A Vanderbilt University Medical Center team is pioneering the use of minimally invasive transcatheter tricuspid valve replacement (TTVR) to resolve severe tricuspid regurgitation, a rare and serious posttransplant complication.
A case using the procedure for a heart transplant recipient has been published in the Journal of Heart and Lung Transplantation. The team led by Kashish Goel, MD, associate professor of Medicine, used an artificial tricuspid valve, EVOQUE, which received Food and Drug Administration approval in February.
“This has opened the door for heart transplant recipients to have a minimally invasive, transcatheter valve replacement to resolve severe tricuspid regurgitation,” said Goel, director of Transcatheter Heart Valve Interventions at VUMC. “Vanderbilt is the No. 1 heart transplant center in the world, in addition to receiving complex cardiac referrals from throughout our region. We are excited to offer this important procedure for patients who develop this serious complication.
“This procedure using a prosthetic heart valve proven in clinical trials to improve quality of life was the best option for this specific patient, due to the severity of their symptoms and recent heart transplant. Repeat open-heart surgery was determined to be high risk.”
The valve used during the procedure is made of cow tissue attached to a self-expanding metal (nickel-titanium) frame. It is approved for use for patients with symptomatic, severe tricuspid valve regurgitation not responding to medical therapy, for improvement in health status. Tricuspid regurgitation (TR) occurs when the valve between the heart’s two right chambers doesn’t close properly and allows blood to flow backward.
Following a heart transplant, the heart is monitored for signs of rejection through frequent biopsies of the right ventricle. These biopsies can show early cellular changes that signal transplant rejection before symptoms develop. The biopsies are performed using a tool called a bioptome, which is inserted through the tricuspid valve.
This process can cause damage to the leaflets of the valve, resulting in severe TR in a small percentage of heart transplant patients. The patient in the case study developed severe TR just two months after receiving a heart transplant.
The TTVR procedure, performed in a hybrid operating room under general anesthesia, involved the team feeding a specialized catheter through the right femoral vein and guiding it up to the failing tricuspid valve between the right atrium and right ventricle. The prosthetic valve was sent through the catheter and placed into the heart’s existing tricuspid valve, successfully reducing the TR from severe to none.
Following the procedure, the patient continued to require biopsies for rejection surveillance. To avoid damage to the prosthetic valve, the team developed a modified protocol for performing biopsies through the prosthetic valve.
“We quickly realized that conventional methods to perform these necessary posttransplant procedures might damage the new valve, so instead, a steerable guide catheter was used under fluoroscopic guidance,” Goel said. “The biopsy was then performed successfully without damage to the prosthetic valve. This method is presented in the published case study, so it can easily be replicated by other medical centers.”
This case was also the first time that a patient had follow-up right heart catheterizations (done in conjunction with biopsies) after EVOQUE TTVR. The VUMC team analyzed these data and realized that it takes a couple of months for pressures in the right heart to normalize. This also correlated to improvement in heart size and patient symptoms, Goel said.
Seeing the improvement in symptoms and quality of life for patients after TTVR is extremely rewarding, Goel said.
“I’ve seen all of our patients since their procedures, and they are feeling much better,” he said. “They go from being able to do next to nothing to basically going back to their lives.”
VUMC participated in the TRISCEND II prospective, multicenter, randomized controlled trial, which demonstrated the superiority of TTVR using the EVOQUE valve to optimal medical therapy alone in improving symptoms and quality of life. Since the February FDA approval of the EVOQUE valve, more than 30 replacements have been performed at VUMC, including for additional heart transplant recipients.
The VUMC team that performed the TTVR for the heart transplant recipient included Goel, Charlene Rohm, MD, former fellow in the Division of Cardiovascular Medicine, Mias Pretorius, MBChB, MSCI, professor of Anesthesiology and director of Interventional Structural Imaging in the Department of Anesthesiology, and Colin Barker, MD, associate professor of Medicine and director of Interventional Cardiology.
