Jagielak Dariusz, Targonński Radoslaw, Ciećwierz Dariusz
Department of Cardiac and Vascular Surgery, Medical University of Gdansk Gdansk, Poland.
First Department of Cardiology, Medical University of Gdansk Gdansk, Poland.
Interv Cardiol. 2021 Feb 2;16(Suppl 1):1-4. doi: 10.15420/icr.2021.S1. eCollection 2021 Apr.
Cerebral embolic protection (CEP) devices aim to reduce the risk of periprocedural cerebrovascular events during transcatheter aortic valve implantation (TAVI). Here, the authors describe the first-in-human experience with the ProtEmbo Cerebral Protection System (Protembis), a next-generation CEP device, during TAVI. This case is part of a larger European trial evaluating the safety and performance of this device. After deployment of the ProtEmbo in the aortic arch, a first transcatheter heart valve was implanted. Despite postdilatation, moderate to severe aortic regurgitation persisted. The operating team decided to perform a valve-in-valve procedure using a second transcatheter heart valve. The ProtEmbo demonstrated good coverage of all three head vessels and no interaction with TAVI catheters in the aortic arch throughout the entire procedure. No adverse events were observed during hospitalisation or follow-up, and there was a significant reduction in aortic regurgitation at follow-up echocardiography. Despite a challenging overall procedure with presumably high embolic burden, diffusion-weighted MRI at follow-up showed a low number (n=3) and volume (156 mm) of new hyperintense lesions. The first-in-human use of the ProtEmbo was safe and feasible, despite a challenging TAVI valve-in-valve procedure.
脑栓塞保护（CEP）装置旨在降低经导管主动脉瓣植入术（TAVI）期间围手术期脑血管事件的风险。在此，作者描述了在TAVI期间使用新一代CEP装置ProtEmbo脑保护系统（Protembis）的首例人体经验。该病例是一项评估该装置安全性和性能的大型欧洲试验的一部分。在主动脉弓中部署ProtEmbo后，植入了第一个经导管心脏瓣膜。尽管进行了后扩张，但中度至重度主动脉瓣反流仍然存在。手术团队决定使用第二个经导管心脏瓣膜进行瓣中瓣手术。在整个手术过程中，ProtEmbo对所有三根头臂血管均显示出良好的覆盖，且与主动脉弓中的TAVI导管无相互作用。住院期间或随访期间未观察到不良事件，随访超声心动图显示主动脉瓣反流显著减少。尽管整个手术具有挑战性且栓塞负荷可能较高，但随访时的扩散加权磁共振成像显示新的高强度病变数量较少（n=3）且体积较小（156立方毫米）。尽管TAVI瓣中瓣手术具有挑战性，但ProtEmbo的首例人体使用是安全可行的。
