Purpose To assess the outcomes of patients with giant intracranial aneurysms who have undergone treatment with the Pipeline Embolic Device (PED) during the ASPIRE (Aneurysm Study of Pipeline In an Observational Registry) study.
Methods ASPIRe was a prospective, global, multi-center, single-arm, observational evaluation of the treatment of intracranial aneurysms using the Pipeline ™ Embolization Device. PED was evaluated when used in routine practice according to its country-specific IFU. 28 Sites (20 US, 7 Europe, 1 Canada) obtained approval by local IRB/EC for study enrollment and treated patients with an intracranial aneurysm meeting the labeled indication for the relevant geography.
Results A total 191 patients with 207 aneurysms were treated in ASPIRE with 21 patients harboring 21 giant aneurysms (18 ICA, 2 MCA, 1 Basilar). Patients with giant aneurysms were enrolled and followed for a mean duration of 6 months (SD 5, range 0.0–16.3). Median age was 63 years. 18 (85.7%) were females. 16 (76.2%) of 21 aneurysms were saccular and 5(23.8%) were fusiform or dissecting. All lesions were unruptured. 6 (28.6%) were treated with multiple PEDs. Primary safety events were noted in 5 (23.8%) of cases. Mortality occurred in 2 patients (9.5%) Delayed aneurysm rupture occurred in 2 of 21 cases (9.5%); Parenchymal hemorrhage in 1/21 (4.8%) and Ischemic Strokes in 2/21 (9.5%). At present time, mean follow up is 10 months, 11 patients have completed follow up image demonstrating total occlusion of 73% (8/11).
Conclusions The present analysis of ASPIRE subjects harboring giant intracranial aneurysms demonstrates higher risk of delayed aneurysm ruptured when compared to smaller lesions. There is very good long term results with similar peri-operative morbidity and mortality rates as alternative endovascular treatment options.
Disclosures R. Hanel: 2; C; Covidien, Codman, Stryker. 4; C; Blockade. 6; C; SAB - Medina. A. Bonafe: None. S. Fischer: None. O. Diaz: None. D. Kallmes: None. S. Barnwell: None. H. Woo: None.
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