Background and purpose Flow diversion with the Pipeline Embolization Device (PED) has been shown to be effective and safe in several trials and registries. The PUFS trial demonstrated over 90% complete occlusion rate and a 5.6% major ipsilateral stroke and neurologic death rate in large and giant internal carotid artery aneurysms. We sought to determine the relationship between aneurysm shape and these primary endpoint outcomes in the PUFS patient population.
Materials and methods Ten centers prospectively enrolled and treated 107 patients with 109 aneurysms in the PUFS trial. All centers obtained IRB or EC approval. Prospectively collected information included demographic characteristics, aneurysm size and location, aneurysm neck size, aneurysm shape, number of PEDs used, and any complications (including stroke and death). All complications were reviewed and adjudicated by a Clinical Events Committee. All angiographic images were evaluated by an independent Core Radiology Laboratory. For the purposes of this analysis, fusiform aneurysm were defined as having an aneurysm neck involving ≥50% of the parent artery circumference vs <50% for saccular aneurysms.
Results Of the 109 aneurysms treated, 46% (50 aneurysms in 49 patients) were fusiform and 54% (59 aneurysms in 58 patients) were saccular. The rate of major ipsilateral ischemic or hemorrhagic stroke was 6.1% (3/49) for patients with fusiform aneurysms and 3.4% (2/58) for patients with saccular aneurysms. The neurologic death rate was 0% (0/49) and 1.7% (1/58) for patients with fusiform and saccular aneurysms, respectively. The combined rate of major ipsilateral stroke and neurological mortality was 6.1% (3/49) for patients with fusiform aneurysms and 5.2% (3/58) for patients with saccular aneurysms. At 5 years post-procedure, the complete aneurysm occlusion rate was 95.8% (23/24) for fusiform aneurysms and 95% (38/40) for saccular aneurysms.
Conclusions The PED demonstrates high levels of safety and effectiveness in the treatment of both fusiform and saccular ICA aneurysms.
Disclosures T. Becske: 2; C; Covidien proctor. M. Potts: None. W. Brinjikji: None. D. Kallmes: 1; C; Covidien. 2; C; Covidien. M. Shapiro: 2; C; Covidien proctor. P. Nelson: 2; C; Covidien.
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