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Mechanical thrombectomy with a novel device: initial clinical experience with the ANA thrombectomy device - 30/12/20

Doi : 10.1016/j.neurad.2020.11.003 
Alejandro Tomasello a , David Hernandez a, Carlos Piñana a, Manuel Requena b, , David S. Liebeskind c, Raul G. Nogueira d, Tudor Jovin e, Tommy Andersson f, g, Christoph Cognard h, Adnan Siddiqui i, Marc Ribo b
a Interventional Neuroradiology Section, Department of Radiology, Vall d'Hebron University Hospital, Barcelona, Spain 
b Stroke Unit, Hospital Universitari Vall d’Hebron, Universitat Autònoma de Barcelona, Spain 
c Neurovascular Imaging Research Core and University of California Los Angeles Stroke Center, Department of Neurology, University of California, Los Angeles, CA, USA 
d Department of Neurology, Neurosurgery and Radiology, Emory University School of Medicine, Atlanta, GA, USA 
e Department of Neurology, UPMC, Pittsburgh, PA, USA 
f Departments of Radiology and Neurology, AZ Groeninge, Kortrijk, Belgium 
g Departments of Neuroradiology and Clinical Neuroscience, Karolinska University Hospital, Karolinska Institutet, Stockholm, Sweden 
h Diagnostic and Therapeutic Neuroradiology, Hôpital Purpan, 31300, Toulouse, France 
i Department of Neurosurgery, University of Buffalo Jacobs School of Medicine and Biomedical Sciences, Buffalo, NY, USA 

Corresponding author at: Unitat d’Ictus, Hospital Vall d ́Hebron, Passeig Vall d ́Hebron 119, Barcelona 08035, Spain.Unitat d’IctusHospital Vall d ́HebronPasseig Vall d ́Hebron 119Barcelona08035Spain
Sous presse. Épreuves corrigées par l'auteur. Disponible en ligne depuis le Wednesday 30 December 2020

Graphical abstract




Le texte complet de cet article est disponible en PDF.

Highlights

The ANA™ thrombectomy system is a novel device comprising a self-expanding funnel designed to reduce fragmentation by locally restricting flow.
In in vitro phantom and swine models ANA™ device showed high recanalization rates with no safety concerns.
In this first-in-human study, the ANA™ device achieved a high rate of complete reperfusion, sudden recanalization, and a good safety profile.

Le texte complet de cet article est disponible en PDF.

Abstract

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.

Le texte complet de cet article est disponible en PDF.

Keywords : Mechanical thrombectomy, Stroke, New device


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© 2020  The Authors. Publié par Elsevier Masson SAS. Tous droits réservés.
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