O-054 Prospective study on embolization of intracranial aneurysms with the pipeline device (PREMIER study): 3-year results with the application of a specific flow-diverter occlusion classification

Introduction Flow diverters proved to be a safe and efficacious approach for the management of large intracranial lesions. The PREMIER trial was the first prospective study to examine the efficacy of the pipeline embolization device (PED, Medtornic) for the management of small and medium size wide-necked aneurysms. Herein, we present the 3-year follow-up results from the PREMIER cohort. Methods The PREMIER was a prospective, single-arm study, including patients with a target wide-necked aneurysm of ≤ 12 mm, located in the internal carotid artery or vertebral artery. The primary effectiveness endpoint (complete aneurysm occlusion) and primary safety endpoint (major stroke in the supplied territory or neurologic death) were independently monitored and adjudicated. Additional angiographic evaluation to highlight the natural history of aneurysms treated with flow diverters was performed using the modified Cekirge-Saatci Classification (mCSC). Results According to CRL review, of 141 patients treated with PED, 25 (17.7%) required angiographic follow-up after the first year due to incomplete aneurysm occlusion. Three (12%) of these patients progressed to complete occlusion, resulting in a complete aneurysm occlusion rate at 3-year of 83.3% (115/138). Further angiographic evaluation using mCSC demonstrated that complete occlusion, neck residual, or aneurysm size reduction occurred in all cases with consecutive available follow-ups (97.1%). Overall safety endpoint occurred in 2.8% (4/140) of the patients over the 3-year follow-up, with only one event occurring after the first year – which was non-disabling at 2-year follow-up. Retreatment rate since initial device implantation was 5.0% (7/138): 4 within the first year and 3 within the second year, all carried on with PED in elective procedures. There was one case of aneurysm recurrence (0.7%) in a patient with an initially occluded aneurysm who afterward demonstrated residual neck at a 3-year follow-up. Not a single case of aneurysm rupture occurred in the series. Conclusions A high rate of aneurysm occlusion, low morbidity, and absence of aneurysm rupture emphasize the PED as a safe treatment strategy for small and medium-sized aneurysms located along the ICA and VA in the long term. Disclosures R. Hanel: 1; C; Unrestricted research grant from NIH, Interline Endowment, Microvention, Stryker, CNX. 2; C; 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. 4; C; InNeuroCo, Cerebrotech, eLum, Endostream, Three Rivers Medical Inc, Scientia, RisT, BlinkTBI, and Corindus. G. Cortez: None. D. Lopes: 2; C; Asahi, Medtronic, and Stryker; honoraria from Siemens, Medtronic, Stryker, and Phenox. P. Nelson: 2; C; Medtronic, Phenox, and GmbH. A. Siddiqui: 2; C; Amnis Therapeutics, Boston Scientific, Canon Medical Systems USA, Cerebrotech Medical Systems, Claret Medical, Corindus, Endostream Medical, Guidepoint Global Consulting, Imperative Care, Integra, Rap. 4; C; in Amnis Therapeutics, Apama Medical, BlinkTBI, Buffalo Technology Partners, Cardinal Health, Cerebrotech Medical Systems, Claret Medical, Cognition Medical, Endostream Medical Ltd, Imperative Care, I. P. Jabbour: 2; C; Medtronic, Cerenovus, and Microvention. V. Pereira: 1; C; Philips. 2; C; Stryker, Penumbra, Balt, Medtronic, and Neurovasc. I. István: 2; C; Medtronic. O. Zaidat: 2; C; Medtronic, Stryker, Penumbra, and Cerenovus. C. Bettegowda: 2; C; Depuy-Synthes, Bionaut labs, and Galectin Therapeutics. G. Colby: 2; C; Medtronic, Microvention-Terumo, and Stryker. M. Mokin: 2; C; Cerebrotech, Imperative Care, and Penumbra; consulting fees form Medtronic, Cerenovus, and Canon Medical. C. Schirmer: 6; C; received honoraria from the American Association of Neurological Surgeons and Toshiba, and has ownership interest in NTI. F. Hellinger: None. C. Given II: 2; C; Medtronic and Stryker. 3; C; Medtronic and Stryker. T. Krings: 2; C; Stryker, Cerenovus, Penumbra, and Medtronic. P. Taussky: 2; C; Stryker Neurovascular, Cerenovus, and Medtronic. G. Toth: 2; C; Dynamed EBSCO and Microvention. J. Fraser: 2; C; Stream Biomedical, Penumbra, and Medtronic. 4; C; Fawkes Biotechnology, LLC, and Cerelux. M. Chen: 2; C; Medtronic, Stryker, Penumbra, Genentech, and GE. R. Priest: 2; C; Medtronic, Stryker, and Cerenovus. P. Kan: 2; C; Stryker Neurovascular, Medtronic, and Cerenovus. D. Fiorella: 1; C; Balt USA, Microvention, Penumbra, Siemens, and Stryker. 2; C; Arsenal Medical, Balt USA, Cerenovous, Marblehead, Medtronic, MENTICE-Vascular Simulations, Microvention, Neurogami, Qapel Medical, RAPID Medical, RAPID.AI, Stryker, Siemens. 6; C; honorarium from Qapel Medicine. D. Frei: 2; C; Penumbra, Stryker Neurovascular, Genentech, MicroVention, and Codman. B. Aagaard-Kienitz: None. O. Diaz: 6; C; proctor for Microvention/Terumo. A. Malek: 6; C; Cofounder, investor, and shareholder of CereVasc. C. Cawley: None. A. Puri: 1; C; Medtronic Neurovascular, Stryker Neurovascular, and Cerenovus. 2; C; Microvention, Agile, Merit, Corindus, QApel, Arsenal, and Imperative Care. D. Kallmes: 1; C; Medtronic, MicroVention, NeuroSave, Neurogami, Sequent Medical, NeuroSigma, and Insera. 6; C; President of Marblehead Medical and has patent pending in balloon catheter technologies.