Shrestha Dhan Bahadur, Shtembari Jurgen, Lamichhane Sandesh, Baniya Abinash, Shahi Manoj, Dhungel Swati, Pant Kailash, Sutton Nadia R, Villablanca Pedro, Mungee Sudhir
Department of Internal Medicine Mount Sinai Hospital Chicago Illinois USA.
Department of Internal Medicine Chitwan Medical College Teaching Hospital Bharatpur Nepal.
Health Sci Rep. 2023 Jul 1;6(7):e1391. doi: 10.1002/hsr2.1391. eCollection 2023 Jul.
Cerebral embolic protection (CEP) devices are employed to capture embolic debris and reduce the risk of stroke during transcatheter aortic valve replacement (TAVR). Evidence is mixed regarding the safety and efficacy of CEP. We aimed to summarize the safety and effectiveness of CEP use during TAVR.
Electronic databases, including PubMed, PubMed Central, Scopus, Cochrane Library, and Embase, were searched using relevant search terms for articles relating to CEP. All relevant data from 20 studies were extracted into a standardized form. Statistical analyses were performed using Revman 5.4. Odds ratio (OR) or mean differences (MDs) were used to estimate the desired outcome with a 95% confidence interval (CI).
Twenty studies (eight randomized controlled trials [RCTs]) involving 210,871 patients (19,261 in the CEP group and 191,610 in TAVR without the CEP group) were included. The use of CEP was associated with a lower odds of 30-day mortality by 39% (OR: 0.61, 95% CI: 0.53-0.70) and stroke by 31% (OR: 0.69, 95% CI: 0.52-0.92). Comparing devices, benefit in terms of mortality and stroke was observed with the use of the Sentinel device (Boston Scientific), but not among other devices. No differences were observed in the outcomes of acute kidney injury, major or life-threatening bleeding events, or major vascular complications between groups. When only RCTs were included, there were no observed differences in the primary or secondary outcomes for CEP versus no CEP use during TAVR.
The totality of evidence suggests a net benefit for the use of CEP, weighted by studies in which the Sentinal device was used. However, given the RCT subanalysis, additional evidence is needed to identify patients at the highest risk of stroke for optimal decision-making.
脑栓塞保护（CEP）装置用于捕获栓塞碎片并降低经导管主动脉瓣置换术（TAVR）期间的中风风险。关于CEP安全性和有效性的证据不一。我们旨在总结TAVR期间使用CEP的安全性和有效性。
使用相关检索词在包括PubMed、PubMed Central、Scopus、Cochrane图书馆和Embase在内的电子数据库中检索与CEP相关的文章。从20项研究中提取所有相关数据并整理成标准化表格。使用Revman 5.4进行统计分析。采用比值比（OR）或均值差（MD）来估计预期结果，并给出95%置信区间（CI）。
纳入了20项研究（8项随机对照试验[RCT]），涉及210871例患者（CEP组19261例，未使用CEP的TAVR组191610例）。使用CEP使30天死亡率降低39%（OR：0.61，95%CI：0.53 - 0.70），中风发生率降低31%（OR：0.69，95%CI：0.52 - 0.92）。比较不同装置，使用Sentinel装置（波士顿科学公司）在死亡率和中风方面有获益，但其他装置未观察到此类情况。两组在急性肾损伤、严重或危及生命的出血事件或主要血管并发症的结果方面未观察到差异。仅纳入RCT时，TAVR期间使用CEP与不使用CEP在主要或次要结局方面未观察到差异。
总体证据表明，考虑到使用Sentinel装置的研究，使用CEP有净获益。然而，鉴于RCT亚组分析，需要更多证据来确定中风风险最高的患者，以做出最佳决策。
