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低至中度手术风险患者经导管与外科主动脉瓣置换术的比较:一项荟萃分析与系统评价

Transcatheter vs surgical aortic-valve replacement in low- to intermediate-surgical-risk candidates: A meta-analysis and systematic review.

作者信息

Khan Safi U, Lone Ahmad N, Saleem Muhammad A, Kaluski Edo

机构信息

Department of Internal Medicine, Guthrie Clinic/Robert Packer Hospital, Sayre, Pennsylvania.

Department of Family Medicine, Mercy Health, Janesville, Wisconsin.

出版信息

Clin Cardiol. 2017 Nov;40(11):974-981. doi: 10.1002/clc.22807. Epub 2017 Nov 23.

Abstract

The American and European expert documents recommend transcatheter aortic valve replacement (TAVR) for inoperable or high-surgical-risk patients with severe aortic stenosis. In comparison, efficacy of TAVR is relatively less studied in low- to intermediate-surgical-risk patients. We sought to discover whether TAVR can be as effective as surgical aortic valve replacement (SAVR) in low- to intermediate-surgical-risk candidates. Four randomized clinical trials (RCTs) and 8 prospective matched studies were selected using PubMed/MEDLINE, Embase, and Cochrane Library (inception: March 2017). Results were reported as random-effects odds ratio (OR) with 95% confidence interval (CI). Among 9851 patients, analyses of RCTs showed that all-cause mortality was comparable between TAVR and SAVR (short term, OR: 1.19, 95% CI: 0.86-1.64, P = 0.30; mid-term, OR: 0.97, 95% CI: 0.75-1.26, P = 0.84; and long term, OR: 0.97, 95% CI: 0.81-1.16, P = 0.76). The analysis restricted to matched studies showed similar outcomes. In the analysis stratified by study design, no significant differences were noted in the RCTs for stroke, whereas TAVR was better than SAVR in matched studies at short term only (OR: 0.46, 95% CI: 0.33-0.65, P < 0.001). TAVR is associated with reduced risk of acute kidney injury and new-onset atrial fibrillation (P < 0.05). However, increased incidence of permanent pacemaker implantation and paravalvular leaks was observed with TAVR. TAVR can provide similar mortality outcome compared with SAVR in low- to intermediate-surgical-risk patients with critical aortic stenosis. However, both procedures are associated with their own array of adverse events.

摘要

美国和欧洲的专家文件推荐,对于患有严重主动脉瓣狭窄的无法手术或手术风险高的患者,采用经导管主动脉瓣置换术(TAVR)。相比之下,在手术风险低至中等的患者中,TAVR疗效的研究相对较少。我们试图探究在手术风险低至中等的患者中,TAVR是否能与外科主动脉瓣置换术(SAVR)一样有效。使用PubMed/MEDLINE、Embase和Cochrane图书馆(起始时间:2017年3月)筛选出四项随机临床试验(RCT)和八项前瞻性匹配研究。结果报告为随机效应比值比(OR)及95%置信区间(CI)。在9851例患者中,RCT分析显示,TAVR和SAVR的全因死亡率相当(短期,OR:1.19,95%CI:0.86 - 1.64,P = 0.30;中期,OR:0.97,95%CI:0.75 - 1.26,P = 0.84;长期,OR:0.97,95%CI:0.81 - 1.16,P = 0.76)。仅限于匹配研究的分析显示了相似的结果。在按研究设计分层的分析中,RCT中卒中方面未观察到显著差异,而在匹配研究中,仅短期来看TAVR优于SAVR(OR:0.46,95%CI:0.33 - 0.65,P < 0.001)。TAVR与急性肾损伤和新发房颤风险降低相关(P < 0.05)。然而,观察到TAVR后永久起搏器植入和瓣周漏的发生率增加。对于患有严重主动脉瓣狭窄、手术风险低至中等的患者,TAVR与SAVR相比可提供相似的死亡率结果。然而,两种手术都伴有各自一系列的不良事件。

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