R&D, Anaconda Biomed, Barcelona, St Cugat del Valles, Spain.
CBSET Inc, Lexington, Massachusetts, USA.
J Neurointerv Surg. 2020 Oct;12(10):1008-1013. doi: 10.1136/neurintsurg-2019-015548. Epub 2020 Jan 20.
The Advanced Thrombectomy System (ANCD) provides a new funnel component designed to reduce clot fragmentation and facilitate retrieval in patients with stroke by locally restricting flow, allowing distal aspiration in combination with a stent retriever (SR).
To evaluate the preclinical efficacy and safety of the ANCD in a swine clot model.
Soft and firm clots were implanted in the lingual and cervical arteries of 11 swine to obtain Thrombolysis in Cerebral Infarction (TICI) 0 blood flow. Mechanical thrombectomy was performed with either a balloon guide catheter+Solitaire 2 stent retriever (BGC+SR, n=13) or ANCD+SR (n=13). TICI flow was evaluated and successful revascularization was defined as TICI 3 (normal perfusion). To characterize safety, a total of 3 passes were performed in each vessel independent of recanalization. Tissues were explanted for histopathological analysis after 3 and 30 days, respectively.
First pass reperfusion rates were ANCD+SR: 69% and BGC+SR: 46%. Reperfusion increased after the third pass in both groups (ANCD+SR: 100%, vs BGC+SR: 77%). Recanalization was achieved after an average of 1.4 and 1.9 passes in ANCD+SR and BGC+SR (p=0.095), respectively. Vessel injury was comparable in both groups; endothelial loss at 3 days was the most common injury seen (ANCD+SR: 1.78±1.22; BGC+SR: 2.03±1.20; p=0.73), while other histopathological markers were absent or minimal. Tissues downstream from targeted vessels also showed absence or minimal lesions across both groups.
Results in a swine clot model support the high efficacy of the ANCD+SR without causing clinically significant vessel injury potentially related to the new funnel component.
高级血栓切除术系统（ANCD）提供了一种新的漏斗部件，旨在通过局部限制血流，允许与支架取栓器（SR）结合进行远端抽吸，从而减少血栓碎片并促进卒中患者的取栓。
在猪血栓模型中评估 ANCD 的临床前疗效和安全性。
在 11 头猪的舌动脉和颈总动脉中植入软栓和硬栓，以获得血流为 Thrombolysis in Cerebral Infarction（TICI）0 的血栓。分别使用球囊引导导管+Solitaire 2 支架取栓器（BGC+SR，n=13）或 ANCD+SR（n=13）进行机械取栓。评估 TICI 血流，成功再通定义为 TICI 3（正常灌注）。为了评估安全性，在每个血管中均独立于再通进行了总共 3 次通过。分别在第 3 天和第 30 天取出组织进行组织病理学分析。
首次再灌注率分别为 ANCD+SR：69%和 BGC+SR：46%。两组在第三次通过后再灌注均增加（ANCD+SR：100%，vs BGC+SR：77%）。ANCD+SR 和 BGC+SR 分别平均 1.4 次和 1.9 次通过后实现再通（p=0.095）。两组血管损伤相当；3 天时内皮丢失最为常见（ANCD+SR：1.78±1.22；BGC+SR：2.03±1.20；p=0.73），而其他组织病理学标志物缺失或很少见。靶血管下游的组织在两组中也表现出缺失或很少见的病变。
在猪血栓模型中的结果支持 ANCD+SR 的高效性，而不会导致与新漏斗部件相关的临床显著血管损伤。
