Dan E. Azagury, MD

All Publications

• Long-term outcomes of per-oral endoscopic myotomy compared to laparoscopic Heller myotomy for achalasia: a single-center experience. Surgical endoscopy Podboy, A. J., Hwang, J. H., Rivas, H., Azagury, D., Hawn, M., Lau, J., Kamal, A., Friedland, S., Triadafilopoulos, G., Zikos, T., Clarke, J. O. 2020

  Abstract

  INTRODUCTION: Many centers have reported excellent short-term efficacy of per-oral endoscopic myotomy (POEM) for the treatment of achalasia. However, long-term data are limited and there are few studies comparing the efficacy of POEM versus Heller Myotomy (HM).AIMS: To compare the long-term clinical efficacy of POEM versus HM.METHODS: Using a retrospective, parallel cohort design, all cases of POEM or HM for achalasia between 2010 and 2015 were assessed. Clinical failure was defined as (a) Eckardt Score>3 for at least 4weeks, (b) achalasia-related hospitalization, or (c) repeat intervention. All index manometries were classified via Chicago Classification v3. Pre-procedural clinical, manometric, radiographic data, and procedural data were reviewed.RESULTS: 98 patients were identified (55 POEM, 43 Heller) with mean follow-up of 3.94years, and 5.44years, respectively. 83.7% of HM patients underwent associated anti-reflux wrap (Toupet or Dor). Baseline clinical, demographic, radiographic, and manometric data were similar between the groups. There was no statistical difference in overall long-term success (POEM 72.7%, HM 65.1% p=0.417, although higher rates of success were seen in Type III Achalasia in POEM vs Heller (53.3% vs 44.4%, p<0.05). Type III Achalasia was the only variable associated with failure on a univariate COX analysis and no covariants were identified on a multivariate Cox regression. There was no statistical difference in GERD symptoms, esophagitis, or major procedural complications.CONCLUSION: POEM and HM have similar long-term (4-year) efficacy with similar adverse event and reflux rates. POEM was associated with greater efficacy in Type III Achalasia.

  View details for DOI 10.1007/s00464-020-07450-6

  View details for PubMedID 32157405

• Analysis of Gender Perceptions in Health Technology: A Call to Action. Annals of biomedical engineering Denend, L., McCutcheon, S., Regan, M., Sainz, M., Yock, P., Azagury, D. 2020

  Abstract

  Gender diversity has been linked to positive business results. Yet limited data exist to characterize the gender landscape in health technology, a field that draws employees from both biomedical engineering and medicine. To better understand the state of gender diversity in this industry, we developed a survey to explore leadership representation and perceptions of workplace equality, job satisfaction, and work-life balance. Data from 400 + health technology professionals revealed that women are significantly underrepresented in senior leadership and that men and women experience the workplace differently. Men believe in greater numbers than females that senior leaders are focused on recruiting and promoting women, promotion criteria are equitable, and the major barrier to leadership roles for women is work/family balance. In contrast, women perceive a less meritocratic and inclusive workplace in which their ability to rise is hampered by exclusion from influential communication networks and stereotyping/bias. Perhaps as a result, more than one-third of female respondents are considering leaving their current jobs, citing dissatisfaction with management and a desire for greater advancement opportunities. This study highlights significant gender perception differences in health technology that require further study and proactive remediation for the field to fully realize the benefits of gender diversity.

  View details for DOI 10.1007/s10439-020-02478-0

  View details for PubMedID 32078709

• Stanford's Biodesign Innovation program: Teaching opportunities for value-driven innovation in surgery. Surgery Augustin, D. A., Yock, C. A., Wall, J., Lucian, L., Krummel, T., Pietzsch, J. B., Azagury, D. E. 2019

  Abstract

  The Stanford Biodesign Innovation process, which identifies meaningful clinical needs, develops solutions to meet those needs, and plans for subsequent implementation in clinical practice, is an effective training approach for new generations of healthcare innovators. Continued success of this process hinges on its evolution in response to changes in healthcare delivery and an ever-increasing demand for economically viable solutions. In this article, we provide perspective on opportunities for value-driven innovation in surgery and relate these to value-related teaching elements currently integrated in the Stanford Biodesign process.

  View details for DOI 10.1016/j.surg.2019.10.012

  View details for PubMedID 31862172

• PER-ORAL ENDOSCOPIC MYOTOMY HAS SIMILAR EFFICACY COMPARED TO LAPAROSCOPIC HELLER MYOTOMY AFTER 4 YEARS: A SINGLE CENTER EXPERIENCE Podboy, A. J., Hwang, J., Rivas, H., Azagury, D., Hawn, M. T., Kamal, A., Triadafilopoulos, G., Zikos, T., Clarke, J. O. MOSBY-ELSEVIER. 2019: AB201–AB202

  View details for Web of Science ID 000470094901010

• Novel device to detect enterotomies in real time during laparoscopy: first in human trial during Roux-en-y gastric bypass SURGICAL ENDOSCOPY AND OTHER INTERVENTIONAL TECHNIQUES Wynne, E. K., Azagury, D. E. 2019; 33 (5): 1687–92

  View details for DOI 10.1007/s00464-018-06637-2

  View details for Web of Science ID 000465640800040

• Preoperative weight loss: is waiting longer before bariatric surgerymore effective? Surgery for obesity and related diseases : official journal of the American Society for Bariatric Surgery Eng, V., Garcia, L., Khoury, H., Morton, J., Azagury, D. 2019

  Abstract

  BACKGROUND: Many insurance companies require patients to undergo supervised weight loss programs lasting several months. However, the association between time to surgery (TTS)-the wait time between the initial consultation visit and the immediate preoperative visit-and weight loss is not well documented.OBJECTIVES: To investigate whether TTS affects pre- or postoperative weight loss or complication rates.SETTING: University hospital, United States.METHODS: Data from 415 patients undergoing laparoscopic Roux-en-Y gastric bypass (n = 263) or sleeve gastrectomy (n = 152) at a single academic institution between 2014 and 2015 were retrospectively reviewed. TTS was compared with the percentage of total weight lost, change in body mass index, and adverse surgical events.RESULTS: Participants had an average body mass index of 47.42 kg/m2 at the consultation visit and TTS ranged from 7 to 1813 days with an average wait of 209.23 days. There was a statistically significant negative correlation between TTS and preoperative percentage of total weight lost among gastric bypass patients (b = -.005; P = .0492 2-tailed). A similar inverse relationship was identified among sleeve gastrectomy patients. Extended TTS provided no significant long-term benefits in weight loss by 24 months. No significant difference in rates of complications or readmissions was identified.CONCLUSIONS: Longer preoperative wait times do not result in improved weight loss or reducedadverse events. Determination of patient eligibility for bariatric surgery should rest with the health team and delay of treatment should be minimized.

  View details for DOI 10.1016/j.soard.2019.03.012

  View details for PubMedID 31104959

• Heterogeneity of weight loss after gastric bypass, sleeve gastrectomy, and adjustable gastric banding SURGERY Azagury, D., Mokhtari, T. E., Garcia, L., Rosas, U. S., Garg, T., Rivas, H., Morton, J. 2019; 165 (3): 565–70

  View details for DOI 10.1016/j.surg.2018.08.023

  View details for Web of Science ID 000460845400011

• Novel device to detect enterotomies in real time during laparoscopy: first in human trial during Roux-en-y gastric bypass. Surgical endoscopy Wynne, E. K., Azagury, D. E. 2019

  Abstract

  BACKGROUND: Undetected bowel perforations occur in 0.3-1% of laparoscopic surgical procedures with an associated mortality rate of 5.3%.OBJECTIVE: The purpose of the study was to evaluate the clinical feasibility of a novel medical device to accurately detect bowel gas, specifically hydrogen (H2) and methane (CH4), from a sample of gas from the abdominal cavity during laparoscopic surgery when a known bowel wall perforation has occurred.SETTING: University (Academic) Hospital.METHODS: A prospective single arm study was composed of 8 patients undergoing a standard laparoscopic roux-en-y gastric bypass. At seven time points during the operation intra-abdominal gas was pulled from the abdominal cavity and analyzed using the novel device for H2 and CH4. The time points included after insufflation (T1), after first jejunotomy (T2), after closure of jejunotomy (T3), after recycle of carbon dioxide gas (T4), after gastrostomy (T5), after jejunotomy (T6), at procedure end (T7).RESULTS: Eight patients were enrolled in the study; in 7 (87.5%) patients data from all 7 time points were obtained. After the first opening of the small bowel (T2) mean hydrogen levels were significantly increased compared to baseline hydrogen levels (T1, T4, T7) (p<0.001). At all time points, there was no significant detection of methane. There were no intra-operative or post-operative complications during the study.CONCLUSION: Hydrogen gas is released into the intra-abdominal cavity when bowel is opened and can be detected in real time using a novel device during laparoscopic surgery. The presence or absence of hydrogen directly correlates to whether the bowel is open (perforated) or intact. This device could be used in the future to detect unintended bowel perforations during laparoscopic surgery, prior to the conclusion of the operation. This technology could also potentially lead to novel mechanism for detecting postoperative leaks using gas detection technology.

  View details for PubMedID 30693391

• Heterogeneity of weight loss after gastric bypass, sleeve gastrectomy, and adjustable gastric banding. Surgery Azagury, D., Mokhtari, T. E., Garcia, L., Rosas, U. S., Garg, T., Rivas, H., Morton, J. 2018

  Abstract

  BACKGROUND: Laparoscopic Roux-en-Y gastric bypass, laparoscopic sleeve gastrectomy, and laparoscopic adjustable gastric banding all lead to substantial weight loss in obese patients. Long-term weight loss can be highly variable beyond 1-year postsurgery. This study examines and compares the frequency distribution of weight loss and lack of treatment effect rates after laparoscopic Roux-en-Y gastric bypass, laparoscopic sleeve gastrectomy, and laparoscopic adjustable gastric banding.METHODS: A total of 1,331 consecutive patients at a single academic institution were reviewed from a prospectively collected database. Preoperative data collected included demographics, body mass index, and percent excess weight loss. Postoperative BMI and %EWL were collected at 12, 24, and 36 months. Percent excess weight loss was analyzed by the percentiles of excess weight lost, and the distribution of percent excess weight loss was evaluated in 10% increments. Lack of a successful treatment effect was defined as <25% excess weight loss.RESULTS: Of the 1,331 patients, 72.4% (963) underwent laparoscopic Roux-en-Y gastric bypass, 18.3% (243) laparoscopic sleeve gastrectomy, and 9.4%(125) laparoscopic adjustable gastric banding. Mean percent excess weight loss was greatest for laparoscopic Roux-en-Y gastric bypass, followed by laparoscopic sleeve gastrectomy, and then by laparoscopic adjustable gastric banding at every time point: at 2 years mean percent excess weight loss was 77.9± 24.4 for laparoscopic Roux-en-Y gastric bypass, 50.8 ± 25.8 for laparoscopic sleeve gastrectomy, and 40.8± 25.9 for laparoscopic adjustable gastric banding (P < .0001). The rates of a successful treatment effect s for laparoscopic Roux-en-Y gastric bypass, laparoscopic sleeve gastrectomy, and laparoscopic adjustable gastric banding were 0.9%, 5.2%, and 24.3% at 1 year; 0.3%, 11.1%, and 26.0% at 2 years; and 1.0%, 25.3%, and 30.2% at 3 years. At 1 year, the odds ratio of lack of a successful treatment effect of laparoscopic sleeve gastrectomy versus laparoscopic Roux-en-Y gastric bypass was 6.305 (2.125-19.08; P = .0004), the odds ratio for laparoscopic adjustable gastric banding versus laparoscopic Roux-en-Y gastric bypass was 36.552 (15.64-95.71; P < .0001), and the odds ratio for laparoscopic adjustable gastric banding versus laparoscopic sleeve gastrectomy was 5.791 (2.519-14.599; P < .0001). At 2 years, the odds ratio for laparoscopic sleeve gastrectomy versus laparoscopic Roux-en-Y gastric bypass increased to 70.7 (9.4-531.7; P < .0001), the odds ratio for laparoscopic adjustable gastric banding versus laparoscopic Roux-en-Y gastric bypass increased to 128.1 (16.8-974.3; P < .0001), and the odds ratio for laparoscopic adjustable gastric banding versus laparoscopic sleeve gastrectomy decreased to 1.8 (0.9-3.6; P = .09).CONCLUSION: This study emphasizes the existing variability in weight loss across bariatric procedures as well as in the lack of a treatment effect for each procedure. Although laparoscopic adjustable gastric banding has the greatest rate of a lack of a successful treatment effect, the rate remained stable over 3 years postoperatively. Laparoscopic sleeve gastrectomy showed a doubling in the rate of a lack of a successful treatment effect every year reaching 25% at year 3. The rates for lack of a successful treatment effect for laparoscopic Roux-en-Y gastric bypass remained stable at about 1% for the first 3 years postoperatively.

  View details for PubMedID 30316577

• Surgical Outcomes after Laparoscopic Sleeve Gastrectomy and Gastric Bypass: Findings from the Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program (MBSAQIP) Garcia, L. C., Azagury, D. E., Rivas, H., Morton, J. M. ELSEVIER SCIENCE INC. 2018: S28

  View details for DOI 10.1016/j.jamcollsurg.2018.07.023

  View details for Web of Science ID 000447760600032

• ASMBS Position Statement on medium- and long-term durability of weight loss and diabetic outcomes after conventional stapled bariatric procedures SURGERY FOR OBESITY AND RELATED DISEASES Azagury, D., Papasavas, P., Hamdallah, I., Gagner, M., Kim, J. 2018; 14 (10): 1425–41

  View details for DOI 10.1016/j.soard.2018.08.001

  View details for Web of Science ID 000453109600001

• ASMBS Position Statement on medium- and long-term durability of weight loss and diabetic outcomes after conventional stapled bariatric procedures. Surgery for obesity and related diseases : official journal of the American Society for Bariatric Surgery Azagury, D., Papasavas, P., Hamdallah, I., Gagner, M., Kim, J. 2018

  View details for PubMedID 30242000

• Biodesign for Digital Health DIGITAL HEALTH: SCALING HEALTHCARE TO THE WORLD Harris, B., Denend, L., Azagury, D. E., Rivas, H., Wac, K. 2018: 215–33

  View details for DOI 10.1007/978-3-319-61446-5_16

  View details for Web of Science ID 000431892700017

• How Good Ideas Die: Understanding Common Pitfalls of Medtech Innovation MEDICAL INNOVATION: CONCEPT TO COMMERCIALIZATION Blevins, K. S., Azagury, D. E., Wall, J. K., Chandra, V., Wynne, E. K., Krummel, T. M., Behrns, K. E., Gingles, B., Sarr, M. G. 2018: 117–27

  View details for DOI 10.1016/B978-0-12-814926-3.00012-7

  View details for Web of Science ID 000488302600013

• Nonerosive reflux disease: clinical concepts. Annals of the New York Academy of Sciences Gyawali, C. P., Azagury, D. E., Chan, W. W., Chandramohan, S. M., Clarke, J. O., de Bortoli, N., Figueredo, E., Fox, M., Jodorkovsky, D., Lazarescu, A., Malfertheiner, P., Martinek, J., Murayama, K. M., Penagini, R., Savarino, E., Shetler, K. P., Stein, E., Tatum, R. P., Wu, J. 2018

  Abstract

  Esophageal symptoms can arise from gastroesophageal reflux disease (GERD) as well as other mucosal and motor processes, structural disease, and functional esophageal syndromes. GERD is the most common esophageal disorder, but diagnosis may not be straightforward when symptoms persist despite empiric acid suppressive therapy and when mucosal erosions are not seen on endoscopy (as for nonerosive reflux disease, NERD). Esophageal physiological tests (ambulatory pH or pH-impedance monitoring and manometry) can be of value in defining abnormal reflux burden and reflux-symptom association. NERD diagnosed on the basis of abnormal reflux burden on ambulatory reflux monitoring is associated with similar symptom response from antireflux therapy for erosive esophagitis. Acid suppression is the mainstay of therapy, and antireflux surgery has a definitive role in the management of persisting symptoms attributed to NERD, especially when the esophagogastric junction is compromised. Adjunctive approaches and complementary therapy may be of additional value in management. In this review, we describe the evaluation, diagnosis, differential diagnosis, and management of NERD.

  View details for PubMedID 29761528

• Tool Detection and Operative Skill Assessment in Surgical Videos Using Region-Based Convolutional Neural Networks Jin, A., Yeung, S., Jopling, J., Krause, J., Azagury, D., Milstein, A., Li Fei-Fei, IEEE IEEE. 2018: 691–99

  View details for DOI 10.1109/WACV.2018.00081

  View details for Web of Science ID 000434349200075

• Surgical Anti-Reflux Options Beyond Fundoplication. Current gastroenterology reports Azagury, D., Morton, J. 2017; 19 (7): 35

  Abstract

  PURPOSE OF REVIEW: This paper provides an overview of current and future surgical interventions available for the management of gastroesophageal reflux disease (GERD) beyond the well established and recognized fundoplication. Review the current indications and outcomes of these surgical procedures.RECENT FINDINGS: Fundoplication has been a cornerstone of the surgical management of GERD. However, other effective surgical options exist and can be considered based on prior interventions as well as patient, anatomical or other factors. These options are intended to address some of the shortcomings or potential complications of fundoplication such as symptom recurrence, dysphagia, or gas bloating, for example. Alternative procedures to fundoplication include magnetic sphincter augmentation, electrical stimulation and Roux-en-Y gastric bypass. The indication for surgical management remains failure of or inability to tolerate medical therapy.

  View details for PubMedID 28725999

• Needs-Based Innovation in Interventional Radiology: The Biodesign Process TECHNIQUES IN VASCULAR AND INTERVENTIONAL RADIOLOGY Steinberger, J. D., Denend, L., Azagury, D. E., Brinton, T. J., Makower, J., Yock, P. G. 2017; 20 (2): 84–89

  Abstract

  There are many possible mechanisms for innovation and bringing new technology into the marketplace. The Stanford Biodesign innovation process is based in a deep understanding of clinical unmet needs as the basis for focused ideation and development. By identifying and vetting a compelling unmet need, the aspiring innovator can "derisk" a project and maximize chances for successful development in an increasingly challenging regulatory and economic environment. As a specialty founded by tinkerers, with a history of disruptive innovation that has yielded countless new ways of delivering care with minimal invasiveness, lower morbidity, and lower cost, interventional radiologists are uniquely well positioned to identify unmet needs and develop novel solutions free of dogmatic convention.

  View details for PubMedID 28673651

• Quality of Life After Bariatric Surgery. Current obesity reports Mazer, L. M., Azagury, D. E., Morton, J. M. 2017; 6 (2): 204-210

  Abstract

  The purpose of this review is to provide an introduction to quality of life (QOL) outcomes after bariatric surgery and a summary of the current evidence.QOL has been emphasized in bariatric surgery since the NIH Consensus Conference statement in 1991. Initial studies were limited to 1- and 2-year follow-up. More recent findings have expanded the follow-up period up to 12 years, providing a better description of the impact on long-term QOL. Overall, there is little to no consensus regarding the definition of QOL or the ideal survey. Bariatric surgery has the greatest impact on physical QOL, and the impact on mental health remains unclear. There are some specific and less frequently reported threats to quality of life after bariatric surgery that are also discussed. Obesity has a definite impact on quality of life, even without other comorbidities, and surgery for obesity results in significant and lasting improvements in patient-reported quality of life outcomes. This conclusion is limited by a wide variety of survey instruments and absence of consensus on the definition of QOL after bariatric surgery.

  View details for DOI 10.1007/s13679-017-0266-7

  View details for PubMedID 28527103

• The Impact of Postgraduate Health Technology Innovation Training: Outcomes of the Stanford Biodesign Fellowship ANNALS OF BIOMEDICAL ENGINEERING Wall, J., Hellman, E., Denend, L., Rait, D., Venook, R., Lucian, L., Azagury, D., Yock, P. G., Brinton, T. J. 2017; 45 (5): 1163-1171

  Abstract

  Stanford Biodesign launched its Innovation Fellowship in 2001 as a first-of-its kind postgraduate training experience for teaching biomedical technology innovators a need-driven process for developing medical technologies and delivering them to patients. Since then, many design-oriented educational programs have been initiated, yet the impact of this type of training remains poorly understood. This study measures the career focus, leadership trajectory, and productivity of 114 Biodesign Innovation Fellowship alumni based on survey data and public career information. It also compares alumni on certain publicly available metrics to finalists interviewed but not selected. Overall, 60% of alumni are employed in health technology in contrast to 35% of finalists interviewed but not selected. On leadership, 72% of alumni hold managerial or higher positions compared to 48% of the finalist group. A total of 67% of alumni reported that the fellowship had been "extremely beneficial" on their careers. As a measure of technology translation, more than 440,000 patients have been reached with technologies developed directly out of the Biodesign Innovation Fellowship, with another 1,000,000+ aided by solutions initiated by alumni after their training. This study suggests a positive impact of the fellowship program on the career focus, leadership, and productivity of its alumni.

  View details for DOI 10.1007/s10439-016-1777-1

  View details for Web of Science ID 000399805600001

  View details for PubMedCentralID PMC5397448

• Novel technologies and techniques in bariatric surgery. Minerva chirurgica Rahman, R., Azagury, D. E. 2017; 72 (2): 125-139

  Abstract

  Obesity has been on the rise globally and more people are now clinically obese than ever before in the US. This issue has a significant impact on both health and cost to healthcare systems. Bariatric surgery is efficacious in treatment of obesity but only in late stages of the disease, and there is a requirement for less invasive techniques/devices to treat obesity at earlier stages. Currently a number of these are either in clinical trials or have recently been approved by the Food and Drug Administration for weight loss. This review aims to give an overview of the newer technologies and techniques being used in bariatric surgery. It will also give a glimpse into future methods and those that have fallen short in recent times.

  View details for DOI 10.23736/S0026-4733.16.07265-5

  View details for PubMedID 27981827

• ASMBS Position Statement on Postprandial Hyperinsulinemic H ypoglycemia after Bariatric Surgery SURGERY FOR OBESITY AND RELATED DISEASES Eisenberg, D., Azagury, D. E., Ghiassi, S., Grover, B. T., Kim, J. J. 2017; 13 (3): 371-378

  View details for DOI 10.1016/j.soard.2016.12.005

  View details for Web of Science ID 000398016500001

• Buttressing of the EEA stapler during gastrojejunal anastomosis decreases rate of bleeding-related complications for laparoscopic gastric bypass. Surgery for obesity and related diseases Ichter, Z. A., Voeller, L., Rivas, H., Khoury, H., Azagury, D., Morton, J. M. 2017

  Abstract

  Bariatric surgery is a well-tolerated and effective treatment for severe obesity. Newer surgical techniques and equipment have improved safety standards surrounding bariatric surgery. In particular, buttressing of the staple line in sleeve gastrectomy has decreased rates of clinically significant postoperative bleeding. The present study investigates the effectiveness of buttressing the circular stapled anastomosis during laparoscopic Roux-en-Y gastric bypass (LRYGB).Academic, accredited hospital.A total of 253 patients undergoing LRYGB at a single academic institution were included in this retrospective study between 2014 and 2015. Buttressing material was used in 125 of these cases. Demographic information was collected from both groups preoperatively. Surgical characteristics were also obtained analyzed using unpaired t or χ(2) tests.Patients in both buttressing and nonbuttressing groups were on average 46 years old and predominantly female (79.2% versus 74.2% female, respectively), with a body mass index of approximately 48 kg/m(2). Postoperative weight loss did not significantly differ between groups at any time point (buttressing versus nonbuttressing percentage of excess weight loss: 39.5% versus 41.5% at 3 mo, P = .3860; 56.4% versus 56.7% at 6 mo, P = .9341). There were no significant differences for operating time, length of stay, readmissions, or reoperations. Complications due to strictures were found to be lower for the buttressing group (0% buttressing versus 2.3% nonbuttressing, P = .0851). Specific rates of bleeding-related complications were significantly lower for the group in which buttressing was used (0% buttressing versus 3.1% nonbuttressing, P = .0463).Buttressing of the gastrojejunal anastomosis during LRYGB significantly reduces bleeding-related complications and increases tolerability of the procedure.

  View details for DOI 10.1016/j.soard.2017.01.019

  View details for PubMedID 28325504

• Novel Technologies in Bariatric Surgery CURRENT SURGERY REPORTS Azagury, D. E. 2017; 5 (1)

  View details for DOI 10.1007/s40137-017-0167-4

  View details for Web of Science ID 000406541200004

• The Impact of Postgraduate Health Technology Innovation Training: Outcomes of the Stanford Biodesign Fellowship. Annals of biomedical engineering Wall, J., Hellman, E., Denend, L., Rait, D., Venook, R., Lucian, L., Azagury, D., Yock, P. G., Brinton, T. J. 2016

  Abstract

  Stanford Biodesign launched its Innovation Fellowship in 2001 as a first-of-its kind postgraduate training experience for teaching biomedical technology innovators a need-driven process for developing medical technologies and delivering them to patients. Since then, many design-oriented educational programs have been initiated, yet the impact of this type of training remains poorly understood. This study measures the career focus, leadership trajectory, and productivity of 114 Biodesign Innovation Fellowship alumni based on survey data and public career information. It also compares alumni on certain publicly available metrics to finalists interviewed but not selected. Overall, 60% of alumni are employed in health technology in contrast to 35% of finalists interviewed but not selected. On leadership, 72% of alumni hold managerial or higher positions compared to 48% of the finalist group. A total of 67% of alumni reported that the fellowship had been "extremely beneficial" on their careers. As a measure of technology translation, more than 440,000 patients have been reached with technologies developed directly out of the Biodesign Innovation Fellowship, with another 1,000,000+ aided by solutions initiated by alumni after their training. This study suggests a positive impact of the fellowship program on the career focus, leadership, and productivity of its alumni.

  View details for DOI 10.1007/s10439-016-1777-1

  View details for PubMedID 28004213

  View details for PubMedCentralID PMC5397448

• ASMBS Position Statement on Postprandial Hyperinsulinemic Hypoglycemia after Bariatric Surgery. Surgery for obesity and related diseases Eisenberg, D., Azagury, D. E., Ghiassi, S., Grover, B. T., Kim, J. J. 2016

  View details for DOI 10.1016/j.soard.2016.12.005

  View details for PubMedID 28110984

• Characterizing Readmissions After Bariatric Surgery. Journal of gastrointestinal surgery Garg, T., Rosas, U., Rogan, D., Hines, H., Rivas, H., Morton, J. M., Azagury, D. 2016; 20 (11): 1797-1801

  Abstract

  Readmissions are an important quality metric for surgery. Here, we compare characteristics of readmissions across laparoscopic Roux-en-Y gastric bypass (LRYGB), sleeve gastrectomy (LSG), and adjustable gastric band (LAGB).Demographic, intraoperative, anthropometric, and laboratory data were prospectively obtained for 1775 patients at a single academic institution. All instances of readmissions within 1 year were recorded. Data were analyzed using STATA, release 12.For the 1775 patients, 113 (6.37 %) were readmitted. Mean time to readmission was 52.1 days. Of all the readmissions, 64.6 % were within 30 days, 22.1 % from 30 to 90 days, 1.77 % from 90 to 180 days, and 11.5 % from 180 to 365 days. Incidence of 30-day readmissions varied across surgeries (LRYGB: 7.17 %; LAGB: 3.05 %; LSG: 4.25 %, p = 0.04). Time to readmission varied as well, with 90.0 % of LSG and 80.0 % of LABG patients within the first 30 days, versus 60.8 % of LRYGB (p = 0.02). The most common causes of readmissions were gastrointestinal issues related to index procedure (34.5 %) and did not vary across surgeries. In multivariable logistic regression, index hospital length of stay (LOS) was associated with readmission (OR = 1.07, 95 % CI 1.02-1.13, p = 0.01).Readmissions after bariatric surgery are associated with high index hospital LOS, and a measureable proportion of procedure-related readmissions can occur up to 1 year, especially for LRYGB.

  View details for PubMedID 27613733

• Characterizing Readmissions After Bariatric Surgery JOURNAL OF GASTROINTESTINAL SURGERY Garg, T., Rosas, U., Rogan, D., Hines, H., Rivas, H., Morton, J. M., Azagury, D. 2016; 20 (11): 1797–1801

  View details for DOI 10.1007/s11605-016-3247-3

  View details for Web of Science ID 000387032200003

• How can we deal with the GERD treatment gap? Annals of the New York Academy of Sciences Triadafilopoulos, G., Azagury, D. 2016; 1381 (1): 14-20

  Abstract

  Patients experiencing heartburn and acid regurgitation despite proton pump inhibition therapy who are averse to antireflux surgery fall into what is called the gastroesophageal reflux disease (GERD) treatment gap. This gap may be potentially addressed by several endoscopic and laparoscopic techniques, including gastric bypass surgery for those patients who are obese. These novel techniques do not significantly alter the anatomy of the esophagogastric junction, minimizing short- and long-term adverse effects. This review provides an overview of the assessment of patients with refractory GERD and highlights the strengths and weaknesses of these minimally invasive therapies.

  View details for DOI 10.1111/nyas.13104

  View details for PubMedID 27384084

• Bariatric Surgery Outcomes in US Accredited vs Non-Accredited Centers: A Systematic Review. Journal of the American College of Surgeons Azagury, D., Morton, J. M. 2016; 223 (3): 469-477

  Abstract

  Accreditation for bariatric surgery has been scrutinized recently for its impact on surgical outcomes. This study aimed to systematically examine the medical literature to examine the impact of bariatric accreditation on surgical outcomes.The PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines and checklist were used. The MEDLINE database was searched for the following terms (2000 through September 2014): gastric bypass or bariatric surgery or sleeve gastrectomy or vertical banded gastroplasty or biliopancreatic diversion or duodenal switch or adjustable gastric band or weight loss surgery and accreditation or center of excellence or credentialing or national coverage decision or CMS or Medicare. Only studies in English and articles comparing accredited with non-accredited centers were included. Quality was assessed using the Newcastle-Ottawa scale for evaluation of all studies.Thirteen studies were published in a very short time frame and covered >1.5 million patients. Ten of the 13 studies identified a substantial benefit of Center of Excellence accreditation for risk-adjusted outcomes. Six of the 8 studies reported a considerable reduction in mortality in patients operated on in Centers of Excellence, with odds ratios ranging from 2.26 to 3.57 for non-accredited centers; 2 studies showed no significant difference. Similarly, morbidity was reduced in 8 of 11 studies, although more discreetly, with odds ratios ranging from 1.09 to 1.39.This study found that the preponderance of medical evidence supports accreditation for bariatric surgery.

  View details for DOI 10.1016/j.jamcollsurg.2016.06.014

  View details for PubMedID 27423398

• Bariatric Surgery: Overview of Procedures and Outcomes. Endocrinology and metabolism clinics of North America Azagury, D. E., Morton, J. M. 2016; 45 (3): 647-656

  Abstract

  Bariatric surgery is the most efficient and long-lasting weight loss therapy available. Its safety has improved over tenfold over the last decade. With the advent of laparoscopy, mortality rates of are now under 1 per 1400 cases in accredited centers. Gastric bypass reduces diabetes-related mortality by 92% over 7 years and long lasting remission has been demonstrated in observational studies covering >10,000 patients and multiple randomized control trials. The benefit of bariatric surgery on diabetes is so substantial that these procedures should be considered in all type 2 diabetic patients with a BMI > 35 kg/m(2).

  View details for DOI 10.1016/j.ecl.2016.04.013

  View details for PubMedID 27519136

• Patient Safety and Quality Improvement Initiatives in Contemporary Metabolic and Bariatric Surgical Practice. Surgical clinics of North America Azagury, D. E., Morton, J. M. 2016; 96 (4): 733-742

  Abstract

  Patient safety and quality improvement have been part of bariatric surgery since its inception, and there have been significant improvements in outcomes of bariatric surgery over the past 2 decades. A strong accreditation program exists. This program defines 2 tiers of accredited centers: low-acuity and comprehensive centers similar to the trauma systems. Accreditation has been shown to have a favorable impact on outcomes of bariatric surgery. Bariatric surgery lends itself well to improvements in processes and use of perioperative protocols, such as ulcer and thromboembolic prophylaxis prevention or gallstone prevention and management.

  View details for DOI 10.1016/j.suc.2016.03.014

  View details for PubMedID 27473798

• National prevalence, causes, and risk factors for bariatric surgery readmissions AMERICAN JOURNAL OF SURGERY Garg, T., Rosas, U., Rivas, H., Azagury, D., Morton, J. M. 2016; 212 (1): 76-80

  Abstract

  Readmissions are often used as a quality metric particularly in bariatric surgery.Laparoscopic Roux en Y gastric bypass, laparoscopic adjustable gastric banding, and laparoscopic sleeve gastrectomy were identified using Current Procedure Terminology codes in the 2012 National Surgical Quality Improvement Program public use file.A total of 18,296 patients were included, 10,080 (55.1%) were laparoscopic Roux en Y gastric bypass, 1,829 (10.0%) were laparoscopic adjustable gastric banding, and 6,387 (34.9%) were laparoscopic sleeve gastrectomy. Among all patients, 955 (5.22%) were readmitted. Patients with readmissions had a higher proportion of body mass index greater than 50 (30.2% vs 24.6%, P < .001), higher index operative time (132 minutes vs 115, P < .001) and greater proportion with length of stay greater than 4 days (9.57% vs 3.36%, P < .001). Readmitted patients were more likely to have diabetes (31.1% vs 27.7%, P = .02), chronic obstructive pulmonary disease (2.63% vs 1.72%, P = .04), and hypertension (54.5% vs 50.8%, P = .03). Overall, 40.6% of readmitted patients had a complication. Common readmissions were gastrointestinal-related (45.0%), dietary (33.5%), and bleeding (6.57%). Readmission was independently associated with African-American race (odds ratio [OR] = 1.53, P = .02), complication (OR = 11.3, 95%, P < .001), and resident involvement (OR = .53, P = .04).A 30-day readmission after bariatric surgery is prevalent and closely associated with complications.

  View details for DOI 10.1016/j.amjsurg.2016.01.023

  View details for Web of Science ID 000378063100011

  View details for PubMedID 27133197

• A postoperative nutritional consult improves bariatric surgery outcomes. Surgery for obesity and related diseases Garg, T., Birge, K., Ulysses Rosas, Azagury, D., Rivas, H., Morton, J. M. 2016; 12 (5): 1052-1056

  Abstract

  Bariatric surgery is the most effective treatment for obesity. Guidelines for optimizing postoperative care are emerging, and roles of the surgeon and registered dietician (RD) have opportunities for coordination.The study objective was to better define the appropriate guidelines for postoperative care by investigating whether a combined surgeon and RD follow-up for the initial postoperative visit within 2 to 6 weeks after surgery improves patient outcomes.The setting was an accredited bariatric hospital in an academic setting.A retrospective analysis of a prospective database was performed on patients who underwent bariatric surgery and were followed up by either a surgeon alone or by a surgeon and RD for initial postoperative visit.There were 302 patients in the surgeon follow-up group and 268 in the RD follow-up. Patients in the RD follow-up group had significantly fewer readmissions due to dietary-related problems (9 versus 0; P = .004), more favorable 3-month change in serum thiamine (-30.5 versus-4.04; P = .002), high-density lipoprotein (-3.42 versus-1.67; P = .053), and triglycerides (-17.5 versus-31.5; P = .03), and trended lower number of minor complications (16 versus 6; P = .08). No significant differences in percent excess weight loss were observed at all time points after surgery. Multivariate logistic models controlling for demographic features found that RD follow-up predicted 3-month increase in thiamine (odds ratio = 2.49; P<.000) and high-density lipoprotein cholesterol (OR = 1.73; P = .01), and decrease in total cholesterol (OR = 1.58; P = .03) and triglycerides (OR = 1.55; P = .03).Follow-up with a surgeon and RD for the initial postoperative visit may help improve patient outcomes.

  View details for DOI 10.1016/j.soard.2016.01.008

  View details for PubMedID 27220825

• Roux-en-Y gastric bypass for super obese patients: what approach? INTERNATIONAL JOURNAL OF MEDICAL ROBOTICS AND COMPUTER ASSISTED SURGERY Buchs, N. C., Azagury, D. E., Pugin, F., Jung, M. K., Huber, O., Chassot, G., Morel, P. 2016; 12 (2): 276-282

  Abstract

  Super obese (SO) patients with a Body Mass Index (BMI) ≥ 50 kg/m(2) still represent a real anesthesiological and surgical challenge. While the best procedure to perform in this population remains unclear, robotic technology has been proposed to accomplish Roux-en-Y gastric bypass (RYGB). The study aim is to report our experience of robotic RYGB for SO patients and to compare it with open and laparoscopic surgery.From July 1997 to March 2014, all consecutive RYGB cases for SO patients were collected in a dedicated database and reviewed retrospectively. Two hundred and fourteen SO patients were operated on: 65 by a robotic approach (30.4%), 54 by a laparoscopic approach (25.2%), and 95 using an open approach (44.4%). Peri- and post-operative data were compared between the three approaches.There were more male patients in the robotic group, but with a slightly lower BMI. The operative time was longer for the robotic (+27 min) and laparoscopic (+21 min) groups in comparison with the open group (P < 0.05). Overall, there were less reoperations (P < 0.05) and a shorter hospital stay (P < 0.05) in the robotic group in comparison with other groups. Of note there was also a trend in favor of robotics with less conversions (P = 0.08) and less postoperative complications (P ≥ 0.05).Robotic RYGB can be performed safely in super obese patients with results that compare favorably with laparoscopic and open surgery. However, the robotic approach has a longer operative time. The exact role of robotics for super obese population needs to be clarified in larger and randomized trials before drawing definitive conclusions. Copyright © 2015 John Wiley & Sons, Ltd.

  View details for DOI 10.1002/rcs.1660

  View details for Web of Science ID 000384840500012

  View details for PubMedID 25892087

• Lipids and bariatric procedures Part 2 of 2: scientific statement from the American Society for Metabolic and Bariatric Surgery (ASMBS), the National Lipid Association (NLA), and Obesity Medicine Association (OMA) SURGERY FOR OBESITY AND RELATED DISEASES Bays, H., Kothari, S. N., Azagury, D. E., Morton, J. M., Nguyen, N. T., Jones, P. H., Jacobson, T. A., Cohen, D. E., Orringer, C., Westman, E. C., Horn, D. B., Scinta, W., Primack, C. 2016; 12 (3): 468-495

  Abstract

  Bariatric procedures generally improve dyslipidemia, sometimes substantially so. Bariatric procedures also improve other major cardiovascular risk factors. This 2-part Scientific Statement examines the lipid effects of bariatric procedures and reflects contributions from authors representing the American Society for Metabolic and Bariatric Surgery (ASMBS), the National Lipid Association (NLA), and the Obesity Medicine Association (OMA). Part 1 was published in the Journal of Clinical Lipidology, and reviewed the impact of bariatric procedures upon adipose tissue endocrine and immune factors, adipose tissue lipid metabolism, as well as the lipid effects of bariatric procedures relative to bile acids and intestinal microbiota. This Part 2 reviews: (1) the importance of nutrients (fats, carbohydrates, and proteins) and their absorption on lipid levels; (2) the effects of bariatric procedures on gut hormones and lipid levels; (3) the effects of bariatric procedures on nonlipid cardiovascular disease (CVD) risk factors; (4) the effects of bariatric procedures on lipid levels; (5) effects of bariatric procedures on CVD; and finally, (6) the potential lipid effects of vitamin, mineral, and trace element deficiencies, that may occur after bariatric procedures.

  View details for DOI 10.1016/j.soard.2016.01.007

  View details for PubMedID 27050404

• American Society for Metabolic and Bariatric Surgery position statement on long-term survival benefit after metabolic and bariatric surgery SURGERY FOR OBESITY AND RELATED DISEASES Kim, J., Eisenberg, D., Azagury, D., Rogers, A., Campos, G. M. 2016; 12 (3): 453-459

  Abstract

  The following position statement has been issued by the American Society for Metabolic and Bariatric Surgery in response to numerous inquiries made to the Society by patients, physicians, society members, hospitals, health insurance payors, the media, and others regarding the benefit of metabolic and bariatric surgery on long-term survival. An overview of the current available published peer-reviewed scientific evidence is presented.

  View details for DOI 10.1016/j.soard.2015.11.021

  View details for Web of Science ID 000376223300001

  View details for PubMedID 26944548

• Twelve key nutritional issues in bariatric surgery. Clinical nutrition Thibault, R., Huber, O., Azagury, D. E., Pichard, C. 2016; 35 (1): 12-17

  Abstract

  In morbidly obese patients, i.e. body mass index ≥35, bariatric surgery is considered the only effective durable weight-loss therapy. Laparoscopic Roux-en-Y gastric bypass (LRYGBP), laparoscopic sleeve gastrectomy (LSG), and biliopancreatic diversion with duodenal switch (BPD-DS) are associated with risks of nutritional deficiencies and malnutrition. Therefore, preoperative nutritional assessment and correction of vitamin and micronutrient deficiencies, as well as long-term postoperative nutritional follow-up, are advised. Dietetic counseling is mandatory during the first year, optional later. Planned and structured physical exercise should be systematically promoted to maintain muscle mass and bone health. In this review, twelve key perioperative nutritional issues are raised with focus on LRYGBP and LSG procedures, the most common current bariatric procedures.

  View details for DOI 10.1016/j.clnu.2015.02.012

  View details for PubMedID 25779332

• Lipids and bariatric procedures part 1 of 2: Scientific statement from the National Lipid Association, American Society for Metabolic and Bariatric Surgery, and Obesity Medicine Association: FULL REPORT. Journal of clinical lipidology Bays, H. E., Jones, P. H., Jacobson, T. A., Cohen, D. E., Orringer, C. E., Kothari, S., Azagury, D. E., Morton, J., Nguyen, N. T., Westman, E. C., Horn, D. B., Scinta, W., Primack, C. 2016; 10 (1): 33-57

  Abstract

  Bariatric procedures often improve lipid levels in patients with obesity. This 2 part scientific statement examines the potential lipid benefits of bariatric procedures and represents the contributions from authors representing the National Lipid Association, American Society for Metabolic and Bariatric Surgery, and the Obesity Medicine Association. The foundation for this scientific statement was based on published data through June 2015. Part 1 of this 2 part scientific statement provides an overview of: (1) adipose tissue, cholesterol metabolism, and lipids; (2) bariatric procedures, cholesterol metabolism, and lipids; (3) endocrine factors relevant to lipid influx, synthesis, metabolism, and efflux; (4) immune factors relevant to lipid influx, synthesis, metabolism, and efflux; (5) bariatric procedures, bile acid metabolism, and lipids; and (6) bariatric procedures, intestinal microbiota, and lipids, with specific emphasis on how the alterations in the microbiome by bariatric procedures influence obesity, bile acids, and inflammation, which in turn, may all affect lipid levels. Included in part 2 of this comprehensive scientific statement will be a review of (1) the importance of nutrients (fats, carbohydrates, and proteins) and their absorption on lipid levels; (2) the effects of bariatric procedures on gut hormones and lipid levels; (3) the effects of bariatric procedures on nonlipid cardiovascular disease (CVD) risk factors; (4) the effects of bariatric procedures on lipid levels; (5) effects of bariatric procedures on CVD; and finally, (6) the potential lipid effects of vitamin, mineral, and trace element deficiencies that may occur after bariatric procedures. This document represents the full report of part 1.

  View details for DOI 10.1016/j.jacl.2015.12.002

  View details for PubMedID 26892120

• Needs-Based Innovation in Cardiovascular Medicine The Stanford Biodesign Process JACC. Basic to translational science Schwartz, J. G., Kumar, U. N., Azagury, D. E., Brinton, T. J., Yock, P. G. 2016; 1 (6): 541-547

  View details for DOI 10.1016/j.jacbts.2016.06.011

• Needs-Based Innovation in Cardiovascular Medicine: The Stanford Biodesign Process. JACC. Basic to translational science Schwartz, J. G., Kumar, U. N., Azagury, D. E., Brinton, T. J., Yock, P. G. 2016; 1 (6): 541–47

  Abstract

  More than a decade ago, a formalized fellowship training program in medical device innovation, the first of its kind, was created at Stanford University. Now in its 15th year, the Stanford Biodesign Fellowship Program is a 10-month program whereby postgraduate students with a prior background in medicine, engineering, and/or business form interdisciplinary teams for an experiential process of identifying unmet clinical needs, inventing new solutions, and implementing these ideas (the 3 "I's"). A key component of this structured process is focused attention on needs finding and characterization, which differs from the traditional "tech-push" model (i.e., technologies looking for problems to solve). Although the Stanford Biodesign process can be applied to a wide variety of clinical areas, cardiovascular medicine is particularly well suited, given the breadth of clinical presentations it touches and its history of innovation to solve important clinical problems. Physicians play a vital role in the process, especially for needs identification and characterization. This paper outlines the Stanford Biodesign process and presents an argument for its repeat applicability, discusses its relevance to physicians and to cardiologists in particular, and provides a case study of the process that resulted in a currently available cardiovascular medical technology that came directly from the Fellowship Program.

  View details for PubMedID 30167537

• Lipids and bariatric procedures part 1 of 2: Scientific statement from the National Lipid Association, American Society for Metabolic and Bariatric Surgery, and Obesity Medicine Association: EXECUTIVE SUMMARY. Journal of clinical lipidology Bays, H. E., Jones, P. H., Jacobson, T. A., Cohen, D. E., Orringer, C. E., Kothari, S., Azagury, D. E., Morton, J., Nguyen, N. T., Westman, E. C., Horn, D. B., Scinta, W., Primack, C. 2016; 10 (1): 15-32

  Abstract

  Bariatric procedures often improve lipid levels in patients with obesity. This 2-part scientific statement examines the potential lipid benefits of bariatric procedures and represents contributions from authors representing the National Lipid Association, American Society for Metabolic and Bariatric Surgery, and the Obesity Medicine Association. The foundation for this scientific statement was based on data published through June 2015. Part 1 of this 2-part scientific statement provides an overview of: (1) adipose tissue, cholesterol metabolism, and lipids; (2) bariatric procedures, cholesterol metabolism, and lipids; (3) endocrine factors relevant to lipid influx, synthesis, metabolism, and efflux; (4) immune factors relevant to lipid influx, synthesis, metabolism, and efflux; (5) bariatric procedures, bile acid metabolism, and lipids; and (6) bariatric procedures, intestinal microbiota, and lipids, with specific emphasis on how the alterations in the microbiome by bariatric procedures influence obesity, bile acids, and inflammation, which in turn, may all affect lipid levels. Included in part 2 of this comprehensive scientific statement will be a review of: (1) the importance of nutrients (fats, carbohydrates, and proteins) and their absorption on lipid levels; (2) the effects of bariatric procedures on gut hormones and lipid levels; (3) the effects of bariatric procedures on nonlipid cardiovascular disease risk factors; (4) the effects of bariatric procedures on lipid levels; (5) effects of bariatric procedures on cardiovascular disease; and finally (6) the potential lipid effects of vitamin, mineral, and trace element deficiencies that may occur after bariatric procedures. This document represents the executive summary of part 1.

  View details for DOI 10.1016/j.jacl.2015.12.003

  View details for PubMedID 26892119

• Image-guided surgery. Current problems in surgery Azagury, D. E., Dua, M. M., Barrese, J. C., Henderson, J. M., Buchs, N. C., Ris, F., Cloyd, J. M., Martinie, J. B., Razzaque, S., Nicolau, S., Soler, L., Marescaux, J., Visser, B. C. 2015; 52 (12): 476-520

  View details for DOI 10.1067/j.cpsurg.2015.10.001

  View details for PubMedID 26683419

• SAGES TAVAC safety and effectiveness analysis: da Vinci(®) Surgical System (Intuitive Surgical, Sunnyvale, CA). Surgical endoscopy Tsuda, S., Oleynikov, D., Gould, J., Azagury, D., Sandler, B., Hutter, M., Ross, S., Haas, E., Brody, F., Satava, R. 2015; 29 (10): 2873-2884

  Abstract

  The da Vinci(®) Surgical System (Intuitive Surgical, Sunnyvale, CA, USA) is a computer-assisted (robotic) surgical system designed to enable and enhance minimally invasive surgery. The Food and Drug Administration (FDA) has cleared computer-assisted surgical systems for use by trained physicians in an operating room environment for laparoscopic surgical procedures in general, cardiac, colorectal, gynecologic, head and neck, thoracic and urologic surgical procedures. There are substantial numbers of peer-reviewed papers regarding the da Vinci(®) Surgical System, and a thoughtful assessment of evidence framed by clinical opinion is warranted.The SAGES da Vinci(®) TAVAC sub-committee performed a literature review of the da Vinci(®) Surgical System regarding gastrointestinal surgery. Conclusions by the sub-committee were vetted by the SAGES TAVAC Committee and SAGES Executive Board. Following revisions, the document was evaluated by the TAVAC Committee and Executive Board again for final approval.Several conclusions were drawn based on expert opinion organized by safety, efficacy, and cost for robotic foregut, bariatric, hepatobiliary/pancreatic, colorectal surgery, and single-incision cholecystectomy.Gastrointestinal surgery with the da Vinci(®) Surgical System is safe and comparable, but not superior to standard laparoscopic approaches. Although clinically acceptable, its use may be costly for select gastrointestinal procedures. Current data are limited to the da Vinci(®) Surgical System; further analyses are needed.

  View details for DOI 10.1007/s00464-015-4428-y

  View details for PubMedID 26205559

• Small bowel obstruction: A practical step-by-step evidence-based approach to evaluation, decision making, and management. journal of trauma and acute care surgery Azagury, D., Liu, R. C., Morgan, A., Spain, D. A. 2015; 79 (4): 661-668

  Abstract

  The initial goal of evaluating a patient with SBO is to immediately identify strangulation and need for urgent operative intervention, concurrent with rapid resuscitation. This relies on a combination of traditional clinical signs and CT findings. In patients without signs of strangulation, a protocol for administration of Gastrografin immediately in the emergency department efficiently sorts patients into those who will resolve their obstructions and those who will fail nonoperative management.Furthermore, because of the unique ability of Gastrografin to draw water into the bowel lumen, it expedites resolution of partial obstructions, shortening time to removal of nasogastric tube liberalization of diet, and discharge from the hospital. Implementation of such a protocol is a complex, multidisciplinary, and time-consuming endeavor. As such, we cannot over emphasize the importance of clear, open communication with everyone involved.If surgical management is warranted, we encourage an initial laparoscopic approach with open access. Even if this results in immediate conversion to laparotomy after assessment of the intra-abdominal status, we encourage this approach with a goal of 30% conversion rate or higher. This will attest that patients will have been given the highest likelihood of a successful laparoscopic LOA.

  View details for DOI 10.1097/TA.0000000000000824

  View details for PubMedID 26402543

• Male sex hormones normalize after laparoscopic sleeve gastrectomy Morton, J. M., Mokhrati, T., Nair, A. A., Rivas, H., Azagury, D. E. ELSEVIER SCIENCE INC. 2015: E2

  View details for DOI 10.1016/j.jamcollsurg.2015.08.306

  View details for Web of Science ID 000386899000006

• ASMBS position statement on prevention, detection, and treatment of gastrointestinal leak after gastric bypass and sleeve gastrectomy, including the roles of imaging, surgical exploration, and nonoperative management SURGERY FOR OBESITY AND RELATED DISEASES Kim, J., Azagury, D., Eisenberg, D., DeMaria, E., Campos, G. M. 2015; 11 (4): 739-748

  View details for DOI 10.1016/j.soard.2015.05.001

  View details for Web of Science ID 000359329500001

  View details for PubMedID 26071849

• Does perioperative nutrition and oral carbohydrate load sustainably preserve muscle mass after bariatric surgery? A randomized control trial SURGERY FOR OBESITY AND RELATED DISEASES Azagury, D. E., Ris, F., Pichard, C., Volonte, F., Karsegard, L., Huber, O. 2015; 11 (4): 920-926

  Abstract

  Perioperative nutrition and preoperative oral carbohydrate loading (CHL) have a beneficial impact on the outcomes of gastrointestinal oncological surgery. However no data exists on their effect on morbidly obese patients.Our aim was to establish the short-term and long-term impact of these modalities, notably on metabolically active lean body mass (LBM) - an important factor in maintaining long-term weight loss.Patients undergoing laparoscopic Roux-en-Y gastric bypass were randomized to standard management or intervention: CHL drinks consumed 12 and 2 hours presurgery, and immediate postoperative peripheral parenteral nutrition. The primary outcome measured was LBM, measured by Bioelectrical Impedance Analysis (BIA), one and 12 months postsurgery. Secondary outcomes included excess weight loss (EBWL), 30-day complication rate, and length of stay.Of the 203 randomized patients, 198 were included in the analysis. All 101 patients in the control group completed the one-year follow up and 76 completed the BIA. In the intervention group, 93 of 97 patients completed the one-year follow-up and 71 completed the BIA. At one and 12 months follow-up, body composition, LBM, or EBWL were comparable. There was no difference in operative outcomes, complications rates, or length of stay. There was no adverse effect in the intervention group.In a highly homogeneous group of morbidly obese patients with one-year follow-up, CHL and short-term parenteral nutrition did not lead to significant or sustained LBM preservation or modification in EBWL. There was no significant decrease in complications or length of stay. Our study confirms the safety of these interventions, even in previously unstudied Type 2 diabetic patients.

  View details for DOI 10.1016/j.soard.2014.10.016

  View details for Web of Science ID 000359329500037

  View details for PubMedID 25851776

• Do adverse childhood experiences affect surgical weight loss outcomes? Journal of gastrointestinal surgery Lodhia, N. A., Rosas, U. S., Moore, M., Glaseroff, A., Azagury, D., Rivas, H., Morton, J. M. 2015; 19 (6): 993-998

  Abstract

  Bariatric surgery is an effective and enduring treatment for obesity; however, variation in weight loss may occur following surgery. Many factors beyond technical considerations may influence postoperative outcomes. A better understanding of the influence of adverse childhood experiences (ACE) on surgical weight loss may improve preoperative care. Demographic and preoperative and postoperative data were prospectively obtained for 223 patients undergoing bariatric surgery. All cases were completed laparoscopically without serious complication. Patients completed the ACE questionnaire, which assesses childhood maltreatment. Patients had an average age of 48 years and 77 % were female. There was a significant reduction from preoperative to 12-month postoperative BMI (45 to 31 kg/m(2), p ≤ 0.01). The average ACE score was 2.9 and these patients were more likely than population norms to have an ACE score ≥4 (35.9 vs. 12.5 %, p < 0.001). There was a positive correlation between the number of preoperative comorbidities and preoperative ACE score (R = 0.112, p = 0.09). Patients with a high ACE score (≥6) vs. patients low ACE scores had a higher postoperative BMI at 6-months (36.9 vs. 33.4 kg/m(2), p = 0.03) and 12-months postoperatively (34.5 vs. 30.5 kg/m(2), p = 0.07). High ACE patients had higher total cholesterol (191 vs. 169 mg/dL, p = 0.02) and LDL cholesterol (116 vs. 94 mg/dL, p = 0.02) than low ACE patients 12-months postoperatively. A high preoperative ACE score decreases weight loss following bariatric surgery and may warrant an increased preoperative counseling.

  View details for DOI 10.1007/s11605-015-2810-7

  View details for PubMedID 25832488

• Deep brain stimulation for obesity: rationale and approach to trial design NEUROSURGICAL FOCUS Ho, A. L., Sussman, E. S., Pendharkar, A. V., Azagury, D. E., Bohon, C., Halpern, C. H. 2015; 38 (6)

  Abstract

  Obesity is one of the most serious public health concerns in the US. While bariatric surgery has been shown to be successful for treatment of morbid obesity for those who have undergone unsuccessful behavioral modification, its associated risks and rates of relapse are not insignificant. There exists a neurological basis for the binge-like feeding behavior observed in morbid obesity that is believed to be due to dysregulation of the reward circuitry. The authors present a review of the evidence of the neuroanatomical basis for obesity, the potential neural targets for deep brain stimulation (DBS), as well as a rationale for DBS and future trial design. Identification of an appropriate patient population that would most likely benefit from this type of therapy is essential. There are also significant cost and ethical considerations for such a neuromodulatory intervention designed to alter maladaptive behavior. Finally, the authors present a consolidated set of inclusion criteria and study end points that should serve as the basis for any trial of DBS for obesity.

  View details for DOI 10.3171/2015.3.FOCUS1538

  View details for Web of Science ID 000355539900008

  View details for PubMedID 26030708

• Deep brain stimulation for obesity: rationale and approach to trial design. Neurosurgical focus Ho, A. L., Sussman, E. S., Pendharkar, A. V., Azagury, D. E., Bohon, C., Halpern, C. H. 2015; 38 (6): E8-?

  Abstract

  Obesity is one of the most serious public health concerns in the US. While bariatric surgery has been shown to be successful for treatment of morbid obesity for those who have undergone unsuccessful behavioral modification, its associated risks and rates of relapse are not insignificant. There exists a neurological basis for the binge-like feeding behavior observed in morbid obesity that is believed to be due to dysregulation of the reward circuitry. The authors present a review of the evidence of the neuroanatomical basis for obesity, the potential neural targets for deep brain stimulation (DBS), as well as a rationale for DBS and future trial design. Identification of an appropriate patient population that would most likely benefit from this type of therapy is essential. There are also significant cost and ethical considerations for such a neuromodulatory intervention designed to alter maladaptive behavior. Finally, the authors present a consolidated set of inclusion criteria and study end points that should serve as the basis for any trial of DBS for obesity.

  View details for DOI 10.3171/2015.3.FOCUS1538

  View details for PubMedID 26030708

• Deep Brain Stimulation for Obesity. Cureus Ho, A. L., Sussman, E. S., Zhang, M., Pendharkar, A. V., Azagury, D. E., Bohon, C., Halpern, C. H. 2015; 7 (3)

  Abstract

  Obesity is now the third leading cause of preventable death in the US, accounting for 216,000 deaths annually and nearly 100 billion dollars in health care costs. Despite advancements in bariatric surgery, substantial weight regain and recurrence of the associated metabolic syndrome still occurs in almost 20-35% of patients over the long-term, necessitating the development of novel therapies. Our continually expanding knowledge of the neuroanatomic and neuropsychiatric underpinnings of obesity has led to increased interest in neuromodulation as a new treatment for obesity refractory to current medical, behavioral, and surgical therapies. Recent clinical trials of deep brain stimulation (DBS) in chronic cluster headache, Alzheimer's disease, and depression and obsessive-compulsive disorder have demonstrated the safety and efficacy of targeting the hypothalamus and reward circuitry of the brain with electrical stimulation, and thus provide the basis for a neuromodulatory approach to treatment-refractory obesity. In this study, we review the literature implicating these targets for DBS in the neural circuitry of obesity. We will also briefly review ethical considerations for such an intervention, and discuss genetic secondary-obesity syndromes that may also benefit from DBS. In short, we hope to provide the scientific foundation to justify trials of DBS for the treatment of obesity targeting these specific regions of the brain.

  View details for DOI 10.7759/cureus.259

  View details for PubMedID 26180683

• Deep Brain Stimulation for Obesity CUREUS Ho, A. L., Sussman, E. S., Zhang, M., Pendharkar, A. V., Azagury, D. E., Bohon, C., Halpern, C. H. 2015; 7 (3)

  View details for DOI 10.7759/cureus.259

  View details for Web of Science ID 000453602300008

• Laparoscopic Versus Robotic Roux-En-Y Gastric Bypass: Lessons and Long-Term Follow-Up Learned From a Large Prospective Monocentric Study OBESITY SURGERY Buchs, N. C., Morel, P., Azagury, D. E., Jung, M., Chassot, G., Huber, O., Hagen, M. E., Pugin, F. 2014; 24 (12): 2031-2039

  Abstract

  Laparoscopic Roux-en-Y gastric bypass (RYGB) has become the procedure of choice for the treatment of morbid obesity. Recently, several reports have shown the potential advantages of the robotic approach, notably by reducing complications. The aim of this study is to report our long-term experience with robotic Roux-en-Y gastric bypass (RYGB) and to compare outcomes with the laparoscopic approach.From January 2003 to September 2013, 777 consecutive minimally invasive RYGB have been performed in our institution: 389 laparoscopically (50.1 %) and 388 robotically (49.9 %). During the study period, all the data regarding these consecutive RYGB has been prospectively collected in a dedicated database.While longer in duration compared to laparoscopy (+30 min; p=0.0001), the robotic approach had a lower conversion rate (0.8 vs. 4.9 %; p=0.0007), and less complications (11.6 % vs. 16.7 %; p=0.05), in particular, less gastrointestinal leaks (0.3 vs. 3.6 %; p=0.0009). There were also less early reoperations (1 vs. 3.3 %; p=0.05) and a shorter hospital stay in the robotic group (6.2 vs. 10.4 days; p=0.0001). There were no statistical differences between the early and the current robotic experience, except in operative time and hospital stay, which were shorter for the last 100 cases. Finally, the BMI loss was significantly higher in the laparoscopic group starting at the first post-operative year.Robotic RYGB is not only safe and feasible, but also a valid option in comparison to laparoscopy. At the cost of a longer operative time, we observed better short-term outcomes with the robotic approach.

  View details for DOI 10.1007/s11695-014-1335-6

  View details for Web of Science ID 000346780400005

  View details for PubMedID 24962109

• Robotic revisional bariatric surgery: a comparative study with laparoscopic and open surgery INTERNATIONAL JOURNAL OF MEDICAL ROBOTICS AND COMPUTER ASSISTED SURGERY Buchs, N. C., Pugin, F., Azagury, D. E., Huber, O., Chassot, G., Morel, P. 2014; 10 (2): 213-217

  Abstract

  Revisional bariatric procedures (RBP) can be technically challenging. While robotics might provide help for complex procedures, the study aim was to report our experience with robotic RBP.From March 2000 to June 2013, 60 consecutive RBP (11 robotic, 21 laparoscopic, 28 open) have been prospectively entered into a dedicated database and reviewed retrospectively. Outcomes have been compared between the three approaches.The robotic group had fewer complications (0 vs. 14.3% for laparoscopy, vs. 10.7% for open; P > 0.05), but took longer than the other approaches (352 vs. 270 vs. 250 minutes respectively; P < 0.05). There were fewer conversions in the robotic group (0 vs. 14.3% for laparoscopy; P > 0.05), and a significantly shorter hospital stay (6 vs. 8 vs. 9 days, respectively).Robotic RBP is feasible and safe, but at the price of a longer operative time. The exact role of robotics remains yet to be defined for this indication in larger studies. Copyright © 2013 John Wiley & Sons, Ltd.

  View details for DOI 10.1002/rcs.1549

  View details for Web of Science ID 000337673200011

  View details for PubMedID 24167029

• Robotic single-site cholecystectomy JOURNAL OF HEPATO-BILIARY-PANCREATIC SCIENCES Morel, P., Buchs, N. C., Iranmanesh, P., Pugin, F., Buehler, L., Azagury, D. E., Jung, M., Volonte, F., Hagen, M. E. 2014; 21 (1): 18-25

  Abstract

  Minimally invasive approaches for cholecystectomy are evolving in a surge for the best possible clinical outcome for the patients. As one of the most recent developments, a robotic set of instrumentation to be used with the da Vinci Si Surgical System has been developed to overcome some of the technical challenges of manual single incision laparoscopy.From February 2011 to February 2013, all consecutive robotic single site cholecystectomies (RSSC) were prospectively collected in a dedicated database. Demographic, intra- and postoperative data of all patients that underwent RSSC at our institution were analyzed. Data were evaluated for the overall patient cohort as well as after stratification according to patient BMI (body mass index) and surgeon's experience.During the study period, 82 patients underwent robotic single site cholecystectomy at our institution. The dominating preoperative diagnosis was cholelithiasis. Mean overall operative time was 91 min. Intraoperative complications occurred in 2.4% of cases. One conversion to open surgery due to the intraoperative finding of a gallbladder carcinoma was observed and two patients needed an additional laparoscopic trocar. The rate of postoperative complications was 4.9% with a mean length of stay of 2.4 days. No significant differences were observed when comparing results between robotic novices and robotic experts. Patients with higher BMI trended towards longer surgical console and overall operative time, but resulted in similar rates of conversions and complications when compared to normal weight patients.Robotic Single-Site cholecystectomy can be performed safely and effectively with low rates of complications and conversions in patients with differing BMI and by surgeons with varying levels of experience.

  View details for DOI 10.1002/jhbp.36

  View details for Web of Science ID 000328792500006

  View details for PubMedID 24142898

• Patient safety and surgical innovation-complementary or mutually exclusive? Patient safety in surgery Azagury, D. E. 2014; 8 (1): 17-?

  View details for DOI 10.1186/1754-9493-8-17

  View details for PubMedID 24690567

  View details for PubMedCentralID PMC3992164

• Robotic distal pancreatectomy: a valid option? MINERVA CHIRURGICA Jung, M. K., Buchs, N. C., Azagury, D. E., Hagen, M. E., Morel, P. 2013; 68 (5): 489-497

  Abstract

  Although reported in the literature, conventional laparoscopic approach for distal pancreatectomy is still lacking widespread acceptance. This might be due to two-dimensional vision and decreased range of motion to reach and safely dissect this highly vascularized retroperitoneal organ by laparoscopy. However, interest in minimally invasive access is growing ever since and the robotic system could certainly help overcome limitations of the laparoscopic approach in the challenging domain of pancreatic resection, notably in distal pancreatectomy. Robotic distal pancreatectomy with and without spleen preservation has been reported with encouraging outcomes for benign and borderline malignant disease. As a result of upgraded endowristed manipulation and three-dimensional visualization, improved outcome might be expected with the launch of the robotic system in the procedure of distal pancreatectomy. Our aim was thus to extensively review the current literature of robot-assisted surgery for distal pancreatectomy and to evaluate advantages and possible limitations of the robotic approach.

  View details for Web of Science ID 000327754000007

  View details for PubMedID 24101006

• Real-time near-infrared fluorescent cholangiography could shorten operative time during robotic single-site cholecystectomy SURGICAL ENDOSCOPY AND OTHER INTERVENTIONAL TECHNIQUES Buchs, N. C., Pugin, F., Azagury, D. E., Jung, M., Volonte, F., Hagen, M. E., Morel, P. 2013; 27 (10): 3897-3901

  Abstract

  With the introduction of a new platform, robotic single-site cholecystectomy (RSSC) has been reported as feasible and safe for selected cases. In parallel, the development of real-time near-infrared fluorescent cholangiography using indocyanine green (ICG) has been seen as a help during the dissection, even if the data are still preliminary. The study purpose is to report our experience with ICG RSSC and compare the outcomes to standard RSSC.From February 2011 to December 2011, 44 selected patients underwent RSSC for symptomatic cholelithiasis. Among them, 23 (52.3%) were included in an experimental protocol using the ICG, and the remainder (47.7%) underwent standard RSSC. There was no randomization. The endpoints were the perioperative outcomes. This is a prospective study, approved by our local Ethics Committee.There were no differences in terms of patients' characteristics, except that there were more male patients in the ICG group (47.8 vs. 9.5%; p = 0.008). Regarding the surgical data, the overall operative time was shorter for the ICG group, especially for patients with a body mass index (BMI) ≤25 (-24 min) but without reaching statistical significance (p = 0.06). For BMI >25, no differences were observed. Otherwise, there were no differences in terms of conversion, complications, or length of stay between both groups.A RSSC with a real-time near-infrared fluorescent cholangiography can be performed safely. In addition, for selected patients with a low BMI, ICG could shorten the operative time during RSSC. Larger studies are still required before drawing definitive conclusions.

  View details for DOI 10.1007/s00464-013-3005-5

  View details for Web of Science ID 000324268200052

  View details for PubMedID 23670747

• Resection or reduction? The dilemma of managing retrograde intussusception after Roux-en-Upsilon gastric bypass SURGERY FOR OBESITY AND RELATED DISEASES Varban, O., Ardestani, A., Azagury, D., Lautz, D. B., Vernon, A. H., Robinson, M. K., Tavakkoli, A. 2013; 9 (5): 725-730

  Abstract

  Retrograde intussusception (RI) at the jejunojejunostomy can occur after Roux-en-Y gastric bypass (RYGB). Although this complication is rare, it has been encountered more frequently as the number of bariatric procedures have increased. Little data is available to assist surgeons with the optimal management of this condition. Our objectives were to identify the risk factors for RI after RYGB and report on outcomes after surgical intervention at a tertiary academic surgical unit.We used our prospective longitudinal institutional bariatric surgical database to identify patients with post-RYGB RI from 1996 to 2011.We identified 28 post-RYGB RI cases. The median interval between RYGB and RI was 52 months, and the median percentage of excess weight loss was 75%. Patients presented with acute symptoms in 36% of the cases. All patients underwent surgical exploration, including resection and revision of the jejunojejunostomy (46%) or operative reduction with or without enteropexy (54%). Those undergoing resection had a longer hospital stay but similar 30-day complication rates. At a median follow-up of 9 months, only 1 recurrence was documented.RI is a rare and late complication of RYGB and typically occurs after significant weight loss. In the presence of ischemia or nonreducible RI, resection and revision of the jejunojejunostomy is recommended. In less acute patients, laparoscopic management with reduction and/or enteropexy offers a reduced hospital length of stay while maintaining equivalent morbidity and low recurrence compared with resection.

  View details for DOI 10.1016/j.soard.2012.05.004

  View details for Web of Science ID 000325782900026

  View details for PubMedID 22738754

• Contemporary Management of Adult Intussusception: Who Needs a Resection? WORLD JOURNAL OF SURGERY Varban, O. A., Ardestani, A., Azagury, D. E., Kis, B., Brooks, D. C., Tavakkoli, A. 2013; 37 (8): 1872-1877

  Abstract

  Surgical resection is often recommended in adults with intestinal intussusception (AI) because of its potential association with malignancy. We provide a contemporary algorithm for managing AI by focusing on the probability of discovering a lead point.This is a retrospective study of adult patients with computed tomography (CT)-confirmed intussusception who underwent operative management of AI between 1996 and 2011 at a single academic institution.Sixty-four patients were diagnosed with AI by CT scan and then managed operatively. The incidence of colonic (CI), small bowel (SBI), and retrograde intussusception (RI) was 14, 55, and 31 %, respectively. All patients with CI had a lead point, whereas none were found among patients with RI. Some 46 % of patients with SBI had a lead point. The probability of discovering a lead point in SBI was increased by past history of malignancy (RR, 3.7, p < 0.001), a mass seen on preoperative CT scan (RR, 2.9, p = 0.005), and age over 60 years (RR, 2.2, p = 0.07).A pathologic lead point is likely with CI but not with RI. Patients with SBI who are over the age of 60 years and have a history of malignancy or a mass noted on CT scan have a higher likelihood of harboring a pathologic lead point.

  View details for DOI 10.1007/s00268-013-2036-3

  View details for Web of Science ID 000322023600019

  View details for PubMedID 23571865

• [Robotic general surgery: where do we stand in 2013?]. Revue médicale suisse Buchs, N. C., Pugin, F., Ris, F., Jung, M., Hagen, M. E., Volonté, F., Azagury, D., Morel, P. 2013; 9 (391): 1317-1322

  Abstract

  While the number of publications concerning robotic surgery is increasing, the level of evidence remains to be improved. The safety of robotic approach has been largely demonstrated, even for complex procedures. Yet, the objective advantages of this technology are still lacking in several fields, notably in comparison to laparoscopy. On the other hand, the development of robotic surgery is on its way, as the enthusiasm of the public and the surgical community can testify. Still, clear clinical indications remain to be determined in the field of general surgery. The study aim is to review the current literature on robotic general surgery and to give the reader an overview in 2013.

  View details for PubMedID 23875261

• [Medical technology innovation: why get involved and how?]. Revue médicale suisse Azagury, D. E., Buchs, N. C., Volonté, F., Morel, P. 2013; 9 (391): 1323-1326

  Abstract

  Medical technologies are an intrinsic part of our daily practice. More than a simple recipient of novel medical devices, clinicians have a unique role to play in medtech innovation. They are invaluable assets for testing devices and guiding manufacturers towards the most clinically relevant solutions. More importantly, they have a direct view on patient needs and can therefore identify unmet clinical needs. As these skills are not part of medical school curricula, new centers in medtech innovation education are arising across Europe following the success of US programs. These centers offer a full curriculum in medtech innovation so that doctors can more actively participate and foster innovation in their field. This new knowledge can allow us to initiate our own innovations and potentially influence the future of our own practice.

  View details for PubMedID 23875262

• Does laparoscopic gastric banding create hiatal hernias? SURGERY FOR OBESITY AND RELATED DISEASES Azagury, D. E., Varban, O., Tavakkolizadeh, A., Robinson, M. K., Vernon, A. H., Lautz, D. B. 2013; 9 (1): 48-54

  Abstract

  We hypothesized that laparoscopic adjustable gastric band (LAGB) placement might result in the development of a hiatal hernia (HH) over time. The objective of our study was to determine whether HHs develop after LAGB in the setting of a university hospital.We retrospectively reviewed all outcomes for consecutive LAGB patients in our institutional, longitudinal prospective bariatric surgical database to identify those patients without evidence of a HH at LAGB placement, who subsequently underwent delayed HH repair.From 2005 to 2009, 695 gastric bands were implanted. Twelve patients (1.72%) were identified who had no radiographic or intraoperative evidence of a HH at LAGB placement and who subsequently underwent HH repair at re-exploration. Patients presented 18 ± 10 months after band placement. Of these patients, 75% presented with gastroesophageal reflux disease or food intolerance (50% with gastroesophageal reflux disease alone). Also, 2 presented with acute pain due to band slippage and 1 with chronic pain and vomiting. In 50% of the patients, revision procedures detected the HH at operation despite negative preoperative studies.In our series, a significant HH developed in 1.7% of LAGB patients who had no clinically identifiable HH at LAGB placement. Persistent dysphagia after band deflation requires careful inspection of the hiatus during surgical revision, even in the absence of radiologic depiction of HH, and might represent an underlying etiology of LAGB dysfunction. This complication, along with esophageal dilation and annular pouch dilation, might represent a constellation of conditions with a common etiology. From the results of our small series, we raise the question of the existence of chronic backpressure created by LAGB restriction and accounting for these complications.

  View details for DOI 10.1016/j.soard.2011.07.015

  View details for Web of Science ID 000314669900008

  View details for PubMedID 21925963

• Establishing a reproducible large animal survival model of laparoscopic Roux-en-Y gastric bypass SURGERY FOR OBESITY AND RELATED DISEASES Escareno, C. E., Azagury, D. E., Flint, R. S., Nedder, A., Thompson, C. C., Lautz, D. B. 2012; 8 (6): 764-769

  Abstract

  The advent of metabolic surgery and the increasing focus on the substantial resolution rate of type 2 diabetes after laparoscopic Roux-en-Y gastric bypass (LRYGB) call for additional fundamental investigations as to the mechanisms behind this effect. These investigations require an adequate animal model. Our objective was to develop a reproducible survival model of LRYGB performed in a large animal at a tertiary university hospital.LRYGB was performed on 11 Yorkshire pigs that where then followed for 6 weeks. The operative time, morbidity, and mortality were recorded for each case. Necropsy was performed, and the anastomoses were harvested and inspected for leaks.The surgical technique and difficulties are carefully described. Of the 11 pigs, 10 survived to the end of the study period. The 1 death was from intraoperative cardiac dysrhythmia. The postoperative complications consisted of a postoperative febrile episode in 2 pigs. The mean initial weight was 31.5 ± 3.4 kg. The mean operative time was 214 ± 71 minutes. No anastomotic leaks were identified at necropsy or on histologic examination of anastomoses. The mean weight gain at the end of the study period was .8 ± 1.4 kg compared with an expected 17.5 kg weight gain.We have described an effective survival porcine model of LRYGB that can be consistently reproduced. This will enable additional investigation into the complex physiologic mechanisms that control hunger, weight loss, and the development, as well as resolution, of type 2 diabetes, potentially leading to the development of novel, targeted bariatric procedures and diabetic treatments.

  View details for DOI 10.1016/j.soard.2011.05.021

  View details for Web of Science ID 000311919800022

  View details for PubMedID 21996597

• Real-time computed tomography-based augmented reality for natural orifice transluminal endoscopic surgery navigation. British journal of surgery Azagury, D. E., Ryou, M., Shaikh, S. N., San José Estépar, R., Lengyel, B. I., Jagadeesan, J., Vosburgh, K. G., Thompson, C. C. 2012; 99 (9): 1246-1253

  Abstract

  Natural orifice transluminal endoscopic surgery (NOTES) is technically challenging owing to endoscopic short-sighted visualization, excessive scope flexibility and lack of adequate instrumentation. Augmented reality may overcome these difficulties. This study tested whether an image registration system for NOTES procedures (IR-NOTES) can facilitate navigation.In three human cadavers 15 intra-abdominal organs were targeted endoscopically with and without IR-NOTES via both transgastric and transcolonic routes, by three endoscopists with different levels of expertise. Ease of navigation was evaluated objectively by kinematic analysis, and navigation complexity was determined by creating an organ access complexity score based on the same data.Without IR-NOTES, 21 (11·7 per cent) of 180 targets were not reached (expert endoscopist 3, advanced 7, intermediate 11), compared with one (1 per cent) of 90 with IR-NOTES (intermediate endoscopist) (P = 0·002). Endoscope movements were significantly less complex in eight of the 15 listed organs when using IR-NOTES. The most complex areas to access were the pelvis and left upper quadrant, independently of the access route. The most difficult organs to access were the spleen (5 failed attempts; 3 of 7 kinematic variables significantly improved) and rectum (4 failed attempts; 5 of 7 kinematic variables significantly improved). The time needed to access the rectum through a transgastric approach was 206·3 s without and 54·9 s with IR-NOTES (P = 0·027).The IR-NOTES system enhanced both navigation efficacy and ease of intra-abdominal NOTES exploration for operators of all levels. The system rendered some organs accessible to non-expert operators, thereby reducing one impediment to NOTES procedures.

  View details for DOI 10.1002/bjs.8838

  View details for PubMedID 22864885

• Real-time computed tomography-based augmented reality for natural orifice transluminal endoscopic surgery navigation BRITISH JOURNAL OF SURGERY Azagury, D. E., Ryou, M., Shaikh, S. N., Estepar, R. S., Lengyel, B. I., Jagadeesan, J., Vosburgh, K. G., Thompson, C. C. 2012; 99 (9): 1246-1253

  View details for DOI 10.1002/bjs.8838

  View details for Web of Science ID 000307071100014

• Magnetic pancreaticobiliary stents and retrieval system: obviating the need for repeat endoscopy (with video) GASTROINTESTINAL ENDOSCOPY Ryou, M., Cantillon-Murphy, P., Shaikh, S. N., Azagury, D., Ryan, M. B., Lang, J. H., Thompson, C. C. 2012; 75 (4): 888-892

  Abstract

  Plastic stents are routinely placed in the pancreaticobiliary system to facilitate drainage. A second endoscopy is often required for stent removal. We have developed magnetic pancreaticobiliary stents that can be removed by using an external hand-held magnet, thereby obviating the need for a second endoscopy.To develop and test magnetic pancreaticobiliary stents and retrieval system in ex-vivo and in-vivo porcine models.Animal laboratory.Benchtop and animal study.5 pigs.Design: Computer simulations determined both the optimal design of cylindrical magnets attached to the distal aspect of existing plastic stents and the optimal design of the external hand-held magnet. Benchtop ex-vivo experiments measured magnetic force to validate the design. In-vivo analysis: In 5 Yorkshire pigs, magnetic stents were deployed into the common bile duct by using a conventional duodenoscope. An external hand-held magnet was applied for stent removal. Stent insertion and removal times were recorded.Technical feasibility.Magnetic stents of varying lengths and calibers were successfully created. In ex-vivo testing, the capture distance was 10.0 cm. During in-vivo testing, the magnetic stents were inserted and removed easily. The mean insertion and removal times were 3.2 minutes and 33 seconds, respectively.Animal study, small numbers.Magnetic pancreaticobiliary stents and associated retrieval system were successfully designed and tested in the acute porcine model. An external, noninvasive means of stent removal potentially obviates the need for a second endoscopy, which could represent a major gain both for patients and in health care savings.

  View details for DOI 10.1016/j.gie.2011.09.051

  View details for Web of Science ID 000302186100027

  View details for PubMedID 22226385

• Laparoscopic cholecystectomy after a quarter century: why do we still convert? Annual Meeting of the Society-of-American-Gastrointestinal-and-Endoscopic-Surgeons (SAGES) Lengyel, B. I., Azagury, D., Varban, O., Panizales, M. T., Steinberg, J., Brooks, D. C., Ashley, S. W., Tavakkolizadeh, A. SPRINGER. 2012: 508–13

  Abstract

  Laparoscopic cholecystectomy (LC) is the gold standard procedure for gallbladder removal. However, conversion to open surgery is sometimes needed. The factors underlying a surgeon's decision to convert a laparoscopic case to an open case are complex and poorly understood. With decreasing experience in open cholecystectomy, this procedure is however no longer the "safe" alternative it once was. With such an impending paradigm shift, this study aimed to identify the main reasons for conversion and ultimately to develop guidelines to help reduce the conversion rates.Using the National Surgical Quality Improvement Program (NSQIP) database and financial records, the authors retrospectively reviewed 1,193 cholecystectomies performed at their institution from 2002 to 2009 and identified 70 conversions. Two independent surgeons reviewed the operative notes and determined the reasons for conversion. The number of ports at the time and the extent of dissection before conversion were assessed and used to create new conversion categories. Hospital length of stay (LOS), 30-day complications, operative times and charges, and hospital charges were compared between the new groups.In 91% of conversion cases, the conversion was elective. In 49% of these conversions, the number of ports was fewer than four. According to the new conversion categories, most conversions were performed after minimal or no attempt at dissection. There were no differences in LOS, complications, operating room charges, or hospital charges between categories. Of the six emergent conversions (9%), bleeding and concern about common bile duct (CBD) injury were the main reasons. One CBD injury occurred.In 49% of the cases, conversion was performed without a genuine attempt at laparoscopic dissection. Considering this new insight into the circumstances of conversion, the authors recommend that surgeons make a genuine effort at a laparoscopic approach, as reflected by placing four ports and trying to elevate the gallbladder before converting a case to an open approach.

  View details for DOI 10.1007/s00464-011-1909-5

  View details for Web of Science ID 000299293500031

  View details for PubMedID 21938579

• Marginal ulceration after Roux-en-Y gastric bypass surgery: characteristics, risk factors, treatment, and outcomes ENDOSCOPY Azagury, D. E., Abu Dayyeh, B. K., Greenwalt, I. T., Thompson, C. C. 2011; 43 (11): 950-954

  Abstract

  Marginal ulcers are one of the most common complications after gastric bypass. Reported incidence varies widely (0.6-16 %) and pathogenesis is unclear. The aim of the present study was to describe characteristics, risk factors, management, and outcomes of endoscopically documented ulcers.Data from all patients diagnosed with marginal ulcers at endoscopy between 2003 and 2010 were retrospectively reviewed.A total of 103 patients with marginal ulcers presented with pain (63 %) and/or bleeding (24 %), a median of 22 months after surgery. Ulcers were located on the anastomosis (50 %) or the jejunum (40 %); sutures were visible in 35 %, and gastrogastric fistulae in 8 %. The mean pouch length was 5.6 cm. Diabetes (odds ratio [OR] 2.5; P = 0.03), smoking (OR 2.5; P = 0.02), and gastric pouch length (OR 1.2; P = 0.02) were significantly associated with marginal ulcer formation on univariate analysis; diabetes was significantly associated on multivariate analysis (OR 5.6; P = 0.003). The risk of developing a marginal ulcer decreased with time (OR 0.8; P < 0.01) and was not associated with the use of nonsteroidal anti-inflammatory drugs. At first endoscopic follow-up, 67 % of ulcers had healed. Recurrence occurred in four patients and nine patients required surgical revision.The vast majority of marginal ulcers had a favorable outcome after medical treatment. However, 9 % of patients eventually required surgical revision. Therefore, endoscopic follow-up is essential. Diabetes, smoking, and long gastric pouches were significant risk factors for marginal ulcer formation, suggesting increased acid exposure and mucosal ischemia are both involved in marginal ulcer pathogenesis. Management of these factors may prove effective in managing marginal ulcers, and tailoring postoperative proton pump inhibitor therapy to patients with multiple risk factors could be effective.

  View details for DOI 10.1055/s-0030-1256951

  View details for Web of Science ID 000296749000005

  View details for PubMedID 21997722

• An implantable wireless biosensor for the immediate detection of upper GI bleeding: a new fluorescein-based tool for diagnosis and surveillance (with video). Gastrointestinal endoscopy Ryou, M., Nemiroski, A., Azagury, D., Shaikh, S. N., Ryan, M. B., Westervelt, R. M., Thompson, C. C. 2011; 74 (1): 189-194 e1

  Abstract

  Early recurrent hemorrhage after endoscopic intervention for acute upper GI bleeding (UGIB) can approach 20% and leads to increased morbidity and mortality. Little has changed over the past several decades regarding immediate posthemorrhage surveillance, and there has likewise been no significant improvement in outcomes.To develop and test an endoscopically implantable wireless biosensor for real-time detection of fluorescein-labeled blood in ex vivo and in vivo porcine models of UGIB.Animal laboratory.Benchtop and acute animal studies.Five pigs.UGIB models were surgically created in living pigs. Biosensors were endoscopically deployed in the stomach using standard endoscopic clips. The ability to detect acute UGIB and estimated blood loss leading to biosensor activation were recorded. Feasibility of wireless data transmission out of the body to an external computer and cell phone was assessed.Technical feasibility and immediate complications.A porcine UGIB model was successfully created. Biosensors were able to detect all acute bleeding events and wirelessly transmit out of the body, and successfully sent an emergency text message to the intended cell phone in all cases. Average estimated blood loss leading to biosensor activation was 30 mL (10-75 mL).Animal study; small numbers.An endoscopically implantable wireless biosensor successfully detected acute hemorrhage in a porcine UGIB model and sent an emergency cell-phone alert in real time.

  View details for DOI 10.1016/j.gie.2011.03.1182

  View details for PubMedID 21704817

• An implantable wireless biosensor for the immediate detection of upper GI bleeding: a new fluorescein-based tool for diagnosis and surveillance GASTROINTESTINAL ENDOSCOPY Ryou, M., Netniroski, A., Azagury, D., Shaikh, S. N., Ryan, M. B., Westervelt, R. M., Thompson, C. C. 2011; 74 (1): 189-194

  View details for DOI 10.1016/j.gie.2011.03.1182

  View details for Web of Science ID 000292429400028

• Obesity overview: epidemiology, health and financial impact, and guidelines for qualification for surgical therapy. Gastrointestinal endoscopy clinics of North America Azagury, D. E., Lautz, D. B. 2011; 21 (2): 189-201

  Abstract

  The aim of this article is to describe the context in which this issue of Gastrointestinal Endoscopy Clinics of North America is established. The authors review the current worldwide dimensions and trends of the obesity epidemic; associated mortality and comorbid diseases including diabetes, cancer, cardiovascular disease and obstructive sleep apnea; the financial impact of obesity; and current national and international guidelines for referral and qualification for surgical treatment of obesity.

  View details for DOI 10.1016/j.giec.2011.02.001

  View details for PubMedID 21569972

• Smart Self-Assembling MagnetS for ENdoscopy (SAMSEN) for transoral endoscopic creation of immediate gastrojejunostomy GASTROINTESTINAL ENDOSCOPY Ryou, M., Cantillon-Murphy, P., Azagury, D., Shaikh, S. N., Ha, G., Greenwalt, I., Ryan, M. B., Lang, J. H., Thompson, C. C. 2011; 73 (2): 353-359

  Abstract

  Gastrojejunostomy is important for palliation of malignant gastric outlet obstruction and surgical obesity procedures. A less-invasive endoscopic technique for gastrojejunostomy creation is conceptually attractive. Our group has developed a compression anastomosis technology based on endoscopically delivered self-assembling magnets for endoscopy (SAMSEN) to create an instant, large-caliber gastrojejunostomy.To develop and evaluate an endoscopic means of gastrojejunostomy creation by using SAMSEN.Developmental laboratory and animal facility.Animal study and human cadaveric study.Yorkshire pigs (7 cadaver, 5 acute); human (1 cadaver).A transoral procedure for SAMSEN delivery was developed in porcine and human cadaver models. Subsequently, gastrojejunostomy creation by using SAMSEN was performed in 5 acute pigs. The endoscope was advanced into the peritoneal cavity through the gastrotomy, and a segment of the small bowel was grasped and pulled closer to the stomach. An enterotomy was created, and a custom overtube was advanced into the small bowel for deployment of the first magnetic assembly. Next, a reciprocal magnetic assembly was deployed in the stomach. The 2 magnetic systems were mated under fluoroscopic and endoscopic guidance. Contrast studies assessed for gastrojejunostomy leak. Immediate necropsies were performed.Technical feasibility and complications.Gastrojejunostomy creation by using SAMSEN was successful in all 5 animals. Deep enteroscopy was performed through the stoma without difficulty. No leaks were identified on contrast evaluation. At necropsy, the magnets were properly deployed and robustly coupled together, resistant to vigorous tissue manipulation.Acute animal study.Endoscopic creation of immediate gastrojejunostomy by using SAMSEN is technically feasible.

  View details for DOI 10.1016/j.gie.2010.10.024

  View details for Web of Science ID 000287001900025

  View details for PubMedID 21183179

• Comment on: Effect of staple height on gastrojejunostomy during laparoscopic gastric bypass: a multicenter prospective randomized trial SURGERY FOR OBESITY AND RELATED DISEASES Azagury, D. E., Lautz, D. B. 2010; 6 (5): 482-484

  View details for Web of Science ID 000282673400005

  View details for PubMedID 20870180

• A Magnetic Retrieval System for Stents in the Pancreaticobiliary Tree IEEE TRANSACTIONS ON BIOMEDICAL ENGINEERING Cantillon-Murphy, P., Ryou, M., Shaikh, S. N., Azagury, D., Ryan, M., Thompson, C. C., Lang, J. H. 2010; 57 (8): 2018-2025

  Abstract

  Clinical endoscopic intervention of the pancreaticobiliary tree [endoscopic retrograde cholangiopancreatography (ERCP)] often concludes with the insertion of a temporary plastic stent to reduce the risk of post-ERCP complications by promoting continued flow of bile and pancreatic fluids. This stent is later removed once the patient has fully recovered, but today this necessitates a second endoscopic intervention. The final goal of this work is to obviate the second intervention. This is to be achieved by adding a magnetic ring to the stent such that the stent is removed using a hand-held magnet, held in a suitable position ex vivo . This paper details the design, optimization, and both ex vivo and in vivo testing of the magnetized stent and hand-held magnet, which has been accomplished to date. The optimized design for the hand-held magnet and the modified stent with a magnetic attachment performs in line with simulated expectations, and successful retrieval is achieved in the porcine ex vivo setting at 9-10 cm separation. This is comparable to the mean target capture distance of 10 cm between the entry point to the biliary system and the closest cutaneous surface, determined from random review of clinical fluoroscopies in ten human patients. Subsequently, the system was successfully tested in vivo in the acute porcine model, where retrieval at an estimated separation of 5-6 cm was captured on endoscopic video. These initial results indicate that the system may represent a promising approach for the elimination of a second endoscopic procedures following placement of pancreatic and biliary stents.

  View details for DOI 10.1109/TBME.2010.2045653

  View details for Web of Science ID 000282000900022

  View details for PubMedID 20483696

• Management of acute gastrothorax with respiratory distress: insertion of nasogastric tube as a life saving procedure EUROPEAN JOURNAL OF EMERGENCY MEDICINE Azagury, D. E., Karenovics, W., Staehli, D. M., Mathis, J., Schneider, R. 2008; 15 (6): 357-358

  Abstract

  An 86-year-old patient was transferred to our institution with acute respiratory distress. A tension pneumothorax was suspected, but needle decompression was unsuccessful. Instead of the suspected pneumothorax, the chest radiograph revealed a large 'tension gastrothorax'. In a matter of seconds, the insertion of a nasogastric tube resulted in drastic improvement of the critical clinical state. Acute tension gastrothorax is a rare, but classic, complication of paraoesophageal hernias. Its clinical presentation can be dramatic and rapidly lethal, immediate action is therefore warranted. Nasograstric tube insertion is a life saving procedure to be undertaken without delay. However, tension gastrothorax is a rare entity. Therefore, if tension pneumothorax is suspected, needle decompression should not be delayed.

  View details for DOI 10.1097/MEJ.0b013e32830346c3

  View details for Web of Science ID 000261398600013

  View details for PubMedID 19078843

• Isolated alveolar echinococcosis of the spleen - clinical presentation and management review SWISS MEDICAL WEEKLY Karenovics, W., Azagury, D. E., Groebli, Y. 2008; 138 (45-46): 689-690

  Abstract

  Alveolar echinococcosis is a zoonosis which infects primarily the liver, and secondary involvement of other organs is common. However, exclusive extrahepatic involvement is exceedingly rare, and isolated splenic involvement even more so. Workup, differential diagnosis and management of isolated splenic alveolar echinococcosis are discussed and literature is reviewed based on a clinical case.

  View details for Web of Science ID 000261118700006

  View details for PubMedID 19043815

• Bouveret's syndrome: Management and strategy of a rare cause of gastric outlet obstruction DIGESTION Buchs, N. C., Azagury, D., Chilcott, M., Nguyen-Tang, T., Dumonceau, J., Morel, P. 2007; 75 (1): 17-19

  View details for DOI 10.1159/000101561

  View details for Web of Science ID 000246059700004

  View details for PubMedID 17429202

• Preoperative work-up in asymptomatic patients undergoing Roux-en-Y gastric bypass: Is endoscopy mandatory? OBESITY SURGERY Azagury, D., Dumonceau, J. M., Morel, P., Chassot, G., Huber, O. 2006; 16 (10): 1304-1311

  Abstract

  We aimed to determine before Roux-en-Y gastric bypass (RYGBP) in asymptomatic morbidly obese patients: 1) the prevalence of abnormal findings at upper gastrointestinal (UGI) endoscopy; 2) Helicobacter pylori (HP) status; 3) clinical consequences of these findings; and 4) associated costs.We retrospectively reviewed 468 consecutive patients, excluded those with UGI symptoms, drug intake or previous UGI endoscopy/surgery, and analyzed findings in the 319 remaining patients (68%).There were abnormal findings in 147 patients (46%), including 54 hiatal hernias and 146 parietal (i.e. mucosal or submucosal) lesions. The most significant were 7 ulcers and 2 gastric polyposis. HP was detected (using CLO-test) in 124 patients (39%). Histopathological examination of biopsies was abnormal in 109/161 patients (68%), and disclosed mainly chronic gastritis (n=98). Abnormal findings were more frequent in HP-positive compared to HP-negative patients (94 vs 51%, P<0.001). Findings had clinical implications in only 4% of patients: delayed surgery (7 ulcers), prophylactic gastrectomy (2 gastric polyposis), unnecessary work-up (3 irrelevant/false-positive diagnoses), and inclusion in a screening program (1 Barrett's esophagus). Mean cost of complete UGI work-up was 389 euro/patient.Asymptomatic morbidly obese patients frequently harbour UGI lesions warranting UGI work-up before RYGBP. However, routine endoscopy presents drawbacks. We propose a less invasive strategy which reduces costs and limits false-positive results and the subsequent investigations that they require. In our series, it would have missed two gastric polyposis only, for which no formal recommendation has yet been issued. This strategy could be a valuable alternative to routine UGI endoscopy before RYGBP in asymptomatic patients.

  View details for Web of Science ID 000241209200007

  View details for PubMedID 17059738

• Reflux, dysphagia, and gas bloat after laparoscopic fundoplication in patients with incidentally discovered hiatal hernia and in a control group SURGERY Triponez, F., Dumonceau, J. M., Azagury, D., Volonte, F., Slim, K., Mermillod, B., Huber, O., Morel, P. 2005; 137 (2): 235-242

  Abstract

  Laparoscopic fundoplication effectively controls reflux symptoms in patients with gastroesophageal reflux disease (GERD). However, symptom relapse and side effects, including dysphagia and gas bloat, may develop after surgery. The aim of the study was to assess these symptoms in patients who underwent laparoscopic fundoplication, as well as in control subjects and patients with hiatal hernia.A standardized, validated questionnaire on reflux, dysphagia, and gas bloat was filled out by 115 patients with a follow-up of 1 to 7 years after laparoscopic fundoplication, as well as by 105 subjects with an incidentally discovered hiatal hernia and 238 control subjects.Patients who underwent fundoplication had better reflux scores than patients with hiatal hernia ( P = .0001) and similar scores to control subjects ( P = .11). They also had significantly more dysphagia and gas bloat than patients with hiatal hernia and controls ( P < .005 for all comparisons). Gas bloat and dysphagia were more severe in hiatal hernia patients than in controls ( P < 0.005). After fundoplication, the 25% of the patients with the shortest follow-up (1.5 +/- 0.2 years) and the 25% patients with the longest follow-up (5.8 +/- 0.6 years) had similar reflux, dysphagia, and gas bloat scores ( P = .43, .82, and .85, respectively).In patients with severe GERD, laparoscopic fundoplication decreases reflux symptoms to levels found in control subjects. These results appear to be stable over time. However, patients who underwent fundoplication experience more dysphagia and gas bloat than controls and patients with hiatal hernia-symptoms that should be seen as a side effect of the procedure and of GERD itself.

  View details for DOI 10.1016/j.surg.2004.07.016

  View details for Web of Science ID 000226873700017

  View details for PubMedID 15674207

• [Intestinal barotrauma after diving--mechanical ileus in incarceration of the last loop of the small intestine between a mobile cecum and sigmoid]. Swiss surgery = Schweizer Chirurgie = Chirurgie suisse = Chirurgia svizzera Haller, C., Guenot, C., Azagury, D., Rosso, R. 2003; 9 (4): 181-183

  Abstract

  A few hours after a self-contained underwater breathing apparatus (SCUBA) dive at 30 meters depth, a 49 years-old man complained of diffuse abdominal pain with nausea and vomitus. A laparotomy was performed 36 hours after a conservative treatment because of persistent mechanical small bowel obstruction. The last ileal loop was strangulated between a mobile ceacum and a long sigmoid loop. The man never had previous abdominal surgery. In absence of intestinal necrosis, a caecopexy was done and there was no post-operative complications. The gas distension during the ascension following the Boyle-Mariotte law and its distribution induced in this man with a special anatomy a mechanical small bowel obstruction. The treatment of mobile caecum and the literature of abdominal barotrauma is reviewed.

  View details for PubMedID 12974175