Abstract: FR-PO523
The Tablo Hemodialysis System at Home: Comparing Real World to the IDE Trial
Session Information
- Home Dialysis, Policy, Novel Approaches
November 04, 2022 | Location: Exhibit Hall, Orange County Convention Center‚ West Building
Abstract Time: 10:00 AM - 12:00 PM
Category: Dialysis
- 702 Dialysis: Home Dialysis and Peritoneal Dialysis
Authors
- Schumacher, Josh, Outset Medical, Inc., San Jose, California, United States
- Aragon, Michael A., Outset Medical, Inc., San Jose, California, United States
- D'Alessandri-Silva, Cynthia J., Outset Medical, Inc., San Jose, California, United States
Background
The Tablo® Hemodialysis System (“Tablo”) obtained FDA clearance for home hemodialysis (HHD) in March 2020. Approval was based on a prospective, crossover trial, where 30 patients were followed for 8 weeks during each study phase (in-center and home). Tablo met all safety and effectiveness endpoints, reported high rates of treatment adherence, patient retention, and included a diverse patient population (NCT02460263).
The HOME Registry (NCT04526301) is an ongoing study of real-world patients utilizing Tablo for HHD.
Methods
Using the same eligibility criteria as the Tablo IDE, incident and prevalent patients were initiated on Tablo at participating study sites. Treatment data were obtained wirelessly via the Tablo data platform. All other data were reported by site staff into the study database. Data collected from the first 30 patients on the HOME Registry over the first 8 weeks was compared to the 30 patients who participated in the IDE.
Results
Mean patient age was 55.2 years, with the majority being male (66.7%), white (73.3%) and with an AV fistula (60.0%). Mean prescribed treatment time was 3.3 hours, with a mean prescribed frequency of 3.8 treatments per week.
Treatment adherence was 95%, with 92% of treatments completing at least 90% of prescribed time. The mean number of clinically significant alarms per treatment was 1.3 (±2.9), with an average time to resolution of 10.8 (±23.1) seconds. The mean weekly standard Kt/V at the 4-week visit was 2.3±0.5.
Patient retention was 100%, with no patients opting out of HHD with Tablo. One serious adverse event (SAE) was reported, a seizure and subsequent hospitalization. The event was deemed not related to Tablo or to the HD treatment by the site investigator.
Conclusion
Initial real-world experience from the Home Registry mirrors the IDE with reports of high treatment adherence and patient retention, with low rates of treatment alarms and SAEs. This data supports that Tablo achieves standard adequacy goals in more flexible dialysis schedules than current HHD options for a diverse patient population.
Funding
- Commercial Support –