Safety and efficacy of the Tablo hemodialysis system for in-center and home hemodialysis.
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., Prichard, S. S., Chertow, G. M., Aragon, M. A.
2019
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
INTRODUCTION: A majority of patients with end-stage renal disease (ESRD) on in-center hemodialysis (HD) require several hours to recover from an HD session. Patients and caregivers identify fatigue as a high priority for improvement. However, evidence for practical interventions to improve recovery time from conventional in-center HD is lacking. The effect of blood flow rate reduction on dialysis recovery time (DRT) is unknown.METHODS: Multicenter, single-blinded, randomized, parallel-design controlled trial of blood flow rate reduction vs. usual care. One-hundred two patients with ESRD undergoing maintenance HD in 18 centers with baseline DRT of greater than 6 hours were included as subjects. The intervention was a blood flow rate reduction of 100mL/min, to a minimum of 300mL/min. The primary outcome was the between-group difference in change in DRT. Secondary outcomes were changes in London Evaluation of Illness (LEVIL) survey responses from baseline.FINDINGS: Baseline median DRT was 720 (IQR 360-1013) minutes in controls and 720 (IQR 360-1106) minutes in the intervention group. DRT decreased in both groups. Mean change from baseline (95% confidence interval) at Week 4 in the study was -324 (-473, -175) minutes in the control group and -120 (-329, 90) minutes in the intervention group. The change from baseline was more profound in the control group (P=0.05). Secondary outcomes of measures of quality of life reported on the LEVIL survey showed more improvement in patients' feelings of general well-being in the control group (P=0.01). Differences between groups in pain, feeling washed out or drained, sleep quality, shortness of breath, and appetite were not statistically significant.DISCUSSION: Blood flow rate reduction did not improve DRT over usual care. Though more work needs to be done to address patient-reported fatigue, a significant positive impact may not be achieved without substantial changes in dialysis prescription.
View details for PubMedID 30834652
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
