November 6th 2019
Paris, November 6, 2019 – 7.00 am CET
CARMAT (FR0010907956, ALCAR), the designer and developer of the world’s most advanced total artificial heart project, aiming to provide a therapeutic alternative for people suffering from end-stage biventricular heart failure, today published an update on the progress of its clinical experience within the framework of the PIVOTAL study.
Stéphane Piat, Chief Executive Officer of CARMAT, said: “As we prepare to resume the PIVOTAL study in the coming weeks, I am delighted to observe that the results recorded with the first 11 patients, very encouraging, continue to strengthen the future positioning of CARMAT as a credible and efficient therapy to provide a response to the issue of biventricular heart failure. Indeed, it is extremely rare to generate such conclusive results as quickly as this in clinical research. In addition to achieving a high 6-month survival rate, we have also significantly reduced perioperative bleeding in the last three patients, while avoiding the risk of cerebrovascular accidents, gastrointestinal bleeding or infections associated with the percutaneous power cable. These compelling results should enable us to rapidly obtain the necessary authorizations in the Czech Republic and Kazakhstan, where we intend to resume the study by capitalizing on the level of experience they have acquired during the first part of the study”.
The primary endpoint of the study, corresponding to 6-month survival with the bioprosthesis or a successful transplant within 6 months after device implant, was achieved in 73% of the first 11 patients enrolled in the PIVOTAL study. By comparison, this rate was just 50% during the feasibility study (4 patients), and is 54-62% for the only total artificial heart currently on the market[1] and 46%-68% for mechanical biventricular circulatory support systems[2].
The analyses of the secondary objectives of the PIVOTAL study also help establish excellent 6-month safety profile of the prosthesis. Indeed, no adverse effects related to the device, such as a cerebrovascular accident, gastrointestinal bleeding or infections associated with the percutaneous power cable, have been observed. Perioperative bleeding was observed in just 36% of patients, a lower rate than that of the only total artificial heart currently on the market (41%)[3]. Furthermore, applying the new protocol has helped totally eliminate perioperative bleeding in the last three patients.
The device has also proven its ability to respond to variations in the patient’s physical efforts by automatically modifying the flow, confirming that the self regulation system works correctly.
Moreover, excellent results have been observed in patients eligible for a heart transplant: following between 3 and 10 months of support with the CARMAT artificial heart, 5 patients have received a new heart following a successful explantation procedure.
Patients in the study who are continuing to benefit from the support of the bioprosthesis have seen their quality of life improve thanks to the portable system that has enabled them to swiftly return home and regain their mobility.
To date, the maximum duration of individual support is over 20 months, which is particularly encouraging for the second part of the study given the technical enhancements made to the new generation of prostheses manufactured at the Bois-d’Arcy plant.
[1] Kirklin JK et al, J Heart Lung Transplant 2018;37:685-691. Arabia F et al, J Heart Lung Transplant, 2018;37:1304–1312
[2] Lavee J et al, J Heart Lung Transplant 2018;37:1399−1402. Arabia F et al, Ann Thorac Surg 2018;105:548–56
[3] Kirklin JK et al., JHLT 2018;37:685-691. Arabia F et al., JHLT, 2018;37:1304–1312. Demondion P et al., EJCS. 2013 Nov;44(5):843-8