A cardiothoracic surgical team with UofL Health–Jewish Hospital and the University of Louisville (Louisville, USA) has performed the world’s first Aeson bioprosthetic total artificial heart implantation in a female patient.
The investigational device, currently intended as a bridge to heart transplant, is part of an Early Feasibility Study (EFS) sponsored by CARMAT in partnership with UofL, UofL Health–Jewish Hospital and the UofL Health–Trager Transplant Center.
Led by cardiothoracic surgeons Mark Slaughter and Siddharth Pahwa both of UofL Health–UofL Physicians and the UofL School of Medicine, the team performed the implant of the device on 14 September at UofL Health–Jewish Hospital. The same team completed the nation’s second implantation in a male patient last month, also at Jewish Hospital.
“For the other half of the world’s population, completion of this procedure by the Jewish Hospital team brings new hope for extended life,” said Slaughter, UofL Health surgical director of heart transplant and professor and chair of the Department of Cardiovascular and Thoracic Surgery in the UofL School of Medicine. “Size limitations can make it harder to implant artificial hearts in women, but the Aeson artificial heart is compact enough to fit inside the smaller chest cavities more frequently found in women, which gives hope to a wider variety of men and women waiting for a heart transplant and increases the chances for success.”
During this procedure, the Aeson total artificial heart was implanted into a 57-year-old Kentucky woman with severe biventricular heart failure during an eight-hour surgery. The recipient, whose identity is being withheld upon request, was referred to the Advanced Heart Failure Therapies Program at Jewish Hospital earlier this year with end-stage heart failure and had undergone cardiac surgery years before. The patient is recovering well in the cardiovascular intensive care unit (CVICU). Jewish Hospital is just one of four programs in the nation approved to perform this clinical trial procedure.
“The varying pumping ability of the Aeson device increases its viability among more patients,” said Pahwa, UofL Physicians cardiothoracic surgeon and assistant professor in the UofL Department of Cardiovascular and Thoracic Surgery. “While other devices are set at a fixed rate or create a continuous flow, CARMAT has developed the Aeson to automatically adjust the flow, creating an improved performance to meet the body’s changing blood flow needs.”
Stéphane Piat, chief executive officer of CARMAT, said, “This third implant in the USA was a landmark event not only because it allowed us to finalise the enrolment of the first cohort of patients of the EFS, but very importantly because it is the first time ever that our device has helped a woman suffering from heart failure. This achievement confirms that the size limitations for adults are minimal, which makes us very confident in Aeson’s potential to become a therapy of choice for a broad patient population.”