Interventional Neuroradiology Section, Department of Radiology, Vall d'Hebron University Hospital, Barcelona, Spain. Electronic address: https://twitter.com/atomasell.
Interventional Neuroradiology Section, Department of Radiology, Vall d'Hebron University Hospital, Barcelona, Spain.
J Neuroradiol. 2022 Jun;49(4):324-328. doi: 10.1016/j.neurad.2020.11.003. Epub 2020 Dec 16.
The ANA™ (Anaconda Biomed) thrombectomy system is a novel stroke thrombectomy device comprising a self-expanding funnel designed to reduce clot fragmentation by locally restricting flow while becoming as wide as the lodging artery. Once deployed, ANA allows distal aspiration in combination with a stentretriever (SR) to mobilize the clot into the funnel where it remains copped during extraction. We investigate safety and efficacy of ANA™ in a first-in-man study.
Prospective data was collected on 35 consecutive patients treated as first line with ANA™ at a single centre. Outcome measures included per-pass reperfusion scores, symptomatic intracerebral hemorrhage (sICH), NIHSS at day 5, and mRS at 90 days.
Median NIHSS was 12(9-18). Sites of primary occlusion were: 5 ICA, 15 M1-MCA, 15 M2-MCA. Primary performance endpoint, mTICI 2b-3 within 3 passes without rescue therapy was achieved in 91.4% (n = 32) of patients; rate of complete recanalization (mTICI 2c-3) was 65.7%. First pass complete recanalization rate was 42.9%, and median number of ANA passes 1(IQR: 1-2). In 17.1% (n = 6) rescue treatment was used; median number of rescue passes was 2(1-7), leading to a final mTICI2b-3rate of 94.3% (n = 33). There were no device related serious adverse events, and rate of sICH was 5.7% (n = 2). At 5 days median NIHSS was 1 (IQR 1-6) and 90 days mRS 0-2 was achieved in 60% of patients.
In this initial clinical experience, the ANA™ device achieved a high rate of complete recanalization with a good safety profile and favourable 90 days clinical outcomes.
ANA™（Anaconda Biomed）血栓切除术系统是一种新型的卒中取栓装置，由一个自膨式漏斗组成，旨在通过局部限制血流来减少血栓碎片形成，同时使漏斗与嵌入动脉等宽。一旦部署，ANA 允许在远端进行抽吸，并与支架取栓器（SR）联合使用，将血栓移动到漏斗中，在提取过程中保持包裹。我们在一项首例人体研究中调查了 ANA™ 的安全性和疗效。
在一家单中心对 35 例连续接受 ANA™ 一线治疗的患者进行前瞻性数据收集。观察指标包括单次通过再灌注评分、症状性颅内出血（sICH）、第 5 天 NIHSS 和 90 天 mRS。
中位 NIHSS 为 12（9-18）。主要闭塞部位为：5 例颈内动脉，15 例大脑中动脉 M1-MCA，15 例大脑中动脉 M2-MCA。主要性能终点为在 3 次通过内无挽救性治疗达到 mTICI 2b-3 的患者比例为 91.4%（n=32）；完全再通率（mTICI 2c-3）为 65.7%。初次通过完全再通率为 42.9%，ANA 通过次数中位数为 1（IQR：1-2）。17.1%（n=6）患者使用了挽救性治疗；挽救性治疗通过次数中位数为 2（1-7），最终 mTICI2b-3 率为 94.3%（n=33）。无器械相关严重不良事件，sICH 发生率为 5.7%（n=2）。第 5 天中位 NIHSS 为 1（IQR 1-6），90 天 mRS 0-2 的患者比例为 60%。
在这一初步临床经验中，ANA™ 装置实现了较高的完全再通率，具有良好的安全性和良好的 90 天临床结局。
