Self-expanding and balloon-expandable valves in low risk TAVR patients

Transcatheter aortic valve replacement (TAVR) has been established as a safe and effective therapy for severe aortic stenosis in extreme-, high-, and intermediate-surgical-risk patients. Recent randomized studies [1,2] have broadened the indication of TAVR to include low-surgical-risk patients. Further, the Low Risk TAVR (LRT) trial successfully evaluated the safety and effectiveness of TAVR in low-risk patients [3]. Given the low incidence of mortality and serious adverse events with surgical aortic valve replacement (SAVR), the bar for TAVR in low-risk patients is high and necessitates excellent procedural outcomes. Clinical outcomes such as major bleeding, stroke, conversion to surgery, coronary artery occlusion, permanent pacemaker (PPM) implantation, and hemodynamic outcomes all require careful scrutiny in order to justify not sending these otherwise healthy patients to surgery. The two most commonly used valves in contemporary practice are the balloon-expandable (BE) Edwards SAPIEN 3 (Edwards Lifesciences, Irvine, California) and self-expanding (SE) CoreValve Evolut R and PRO+ (Medtronic, Minneapolis, Minnesota) systems. While Edwards SAPIEN 3 is composed of a BE cobalt‑chromium frame with trileaflet bovine pericardial tissue valve and polyethylene terephthalate skirt, the CoreValve Evolut R and PRO (with additional pericardial skirt) systems are composed of three porcine pericardial leaflets mounted on a self-expanding nitinol frame. The optimal choice of valve involves the careful weighing of the procedural risks based on the clinical picture and anatomy of the individual patient and requires a thoughtful and individualized approach. Previously, only a few studies (two randomized [4,5] and two registries [6,7]) had assessed the outcomes of SE and BE transcatheter heart valves (THVs) in intermediate- to high-risk patients. However, the data among low-risk patients remain sparse. Therefore, we herein sought to report the 30-day outcomes of SE and BE valves in low-surgical-risk patients enrolled in the LRT trials.

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