Dr. Steven Yakubov presented findings at the 2023 annual meeting of Cardiovascular Research Technologies (CRT 2023). The data showed significantly better valve performance and durability compared to surgical aortic valve replacement (SAVR). Medtronic’s study evaluated bioprosthetic valve dysfunction (BVD) with TAVR at five years.
CoreValve and the next-generation Evolut TAVR systems offer a valve replacement procedure that is less invasive than traditional open-heart surgery for patients with severe aortic stenosis.
Yakubov, who serves as system chief of structural heart disease at the Ohio Health, Riverside Methodist Hospital, said the results add further proof of the benefits of TAVR compared to surgery.
“With valve durability becoming more critical as TAVR expands to younger, healthier patients, this analysis underscores the long-term promise of this minimally invasive approach and should be taken into consideration during initial valve selection,” Yakubov said.
About the Medtronic CoreValve Evolut TAVR study
The study retrospectively analyzed 1,128 TAVR and 971 surgery patients from its CoreValve U.S. High Risk and Surtavi trials. Its pooled analysis evaluated performance and durability by incidence of overall BVD. Overall BVD includes structural valve deterioration (SVD), non-structural valve dysfunction (NSVD), thrombosis, and endocarditis.
Medtronic said it marks the first comprehensive analysis to support clinical criteria for valve performance and durability using all four components of BVD and its association with clinical outcomes.
CoreValve Evolut demonstrated significantly lower BVD cumulative incidence rate (7.8%) compared to surgery (14.2%). Rates of SVD (2.2% to 4.4%) and NSVD (4.3% to 8.8%) came in significantly lower after TAVR compared to surgery, too. TAVR also demonstrated three-times lower severe prosthesis-patient mismatch (3.7% to 11.8%) at 30 days/discharge. This occurs when the valve is too small for the patient’s body size.
The different methods recorded no significant differences in rates of thrombosis (0.3% to 0.2%) or endocarditis (1.1% to 1.3%).
Medtronic said patients in both groups who developed BVD through five years had about a 1.5-fold greater risk of death or hospitalization for valve-related disease or heart failure compared to patients who did not develop BVD.
“These extraordinary results reinforce the hemodynamic durability and valve performance of the CoreValve/Evolut system and demonstrate again that Evolut is a safe and effective alternative to surgery,” said Nina Goodheart, SVP and president of the Structural Heart & Aortic business at Medtronic. “As a pioneer and leader in the early treatment of aortic stenosis, Medtronic strives to continually improve our CoreValve/Evolut platform to ensure it is meeting the needs of the physicians and the growing patient population that will benefit from this type of procedure.”