Clinical Trial

. 2023 Mar;15(3):248-254.

doi: 10.1136/neurintsurg-2021-018501. Epub 2022 Mar 15.

Prospective study on embolization of intracranial aneurysms with the pipeline device (PREMIER study): 3-year results with the application of a flow diverter specific occlusion classification

Ricardo A Hanel¹, Gustavo M Cortez², Demetrius Klee Lopes³, Peter Kim Nelson⁴, Adnan H Siddiqui⁵, Pascal Jabbour⁶, Vitor Mendes Pereira⁷, Istvan Szikora István⁸, Osama O Zaidat⁹, Chetan Bettegowda¹⁰, Geoffrey P Colby¹¹, Maxim Mokin¹², Clemens M Schirmer¹³, Frank R Hellinger¹⁴, Curtis Given¹⁵, Timo Krings¹⁶, Philipp Taussky¹⁷, Gabor Toth¹⁸, Justin F Fraser¹⁹, Michael Chen²⁰, Ryan Priest²¹, Peter Kan²², David Fiorella²³, Donald Frei²⁴, Beverly Aagaard-Kienitz²⁵, Orlando Diaz²⁶, Adel M Malek²⁷, C Michael Cawley²⁸, Ajit S Puri²⁹, David F Kallmes³⁰

Affiliations

¹ Lyerly Neurosurgery, Baptist Neurological Institute, Jacksonville, Florida, USA rhanel@lyerlyneuro.com.
² Lyerly Neurosurgery, Baptist Neurological Institute, Jacksonville, Florida, USA.
³ Brain and Spine Institute, Advocate Aurora Health, Park Ridge, Illinois, USA.
⁴ Interventional Radiology, NYU Langone Medical Center, New York, New York, USA.
⁵ Department of Neurosurgery, University at Buffalo Jacobs School of Medicine and Biomedical Sciences, Buffalo, New York, USA.
⁶ Department of Neurosurgery, Thomas Jefferson University Hospital, Philadelphia, Pennsylvania, USA.
⁷ Division of Neuroradiology, Department of Medical Imaging and Division of Neurosurgery, Department of Surgery, Toronto Western Hospital, Toronto, Ontario, Canada.
⁸ Department of Neuroradiology, National Institute of Neurosciences, Budapest, Hungary.
⁹ Neuroscience Institute, Mercy Health Saint Vincent Medical Center, Toledo, Ohio, USA.
¹⁰ Department of Neurosurgery, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.
¹¹ Department Neurosurgery, University of California Los Angeles, Los Angeles, California, USA.
¹² Department of Neurosurgery, University of South Florida College of Medicine, Tampa, Florida, USA.
¹³ Department of Neurosurgery, Geisinger Health System, Danville, Pennsylvania, USA.
¹⁴ Department of Radiology, Florida Hospital Neuroscience Institute, Winter Park, Florida, USA.
¹⁵ Department of Radiology, Baptist Health Lexington, Lexington, Kentucky, USA.
¹⁶ Department of Medical Imaging, Toronto Western Hospital, Toronto, Ontario, Canada.
¹⁷ Department of Neurosurgery, University of Utah Health, Salt Lake City, Utah, USA.
¹⁸ Cerebrovascular Center, Cleveland Clinic, Cleveland, Ohio, USA.
¹⁹ Department of Neurological Surgery, University of Kentucky, Lexington, Kentucky, USA.
²⁰ Department of Neurological Surgery, Rush University Medical Center, Chicago, Illinois, USA.
²¹ Charles T Dotter Department of Interventional Radiology, Dotter Interventional Institute, Oregon Health and Science University, Portland, Oregon, USA.
²² Department of Neurosurgery, Baylor College of Medicine, Houston, Texas, USA.
²³ Department of Neurosurgery, Cerebrovascular Center, Stony Brook University, Stony Brook, New York, USA.
²⁴ Department of Neuroradiology, Swedish Medical Center, Englewood, Colorado, USA.
²⁵ Department of Neurological Surgery, University of Wisconsin-Madison School of Medicine and Public Health, Madison, Wisconsin, USA.
²⁶ Cerebrovascular Center, Houston Methodist Research Institute, Houston, Texas, USA.
²⁷ Department of Neurosurgery, Tufts Medical Center, Boston, Massachusetts, USA.
²⁸ Department of Neurointerventional Radiology and Neurosurgery, Emory University School of Medicine, Atlanta, Georgia, USA.
²⁹ Department of Radiology, University of Massachusetts Medical School, Worcester, Massachusetts, USA.
³⁰ Department of Radiology, Mayo Clinic, Rochester, Minnesota, USA.

PMID: 35292570
PMCID: PMC9985759
DOI: 10.1136/neurintsurg-2021-018501

Clinical Trial

Prospective study on embolization of intracranial aneurysms with the pipeline device (PREMIER study): 3-year results with the application of a flow diverter specific occlusion classification

Ricardo A Hanel et al. J Neurointerv Surg. 2023 Mar.

. 2023 Mar;15(3):248-254.

doi: 10.1136/neurintsurg-2021-018501. Epub 2022 Mar 15.

Authors

Affiliations

¹ Lyerly Neurosurgery, Baptist Neurological Institute, Jacksonville, Florida, USA rhanel@lyerlyneuro.com.
² Lyerly Neurosurgery, Baptist Neurological Institute, Jacksonville, Florida, USA.
³ Brain and Spine Institute, Advocate Aurora Health, Park Ridge, Illinois, USA.
⁴ Interventional Radiology, NYU Langone Medical Center, New York, New York, USA.
⁵ Department of Neurosurgery, University at Buffalo Jacobs School of Medicine and Biomedical Sciences, Buffalo, New York, USA.
⁶ Department of Neurosurgery, Thomas Jefferson University Hospital, Philadelphia, Pennsylvania, USA.
⁷ Division of Neuroradiology, Department of Medical Imaging and Division of Neurosurgery, Department of Surgery, Toronto Western Hospital, Toronto, Ontario, Canada.
⁸ Department of Neuroradiology, National Institute of Neurosciences, Budapest, Hungary.
⁹ Neuroscience Institute, Mercy Health Saint Vincent Medical Center, Toledo, Ohio, USA.
¹⁰ Department of Neurosurgery, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.
¹¹ Department Neurosurgery, University of California Los Angeles, Los Angeles, California, USA.
¹² Department of Neurosurgery, University of South Florida College of Medicine, Tampa, Florida, USA.
¹³ Department of Neurosurgery, Geisinger Health System, Danville, Pennsylvania, USA.
¹⁴ Department of Radiology, Florida Hospital Neuroscience Institute, Winter Park, Florida, USA.
¹⁵ Department of Radiology, Baptist Health Lexington, Lexington, Kentucky, USA.
¹⁶ Department of Medical Imaging, Toronto Western Hospital, Toronto, Ontario, Canada.
¹⁷ Department of Neurosurgery, University of Utah Health, Salt Lake City, Utah, USA.
¹⁸ Cerebrovascular Center, Cleveland Clinic, Cleveland, Ohio, USA.
¹⁹ Department of Neurological Surgery, University of Kentucky, Lexington, Kentucky, USA.
²⁰ Department of Neurological Surgery, Rush University Medical Center, Chicago, Illinois, USA.
²¹ Charles T Dotter Department of Interventional Radiology, Dotter Interventional Institute, Oregon Health and Science University, Portland, Oregon, USA.
²² Department of Neurosurgery, Baylor College of Medicine, Houston, Texas, USA.
²³ Department of Neurosurgery, Cerebrovascular Center, Stony Brook University, Stony Brook, New York, USA.
²⁴ Department of Neuroradiology, Swedish Medical Center, Englewood, Colorado, USA.
²⁵ Department of Neurological Surgery, University of Wisconsin-Madison School of Medicine and Public Health, Madison, Wisconsin, USA.
²⁶ Cerebrovascular Center, Houston Methodist Research Institute, Houston, Texas, USA.
²⁷ Department of Neurosurgery, Tufts Medical Center, Boston, Massachusetts, USA.
²⁸ Department of Neurointerventional Radiology and Neurosurgery, Emory University School of Medicine, Atlanta, Georgia, USA.
²⁹ Department of Radiology, University of Massachusetts Medical School, Worcester, Massachusetts, USA.
³⁰ Department of Radiology, Mayo Clinic, Rochester, Minnesota, USA.

PMID: 35292570
PMCID: PMC9985759
DOI: 10.1136/neurintsurg-2021-018501

Abstract

Background: The pipeline embolization device (PED; Medtronic) has presented as a safe and efficacious treatment for small- and medium-sized intracranial aneurysms. Independently adjudicated long-term results of the device in treating these lesions are still indeterminate. We present 3-year results, with additional application of a flow diverter specific occlusion scale.

Methods: PREMIER (prospective study on embolization of intracranial aneurysms with pipeline embolization device) is a prospective, single-arm trial. Inclusion criteria were patients with unruptured wide-necked intracranial aneurysms ≤12 mm. Primary effectiveness (complete aneurysm occlusion) and safety (major neurologic event) endpoints were independently monitored and adjudicated.

Results: As per the protocol, of 141 patients treated with a PED, 25 (17.7%) required angiographic follow-up after the first year due to incomplete aneurysm occlusion. According to the Core Radiology Laboratory review, three (12%) of these patients progressed to complete occlusion, with an overall rate of complete aneurysm occlusion at 3 years of 83.3% (115/138). Further angiographic evaluation using the modified Cekirge-Saatci classification demonstrated that complete occlusion, neck residual, or aneurysm size reduction occurred in 97.1%. The overall combined safety endpoint at 3 years was 2.8% (4/141), with only one non-debilitating major event occurring after the first year. There was one case of aneurysm recurrence but no cases of delayed rupture in this series.

Conclusions: The PED device presents as a safe and effective modality in treating small- and medium-sized intracranial aneurysms. The application of a flow diverter specific occlusion classification attested the long-term durability with higher rate of successful aneurysm occlusion and no documented aneurysm rupture.

Trial registration: NCT02186561.

Keywords: aneurysm; flow diverter; intervention.

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Conflict of interest statement

Competing interests: 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; he has received unrestricted research grants from NIH, Interline Endowment, Microvention, Stryker, CNX; he is an investor/stockholder for InNeuroCo, Cerebrotech, eLum, Endostream, Three Rivers Medical Inc, Scientia, RisT, BlinkTBI, and Corindus. DKL is a consultant for Asahi, Medtronic, and Stryker; has received honoraria from Siemens, Medtronic, Stryker, and Phenox. PKN is a consultant for Medtronic, Phenox, and GmbH. AHS is a modest consultant for Amnis Therapeutics, Boston Scientific, Canon Medical Systems USA, Cerebrotech Medical Systems, Claret Medical, Corindus, Endostream Medical, Guidepoint Global Consulting, Imperative Care, Integra, Rapid Medical, Rebound Therapeutics Corp, Silk Road Medical, StimMed, Stryker, Three Rivers Medical, VasSol, and WL Gore and Associates; he is a consultant and serves on the national PI/steering committee for Cerenovus, Medtronic, MicroVention, and Penumbra; he serves on the National PI/steering committee for the POSITIVE Trial for the Medical University of South Carolina and as DSMB Chair for the HEAT Trial for Northwest University and has ownership interest in Amnis Therapeutics, Apama Medical, BlinkTBI, Buffalo Technology Partners, Cardinal Health, Cerebrotech Medical Systems, Claret Medical, Cognition Medical, Endostream Medical Ltd, Imperative Care, International Medical Distribution Partners, Rebound Therapeutics Corp, Silk Road Medical, StimMed, Synchron, Three Rivers Medical, and Viseon. PJ serves as a consultant for Medtronic, Cerenovus, and Microvention. VMP serves as a consultant/steering committee member for Stryker, Penumbra, and Balt, and as a consultant for Medtronic and Neurovasc, and receives a research grant from Philips. ISI serves as a scientific consultant regarding trial design and conduct to Medtronic. OOZ is a consultant for Medtronic, Stryker, Penumbra, and Cerenovus. CB is a consultant for Depuy-Synthes, Bionaut labs, and Galectin Therapeutics. GPC serves as a consultant for Medtronic, Microvention-Terumo, and Stryker. MM serves as a consultant for Cerebrotech, Imperative Care, and Penumbra; receives consulting fees from Medtronic, Cerenovus, and Canon Medical; and is a member of the Journal of NeuroInterventional Surgery editorial board. CMS has received honoraria from the American Association of Neurological Surgeons and Toshiba, and has ownership interest in NTI. CG serves as a consultant, proctor, and on the Speakers’ Bureau for Medtronic and Stryker. TK is a consultant for Stryker, Cerenovus, Penumbra, and Medtronic. PT serves as a consultant for Stryker Neurovascular, Cerenovus, and Medtronic. GT serves as a consultant for Dynamed EBSCO and Microvention; and is a member of the Journal of NeuroInterventional Surgery editorial board. JFF is an equity interest holder for Fawkes Biotechnology, LLC, and Cerelux; is a consultant for Stream Biomedical, Penumbra, and Medtronic; and is a member of the Journal of NeuroInterventional Surgery editorial board. MC is a consultant for Medtronic, Stryker, Penumbra, Genentech, and GE; and a member of the Journal of NeuroInterventional Surgery editorial board. RP is a consultant for Medtronic, Stryker, and Cerenovus. PK is a consultant for Stryker Neurovascular, Medtronic, and Cerenovus; and a member of the Journal of NeuroInterventional Surgery editorial board. DFi is a consultant for Arsenal Medical, Balt USA, Cerenovous, Marblehead, Medtronic, MENTICE-Vascular Simulations, Microvention, Neurogami, Qapel Medical, RAPID Medical, RAPID.AI, Stryker, and Siemens; received research support from Balt USA, Microvention, Penumbra, Siemens, and Stryker; has received honorarium from Qapel Medicine; is a stockholder in Marblehead, MENTICE-Vascular Simulations, and Neurogami; and a member of the Journal of NeuroInterventional Surgery editorial board. DFr is a consultant and on the Speakers’ Bureau for Penumbra, Stryker Neurovascular, Genentech, MicroVention, and Codman. OD serves as a proctor for Microvention/Terumo. AMM is a cofounder, investor, and shareholder of CereVasc. ASP consults for and has received research grants from Medtronic Neurovascular, Stryker Neurovascular, and Cerenovus; serves as a consultant for Microvention, Agile, Merit, Corindus, QApel, Arsenal, and Imperative Care. DFK is president of Marblehead Medical and has patent pending in balloon catheter technologies; he has received research support from Medtronic, MicroVention, NeuroSave, Neurogami, Sequent Medical, NeuroSigma, and Insera; and serves on the Scientific Advisory Board for Triticum and Boston Scientific.

Figures

**Figure 1**
PREMIER (prospective study on embolization of intracranial aneurysms with pipeline embolization device) patient disposition at the 3-year time point. FU, follow-up; mRS, modified Rankin Scale; yr, year.Primary effectiveness endpoint was evaluated using imputation by the last observation carried forward method. Angiographic follow-up was only required per protocol if complete aneurysm occlusion had not been achieved.

See this image and copyright information in PMC

References

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Prospective study on embolization of intracranial aneurysms with the pipeline device (PREMIER study): 3-year results with the application of a flow diverter specific occlusion classification

Affiliations

Prospective study on embolization of intracranial aneurysms with the pipeline device (PREMIER study): 3-year results with the application of a flow diverter specific occlusion classification

Authors

Affiliations

Abstract

Conflict of interest statement

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LinkOut - more resources

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Research Materials