Medtronic CoreValve/Evolut TAVR Systems’ Performance Evaluated in Updated Analyses

June 7, 2024—Medtronic announced new data from the CoreValve Evolut clinical program, evaluating the performance of the company’s Evolut transcatheter aortic valve replacement (TAVR) system compared to surgical aortic valve replacement (SAVR) and other TAVR devices. Medtronic’s CoreValve and next-generation Evolut TAVR systems are used to treat patients with symptomatic severe aortic stenosis.

A secondary analysis from the SMART trial showed significantly less bioprosthetic valve dysfunction (BVD) with Evolut TAVR across the entire range of small annulus areas when compared with the Sapien 3 TAVR platform (Edwards Lifesciences).

Additionally, an expanded analysis of BVD outcomes from a CoreValve-Evolut pooled analysis demonstrated valve performance and durability benefits versus SAVR.

The late-breaking data were presented at New York Valves 2024: The Structural Heart Summit held June 5-7 in New York, New York.

The SMART trial’s coprimary outcomes were presented at ACC.24, the American College of Cardiology’s annual scientific session held April 6-8 in Atlanta, Georgia, and simultaneously published online by Howard C. Herrmann, MD, et al in The New England Journal of Medicine (2024;390:1959-1971).

According to Medtronic, results from the secondary predictor analysis presented by Dr. Herrmann at NY Valves showed that—across all annular sizes—patients who received an Evolut self-expanding valve (SEV) had less BVD compared those who received a Sapien balloon-expandable valve (BEV) through 1 year.

Also, the SMART trial demonstrated noninferior clinical outcomes for Evolut SEV versus Sapien BEV, including a lower composite rate of all-cause mortality, disabling stroke, or heart failure rehospitalization (9.4% vs 10.6%; P < .001 for noninferiority) and superior valve performance (9.4% vs 41.6%; P < .001 for superiority).

Medtronic stated that in addition to being the largest comparative trial of TAVR, SMART is the largest TAVR trial to enroll primarily women (87%). Because of their smaller aortic annuli, women can often receive a valve replacement that does not properly fit their anatomy—highlighting the need for more clinical evidence to inform the best treatment approaches.

Dr. Herrmann, who is from the Perelman School of Medicine at the University of Pennsylvania in Philadelphia, Pennsylvania, serves as lead investigator of the SMART trial.

“In our analysis, the clearest predictor of valve performance was valve type,” commented Dr. Herrmann in Medtronic’s press release. “In addition, we demonstrated that the supra-annular SEV had superior valve performance across the entire range of annular areas included in the trial.”

Dr. Herrmann continued, “The findings from the SMART trial further emphasize the importance of considering valve function when making clinical decisions, especially when looking at specific patient populations like women, who may require more customized approaches.”

In the expanded results from the CoreValve-Evolut pooled analysis of bioprosthetic valve performance, the 5-year valve performance was significantly better in patients with symptomatic severe aortic stenosis undergoing TAVR with the Medtronic CoreValve/Evolut TAVR system compared to surgery. The analysis showed a lower risk of BVD for both small and large annuli patients with CoreValve/Evolut TAVR compared to surgery.

The study assessed the validity of clinical criteria for valve function using a modern, comprehensive definition of BVD that incorporates changes in gradient from more than 5,000 patients. The study was previously presented in February 2023 at CRT 2023, the Cardiovascular Research Technologies conference and in May 2023, at the EuroPCR conference.

This pooled analysis was expanded for a more comprehensive dataset including additional valve reinterventions, valve-related deaths, and unscheduled echoes, noted the company.

The data were presented at NY Valves by Steven J. Yakubov, MD, from Riverside Methodist at Ohio Health in Columbus, Ohio.

“This new data demonstrates that the CoreValve/Evolut platform is the first and only TAVR platform to demonstrate a performance and durability benefit over surgery at 5 years in randomized controlled trials,” commented Dr. Yakubov in the press release. “This is clinically significant as poor valve performance, regardless of therapy, can result in worse patient outcomes. Further, this reinforces the importance of valve selection for patients with intermediate or greater surgical risk to potentially improve long-term outcomes.”