Investigators, IntrePED

Purpose: To assess the association of procedure time with neurologic adverse events post Pipeline Embolization Device (PED) placement for intracranial aneurysm treatment. Methods: In the IntrePED Registry, a retrospective review was performed at 17 centers to identify consecutive intracranial aneurysms treated with the PED following regulatory approval in the given country. All patients in whom at least one PED was placed and follow-up was available prior to IRB approval were enrolled. “Primary adverse events” included major stroke, major hemorrhage, and neurological mortality. Results: 793 patients with 906 aneurysms, including 311 large ICA, 536 other anterior and 59 posterior circulation aneurysms were enrolled and followed for a mean duration of 19.3 months. 689 (77%) of 906 aneurysms were saccular and 116(13%) were fusiform. 824 (91%) were unruptured. 308 (34%) treated with multiple PEDs. Incidence of major hemorrhage, stroke and neurological mortality was 2.4%, 4.7% and 3.8% respectively. Heparin was administered in 89% of the patients during the procedure. An average of 1.5 PEDs were utilized per case. The mean procedure time was 101.5 ± 50.5 mins. Patients with a major complication (major stroke, major hemorrhage, neurological mortality) had procedure time of 138.2 + 81.5 min, and those without a major complication had procedure time of 98.3 + 45.5 min (p< 0.001). A logistic regression incorporating aneurysm size and number of PEDs used still showed a highly significant relationship between major complications and procedure time (p<0.001) and also found aneurysm size to be an independent predictor of longer procedures (p=0.007). Conclusions: The present analysis of IntrePED Registry subjects demonstrates a strong association of procedure time with complication rates. Further analyses of factors leading to longer procedure times is needed.