Wolfson Medical Center, Holon, Israel.
The Faculty of Medicine, Tel Aviv University, Ramat Aviv, Tel Aviv, Israel.
EuroIntervention. 2023 Dec 18;19(11):e948-e952. doi: 10.4244/EIJ-D-23-00465.
Stroke and other clinically significant embolic complications are well documented in the early period following transcatheter aortic valve replacement (TAVR). The CAPTIS device is an embolic protection system, designed to provide neurovascular and systemic protection by deflecting debris away from the brain's circulation, capturing the debris and thus avoiding systemic embolisation.
We aimed to study the safety and feasibility study of the CAPTIS complete cerebral and full-body embolic protection system during TAVR.
A first-in-human study investigated the safety, feasibility and debris capturing ability of CAPTIS during TAVR. Patients were followed for 30 days. The primary endpoints were device safety and cerebrovascular events at 72 hours.
Twenty patients underwent TAVR using balloon-expandable or self-expanding valve systems. CAPTIS was successfully delivered, positioned, deployed, and retrieved in all cases, and TAVR was successfully completed without device-related complications. No cerebrovascular events were observed. High numbers of debris particles were captured in all patients.
The use of the CAPTIS full-body embolic protection system during TAVR was safe, and it captured a substantial number of debris particles. No patient suffered from a cerebrovascular event. A randomised clinical trial is warranted to prove its efficacy.
经导管主动脉瓣置换术（TAVR）后早期，中风和其他临床上显著的栓塞并发症已有充分记录。CAPTIS 装置是一种栓塞保护系统，旨在通过将碎片从大脑循环中偏转开，捕获碎片并避免全身栓塞，从而提供神经血管和全身保护。
我们旨在研究 CAPTIS 完整脑和全身栓塞保护系统在 TAVR 中的安全性和可行性研究。
一项首次人体研究调查了 CAPTIS 在 TAVR 期间的安全性、可行性和碎片捕获能力。患者随访 30 天。主要终点是 72 小时内设备安全性和脑血管事件。
20 例患者接受了球囊扩张或自扩张瓣膜系统的 TAVR。在所有情况下，CAPTIS 均成功输送、定位、展开和取回，并且 TAVR 成功完成，无器械相关并发症。未观察到脑血管事件。所有患者均捕获了大量的碎片颗粒。
在 TAVR 期间使用 CAPTIS 全身栓塞保护系统是安全的，并且捕获了大量的碎片颗粒。没有患者发生脑血管事件。需要进行随机临床试验来证明其疗效。
