Self-care training using the Tablo hemodialysis system.
Hemodialysis international. International Symposium on Home Hemodialysis
Plumb, T. J., Alvarez, L., Ross, D. L., Lee, J. J., Mulhern, J. G., Bell, J. L., Abra, G. E., Prichard, S. S., Chertow, G. M., Aragon, M. A.
2020
Abstract
INTRODUCTION: Recently published results of the investigational device exemption (IDE) trial using the Tablo hemodialysis system confirmed its safety and efficacy for home dialysis. This manuscript reports additional data from the Tablo IDE study on the training time required to be competent in self-care, the degree of dependence on health care workers and caregivers after training was complete, and participants' assessment of the ease-of-use of Tablo.METHODS: We collected data on the time required to set up concentrates and the Tablo cartridge prior to treatment initiation. We asked participants to rate system setup, treatment, and takedown on a Likert scale from 1 (very difficult) to 5 (very simple) and if they had required any assistance with any aspect of treatment over the prior 7days. In a subgroup of 15 participants, we recorded the number of training sessions required to be deemed competent to do self-care dialysis.FINDINGS: Eighteen men and 10 women with a mean age of 52.6years completed the study. Thirteen had previous self-care experience using a different dialysis system. Mean set up times for the concentrates and cartridge were 1.1 and 10.0minutes, respectively. Participants with or without previous self-care experience had similar set-up times. The mean ease-of-use score was 4.5 or higher on a scale from 1 to 5 during the in-home phase. Sixty-five percent required no assistance at home and on average required fewer than four training sessions to be competent in managing their treatments. Results were similar for participants with or without previous self-care experience.CONCLUSIONS: Participants in the Tablo IDE trial were able to quickly learn and manage hemodialysis treatments in the home, found Tablo easy to use, and were generally independent in performing hemodialysis.
View details for DOI 10.1111/hdi.12890
View details for PubMedID 33047477
Abstract
Peritoneal dialysis transfer sets (extension lines) are replaced every six to nine months to minimize peritoneal dialysis catheter complications. The aim of this study was to compare a revised non-bag transfer set exchange procedure with the standard bag exchange procedure on nursing time, costs, and safety. Thirty-three people were randomized to two groups - a standard bag exchange procedure group (n = 16) and a non-bag transfer set exchange procedure group (n = 17). The standard bag exchange procedure took a median of 32 minutes (interquartile range [IQR] 25 to 38 minutes) compared to the non-bag transfer set exchange procedure of 6 minutes (IQR 4 to 8 minutes) (p Ò 0.0001). There was one episode of peritonitis in each group within the 72-hour follow-up period. The average cost of the non-bag transfer set exchange procedure was $24.54 lower, a 37% cost reduction. This study has shown the revised non-bag transfer set replacement procedure appears to be safe, consume less participant and staff time, and decreases costs.
View details for PubMedID 32830940
Abstract
RATIONALE & OBJECTIVE: The incidence of left ventricular assist device (LVAD) implantation as destination therapy for heart failure is increasing and kidney failure requiring maintenance hemodialysis is a common complication. As little is known about the safety or efficacy of outpatient hemodialysis among patients with LVADs, this study sought to describe their clinical course.STUDY DESIGN: Case series of patients with a LVAD undergoing maintenance outpatient hemodialysis whose clinical data were obtained from an electronic medical record.SETTING & PARTICIPANTS: Adults who received an LVAD, survived to hospital discharge, and were subsequently treated with maintenance hemodialysis by a non-profit dialysis provider between 2011 and 2019.RESULTS: Eleven patients were included. Six had a known prior history of chronic kidney disease. Patients underwent outpatient hemodialysis for a mean duration of 165.2 days (range 31-542) during which they were treated with 544 total dialysis sessions. Six of these sessions were stopped early due to dialysis-related adverse events (1.1%). Over 80% of follow-up time was spent out of hospital, however, 54.5% of patients were rehospitalized within one month of starting outpatient hemodialysis. The most common reason for hospitalization was infection (32.1%), followed by hypervolemia (14.3%), and cerebrovascular accident (CVA) or transient ischemic attack (TIA) (10.7%). Four patients recovered kidney function, one underwent combined heart and kidney transplantation, two continued treatment, two died, and two were lost to follow-up.LIMITATIONS: Retrospective design, small number of cases, and lack of complete follow-up data.CONCLUSIONS: Approximately half of the patients with complete follow-up either recovered kidney function or underwent combined heart and kidney transplantation. This case series demonstrates that outpatient hemodialysis centers, in partnership with LVAD treatment teams, can successfully provide hemodialysis to patients on LVAD support.
View details for DOI 10.1053/j.ajkd.2020.04.018
View details for PubMedID 32711070
Abstract
BACKGROUND: Myelin figures, or zebra bodies, seen on electron microscopy were historically considered pathognomonic of Fabry disease, a rare lysosomal storage disorder caused by alpha-galactosidase A deficiency and associated with X-linked recessive mode of inheritance. More recently, iatrogenic phospholipidosis has emerged as an important alternate cause of myelin figures in the kidney.METHODS: We report two families with autosomal dominant nephropathy presenting with proteinuria and microscopic hematuria, and the kidney biopsies were notable for the presence of myelin figures and zebra bodies.RESULTS: Laboratory and genetic work-up for Fabry disease was negative. Genetic testing in both families revealed the same heterozygous missense mutation in LMX1B (C.737G>A, p.Arg246Gln). LMX1B mutations are known to cause nail-patella syndrome, featuring dysplastic nails and patella with or without nephropathy, as well as isolated LMX1B-associated nephropathy in the absence of extrarenal manifestations.CONCLUSIONS: LMX1B mutation-associated nephropathy should be considered in hereditary cases of proteinuria and/or hematuria, even in the absence of unique glomerular basement membrane changes indicative of nail-patella syndrome. In addition, LMX1B mutation should be included in the differential diagnosis of myelin figures and zebra bodies on kidney biopsy, so as to avoid a misdiagnosis.
View details for DOI 10.1007/s00467-020-04564-w
View details for PubMedID 32356190
Abstract
Patients with end-stage kidney disease (ESKD) require dialysis or a kidney transplant for survival and over 760 000 patients now benefit from these therapies in the United States. Dialysis in the United States in the late 1960s and early 1970s was often done in the home. After the advent of Medicare coverage for ESKD in 1972 and the subsequent easier access to center based hemodialysis, the use of home modalities dramatically declined. This stands in contrast to home dialysis uptake in other industrialized healthcare systems where both peritoneal dialysis and home hemodialysis are more frequently used. Characteristics unique to the US healthcare system as well as the cultures of providers (physicians and dialysis providers) and recipients of ESKD care are hypothesized as the main reasons for observed differences in home dialysis use. To address these issues, the Centers for Medicare and Medicaid Services have recently proposed new payment programs under an Executive Order from the President of the United States, with the explicit goal of increasing the number of patients using home dialysis. This perspective outlines policy opportunities and programs with a proven track record of home dialysis growth in other countries or hypothesized promise based on identified barriers and needs.
View details for DOI 10.1111/sdi.12850
View details for PubMedID 31943408
Abstract
Central venous catheters (CVC) are a major contributor to infections in hemodialysis (HD) patients, leading to high morbidity and mortality. Gentamicin-citrate (GC) lock is used as standard of care at centers belonging to a mid-size dialysis organization. Four outpatient HD centers acquired by the organization continued to use heparin for catheter locks for a period of time before converting to the provider's standard of using GC lock.In this retrospective observational study, we included patients receiving HD by CVC at these four centers. We report rates of CVC-related bloodstream infections (CVC-BSI) during the heparin lock and the GC lock periods; crude rate ratios and adjusted rate ratios using Cox survival analyses adjusting for potential confounders; microbiology patterns; safety signals (gentamicin resistance, hospitalizations and deaths); and financial impact on payer.A total of 220 and 281 patients used tunneled CVCs, accounting for 25,245 and 44,550 catheter days in the heparin and the GC lock periods, respectively. CVC-BSI event rates were 66% lower in the GC lock period (CVC-BSI event rate: 0.20 per 1000 catheter-days) than the heparin lock period (rate: 0.59 per 1000 catheter days); rate ratio 0.34 (95% confidence interval (CI) 0.15-0.78, P = 0.01). In the fully adjusted multivariable Cox model, use of GC lock was associated with 70% reduction in CVC-BSI events (HR 0.30, 95% CI 0.12-0.72, P = 0.01). No increased risk of gentamicin resistance, hospitalizations, or death associated with use of GC lock were observed. Use of GC lock was associated with an estimated saving of $1533 (95% CI: $259-$4882) per patient per year.Use of GC lock led to significant reductions in CVC-BSIs with no signal for harm, and is associated with significant cost savings in dialysis care.
View details for DOI 10.1111/hdi.12880
View details for PubMedID 33006269
Abstract
INTRODUCTION: Home hemodialysis remains underutilized despite observational data indicating more favorable outcomes with home compared with in-center hemodialysis. The Tablo Hemodialysis system is designed to be easy to learn and use and to facilitate adoption of home hemodialysis. The objective of the current investigational device exemption (IDE) study was to evaluate the safety and efficacy of Tablo managed in-center by health care professionals and in-home by patients and/or caregivers.METHODS: A prospective, multicenter, open-label, crossover trial comparing in-center and in-home hemodialysis using Tablo. There were 4 treatment periods during which hemodialysis was prescribed 4 times per week: 1-week Run-In, 8-week In-Center, 4-week Transition, and 8-week In-Home. The primary efficacy endpoint was weekly standard Kt/Vurea ≥2.1. The secondary efficacy endpoint was delivery of ultrafiltration (UF) within 10% of prescribed UF. We collected safety and usability data.FINDINGS: Thirty participants enrolled and 28 completed all trial periods. Adherence to the protocol requirement of 4 treatments per week was 96% in-center and 99% in-home. The average prescribed and delivered session lengths were 3.4hours for both the In-Center and the In-Home periods. The primary efficacy endpoint for the intention-to-treat cohort was achieved in 199/200 (99.5%) of measurements during the In-Center period and 168/171 (98.3%) In-Home. The average weekly standard Kt/Vurea was 2.8 in both periods. The secondary efficacy UF endpoint was achieved in the ITT cohort in 94% in both in-center and in-home. Two prespecified adverse events (AEs) occurred during the In-Center period and 6 in the In-Home period. None of the AEs were deemed by investigators as related to Tablo. The median resolution time of alarms was 8seconds in-center and 5seconds in-home.CONCLUSION: Primary and secondary efficacy and safety endpoints were achieved during both In-Center and In-Home trial periods. This study confirms that Tablo is safe and effective for home hemodialysis use.
View details for DOI 10.1111/hdi.12795
View details for PubMedID 31697042
Abstract
The past 15 years have seen tremendous growth in the initiation of dialysis at higher levels of kidney function in the setting of mixed evidence and at great societal economic cost. We review recent data on the early dialysis initiation trend, the clinical and economic impact of early dialysis initiation and the future implications for the management of advanced chronic kidney disease (CKD).The percentage of patients who initiate dialysis with an estimated glomerular filtration rate (eGFR) above 10 ml/min/1.73m(2) is now greater than 50%, including 20% who initiate with an eGFR above 15 ml/min/1.73m(2). The drivers behind these findings are probably diverse but recent literature does not seem to support a higher symptom burden among the ageing CKD population as the major cause. The Initiating Dialysis Early And Late (IDEAL) trial provides guidance on the safety of waiting for symptoms or lower levels of estimated glomerular filtration rate prior to beginning dialysis. In addition, economic analyses based on the IDEAL and US Renal Data System findings suggest that significant cost savings could be achieved by reversing the early initiation trend.These findings should help clinicians and policy makers looking to rein in costs while maintaining the quality of CKD care.
View details for DOI 10.1097/MNH.0b013e328351c244
View details for Web of Science ID 000302769500014
View details for PubMedID 22388556
View details for PubMedCentralID PMC3458516
