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Neurological outcomes with embolic protection devices in patients undergoing transcatheter aortic valver replacement a systematic review and meta-analysis of randomized controlled trials

机译：经导管主动脉瓣置换术患者栓塞保护装置的神经学结果随机对照试验的系统评价和荟萃分析

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Objectives The aim of this study was to investigate the efficacy and safety of intraprocedural embolic protection (EP) during transcatheter aortic valve replacement (TAVR). Background Randomized controlled trials (RCTs) investigating the efficacy of EP devices during TAVR were relatively underpowered. Methods A systematic review and study-level meta-analysis was performed of randomized controlled trials that tested the efficacy and safety of EP during TAVR. Trials using any type of EP and TAVR vascular access were included. Primary imaging efficacy endpoints were total lesion volume and number of new ischemic lesions. Primary clinical efficacy endpoints were any deterioration in National Institutes of Health Stroke Scale and Montreal Cognitive Assessment scores at hospital discharge. Primary analyses were performed using the intention-to-treat approach. Results Four randomized clinical trials (total n = 252) were included. Use of EP was associated with lower total lesion volume (standardized mean difference −0.65; 95% confidence interval [CI]: −1.06 to −0.25; p = 0.002) and smaller number of new ischemic lesions (standardized mean difference −1.27; 95% CI: −2.45 to −0.09; p = 0.03). EP was associated with a trend toward lower risk for deterioration in National Institutes of Health Stroke Scale score at discharge (risk ratio: 0.55; 95% CI: 0.27 to 1.09; p = 0.09) and higher Montreal Cognitive Assessment score (standardized mean difference 0.40; 95% CI: 0.04 to 0.76; p = 0.03). Risk for overt stroke and all-cause mortality were nonsignificantly lower in the EP group. Conclusions Use of EP seems to be associated with reductions in imaging markers of cerebral infarction and early clinical neurological effectiveness in patients undergoing TAVR.
机译：目的本研究的目的是研究经导管主动脉瓣置换术（TAVR）期间术中栓塞保护（EP）的有效性和安全性。背景技术研究TAVR期间EP装置功效的随机对照试验（RCT）相对不足。方法对TAVR期间EP的有效性和安全性的随机对照试验进行系统的回顾和研究水平的荟萃分析。包括使用任何类型的EP和TAVR血管通路的试验。主要的影像学疗效终点是总病变体积和新发缺血性病变的数量。主要临床疗效终点是出院时国立卫生研究院卒中量表和蒙特利尔认知评估得分的任何恶化。使用意向性治疗方法进行初步分析。结果纳入四项随机临床试验（总计n = 252）。 EP的使用与较低的总病变量（标准平均差-0.65； 95％置信区间[CI]：-1.06至-0.25； p = 0.002）和新发缺血性病变的数目较少（标准平均差-1.27; 95）相关％CI：-2.45至-0.09； p = 0.03）。 EP与国立卫生研究院卒中量表评分出现恶化风险降低趋势相关（风险比：0.55； 95％CI：0.27至1.09； p = 0.09）和更高的蒙特利尔认知评估得分（标准化平均差异0.40） ； 95％CI：0.04至0.76； p = 0.03）。 EP组的明显中风风险和全因死亡率显着降低。结论EP的使用似乎与TAVR患者脑梗死的影像学标志物减少和早期临床神经学有效性有关。

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