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Early Surgery for Patients With Asymptomatic Severe Aortic Stenosis: A Meta-Analysis of Randomized Controlled Trials
Yousif Ahmad1, James P Howard2, Henry Seligman2
1Section of Cardiovascular Medicine, Yale School of Medicine, Yale University, New Haven, Connecticut.
Insights
Early surgical aortic valve replacement (SAVR) significantly reduces mortality and heart failure hospitalizations in patients with asymptomatic severe aortic stenosis (AS). This finding challenges current watchful waiting guidelines for this patient group.
Area of Science:
- Cardiology
- Cardiac Surgery
- Clinical Trials
Background:
- Current guidelines recommend watchful waiting for asymptomatic severe aortic stenosis (AS).
- This approach is based on historical nonrandomized data.
- Randomized controlled trials (RCTs) now provide evidence on early surgical aortic valve replacement (SAVR).
Purpose of the Study:
- To perform a meta-analysis of RCTs comparing early SAVR to watchful waiting in asymptomatic severe AS.
- To focus on the individual endpoints of death and heart failure (HF) hospitalization.
Main Methods:
- Systematic identification of all RCTs comparing early SAVR versus watchful waiting in asymptomatic severe AS.
- Data synthesis using a random-effects meta-analysis.
- Primary endpoint: all-cause mortality.
Main Results:
- Two trials with 302 patients were included.
- Early SAVR showed a 55% reduction in all-cause mortality (HR, 0.45; P=.014).
- Early SAVR demonstrated a 79% reduction in HF hospitalization (HR, 0.21; P=.044).
Conclusions:
- Early SAVR reduces death and HF hospitalization in severe asymptomatic AS with normal ejection fraction.
- This challenges current treatment standards and guidelines for AS management.
- Findings have significant implications for clinical care and future guideline development.
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.
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