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

Samer G. Zammar, Thomas J. Buell, Ching Jen Chen, R. Webster Crowley, Dale Ding, Christoph J. Griessenauer, Brian L. Hoh, Kenneth C. Liu, Christopher S. Ogilvy, Daniel M. Raper, Amit Singla, Ajith J. Thomas, Kevin M. Cockroft, Scott D. Simon

Research output: Contribution to journalArticlepeer-review

5 Scopus citations

Abstract

Objective: To examine outcomes of Pipeline embolization device (PED) use for treatment of intracranial aneurysms outside of U.S. Food and Drug Administration–approved indications. Methods: Data from patients with aneurysms treated with off-label use of PED were pooled from 4 centers in a retrospective multicenter cohort study. Primary endpoints were decline in modified Rankin Scale score by at least 1 point and angiographic aneurysm occlusion at follow-up. Results: The study cohort comprised 109 patients. Mean aneurysm size was 8.4 ± 7.4 mm, 20.2% of aneurysms were located in the posterior circulation, and 11.9% of aneurysms were ruptured. The most common reasons for off-label use were aneurysm size (50.5%), aneurysm location (25.7%), and both size and location (10.1%). Mean follow-up was 9 months. Complete occlusion was achieved in 82.5% of cases at last angiographic follow-up. Modified Rankin Scale score decline was found in 18.8% of cases. On univariate analysis, age, aneurysm size, aneurysm morphology, aneurysm location, reason for off-label use, and rupture status were not associated with clinical decline or aneurysm occlusion on angiography. On multivariate analysis, treatment of a ruptured aneurysm with PED was found to be an independent predictor of postoperative decline in modified Rankin Scale score, and size as the only reason for off-label PED use was found to be an independent predictor of complete occlusion on final angiography. Conclusions: Off-label use of 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.

Original languageEnglish (US)
Pages (from-to)e200-e205
JournalWorld neurosurgery
Volume115
DOIs
StatePublished - Jul 2018

All Science Journal Classification (ASJC) codes

  • Surgery
  • Clinical Neurology

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