For the first time, a new generation of artificial heart has been used in the United States

A surgical team at Duke University Hospital, led by Drs. Jacob Schroder and Carmelo Milano, successfully implanted a new-generation artificial heart in a 39-year-old man with heart failure, becoming the first center in North America to perform the procedure.

The artificial heart was developed by CARMAT and has been studied in Europe, where it is approved for use. Last year, the company received FDA approval to begin studies in the U.S. to potentially enroll 10 patients with end-stage biventricular heart failure. The study will evaluate whether the artificial heart is a viable option as a life-saving step before transplant.

“We are encouraged that our patient is doing so well after the procedure Monday (12 July),” said Milano, a transplant surgeon and the principal investigator of the device study at Duke. “As we evaluate this device, we are both excited and hopeful that patients who otherwise have few to no options could have a lifeline.”

The Duke patient, Matthew Moore, is from Shallotte, N.C., and was referred to Duke in June after a sudden, unexpected diagnosis of heart failure. Moore and his wife, Rachel, recently adopted their two-year-old foster son, Marshall, and arrived at Duke expecting only to undergo heart bypass surgery.

As Moore’s condition quickly deteriorated, however, traditional options, including transplant, became too risky. Meanwhile, Duke was among just three transplant centers in the United States selected to join the device study, and the procedure team received specialized training to prepare for the implant surgery.

“As a nurse, I understand how important it is to bring these advancements forward,” Rachel Moore said. “Both Matthew and I are so grateful that we’ve been provided an opportunity to participate in something that has the potential to have an impact on so many lives. We are just taking it day-by-day and hope everything continues to progress well.”

The artificial heart developed by CARMAT is an implantable prosthetic that includes biological valves derived from bovine tissue. It operates on an external power supply.

If the device receives FDA approval, it would provide a bridge to transplant for patients whose hearts require assistance to pump blood through both chambers. Current technology – notably a left-ventricular assist device (LVAD) -- supports just one chamber.

“Because of the shortages of donor hearts, many patients die while waiting for a heart transplant,” said Schroder, a transplant surgeon who led the implant procedure. “We are hopeful for new options to help these patients, many like Mr. Moore who have devastating disease and cannot otherwise be considered for a transplant.”

Manesh Patel, M.D., chief of the Division of Cardiology at Duke, said the heart care program at Duke has fostered a culture of innovation over decades, aimed at improving care for patients.

“Our goal is to both deliver the best health care and to play a role in discovering it,” Patel said. “Innovation is essential for this. Patients locally and nationally are seen by our heart transplant team for care they may not get elsewhere. The key is the culture of innovation and the teamwork between our cardiac surgeons, heart failure cardiologists, nurses and all the heart center staff that care for our patients.”

“The Duke Heart Transplant Program is globally recognized not only for its robust clinical volume, but more importantly, providing outstanding quality and innovative patient care at the highest level possible,” said Edward P. Chen, M.D., chief of the Division of Cardiovascular and Thoracic Surgery. “The successful implant of the CARMAT artificial heart represents the latest in a long list of accomplishments by the Duke heart transplant team aimed at further expanding the treatment options available for patients with end-stage cardiac disease.”

About the Duke heart transplant program:

· Duke is the nation’s leading center for enrollment in a study of the donation after circulatory death (DCD) heart transplant. After performing the first adult DCD heart transplant in the U.S., Duke has now completed more than 50 of these procedures, which have increased the number of transplanted organs, decreased wait times, and reduced deaths that occur while people are waiting for donated hearts.

· Duke’s heart transplant program has performed twice as many heart transplants than any other center in North Carolina and is in the top six programs by volume in the U.S.

· The program has a median time to transplant of 82 days and has decreased wait time by 50% from July 2019 to July 2021.

· Duke also provides therapy with left ventricular assist devices (LVADs) for patients who do not meet the criteria for transplant.

Members of the surgical team, the patient’s wife and leadership of Duke’s heart transplant and cardiology programs presented information about the first-in-U.S. procedure during a virtual press conference on July 15, 2021: