The SMART Registry: Long-Term Results on the Utility of the Penumbra SMART COIL System for Treatment of Intracranial Aneurysms and Other Malformations

Abstract

Introduction: Penumbra SMART COIL® (SMART) System is a novel generation embolic coil with varying stiffness. The study purpose was to report real-world usage of the SMART System in patients with intracranial aneurysms (ICA) and non-aneurysm vascular lesions.Materials and Methods: The SMART Registry is a post-market, prospective, multicenter registry requiring ≥75% Penumbra Coils, including SMART, PC400, and/or POD coils. The primary efficacy endpoint was retreatment rate at 1-year and the primary safety endpoint was the procedural device-related serious adverse event rate.Results: Between June 2016 and August 2018, 995 patients (mean age 59.6 years, 72.1% female) were enrolled at 68 sites in the U.S. and Canada. Target lesions were intracranial aneurysms in 91.0% of patients; 63.5% were wide-neck and 31.8% were ruptured. Adjunctive devices were used in 55.2% of patients. Mean packing density was 32.3%. Procedural device-related serious adverse events occurred in 2.6% of patients. The rate of immediate post-procedure adequate occlusion was 97.1% in aneurysms and the rate of complete occlusion was 85.2% in non-aneurysms. At 1-year, the retreatment rate was 6.8%, Raymond Roy Occlusion Classification (RROC) I or II was 90.0% for aneurysms, and Modified Rankin Scale (mRS) 0-2 was achieved in 83.1% of all patients. Predictors of 1-year for RROC III or retreatment (incomplete occlusion) were rupture status (P < 0.0001), balloon-assisted coiling (P = 0.0354), aneurysm size (P = 0.0071), and RROC III immediate post-procedure (P = 0.0086) in a model that also included bifurcation aneurysm (P = 0.7788). Predictors of aneurysm retreatment at 1-year was rupture status (P < 0.0001).Conclusions: Lesions treated with SMART System coils achieved low long-term retreatment rates.Clinical Trial Registration:https://www.clinicaltrials.gov/, identifier NCT02729740.

Randomized Clinical Trials in Cerebrovascular Neurosurgery From 2018 to 2022

“…Long-term results of a post-market, prospective, multicenter registry of the Penumbra SMART COIL system (Penumbra) demonstrated Raymond Roy occlusion I or II in 90.0% of aneurysms and a 6.8% re-treatment rate at one year [ 84 ].…”

Safety and Long-Term Efficacy Outcomes for Endovascular Treatment of Wide-Neck Bifurcation Aneurysms of the Middle Cerebral Artery: Insights From the SMART Registry

“…The Penumbra SMART Coil (Penumbra Inc.; Alameda, CA, United States) is commonly utilized in the treatment of intracranial aneurysms. The SMART registry is a prospective, single-arm, multi-center registry that includes imaging, demographic characteristics, procedural information and clinical outcomes for, patients treated for intracranial aneurysms, and vascular lesions using SMART COIL R (SMART), Penumbra Coil 400 R (PC 400), and Penumbra Occlusive Device R (POD) (Penumbra Inc. ; Alameda, CA) (6). The Penumbra SMART Registry consisted of an initial 75 sites that were activated, from which 68 enrolled subjects.…”

m6A regulator–mediated RNA methylation modification patterns and immune microenvironment infiltration characterization in patients with intracranial aneurysms

“…According to previous studies, unruptured IA may exist in ∼3% of the US population (6, 7) and 6-7% of the Chinese population (8). Available treatment modalities for IA include surgical clamping and various endovascular treatment options (e.g., endovascular coils, bypasses, and endovascular devices) (9). However, the choice of treatment modality and the timing of treatment initiation for IA in different conditions (ruptured or unruptured) remains controversial (10).…”