Outcomes With Self-Expanding Prostheses in TAVR Examined in NCDR Study
Commercial adoption of the self-expanding platform Evolut R, approved in 2015, is associated with several outcome improvements for patients undergoing transcatheter aortic valve replacement (TAVR). By comparing the Evolut R device to its predecessor, the CoreValve, researchers highlight the importance of device iterations in a study published Oct. 16 in JACC: Interventions.
Using the STS/ACC TVT Registry, Paul Sorajja, MD, FACC, et al., gathered data on 9,616 patients who underwent TAVR with a self-expanding prosthesis between January 2014 and April 2016. Researchers included patients who underwent TAVR with a 23, 26 or 29 mm prosthesis, with 29 mm being the most common size. The total study population was split between those who received a CoreValve (n = 5,806) and those who were treated with an Evolut R device (n = 3,810). Those in the Evolut R group were more likely to be men, have severe insufficiency or dialysis and have a lower incidence of prior cardiac surgery.
Compared with those treated with a CoreValve TAVR, patients who received Evolut R TAVR had a higher rate of device success (96.3 percent vs. 94.9 percent; p = 0.001) and lower need for a second prosthesis (2.2 percent vs. 4.5 percent; p < 0.001) than those with the CoreValve device. At 30 days, mortality rates (3.7 percent vs. 5.3 percent; p < 0.001) and need for a pacemaker (18.3 percent vs. 20.1 percent; p = 0.03) were also lower in Evolut R patients.
“These findings underscore the importance of continued device iteration for further optimizing patient outcomes, even when prior technology has been found to be effective, safe, and already employed in routine use,” note the authors.
Regarding vascular injury, the Evolut R device and CoreValve device resulted in a similar incidence of vascular complications (4.8 percent for both; p = 0.69) and bleeding events. As such, the authors note that “for patients who undergo TAVR with Evolut R, the relation between patient selection, peripheral access, and vascular injury requires further study.”
In an editorial comment, Alec Vahanian, MD, and Marina Urena, MD, PhD, note that the “Evolut R incorporated several advances, the main ones being its ability to be repositioned and recaptured,” which “did not increase the risk of stroke or reduce the rate of moderate or severe paravalvular leaks at 30 days.”
They agree with the study authors that “long-term follow-up data will be crucial to assess valve durability.”
Keywords: Transcatheter Aortic Valve Replacement, Incidence, Patient Selection, Vascular System Injuries, Research Personnel, Follow-Up Studies, Stroke, Registries, Pacemaker, Artificial, Prostheses and Implants, Renal Dialysis
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