Cardiac Surgery Department, Hospital Universitario Clínico San Carlos, Madrid, Spain.
Cardiology Department, Hospital Universitario Clínico San Carlos, Madrid, Spain.
J Stroke Cerebrovasc Dis. 2022 Sep;31(9):106605. doi: 10.1016/j.jstrokecerebrovasdis.2022.106605. Epub 2022 Jul 14.
Cerebral embolic protection devices (CEPDs) are designed to prevent embolization of debris during transcatheter aortic valve implantation (TAVI). Current evidence from randomized clinical trials (RCTs) and observational studies is controversial.
The purpose of this meta-analysis was to study the influence of CEPDs on stroke, silent ischemic lesions and neurocognitive function.
A systematic search was conducted including RCTs or adjusted observational studies comparing TAVI with or without CEPDs. Pooled odds ratios, risk ratios or standardized mean differences with 95% confidence intervals were calculated using the inverse of variance method. Risk of bias sensitivity analyses and meta regression for CEPD type were also conducted.
Five RCTs and five adjusted observational studies were included (n= 159,865). Mean age of the patients was 81.1 (SD 1.04) years in CEPDs and 81 (SD 1.86) in non-CEPD. The overall quality of evidence using the GRADE system for each endpoint was low to very low, mainly due to serious risk of bias, inconsistency and imprecision. Random effects meta-analysis detected no significant differences between CEPD and non-CEPD (OR= 0.74; 95% CI 0.51-1.07; P= 0.105; I= 82.1%) for 30-day stroke. This finding was consistent in meta regression for CEPD type and subgroup analyses by study type and CEPD type. No significant differences between groups were observed in cerebral DW-MRI assessment and neurocognitive function evaluation.
In the present meta- analysis of five RCTs and five adjusted observational studies, the use of a CEPD during TAVI was not associated with a significant benefit on 30- day stroke, total lesion volume per patient, number of ischemic lesions per patient and neurocognitive function assessments.
脑栓塞保护装置 (CEPD) 旨在防止经导管主动脉瓣植入术 (TAVI) 期间碎片栓塞。来自随机临床试验 (RCT) 和观察性研究的现有证据存在争议。
本荟萃分析旨在研究 CEPD 对中风、无症状性缺血性病变和神经认知功能的影响。
系统检索了比较 TAVI 联合与不联合 CEPD 的 RCT 或调整后的观察性研究。使用方差倒数法计算合并优势比、风险比或标准化均数差值及其 95%置信区间。还进行了 CEPD 类型的敏感性分析和荟萃回归分析。
纳入了 5 项 RCT 和 5 项调整后的观察性研究 (n=159865)。CEPD 组患者的平均年龄为 81.1(SD 1.04)岁，非 CEPD 组为 81(SD 1.86)岁。使用 GRADE 系统对每个终点的总体证据质量评价为低至极低，主要原因是存在严重的偏倚风险、不一致性和不精确性。随机效应荟萃分析发现，CEPD 与非 CEPD 之间 30 天中风发生率无显著差异 (OR=0.74；95%CI 0.51-1.07；P=0.105；I=82.1%)。这一发现与 CEPD 类型的荟萃回归以及研究类型和 CEPD 类型的亚组分析一致。两组间在脑 DW-MRI 评估和神经认知功能评估方面无显著差异。
在本项包括 5 项 RCT 和 5 项调整后的观察性研究的荟萃分析中，TAVI 期间使用 CEPD 与 30 天中风、每位患者的总病变体积、每位患者的缺血性病变数量和神经认知功能评估无显著相关性。
