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

Francesco Moroni, Lorenzo Azzalini, Lars Sondergaard, Guilherme F Attizzani, Santiago García, Hani Jneid, Mamas A Mamas, Rodrigo Bagur
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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]; I2=0%), stroke (n=4121; OR, 1.09 [95% CI, 0.74-1.62]; I2=0%), coronary obstruction (n=3000; OR, 2.35 [95% CI, 0.17-33.47]; I2=75%), major vascular complications (n=3125; OR, 0.92 [95% CI, 0.66-1.33]; I2=0%), major bleeding (n=3125; OR, 1.13 [95% CI, 0.94-2.01]; I2=39%), acute kidney injury (n=3495; OR, 1.30 [95% CI, 0.64-2.62]; I2=44%), and efficacy outcomes: device success (n=1196; OR, 0.77 [95% CI, 0.51-1.14]; I2=0%), need for a second valve (n=3170; OR, 2.86 [95% CI, 0.96-8.48]; I2=62%), significant (moderate or higher) paravalvular leak (n=1151; OR, 1.53 [95% CI, 0.83-2.80]; I2=0%), and permanent pacemaker implantation (n=1908; OR, 1.04 [95% CI, 0.68-1.57]; I2=58%). One-year mortality was similar between groups (n=1972; OR, 1.00 [95% CI, 0.68-1.47]; I2=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.

经导管主动脉瓣植入术伴或不伴复位:一项系统综述和荟萃分析。
研究背景:经导管主动脉瓣植入术(TAVI)中,经导管心脏瓣膜的换套/重新定位可能导致围手术期并发症的风险增加。我们的目的是评估在TAVI手术过程中,经导管心脏瓣膜重新定位的修复对临床结果的短期和长期影响。方法和结果我们对Embase、MEDLINE和Cochrane中央对照试验注册数据库进行了系统检索,以确定在TAVI期间需要和不需要重新定位的患者之间比较结果的研究。随机效应荟萃分析用于估计TAVI后,与未进行翻修相比,翻修与临床结果的关系。7项研究纳入4501名受试者(合并平均年龄80.9±7.4岁;54%的女性;1374例(30.5%)患者需要重新植皮/重新定位。两组在安全性方面无显著差异:30天死亡率(n=3125;优势比[OR], 0.74[95%可信区间[CI], 0.41-1.33];I2=0%),行程(n=4121;Or为1.09 [95% ci, 0.74-1.62];I2=0%),冠状动脉阻塞(n=3000;Or为2.35 [95% ci, 0.17-33.47];I2=75%),主要血管并发症(n=3125;Or为0.92 [95% ci, 0.66-1.33];I2=0%),大出血(n=3125;Or为1.13 [95% ci, 0.94-2.01];I2=39%),急性肾损伤(n=3495;Or为1.30 [95% ci, 0.64-2.62];I2=44%),以及疗效结局:器械成功(n=1196;Or为0.77 [95% ci, 0.51-1.14];I2=0%),需要第二个阀门(n=3170;Or为2.86 [95% ci, 0.96-8.48];I2=62%),显著(中度或更高)瓣旁漏(n=1151;Or为1.53 [95% ci, 0.83-2.80];I2=0%),永久起搏器植入(n=1908;Or为1.04 [95% ci, 0.68-1.57];I2 = 58%)。两组间一年死亡率相似(n=1972;Or为1.00 [95% ci, 0.68-1.47];I2 = 0%)。结论:经导管心脏瓣膜置换术与不置换术相比,在TAVI中有相似的围手术期风险。这些数据支持目前具有修复功能的自膨胀经导管心脏瓣膜的安全性。注册网址:https://www.crd.york.ac.uk/prospero/;唯一标识符:CRD42021273715。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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