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TAVR outcomes comparable among two newer-generation valves
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A study comparing novel self-expanding and balloon-expandable transcatheter heart valves determined that clinical and procedural results at 30 days were similar between two next-generation valves in patients undergoing transcatheter aortic valve replacement.
The findings published in JACC: Cardiovascular Interventions showed the self-expanding Acurate Neo valve (Symetis/Boston Scientific) and the balloon-expandable Sapien 3 valve (Edwards Lifesciences) had similar clinical and procedural results. Although the self-expanding valve was linked to fewer new pacemaker implantations and elevated gradients, it had higher rates of paravalvular leakage compared with the balloon-expandable valve, researchers wrote.
“Both technologies have been used in large clinical registries with very good clinical outcomes,” Oliver Husser, MD, PhD, from the Klinik für Herz-und Kreislauferkrankungen, Deutshes Herzzentrum München, Technical University Munich, and colleagues wrote. “The only randomized comparison between both technologies in earlier-generation devices showed superiority for device success with balloon-expandable over self-expanding [transcatheter heart valves]; however, clinical outcome at 1 year was equivalent.”
According to Husser and colleagues, since that time there has been considerable development of balloon-expandable and self-expanding valves to address paravalvular leakage, new permanent pacemaker implantations and vascular complications.
Comparable results
The researchers analyzed patients undergoing TAVR with matching to identify two patients treated with the balloon-expandable valve (n = 622) for each patient treated with the self-expanding valve (n = 311).
Rates of in-hospital complications were comparable between the valves, including stroke (self-expanding, 1.9%; balloon-expandable, 2.4%; P = .64), major vascular complications (self-expanding, 10.3%; balloon-expandable, 8.5%; P = .38), or life-threatening bleeding (self-expanding, 4.2%; balloon-expandable, 3.7%; P = .72).
Rates of device failure were also comparable between the valves (self-expanding, 10.9%; balloon-expandable, 9.6%; OR = 1.09; 95% CI, 0.69-1.73). The self-expanding valve was associated with more paravalvular leakage (4.8% vs. 1.8%; P = .01), but fewer gradients of at least 20 mm Hg (3.2% vs. 6.9%; P = .02) and permanent pacemaker implantations (9.9% vs. 15.5%; P = .02), according to the researchers.
There were no significant differences between the valves in 30-day mortality (self-expanding, 2.3%; balloon-expandable, 1.9%; P = .74) and an early safety composite endpoint determined by Valve Academic Research Consortium-2 criteria (self-expanding, 15.8%; balloon-expandable, 15.6%; HR = 0.97; 95% CI: 0.68-1.39), Husser and colleagues wrote.
Identifying differences
Kreton Mavromatis, MD, from the cardiology division and department of medicine at the Atlanta VA Medical Center at Emory University School of Medicine, wrote in a related editorial that the study has several limitations, including selection bias unlikely to have been adequately addressed by propensity matching, lack of core lab assessment of paravalvular leak, lack of adjudication of clinical events and inadequate power to detect difference in infrequent but catastrophic events such as annular rupture and valve embolization.
“Identifying any differences between Acurate Neo and other [transcatheter heart valves] is critically important for it to survive in the increasingly crowded market,” Mavromatis wrote. by Dave Quaile
Disclosures: Husser reports he has received travel grants from Edwards Lifesciences and travel grants and proctor fees from Symetis S.A. Mavromatis reports no relevant financial disclosures. Please see the study for all other authors’ relevant financial disclosures.
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