经导管与外科主动脉瓣置换术在低至中危患者中的疗效与安全性:一项荟萃分析

Efficacy and Safety of Transcatheter vs. Surgical Aortic Valve Replacement in Low-to-Intermediate-Risk Patients: A Meta-Analysis.

作者信息

Lou Yake, Gao Yanan, Yu Ying, Li Yanli, Xi Ziwei, Swe Khaing Nyein Chan, Zhou Yujie, Nie Xiaomin, Liu Wei

机构信息

Department of Cardiology, Beijing Institute of Heart Lung and Blood Vessel Disease, Beijing Anzhen Hospital, Capital Medical University, Beijing, China.

Department of Neurology, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.

出版信息

Front Cardiovasc Med. 2020 Nov 16;7:590975. doi: 10.3389/fcvm.2020.590975. eCollection 2020.

Abstract

The efficacy and safety of transcatheter aortic-valve replacement (TAVR) vs. surgical aortic valve replacement (SAVR) for low- to intermediate-surgical risk patients remains uninvestigated. We aimed to investigate the efficacy and safety of transcatheter aortic-valve replacement (TAVR) vs. surgical aortic valve replacement (SAVR) for low-intermediate surgical risk patients. PubMed, Cochrane Library, and Embase databases were searched to identify potential references. Only randomized controlled trials (RCTs) or observational studies using propensity score matching were eligible for screening. The primary endpoint was all-cause death. The secondary outcomes were bleeding, stroke, myocardial infarction (MI), and other complications of aortic-valve replacement. In addition, we performed subgroup analysis based on surgical risk and study type. Eight RCTs and 13 observational studies covering 12,467 patients were included in the current meta-analysis. For patients with low-surgical risk, compared with SAVR, TAVR was found to be associated with a lower mortality at a follow-up period of 1 year (odds ratio, OR: 0.66, 95% CI: [0.46, 0.96], = 0.03). This benefit disappeared when the follow-up was extended to 2 years (OR: 0.89, 95% CI: [0.61, 1.30], = 0.56). For patients with intermediate-surgical risk, TAVR showed to have similar mortality with SAVR regardless of follow-up period (30-day, 1-year, or 2-year). TAVR could reduce the incidence of bleeding, AF, and AKI. For complications, such as MI and stroke, TAVR exhibited to have similar safety with SAVR. However, TAVR was found to be associated with a higher incidence of reintervention, major vascular complication, paravalvular leak, and PPI. For patients with a low-to-intermediate surgical risk, TAVR has at least an equivalent clinical effect to SAVR for 2 years after the procedure.

摘要

对于手术风险较低至中等的患者,经导管主动脉瓣置换术(TAVR)与外科主动脉瓣置换术(SAVR)的疗效和安全性仍未得到研究。我们旨在研究经导管主动脉瓣置换术(TAVR)与外科主动脉瓣置换术(SAVR)用于手术风险低至中等患者的疗效和安全性。检索了PubMed、Cochrane图书馆和Embase数据库以识别潜在参考文献。仅随机对照试验(RCT)或使用倾向评分匹配的观察性研究符合筛选条件。主要终点是全因死亡。次要结局是出血、中风、心肌梗死(MI)以及主动脉瓣置换的其他并发症。此外,我们根据手术风险和研究类型进行了亚组分析。本荟萃分析纳入了8项RCT和13项观察性研究,涵盖12467例患者。对于手术风险低的患者,与SAVR相比,发现TAVR在1年随访期时死亡率较低(优势比,OR:0.66,95%可信区间:[0.46, 0.96],P = 0.03)。当随访延长至2年时,这种益处消失(OR:0.89,95%可信区间:[0.61, 1.30],P = 0.56)。对于手术风险中等的患者,无论随访期(30天、1年或2年)如何,TAVR显示出与SAVR相似的死亡率。TAVR可降低出血、房颤和急性肾损伤的发生率。对于心肌梗死和中风等并发症,TAVR显示出与SAVR相似的安全性。然而,发现TAVR与再次干预、主要血管并发症、瓣周漏和永久起搏器植入的发生率较高相关。对于手术风险低至中等的患者,TAVR在术后2年内至少具有与SAVR相当的临床效果。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8f18/7701058/877e6e071536/fcvm-07-590975-g0001.jpg

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