Outcomes of Transcatheter Aortic Valve Replacement in Low-Risk Patients in the United States: A Report From the STS/ACC TVT Registry

作者：Andrew M. Vekstein, Zachary K. Wegermann, Pratik Manandhar, Michael J. Mack, David J. Cohen, G. Chad Hughes, Jeffrey K. Harrison, Tsuyoshi Kaneko, Samir Kapadia, Konstantinos Stathogiannis, William F. Fearon, Suzanne V. Arnold, Andrzej S. Kosinski, Martin B. Leon, Wayne Batchelor, Vinod H. Thourani, Sreekanth Vemulapalli · 发表于：Circulation · 年份：2025 · DOI：10.1161/circulationaha.124.071838 · 被引用次数：18 · 研究领域：Cardiac Valve Diseases and Treatments、Atrial Fibrillation Management and Outcomes、Cardiovascular Function and Risk Factors

BACKGROUND: Real-world low-risk transcatheter aortic valve replacement (TAVR) outcomes in the United States have not been assessed comprehensively versus pivotal trials, which is a key component of measuring the quality of clinical technology adoption. METHODS: We identified heart team-designated low-risk patients undergoing TAVR for trileaflet severe, symptomatic aortic stenosis in the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Registry, as well as a subset of patients who met low-risk trial inclusion and exclusion criteria, from January 2020 to March 2024. Outcomes (mortality, stroke, new pacemaker, and "alive and well," defined as alive at 1 year with Kansas City Cardiomyopathy Questionnaire score ≥60 and ≤10-point decrease from baseline) at 30 days and 1 year were assessed. Multivariable models were developed to assess predictors of death and stroke within 1 year after TAVR. RESULTS: Among 383 030 patients who underwent TAVR during the study period, 108 407 (28%) were designated low-risk by the heart team, and 68 194 (18%) met other study inclusion and exclusion criteria. Of these, 62% (n=42 093) would have been eligible for the low-risk trials. In the overall heart team-designated low-risk population, 30-day outcomes included 0.8% mortality, 1.5% stroke, and 8.4% new permanent pacemaker requirement; 1-year outcomes included 4.6% mortality, 2.6% stroke, and 90% alive and well. In the trial-eligible population, 0.6% mortality, 1.4% stro...