Early Valve Replacement vs Surveillance in Moderate Aortic Stenosis: Meta-Analysis of Randomized and Observational Evidence

BACKGROUND: Moderate aortic stenosis (AS) is associated with excess mortality, and 2 randomized trials have tested early transcatheter aortic valve replacement (TAVR). OBJECTIVES: The authors sought to estimate the effects of early TAVR vs clinical surveillance and to compare randomized with observational estimates. METHODS: Six databases and registries were searched through November 3, 2026. Adjusted observational studies were synthesized separately from trials. Certainty was rated with GRADE. RESULTS: Two trials (922 patients; TAVR UNLOAD, n = 178, HF with reduced ejection fraction; PROGRESS, n = 744, 96.4% symptomatic) and 7 cohorts were included. Early TAVR did not detectably change death over approximately 2 years (HR: 1.05; 95% CI: 0.74-1.49; low certainty), with one-fifth of the deaths needed to detect a 20% reduction. Heart failure (HF) hospitalization was lower (RR: 0.53; 95% CI: 0.36-0.77; low certainty), or 70 fewer patients per 1,000 at 2 years. New pacemakers were more frequent (PROGRESS: 17.3% vs 9.3%; moderate certainty). About half of surveillance patients underwent valve replacement within 2 years. Observational cohorts estimated a 48% mortality reduction (HR: 0.52; 95% CI: 0.43-0.64; very low certainty), which differed from the randomized estimate (ratio of HRs: 2.01; 95% CI: 1.37-2.95). CONCLUSIONS: In older, predominantly symptomatic patients with moderate AS, early TAVR may make little or no difference to 2-year mortality and may reduce HF hospitalization, at the cost of more pacemakers. Because about half of patients under surveillance receive a valve within 2 years, the decision largely concerns timing. Observational survival estimates should not guide practice.

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Journal
medRxiv
Published
2026-11-05
DOI
https://doi.org/10.64898/2026.11.04.26367266
Primary Topic
Cardiac Valve Diseases and Treatments
Type
preprint
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preprint

Early Valve Replacement vs Surveillance in Moderate Aortic Stenosis: Meta-Analysis of Randomized and Observational Evidence

Hamza Kahwaji, Georges Ghanem, Pia Kmeid, Ali Majed et al.
medRxiv
Cardiac Valve Diseases and Treatments
preprint

Early Valve Replacement vs Surveillance in Moderate Aortic Stenosis: Meta-Analysis of Randomized and Observational Evidence

Hamza Kahwaji, Georges Ghanem, Pia Kmeid, Ali Majed, Ayah Safa, Hashem Safieddine
preprint en

Abstract

BACKGROUND: Moderate aortic stenosis (AS) is associated with excess mortality, and 2 randomized trials have tested early transcatheter aortic valve replacement (TAVR). OBJECTIVES: The authors sought to estimate the effects of early TAVR vs clinical surveillance and to compare randomized with observational estimates. METHODS: Six databases and registries were searched through November 3, 2026. Adjusted observational studies were synthesized separately from trials. Certainty was rated with GRADE. RESULTS: Two trials (922 patients; TAVR UNLOAD, n = 178, HF with reduced ejection fraction; PROGRESS, n = 744, 96.4% symptomatic) and 7 cohorts were included. Early TAVR did not detectably change death over approximately 2 years (HR: 1.05; 95% CI: 0.74-1.49; low certainty), with one-fifth of the deaths needed to detect a 20% reduction. Heart failure (HF) hospitalization was lower (RR: 0.53; 95% CI: 0.36-0.77; low certainty), or 70 fewer patients per 1,000 at 2 years. New pacemakers were more frequent (PROGRESS: 17.3% vs 9.3%; moderate certainty). About half of surveillance patients underwent valve replacement within 2 years. Observational cohorts estimated a 48% mortality reduction (HR: 0.52; 95% CI: 0.43-0.64; very low certainty), which differed from the randomized estimate (ratio of HRs: 2.01; 95% CI: 1.37-2.95). CONCLUSIONS: In older, predominantly symptomatic patients with moderate AS, early TAVR may make little or no difference to 2-year mortality and may reduce HF hospitalization, at the cost of more pacemakers. Because about half of patients under surveillance receive a valve within 2 years, the decision largely concerns timing. Observational survival estimates should not guide practice.

medRxiv
University Medical Center Rizk Hospital (LB), Lebanese American University (LB)
Cardiac Valve Diseases and Treatments
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