Sistema de Salut de Catalunya
Institut Català de la Salut
[Tomasello A, Hernandez D, Piñana C] Servei de Neuroradiologia, Vall d'Hebron Hospital Universitari, Barcelona, Spain. [Requena M, Ribo M] Unitat d’Ictus, Vall d’Hebron Hospital Universitari, Barcelona, Spain. Universitat Autònoma de Barcelona, Bellaterra, Spain. [Liebeskind DS] Neurovascular Imaging Research Core and University of California Los Angeles Stroke Center, Department of Neurology, University of California, Los Angeles, CA, USA. [Nogueira RG] Department of Neurology, Neurosurgery and Radiology, Emory University School of Medicine, Atlanta, GA, USA
Vall d'Hebron Barcelona Hospital Campus
2023-01-10T08:27:40Z
2023-01-10T08:27:40Z
2022-06
Mechanical thrombectomy; New device; Stroke
Trombectomia mecànica; Nou dispositiu; Ictus
Trombectomía mecánica; Nuevo dispositivo; Ictus
Introduction 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. Methods 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. Results 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. Conclusions 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.
The study was funded by Anaconda Biomed S.L.
Article
Published version
English
Vasos sanguinis - Cirurgia; Malalties cerebrovasculars; Avaluació de resultats (Assistència sanitària); ANALYTICAL, DIAGNOSTIC AND THERAPEUTIC TECHNIQUES, AND EQUIPMENT::Surgical Procedures, Operative::Cardiovascular Surgical Procedures::Vascular Surgical Procedures::Thrombectomy::Mechanical Thrombolysis; DISEASES::Nervous System Diseases::Central Nervous System Diseases::Brain Diseases::Cerebrovascular Disorders::Stroke; ANALYTICAL, DIAGNOSTIC AND THERAPEUTIC TECHNIQUES, AND EQUIPMENT::Diagnosis::Prognosis::Treatment Outcome; TÉCNICAS Y EQUIPOS ANALÍTICOS, DIAGNÓSTICOS Y TERAPÉUTICOS::intervenciones quirúrgicas::procedimientos quirúrgicos cardiovasculares::procedimientos quirúrgicos vasculares::trombectomía::trombólisis mecánica; ENFERMEDADES::enfermedades del sistema nervioso::enfermedades del sistema nervioso central::enfermedades cerebrales::trastornos cerebrovasculares::accidente cerebrovascular; TÉCNICAS Y EQUIPOS ANALÍTICOS, DIAGNÓSTICOS Y TERAPÉUTICOS::diagnóstico::pronóstico::resultado del tratamiento
Elsevier
Journal of Neuroradiology;49(4)
https://doi.org/10.1016/j.neurad.2020.11.003
Attribution-NonCommercial-NoDerivatives 4.0 International
http://creativecommons.org/licenses/by-nc-nd/4.0/
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