Department of Medicine, Rawalpindi Medical University, Rawalpindi, Pakistan.
Department of Internal Medicine, Wayne State University, Michigan, USA.
Expert Rev Cardiovasc Ther. 2024 Aug;22(8):409-420. doi: 10.1080/14779072.2024.2385989. Epub 2024 Aug 2.
Cerebral Embolic Protection Device (CEPD) captures emboli during Transcatheter Aortic Valve Replacement (TAVR). With recently published pivotal trials and multiple cohort studies reporting new data, there is a need to re-calibrate available statistical evidence.
A systematic literature search was conducted across databases from inception till February 2023. Dichotomous outcomes were pooled using Odds Ratio (OR), while continuous outcomes were pooled using Standardized Mean Difference (SMD) along with 95% corresponding intervals (95% CIs).
Data was included from 17 studies (7 RCTs, 10 cohorts, = 155,829). Use of CEPD was associated with significantly reduced odds of stroke (OR = 0.60, 95% CI = 0.43-0.85, = 0.003). There was no significant difference in disabling stroke ( = 0.25), non-disabling stroke ( = 0.72), and 30-day mortality ( = 0.10) between the two groups. There were no significant differences between the two groups for Diffusion-Weighted Magnetic Resonance Imaging (DW-MRI) findings, acute kidney injury, risk of pacemaker implantation life-threatening bleed, major bleed, minor bleed, worsening National Institute of Health Stroke Scale (NIHSS), modified Rankin Scale (mRS) and vascular complications ( > 0.05).
The use of CEPD during TAVR reduced the incidence of all-stroke ( = 0.003); however, there were no significant differences in any of the other pooled outcomes ( > 0.05).
The protocol of this meta-analysis was registered with the Open Science framework [https://doi.org/10.17605/OSF.IO/7W564] before data acquisition was started.
在经导管主动脉瓣置换术（TAVR）期间，脑栓塞保护装置（CEPD）可捕获栓子。随着最近发表的关键性试验和多项队列研究报告新数据，需要重新校准现有统计证据。
从开始到 2023 年 2 月，我们在数据库中进行了系统的文献检索。使用优势比（OR）对二项结果进行汇总，而使用标准化均数差（SMD）及其 95%相应区间（95%CI）对连续结果进行汇总。
纳入了 17 项研究的数据（7 项 RCT、10 项队列研究，共 155829 名患者）。使用 CEPD 与卒中发生率显著降低相关（OR=0.60，95%CI=0.43-0.85，P=0.003）。两组间致残性卒中（P=0.25）、非致残性卒中（P=0.72）和 30 天死亡率（P=0.10）无显著差异。两组间弥散加权磁共振成像（DW-MRI）结果、急性肾损伤、起搏器植入相关的危及生命的出血风险、大出血、小出血、美国国立卫生研究院卒中量表（NIHSS）恶化、改良 Rankin 量表（mRS）和血管并发症发生率无显著差异（P>0.05）。
在 TAVR 期间使用 CEPD 可降低全卒中发生率（P=0.003）；然而，其他汇总结果均无显著差异（P>0.05）。
本荟萃分析的方案在开始数据收集之前在开放科学框架[https://doi.org/10.17605/OSF.IO/7W564]上进行了注册。
