August 6th 2020
The 5 successful transplants performed during the PIVOTAL study point to the efficacy of the CARMAT heart for patients waiting for a graft
Paris, August 6, 2020 – 5.45 pm CEST
CARMAT (FR0010907956, ALCAR), the designer and developer of the world’s most advanced total artificial heart, aiming to provide a therapeutic alternative for people suffering from end-stage biventricular heart failure, announces the publication ahead of printing of the bridge-to-transplant experience performed during the PIVOTAL study in the Journal of Heart and Lung Transplantation, the most recognized peer-reviewed journal in the field of transplantation.
The article entitled “Initial bridge-to-transplant experience with a bioprosthetic autoregulated artificial heart” analyzed data from seven transplant-eligible patients enrolled in the PIVOTAL study by the surgical teams in Prague (Czech Republic) and Nur-Sultan (Kazakhstan).
The five patients who were discharged from hospital with the CARMAT device after a median duration of 48 days all recovered to an optimal condition for receiving a donor heart. They received donor hearts after median support of 243 days on the CARMAT device in predominantly outpatient follow-up. The CARMAT device explant procedure and the subsequent heart transplant procedure were uneventful in all five cases.
All transplanted patients were successfully discharged after the transplant with an 80% survival rate at 12 months, as one patient developed pneumonia followed by a debilitating ischemic stroke ten weeks after the transplant and passed away on day 110.
As a reminder, the primary endpoint of the PIVOTAL study corresponds to a 6-month survival with the bioprosthesis or a successful heart transplant within 6 months post-implant.
Ivan Netuka, MD, PhD, Chair of the Department of Cardiovascular Surgery at the Institute for Clinical and Experimental Medicine, Prague, and the first author of the publication, comments: “The accumulated experience suggests that a successful bridging to heart transplant by using the CARMAT device is feasible and may also offer several substantial advantages. Indeed, the fully pulsatile biventricular support, along with a low incidence of adverse events, keep patients in a favorable condition for the transplant procedure to optimize the post-transplant outcomes. Furthermore, as there were minimal tissue adhesions observed around the device, the explant procedure was shorter while mitigating the bleeding risk. Last but not least, the shape and size of the device resemble that of a natural heart, and thus leave sufficient space for the transplanted donor heart.”
Stéphane Piat, Chief Executive Officer of CARMAT, concludes: “We are glad that this excellent bridge-to-transplant data was accepted in such a respected peer-reviewed publication as the Journal of Heart and Lung Transplantation. I would like to congratulate the teams in Prague and Nur-Sultan for their tenacity and substantial involvement in our PIVOTAL study. To date, 13 patients have received our device within the framework of the study, and this successful experience on five of them shows that our prosthesis could become a credible therapeutic solution for a number of transplant-eligible patients who are on waiting lists for a donor heart.”