Written by Peter Liu
Spoon Feed
Transcatheter aortic valve replacement (TAVR) improved quality of life (QOL) in patients with heart failure and reduced-ejection fraction (HFrEF) plus moderate aortic stenosis but failed to show differences in mortality, stroke, or major adverse events when compared to clinical surveillance.
Synopsis
The TAVR UNLOAD trial investigated whether transcatheter aortic valve replacement (TAVR) benefits patients with systolic heart failure and moderate aortic stenosis (AS) beyond guideline-directed medical therapy (GDMT). This international randomized controlled trial (n=178) compared TAVR to clinical AS surveillance (CASS). At a median follow-up of 23 months, TAVR did not significantly improve the primary composite outcome (win ratio: 1.31; 95% CI: 0.91-1.88; p=0.14). However, TAVR was associated with greater quality-of-life improvements (Kansas City Cardiomyopathy Questionnaire score: 12.8 vs. 3.2; p=0.018). Limitations include underpowered design and high crossover. Conclusion: TAVR appears safe but lacks superiority in composite outcomes. (AI-generated)
Could TAVR UNLOAD offload afterload?
The exciting development of TAVR has allowed clinicians to offer treatment for aortic stenosis at significantly decreased procedural risk compared to surgical AVR, with comparable cardiovascular outcomes. The benefits of AVR for severe AS are well established. In this trial, TAVR for moderate AS improved quality of life in patients with HFrEF. Unfortunately, the study had lower-than-expected enrollment and was likely underpowered. Significant improvements in questionnaire-based QOL measures at 1 year were noted in the TAVR cohort, and cardiovascular outcomes appeared improved but did not reach statistical significance. These findings, paired with a 43% crossover of patients in the non-intervention arm to TAVR within a year, suggest that patients with HFrEF and moderate AS should be closely followed, and intervention earlier than later may be justified.
Source
Transcatheter Aortic Valve Replacement in Patients With Systolic Heart Failure and Moderate Aortic Stenosis: TAVR UNLOAD. J Am Coll Cardiol. 2024 Oct 22:S0735-1097(24)09960-1. doi: 10.1016/j.jacc.2024.10.070. Epub ahead of print. PMID: 39480381
