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 (Walrus Large Bore guide Catheter Impact on reCanalization first pass Effect anD outcomes).
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 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 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.
Data availability statement
Data are available upon reasonable request.
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Contributors All authors have substantially contributed to the conception and design of the study and/or data acquisition. All authors made critical revisions to the manuscript. GMC drafted the original manuscript.
Funding A research grant was provided by Q’Apel Medical. The company had no role in collecting, analyzing, and interpreting the data, writing the report, and deciding to submit the paper for publication.
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.
Provenance and peer review Not commissioned; externally peer reviewed.