Cerebral Embolic Protection and Outcomes of Transcatheter Aortic Valve Replacement: Results From the Transcatheter Valve Therapy Registry.
Cerebral Embolic Protection and Outcomes of Transcatheter Aortic Valve Replacement: Results From the Transcatheter Valve Therapy Registry.
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DOI：
10.1161/circulationaha.120.052874
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发表时间：
2021-06-08
期刊：
影响因子：
37.8
通讯作者：
Cohen DJ
中科院分区：
文献类型：
--
作者：
Butala NM;Makkar R;Secemsky EA;Gallup D;Marquis-Gravel G;Kosinski AS;Vemulapalli S;Valle JA;Bradley SM;Chakravarty T;Yeh RW;Cohen DJ
中风仍然是经导管主动脉瓣置换术 (TAVR) 的毁灭性并发症，尽管技术不断改进且操作者经验不断增加，但中风仍然持续存在。虽然脑栓塞保护装置 (EPD) 已被开发出来以减轻这种风险，但有关其对 TAVR 后中风和其他结果影响的数据有限。我们使用 STS/ACC-TVT 登记处的数据进行了一项观察性研究。如果患者在 2018 年 1 月至 2019 年 12 月期间接受选择性或紧急经股动脉 TAVR，则被纳入研究。主要结局是院内卒中。为了调整混杂因素，使用工具变量（IV）分析评估了 EPD 使用与临床结果之间的关联，这是一种旨在支持从观察数据进行因果推断的技术，在与工具相同的程序季度内，站点级别偏好 EPD 使用。我们还使用重叠权重进行了基于倾向得分的二次分析。我们的分析样本包括来自 599 个地点的 123,186 名患者。随着时间的推移，TAVR 期间 EPD 的使用不断增加，到 2019 年 12 月，已达到 28% 的中心和 13% 的 TAVR 手术。各医院的 EPD 使用情况差异很大，8% 的中心使用 EPD 执行超过 50% 的 TAVR 手术，72% 的中心在 2019 年最后一个季度使用 EPD 执行零次手术。在我们使用 IV 模型的初步分析中，EPD 使用与院内卒中之间没有关联。 （调整后的相对风险（0.90 [95% CI: 0.68, 1.13]，绝对风险差 −0.15% [95% CI: −0.49, 0.20]）。然而，在我们使用基于倾向评分的模型进行的二次分析中，使用 EPD 与院内卒中发生率降低 18% 相关（调整后 OR 0.82 [95% CI 0.69， 0.97]，绝对风险差异-0.28% [95% CI：-0.52，-0.03]）在这项具有全国代表性的观察性研究中，我们在主要 IV 分析中没有发现 EPD 使用 TAVR 与院内卒中之间存在关联，并且在我们的次要倾向加权中发现院内卒中风险略有降低。这些发现为大规模随机对照试验提供了坚实的基础，以测试 EPD 是否为接受 TAVR 的患者提供有意义的临床益处。
Stroke remains a devastating complication of transcatheter aortic valve replacement (TAVR), which has persisted despite refinements in technique and increased operator experience. While cerebral embolic protection devices (EPDs) have been developed to mitigate this risk, data regarding their impact on stroke and other outcomes after TAVR are limited. We performed an observational study using data from the STS/ACC-TVT Registry. Patients were included if they underwent elective or urgent transfemoral TAVR between January 2018 and December 2019. The primary outcome was in-hospital stroke. To adjust for confounding, the association between EPD use and clinical outcomes was evaluated using instrumental variable (IV) analysis, a technique designed to support causal inference from observational data, with site-level preference for EPD use within the same quarter of the procedure as the instrument. We also performed a propensity score-based secondary analysis using overlap weights. Our analytic sample included 123,186 patients from 599 sites. The use of EPD during TAVR increased over time, reaching 28% of sites and 13% of TAVR procedures by December 2019. There was wide variation in EPD use across hospitals, with 8% of sites performing >50% of TAVR procedures with an EPD and 72% performing zero procedures with an EPD in the last quarter of 2019. In our primary analysis using the IV model, there was no association between EPD use and in-hospital stroke (adjusted relative risk (0.90 [95% CI: 0.68, 1.13], absolute risk difference −0.15% [95% CI: −0.49, 0.20]). However, in our secondary analysis using the propensity score-based model, EPD use was associated with 18% lower odds of in-hospital stroke (adjusted OR 0.82 [95% CI 0.69, 0.97], absolute risk difference −0.28% [95% CI: −0.52, −0.03]). Results were generally consistent across the secondary endpoints as well as subgroup analyses. In this nationally-representative observational study, we did not find an association between EPD use for TAVR and in-hospital stroke in our primary IV analysis, and found only a modestly lower risk of in-hospital stroke in our secondary propensity-weighted analysis. These findings provide a strong basis for large-scale RCTs to test whether EPDs provide meaningful clinical benefit for patients undergoing TAVR.