Samim Mariam, van der Worp Bart, Agostoni Pierfrancesco, Hendrikse Jeroen, Budde Ricardo P J, Nijhoff Freek, Ramjankhan Faiz, Doevendans Pieter A, Stella Pieter R
Department of Cardiology, University Medical Centre Utrecht, the Netherlands.
Department of Neurology, University Medical Centre Utrecht, the Netherlands.
Catheter Cardiovasc Interv. 2017 Feb 15;89(3):470-477. doi: 10.1002/ccd.26566. Epub 2016 Apr 28.
This study aims to evaluate the safety and performance of the new embolic deflection device TriGuard™HDH in patients undergoing TAVR.
Transcatheter aortic valve replacement (TAVR) is associated with a high incidence of new cerebral ischemic lesions. The use of an embolic protection device may reduce the frequency of TAVR-related embolic events.
This prospective, single arm feasibility pilot study included 14 patients with severe symptomatic aortic stenosis scheduled for TAVR. Cerebral diffusion weighted magnetic resonance imaging (DWI) was planned in all patients one day before and at day 4 (±2) after the procedure. Major adverse cerebral and cardiac events (MACCEs) were recorded for all patients. Primary endpoints of this study were I) device performance success defined as coverage of the aortic arch takeoffs throughout the entire TAVR procedure and II) MACCE occurrence. Secondary endpoints included the number and the volume of new cerebral ischemic lesions on DWI.
Thirteen patients underwent transfemoral TAVR and one patient a transapical procedure. Edwards SAPIEN valve prosthesis was implanted in 8 (57%) patients and Medtronic CoreValve prosthesis in the remaining 6 (43%). Predefined performance success of the TriGuard™HDH device was achieved in 9 (64%) patients. The composite endpoint MACCE occurred in none of the patients. Post-procedural DWI was performed in 11 patients. Comparing the DWI of these patients to a historical control group showed no reduction in number [median 5.5 vs. 5.0, P = 0.857], however there was a significant reduction in mean lesion volume per patient [median 13.8 vs. 25.1, P = 0.049].
This study showed the feasibility and safety of using the TriGuard™HDH for cerebral protection during TAVR. This device did not decrease the number of post-procedural new cerebral DWI lesions, however its use showed decreased lesion volume as compared to unprotected TAVR. © 2016 Wiley Periodicals, Inc.
本研究旨在评估新型栓塞偏转装置TriGuard™HDH在接受经导管主动脉瓣置换术（TAVR）患者中的安全性和性能。
经导管主动脉瓣置换术与新发脑缺血性病变的高发生率相关。使用栓塞保护装置可能会降低TAVR相关栓塞事件的发生频率。
这项前瞻性、单臂可行性初步研究纳入了14例计划接受TAVR的重度有症状主动脉瓣狭窄患者。所有患者在手术前一天和术后第4天（±2天）均计划进行脑扩散加权磁共振成像（DWI）检查。记录所有患者的主要不良脑和心脏事件（MACCE）。本研究的主要终点为：I）装置性能成功，定义为在整个TAVR手术过程中主动脉弓分支得到覆盖；II）MACCE的发生情况。次要终点包括DWI上新发脑缺血性病变的数量和体积。
13例患者接受了经股动脉TAVR，1例患者接受了经心尖手术。8例（57%）患者植入了爱德华SAPIEN瓣膜假体，其余6例（43%）患者植入了美敦力CoreValve瓣膜假体。9例（64%）患者实现了TriGuard™HDH装置的预设性能成功。没有患者发生复合终点MACCE。11例患者进行了术后DWI检查。将这些患者的DWI与一个历史对照组进行比较，结果显示病变数量没有减少[中位数5.5对5.0，P = 0.857]，然而每位患者的平均病变体积有显著减少[中位数13.8对25.1，P = 0.049]。
本研究表明在TAVR期间使用TriGuard™HDH进行脑保护具有可行性和安全性。该装置并未减少术后新发脑DWI病变的数量，但其使用与未受保护的TAVR相比，病变体积有所减小。©2016威利期刊公司。
