Why is this study important  

TAVR unload trial showed TAVR was not superior to clinical surveillance and guideline-directed medical therapy (GDMT) in patients with heart failure and reduced ejection fraction (HFrEF) with concomitant moderate aortic valve stenosis. The primary hierarchical composite endpoint was 1) all-cause death; 2) disabling stroke; 3) disease-related hospitalizations and heart failure equivalents; and 4) change from baseline in the Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Summary Score analyzed using the win ratio. Preemptive TAVR in this population was safe and may provide clinically meaningful quality-of-life benefits. 

Should I change my practice because of these findings?  

Based on this study, we expect the current practice to continue without changes. 

What question was the study supposed to answer?  

This study sought to determine whether TAVR for moderate AS provides clinical benefit in patients with HFrEF on top of GDMT.  

What did the study show? 

The TAVR unload trial randomized 178 patients to TAVR (n=89) or clinical aortic stenosis surveillance (CASS) (n=89). The median follow-up duration was 23 months. Mean LVEF was 39%, mean aortic valve gradient at baseline was 18.8 ± 5.9 mmHg and 21.9 ± 6.8 mmHg with dobutamine. Aortic valve area 1.2 ± 0.2 cm2 at baseline and with dobutamine. A total of 38 (43%) patients in the CASS group (of whom 35 had progressed to severe AS) underwent TAVR at a median of 12 months post-randomization. TAVR was associated with wins in 47.6% of pairs, compared with 36.6% in the CASS group, resulting in a win ratio of 1.31 (95% CI: 0.91-1.88; P = 0.14). At 1 year, TAVR resulted in a greater improvement in the KCCQ Overall Summary Score compared with the CASS group (12.8 ± 21.9 points vs 3.2 ± 22.8 points; P = 0.018). 

How good was the approach/methodology? 

TAVR unload was a well-designed study that answered an important clinical question about the management of patients with HFrEF and moderate aortic valve stenosis. While preemptive TAVR was safe and provided some improvement in quality of life, it did not improve survival, heart failure hospitalizations, or stroke.