Aortic Valve Replacement vs Clinical Surveillance in Asymptomatic Severe Aortic Stenosis: A Systematic Review and Meta-Analysis
- PMID: 39641732
- DOI: 10.1016/j.jacc.2024.11.006
Aortic Valve Replacement vs Clinical Surveillance in Asymptomatic Severe Aortic Stenosis: A Systematic Review and Meta-Analysis
Abstract
Background: Current guidelines recommend a strategy of clinical surveillance (CS) for patients with asymptomatic severe aortic stenosis (AS) and a normal left ventricular ejection fraction.
Objectives: The aim of this study was to conduct a study-level meta-analysis of randomized controlled trials (RCTs) evaluating the effect of early aortic valve replacement (AVR) compared with CS in patients with asymptomatic severe AS.
Methods: Studies were quantitatively assessed in a meta-analysis using random-effects modeling. Prespecified outcomes included all-cause and cardiovascular mortality, unplanned cardiovascular or heart failure (HF) hospitalization, and stroke. The meta-analysis is registered at the International Platform of Registered Systematic Review and Meta-Analysis Protocols (INPLASY202490002).
Results: Four RCTs were identified, including a total of 1,427 patients (719 in the early AVR group and 708 in the CS group). At an average follow-up time of 4.1 years, early AVR was associated with a significant reduction in unplanned cardiovascular or HF hospitalization (pooled rate 14.6% vs 31.9%; HR: 0.40; 95% CI: 0.30-0.53; I2 = 4%; P < 0.01) and stroke (pooled rate 4.5% vs 7.2%; HR: 0.62; 95% CI: 0.40-0.97; I2 = 0%; P = 0.03). No differences in all-cause mortality (pooled rate 9.7% vs 13.7%; HR: 0.68; 95% CI: 0.40-1.17; I2 = 61%; P = 0.17) and cardiovascular mortality (pooled rate 5.1% vs 8.3%; HR: 0.67; 95% CI: 0.35-1.29; I2 = 50%; P = 0.23) were observed with early AVR compared with CS, although there was a high degree of heterogeneity among studies.
Conclusions: In this meta-analysis of 4 RCTs, early AVR was associated with a significant reduction in unplanned cardiovascular or HF hospitalization and stroke and no differences in all-cause and cardiovascular mortality compared with CS.
Keywords: aortic stenosis; aortic valve replacement; meta-analysis; systematic review; transcatheter aortic valve implantation; transcatheter aortic valve replacement.
Copyright © 2025 The Authors. Published by Elsevier Inc. All rights reserved.
Conflict of interest statement
Funding Support and Author Disclosures Edwards Lifesciences is the sponsor of the EARLY TAVR (Evaluation of TAVR Compared to Surveillance for Patients With Asymptomatic Severe Aortic Stenosis) trial, one of the studies included in the meta-analysis, and facilitated data integration and analysis. Dr Généreux has received institutional research grants from Edwards Lifesciences; has received consulting fees from Abbott, Cordis, Edwards Lifesciences, Egnite, Haemonetics, Medtronic, Opsens, Puzzle Medical, Pi-Cardia, and 4C Medical; holds equity in Puzzle Medical and Pi-Cardia; and is the principal investigator of the EARLY TAVR trial and the PROGRESS trial, both sponsored by Edwards Lifesciences. Dr Prendergast has received consulting fees from Anteris and MicroPort; has received speaker fees from Edwards Lifesciences; and is a data and safety monitoring board member for Valvosoft and Medtronic. Dr Lindman has received consulting fees from AstraZeneca, Medtronic, and Edwards Lifesciences; has received investigator-initiated research grants from Edwards Lifesciences; and is principal investigator of the biobank core laboratory for the EARLY TAVR trial, sponsored by Edwards Lifesciences. Dr Newby has received institutional research grants from the British Heart Foundation (CH/09/002, RG/F/22/110093, and RE/24/130012). Dr Pibarot has received institutional funding for echocardiography core laboratory analyses and research studies on transcatheter valve therapies from Edwards Lifesciences, with no personal compensation; has received payments to his institution from Edwards Lifesciences for lectures, presentations, and educational events; has received institutional funding for research studies on transcatheter valve therapies from Medtronic, with no personal compensation; has received institutional funding for echocardiography core laboratory analyses on the pharmacotherapy of valvular heart disease from Pi-Cardia, with no personal compensation; and has received institutional funding for echocardiography core laboratory analyses on HF therapy from Cardiac Success, with no personal compensation. Dr Seyedin is an employee of Edwards Lifesciences. Dr Cohen has received research grants to the institution and personal consulting fees from Edwards Lifesciences, Abbott, Boston Scientific, and Medtronic. Dr Leon holds equity or interest in Ancora, CroíValve, Concept Medical, East End Medical, Laminar, Mirus, Medinol, Pi-Cardia, Trajectory, SoloPace, Valve Medical, xDot, and XenterMD; has received institutional research funding from Abbott, Boston Scientific, Edwards Lifesciences, Johnson & Johnson, and Medtronic; and has received consulting fees from Anteris, Bain Capital, Foldax, and MicroPort. Dr Dweck has received consultancy fees from AstraZeneca, Novartis, and Silence Therapeutics; has received speaker fees from Silence Therapeutics and AstraZeneca; and is an advisory board member for Novartis, AstraZeneca, and Silence Therapeutics. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
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