by Matt Batcheldor
The Structural Heart and Valve Center at Vanderbilt Heart and Vascular Institute (VHVI) has recently completed multiple groundbreaking transcatheter clinical trial procedures treating severe regurgitation of the mitral and tricuspid valves, a continuation of a decade of research that is revolutionizing the treatment of these conditions.
In June alone, the heart valve team performed the first tricuspid repair procedure in the world with the PASCAL Precision system, and Vanderbilt’s first transcatheter tricuspid valve replacement using the EVOQUE valve, both manufactured by Edwards Lifesciences to treat patients with severe tricuspid valve regurgitation.
Last August, in the midst of the pandemic, the team also completed its first mitral valve replacement using Medtronic’s Intrepid valve under the APOLLO trial and recently implanted a second in June as well. Those firsts represent only three of the seven transcatheter valve device trials underway at VHVI.
“There’s been explosive growth in the whole field, and we at Vanderbilt are participating in these innovative advancements in the transcatheter valve therapy space,” said Brian Lindman, MD, MSCI, medical director of the Structural Heart and Valve Center and associate professor of Medicine.
Tricuspid valve regurgitation is a serious condition that occurs when the tricuspid valve on the right side of the heart doesn’t close fully, allowing blood to flow back into the body.
Similarly, mitral valve regurgitation occurs when the mitral valve doesn’t close all the way. Tricuspid and mitral regurgitation typically manifest as shortness of breath and swelling in the extremities.
Left untreated, these heart valve diseases can lead to heart failure and death.
Standard treatment for mitral and tricuspid regurgitation has been either open heart surgery, which carries risk and a long recovery, or medications, which have been modestly effective or ineffective. The clinical trials underway at VHVI are intended to show the feasibility and promise of minimally invasive procedures using a catheter to place a small investigational device in the tricuspid or mitral valves to reduce the opening and prevent backflow of blood. The procedures are relatively quick and painless compared to surgical alternatives, and patients typically require a significantly shorter stay in the hospital to recover.
While research on transcatheter therapies to treat tricuspid regurgitation has been the most recent to start, prior trials have demonstrated the effectiveness of transcatheter devices for treatment of mitral regurgitation.
Separately, research is farthest along for demonstrating the safety and effectiveness of transcatheter therapies to treat aortic stenosis, another common heart valve disease. For example, several studies completed over the last decade have shown that FDA-approved trans-catheter heart valves are as good as surgery or in some cases better for treatment of aortic stenosis, Lindman said.
The breadth of the clinical trials at Vanderbilt and the deep expertise and research interests of the heart valve team have made the valve center a destination for patients.
“Because of the people here and resources, we’re poised to not only be participants in these multicenter national clinical trials, but to do innovative investigator-initiated research to improve clinical management and optimize timing of valve repair or replacement,” Lindman said.
With these innovations, “Vanderbilt has become a leader in the management of valvular heart disease in Tennessee and the Southeastern United States,” said Kashish Goel, MD, interventional/structural cardiologist and assistant professor of Medicine. “We are now able to offer all the minimally invasive catheter-based treatment options for patients with valvular heart disease.”
The Structural Heart Valve Center follows an interdisciplinary, team-based approach from initial evaluation to and during the procedure to post-procedure follow-up. The transcatheter device procedures are “completely paradigm shifting and different,” said Colin Barker, MD, MA, director of Interventional and Structural Cardiology and associate professor of Medicine.
“They depend on a team of diverse procedural and imaging specialists using advanced equipment and imaging systems as the device is placed, and require mutual trust and clear and consistent communication throughout.”
Holly Gonzales, MD, lead implant echocardiologist and assistant professor of Medicine, said that the heart valve team strives to provide personalized care to each patient.
“No matter the valve, no matter the problem, you will get a diverse group with expertise in surgery, interventional cardiology and cardiac imaging looking at that patient’s whole story and all their diagnostic testing. We arrive at treatment recommendations in a multidisciplinary manner, consider all surgical, transcatheter and medical options, and elicit and incorporate the patient’s goals and preferences as we aim to provide the right therapy to the patient at the right time,” she said.
Patients interested in being considered/evaluated for a trial or learning more about them can call the Structural Heart and Valve Center at 615-875-5035 or email the valve program coordinator, Melissa Long, MSN, RN, at melissa.long@vumc.org. Providers requesting further information about Vanderbilt’s participation in clinical trials or who would like resources can contact the research manager, Natalie Jackson, MPH, at 615-343-1782 or natalie.jackson@-vumc.org.