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低风险患者行主动脉瓣置换术后的生存情况:一项当代试验基准

Survival After Surgical Aortic Valve Replacement in Low-Risk Patients: A Contemporary Trial Benchmark.

作者信息

Thourani Vinod H, Habib Robert, Szeto Wilson Y, Sabik Joseph F, Romano Jennifer C, MacGillivray Thomas E, Badhwar Vinay

机构信息

Department of Cardiothoracic Surgery, Piedmont Healthcare, Atlanta, Georgia.

The Society of Thoracic Surgeons Research and Analytic Center, Chicago, Illinois.

出版信息

Ann Thorac Surg. 2024 Jan;117(1):106-112. doi: 10.1016/j.athoracsur.2023.10.006. Epub 2023 Oct 17.

Abstract

BACKGROUND

The use of transcatheter aortic valve replacement for severe aortic stenosis in low-risk patients necessitates an evaluation of contemporary long-term, real-world outcomes of similar patients undergoing surgical aortic valve replacement (SAVR) in a national cohort.

METHODS

All patients undergoing primary, isolated SAVR in The Society of Thoracic Surgeons (STS) database between 2011 and 2019 were examined. The study population of 42,586 adhered to the inclusion/exclusion criteria of the Placement of Aortic Transcatheter Valves (PARTNER) 3 and Evolut Low Risk randomized trials. Patients were further stratified by STS predicted risk of mortality (PROM), age, and left ventricular ejection fraction. The primary end-point was all-cause National Death Index mortality. Unadjusted survival to 8 years was estimated using the Kaplan-Meier method.

RESULTS

Mean age was 74.3 ± 5.7 years and mean STS PROM was 1.9% ± 0.8%. The overall Kaplan-Meier time to event analysis for all-cause mortality at 1, 3, 5, and 8 years was 2.6%, 4.5%, 7.1%, and 12.4%, respectively. In subset analyses, survival was significantly better for (1) lower STS PROM (P < .001), (2) younger vs older age (P < .001), and (3) higher vs lower left ventricular ejection fraction (P < .001). When STS PROM was below 1% or the patient age was below age 75 years, the 8-year survival after SAVR was 95%.

CONCLUSIONS

The results of this national study confirm that long-term survival after SAVR remains excellent, at 92.9% at 5 years. These contemporary longitudinal data serve to aid in the balanced interpretation of current and future trials comparing SAVR and transcatheter aortic valve replacement and may assist in the clinical decision-making process for patients of lower surgical risk.

摘要

背景

对于低风险患者,采用经导管主动脉瓣置换术治疗严重主动脉瓣狭窄,需要评估在全国队列中接受外科主动脉瓣置换术(SAVR)的类似患者的当代长期真实世界结局。

方法

对2011年至2019年期间在胸外科医师协会(STS)数据库中接受初次、孤立性SAVR的所有患者进行检查。42586名研究人群符合主动脉经导管瓣膜置入(PARTNER)3和Evolut低风险随机试验的纳入/排除标准。患者进一步按STS预测的死亡风险(PROM)、年龄和左心室射血分数进行分层。主要终点是全因国家死亡指数死亡率。使用Kaplan-Meier方法估计8年的未调整生存率。

结果

平均年龄为74.3±5.7岁,平均STS PROM为1.9%±0.8%。全因死亡率在1年、3年、5年和8年的总体Kaplan-Meier事件发生时间分析分别为2.6%、4.5%、7.1%和12.4%。在亚组分析中,(1)较低的STS PROM(P<.001)、(2)较年轻与较年长年龄(P<.001)以及(3)较高与较低左心室射血分数(P<.001)的患者生存率显著更高。当STS PROM低于1%或患者年龄低于75岁时,SAVR术后8年生存率为95%。

结论

这项全国性研究的结果证实,SAVR术后的长期生存率仍然很高,5年时为92.9%。这些当代纵向数据有助于对比较SAVR和经导管主动脉瓣置换术的当前和未来试验进行平衡解读,并可能有助于低手术风险患者的临床决策过程。

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