Abstract
Objectives: The aim of this retrospective multicenter cohort study is to examine the outcomes of the Pipeline embolization device (PED) for the treatment of intracranial aneurysms outside of United States Food and Drug Administration approved (off-label) indications. Methods: Data from aneurysm patients treated with the PED for off-label indications was pooled from four different centers. The primary endpoints were decline in modified Rankin Scale (mRS) by at least 1 point and angiographic aneurysm occlusion at follow-up. Results: The study cohort was comprised of 109 patients. The mean aneurysm size was , 20% were located in the posterior circulation, and 12% were ruptured. The most common reasons for off-label use were aneurysm size (57%), location (11%) or both (12%). The mean follow-up was 9 months. Complete occlusion was achieved in 82% of cases at last angiographic follow-up and mRS decline was found in 18.8% of the cases. In the univariate analysis, only ruptured aneurysm presentation was significantly associated with mRS decline (p=0.016) (Table 1). In the multivariate analysis, size as the indication for off-label use was associated with higher odds of complete aneurysm occlusion on final angiography (Table 2). Conclusion: The off-label use of the PED has a reasonable risk to benefit profile for appropriately selected aneurysms. Posterior circulation location and fusiform morphology do not appear to be associated with worse clinical or angiographic outcomes.
Published Version
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