背景:前哨脑栓塞保护装置(CEP)旨在降低经导管主动脉瓣置换术(TAVR)期间的中风风险。我们对倾向评分匹配(PSM)和随机对照试验(RCT)进行了系统评价和荟萃分析,调查了前哨CEP在TAVR期间预防中风的效果。
方法:通过PubMed搜索符合条件的试验,ISI网络科学数据库,Cochrane数据库,和主要代表大会的会议。主要结果是卒中。次要结果包括全因死亡率,严重或危及生命的出血,出院时主要血管并发症和急性肾损伤。使用固定和随机效应模型来计算具有95%置信区间(CI)和绝对风险差(ARD)的合并风险比(RR)。
结果:共纳入4个随机对照试验(3个506例)和1个PSM研究(560例)的4066例患者。92%的患者使用SentinelCEP成功,并与卒中风险显着降低相关(RR:0.67,95%CI:0.48-0.95,p=0.02。ARD:-1.3%,95%CI:-2.3--0.2,p=0.02,需要治疗的数量(NNT)=77),并降低致残卒中的风险(RR:0.33,95%CI:0.17-0.65。ARD:-0.9%,95%CI:-1.5--0.3,p=0.004,NNT=111)。使用SentinelCEP与严重或危及生命的出血风险较低相关(RR:0.37,95%CI:0.16-0.87,p=0.02)。非致残性中风的风险(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)相似.
结论:在TAVR期间使用CEP与任何卒中和致残卒中的风险较低相关,NNT分别为77和111。
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.