Heart Center Lucerne, Luzerner Kantonsspital, Lucerne, Switzerland.
Department of Internal Medicine, Division of Cardiology and Angiology, Magdeburg University, Magdeburg, Germany.
BMC Cardiovasc Disord. 2023 Jun 17;23(1):306. doi: 10.1186/s12872-023-03338-0.
The Sentinel cerebral embolic protection device (CEP) aims to reduce the risk of stroke during transcatheter aortic valve replacement (TAVR). We performed a systematic review and meta-analysis of propensity score matched (PSM) and randomized controlled trials (RCT) investigating the effect of the Sentinel CEP to prevent strokes during TAVR.
Eligible trials were searched through PubMed, ISI Web of science databases, Cochrane database, and proceedings of major congresses. Primary outcome was stroke. Secondary outcomes included all-cause mortality, major or life-threatening bleeding, major vascular complications and acute kidney injury at discharge. Fixed and random effect models were used to calculate the pooled risk ratio (RR) with 95% confidence intervals (CI) and absolute risk difference (ARD).
A total of 4066 patients from 4 RCTs (3'506 patients) and 1 PSM study (560 patients) were included. Use of Sentinel CEP was successful in 92% of patients and was associated with a significantly lower risk of stroke (RR: 0.67, 95% CI: 0.48-0.95, p = 0.02. ARD: -1.3%, 95% CI: -2.3 - -0.2, p = 0.02, number needed to treat (NNT) = 77), and a reduced risk of disabling stroke (RR: 0.33, 95% CI: 0.17-0.65. ARD: -0.9%, 95% CI: -1.5 - -0.3, p = 0.004, NNT = 111). Use of Sentinel CEP was associated with a lower risk of major or life-threatening bleeding (RR: 0.37, 95% CI: 0.16-0.87, p = 0.02). Risk for nondisabling stroke (RR: 0.93, 95% CI: 0.62-1.40, p = 0.73), all-cause mortality (RR: 0.70, 95% CI: 0.35-1.40, p = 0.31), major vascular complications (RR: 0.74, 95% CI: 0.33-1.67, p = 0.47) and acute kidney injury (RR: 0.74, 95% CI: 0.37-1.50, p = 0.40) were similar.
The use of CEP during TAVR was associated with lower risks of any stroke and disabling stroke with an NNT of 77 and 111, respectively.
Sentinel 脑保护装置（CEP）旨在降低经导管主动脉瓣置换术（TAVR）期间中风的风险。我们对倾向性评分匹配（PSM）和随机对照试验（RCT）进行了系统评价和荟萃分析，以调查 Sentinel CEP 在预防 TAVR 期间中风的效果。
通过 PubMed、ISI Web of Science 数据库、Cochrane 数据库和主要会议的会议记录搜索符合条件的试验。主要结局为中风。次要结局包括全因死亡率、主要或危及生命的出血、主要血管并发症和出院时急性肾损伤。使用固定效应模型和随机效应模型计算汇总风险比（RR）及其 95%置信区间（CI）和绝对风险差异（ARD）。
共有 4 项 RCT（3506 例患者）和 1 项 PSM 研究（560 例患者）的 4066 例患者纳入研究。Sentinel CEP 的使用成功率为 92%，且显著降低了中风风险（RR：0.67，95%CI：0.48-0.95，p=0.02，ARD：-1.3%，95%CI：-2.3 - -0.2，p=0.02，NNT=77）和致残性中风风险（RR：0.33，95%CI：0.17-0.65，ARD：-0.9%，95%CI：-1.5 - -0.3，p=0.004，NNT=111）。Sentinel CEP 的使用与主要或危及生命的出血风险降低相关（RR：0.37，95%CI：0.16-0.87，p=0.02）。非致残性中风风险（RR：0.93，95%CI：0.62-1.40，p=0.73）、全因死亡率（RR：0.70，95%CI：0.35-1.40，p=0.31）、主要血管并发症（RR：0.74，95%CI：0.33-1.67，p=0.47）和急性肾损伤（RR：0.74，95%CI：0.37-1.50，p=0.40）无显著差异。
TAVR 期间使用 CEP 与降低任何中风和致残性中风的风险相关，NNT 分别为 77 和 111。
