Objectives

This study sought to evaluate the feasibility of complete cerebral protection during transcatheter aortic valve replacement (TAVR) with a novel embolic protection device.

Background

Evidences and data about new cerebral embolic protection devices are lacking and scarce.

Methods

A prospective, nonrandomized, multicenter, first-in-man pilot study designed to evaluate the efficacy and safety of cerebral embolic protection utilizing the Emblok embolic protection system (Innovative Cardiovascular Solutions, Grand Rapids, Michigan) during TAVR. The Emblok is a transfemoral aortic filter that provide full coverage of the epiaortic vessels. Brain diffusion-weighted magnetic resonance imaging (DW-MRI) was performed at baseline and 2 to 5 days after TAVR. Primary endpoints were technical success and immediate cerebral embolic burden after TAVR, defined as number and volume of new brain lesions detected with DW-MRI at days 2 to 5 post-TAVR compared with baseline.

Results

A total of 20 subjects were enrolled. The Emblok system was successfully positioned in all the cases. At 30-day follow-up, no major adverse cardiovascular and cerebrovascular events occurred. Nineteen (95%) patients had new ischemic defects at post-procedural DW-MRI. The median number of new lesions per patient was 10.00 (interquartile range [IQR]: 4.75 to 15.25). The total new lesion volume was 199.9 mm³ (IQR: 83.9 to 447.5 mm³) and the mean lesion volume per lesion was 42.5 mm³ (IQR: 21.5 to 75.6 mm³). Histopathologic analysis showed evidence of significant debris in 18 (90%) filters.

Conclusions

The Emblok embolic protection system appears to be feasible and safe during TAVR. The device was successfully placed and retrieved in all cases and no neurological events were observed. Cerebral total new lesion volume was similar to other trials on cerebral protection during TAVR, thus warranting a larger study. (European Study Evaluating the Emblok Embolic Protection System During TAVR; NCT03130491)

中文翻译：

---

评估经导管主动脉瓣置换过程中栓塞栓塞保护系统的首次人体研究

目标

这项研究试图评估用新型栓塞保护装置在经导管主动脉瓣置换术（TAVR）期间进行完全脑保护的可行性。

背景

缺乏关于新型脑栓塞保护装置的证据和数据。

方法

A prospective, nonrandomized, multicenter, first-in-man pilot study designed to evaluate the efficacy and safety of cerebral embolic protection utilizing the Emblok embolic protection system (Innovative Cardiovascular Solutions, Grand Rapids, Michigan) during TAVR. The Emblok is a transfemoral aortic filter that provide full coverage of the epiaortic vessels. Brain diffusion-weighted magnetic resonance imaging (DW-MRI) was performed at baseline and 2 to 5 days after TAVR. Primary endpoints were technical success and immediate cerebral embolic burden after TAVR, defined as number and volume of new brain lesions detected with DW-MRI at days 2 to 5 post-TAVR compared with baseline.

Results

A total of 20 subjects were enrolled. The Emblok system was successfully positioned in all the cases. At 30-day follow-up, no major adverse cardiovascular and cerebrovascular events occurred. Nineteen (95%) patients had new ischemic defects at post-procedural DW-MRI. The median number of new lesions per patient was 10.00 (interquartile range [IQR]: 4.75 to 15.25). The total new lesion volume was 199.9 mm³ (IQR: 83.9 to 447.5 mm³) and the mean lesion volume per lesion was 42.5 mm³ (IQR: 21.5 to 75.6 mm³). Histopathologic analysis showed evidence of significant debris in 18 (90%) filters.

Conclusions

在TAVR期间，Emblok栓塞保护系统似乎是可行且安全的。在所有情况下都成功放置并取回了该设备，未观察到神经系统事件。在TAVR期间，脑新病变总体积与其他有关脑保护的试验相似，因此值得进行更大的研究。（欧洲评估TAVR期间栓塞栓塞保护系统的研究; NCT03130491）