Treatment of giant intracranial aneurysms using the Pipeline flow-diverting stent: Long-term results from the International Retrospective Study of the Pipeline Embolization Device (IntrePED) study.

Background: Traditional endovascular treatments of giant intracranial aneurysms are associated with high rates of complications and retreatment. Our objective was to examine the safety and long-term efficacy of the Pipeline Embolization Device for treatment of these aneurysms.

Methods: This retrospective study using the IntrePED database included all patients with giant intracranial aneurysms treated with the Pipeline device between July 2008 and February 2013. Efficacy outcomes were stratified by using the Raymond-Roy Occlusion Classification. Predefined safety outcomes included spontaneous rupture of the target aneurysm; ipsilateral intracranial hemorrhage; ischemic stroke; parent artery stenosis; and sustained cranial neuropathy.

Results: Sixty-six embolizations were performed to treat 63 giant intracranial aneurysms (including 2 ruptured): 49 (77.8%) in the anterior and 14 (22.2%) in the posterior circulation. The median follow-up was 22.4 (0.1-60.5) months. Class I angiographic occlusion was achieved in 72.0% (36/50). The neurological morbidity/mortality rate was 23.8% (15/63), with higher rates in the posterior circulation than in the anterior circulation (22.4% vs. 28.6%). Among seven deaths, five had neurological causes. The procedure-related neurological morbidity and mortality rates were 22.7% (15/66) and 7.6% (5/66), respectively. The spontaneous rupture rate was 4.5% (3/66). Two spontaneous ruptures (1 death), 4/4 postprocedural intracranial hemorrhages, and 6/9 ischemic events occurred within 30 days. In-stent stenosis and new-onset cranial neuropathy were not observed during the angiographic follow-up period.

Conclusions: Although procedure-related neurological morbidity/mortality rates were not insignificant, this study confirms the feasibility and long-term efficacy of the Pipeline Embolization Device to treat giant intracranial aneurysms.