Atlanta, Ga. (March 29, 2024) – Piedmont Heart Institute physicians Vinod H. Thourani, M.D., Pradeep Yadav, M.D., James Stewart, M.D., and Peter Flueckiger, M.D., performed the first Edwards Lifesciences Corporation (NYSE: EW) EVOQUE tricuspid valve replacement system in the East Coast of the U. S. since the transcatheter therapy received U.S. Food and Drug Administration (FDA) approval for the treatment of tricuspid regurgitation (TR).
The procedure was performed at Piedmont Atlanta Hospital, which was one of the top five enrolling hospitals in the country for the TRISCEND II trial, which served as the basis for the EVOQUE system to receive FDA approval. Dr. Thourani was the National Co-Principal Investigator for the TRISCEND II trial.
The EVOQUE system received approval on Feb. 2 and the procedure was performed on Feb. 7 by Dr. Thourani, Bernie Marcus Chairman of the Department of Cardiovascular Surgery at Piedmont; Dr. Yadav, Director of Structural Interventions; Piedmont Healthcare; Dr. Stewart, Structural Interventional Cardiologist at Piedmont Atlanta, and Dr. Flueckiger, Advanced Imaging Cardiologist at Piedmont Atlanta.
“We are excited to be able to offer this therapy to the patients of Georgia and beyond who suffer from tricuspid regurgitation,” Dr. Thourani said. “Piedmont Heart is a national leader in all aspects of heart care and as a center of research and innovation, we are able to serve patients from throughout the country who require the highest level of care.”
Dr. Yadav added: “This is a paradigm shift and begins a new era in the management of patients with tricuspid regurgitation. We at Piedmont are blessed to be at the forefront of transcatheter tricuspid and other valvular therapies.”
The EVOQUE system is indicated for the improvement of health status in patients with symptomatic severe TR despite optimal medical therapy (OMT), for whom tricuspid valve replacement is deemed appropriate by a heart team.
The EVOQUE system is comprised of a nitinol self-expanding frame, intra-annular sealing skirt and tissue leaflets made from the company’s proven bovine pericardial tissue. The EVOQUE valve will be available in three sizes, all delivered through the same low-profile transfemoral 28F system.
Successful six-month results from the randomized controlled pivotal trial, TRISCEND II, were presented at the Transcatheter Cardiovascular Therapeutics® (TCT) Conference 2023 and reported favorable safety and effectiveness outcomes, demonstrating superiority to OMT alone and meeting all primary endpoints. Key findings in the trial included significant reduction or elimination of tricuspid regurgitation and significant and sustained quality of life improvement, while demonstrating a favorable balance between risk and benefit.
In addition to the six-month cohort, 318 of the total 392 randomized patients completed a one-year visit. The results showed favorable trends in the device group compared to the control group in the primary composite endpoints, including all-cause mortality, tricuspid intervention, heart failure hospitalization, KCCQ, NYHA and 6MWD. Edwards expects to present the full cohort of 392 TRISCEND II pivotal trial patients at TCT 2024.
The EVOQUE system received CE Mark approval in October 2023, making it the world’s first transcatheter valve replacement therapy to receive regulatory approval to treat TR.