For high-risk surgical patients with severe symptomatic mitral regurgitation (MR), insertion of the Tendyne transcatheter mitral valve replacement (TMVR; Abbott) using a cardiac transapical approach resulted in excellent procedural success, relief of mitral regurgitation, and increases in cardiac hemodynamics and quality of life sustained at 1 year.
Further, patients with severe mitral annular calcification (MAC) showed improvements in hemodynamics, functional status, and quality of life after the procedure.
With 70 centers participating in the Tendyne SUMMIT trial, the first 100 trial roll-in patients accrued from the first one or two patients from each site without previous Tendyne TMVR experience.
"For this new procedure, with new operators, there was no intraprocedural mortality, and procedural survival was 100%," co-primary investigator Jason Rogers, MD, of the University of California Davis Medical Center, Sacramento, told attendees at a Late-Breaking Clinical Science session here at the Transcatheter Cardiovascular Therapeutics 2023 congress.
"The survival was 74% at 12 months. The valve was very effective at eliminating much regurgitation, and 96.5% of patients had either zero or 1+ at a year, and 97% at 30 days had no mitral regurgitation," he reported. As follow-up was during the COVID-19 pandemic, several of the deaths were attributed to COVID.
