Safety and Efficacy of the Off-Label Use of Pipeline Embolization Device Based on the 2018 Food and Drug Administration-Approved Indications for Intracranial Aneurysms: A Single-Center Retrospective Cohort Study.

BACKGROUND: The pipeline embolization device (PED; ev3/Covidien) has proven safe and effective for treating selected intracranial aneurysms. This device's versatility and popularity have driven increased interest in expanding the latest 2018 Food and Drug Administration-approved indications. OBJECTIVE: To compare "off-label" and "on-label" PED treatment. METHODS: Retrospective analysis of aneurysms treated with PED at a single center from 2013 to 2019. Comparisons were made based on the 2018 Food and Drug Administration-approved indications. RESULTS: A total of 492 treated aneurysms were included (65.2% on-label and 34.8% off-label). Aneurysm complete and near-complete occlusion rate was nonsignificantly lower in the off-label group (80.9% vs 85.7%; P = .19). Off-label treatment had higher rate of poor functional outcomes (modified Rankin Scale [mRS] >2: 10.3% vs 3.5%; P = .002). Although pretreatment mRS was already higher in the off-label group (5.3% vs 0.3%; P < .001) and there were no differences in mRS worsening during follow-up (5.5% vs 2.9%; P = .15). We also found a trend to a higher rate of intracranial hemorrhagic complications in the off-label group (4.7% vs 1.6%; P = .05), but there were no differences in hemorrhages requiring surgical intervention (1.8% vs 1.3%; P = .65). There were no differences in retreatment, thromboembolic complications, and mortality rates. CONCLUSION: Off-label PED treatment may be considered for select aneurysms, which are challenging to treat with other techniques. These cases have similar complete and near-complete occlusion rates compared with on-label cases. There are, however, higher risks of poor functional outcomes despite similar rates of thromboembolic and hemorrhagic complications. This is partly explained by the significantly higher pretreatment mRS score in the off-label group.

Pipeline Embolization Device Versus Stent-Assisted Coiling for Intracranial Aneurysm Treatment: A Retrospective Propensity Score-Matched Study.

BACKGROUND: Pipeline embolization device (PED; Medtronic) and stent-assisted coiling (SAC) are established modalities for treatment of intracranial aneurysms. OBJECTIVE: To comparatively assess the efficacy of these techniques. METHODS: We conducted a retrospective analysis of patients with aneurysms treated at our institution with either PED from 2013 to 2017 or SAC from 2009 to 2015. All large (>10 mm), ruptured, fusiform, anterior communicating artery, posterior circulation aneurysms, and patients with no available follow-up imaging were eliminated before running the propensity score matching (PSM). Patients were matched using nearest neighbor controlling for: age, gender, smoking, exact location, maximal diameter, and presence of multiple aneurysms. Total hospital costs for equipment and implants were calculated from procedure product and hospital billing records, and compared between the propensity-matched pairs. RESULTS: Out of 165 patients harboring 202 aneurysms; 170 (84.2%) were treated with the PED, and 32 (15.8%) were treated using SAC. PSM resulted in 23 matched pairs; with significantly longer follow up in the SAC group (mean 29.8 vs 14.1 mo; P = .0002). Complete occlusion rates were not different (82.6 vs 87%; P = .68), with no difference between the groups for modified Rankin Scale on last clinical follow-up, procedural complications or retreatment rates. Average total costs calculated from the hospital records, including equipment and implants, were not different between propensity-score matched pairs (P = .48). CONCLUSION: PED placement and SAC offer equally efficacious occlusion rates, functional outcomes, procedural complication rates, and cost profiles for small unruptured anterior circulation saccular aneurysms which do not involve the anterior communicating artery.