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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
En prensa. Pruebas corregidas por el autor. Disponible en línea desde el Wednesday 30 December 2020
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Graphical abstract




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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.

El texto completo de este artículo está 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.

El texto completo de este artículo está disponible en PDF.

Keywords : Mechanical thrombectomy, Stroke, New device


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© 2020  The Authors. Publicado por Elsevier Masson SAS. Todos los derechos reservados.
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