A 78-year-old Toledo-area woman is the first in the United States to receive a new commercially available heart-valve replacement outside the clinical-trial phase.
The woman, who declined to be identified, underwent surgery performed by Dr. Michael Moront in December at ProMedica Toledo Hospital. The Avalus pericardial aortic surgical valve, developed by Minnesota-based Medtronic, won U.S. Food and Drug Administration approval in 2017.
Dr. Moront was part of the first foray into this valve’s implantation; since October, 2014, he has implanted between 25 and 30 such valves each year in patients as part of the trial phase. Not one has been reoperated on for valve problems, he said.
After years of testing and trials, the valve is available commercially. It will be covered “under all insurance plans,” he said, including Medicare and Medicaid.
“To be involved in something new ... and cutting edge is always exciting,” Dr. Moront said. “The potential to bring to Toledo and to my patients state-of-the-art care is the goal of most surgeons and physicians.”
Innovations in heart-valve replacements offer patients the newest standards for care, said Dr. Vinod Thourani, chair of cardiac surgery at MedStar Heart and Vascular Institute at Georgetown University.
“It’s very exciting and refreshing to see new surgical valve technology,” said Dr. Thourani, adding that many recent developments have been in the field of transcatheter aortic-valve replacement. That method delivers a new valve through a catheter rather than through surgery when the chest is opened, as is the case with the Avalus valve.
“Consumers will have the newest technology implanted, which we believe will give them the best outcomes short and long term,” said Dr. Thourani, who is the former chair of the American College of Cardiology’s Surgeons’ Council.
Initial research shows short-term outcomes after surgery for recipients of the Avalus valve are positive, said Dr. Thourani, who has not worked with the valve in his own practice. Now, research will look at its long-term success, he said.
“The early outcomes appear to be great,” he said. “We will need to follow these patients for structural valve deterioration at five and 10-year marks.”
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