Technical Success and Early Efficacy in 851 Patients with Saccular Intracranial Aneurysms: A Subset Analysis of SMART, a Prospective, Multicenter Registry Assessing the Embolization of Neurovascular Lesions using the Penumbra SMART COIL System

Abstract

The Prospective, Multicenter Registry Assessing the Embolization of Neurovascular Lesions Using the Penumbra SMART COIL® System (SMART) is the largest prospective, multicenter, postmarket registry established to gather real-world experience on Penumbra (Alameda, USA) SMART COIL System, PC400, and POD embolization coils. The goal of this study is to report the technical success and efficacy of SMART COIL System coils in treating saccular intracranial aneurysms. This subgroup analysis from the SMART registry included patients with saccular intracranial aneurysms treated using ≥75% SMART COIL System or PC400 coils. Baseline and procedural data, angiographic data, and clinical outcomes were collected. Predictors of catheter kickout, packing density, and postprocedural angiographic outcome were analyzed using multivariable regression models in saccular aneurysm cases. Between June 2016 and August 2018, the SMART registry enrolled 995 patients at 68 sites, of which 851 of 995 (85.5%) were treated for saccular aneurysms (mean age, 59.9 years). Aneurysms had a mean size of 6.8 mm, were wide neck in 63.1%, and ruptured in 31.0% of patients. Mean aneurysm packing density was 32.3%. Postprocedural Raymond-Roy Occlusion Classification (RROC) I-II was achieved in 80.3% of patients; smaller aneurysms, non-wide-neck aneurysms, and high packing density were predictive of RROC I-II. Overall, mean fluoroscopic time was 43.4 minutes, rate of reaccess attempts because of catheter kickout was 6.2%, and mean procedure time was 83.2 minutes. SMART COIL System coils achieved good technical success and adequate occlusion in treating saccular intracranial aneurysms in a real-world setting.