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经导管主动脉瓣置换术与球囊扩张式瓣膜和自扩张式瓣膜的荟萃分析比较。

Meta-Analysis Comparing Transcatheter Aortic Valve Implantation With Balloon Versus Self-Expandable Valves.

机构信息

Division of Cardiology, West Virginia University, Morgantown, West Virginia.

Oregon Knight Cardiovascular Institute, Portland, Oregon.

出版信息

Am J Cardiol. 2019 Oct 15;124(8):1252-1256. doi: 10.1016/j.amjcard.2019.07.028. Epub 2019 Jul 29.

DOI:10.1016/j.amjcard.2019.07.028
PMID:31470973
Abstract

Two transcatheter aortic valve systems are currently in use in the United States; balloon-expandable valves (BEV) and the self-expanding valve (SEV). However, comparative data outcomes between the 2 systems are limited, as only one randomized trial (RCT) performed a head-to-head comparison between BEVs and SEVs. However, there are several RCTs comparing BEV or SEV to surgical valve replacement. In this analysis, we used Bayesian network meta-analysis techniques to compare BEVs and SEVs. The primary outcome was all-cause mortality at maximum follow-up. Secondary outcomes were cardiovascular mortality, stroke, pacemaker implantation, reintervention, heart failure hospitalization, and moderate-severe paravalvular leak (PVL.). Eight RCTs with 8,095 patients were included. With the exception of less pacemaker implantation in BEV versus SEV (odds ratio [OR] 0.29, 95% confidence interval [CI] 0.11 to 0.77, I = 51%), there was no difference between BEV and SEV in 30-day outcomes. During long-term follow-up (mean 3 ± 2 years); there was no difference between BEV and SEV in all-cause mortality (hazard ratio [HR] 1.1, 95% CI 0.87 to 1.5, I = 19.6%), cardiovascular mortality (HR 1.1, 95% CI 0.73 to 1.6, I = 18.5%), stroke (HR 1.3, 95% CI 0.73 to 2.1, I = 16.9%), hospitalization (HR 0.87, 95% CI 0.41 to 1.6, I = 62%), and reintervention (HR 0.68, 95% CI 0.2 to 2.3, I = 62%). New pacemaker implantation and PVL were significantly less in BEV group (HR 0.45, 95% CI 0.24 to 0.80, I = 38.2%), and (HR 0.03, 95% CI 0.0004 to 0.28, I = 79%), respectively. In conclusion, similar outcomes were seen following transcatheter aortic valve implantation with BEV and SEV with the exception of higher rates of pacemaker implantation and PVL in SEV group.

摘要

两种经导管主动脉瓣系统目前在美国使用;球囊扩张瓣膜(BEV)和自扩张瓣膜(SEV)。然而,这两种系统之间的比较数据结果有限,因为只有一项随机试验(RCT)对 BEV 和 SEV 进行了头对头比较。然而,有几项 RCT 将 BEV 或 SEV 与外科瓣膜置换进行了比较。在这项分析中,我们使用贝叶斯网络荟萃分析技术比较了 BEV 和 SEV。主要结局是最大随访时的全因死亡率。次要结局是心血管死亡率、卒中和心脏骤停、再介入、心力衰竭住院和中重度瓣周漏(PVL)。纳入了 8 项包含 8095 名患者的 RCT。除了 BEV 组的起搏器植入较少(比值比 [OR] 0.29,95%置信区间 [CI] 0.11 至 0.77,I=51%)外,BEV 和 SEV 在 30 天结局方面没有差异。在长期随访期间(平均 3±2 年),BEV 和 SEV 的全因死亡率(风险比 [HR] 1.1,95%CI 0.87 至 1.5,I=19.6%)、心血管死亡率(HR 1.1,95%CI 0.73 至 1.6,I=18.5%)、卒中和心脏骤停(HR 1.3,95%CI 0.73 至 2.1,I=16.9%)、住院(HR 0.87,95%CI 0.41 至 1.6,I=62%)和再介入(HR 0.68,95%CI 0.2 至 2.3,I=62%)没有差异。在 BEV 组,新的起搏器植入和 PVL 明显减少(HR 0.45,95%CI 0.24 至 0.80,I=38.2%)和(HR 0.03,95%CI 0.0004 至 0.28,I=79%)。总之,与 SEV 相比,BEV 和 SEV 经导管主动脉瓣植入后的结局相似,但 SEV 组的起搏器植入和 PVL 发生率较高。

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