Data compares Medtronic’s TAVR system to surgical aortic valve replacement (SAVR) and other TAVR valves. The medtech giant presented findings from two analyses at the New York Valves Structural Heart Summit.
One analysis highlighted the performance of Evolut in small annuli, while the other demonstrated its potential compared to surgery.
“The late-breaking findings presented at New York Valves build on the proven valve performance and durability legacy for the CoreValve/Evolut System. We know how important valve performance and durability are when clinicians are seeking a TAVR product that is not only safe, but also reduces the risk of rehospitalization and mortality,” said Nina Goodheart, SVP and president of the Structural Heart & Aortic business at Medtronic. “We believe the intentional and innovative design of the Evolut TAV platform enables the excellent and consistent clinical evidence demonstrated in randomized clinical trials. The quality of our design and the valve performance set Evolut apart from other TAVs in the market.”
More data from the SMART trial
Last month, Medtronic announced new data from a head-to-head trial of heart valve technology with Edwards Lifesciences. The study looks at the TAVR implants in individuals with aortic stenosis (AS) with small aortic annuli (SAA). This patient population primarily includes women (87%).
The trial previously demonstrated noninferior clinical outcomes and superior valve performance, measured by bioprosthetic valve dysfunction (BVD) performance for Evolut.
Data presented in New York found that, across all annular sizes of patients who received an Evolut self-expanding valve (SEV), subjects had less bioprosthetic valve dysfunction (BVD) compared to those who received an Edwards Sapien balloon-expandable valve (BEV) through one year.
SMART also demonstrated non-inferior clinical outcomes compared to Sapien as well. Medtronic reported a lower composite rate of all-cause mortality, disabling stroke or heart failure rehospitalization (9.4% for Evolut vs. 10.6% for Sapien).
“In our analysis, the clearest predictor of valve performance was valve type. In addition, we demonstrated that the supraannular self-expanding valve had superior valve performance across the entire range of annular areas included in the trial,” said Dr. Howard C. Herrmann, Perelman School of Medicine at the University of Pennsylvania, and lead investigator of the SMART Trial. “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.”
Edwards itself recently reported separate data analyzing previous trials of its Sapien valve highlighting its performance in patients with small annuli.
Comparing the Medtronic valve to surgery
Expanded results from a pooled CoreValve-Evolut analysis also demonstrated better five-year valve performance in patients with symptomatic severe AS undergoing TAVR with Medtronic’s valve compared to surgery. The analysis showed a lower risk of BVD for both small and large annuli patients with Evolut.
Medtronic said this is the first study to assess the validity of clinical criteria for valve function using a modern, comprehensive definition of BVD. This definition incorporates changes in gradient from more than 5,000 patients. Previously, Medtronic presented data at CRT 2023 to share data from this more comprehensive dataset, which includes additional valve reinterventions, valve-related deaths and unscheduled echoes.
“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 five years in randomized controlled trials,” said Dr. Steven J. Yakubov, Riverside Methodist at Ohio Health and CoreValve-Evolut clinical investigator. “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.”
