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经导管主动脉瓣植入术伴和不伴重新护套和重新定位:系统评价和荟萃分析。

Transcatheter Aortic Valve Implantation With and Without Resheathing and Repositioning: A Systematic Review and Meta-analysis.

机构信息

Division of Cardiology Pauley Heart CenterVirginia Commonwealth University Richmond VA.

Division of Cardiology Department of Medicine University of Washington Seattle WA.

出版信息

J Am Heart Assoc. 2022 Jun 21;11(12):e024707. doi: 10.1161/JAHA.121.024707. Epub 2022 Jun 14.

Abstract

Background There is a concern that resheathing/repositioning of transcatheter heart valves during transcatheter aortic valve implantation (TAVI) may lead to an increased risk of periprocedural complications. We aimed to evaluate the short- and long-term impact on clinical outcomes of resheathing for repositioning of transcatheter heart valves during TAVI procedures. Methods and Results We conducted a systematic search of Embase, MEDLINE, and Cochrane Central Register of Controlled Trials databases to identify studies comparing outcomes between patients requiring resheathing/repositioning during TAVI and those who did not. Random-effects meta-analyses were used to estimate the association of resheathing compared with no resheathing with clinical outcomes after TAVI. Seven studies including 4501 participants (pooled mean age, 80.9±7.4 years; 54% women; and 1374 [30.5%] patients requiring resheathing/repositioning) were included in this study. No significant differences between the 2 groups were identified with regards to safety: 30-day mortality (n=3125; odds ratio [OR], 0.74 [95% confidence interval [CI], 0.41-1.33]; =0%), stroke (n=4121; OR, 1.09 [95% CI, 0.74-1.62]; =0%), coronary obstruction (n=3000; OR, 2.35 [95% CI, 0.17-33.47]; =75%), major vascular complications (n=3125; OR, 0.92 [95% CI, 0.66-1.33]; =0%), major bleeding (n=3125; OR, 1.13 [95% CI, 0.94-2.01]; =39%), acute kidney injury (n=3495; OR, 1.30 [95% CI, 0.64-2.62]; =44%), and efficacy outcomes: device success (n=1196; OR, 0.77 [95% CI, 0.51-1.14]; =0%), need for a second valve (n=3170; OR, 2.86 [95% CI, 0.96-8.48]; =62%), significant (moderate or higher) paravalvular leak (n=1151; OR, 1.53 [95% CI, 0.83-2.80]; =0%), and permanent pacemaker implantation (n=1908; OR, 1.04 [95% CI, 0.68-1.57]; =58%). One-year mortality was similar between groups (n=1972; OR, 1.00 [95% CI, 0.68-1.47]; =0%). Conclusions Resheathing of transcatheter heart valves during TAVI is associated with similar periprocedural risk compared with no resheathing in several patient-important outcomes. These data support the safety of current self-expanding transcatheter heart valves with resheathing features. Registration URL: https://www.crd.york.ac.uk/prospero/; Unique identifier: CRD42021273715.

摘要

背景

经导管主动脉瓣置换术(TAVI)期间重新护套/重新定位经导管心脏瓣膜可能会增加围手术期并发症的风险。我们旨在评估重新护套对 TAVI 手术期间经导管心脏瓣膜重新定位的临床结果的短期和长期影响。

方法和结果

我们对 Embase、MEDLINE 和 Cochrane 对照试验中心注册数据库进行了系统搜索,以确定比较 TAVI 期间需要重新护套/重新定位的患者与不需要重新护套/重新定位的患者之间结局的研究。使用随机效应荟萃分析来估计与不重新护套相比,重新护套与 TAVI 后临床结局的相关性。这项研究纳入了 7 项研究共 4501 名参与者(汇总平均年龄为 80.9±7.4 岁;54%为女性;1374 [30.5%]名患者需要重新护套/重新定位)。两组在安全性方面没有显著差异:30 天死亡率(n=3125;优势比 [OR],0.74 [95%置信区间 [CI],0.41-1.33];=0%)、卒中(n=4121;OR,1.09 [95% CI,0.74-1.62];=0%)、冠状动脉阻塞(n=3000;OR,2.35 [95% CI,0.17-33.47];=75%)、主要血管并发症(n=3125;OR,0.92 [95% CI,0.66-1.33];=0%)、大出血(n=3125;OR,1.13 [95% CI,0.94-2.01];=39%)、急性肾损伤(n=3495;OR,1.30 [95% CI,0.64-2.62];=44%)和疗效结局:器械成功率(n=1196;OR,0.77 [95% CI,0.51-1.14];=0%)、需要第二个瓣膜(n=3170;OR,2.86 [95% CI,0.96-8.48];=62%)、显著(中度或更高)瓣周漏(n=1151;OR,1.53 [95% CI,0.83-2.80];=0%)和永久性起搏器植入(n=1908;OR,1.04 [95% CI,0.68-1.57];=58%)。两组 1 年死亡率相似(n=1972;OR,1.00 [95% CI,0.68-1.47];=0%)。

结论

与不重新护套相比,TAVI 期间重新护套与几种重要患者结局的围手术期风险相似。这些数据支持具有重新护套功能的当前自膨式经导管心脏瓣膜的安全性。

注册网址

https://www.crd.york.ac.uk/prospero/;独特标识符:CRD42021273715。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3dac/9238664/d8838901e749/JAH3-11-e024707-g001.jpg

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