Walrus large bore guide catheter impact on recanalization first pass effect and outcomes: the WICkED study.


Journal

Journal of neurointerventional surgery
ISSN: 1759-8486
Titre abrégé: J Neurointerv Surg
Pays: England
ID NLM: 101517079

Informations de publication

Date de publication:
Mar 2022
Historique:
received: 06 03 2021
revised: 31 03 2021
accepted: 01 04 2021
pubmed: 17 4 2021
medline: 19 2 2022
entrez: 16 4 2021
Statut: ppublish

Résumé

The use of a balloon-guide catheter (BGC) in acute stroke treatment has been widely adopted after demonstrating optimized procedure metrics and outcomes. Initial technical constraints of previous devices included catheter stiffness and smaller inner diameters. We aim to evaluate the performance and safety of the Walrus BGC, a variable stiffness catheter with a large bore 0.087 inch inner diameter (ID), via the the WICkED study ( This is a retrospective, site adjudicated, multicenter study on consecutive patients with large vessel occlusion treated with the Walrus BGC. Baseline characteristics, procedural outcomes and functional outcomes were analyzed. A total of 338 patients met the inclusion criteria. The Walrus was successfully tracked into distal vasculature and allowed therapeutic device delivery in all but 3 cases (0.9%). Large aspiration catheters ≥0.070 inch ID were used in 71.9% of cases. Stent retriever thrombectomy was used as the first-line modality in 59.2% and thromboaspiration in 40.8% of cases. The successful recanalization rate (modified treatment in cerebral ischemia (mTICI) 2b/3) was 94.4%, with 64.8% of the patients achieving mTICI 2b/3 after the first pass. The Walrus-related adverse event rate was 0.6%, corresponding to two vessel dissections. Functional independence was 50% (126/252) and mortality 25% (63/252). Unfavorable outcomes were more likely in older patients, who had unsuccessful reperfusion, longer procedure times, and a higher mean number of passes. In acute ischemic stroke patients presenting with large vessel occlusion, the Walrus BGC demonstrated excellent navigability and safety profile, allowed the accommodation of leading large bore aspiration catheters, and demonstrated high vessel recanalization rates.

Sections du résumé

BACKGROUND BACKGROUND
The use of a balloon-guide catheter (BGC) in acute stroke treatment has been widely adopted after demonstrating optimized procedure metrics and outcomes. Initial technical constraints of previous devices included catheter stiffness and smaller inner diameters. We aim to evaluate the performance and safety of the Walrus BGC, a variable stiffness catheter with a large bore 0.087 inch inner diameter (ID), via the the WICkED study (
METHODS METHODS
This is a retrospective, site adjudicated, multicenter study on consecutive patients with large vessel occlusion treated with the Walrus BGC. Baseline characteristics, procedural outcomes and functional outcomes were analyzed.
RESULTS RESULTS
A total of 338 patients met the inclusion criteria. The Walrus was successfully tracked into distal vasculature and allowed therapeutic device delivery in all but 3 cases (0.9%). Large aspiration catheters ≥0.070 inch ID were used in 71.9% of cases. Stent retriever thrombectomy was used as the first-line modality in 59.2% and thromboaspiration in 40.8% of cases. The successful recanalization rate (modified treatment in cerebral ischemia (mTICI) 2b/3) was 94.4%, with 64.8% of the patients achieving mTICI 2b/3 after the first pass. The Walrus-related adverse event rate was 0.6%, corresponding to two vessel dissections. Functional independence was 50% (126/252) and mortality 25% (63/252). Unfavorable outcomes were more likely in older patients, who had unsuccessful reperfusion, longer procedure times, and a higher mean number of passes.
CONCLUSION CONCLUSIONS
In acute ischemic stroke patients presenting with large vessel occlusion, the Walrus BGC demonstrated excellent navigability and safety profile, allowed the accommodation of leading large bore aspiration catheters, and demonstrated high vessel recanalization rates.

Identifiants

pubmed: 33858971
pii: neurintsurg-2021-017494
doi: 10.1136/neurintsurg-2021-017494
doi:

Types de publication

Journal Article Multicenter Study

Langues

eng

Sous-ensembles de citation

IM

Pagination

280-285

Informations de copyright

© Author(s) (or their employer(s)) 2022. No commercial re-use. See rights and permissions. Published by BMJ.

Déclaration de conflit d'intérêts

Competing interests: RDT is also an employee of Siemens Healthineers and Corindus, and a consultant for Johnson and Johnson, Q’Apel Medical, Rebound Therapeutics, Integra Lifesciences, Medtronic, Echovate, Viseon; holds stock in Q’Apel Medical, Rebound Therapeutics, Echovate, Viseon, Synchron, Blockade Medical, Endostream Medical, and receives royalty fees from the Medical University of South Carolina. AHS reports grants from Coinvestigator: NIH/NINDS 1R01NS091075 Virtual Intervention of Intracranial Aneurysms; personal fees from Adona Medical, Inc, Amnis Therapeutics, BlinkTBI, Inc, Boston Scientific Corp (for purchase of Claret Medical), Buffalo Technology Partners, Inc, Cardinal Consultants, LLC, Cerebrotech Medical Systems, Inc, Cognition Medical, Endostream Medical, Ltd, Imperative Care, Inc, International Medical Distribution Partners, Neurovascular Diagnostics, Inc, Q’Apel Medical, Inc, Rebound Therapeutics Corp (purchased 2019 by Integra Lifesciences, Corp), Rist Neurovascular, Inc, Sense Diagnostics, Inc, Serenity Medical, Inc, Silk Road Medical, Spinnaker Medical, Inc, StimMed, Synchron, Three Rivers Medical, Inc, Vastrax, LLC, VICIS, Inc, Viseon, Inc, personal fees from Amnis Therapeutics, Boston Scientific, Canon Medical Systems USA, Inc, Cerebrotech Medical Systems, Inc, Cerenovus, Corindus, Inc, Endostream Medical, Ltd, Imperative Care, Inc, Integra LifeSciences Corp, Medtronic, MicroVention, Minnetronix Neuro, Inc, Northwest University, Penumbra, Q’Apel Medical, Inc, Rapid Medical, Rebound Therapeutics Corp, Serenity Medical, Inc, Silk Road Medical, StimMed, Stryker, Three Rivers Medical, Inc, VasSol, W.L. Gore & Associates, and personal fees from Cerenovus; Medtronic; MicroVention; consultant fees for opinion on the design of clinical trials. ASP is a consultant for and has received research grants from Stryker Neurovascular, Medtronic, Cerenovus. He has received NIH grants. He is also a consultant for Microvention, QApel, Perfuze Medical, Arsenal Medical, Merit Medical. Holds stock in InNeuroCo Inc, Galaxy therapeutics, Agile Medical, Perfuze medical and NTI. JM has received research grants from Stryker, Penumbra, and Microvention. He is a consultant to Endostream, Viseon, Imperative Care, RIST, Synchron, Viz.ai, Perflow, CVAid, and Cerebrotech. He is investor/stockholder at Rebound, BlinkTBI, Endostream, Viseon, Imperative Care, Serenity, Cardinal Consulting, NTI, RIST, Synchron, Viz.ai, Q’Apel Medical, and Cerebrotech. JV is a consultant for Integra Life Sciences, Corindus Vascular Robotics, Cerenovus, Integra, and Medtronic. Own equity in Truvic Medical and Visom Technologies, and he is founder and co-partner of Ceretronic LLC.IC is a consultant to Cerenovus (JNJ), Medtronic, Q’Apel Medical, Microvention, and Serenity. He is a stockholder at Truvic, Imperative care, Rist, The Near Center, Q’Apel, Cerebrotech, Synchron, Echovate, Three Rivers Medical Inc, and Serenity. AA is on an advisory board for iSchema View. AST is a consultant for Cardinal Consulting, Cerebrotech, Cerenovus, Corindus Robotics, Endostream Medical, Medtronic, Siemens, Imperative Care, Three Rivers Medical, Vastrax, Shape Memory, Serenity Medical, 880 Medical, and Q’Apel; stock holder in Cerebrotech, Endostream Medical, Imperative Care, Three Rivers Medical, Vastrax, Pipe Therapeutics, Q’Apel, Shape Memory, Synchron, Serenity Medical, Blink TBI, Echovate, RIST, Apama, VIZ AI, Early Bird Medicak, Radical Medical, Spinnaker Medical; co-founder of PipeTherapeutics, Neuro Technology Investors (NTI), National Education and Research Center (NEAR), Imperative Care; on the board of BlinkTBI and provides expert testimony for Corindus Vascular Robotics. RAH is a consultant for Medtronic, Stryker, Cerenovous, Microvention, Balt, Phenox, Rapid Medical and Q’Apel. He is on advisory board for MiVI, eLum, Three Rivers, Shape Medical and Corindus. In restricted research grant from NIH, Interline Endowment, Microvention, Stryker, CNX. Investor/stockholder for InNeuroCo, Cerebrotech, eLum, Endostream, Three Rivers Medical Inc, Scientia, RisT, BlinkTBI, and Corindus. All the other authors have no disclosure to report.

Auteurs

Gustavo M Cortez (GM)

Lyerly Neurosurgery, Baptist Neurological Institute, Jacksonville, Florida, USA.
Research, Jacksonville University, Jacksonville, Florida, USA.

Raymond D Turner (RD)

Neurosurgery, Prisma Health Upstate, Greenville, South Carolina, USA.

Andre Monteiro (A)

Neurosurgery, University at Buffalo Jacobs School of Medicine and Biomedical Sciences, Buffalo, New York, USA.

Ajit S Puri (AS)

Radiology, University of Massachusetts Medical Center, Worcester, Massachusetts, USA.

Adnan H Siddiqui (AH)

Neurosurgery, University at Buffalo Jacobs School of Medicine and Biomedical Sciences, Buffalo, New York, USA.

J Mocco (J)

Neurosurgery, Icahn School of Medicine at Mount Sinai, New York, New York, USA.

Jan Vargas (J)

Neurosurgery, Prisma Health Upstate, Greenville, South Carolina, USA.

Anna L Kuhn (AL)

Radiology, University of Massachusetts Medical Center, Worcester, Massachusetts, USA.

Shahram Majidi (S)

Neurosurgery, Icahn School of Medicine at Mount Sinai, New York, New York, USA.

M Imran Chaudry (MI)

Neurosurgery, Prisma Health Upstate, Greenville, South Carolina, USA.

Amin Aghaebrahim (A)

Lyerly Neurosurgery, Baptist Neurological Institute, Jacksonville, Florida, USA.

Aquilla S Turk (AS)

Neurosurgery, Prisma Health Upstate, Greenville, South Carolina, USA.

Eric Sauvageau (E)

Lyerly Neurosurgery, Baptist Neurological Institute, Jacksonville, Florida, USA.

Ricardo A Hanel (RA)

Lyerly Neurosurgery, Baptist Neurological Institute, Jacksonville, Florida, USA rhanel@lyerlyneuro.com.

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