Contilia Heart- and Vascular Center, Elisabeth Krankenhaus Essen, Essen, Germany.
EuroIntervention. 2012 May 15;8(1):43-50. doi: 10.4244/EIJV8I1A8.
We describe the first-in-human experience with a novel cerebral embolic protection device used during transcatheter aortic valve implantation (TAVI). One current challenge of TAVI is the reduction of procedural stroke. Procedural mobilisation of debris is a known source of cerebral embolisation. Mechanical protection by transient filtration of cerebral blood flow might reduce the embolic burden during TAVI. We aimed to evaluate the feasibility and safety of the Claret CE Pro™ cerebral protection device in patients undergoing TAVI.
Patients scheduled for TAVI were prospectively enrolled at three centres. The Claret CE Pro™ (Claret Medical, Inc. Santa Rosa, CA, USA) cerebral protection device was placed via the right radial/brachial artery prior to TAVI and was removed after the procedure. The primary endpoint was technical success rate. Secondary endpoints encompassed procedural and 30-day stroke rates, as well as device-related complications. Deployment of the Claret CE Pro™ cerebral protection device was intended for use in 40 patients, 35 devices were implanted into the aortic arch. Technical success rate with delivery of the proximal and distal filter was 60% for the first generation device and 87% for the second-generation device. Delivery times for the first-generation device were 12.4±12.1 minutes and 4.4 ± 2.5 minutes for the second-generation device (p<0.05). The quantity of contrast used related to the Claret CE Pro System was 19.6 ± 3.8 ml. Captured debris was documented in at least 19 of 35 implanted devices (54.3%). No procedural transient ischaemic attacks, minor strokes or major strokes occurred. Thirty-day follow-up showed one minor stroke occurring 30 days after the procedure, and two major strokes both occurring well after the patient had completed TAVI.
The use of the Claret CE Pro™ system is feasible and safe. Capture of debris in more than half of the patients provides evidence for the potential to reduce the procedural cerebral embolic burden utilising this dedicated filter system during TAVI.
我们描述了一种新型脑保护装置在经导管主动脉瓣置换术（TAVI）中的首次人体应用经验。TAVI 的一个当前挑战是降低程序中风的发生率。程序性移动碎片是已知的脑栓塞来源。通过短暂过滤脑血流进行机械保护可能会降低 TAVI 期间的栓塞负担。我们旨在评估在接受 TAVI 的患者中使用 Claret CE Pro™脑保护装置的可行性和安全性。
前瞻性地在三个中心招募了计划进行 TAVI 的患者。Claret CE Pro™（Claret Medical，Inc.，美国加利福尼亚州圣罗莎）脑保护装置通过右桡/肱动脉在 TAVI 前放置，并在手术后取出。主要终点是技术成功率。次要终点包括程序和 30 天的中风发生率以及与器械相关的并发症。Claret CE Pro™脑保护装置的部署旨在用于 40 名患者，35 个装置被植入主动脉弓。第一代装置近端和远端过滤器的输送技术成功率为 60%，第二代装置为 87%。第一代装置的输送时间为 12.4±12.1 分钟，第二代装置为 4.4 ± 2.5 分钟（p<0.05）。与 Claret CE Pro 系统相关的造影剂使用量为 19.6 ± 3.8 ml。至少有 19 个植入的装置中记录到了捕获的碎片（54.3%）。没有发生程序性短暂性脑缺血发作、小中风或大中风。30 天随访显示，1 例小中风发生在手术后 30 天，2 例大中风均发生在患者完成 TAVI 后。
Claret CE Pro™系统的使用是可行且安全的。超过一半的患者中捕获到的碎片提供了证据，表明在 TAVI 期间使用这种专用过滤器系统可能会降低程序性脑栓塞负担。
