Duke University surgeons have successfully implanted a new generation of artificial heart in a man with heart failure – a first in a North American hospital.
The artificial heart was developed by the French company, CARMAT and is approved for use and sale in Europe.
Last year, the company received US FDA approval to begin research and enroll 10 patients with end-stage biventricular heart failure — people on a waiting list for donor hearts — and provide a lifeline before transplantation.
“We are encouraged that our patients are well after the procedure on Monday,” said Dr. Carmelo Milano, transplant surgeon and principal investigator on the Duke device study. “In evaluating this device, we are excited and hopeful that patients who do not have money or do not have many options can receive assistance.”
North Carolina patient Matthew Moore, just 39 years old, was referred to Duke in June after a sudden and unexpected diagnosis of heart failure. Moore and his wife Rachel recently adopted their two-year-old son, Marshall, and arrived at the Duke’s house expecting only heart bypass surgery.
As Moore’s condition deteriorated rapidly, traditional options, including transplant, became too risky. Duke, meanwhile, was one of only three transplant centers in the United States selected to participate in the device study, and the procedure team received specialized training to prepare for implant surgery.
Matthew’s wife, a nurse, said, “Matthew and I are so grateful that we have been given the opportunity to participate in something that has the potential to affect so many lives. We just take it every day and hope things continue well. “
The artificial heart device called “Aeson” is an implantable prosthetic containing a biological valve made of bovine tissue and operated with external energy.
If the device receives FDA approval, it will give hope to transplant patients whose hearts need help pumping blood through both chambers. Modern technology – especially the Left Ventricular Assist Device (LVAD) – supports only one chamber.
“Because of the lack of donor hearts, many patients die while waiting for heart transplants,” said Schroeder, the transplant surgeon who directed the implantation process. “We look forward to new opportunities to support these patients, like Mr. Moore, who have a devastating disease and are not eligible for transplant.”