Outcomes after Off-Label Use of the Pipeline Embolization Device for Intracranial Aneurysms: A Multicenter Cohort Study.

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Outcomes after Off-Label Use of the Pipeline Embolization Device for Intracranial Aneurysms: A Multicenter Cohort Study.

World Neurosurg. 2018 Apr 18;:

Authors: Zammar SG, Buell TJ, Chen CJ, Crowley RW, Ding D, Griessenauer CJ, Hoh BL, Liu KC, Ogilvy CS, Raper, Singla A, Thomas AJ, Cockroft KM, Simon SD

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, 20.2% were located in the posterior circulation, and 11.9% were ruptured. The most common reasons for off-label use were aneurysm size (50.5%), location (25.7%) or both (10.1%). The mean follow-up was 9 months. Complete occlusion was achieved in 82.5% of cases at last angiographic follow-up and mRS decline was found in 18.8% of the cases. On univariate analysis, age, aneurysm size aneurysm morphology, aneurysm location, and the reason for off label use as well as the rupture status were not associated with clinical decline or aneurysm occlusion on angiography. On multivariate analysis PED treatment of a ruptured aneurysm was found to be an independent predictor of a postoperative decline in mRS, and size as the only reason for off-label PED use was found to be an independent predictor of complete occlusion on final angiography.
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.

PMID: 29679782 [PubMed - as supplied by publisher]

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