Comparative Efficacy of Flow Diverter Devices in the Treatment of Carotid Sidewall Intracranial Aneurysms: a Retrospective, Multicenter Study

Adam A Dmytriw^{1

2

3

4

5}, Hamza Adel Salim^{6

7

7}, Basel Musmar⁸, Nicole M Cancelliere⁹, Christoph J Griessenauer¹⁰, Robert W Regenhardt¹¹, Jesse Jones¹², Vincent Tutino¹³, Zuha Hasan¹⁴, Nicola Limbucci¹⁵, Sovann V Lay¹⁶, Julian Spears¹⁴, James D Rabinov¹¹, Mark R Harrigan¹⁴, Adnan H Siddiqui¹³, Elad I Levy¹³, Christopher J Stapleton¹¹, Leonardo Renieri¹⁷, Christophe Cognard¹⁸, Hamza Shaikh¹⁹, Anna Luisa Kühn²⁰, Markus A Möhlenbruch²¹, Stavropoula I Tjoumakaris²², Pascal Jabbour²³, Philipp Taussky²⁴, Fabio Settecase²⁵, Manraj K S Heran²⁵, Anh Nguyen²⁶, David Volders²⁷, Pablo Harker²⁸, Diego A Devia²⁹, Ajit S Puri³⁰, Marios Psychogios²⁶, Juan C Puentes²⁹, Giuseppe Leone^{31

32}, Giuseppe Buono³², Margherita Tarantino³², Mario Muto³¹, Francesco Briganti³¹, Shamsher Dalal³³, Vamsi Gontu³⁴, Rodolfo E Alcedo Guardia³⁵, Juan C Vicenty-Padilla³⁵, Patrick Brouwer³⁴, Matthias H Schmidt²⁷, Clemens Schirmer³³, Gwynedd E Pickett²⁷, Tommy Andersson³⁴, Michael Söderman³⁴, Thomas R Marotta²³, Hugo Cuellar-Saenz⁸, Ajith J Thomas³⁶, Aman B Patel¹¹, Vitor Mendes Pereira¹¹, Nimer Adeeb⁸; Flow diversion Multinational Observational cohort Device comparsion (FlowMOD) Investigators

Affiliations

¹ Neurovascular Centre, Departments of Medical Imaging and Neurosurgery, St. Michael's Hospital, Toronto, ON, Canada. admytriw@mgh.harvard.edu.
² Neuroendovascular Program, Massachusetts General Hospital, Harvard University, Boston, MA, USA. admytriw@mgh.harvard.edu.
³ Division of Diagnostic and Therapeutic Neuroradiology, Department of Radiology, St. Michael's Hospital, University of Toronto, Toronto, ON, Canada. admytriw@mgh.harvard.edu.
⁴ Neuroendovascular Program, Massachusetts General Hospital: Brigham, Boston, USA. admytriw@mgh.harvard.edu.
⁵ Women's Hospital, Harvard University, Boston, MA, USA. admytriw@mgh.harvard.edu.
⁶ Neuroendovascular Program, Massachusetts General Hospital, Harvard University, Boston, MA, USA. Hamza.sleeem@gmail.com.
⁷ Department of Radiology, Division of Neuroradiology, Johns Hopkins Medical Center, Baltimore, MD, USA. Hamza.sleeem@gmail.com.
⁸ Department of Neurosurgery and Interventional Neuroradiology, Louisiana State University, Baton Rouge, LA, USA.
⁹ Department of Neuroradiology, St. Michael's Hospital, Toronto, ON, Canada.
¹⁰ Department of Neurosurgery, Christian Doppler University Hospital & Institute of Neurointervention, Salzburg, Austria.
¹¹ Department of Neuroradiology, Massachusetts General Hospital & Brigham and Women's Hospital, Boston, MA, USA.
¹² Deparments of Neurosurgery and Radiology, University of Alabama at Birmingham, Birmingham, AL, USA.
¹³ Department of Neurosurgery, University of Alabama at Birmingham, Birmingham, AL, USA.
¹⁴ Neurovascular Centre, Departments of Medical Imaging and Neurosurgery, St. Michael's Hospital, Toronto, ON, Canada.
¹⁵ Department of Neurosurgery and Neuroradiology, New York Presbyterian Hospital and Weill Cornell School of Medicine, New York, NY, USA.
¹⁶ Department of Neuroradiology, Centre Hospitalier de Toulouse, Toulouse, France.
¹⁷ Interventistica Neurovascolare, Ospedale Careggi di Firenze, Florence, Italy.
¹⁸ Department of Diagnostic and Therapeutic Neuroradiology, Toulouse University Hospital, Toulouse, France.
¹⁹ Department of Neuroradiology, Clinical Hospital Center 'Sisters of Mercy', Zagreb, Croatia.
²⁰ Division of Neurointerventional Radiology, Department of Radiology, University of Massachusetts Medical Center, Worcester, MA, USA.
²¹ Sektion Vaskuläre und Interventionelle Neuroradiologie, Universitätsklinikum Heidelberg, Heidelberg, Germany.
²² Department of Neurosurgery, Thomas Jefferson University Hospital, Philadelphia, PA, USA.
²³ Department of Neurosurgery, Thomas Jefferson University, Philadelphia, PA, USA.
²⁴ Department of Neurosurgery, Clinical Neurosciences Center, University of Utah, Salt Lake City, UT, USA.
²⁵ Division of Neuroradiology, Vancouver General Hospital, University of British Columbia, Vancouver, British Columbia, Canada.
²⁶ Department of Neuroradiology, University Hospital of Basel, Basel, Switzerland.
²⁷ Divisions of Neuroradiology & Neurosurgery, QEII Health Sciences Centre, Dalhousie Medical School, Halifax, NS, USA.
²⁸ Department of Neurology, University of Cincinnati Medical Center, Cincinnati, OH, USA.
²⁹ Hospital Universitario San Ignacio, Pontificia Universidad Javeriana School of Medicine Bogotá, Bogotá, Colombia.
³⁰ Department of Neuroradiology, UMass Memorial Hospital, Worcester, MA, USA.
³¹ Unit of Interventional Neuroradiology, Department of Advanced Diagnostic and Therapeutic Technologies, A.O.R.N. Antonio Cardarelli Hospital, Via Cardarelli 1, Naples, Italy.
³² Unit of Interventional Neuroradiology, Department of Advanced Biomedical Sciences, "Federico II" University, Naples, Italy.
³³ Departments of Neurosurgery and Radiology, Geisinger Hospital, Danville, PA, USA.
³⁴ Departments of Neuroradiology and Neurosurgery, Karolinska University Hospital, Stockholm, Sweden.
³⁵ Department of Neurosurgery, University of Puerto Rico, School of Medicine, San Juan, PR, USA.
³⁶ Departments of Neurological Surgery & Radiology, Mayo Clinic, Rochester, MN, USA.

PMID: 39023541
DOI: 10.1007/s00062-024-01435-x

Comparative Study

Comparative Efficacy of Flow Diverter Devices in the Treatment of Carotid Sidewall Intracranial Aneurysms: a Retrospective, Multicenter Study

Adam A Dmytriw et al. Clin Neuroradiol. 2024 Dec.

. 2024 Dec;34(4):907-917.

doi: 10.1007/s00062-024-01435-x. Epub 2024 Jul 18.

Authors

Affiliations

¹ Neurovascular Centre, Departments of Medical Imaging and Neurosurgery, St. Michael's Hospital, Toronto, ON, Canada. admytriw@mgh.harvard.edu.
² Neuroendovascular Program, Massachusetts General Hospital, Harvard University, Boston, MA, USA. admytriw@mgh.harvard.edu.
³ Division of Diagnostic and Therapeutic Neuroradiology, Department of Radiology, St. Michael's Hospital, University of Toronto, Toronto, ON, Canada. admytriw@mgh.harvard.edu.
⁴ Neuroendovascular Program, Massachusetts General Hospital: Brigham, Boston, USA. admytriw@mgh.harvard.edu.
⁵ Women's Hospital, Harvard University, Boston, MA, USA. admytriw@mgh.harvard.edu.
⁶ Neuroendovascular Program, Massachusetts General Hospital, Harvard University, Boston, MA, USA. Hamza.sleeem@gmail.com.
⁷ Department of Radiology, Division of Neuroradiology, Johns Hopkins Medical Center, Baltimore, MD, USA. Hamza.sleeem@gmail.com.
⁸ Department of Neurosurgery and Interventional Neuroradiology, Louisiana State University, Baton Rouge, LA, USA.
⁹ Department of Neuroradiology, St. Michael's Hospital, Toronto, ON, Canada.
¹⁰ Department of Neurosurgery, Christian Doppler University Hospital & Institute of Neurointervention, Salzburg, Austria.
¹¹ Department of Neuroradiology, Massachusetts General Hospital & Brigham and Women's Hospital, Boston, MA, USA.
¹² Deparments of Neurosurgery and Radiology, University of Alabama at Birmingham, Birmingham, AL, USA.
¹³ Department of Neurosurgery, University of Alabama at Birmingham, Birmingham, AL, USA.
¹⁴ Neurovascular Centre, Departments of Medical Imaging and Neurosurgery, St. Michael's Hospital, Toronto, ON, Canada.
¹⁵ Department of Neurosurgery and Neuroradiology, New York Presbyterian Hospital and Weill Cornell School of Medicine, New York, NY, USA.
¹⁶ Department of Neuroradiology, Centre Hospitalier de Toulouse, Toulouse, France.
¹⁷ Interventistica Neurovascolare, Ospedale Careggi di Firenze, Florence, Italy.
¹⁸ Department of Diagnostic and Therapeutic Neuroradiology, Toulouse University Hospital, Toulouse, France.
¹⁹ Department of Neuroradiology, Clinical Hospital Center 'Sisters of Mercy', Zagreb, Croatia.
²⁰ Division of Neurointerventional Radiology, Department of Radiology, University of Massachusetts Medical Center, Worcester, MA, USA.
²¹ Sektion Vaskuläre und Interventionelle Neuroradiologie, Universitätsklinikum Heidelberg, Heidelberg, Germany.
²² Department of Neurosurgery, Thomas Jefferson University Hospital, Philadelphia, PA, USA.
²³ Department of Neurosurgery, Thomas Jefferson University, Philadelphia, PA, USA.
²⁴ Department of Neurosurgery, Clinical Neurosciences Center, University of Utah, Salt Lake City, UT, USA.
²⁵ Division of Neuroradiology, Vancouver General Hospital, University of British Columbia, Vancouver, British Columbia, Canada.
²⁶ Department of Neuroradiology, University Hospital of Basel, Basel, Switzerland.
²⁷ Divisions of Neuroradiology & Neurosurgery, QEII Health Sciences Centre, Dalhousie Medical School, Halifax, NS, USA.
²⁸ Department of Neurology, University of Cincinnati Medical Center, Cincinnati, OH, USA.
²⁹ Hospital Universitario San Ignacio, Pontificia Universidad Javeriana School of Medicine Bogotá, Bogotá, Colombia.
³⁰ Department of Neuroradiology, UMass Memorial Hospital, Worcester, MA, USA.
³¹ Unit of Interventional Neuroradiology, Department of Advanced Diagnostic and Therapeutic Technologies, A.O.R.N. Antonio Cardarelli Hospital, Via Cardarelli 1, Naples, Italy.
³² Unit of Interventional Neuroradiology, Department of Advanced Biomedical Sciences, "Federico II" University, Naples, Italy.
³³ Departments of Neurosurgery and Radiology, Geisinger Hospital, Danville, PA, USA.
³⁴ Departments of Neuroradiology and Neurosurgery, Karolinska University Hospital, Stockholm, Sweden.
³⁵ Department of Neurosurgery, University of Puerto Rico, School of Medicine, San Juan, PR, USA.
³⁶ Departments of Neurological Surgery & Radiology, Mayo Clinic, Rochester, MN, USA.

PMID: 39023541
DOI: 10.1007/s00062-024-01435-x

Abstract

Background: The comparative efficacy and safety of first-generation flow diverters (FDs), Pipeline Embolization Device (PED) (Medtronic, Irvine, California), Silk (Balt Extrusion, Montmorency, France), Flow Re-direction Endoluminal Device (FRED) (Microvention, Tustin, California), and Surpass Streamline (Stryker Neurovascular, Fremont, California), is not directly established and largely inferred.

Purpose: This study aimed to compare the efficacy of different FDs in treating sidewall ICA intracranial aneurysms.

Methods: We conducted a retrospective review of prospectively maintained databases from eighteen academic institutions from 2009-2016, comprising 444 patients treated with one of four devices for sidewall ICA aneurysms. Data on demographics, aneurysm characteristics, treatment outcomes, and complications were analyzed. Angiographic and clinical outcomes were assessed using various imaging modalities and modified Rankin Scale (mRS). Propensity score weighting was employed to balance confounding variables. The data analysis used Kaplan-Meier curves, logistic regression, and Cox proportional-hazards regression.

Results: While there were no significant differences in retreatment rates, functional outcomes (mRS 0-1), and thromboembolic complications between the four devices, the probability of achieving adequate occlusion at the last follow-up was highest in Surpass device (HR: 4.59; CI: 2.75-7.66, p < 0.001), followed by FRED (HR: 2.23; CI: 1.44-3.46, p < 0.001), PED (HR: 1.72; CI: 1.10-2.70, p = 0.018), and Silk (HR: 1.0 ref. standard). The only hemorrhagic complications were with Surpass (1%).

Conclusion: All the first-generation devices achieved good clinical outcomes and retreatment rates in treating ICA sidewall aneurysms. Prospective studies are needed to explore the nuanced differences between these devices in the long term.

Keywords: Flow Diverter Devices; Hemorrhagic Complications; Intracranial Aneurysms; Modified Rankin Scale; Pipeline Emboliza on Device; Thromboembolic Complications.

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Conflict of interest statement

Declarations Conflict of interest A.A. Dmytriw, H.A. Salim, B. Musmar, N.M. Cancelliere, J. Jones, V. Tutino, Z. Hasan, N. Limbucci, S.V. Lay, J. Spears, J.D. Rabinov, M.R. Harrigan, A.H. Siddiqui, E.I. Levy, C.J. Stapleton, L. Renieri, C. Cognard, H. Shaikh, A.L. Kühn, M.A. Möhlenbruch, P. Taussky, F. Settecase, M.K.S. Heran, A. Nguyen, D. Volders, P. Harker, D.A. Devia, M. Psychogios, J.C. Puentes, G. Leone, G. Buono, M. Tarantino, M. Muto, F. Briganti, S. Dalal, V. Gontu, R.E. Alcedo Guardia, J.C. Vicenty-Padilla, P. Brouwer, M.H. Schmidt, C. Schirmer, G.E. Pickett, T. Andersson, M. Söderman, T.R. Marotta, H. Cuellar-Saenz, A.J. Thomas, A.B. Patel, V. Mendes Pereira and N. Adeeb. R.W. Regenhardt serves on a DSMB for a trial sponsored by Rapid Medical, serves as site PI for studies sponsored by Penumbra and Microvention, and receives stroke research grant funding from the National Institutes of Health, Society of Vascular and Interventional Neurology, and Heitman Stroke Foundation. Dr. Guenego reports consultancy for Rapid Medical and Phenox, not directly related to the present work. C.J. Griessenauer reports a proctoring agreement with Medtronic and research funding by Penumbra. A.S. Puri is a consultant for Medtronic Neurovascular, Stryker NeurovascularBalt, Q’Apel Medical, Cerenovus, Microvention, Imperative Care, Agile, Merit, CereVasc and Arsenal Medical, he received research grants from NIH, Microvention, Cerenovus, Medtronic Neurovascular and Stryker Neurovascular, and holds stocks in InNeuroCo, Agile, Perfuze, Galaxy and NTI. S.I. Tjoumakaris is a consultant for Medtronic and Microvention (funds paid to institution, not personally). P. Jabbour is a consultant for Medtronic, Microvention and Cerus. Dr. Clarençon reports conflicts of interest with Medtronic, Balt Extrusion (consultant), ClinSearch (core lab), Penumbra, Stryker (payment for reading) and Artedrone (Board); all not directly related to the present work. Dr. Henninger received support from W81XWH-19-PRARP-RPA form the CDMRP/DoD, NS131756 and U24NS113844 from the NINDS, and NR020231 from the NINR and received compensation from Myrobalan, Inc. and General Dynamics during the conduct of this study unrelated to this work. Dr. Liebeskind is consultant as Imaging Core Lab to Cerenovus, Genentech, Medtronic, Stryker, Rapid Medical. Dr. Yeo reports Advisory work for AstraZeneca, Substantial support from NMRC Singapore and is a medical advisor for See-mode, Cortiro and Sunbird Bio, with equity in Ceroflo. All unrelated to the present work. Dr. Marnat reports conflicts of interest with Microvention Europe, Stryker Neurovascular, Balt (consulting), Medtronic, Johnson & Johnson and Phenox (paid lectures), all not directly related to the present work. Ethical standards The study received approval from the local ethical standards committee at each participating site, and informed consent from patients was waived. The data supporting this study’s findings are available from the corresponding author upon reasonable request.

References

1. Musmar B, Adeeb N, Ansari J, Sharma P, Cuellar HH. Endovascular Management of Hemorrhagic Stroke. Biomedicines. 2022;10(1):100. https://doi.org/10.3390/biomedicines10010100 . - DOI - PubMed - PMC
1. Brinjikji W, Rabinstein AA, Nasr DM, Lanzino G, Kallmes DF, Cloft HJ. Better outcomes with treatment by coiling relative to clipping of unruptured intracranial aneurysms in the United States, 2001–2008. AJNR Am J Neuroradiol. 2011;32(6):1071–5. https://doi.org/10.3174/ajnr.A2453 . - DOI - PubMed - PMC
1. Gory B, Turjman F. Endovascular treatment of 404 intracranial aneurysms treated with nexus detachable coils: short-term and mid-term results from a prospective, consecutive, European multicenter study. Acta Neurochir (wien). 2014;156(5):831–7. https://doi.org/10.1007/s00701-014-2047-3 . - DOI - PubMed
1. Molyneux AJ, Kerr RSC, Birks J, et al. Risk of recurrent subarachnoid haemorrhage, death, or dependence and standardised mortality ratios after clipping or coiling of an intracranial aneurysm in the International Subarachnoid Aneurysm Trial (ISAT): long-term follow-up. Lancet Neurol. 2009;8(5):427–433. https://doi.org/10.1016/S1474-4422(09)70080-8
1. Brown RD, Broderick JP. Unruptured intracranial aneurysms: epidemiology, natural history, management options, and familial screening. Lancet Neurol. 2014;13(4):393–404. https://doi.org/10.1016/S1474-4422(14)70015-8

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Comparative Efficacy of Flow Diverter Devices in the Treatment of Carotid Sidewall Intracranial Aneurysms: a Retrospective, Multicenter Study

Affiliations

Comparative Efficacy of Flow Diverter Devices in the Treatment of Carotid Sidewall Intracranial Aneurysms: a Retrospective, Multicenter Study

Authors

Affiliations

Abstract

Conflict of interest statement

References

Publication types

MeSH terms

LinkOut - more resources

Full Text Sources

Medical

Miscellaneous