Troy J. Plumb
WASHINGTON — Data presented at ASN Kidney Week show Outset Medical’s Tablo hemodialysis system was safe and effective for both in-center or at-home use.
Troy J. Plumb, MD, of the University of Nebraska Medical Center, told Healio/Nephrology the Tablo device is unique because only a faucet, a drain and an electrical outlet are required; Tablo’s filtration system then makes the dialysate. Tablo is already FDA cleared for use in acute and chronic care facilities.
To compare the safety and efficacy of the Tablo between in-center and at-home use, researchers studied patients who first received treatments for 8 weeks in center. There was then a 4-week transition period (accompanied by training on using the machine, if needed), followed by 8 weeks of treatment at home. Treatments occurred four times per week. Plumb noted patients were “very adherent” to treatments.
Researchers found the system met its primary efficacy endpoint (weekly standard of Kt/V 2.1), with average weekly standard Kt/V being 2.8 in both the in-center and at-home periods. In addition, 94% (both in-center and at-home use) met the secondary efficacy endpoint of the delivery of ultraltration within 10% of prescribed ultrafiltration.
Regarding the safety of the system, two adverse events occurred in-center vs. six at-home use, but none were deemed related to the Tablo. The median time to resolution of alarms was 8 seconds for in-center and 5 seconds for at-home use.
Plumb said the next necessary step is to receive FDA approval for in-home use. Then, he said, it is important for researchers to focus on patient-centered outcomes, such as how treatments make patients feel and how long it takes to learn how to use the machine. “Tablo is set up to be patient friendly. We think that when it goes into use, the training period will be short,” he said. – by Melissa J. Webb
Plumb TJ, et al. Abstract PO1195. Presented at: ASN Kidney Week; Nov. 7-10, 2019; Washington D.C.
Disclosure: Plumb reports no relevant financial disclosures.