May 2, 2026Journal of the American College of Cardiology61 citationsOpen Access
Transcatheter Aortic Valve Replacement in Patients With Systolic Heart Failure and Moderate Aortic Stenosis
Structured PICO
Does preemptive TAVR improve a hierarchical composite of clinical outcomes and quality of life in patients with HFrEF and moderate AS compared to clinical surveillance?
P
Population
178 patients with heart failure with reduced ejection fraction (HFrEF) on guideline-directed medical therapy (GDMT) with concomitant moderate aortic stenosis (AS) suitable for transfemoral TAVR, mean age 77 years, 20.8% female, 55.6% NYHA functional class III or IV.
I
Intervention
Transfemoral transcatheter aortic valve replacement (TAVR) with a balloon-expandable valve added to guideline-directed medical therapy (GDMT).
C
Comparator
Clinical aortic stenosis surveillance (CASS) with aortic valve replacement upon progression to severe AS, on top of guideline-directed medical therapy (GDMT).
O
Outcome
Hierarchical occurrence of: 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 Overall Summary Score analyzed using the win ratio.composite
In patients with HFrEF and moderate AS, preemptive TAVR did not significantly improve a hierarchical composite of clinical outcomes and quality of life compared to routine surveillance, though it did provide quality-of-life benefits at 1 year.
Abstract
Background: Neurohormonal modulation and afterload reduction are key for treatment of heart failure with reduced ejection fraction (HFrEF). In HFrEF patients with concomitant moderate aortic stenosis (AS), treatment with transcatheter aortic valve replacement (TAVR) may be complementary to guideline-directed medical therapy (GDMT). Objectives: This study sought to determine whether TAVR for moderate AS provides clinical benefit in patients with HFrEF on top of GDMT. Methods: We performed an investigator-initiated, international, randomized controlled trial in patients with HFrEF on GDMT with moderate AS who were suitable for transfemoral TAVR with a balloon-expandable valve. Patients were randomized 1:1 to TAVR or clinical aortic stenosis surveillance (CASS) with aortic valve replacement upon progression to severe AS. The primary endpoint was the hierarchical occurrence of: 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 Overall Summary Score analyzed using the win ratio. Results: From January 2017 to December 2022, 178 patients were randomized to TAVR (n = 89) or AS surveillance (n = 89). The mean age was 77 years, 20.8% were female, and 55.6% were in NYHA functional class III or IV. The median follow-up duration was 23 months (Q1-Q3: 12-33 months). 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 postrandomization. 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 Kansas City Cardiomyopathy Questionnaire Overall Summary Score compared with the CASS group (12.8 ± 21.9 points vs 3.2 ± 22.8 points; P = 0.018). Conclusions: TAVR was not superior to AS surveillance for the primary hierarchical composite endpoint in patients with moderate AS and HFrEF on GDMT. Preemptive TAVR for moderate AS was safe and may provide clinically meaningful quality-of-life benefits.