经导管主动脉瓣植入术伴或不伴重新植入术:一项系统综述和Meta分析

F. Moroni, L. Azzalini, L. Søndergaard, G. Attizzani, S. García, H. Jneid, M. Mamas, R. Bagur
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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]; I 2=0%), stroke (n=4121; OR, 1.09 [95% CI, 0.74–1.62]; I 2=0%), coronary obstruction (n=3000; OR, 2.35 [95% CI, 0.17–33.47]; I 2=75%), major vascular complications (n=3125; OR, 0.92 [95% CI, 0.66–1.33]; I 2=0%), major bleeding (n=3125; OR, 1.13 [95% CI, 0.94–2.01]; I 2=39%), acute kidney injury (n=3495; OR, 1.30 [95% CI, 0.64–2.62]; I 2=44%), and efficacy outcomes: device success (n=1196; OR, 0.77 [95% CI, 0.51–1.14]; I 2=0%), need for a second valve (n=3170; OR, 2.86 [95% CI, 0.96–8.48]; I 2=62%), significant (moderate or higher) paravalvular leak (n=1151; OR, 1.53 [95% CI, 0.83–2.80]; I 2=0%), and permanent pacemaker implantation (n=1908; OR, 1.04 [95% CI, 0.68–1.57]; I 2=58%). One‐year mortality was similar between groups (n=1972; OR, 1.00 [95% CI, 0.68–1.47]; I 2=0%). 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引用次数: 0

摘要

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。我们的目的是评估经导管心脏瓣膜置换术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评估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];I 2=0%),笔画(n=4121;Or为1.09 [95% ci, 0.74-1.62];I 2=0%),冠状动脉阻塞(n=3000;Or为2.35 [95% ci, 0.17-33.47];I 2=75%),主要血管并发症(n=3125;Or为0.92 [95% ci, 0.66-1.33];2=0%),大出血(n=3125;Or为1.13 [95% ci, 0.94-2.01];I 2=39%),急性肾损伤(n=3495;Or为1.30 [95% ci, 0.64-2.62];I 2=44%),以及疗效结局:器械成功(n=1196;Or为0.77 [95% ci, 0.51-1.14];I 2=0%),需要第二个阀门(n=3170;Or为2.86 [95% ci, 0.96-8.48];I 2=62%),显著(中度或更高)瓣旁漏(n=1151;Or为1.53 [95% ci, 0.83-2.80];I 2=0%),永久起搏器植入(n=1908;Or为1.04 [95% ci, 0.68-1.57];我2 = 58%)。两组间一年死亡率相似(n=1972;Or为1.00 [95% ci, 0.68-1.47];我2 = 0%)。结论:在TAVI期间,经导管心脏瓣膜置换术与未置换术的围手术期风险相似。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。
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Transcatheter Aortic Valve Implantation With and Without Resheathing and Repositioning: A Systematic Review and Meta‐analysis
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]; I 2=0%), stroke (n=4121; OR, 1.09 [95% CI, 0.74–1.62]; I 2=0%), coronary obstruction (n=3000; OR, 2.35 [95% CI, 0.17–33.47]; I 2=75%), major vascular complications (n=3125; OR, 0.92 [95% CI, 0.66–1.33]; I 2=0%), major bleeding (n=3125; OR, 1.13 [95% CI, 0.94–2.01]; I 2=39%), acute kidney injury (n=3495; OR, 1.30 [95% CI, 0.64–2.62]; I 2=44%), and efficacy outcomes: device success (n=1196; OR, 0.77 [95% CI, 0.51–1.14]; I 2=0%), need for a second valve (n=3170; OR, 2.86 [95% CI, 0.96–8.48]; I 2=62%), significant (moderate or higher) paravalvular leak (n=1151; OR, 1.53 [95% CI, 0.83–2.80]; I 2=0%), and permanent pacemaker implantation (n=1908; OR, 1.04 [95% CI, 0.68–1.57]; I 2=58%). One‐year mortality was similar between groups (n=1972; OR, 1.00 [95% CI, 0.68–1.47]; I 2=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.
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