Study: Medtronic’s Evolut TAVR Platform Improves Quality of Life for Women

Medtronic is touting new study data indicating its Evolut self-expanding valve (SEV) is associated with significantly less bioprosthetic valve dysfunction (BVD) and improved quality of life for women with symptomatic severe aortic stenosis (AS). 

Symptomatic severe AS can be fatal if left untreated and the average patient survival is two years without treatment.¹ Despite women’s longer life expectancy, once impacted by severe AS they suffer from higher mortality than men, even after matching for age.² Both TAVR and surgical aortic valve replacement (SAVR) are options for women to treat AS but due to their smaller aortic annuli, females often receive a valve replacement that does not properly fit their anatomy.³

The SMall Annuli Randomized To Evolut or SAPIEN (SMART) Trial examined the valve’s performance exclusively in women. Study results demonstrated the primary clinical endpoint for composite of death, disabling stroke, or heart failure rehospitalization was similar amongst women with AS and small annulus randomized to balloon-expandable valve (BEV) or SEV at one year. However, compared to a balloon-expandable valve, the Evolut SEV was associated with significantly less BVD (8.4% vs. 41.8% at 12 months), less prosthesis-patient mismatch (11.1% vs. 37.4% at 12 months), less mild or greater total aortic regurgitation (12.3% vs. 18.8% at 12 months), and improved quality of life in women with AS and small annulus.  
 
“This study is a major milestone for women, who have historically been excluded and underrepresented in clinical trials,” said Roxana Mehran, M.D., professor of Medicine and director of Interventional Cardiovascular Research and Clinical Trials, Mount Sinai School of Medicine, and co-lead SMART Trial investigator. “This subset of the data reinforces that compared to balloon-expandable valves, the Evolut TAVR system was associated with significantly less bioprosthetic valve dysfunction and improved quality of life in women.”
 
The SMART trial is the largest transcatheter aortic valve replacement (TAVR) trial to date to enroll primarily women (87%) and was designed to better understand the performance of the two most commonly used TAVR systems in patients with small aortic annuli (SAA), which typically are women. SMART is an international, prospective, multi-center, randomized (one-to-one) post-market trial comparing the safety and performance of SEV versus BEV TAVR in patients with symptomatic severe AS and SAA. The trial randomized and treated 637 women across more than 80 sites worldwide. Eligible patients had a computed tomography aortic valve annulus area of ≤430 mm2 and suitable anatomy for transfemoral TAVR with both an Evolut PRO/PRO+/FX or a SAPIEN 3/3 Ultra valve. 
 
“The data presented today at EuroPCR provides meaningful insights into the benefits Evolut TAVR has for women,” said Nina Goodheart, senior vice president and president, Structural Heart & Aortic, which is part of Medtronic’s Cardiovascular portfolio. “This new analysis reinforces TAVR’s effectiveness as a solution for achieving superior valve performance while also highlighting the importance of clinical evidence to inform the best treatment approaches for women.”
 
Headquartered in Dublin, Ireland, Medtronic is a global healthcare technology company comprised of 95,000-plus employees across 150 countries. its technologies and therapies treat 70 health conditions and include cardiac devices, surgical robotics, insulin pumps, surgical tools, patient monitoring systems, and more. 

SAPIEN, SAPIEN 3, and SAPIEN 3 Ultra are trademarks of Edwards Lifesciences Corporation.

References
¹ Carabello BA, Paulus WJ. Aortic stenosis. Lancet. March 14, 2009;373(9667):956-966.
² Tribouilloy C, Bohbot Y, Rusinaru D, et al. J Am Heart Assoc. 2021;10:e018816. DOI: 10.1161/JAHA.120.018816.
³ Lester SJ, Heilbron B, Gin K, Dodek A, Jue J. The natural history and rate of progression of aortic stenosis. Chest. April 1998;113(4):1109-1114