Abstract: PO0955
Home Hemodialysis with the Tablo System: The First 1000 Real-World Treatments
Session Information
- Home Dialysis: Disparities and Modality Choice
November 04, 2021 | Location: On-Demand, Virtual Only
Abstract Time: 10:00 AM - 12:00 PM
Category: Dialysis
- 702 Dialysis: Home Dialysis and Peritoneal Dialysis
Authors
- Aragon, Michael A., Outset Medical, Inc., San Jose, California, United States
- Chahal, Yaadveer, Outset Medical, Inc., San Jose, California, United States
- Lim, Brittany, Outset Medical, Inc., San Jose, California, United States
- Schumacher, Josh, Outset Medical, Inc., San Jose, California, United States
Background
The Tablo® Hemodialysis System is an all in one, easy-to-learn device capable of achieving clearance goals in as little as three treatments per week. It features integrated water purification, on demand dialysate production and two-way wireless data transmission.
Tablo obtained FDA clearance for home hemodialysis (HHD) in March 2020. Approval was based on a prospective, crossover trial (in-center and at home dialysis) where Tablo successfully met all safety and effectiveness endpoints, reported high rates of treatment adherence and patient retention, with greatly reduced training time (NCT02460263).
The objective is to report on the first 1,000 treatments performed on Tablo by patients at home in the real-world.
Methods
Incident and prevalent patients currently performing in-center dialysis, PD, or HHD were initiated on Tablo at participating Home Dialysis programs. Patients underwent training by facility nurses on the Tablo device prior to beginning treatments at home. Data on the first 1000 treatments was obtained wirelessly via Tablo’s data platform along with corresponding patient training data.
Results
The first 1000 treatments occurred in 20 patients, with a mean follow-up duration of 3.4 months. Patient training on Tablo was completed over an average of 7.4 training days. Patient retention was 100% with no patients opting out of HHD with Tablo.
Mean prescribed treatment time was 3.2 hours with a mean frequency of 3.7 treatments per week. Mean total UF per treatment was 1.9 L. Mean UF rate per treatment was 7.3 mL/kg/hr.
Treatment adherence was 93%, with 95% of treatments completing within 10% of prescribed time. The mean number of clinically significant alarms per treatment was 1.0 (± 3.0), with an average time to resolution of 10.7 (± 18.5) seconds.
Conclusion
Results from the Tablo IDE demonstrating reduced training time, increased treatment adherence, high treatment success rate and a low occurrence of treatment alarms are reproducible in the real world at a frequency of 3-4 treatments/week. This data supports that Tablo is capable of successfully achieving clinical goals while reducing the overall patient burden often associated with HHD.
Tablo Home Hemodialysis Data
| Patient Training [Mean ± SD (n, median, min-max)] | Treatment Data [Mean ± SD (n, median, min-max)] | Treatment Success / Adherence [% (n)] | |||||||
| Training Time (hrs) | Training Sessions (days) | Prescribed Weekly Dialysis (txs/week) | Patient Weight (kg) | Actual UF Volume (L / treatment) | Actual Treatment Time (hours) | Actual UF Rate per treatment (mL/kg/hr) | Treatment Success | UF Success | Treatment Adherence |
| 27.4 ± 11.1 (n=12, 4.0, 12.5 - 43.5) | 7.4 ± 1.5 (n=12, 8.0, 4 - 10) | 3.7 ± 0.6 (n=20, 4.0, 3.0 - 5.0) | 89.8 ± 25.4 (n=1000, 87.3, 41.3 – 153.5) | 1.93 ± 0.98 (n=1000, 2.0, 0 - 5.2) | 3.2 ± 0.8 (n=1000, 3.0, 0.4 - 8.0) | 7.3 ± 4.1 (n=1000, 7.0, 0 - 24.5) | 95.4% (954/1000) | 92.2% (922/1000) | 93.2% (1000/1073) |
Funding
- Commercial Support –