Cardiology Department, Hospital Álvaro Cunqueiro, University Hospital of Vigo, Vigo, Spain.
Cardiovascular Research Group, Galicia Sur Health Research Institute (IISGS), SERGAS-UVIGO, Vigo, Spain.
EuroIntervention. 2023 Sep 18;19(7):549-570. doi: 10.4244/EIJ-D-23-00166.
Stroke remains a devastating complication of transcatheter aortic valve replacement (TAVR), with the incidence of clinically apparent stroke seemingly fixed at around 3% despite TAVR's significant evolution during the past decade. Embolic showers of debris (calcium, atheroma, valve material, foreign material) are captured in the majority of patients who have TAVR using a filter-based cerebral embolic protection device (CEPD). Additionally, in systematic brain imaging studies, the majority of patients receiving TAVR exhibit new cerebral lesions. Mechanistic studies have shown reductions in the volume of new cerebral lesions using CEPDs, yet the first randomised trial powered for periprocedural stroke within 72 hours of a transfemoral TAVR failed to meet its primary endpoint of showing superiority of the SENTINEL CEPD. The present review summarises the clinicopathological rationale for the development of CEPDs, the evidence behind these devices to date and the emerging recognition of cerebral embolisation in many non-TAVR transcatheter procedures. Given the uniqueness of each of the various CEPDs under development, specific trials tailored to their designs will need to be undertaken to broaden the CEPD field, in addition to evaluating the role of CEPD in non-TAVR transcatheter heart interventions. Importantly, the cost-effectiveness of these devices will require assessment to broaden the adoption of CEPDs globally.
经导管主动脉瓣置换术（TAVR）后仍然存在严重的中风并发症，尽管 TAVR 在过去十年中发生了重大变化，但临床上明显中风的发生率似乎固定在 3%左右。使用基于过滤器的脑栓塞保护装置（CEPD）的大多数 TAVR 患者中，都会捕获到碎片（钙、动脉粥样硬化、瓣膜材料、异物）的栓塞阵雨。此外，在系统的脑部成像研究中，大多数接受 TAVR 的患者都有新的脑部病变。机制研究表明，使用 CEPD 可减少新的脑部病变的体积，但第一项针对经股 TAVR 后 72 小时内围手术期中风的随机试验未能达到其主要终点，即 SENTINEL CEPD 的优越性。本综述总结了 CEPD 发展的临床病理原理、迄今为止这些设备背后的证据以及在许多非 TAVR 经导管程序中对脑栓塞的新认识。鉴于每种不同的 CEPD 的独特性，需要开展专门针对其设计的特定试验来拓宽 CEPD 领域，此外还需要评估 CEPD 在非 TAVR 经导管心脏介入中的作用。重要的是，需要评估这些设备的成本效益，以在全球范围内更广泛地采用 CEPD。
