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

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/V urea ≥ 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/V urea 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.

Technology, Telehealth, and Nephrology: The Time Is Now

“…Remote monitoring in high-risk dialysis patients has been linked to decreased hospitalizations, improve quality of life, and cost savings in hemodialysis patients (13), and decreased emergency room visits, reduced disease burden, and improve compliance in PD patients (14). Innovative technology is being used to create simpler machines with touch screens, intuitive setup, and verbal feedback to the patient (15,16). Cloud-based platforms now allow a secure connection with many PD cyclers; this allows remote viewing of treatment summaries including prescription details, ultrafiltration, and any lost dwells, and in some cases allows the nurse or the physician to instantaneously change the prescription for the next cycle of PD (15).…”

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

“…Details of design and implementation of the IDE trial and the primary efficacy and safety results are published elsewhere. 3 Briefly, patients from eight sites were enrolled in the trial after a HIPAA-compliant, IRB-approved consent form was signed. Inclusion criteria included adult patients (age 18 to 75 years) with end stage kidney disease (ESKD) treated with maintenance hemodialysis who consistently achieved a single pool Kt/V urea ≥ 1.2 and who were stable for at least three months with a vascular access providing a blood flow of at least 300 mL/min.…”

“…The trial consisted of four treatment phases during which Tablo was utilized: a run‐in phase of one week in‐center, an in‐center phase of 32 treatments (approximately eight weeks) during which the dialysis staff managed the treatments, a transition phase of up to four weeks to train the patient or care partner to manage the dialysis, and a final in‐home phase of 32 treatments (approximately eight weeks). Details of design and implementation of the IDE trial and the primary efficacy and safety results are published elsewhere 3 …”

“…In the IDE, Tablo achieved an average weekly std Kt/V of 2.8 on 4 sessions per week. 3 The study has several strengths. Retention and adherence were high.…”

“…We recently completed an Investigational Device Exemption (IDE) study evaluating the safety and efficacy of a novel hemodialysis system (Tablo, Outset Medical, Inc., San Jose, CA) used both in-center and at home. 3 We assessed efficacy by achievement of a weekly standard Kt/V urea ≥ 2.1 during the in-center and in-home phases of the trial. We assessed safety primarily by determination of serious and non-serious adverse events.…”