FRANCE – Carmat, the designer and developer of the world’s most advanced total artificial heart, has had the first implantation of its bioprosthetic artificial heart, Aeson in the United States within the framework of the Early Feasibility Study (EFS).
The implant procedure was performed by a team led by Dr. Jacob N. Schroder and Dr. Carmelo A. Milano, heart surgeons at Duke University Hospital, in Durham, North Carolina.
It is the first U.S. hospital to implant Aeson within the framework of the EFS. Three additional U.S. centers are fully trained and are currently screening patients for the study.
In accordance with the study protocol approved by the FDA, 10 transplant-eligible patients are expected to be enrolled in this trial. The primary study endpoint is patient survival at 180 days post-implant or a successful cardiac transplantation within 180 days post-implant.
It is a staged study with a progress report of the first 3 patients after 60 days, before the enrollment of the next 7 patients.
The study trials come barely a month after its initial clinical experiments were reported in American Society for Artificial Internal Organs (ASAIO) journal.
The reports were in response to “pressure sensor-based autoregulation of blood flow” in ten patients for up to two years after implantation of Carmat’s Aeson.
Based on the study, it was found that heart replacement pumps can restore cardiac output in patients with end-stage, biventricular heart failure whose only other option is heart transplantation.
However, to enable patients to go home from the hospital and return to their usual activities, the pump had to emulate normal heart function, with minimal need for adjustment.
To meet that goal, Aeson incorporates an Auto-Mode that automatically adapts the pumping action of the right and left ventricles in response to pressure sensors located inside the device, based on parameters set by the physician.
For this study, 10 patients who had undergone Aeson implantation in early clinal trials across Europe were studied. All patients were men of an average age of 60 years.
In all patients, the artificial heart was successfully switched from manual control to Auto-Mode in the operating room. Auto-Mode led to “an immediate appropriate cardiac output response” to the targeted settings.
Hemodynamic data recorded by Aeson showed expected variations in pumping output of the left and right ventricles, in response to changes in pressures and heart rate. Heart rate averaged 78 to 128 beats per minute; blood pressure was normal as well.
Over almost five years of aggregate follow-up, medical teams made changes in the Auto-Mode settings just 20 times. Most adjustments were performed during the first 30 days after device placement. Only four were done after the patient went home from the hospital: a rate of about 1 change per 11 months.