Intrasaccular flow disruption for ruptured aneurysms: an international multicenter study

Jose Danilo Bengzon Diestro¹, Mahmoud Dibas², Nimer Adeeb³, Robert W Regenhardt⁴, Justin E Vranic⁴, Adrien Guenego⁵, Sovann V Lay⁶, Leonardo Renieri⁷, Ali Al Balushi⁸, Eimad Shotar⁹, Kevin Premat⁹, Kareem El Naamani¹⁰, Guillaume Saliou¹¹, Markus A Möhlenbruch¹², Ivan Lylyk¹³, Paul M Foreman¹⁴, Jay A Vachhani¹⁴, Vedran Župančić¹⁵, Muhammad U Hafeez¹⁶, Caleb Rutledge¹⁷, Hamid Rai¹⁸, Vincent M Tutino¹⁸, Shervin Mirshani², Sherief Ghozy¹⁹, Pablo Harker⁴, Naif M Alotaibi⁴, James D Rabinov⁴, Yifan Ren²⁰, Clemens M Schirmer²¹, Oded Goren²², Mariangela Piano²³, Anna Luisa Kuhn²⁴, Caterina Michelozzi²⁵, Stephanie Elens⁵, Robert M Starke²⁶, Ameer Hassan²⁷, Arsalaan Salehani²⁸, Anh Nguyen²⁹, Jesse Jones²⁸, Marios Psychogios²⁹, Julian Spears^{30

31}, Carmen Parra-Fariñas³⁰, Maria Bres Bullrich³², Michael Mayich³³, Mohamed M Salem³⁴, Jan-Karl Burkhardt³⁴, Brian T Jankowitz³⁴, Ricardo A Domingo³⁵, Thien Huynh³⁶, Rabih Tawk³⁵, Christian Ulfert³⁷, Boris Lubicz⁵, Pietro Panni²⁵, Ajit S Puri²⁴, Guglielmo Pero³⁸, Christoph J Griessenauer^{39

40}, Hamed Asadi²⁰, Adnan Siddiqui¹⁸, Andrew F Ducruet¹⁷, Felipe C Albuquerque¹⁷, Rose Du⁴¹, Peter Kan¹⁶, Vladimir Kalousek¹⁵, Pedro Lylyk¹³, Srikanth Reddy Boddu⁸, Christopher J Stapleton⁴, Jared Knopman⁸, Pascal Jabbour¹⁰, Stavropoula Tjoumakaris¹⁰, Frédéric Clarençon⁴², Nicola Limbucci⁷, Mohammad A Aziz-Sultan², Hugo H Cuellar-Saenz³, Christophe Cognard⁶, Aman B Patel⁴, Adam A Dmytriw^{2

4}

Affiliations

¹ Department of Medical Imaging, Division of Diagnostic and Therapeutic Neuroradiology, St Michael's Hospital, University of Toronto, Toronto, Ontario, Canada danni.diestro@gmail.com.
² Neuroradiology & Neurointervention Service, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts, USA.
³ Department of Neurosurgery and Neurointerventional Surgery, Louisiana State University, Shreveport, Louisiana, USA.
⁴ Neuroendovascular Program, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts, USA.
⁵ Service de Neuroradiologie Interventionnelle, Hôpital Universitaire Erasme, Bruxelles, Belgique.
⁶ Service de Neuroradiologie Diagnostique et Thérapeutique, Centre Hospitalier de Toulouse, Hôpital Purpan, Toulouse, France.
⁷ Interventistica Neurovascolare, Ospedale Careggi di Firenze, Florence, Italy.
⁸ Neurosurgery & Interventional Neuroradiology, New York Presbyterian Hospital, Weill Cornell School of Medicine, New York, New York, USA.
⁹ Department of Interventional Neuroradiology, Sorbonne University, AP-HP, Pitié Salpêtrière - Charles Foix Hospital, Paris, France.
¹⁰ Department of Neurosurgery, Thomas Jefferson University, Philadelphia, Pennsylvania, USA.
¹¹ Service de radiodiagnostic et radiologie interventionnelle, Centre Hospitalier Vaudois de Lausanne, Lausanne, Switzerland.
¹² Department of Neuroradiology, Heidelberg University, Heidelberg, Germany.
¹³ Equipo de Neurocirugía Endovascular y Radiología Intervencionista, Clínica La Sagrada Familia, Buenos Aires, Argentina.
¹⁴ Neurosurgery Department, Orlando Health Neuroscience and Rehabilitation Institute, Orlando, Florida, USA.
¹⁵ Subdivision of Interventional Neuroradiology, Department of Radiology, Clinical Hospital Center 'Sisters of Mercy', Zagreb, Croatia.
¹⁶ Department of Neurosurgery, UTMB and Baylor School of Medicine, Houston, Texas, USA.
¹⁷ Department of Neurosurgery, Barrow Neurological Institute, Phoenix, Arizona, USA.
¹⁸ Department of Neurosurgery, State University of New York at Buffalo, Buffalo, New York, USA.
¹⁹ Department of Neuroradiology, Mayo Clinic, Rochester, Minnesota, USA.
²⁰ Interventional Radiology and Neurointerventional Services, Department of Radiology, Austin Health, Melbourne, Melbourne, Victoria, Australia.
²¹ Department of Neurosurgery, Geisinger, Wilkes-Barre, Pennsylvania, USA.
²² Department of Neurosurgery, Geisinger, Danville, Pennsylvania, USA.
²³ Neuroradiology, ASST Grande Ospedale Metropolitano Niguarda, Milan, Italy.
²⁴ Department of Neurointerventional Radiology, UMass Memorial Hospital, Worcester, Massachusetts, USA.
²⁵ Interventistica Neurovascolare, Ospedale San Raffaele, Milano, Italy.
²⁶ Deparment of Neurosurgery, University of Miami, Miami, Florida, USA.
²⁷ Deparment of Neuroscience, Valley Baptist Neuroscience Institute, Harlingen, Texas, USA.
²⁸ Deparments of Neurosurgery and Radiology, University of Alabama at Birmingham, Birmingham, Alabama, USA.
²⁹ Department of Diagnostic and Interventional Neuroradiology, University Hospital Basel, Basel, Switzerland.
³⁰ Department of Medical Imaging, Division of Diagnostic and Therapeutic Neuroradiology, St Michael's Hospital, University of Toronto, Toronto, Ontario, Canada.
³¹ Department of Surgery, Division of Neurosurgery, University of Toronto, University of Toronto, Toronto, Ontario, Canada.
³² Department of Clinical Neurological Sciences, Schulich School of Medicine and Dentistry, Western University, London, Ontario, Canada.
³³ Departments of Medical Imaging, and Clinical Neurological Sciences, Schulich School of Medicine and Dentistry, Western University, London, Ontario, Canada.
³⁴ Department of Neurosurgery, University of Pennsylvania, Penn Medicine, Philadelphia, Pennsylvania, USA.
³⁵ Department of Neurologic Surgery, Mayo Clinic, Jacksonville, Florida, USA.
³⁶ Department of Radiology, Mayo Clinic, Jacksonville, Florida.
³⁷ Department of Neuroradiology, Heidelberg University Hospital, Heidelberg, Germany.
³⁸ Interventistica Neurovascolare, Ospedale Niguarda Cà Granda, Milano, Italy.
³⁹ Department of Neurosurgery, Christian Doppler University Hospital, Paracelsus Medical University, Salzburg, Austria, Salzburg, Austria.
⁴⁰ Institute of Neurointervention, Paracelsus Medical University, Salzburg, Austria.
⁴¹ Neuroradiology & Neurointervention Service, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts, Canada.
⁴² Department of Interventional Neuroradiology, Hopitaux Universitaires Pitie Salpetriere-Charles Foix, Paris, France.

PMID: 35868856
DOI: 10.1136/jnis-2022-019153

Multicenter Study

Intrasaccular flow disruption for ruptured aneurysms: an international multicenter study

Jose Danilo Bengzon Diestro et al. J Neurointerv Surg. 2023 Sep.

. 2023 Sep;15(9):844-850.

doi: 10.1136/jnis-2022-019153. Epub 2022 Jul 22.

Authors

Affiliations

¹ Department of Medical Imaging, Division of Diagnostic and Therapeutic Neuroradiology, St Michael's Hospital, University of Toronto, Toronto, Ontario, Canada danni.diestro@gmail.com.
² Neuroradiology & Neurointervention Service, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts, USA.
³ Department of Neurosurgery and Neurointerventional Surgery, Louisiana State University, Shreveport, Louisiana, USA.
⁴ Neuroendovascular Program, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts, USA.
⁵ Service de Neuroradiologie Interventionnelle, Hôpital Universitaire Erasme, Bruxelles, Belgique.
⁶ Service de Neuroradiologie Diagnostique et Thérapeutique, Centre Hospitalier de Toulouse, Hôpital Purpan, Toulouse, France.
⁷ Interventistica Neurovascolare, Ospedale Careggi di Firenze, Florence, Italy.
⁸ Neurosurgery & Interventional Neuroradiology, New York Presbyterian Hospital, Weill Cornell School of Medicine, New York, New York, USA.
⁹ Department of Interventional Neuroradiology, Sorbonne University, AP-HP, Pitié Salpêtrière - Charles Foix Hospital, Paris, France.
¹⁰ Department of Neurosurgery, Thomas Jefferson University, Philadelphia, Pennsylvania, USA.
¹¹ Service de radiodiagnostic et radiologie interventionnelle, Centre Hospitalier Vaudois de Lausanne, Lausanne, Switzerland.
¹² Department of Neuroradiology, Heidelberg University, Heidelberg, Germany.
¹³ Equipo de Neurocirugía Endovascular y Radiología Intervencionista, Clínica La Sagrada Familia, Buenos Aires, Argentina.
¹⁴ Neurosurgery Department, Orlando Health Neuroscience and Rehabilitation Institute, Orlando, Florida, USA.
¹⁵ Subdivision of Interventional Neuroradiology, Department of Radiology, Clinical Hospital Center 'Sisters of Mercy', Zagreb, Croatia.
¹⁶ Department of Neurosurgery, UTMB and Baylor School of Medicine, Houston, Texas, USA.
¹⁷ Department of Neurosurgery, Barrow Neurological Institute, Phoenix, Arizona, USA.
¹⁸ Department of Neurosurgery, State University of New York at Buffalo, Buffalo, New York, USA.
¹⁹ Department of Neuroradiology, Mayo Clinic, Rochester, Minnesota, USA.
²⁰ Interventional Radiology and Neurointerventional Services, Department of Radiology, Austin Health, Melbourne, Melbourne, Victoria, Australia.
²¹ Department of Neurosurgery, Geisinger, Wilkes-Barre, Pennsylvania, USA.
²² Department of Neurosurgery, Geisinger, Danville, Pennsylvania, USA.
²³ Neuroradiology, ASST Grande Ospedale Metropolitano Niguarda, Milan, Italy.
²⁴ Department of Neurointerventional Radiology, UMass Memorial Hospital, Worcester, Massachusetts, USA.
²⁵ Interventistica Neurovascolare, Ospedale San Raffaele, Milano, Italy.
²⁶ Deparment of Neurosurgery, University of Miami, Miami, Florida, USA.
²⁷ Deparment of Neuroscience, Valley Baptist Neuroscience Institute, Harlingen, Texas, USA.
²⁸ Deparments of Neurosurgery and Radiology, University of Alabama at Birmingham, Birmingham, Alabama, USA.
²⁹ Department of Diagnostic and Interventional Neuroradiology, University Hospital Basel, Basel, Switzerland.
³⁰ Department of Medical Imaging, Division of Diagnostic and Therapeutic Neuroradiology, St Michael's Hospital, University of Toronto, Toronto, Ontario, Canada.
³¹ Department of Surgery, Division of Neurosurgery, University of Toronto, University of Toronto, Toronto, Ontario, Canada.
³² Department of Clinical Neurological Sciences, Schulich School of Medicine and Dentistry, Western University, London, Ontario, Canada.
³³ Departments of Medical Imaging, and Clinical Neurological Sciences, Schulich School of Medicine and Dentistry, Western University, London, Ontario, Canada.
³⁴ Department of Neurosurgery, University of Pennsylvania, Penn Medicine, Philadelphia, Pennsylvania, USA.
³⁵ Department of Neurologic Surgery, Mayo Clinic, Jacksonville, Florida, USA.
³⁶ Department of Radiology, Mayo Clinic, Jacksonville, Florida.
³⁷ Department of Neuroradiology, Heidelberg University Hospital, Heidelberg, Germany.
³⁸ Interventistica Neurovascolare, Ospedale Niguarda Cà Granda, Milano, Italy.
³⁹ Department of Neurosurgery, Christian Doppler University Hospital, Paracelsus Medical University, Salzburg, Austria, Salzburg, Austria.
⁴⁰ Institute of Neurointervention, Paracelsus Medical University, Salzburg, Austria.
⁴¹ Neuroradiology & Neurointervention Service, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts, Canada.
⁴² Department of Interventional Neuroradiology, Hopitaux Universitaires Pitie Salpetriere-Charles Foix, Paris, France.

PMID: 35868856
DOI: 10.1136/jnis-2022-019153

Abstract

Background: The Woven EndoBridge (WEB) device is a novel intrasaccular flow disruptor tailored for bifurcation aneurysms. We aim to describe the degree of aneurysm occlusion at the latest follow-up, and the rate of complications of aneurysms treated with the WEB device stratified according to rupture status.

Methods: Our data were taken from the WorldWideWeb Consortium, an international multicenter cohort including patients treated with the WEB device. Aneurysms were classified into two groups: ruptured and unruptured. We compared clinical and radiologic outcomes of both groups. Propensity score matching (PSM) was done to match according to age, gender, bifurcation, location, prior treatment, neck, height, dome width, daughter sac, incorporated branch, pretreatment antiplatelets, and last imaging follow-up.

Results: The study included 676 patients with 691 intracranial aneurysms (529 unruptured and 162 ruptured) treated with the WEB device. The PSM analysis had 55 pairs. In both the unmatched (85.8% vs 84.3%, p=0.692) and matched (94.4% vs 83.3%, p=0.066) cohorts there was no significant difference in the adequate occlusion rate at the last follow-up. Likewise, there were no significant differences in both ischemic and hemorrhagic complications between the two groups. There was no documented aneurysm rebleeding after WEB device implantation.

Conclusion: There was no significant difference in both the radiologic outcomes and complications between unruptured and ruptured aneurysms. Our findings support the feasibility of treatment of ruptured aneurysms with the WEB device.

Keywords: Aneurysm.

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Conflict of interest statement

Competing interests: JDBD: Honoraria from Medtronic. Travel grant from Microvention. MD: No relevant relationships NA: No relevant relationships RWR: Grants from National Institutes of Health, Heitman foundation, Society of vascular and interventional neurology; Advisory board participation for Rapid medical; Site PI for Microvention and Penumbra JEV: No relevant relationships AG : No relevant relationships SVL: No relevant relationships LR: No relevant relationships AAB: No relevant relationships ES: No relevant relationships KP: No relevant relationships KEL: No relevant relationships GS : No relevant relationships MAM: No relevant relationships IL: No relevant relationships PMR: No relevant relationships JAV: Fees from MicroVention for proctoring cases for new physician users of the Woven EndoBridge device; Medtronic travel expense VŽ: Participation on the data safety monitoring board or advisory board for KBC Sestre Milosrdnice, Zagreb / OB Nova Gradiška MUH: No relevant relationships CR: No relevant relationships HR: No relevant relationships VMT: No relevant relationships SM: No relevant relationships SG: No relevant relationships PH: No relevant relationships NA: No relevant relationships JDR: No relevant relationships YR: No relevant relationships CMS: No relevant relationships OG: No relevant relationships MP: No relevant relationships ALK: No relevant relationships CM: No relevant relationships SE: No relevant relationships RMS: Supported by the NREF, Joe Niekro Foundation, Brain Aneurysm Foundation, Bee Foundation, and the National Institutes of Health (R01NS111119-01A1, UL1TR002736, and KL2TR002737) through the Miami Clinical and Translational Science Institute, from the National Center for Advancing Translational Sciences and the National Institute on Minority Health and Health Disparities. AH: Consulting or speaker fees from Medtronic, MicroVention, Stryker, Penumbra, Cerenovus, Genentech, GE Healthcare, Scientia, Balt, Viz.ai, Insera Therapeutics, Proximie, NeuroVasc, NovaSignal, Vesalio, and Galaxy Therapeutics. AS: No relevant relationships AN: No relevant relationships JJ: Consulting and speaker fees from Cerenovus MP: No relevant relationships JS: No relevant relationships CPF: No relevant relationships MBB: No relevant relationships MM: Grants from Balt, Medtronic, MicroVention, and Stryker. MMS: No relevant relationships JB: No relevant relationships BTJ: No relevant relationships RAD: No relevant relationships TH: No relevant relationships RT: Medtronic Stocks CU: No relevant relationships BL : No relevant relationships PP: No relevant relationships ASP: Grants from NIH, Microvention, Cerenovus, Medtronic and Stryker; Consulting fees from Neurovascular, Stryker NeurovascularBalt, Q’Apel Medical, Cerenovus, Microvention, Imperative Care, Agile, Merit, CereVasc and Arsenal Medical; stock options from InNeuroCo, Agile, Perfuze, Galaxy and NTI GP: No relevant relationships CJG: Grants to institution from Medtronic and Penumbra; consulting fees from Stryker and MicroVention. HA: Proctoring fees from MicroVention. Grants to institution from the National Institutes of Health; consulting fees from Amnis Therapeutics, Apellis Pharmaceuticals, Boston Scientific, Canon Medical Systems, Cardinal Health 200, Cerebrotech Medical Systems, Cerenovus, Cerevatech Medical, Cordis, Corindus, EndoStream Medical, Imperative Care, Integra, IRRAS, Medtronic, MicroVention, Minnetronix Neuro, Penumbra, Q’Apel Medical, Rapid Medical, Serenity Medical, Silk Road Medical, StimMed, Stryker Neurovascular, Three Rivers Medical, VasSol, Viz.ai, and W.L. Gore & Associates; payment for participation on the steering committees for the Cerenovus EXCELLENT and ARISE II Trial; Medtronic SWIFT PRIME, VANTAGE, EMBOLISE, and SWIFT DIRECT Trials; MicroVention FRED Trial and CONFIDENCE Study; MUSC POSITIVE Trial; Penumbra 3D Separator Trial, COMPASS Trial, INVEST Trial, MIVI Neuroscience EVAQ Trial; Rapid Medical SUCCESS Trial; InspireMD C-GUARDIANS IDE Pivotal Trial; stock or stock options in Adona Medical, Amnis Therapeutics, Bend IT Technologies, BlinkTBI, Buffalo Technology Partners, Cardinal Consultants, Cerebrotech Medical Systems, Cerevatech Medical, Cognition Medical, CVAID, E8, EndoStream Medical, Imperative Care, Instylla, International Medical Distribution Partners, Launch NY, NeuroRadial Technologies, Neurotechnology Investors, Neurovascular Diagnostics, Perflow Medical, Q’Apel Medical, QAS.ai, Radical Catheter Technologies, Rebound Therapeutics (purchased in 2019 by Integra Lifesciences), Rist Neurovascular (purchased in 2020 by Medtronic), Sense Diagnostics, Serenity Medical, Silk Road Medical, Songbird Therapy, Spinnaker Medical, StimMed, Synchron, Three Rivers Medical, Truvic Medical, Tulavi Therapeutics, Vastrax, VICIS, and Viseon AFD: Consulting fees from Cerenovus, Penumbra, Medtronic, Stryker, Oculus, and Koswire. No relevant relationships RD: No relevant relationships PK: No relevant relationships. VK: No relevant relationships. PL: No relevant relationships SB: No relevant relationships CJS: Participation on the data safety monitoring board or advisory board for Zoll Circulation JK: No relevant relationships PJ: No relevant relationships ST: No relevant relationships FC: No relevant relationships NL: Honoraria for lectures from Cerenovus, Stryker, and CrossMed. MAA: Funding to institution from MicroVention for WEBIT trial; proctoring fees from MicroVention. HHC: No relevant relationships CC: Consulting fees from MicroVention, Stryker, Medtronic, MIVI, and Cerenovus. ABP: Grant to institution from Medtronic; consulting fees from MicroVention, Medtronic, and Q’Apel; workstation for research from Siemens AAD: No relevant relationships

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Intrasaccular flow disruption for ruptured aneurysms: an international multicenter study

Affiliations

Intrasaccular flow disruption for ruptured aneurysms: an international multicenter study

Authors

Affiliations

Abstract

Conflict of interest statement

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LinkOut - more resources

Full Text Sources

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