Lansky Alexandra J, Schofer Joachim, Tchetche Didier, Stella Pieter, Pietras Cody G, Parise Helen, Abrams Kevin, Forrest John K, Cleman Michael, Reinöhl Jochen, Cuisset Thomas, Blackman Daniel, Bolotin Gil, Spitzer Stefan, Kappert Utz, Gilard Martine, Modine Thomas, Hildick-Smith David, Haude Michael, Margolis Pauliina, Brickman Adam M, Voros Szilard, Baumbach Andreas
Division of Cardiology, Yale School of Medicine, New Haven, CT, USA Yale Cardiovascular Research Group, New Haven, CT, USA
Cardiovascular Center, Hamburg University, Hamburg, Germany.
Eur Heart J. 2015 Aug 14;36(31):2070-2078. doi: 10.1093/eurheartj/ehv191. Epub 2015 May 19.
To evaluate the safety, efficacy, and performance of the TriGuard™ HDH Embolic Deflection Device (TriGuard) compared with no cerebral protection in patients undergoing transcatheter aortic valve implantation (TAVI).
From February 2014 to March 2015, 85 subjects undergoing TAVI at 13 centres in Europe and Israel were randomized to TriGuard protection vs. no protection. Subjects underwent neurologic and cognitive evaluation at baseline, pre-discharge and 30 days; cerebral diffusion-weighted magnetic resonance imaging was performed at 4 ± 2 days post-procedure and at 30 days. Technical success, which included complete 3-vessel cerebral coverage, was achieved in 88.9% (40/45) of cases. The primary in-hospital procedural safety endpoint (death, stroke, life-threatening or disabling bleeding, stage 2 or 3 acute kidney injury, or major vascular complications) occurred in 21.7% of TriGuard and 30.8% of control subjects (P = 0.34). In the Per Treatment population (subjects with complete three-vessel cerebral coverage), TriGuard use was associated with greater freedom from new ischaemic brain lesions (26.9 vs. 11.5%), fewer new neurologic deficits detected by the National Institutes of Health Stroke Scale (3.1 vs. 15.4%), improved Montreal Cognitive Assessment (MoCA) scores, better performance on a delayed memory task (P = 0.028) at discharge, and a >2-fold increase in recovery of normal cognitive function (MoCA score >26) at 30 days.
TriGuard cerebral protection during TAVI is safe and complete cerebral vessel coverage was achieved in 89% of subjects. In this exploratory study, subjects undergoing protected TAVI had more freedom from ischaemic brain lesions, fewer neurologic deficits, and improved cognitive function in some domains at discharge and 30 days compared with controls.
评估与未进行脑保护相比，TriGuard™ HDH栓塞偏转装置（TriGuard）在接受经导管主动脉瓣植入术（TAVI）患者中的安全性、有效性和性能。
2014年2月至2015年3月，欧洲和以色列13个中心的85例接受TAVI的受试者被随机分为TriGuard保护组和无保护组。受试者在基线、出院前和30天时接受神经和认知评估；术后4±2天和30天时进行脑扩散加权磁共振成像。技术成功（包括完全覆盖三支脑血管）在88.9%（40/45）的病例中实现。主要的院内手术安全终点（死亡、中风、危及生命或致残性出血、2期或3期急性肾损伤或主要血管并发症）在21.7%的TriGuard组和30.8%的对照组受试者中发生（P = 0.34）。在每治疗人群（完全覆盖三支脑血管的受试者）中，使用TriGuard与新发缺血性脑病变的发生率更低（26.9%对11.5%）、美国国立卫生研究院卒中量表检测到的新神经功能缺损更少（3.1%对15.4%）、蒙特利尔认知评估（MoCA）评分改善、出院时延迟记忆任务表现更好（P = 0.028）以及30天时正常认知功能恢复（MoCA评分>26）增加2倍以上相关。
TAVI期间的TriGuard脑保护是安全的，89%的受试者实现了完全的脑血管覆盖。在此探索性研究中，与对照组相比，接受保护性TAVI的受试者在出院时和30天时新发缺血性脑病变的发生率更低、神经功能缺损更少，并且在某些领域的认知功能有所改善。
