Transcatheter aortic valve replacement (TAVR) procedures performed with the self-expandable Evolut valve and balloon-expandable Sapien 3 valve are associated with comparable 30-day outcomes, according to a new meta-analysis published in the American Journal of Cardiology. There are, however, some noteworthy differences between the two solutions.
The study’s authors tracked outcomes from more than 24,000 patients who participated in a total of nine different studies. While 12,411 patients underwent valve implantation with the Sapien 3 valve, another 12,117 patients underwent implantation with the Evolut valve.
Overall, the team observed, there were no significant differences between the two devices when it came to the risk of stroke, major vascular complications, acute kidney injury, device success or moderate-severe residual aortic regurgitation after 30 days.
However, the Evolut valve was associated a risk of 30-day mortality that ranged from 1.3% to 3.9%, with a weighted mean of 3.7%. The Sapien 3 valve, meanwhile, had a risk of 30-day mortality that ranged from 1.6% to 3.1%, with a weighted mean of 2.9%.
In addition, the Evolut valve had a higher risk of permanent pacemaker implantation and lower risk of life-threatening bleeding events.
Writing about that difference in 30-day mortality, the authors said more research was still necessary.
“These findings do not support any valve type effect explaining the increased mortality rate observed among Evolut recipients, and suggest that differences in mortality may be secondary to unbalances regarding baseline characteristics between patients treated with one valve type vs. the other,” wrote lead author Alberto Alperi, MD, of Laval University in Quebec City, Quebec, Canada, and colleagues. “Also, some potentially life-threatening complications like annulus rupture, valve embolization and coronary obstruction were not assessed in this study, although their incidence in the current [TAVR] era is very low. A large randomized trial powered for the mortality endpoint would be necessary to obtain definite results.”
The research team did note that there are some key limitations to their work. Most of the studies included in the meta-analysis were observational, for example. Also, these findings “may not apply” to TAVR approaches that don’t use the transfemoral approach.
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Michael has more than 16 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.