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哨兵脑栓塞保护装置在经导管主动脉瓣置换术中的疗效:一项随机对照试验和倾向评分匹配研究的荟萃分析。

Efficacy of Sentinel Cerebral Embolic Protection Device in Transcatheter Aortic Valve Replacement: A Meta-Analysis of Randomized Controlled Trials and Propensity Score-Matched Studies.

作者信息

Jain Hritvik, Pervez Neha, Dey Debankur, Odat Ramez M, Jain Jyoti, Goyal Aman, Saggar Anmol, Hussein Ayham Mohammad, Mathur Aniket, Khanna Sukul, Ahmed Raheel, Shahid Farhan

机构信息

From the Department of Internal Medicine, All India Institute of Medical Sciences (AIIMS), Jodhpur, India.

Department of Internal Medicine, Dow University of Health Sciences, Karachi, Pakistan.

出版信息

Cardiol Rev. 2024 Sep 30. doi: 10.1097/CRD.0000000000000797.

DOI:10.1097/CRD.0000000000000797
PMID:39345145
Abstract

Transcatheter aortic valve replacement (TAVR) is frequently associated with stroke due to debris embolization. Although the risk of stroke with newer-generation devices is lower, stroke still represents a significant cause of mortality and morbidity post-TAVR. The Sentinel cerebral embolic protection device (CEPD) is a dual-embolic filter device designed to capture debris dislodged during TAVR. A systematic literature search was performed on the major bibliographic databases to retrieve studies that compared TAVR with and without Sentinel CEPD. Pooled odds ratios (ORs) with 95% confidence intervals (CIs) were calculated using the DerSimonian-Laird random-effects model, with a P value of <0.05 considered statistically significant. This meta-analysis included 6 studies with 25,130 patients undergoing TAVR (12,608: Sentinel CEPD; 12,522: without Sentinel CEPD). The use of the Sentinel CEPD in TAVR was associated with a statistically significant lower risk of acute kidney injury (OR: 0.89; 95% CI: 0.81-0.97; P = 0.01]. The use of Sentinel CEPD in TAVR was associated with a statistically insignificant trend toward a reduction in stroke (OR: 0.80; 95% CI: 0.58-1.10; P = 0.18), all-cause mortality (OR: 0.74; 95% CI: 0.51-1.07; P = 0.11), and major vascular complications (OR: 0.74; 95% CI: 0.46-1.19; P = 0.21). The use of Sentinel CEPD in patients undergoing TAVR does not lead to a statistically significant reduction in stroke, all-cause mortality, or major vascular complications; however, the risk of acute kidney injury is lower. Further randomized studies are warranted to confirm these findings.

摘要

经导管主动脉瓣置换术(TAVR)常因碎片栓塞而导致中风。尽管新一代器械导致中风的风险较低,但中风仍是TAVR术后死亡和发病的重要原因。Sentinel脑栓塞保护装置(CEPD)是一种双栓塞过滤装置,旨在捕获TAVR过程中脱落的碎片。我们在主要的文献数据库中进行了系统的文献检索,以获取比较使用和不使用Sentinel CEPD的TAVR的研究。使用DerSimonian-Laird随机效应模型计算合并比值比(OR)及其95%置信区间(CI),P值<0.05被认为具有统计学意义。这项荟萃分析纳入了6项研究,共25130例接受TAVR的患者(12608例:使用Sentinel CEPD;12522例:未使用Sentinel CEPD)。在TAVR中使用Sentinel CEPD与急性肾损伤风险显著降低相关(OR:0.89;95%CI:0.81-0.97;P = 0.01)。在TAVR中使用Sentinel CEPD与中风(OR:0.80;95%CI:0.58-1.10;P = 0.18)、全因死亡率(OR:0.74;95%CI:0.51-1.07;P = 0.11)和主要血管并发症(OR:0.74;95%CI:0.46-1.19;P = 0.21)降低的趋势无统计学意义。在接受TAVR的患者中使用Sentinel CEPD不会导致中风、全因死亡率或主要血管并发症有统计学意义的降低;然而,急性肾损伤的风险较低。需要进一步的随机研究来证实这些发现。

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