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  • Versatile use of catheter systems for deployment of the Pipeline embolization device: a comparison of biaxial and triaxial catheter systems

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Hemorrhagic Stroke
Case series
Versatile use of catheter systems for deployment of the Pipeline embolization device: a comparison of biaxial and triaxial catheter systems
  1. Kunal Vakharia1,2,
  2. Muhammad Waqas1,2,
  3. Hakeem J Shakir1,2,
  4. Felix Chin1,2,
  5. Joelle N Hartke1,
  6. Hussain Shallwani1,2,
  7. Jeffrey S Beecher1,2,
  8. Adnan H Siddiqui2,3,
  9. Elad I Levy2,3
  1. 1 Department of Neurosurgery, University at Buffalo School of Medicine and Biomedical Sciences, Buffalo, New York, USA
  2. 2 Department of Neurosurgery, Gates Vascular Institute, Buffalo, New York, USA
  3. 3 Departments of Neurosurgery and Radiology and Canon Stroke and Vascular Research Center, University at Buffalo, State University of New York, Buffalo, New York, USA
  1. Correspondence to Dr Elad I Levy, Department of Neurosurgery, University at Buffalo, Buffalo, NY 14203, USA; ELevy{at}ubns.com

Abstract

Background A Pipeline embolization device (PED; Medtronic, Dublin, Ireland) can be deployed using either a biaxial or a triaxial catheter delivery system.

Objective To compare the use of these two catheter delivery systems for intracranial aneurysm treatment with the PED.

Methods A retrospective study of patients undergoing PED deployment with biaxial or triaxial catheter systems between 2014 and 2016 was conducted. Experienced neurointerventionalists performed the procedures. Patients who received multiple PEDs or adjunctive coils were excluded. The two groups were compared for PED deployment time, total fluoroscopy time, patient radiation exposure, complications, and cost.

Results Eighty-two patients with 89 intracranial aneurysms were treated with one PED each. In 49 cases, PEDs were deployed using biaxial access; triaxial access was used in 33 cases. Time (min) from guide catheter run to PED deployment was significantly shorter in the biaxial group (24.0±18.7 vs 38.4±31.1, P=0.006) as was fluoroscopy time (28.8±23.0 vs 50.3±27.1, P=0.001). Peak radiation skin exposure (mGy) in the biaxial group was less than in the triaxial group (1243.7±808.2 vs 2074.6±1505.6, P=0.003). No statistically significant differences were observed in transient and permanent complication rates or modified Rankin Scale scores at 30 days. The triaxial access system cost more than the biaxial access system (average $3285 vs $1790, respectively). Occlusion rates at last follow-up (mean 6 months) were similar between the two systems (average 88.1%: biaxial, 89.2%: triaxial).

Conclusion Our results indicate near-equivalent safety and effectiveness between biaxial and triaxial approaches. Some reductions in cost and procedure time were noted with the biaxial system.

  • aneurysm
  • catheter
  • flow diverter
  • technique
  • technology

https://doi.org/10.1136/neurintsurg-2019-015610

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    Footnotes

    • Presented at Digital poster presentation, Congress of Neurological Surgeons Annual Meeting, Boston, Massachusetts USA, October 7-11, 2017.

    • Contributors Conception and design: EIL, HJS, HS, MW; data acquisition: all authors; data analysis and interpretation: MW, KV; drafting the manuscript: MW, KV; critically revising the manuscript: all authors; final approval of the manuscript: all authors.

    • Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.

    • Competing interests AHS: financial interest/investor/stock options/ownership: Amnis Therapeutics, Apama Medical, Blink TBI Inc., Buffalo Technology Partners Inc., Cardinal Consultants, Cerebrotech Medical Systems, Inc. Cognition Medical, Endostream Medical Ltd., Imperative Care, International Medical Distribution Partners, Neurovascular Diagnostics Inc., Q’Apel Medical Inc, Rebound Therapeutics Corp., Rist Neurovascular Inc., Serenity Medical Inc., Silk Road Medical, StimMed, Synchron, Three Rivers Medical Inc., Viseon Spine Inc; consultant/advisory board: Amnis Therapeutics, Boston Scientific, Canon Medical Systems USA Inc., Cerebrotech Medical Systems Inc., Cerenovus, Corindus Inc., Endostream Medical Ltd., Guidepoint Global Consulting, Imperative Care, Integra LifeSciences Corp., Medtronic, MicroVention, Northwest University–DSMB Chair for HEAT Trial, 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; principal investigator/steering comment of the following trials: Cerenovus NAPA and ARISE II; Medtronic SWIFT PRIME and SWIFT DIRECT; MicroVention FRED & CONFIDENCE; MUSC POSITIVE; and Penumbra 3D Separator, COMPASS, and INVEST.EIL; shareholder/ownership interests: NeXtGen Biologics, RAPID Medical, Claret Medical, Cognition Medical, Imperative Care, Rebound Therapeutics, StimMed, Three Rivers Medical; National Principal Investigator/Steering Committees: Medtronic, SWIFT Prime and SWIFT Direct Trials; Honoraria: Medtronic;Consultant: Claret Medical, GLG Consulting, Guidepoint Global, Imperative Care, Medtronic, Rebound, StimMed; Advisory Board: Stryker (AIS Clinical), NeXtGen Biologics, MEDX, Cognition Medical, Endostream Medical; Site Principal Investigator: CONFIDENCE study (MicroVention), STRATIS Study—Sub I (Medtronic).

    • Patient consent for publication Not required.

    • Ethics approval This study was approved by the University at Buffalo Institutional Review Board (IRB ID: 030- 578913).

    • Provenance and peer review Not commissioned; externally peer reviewed.

    • Author note Importance of this work and its contribution to existing literature: (1) Deployment of Pipeline embolization devices (Medtronic, Dublin, Ireland) can be achieved with a biaxial or a triaxial system of catheters. (2) In this study, we share our experience with the use of these two catheter delivery systems for the deployment of Pipeline devices for intracranial aneurysm treatment. (3) To our knowledge, this is the first study to highlight the differences in procedure time, radiation exposure, and potential cost associated with the use of two different catheter systems.