April 3rd 2025
The retrospective analysis on 10 patients shows a 90% survival rate at 6 months, suggesting Aeson® as a therapeutic solution for these patients at risk of death in the short term.
Paris, April 3, 2025 – 6:00 pm CEST
CARMAT (FR0010907956, ALCAR), designer and developer of the world’s most advanced total artificial heart, aiming to provide a therapeutic alternative for people suffering from advanced biventricular heart failure (the “Company” or “CARMAT”), today announces the publication of the results of the initial clinical experience with Aeson® in cardiogenic shock patients previously on temporary extracorporeal life support[2], in the JACC: Heart Failure.
Study characteristics and key findings: 90% survival rate at 6 months, recovery of renal and hepatic function, improvement in functional capacity
The article, entitled “Initial Experience with Aeson Total Artificial Heart in Cardiogenic Shock Patients on Extracorporeal Life Support[3]”, features the results of a retrospective analysis conducted in seven hospitals across France and Germany between November 2022 and April 2024. The analysis is about 10 patients with refractory cardiogenic shock, who were initially stabilized on extracorporeal life support (ECLS) for a median duration of 9 days before receiving an Aeson® total artificial heart.
The analysis reports a 90% survival rate at 6 months following Aeson® implant, with 5 patients successfully transplanted and 4 still on Aeson® support at that time.
In addition, the analysis highlights that Aeson® improves kidney and liver recovery and allows for hospital discharge after a median hospital stay of 42 days, contributing to an improvement in functional capacity and overall health status of the patient while awaiting a heart transplant.
Dr. Anne-Céline Martin, Cardiologist at Hôpital Européen Georges-Pompidou (Paris) and lead author of the article, commented: “Even for critically ill patients in refractory cardiogenic shock requiring temporary circulatory support, transitioning to the Aeson® total artificial heart has demonstrated highly promising results, with a 6-month survival rate of 90%. Moreover, thanks to Aeson®’s autoregulated and pulsatile flow, patients experienced a significant improvement in exercise capacity and quality of life, enabling them to face the challenge of a heart transplant.”
Aeson®: a promising solution for very high-risk patients initially placed on temporary extracorporeal life support
Cardiogenic shock is an acute heart failure condition that poses a life-threatening risk to patients, with still high mortality rates (30% to 60%) despite advancements in treatment. In the most severe cases, extracorporeal life support can be used temporarily to stabilize patients; however, this approach is only viable for a short period of time (around ten days) due to the risk of complications.
Heart transplant often remains the best option for these patients initially placed on extracorporeal life support. However, its access is limited by the lack of available human grafts, and by the sometimes too fragile health status of patients, who may present temporary contraindications to such a transplant.
Aeson® is therefore emerging as a promising therapeutic solution for this population of patients at very high risk of death in the short term, enabling them to improve their state of health before they can benefit from a heart transplant.
Over the past two years, around half of patients treated with Aeson® had previously been placed on extracorporeal life support.
Stéphane Piat, Chief Executive Officer of CARMAT, concluded: “This new publication in a leading scientific journal validates the relevance and clinical value of our therapy, confirming that Aeson® can be used as a bridge to transplant even for the most critical patients, at risk of death in the short term. After several days on extracorporeal life support (ECMO), these patients have no other options but heart transplant or the implant of a total artificial heart if a human graft is not available or if a transplant can’t be made immediately due to the patient’s state of health. Our promising results bring hope to patients and their families. I am convinced that their dissemination within the medical community will drive an always broader adoption of Aeson® across Europe.”
[1] Journal of the American College of Cardiology
[2] Also known as “ECMO” (Extra-Corporeal Membrane Oxygenation) or “ECLS” (Extra-Corporeal Life Support).
[3] https://www.sciencedirect.com/science/article/pii/S2213177925001763?dgcid=author