Ahmad Yousif, Howard James P, Seligman Henry, Arnold Ahran D, Madhavan Mahesh V, Forrest John K, Geirsson Arnar, Mack Michael J, Lansky Alexandra J, Leon Martin B
Section of Cardiovascular Medicine, Yale School of Medicine, Yale University, New Haven, Connecticut.
National Heart and Lung Institute, Imperial College London, London, United Kingdom.
J Soc Cardiovasc Angiogr Interv. 2022 May 25;1(4):100383. doi: 10.1016/j.jscai.2022.100383. eCollection 2022 Jul-Aug.
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.
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.
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; = .014). There was no heterogeneity (I = 0.0%). Early SAVR also lead to a 79% reduction in HF hospitalization (hazard ratio, 0.21; 95% confidence interval, 0.05-0.96; = .044).
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.
指南为有症状的重度主动脉瓣狭窄（AS）或射血分数降低的患者进行主动脉瓣干预提供了I类推荐，但对于无症状患者，管理的基石一直是密切观察等待。这是基于历史非随机数据，但现在已经进行了针对无症状重度AS的早期外科主动脉瓣置换术（SAVR）的随机对照试验（RCT）。我们对比较早期SAVR与无症状重度AS密切观察等待的RCT进行了荟萃分析，重点关注死亡和心力衰竭（HF）住院的个体终点。
我们系统地识别了所有比较无症状重度AS患者早期SAVR与密切观察等待的RCT，并在随机效应荟萃分析中综合了数据。预先设定的主要终点是全因死亡率。
纳入了两项随机分配302例患者的试验。早期SAVR使全因死亡率降低了55%（风险比，0.45；95%置信区间，0.24 - 0.85；P = 0.014）。不存在异质性（I² = 0.0%）。早期SAVR还使HF住院率降低了79%（风险比，0.21；95%置信区间，0.05 - 0.96；P = 0.044）。
在重度无症状AS且射血分数正常的患者中，与初始保守治疗相比，早期SAVR可降低死亡和HF住院率。这对当前的治疗标准提出了挑战，并对这些患者的临床护理和指南产生影响。
