Dataset Information

Early Surgery for Patients With Asymptomatic Severe Aortic Stenosis: A Meta-Analysis of Randomized Controlled Trials.

ABSTRACT:

Background

Guidelines provide class I recommendations for aortic valve intervention for patients with symptomatic severe aortic stenosis (AS) or reduced ejection fraction, but the cornerstone of management for asymptomatic patients has been watchful waiting. This is based on historical nonrandomized data, but randomized controlled trials (RCTs) have now been performed of early surgical aortic valve replacement (SAVR) for asymptomatic severe AS. We performed a meta-analysis of RCTs comparing early SAVR to watchful waiting for asymptomatic severe AS, focusing on individual end points of death and heart failure (HF) hospitalization.

Methods

We systematically identified all RCTs comparing early SAVR to watchful waiting in patients with asymptomatic severe AS and synthesized the data in a random-effects meta-analysis. The prespecified primary end point was all-cause mortality.

Results

Two trials randomizing 302 patients were included. Early SAVR lead to a 55% reduction in all-cause mortality (hazard ratio, 0.45; 95% confidence interval, 0.24-0.85; P = .014). There was no heterogeneity (I² = 0.0%). Early SAVR also lead to a 79% reduction in HF hospitalization (hazard ratio, 0.21; 95% confidence interval, 0.05-0.96; P = .044).

Conclusions

In patients with severe asymptomatic AS and normal ejection fraction, early SAVR reduces death and HF hospitalization compared to initial conservative management. This challenges current treatment standards and has implications for the clinical care of these patients and for guidelines.

SUBMITTER: Ahmad Y

PROVIDER: S-EPMC11307849 | biostudies-literature | 2022 Jul-Aug

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Early Surgery for Patients With Asymptomatic Severe Aortic Stenosis: A Meta-Analysis of Randomized Controlled Trials.

Ahmad Yousif Y Howard James P JP Seligman Henry H Arnold Ahran D AD Madhavan Mahesh V MV Forrest John K JK Geirsson Arnar A Mack Michael J MJ Lansky Alexandra J AJ Leon Martin B MB

Journal of the Society for Cardiovascular Angiography & Interventions 20220525 4

<h4>Background</h4>Guidelines provide class I recommendations for aortic valve intervention for patients with symptomatic severe aortic stenosis (AS) or reduced ejection fraction, but the cornerstone of management for asymptomatic patients has been watchful waiting. This is based on historical nonrandomized data, but randomized controlled trials (RCTs) have now been performed of early surgical aortic valve replacement (SAVR) for asymptomatic severe AS. We performed a meta-analysis of RCTs compar ...[more]

PMID: 39131941

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Project description:ImportanceWhether intervention should be performed in patients with asymptomatic severe aortic stenosis (AS) remains debated.ObjectiveTo meta-analyze the natural history of asymptomatic severe AS and examine the association of early intervention with survival.Data sourcesPubMed, Embase, and Cochrane databases were searched from inception to February 1, 2020.Study selectionObservational studies of adult patients with asymptomatic severe AS.Data extraction and synthesisTwo investigators independently extracted study and patient characteristics, follow-up time, events, and prognostic indicators of events. Random-effects models were used to derive pooled estimates.Main outcomes and measuresThe meta-analysis on natural history was performed on the primary end point of all-cause death occurring during a conservative treatment period, with secondary end points consisting of cardiac death, death due to heart failure, sudden death, development of symptoms, development of an indication for aortic valve intervention, and aortic valve intervention. The primary end point for the meta-analysis of early intervention vs a conservative strategy was all-cause death during long-term follow-up. Finally, meta-analysis was performed on the association of prognostic indicators with the composite of death or aortic valve intervention found in multivariable models.ResultsA total of 29 studies with 4075 patients with 11 901 years of follow-up were included. Pooled rates per 100 patients per year were 4.8 (95% CI, 3.6-6.4) for all-cause death, 3.0 (95% CI, 2.2-4.1) for cardiac death, 2.0 (95% CI, 1.3-3.1) for death due to heart failure, 1.1 (95% CI, 0.6-2.1) for sudden death, 18.1 (95% CI, 12.8-25.4) for an indication for aortic valve intervention, 18.5 (95% CI, 13.4-25.5) for development of symptoms, and 19.2 (95% CI, 15.5-23.8) for aortic valve intervention. Early intervention was associated with a significant reduction in long-term mortality (hazard ratio, 0.38; 95% CI, 0.25-0.58). Factors associated with worse prognosis were severity of AS, low-flow AS, left ventricular damage, and atherosclerotic risk factors.Conclusions and relevanceData from observational studies and a recent randomized clinical trial suggest that many patients with asymptomatic severe AS develop an indication for aortic valve intervention, and their deaths are mostly cardiac but not only sudden. Other end points besides sudden death should be considered during the decision to perform early intervention that are associated with improved survival.

Dataset Information

Early Surgery for Patients With Asymptomatic Severe Aortic Stenosis: A Meta-Analysis of Randomized Controlled Trials.

Background

Methods

Results

Conclusions

Publications

Early Surgery for Patients With Asymptomatic Severe Aortic Stenosis: A Meta-Analysis of Randomized Controlled Trials.

Similar Datasets

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