicular to the vessel and 0.88 when compared with the angiographic diameter measured perpendicular to the imaging catheter. Eighty-three percent of the ultrasound-measured diameters were above the line of identity when compared with the simultaneous angiographic measurement. The more the imaging catheter deviated from the long axis of the vessel, the greater was the discrepancy between the ultrasound and angiographic measurements.(ABSTRACT TRUNCATED AT 250 WORDS)

    View details for Web of Science ID A1991GH89700010

    View details for PubMedID 1894869

Conference Proceedings


  • Photoangioplasty for human peripheral atherosclerosis - Results of a phase I trial of photodynamic therapy with motexafin lutetium (Antrin) Rockson, S. G., Kramer, P., Razavi, M., Szuba, A., Filardo, S., Fitzgerald, P., Cooke, J. P., Yousuf, S., DeVault, A. R., Renschler, M. F., Adelman, D. C. LIPPINCOTT WILLIAMS & WILKINS. 2000: 2322-2324

    Abstract

    In photoangioplasty, light activation of a photosensitive drug offers the potential for treatment of long segments of vascular disease. This is a brief description of a study designed to evaluate the safety and tolerability of a new photosensitizer, Antrin (motexafin lutetium), in the endovascular treatment of atherosclerosis.An open-label, single-dose, escalating drug- and light-dose study was performed in patients with atherosclerotic peripheral arterial insufficiency. Clinical evaluation, serial quantitative angiography, and intravascular ultrasonography were performed. Therapy was well tolerated, and only minor side effects were observed. Treatment produced no deleterious vascular effects. Although this study was not designed to examine clinical efficacy, several secondary end points suggested a favorable therapeutic effect.This phase I study demonstrates that photoangioplasty with motexafin lutetium is well tolerated and safe. Preliminary efficacy data suggest a future role for the treatment of flow-limiting atherosclerosis.

    View details for Web of Science ID 000165169200001

    View details for PubMedID 11067782

  • Development of models of graft vascular disease in nonhuman primates: Evaluation of GVD by intravascular ultrasound in a new cynomolgus model with arterial allograft exchange Ikonen, T. S., Gummert, J. F., Honda, Y., Hayase, M., Perlroth, J., Hausen, B., Barlow, C., Fitzgerald, P., Yock, P. G., Morris, R. E. ELSEVIER SCIENCE INC. 1999: 687-687

    View details for Web of Science ID 000078960600305

    View details for PubMedID 10083296

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