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

Abstract

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 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% stroke, and 8.0% new permanent pacemaker requirement had occurred by 30 days; values at 1 year included 3.1% mortality, 2.4% stroke, and 92% alive and well. Notable multivariable predictors of 1-year mortality were atrial fibrillation, nontransfemoral access, and lower baseline Kansas City Cardiomyopathy Questionnaire score.

Conclusions: One-year outcomes among real-world trial-eligible patients are excellent, but adverse events are higher compared with published clinical trial data, likely because of greater comorbidity burden and lower baseline Kansas City Cardiomyopathy Questionnaire score. These data can help inform expected outcomes and health status after low-risk TAVR.