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在 EWOLUTION 试验中,经皮左心耳封堵术后 2 年死亡率的发生率和预测因素。

Incidence and predictors of 2-year mortality following percutaneous left atrial appendage occlusion in the EWOLUTION trial.

机构信息

Department of Cardiology, St Antonius Ziekenhuis Nieuwegein/AUMC Amsterdam, Koekoekslaan 1, 3435 CM Nieuwegein, The Netherlands.

Department of Cardiology, Vivantes Klinikum Am Urban and Neukölln, Berlin, Germany.

出版信息

Europace. 2024 Jul 2;26(7). doi: 10.1093/europace/euae188.

Abstract

AIMS

Sufficient survival time following left atrial appendage occlusion (LAAO) is essential for ensuring the efficacy and cost-effectiveness of this strategy for stroke prevention. Understanding prognostic factors for early mortality after LAAO could optimize patient selection. In the current study, we perform an in-depth analysis of 2-year mortality after LAAO, focusing particularly on potential predictors.

METHODS AND RESULTS

The EWOLUTION registry is a real-world cohort comprising 1020 patients that underwent LAAO. Endpoint definitions were pre-specified, and death was categorized as cardiovascular, non-cardiovascular, or unknown origin. Mortality rates were calculated from Kaplan-Meier estimates. Baseline characteristics significantly associated with death in univariate Cox regression analysis were incorporated into the multivariate analysis. All multivariate predictors were included in a risk model. Two-year mortality rate was 16.4% [confidence interval (CI): 14.0-18.7%], with 50% of patients dying from a non-cardiovascular cause. Multivariate baseline predictors of 2-year mortality included age [hazard ratio (HR) 1.05, CI: 1.03-1.08, per year increase], heart failure (HR 1.73, CI: 1.24-2.41), vascular disease (HR 1.47, CI: 1.05-2.05), valvular disease (HR 1.63, CI: 1.15-2.33), abnormal liver function (HR 1.80, CI: 1.02-3.17), and abnormal renal function (HR 1.58, CI: 1.10-2.27). Mortality rate exhibited a gradual rise as the number of risk factors increased, reaching 46.1% in patients presenting with five or six risk factors.

CONCLUSION

One in six patients died within 2 years after LAAO. We identified six independent predictors of mortality. When combined, this model showed a gradual increase in mortality rate with a growing number of risk factors, which may guide appropriate patient selection for LAAO.

CLINICAL TRIAL REGISTRATION

The original EWOLUTION registry was registered at clinicaltrials.gov under identifier NCT01972282.

摘要

目的

左心耳封堵(LAAO)后有足够的生存时间对于确保这种预防中风策略的疗效和成本效益至关重要。了解 LAAO 后早期死亡率的预后因素可以优化患者选择。在本研究中,我们对 LAAO 后 2 年的死亡率进行了深入分析,特别关注潜在的预测因素。

方法和结果

EWOLUTION 注册研究是一个真实世界的队列,包含 1020 例接受 LAAO 的患者。终点定义是预先指定的,死亡分为心血管、非心血管或未知原因。死亡率通过 Kaplan-Meier 估计计算。单变量 Cox 回归分析中与死亡显著相关的基线特征被纳入多变量分析。所有多变量预测因素均纳入风险模型。2 年死亡率为 16.4%[置信区间(CI):14.0-18.7%],50%的患者死于非心血管原因。2 年死亡率的多变量基线预测因素包括年龄[风险比(HR)1.05,CI:1.03-1.08,每年增加]、心力衰竭(HR 1.73,CI:1.24-2.41)、血管疾病(HR 1.47,CI:1.05-2.05)、瓣膜疾病(HR 1.63,CI:1.15-2.33)、肝功能异常(HR 1.80,CI:1.02-3.17)和肾功能异常(HR 1.58,CI:1.10-2.27)。随着危险因素数量的增加,死亡率呈逐渐上升趋势,5 或 6 个危险因素的患者死亡率达到 46.1%。

结论

LAAO 后 2 年内每 6 例患者中就有 1 例死亡。我们确定了 6 个独立的死亡预测因素。当组合在一起时,随着危险因素数量的增加,该模型显示死亡率逐渐增加,这可能有助于为 LAAO 选择合适的患者。

临床试验注册

原始 EWOLUTION 注册研究在 clinicaltrials.gov 上以标识符 NCT01972282 注册。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7f47/11289730/61d0ca8efb13/euae188_ga.jpg

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