Department of Cardiovascular Surgery, The Affiliated Hospital of Zunyi Medical University, Zunyi, Guizhou, China.
Clin Cardiol. 2020 Dec;43(12):1414-1422. doi: 10.1002/clc.23454. Epub 2020 Sep 14.
BACKGROUND: Transcatheter aortic valve replacement (TAVR) is regarded as the most superior alternative treatment approach for patients with aortic stenosis (AS) who are associated with high surgical risk, whereas the effectiveness of TAVR vs surgical aortic valve replacement (SAVR) in low to intermediate surgical risk patients remained inconclusive. This study aimed to determine the best treatment strategies for AS with low to intermediate surgical risk based on published randomized controlled trials (RCTs). HYPOTHESIS AND METHODS: RCTs that compared TAVR vs SAVR in AS patients with low to intermediate surgical risk were identified by PubMed, EmBase, and the Cochrane library from inception till April 2019. The pooled relative risks (RRs) with 95% confidence intervals (CIs) were calculated for the data collected using random-effects models. RESULTS: Seven RCTs with a total of 6929 AS patients were enrolled. We noted that TAVR significantly increased the risk of transient ischemic attack (TIA) (RR: 1.43; 95%CI: 1.04-1.96; P = .029), and permanent pacemaker implantation (RR: 3.00; 95%CI: 1.70-5.30; P < .001). However, TAVR was associated with lower risk of post-procedural bleeding (RR: 0.57; 95%CI: 0.33-0.98; P = .042), new-onset or worsening of atrial fibrillation (RR: 0.32; 95%CI: 0.23-0.45; P < .001), acute kidney injury (RR: 0.40; 95%CI: 0.25-0.63; P < .001), and cardiogenic shock (RR: 0.34; 95%CI: 0.19-0.59; P < .001). The risk of aortic-valve reintervention at 1- (RR: 2.63; 95%CI: 1.34-5.15; P = .005), and 2 years (RR: 3.19; 95%CI: 1.63-6.24; P = .001) in low to intermediate surgical risk patients who received TAVR was significantly increased than those who received SAVR. CONCLUSIONS: These findings indicated that low to intermediate surgical risk patients who received TAVR had low risk of complications, whereas the risk of TIA, permanent pacemaker implantation, and aortic-valve reintervention was increased.
背景:经导管主动脉瓣置换术(TAVR)被认为是主动脉瓣狭窄(AS)高危患者的最佳替代治疗方法,而 TAVR 与低至中危手术风险患者的外科主动脉瓣置换术(SAVR)相比的有效性仍不确定。本研究旨在根据已发表的随机对照试验(RCT)确定低至中危手术风险的 AS 的最佳治疗策略。
假设和方法:通过 PubMed、EmBase 和 Cochrane 图书馆从成立到 2019 年 4 月,确定了比较低至中危手术风险 AS 患者 TAVR 与 SAVR 的 RCT。使用随机效应模型计算收集数据的合并相对风险(RR)及其 95%置信区间(CI)。
结果:共纳入 7 项 RCT,共 6929 例 AS 患者。我们注意到,TAVR 显著增加了短暂性脑缺血发作(TIA)(RR:1.43;95%CI:1.04-1.96;P=0.029)和永久性起搏器植入(RR:3.00;95%CI:1.70-5.30;P<0.001)的风险。然而,TAVR 与较低的术后出血(RR:0.57;95%CI:0.33-0.98;P=0.042)、新发或恶化的心房颤动(RR:0.32;95%CI:0.23-0.45;P<0.001)、急性肾损伤(RR:0.40;95%CI:0.25-0.63;P<0.001)和心源性休克(RR:0.34;95%CI:0.19-0.59;P<0.001)风险相关。在低至中危手术风险患者中,TAVR 组 1 年(RR:2.63;95%CI:1.34-5.15;P=0.005)和 2 年(RR:3.19;95%CI:1.63-6.24;P=0.001)的主动脉瓣再介入风险显著高于 SAVR 组。
结论:这些发现表明,接受 TAVR 的低至中危手术风险患者并发症风险较低,而 TIA、永久性起搏器植入和主动脉瓣再介入的风险增加。
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