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Neurosurgery:
doi: 10.1227/01.neu.0000429844.06955.39
Research-Human-Clinical Studies

The Pipeline Embolization Device: Learning Curve and Predictors of Complications and Aneurysm Obliteration

Jabbour, Pascal MD*; Chalouhi, Nohra MD*; Tjoumakaris, Stavropoula MD*; Gonzalez, L. Fernando MD*; Dumont, Aaron S. MD*; Randazzo, Ciro MD*; Starke, Robert M. MD*; Hasan, David MD; Chitale, Rohan MD*; Singhal, Saurabh MD*; Moukarzel, Lea A. BA*; Rosenwasser, Robert MD*

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Abstract

BACKGROUND: The Pipeline Embolization Device (PED) has emerged as a promising treatment for intracranial aneurysms.

OBJECTIVE: To assess the safety and efficacy of the PED, to analyze the effect of operator experience on the complication rate, and to identify predictors of complications and obliteration.

METHODS: A total of 109 patients with 120 aneurysms were treated with PED at our institution. The patient population was divided into 3 consecutive equal groups to assess whether overall and major complication rates decreased over time: group 1, patients 1 through 37; group 2, patients 38 through 73; and group 3, patients 74 through 109.

RESULTS: The number of PEDs used was 1.40 per aneurysm. Symptomatic and major procedure-related complications occurred in 11% and 3.7% of patients, respectively. The rate of complications decreased from 16.2% in group 1 to 5.6% in group 3, and the rate of major complications fell dramatically from 10.8% in group 1 to 0% in groups 2 and 3 (P < .05). Procedure time significantly decreased over time (P = .04). In multivariate analysis, previously treated aneurysms were predictive of procedural complications (P = .02). At the latest follow-up, 65.8% of aneurysms were completely occluded, 9.6% were nearly completely occluded, and 24.6% were incompletely occluded. In multivariate analysis, fusiform aneurysms (P = .05) and shorter angiographic follow-up (P = .03) were negative predictors of aneurysm obliteration.

CONCLUSION: PED therapy may have an acceptable safety-efficacy profile. The risk of complications appears to decrease dramatically with physician experience, supporting the existence of a learning curve. Patients with previously treated aneurysms have higher complication rates, whereas fusiform aneurysms achieve lower obliteration rates.

ABBREVIATIONS: OR, odds ratio

PED, Pipeline Embolization Device

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