TY - JOUR
T1 - Prospective study on embolization of intracranial aneurysms with the pipeline device (PREMIER study)
T2 - 3-year results with the application of a flow diverter specific occlusion classification
AU - Hanel, Ricardo A.
AU - Cortez, Gustavo M.
AU - Lopes, Demetrius Klee
AU - Nelson, Peter Kim
AU - Siddiqui, Adnan H.
AU - Jabbour, Pascal
AU - Pereira, Vitor Mendes
AU - István, Istvan Szikora
AU - Zaidat, Osama O.
AU - Bettegowda, Chetan
AU - Colby, Geoffrey P.
AU - Mokin, Maxim
AU - Schirmer, Clemens M.
AU - Hellinger, Frank R.
AU - Given, Curtis
AU - Krings, Timo
AU - Taussky, Philipp
AU - Toth, Gabor
AU - Fraser, Justin F.
AU - Chen, Michael
AU - Priest, Ryan
AU - Kan, Peter
AU - Fiorella, David
AU - Frei, Donald
AU - Aagaard-Kienitz, Beverly
AU - Diaz, Orlando
AU - Malek, Adel M.
AU - Michael Cawley, C.
AU - Puri, Ajit S.
AU - Kallmes, David F.
N1 - Publisher Copyright:
© Author(s) (or their employer(s)) 2023.
PY - 2023/3
Y1 - 2023/3
N2 - 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 followup 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.
AB - 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 followup 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.
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U2 - 10.1136/neurintsurg-2021-018501
DO - 10.1136/neurintsurg-2021-018501
M3 - Article
C2 - 35292570
AN - SCOPUS:85142770392
SN - 1759-8478
VL - 15
SP - 248
EP - 254
JO - Journal of NeuroInterventional Surgery
JF - Journal of NeuroInterventional Surgery
IS - 3
ER -