Self-care training using the Tablo hemodialysis system.

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 7 days. 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 52.6 years 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 10.0 minutes, 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.

Intradialytic Symptoms and Recovery Time in Patients on Thrice-Weekly In-Center Hemodialysis: A Cross-sectional Online Survey.

RATIONALE & OBJECTIVE: Patients experience various symptoms during hemodialysis. We aimed to assess the frequency and severity of symptoms during hemodialysis and whether intradialytic symptoms are associated with recovery time postdialysis. STUDY DESIGN: An online questionnaire was sent to 10,000 patients in a National Kidney Foundation database. SETTING & PARTICIPANTS: Adult patients receiving in-center hemodialysis 3 times weekly for 3 or more months. EXPOSURE: Online questionnaire. ANALYTIC APPROACH: Tabulation of frequency and severity of events and recovery time as percent of respondents, construction of a total symptom score, followed by rank correlation analysis of symptom characteristics with total recovery time. OUTCOMES: Patient-reported intradialytic symptoms and recovery time postdialysis. RESULTS: 359 patients met screening criteria and completed the questionnaire. Mean age was 62.5 ± 13.8 years, 207 (58%) were men, 74 (21%) were black/African American, 132 (37%) had diabetes, 252 (70%) had hypertension, and 102 (28%) had a history of myocardial infarction, heart surgery, or stent placement. 311 (87%) patients had symptoms during dialysis in the previous week, with mean severity of 2.7 (range for each symptom, 1-5). The most common symptoms were fatigue/feeling washed out (62%), cramps (44%), and symptoms of low blood pressure (42%). Median time to recovery was 3 (range, 0-24) hours, and this correlated with the incidence and severity of intradialytic symptoms (P < 0.0001). 40% of patients had time to recovery times of 4 hours or longer. 1 in 3 patients reported having stopped dialysis early for intradialytic symptoms and 6% reported skipping dialysis at least once because of intradialytic symptoms. LIMITATIONS: Recall-based self-reported data with a relatively low response rate. CONCLUSIONS: A majority of patients receiving in-center hemodialysis experience symptoms such as feeling washed out, fatigue, and cramping; these may be severe and are correlated with longer recovery time following hemodialysis, as well as shortened and skipped hemodialysis sessions.

Patient-reported outcomes from the investigational device exemption study of the Tablo hemodialysis system.

INTRODUCTION: We recently completed an Investigational Device Exemption (IDE) study in which 30 patients were enrolled (13 patients previously on home hemodialysis (HHD) and 17 patients new to HHD) and treated with the Tablo Hemodialysis System (Outset Medical, Inc., San Jose, CA) for 8 weeks in-center and 8 weeks in-home with an interim 2-4 week transition period for home training. METHODS: In addition to assessments of urea kinetics, events related to safety, and operational issues (e.g., alarm resolution), we obtained data on several parameters of health-related quality of life, including time to recovery (TTR), the EQ-5D-5L (a well-validated measure of general health status), and the quality of sleep and related symptoms, to further assess the safety of HHD with Tablo. We compared results obtained during the in-center and in-home phases of the trial. RESULTS: Twenty-eight of 30 patients (93%) completed all trial periods. Adherence to the prescribed four treatments per week schedule was 96% in-center and 99% in-home. Median TTR was 1.5 hours (10th, 90th percentile range 0.17 to 12, mean TTR 3.68 ± 5.88 hours) during the in-center and 2 hours (10th, 90th percentile range 0 to 6.0, mean TTR 3.04 ± 5.14 hours) during the at-home phase (Wilcoxon signed rank p = 0.57). Median index values on the EQ-5D-5L were similar during the in-center (0.832, 10th, 90th percentile range 0.617 to 1, mean 0.817 ± 0.165) and in-home (0.826, 10th, 90th percentile range 0.603 to 1, mean 0.821 ± 0.163) trial phases (Wilcoxon signed rank p = 0.36). Patients reported feeling alert or well-rested with little difficulty falling or staying asleep or feeling tired and worn out when using Tablo in either environment. CONCLUSION: When using Tablo in-home, patients reported similar TTR, general health status, and sleep quality and related symptoms compared to using Tablo in-center. (294 words).

Safety and efficacy of the Tablo hemodialysis system for in-center and home hemodialysis.

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 3.4 hours 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 8 seconds in-center and 5 seconds 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.

Differential Molecular Modeling Predictions of Mid and Conventional Dialysate Flows.

BACKGROUND: High dialysate flow rates (QD) of 500-800 mL/min are used to maximize urea removal during conventional hemodialysis. There are few data describing hemodialysis with use of mid-rate QD (300 mL/min). METHODS: We constructed uremic solute (urea, beta2-microglobulin and phosphate) kinetic models at varying volumes of distribution and blood flow rates to predict solute clearances at QD of 300 and 500 mL/min. RESULTS: Across a range of volumes of distribution a QD of 300 mL/min generally yields a predicted urea spKt/V greater than 1.2 during typical treatment times with a small difference in urea spKt/V between a QD of 300 and 500 mL/min. A larger urea KoA dialyzer and 15 min of additional time narrows the urea spKt/V difference. No substantial differences were observed regarding the kinetics of beta2-microglobulin and phosphate for QD of 300 vs. 500 mL/min. CONCLUSION: A QD of 300 mL/min can achieve urea clearance targets. Hemodialysis systems using mid-rate QD can be expected to provide adequate hemodialysis, as currently defined.

Results of human factors testing in a novel Hemodialysis system designed for ease of patient use.

Introduction Home hemodialysis has not been widely adopted despite superior outcomes relative to conventional in-center hemodialysis. Patients receiving home hemodialysis experience high rates of technique failure owing to machine complexity, training burden, and the inability to master treatments independently. Methods We conducted human factors testing on 15 health care professionals (HCPs) and 15 patients upon release of the defined training program on the Tablo™ Hemodialysis System. Each participant completed one training and one testing session conducted in a simulated clinical environment. Training sessions lasted <3 hours for HCPs and <4 hours for patients, with an hour break between sessions for knowledge decay. During the testing session, we recorded participant behavior and data according to standard performance and safety-based criteria. Findings Of 15 HCPs, 10 were registered nurses and five patient care technicians, with a broad range of dialysis work experience and no limitations other than visual correction. Of 15 patients (average age 48 years), 13 reported no limitations and two reported modest limitations-partial deafness and blindness in one eye, respectively. The average error rate was 4.4 per session for HCPs and 2.9 per session for patients out of a total possible 1,710 opportunities for errors. Despite having received minimal training, neither HCPs nor patients committed safety-related errors that required mitigation; rather, we noted only minor errors and operational difficulties. Discussion The Tablo™ Hemodialysis System is easy to use, and may help to enable self-care and home hemodialysis in settings heretofore associated with high rates of technique failure.

The Peritoneal Dialysis Outcomes and Practice Patterns Study (PDOPPS): Unifying Efforts to Inform Practice and Improve Global Outcomes in Peritoneal Dialysis.

UNLABELLED: ♦ BACKGROUND: Extending technique survival on peritoneal dialysis (PD) remains a major challenge in optimizing outcomes for PD patients while increasing PD utilization. The primary objective of the Peritoneal Dialysis Outcomes and Practice Patterns Study (PDOPPS) is to identify modifiable practices associated with improvements in PD technique and patient survival. In collaboration with the International Society for Peritoneal Dialysis (ISPD), PDOPPS seeks to standardize PD-related data definitions and provide a forum for effective international collaborative clinical research in PD. ♦ METHODS: The PDOPPS is an international prospective cohort study in Australia, Canada, Japan, the United Kingdom (UK), and the United States (US). Each country is enrolling a random sample of incident and prevalent patients from national samples of 20 to 80 sites with at least 20 patients on PD. Enrolled patients will be followed over an initial 3-year study period. Demographic, comorbidity, and treatment-related variables, and patient-reported data, will be collected over the study course. The primary outcome will be all-cause PD technique failure or death; other outcomes will include cause-specific technique failure, hospitalizations, and patient-reported outcomes. ♦ RESULTS: A high proportion of the targeted number of study sites has been recruited to date in each country. Several ancillary studies have been funded with high momentum toward expansion to new countries and additional participation. ♦ CONCLUSION: The PDOPPS is the first large, international study to follow PD patients longitudinally to capture clinical practice. With data collected, the study will serve as an invaluable resource and research platform for the international PD community, and provide a means to understand variation in PD practices and outcomes, to identify optimal practices, and to ultimately improve outcomes for PD patients.

A global overview of renal registries: a systematic review.

BACKGROUND: Patient registries have great potential for providing data that describe disease burden, treatments, and outcomes; which can be used to improve patient care. Many renal registries exist, but a central repository of their scope, quality, and accessibility is lacking. The objective of this study was to identify and assess worldwide renal registries reporting on renal replacement therapy and compile a list of those most suitable for use by a broad range of researchers. METHODS: Renal registries were identified through a systematic literature review and internet research. Inclusion criteria included information on dialysis use (yes/no), patient counts ≥300, and evidence of activity between June 2007 and June 2012. Public availability of information on dialysis modality, outcomes, and patient characteristics as well as accessibility of patient-level data for external research were evaluated. RESULTS: Of 144 identified renal registries, 48 met inclusion criteria, 23 of which were from Europe. Public accessibility to annual reports, publications, or basic data was good for 17 registries and moderate for 22. Patient-level data were available to external researchers either directly or through application and review (which may include usage fees) for 13 of the 48 registries, and were inaccessible or accessibility was unknown for 25. CONCLUSIONS: The lack of available data, particularly in emerging economies, leaves information gaps about health care and outcomes for patients with renal disease. Effective multistakeholder collaborations could help to develop renal registries where they are absent, or enhance data collection and dissemination for currently existing registries to improve patient care.

Relationship between drain volume/fill volume ratio and clinical outcomes associated with overfill complaints in peritoneal dialysis patients.

BACKGROUND: To better understand the spectrum of overfill reports and their corresponding clinical severity and etiology, we conducted a review of overfill reports from the Manufacturer and User Facility Device Experience (MAUDE) database, which is within the Food and Drug Administration (FDA) Web site (www.fda.gov). METHOD: We searched the MAUDE database for events related to overfill reports between 1 January 1995 and 31 December 2008 and recorded drain volume (DV)/fill volume (FV), or DV/FV, and clinical symptoms and signs associated with the overfill report. RESULTS: Among 462 MAUDE reports with a possible overfill event, 440 reports (95.2%) with a confirmed overfill event contained sufficient information to ascertain the clinical severity of the event. The number of reports with a clinical severity rating of minor, moderate, major, or death was 331, 71, 28, and 10, respectively. The median (range) DV/FV for a subgroup of 292 reports with a clinical severity rating of minor, moderate, major, or death was 1.63 (1.06 - 4.29), 1.71 (1.08 - 5.87), 2.14(1.64 - 2.61), and 2.50 (2.28 - 3.33), respectively. Insufficient drain accounted for a majority of overfill reports. CONCLUSION: Our analysis of reports from the MAUDE database suggests an association between DV/FV and clinical severity of the reported overfill event, as well as significant patient-to-patient variability with respect to intraperitoneal volume tolerance.

Will peritoneal dialysis be left behind?

Peritoneal dialysis (PD) enjoyed huge growth in the 1980s, followed by a rapid decline in the late 1990s, and a now persistently low utilization rate in many countries, including the United States. Recent clinical data indicate a survival advantage for patients started on PD. Residual renal function is better preserved with PD. Adequacy targets are being revised and will likely allow PD prescriptions to be simplified. The physiology of the peritoneum is better understood and treatment strategies reflect that understanding. New solutions have been developed in response to studies that have assessed the impact of conventional PD dialysate on the structure and function of the peritoneum. A remaining challenge is to ensure that nephrology trainees and nephrologists in practice are fully informed of the advantages of PD for many patients and of the advances in the therapy. If this can be achieved, PD should start to grow again.

Impact of dyslipidemia in end-stage renal disease.

Heart disease is a major cause of morbidity and mortality among patients with renal failure. Premature atherosclerotic coronary heart disease is driven by multiple risk factors, including dyslipidemia and oxidative stress. In the nondialysis population, there is overwhelming evidence that treatment of dyslipidemia can significantly improve cardiovascular outcomes. Accumulating data indicate that dialysis patients have atherogenic lipid abnormalities. Although LDL cholesterol (LDL-C) levels in patients who undergo hemodialysis are normal or near normal, increased oxidized LDL-C, triglycerides, and lipoprotein (a) [Lp(a)]; decreased HDL cholesterol (HDL-C); and triglyceride-rich VLDL have been noted. Patients who receive peritoneal dialysis have a more atherogenic lipid profile with increased LDL-C, apolipoprotein B, oxidized LDL-C, triglycerides, and Lp(a) and decreased HDL-C. Furthermore, the LDL particles of peritoneal dialysis patients are small and dense. However, there is a dearth of information regarding the goals, efficacy, and safety of dyslipidemia treatment among dialysis patients. Given the strong evidence of risk reduction and the benefits of lipid-lowering treatment in the nondialysis population, the emerging consensus is that dialysis patients should be treated aggressively for dyslipidemia to an LDL-C goal below 100 mg/dl. Although physicians and patients may be reluctant to add medications because of concerns about polypharmacy, potential decreased compliance, and increased cost, the use of agents such as sevelamer that can serve multiple functions, including phosphate control, lipid lowering (decreased LDL-C and total cholesterol), and anti-inflammatory effects (decreased high-sensitivity C-reactive protein), should be explored and considered for patients who would benefit from such treatment.

Cardiovascular risk in peritoneal dialysis.

All patients with CKD have multiple risk factors for CVD and CAD in particular. Some of these risk factors such as age and gender cannot be modified. Others such as diabetes and hypertension are not only CVD risk factors but are also the cause of the patient's CKD. Finally there are a group of risk factors such as disturbances of mineral metabolism and oxidative stress which are present either uniquely in or are exaggerated by renal failure. PD gives patients a more atherogenic lipid and lipoprotein profile, puts them at greater risk for AGE formation and usually causes hyperinsulinemia. All of these contribute to CVD risk. However, they can also achieve excellent blood pressure control, usually easily reach targets for anemia management and have continuous ultrafiltration allowing for the maintenance of good volume status, all of which will reduce risk for CVD. All treatable risk factors should be treated early in the development of CKD and should continue through their time on dialysis and after transplantation.

Risk factors for coronary artery disease in patients with renal failure.

Cardiovascular mortality is markedly increased in patients with end-stage renal disease (ESRD), particularly those receiving dialysis. Coronary artery disease is the most important cause of death in these patients. As in the general population, older age, male gender, and the postmenopausal state in women are cardiovascular risk factors in patients with ESRD. However, hypertension, diabetes mellitus, and dyslipidemia, known to promote cardiovascular disease in the general population, are particularly likely to do so in patients with ESRD because of their high prevalence in this population. In addition, nontraditional cardiovascular risk factors, such as hyperhomocystinemia, inflammation, elevated calcium x phosphate product, endothelial dysfunction, and oxidant stress, occur frequently in patients with ESRD. Vigorous treatment of modifiable cardiovascular risk factors has reduced cardiovascular risk in patients without ESRD. The extent to which such risk factor modification would alter cardiovascular risk in ESRD remains uncertain.

ADEMEX and HEMO trials: where are we going?

Doubt has remained as to whether or not the K/DOQI recommended targets for adequacy of dialysis for peritoneal dialysis patients is appropriate (weekly Kt/V 2 + creatinine clearance 50-60 l/1.73 m(2)). The ADEMEX trial can be interpreted as indicating that lower targets might be acceptable. The HEMO trial, not yet published but presented in April 2002, casts doubts on the advantages of achieving higher than recommended small solute clearance targets. Taken together, these trials require that we broaden our concept of adequacy. There is also a risk of complacency with respect to dialysis adequacy because of these trials and this would be unwise.