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经导管主动脉瓣膜置换术中进行脑栓塞保护不能改善患者预后
作者:小柯机器人 发布时间:2022/9/22 20:06:47

美国克利夫兰诊所Samir R. Kapadia团队研究了经导管主动脉瓣膜置换术中进行脑栓塞保护对患者预后的影响。2022年9月17日出版的《新英格兰医学杂志》发表了这项成果。

经导管主动脉瓣置换术(TAVR)治疗主动脉狭窄可导致碎片栓塞。通过提供脑栓塞保护(CEP)的设备捕获碎片可能会降低中风风险。

研究组随机将主动脉狭窄患者按1:1的比例分为经股动脉TAVR加CEP组(CEP组)和不加CEP组(对照组)。在意向治疗人群中,主要终点是TAVR后72小时内或出院前(以先到者为准)中风。此外,还评估了中风致残、死亡、短暂性脑缺血发作、谵妄、CEP接入点的主要或次要血管并发症以及急性肾损伤。由一名神经病学专业人员在基线检查时和TAVR后对所有患者进行检查。

北美、欧洲和澳大利亚共有3000名患者接受了随机分组;其中1501人分配至CEP组,1499人分配至对照组。在1489名患者中,有1406名(94.4%)尝试使用CEP设备。CEP组和对照组在TAVR后72小时内或出院前的中风发生率无显著差异,分别为2.3%与2.9%。

CEP组中有0.5%的患者发生致残性中风,对照组中有1.3%。CEP组和对照组的死亡患者百分比(分别为0.5%与0.3%);中风、短暂性脑缺血发作或谵妄(分别为3.1%与3.7%);或急性肾损伤(分别为0.5%与0.5%)均没有实质性差异。有1名患者(0.1%)在CEP接入点出现血管并发症。

研究结果表明,在接受股动脉TAVR的主动脉瓣狭窄患者中,CEP的使用对围手术期中风的发生率没有显著影响,但基于此结果的95%置信区间,可能不排除CEP在TAVR期间的临床益处。

附:英文原文

Title: Cerebral Embolic Protection during Transcatheter Aortic-Valve Replacement | NEJM

Author: Samir R. Kapadia, M.D.,, Raj Makkar, M.D.,, Martin Leon, M.D.,, Mohamed Abdel-Wahab, M.D.,, Thomas Waggoner, D.O.,, Steffen Massberg, M.D.,, Wolfgang Rottbauer, M.D., Ph.D.,, Samuel Horr, M.D.,, Lars Sondergaard, M.D.,, Juhana Karha, M.D.,, Robert Gooley, M.B., B.S., Ph.D.,, Lowell Satler, M.D.,, Robert C. Stoler, M.D.,, Steven R. Messé, M.D.,, Suzanne J. Baron, M.D.,, Julia Seeger, M.D.,, Susheel Kodali, M.D.,, Amar Krishnaswamy, M.D.,, Vinod H. Thourani, M.D.,, Katherine Harrington, M.D.,, Stuart Pocock, Ph.D.,, Rodrigo Modolo, M.D., Ph.D.,, Dominic J. Allocco, M.D.,, Ian T. Meredith, M.D., Ph.D.,, and Axel Linke, M.D.

Issue&Volume: 2022-09-17

Abstract:

Background

Transcatheter aortic-valve replacement (TAVR) for the treatment of aortic stenosis can lead to embolization of debris. Capture of debris by devices that provide cerebral embolic protection (CEP) may reduce the risk of stroke.

Methods

We randomly assigned patients with aortic stenosis in a 1:1 ratio to undergo transfemoral TAVR with CEP (CEP group) or without CEP (control group). The primary end point was stroke within 72 hours after TAVR or before discharge (whichever came first) in the intention-to-treat population. Disabling stroke, death, transient ischemic attack, delirium, major or minor vascular complications at the CEP access site, and acute kidney injury were also assessed. A neurology professional examined all the patients at baseline and after TAVR.

Results

A total of 3000 patients across North America, Europe, and Australia underwent randomization; 1501 were assigned to the CEP group and 1499 to the control group. A CEP device was successfully deployed in 1406 of the 1489 patients (94.4%) in whom an attempt was made. The incidence of stroke within 72 hours after TAVR or before discharge did not differ significantly between the CEP group and the control group (2.3% vs. 2.9%; difference, 0.6 percentage points; 95% confidence interval, 1.7 to 0.5; P=0.30). Disabling stroke occurred in 0.5% of the patients in the CEP group and in 1.3% of those in the control group. There were no substantial differences between the CEP group and the control group in the percentage of patients who died (0.5% vs. 0.3%); had a stroke, a transient ischemic attack, or delirium (3.1% vs. 3.7%); or had acute kidney injury (0.5% vs. 0.5%). One patient (0.1%) had a vascular complication at the CEP access site.

Conclusions

Among patients with aortic stenosis undergoing transfemoral TAVR, the use of CEP did not have a significant effect on the incidence of periprocedural stroke, but on the basis of the 95% confidence interval around this outcome, the results may not rule out a benefit of CEP during TAVR.

DOI: 10.1056/NEJMoa2204961

Source: https://www.nejm.org/doi/full/10.1056/NEJMoa2204961

 

期刊信息

The New England Journal of Medicine:《新英格兰医学杂志》,创刊于1812年。隶属于美国麻省医学协会,最新IF:70.67
官方网址:http://www.nejm.org/
投稿链接:http://www.nejm.org/page/author-center/home