In a novel procedure, the Vanderbilt Heart & Vascular Institute (VHVI) successfully performed the first large-flange Innovalve transcatheter mitral valve replacement (TMVR).
Doug Floyd, 78, of Mt. Juliet, Tennessee, received the first implant in a minimally invasive, catheterization-based procedure in December 2023 as part of an FDA-approved early feasibility study of the new Innovalve TMVR System.
The device is intended to treat mitral regurgitation, which occurs when the mitral valve doesn’t close all the way. Mitral regurgitation typically manifests as shortness of breath and swelling in the extremities. Left untreated, these heart valve diseases can lead to heart failure and death.
The device, called the Innovalve TMVR System, is currently only available as part of a clinical trial in the U.S.
The procedure was performed by Kashish Goel, MD, assistant professor of Medicine (principal investigator) and director of Transcatheter Heart Valve Interventions; Colin Barker, MD, associate professor of Medicine and director of the Section of Interventional Cardiology; and Ryan Lefevre, MD, assistant professor of Anesthesiology.
In the decades prior to his procedure, Floyd lived a very active life, from running marathons and triathlons in his 40s and 50s to walking three to five miles a day in his recent retirement years. But starting around December 2022 he had difficulty walking to his mailbox. “It was quite alarming,” he said.
He came to VHVI and saw Goel, who diagnosed his mitral regurgitation and told him about the Innovalve trial.
“I didn’t want to have open heart surgery,” the conventional treatment for mitral regurgitation, Floyd said.
Goel said VHVI’s leadership in the field and ability to be invited to early feasibility studies such as the Innovalve TWIST-EFS trial shows the confidence in its heart valve team and the volume of work it does, which is among the top 10 in the country.
“We have become a destination valve center,” Goel said. “An early feasibility study such as this gives us early expertise in innovative devices, and it gives our patients early exposure to clinical trials. It also provides options for patients who have been declined for other therapies.”
Now, a month after Floyd’s procedure, he is no longer winded walking to the mailbox and is ready to gradually work his way to walk three to five miles per day. “I’m feeling very well,” he said. “I feel my walking is better.”
He credits his Vanderbilt medical team with his success. “The nurses were phenomenal,” he said, “and the doctor, Dr. Goel, I really liked him, too.”
Floyd, a musician since about 1962, looks forward to continuing to play the electric bass and upright bass, including with his two buddies in the band JBD Express.
“As long as I can still be active and do things and feel good when I get up in the morning and drink coffee and just feel alert, well that’s the most I could ever hope for,” he said. “If you have a goal, try to stick with it; it’s amazing what you can do.”