1. The SMART Registry: Long-Term Results on the Utility of the Penumbra SMART COIL System for Treatment of Intracranial Aneurysms and Other Malformations
- Author
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Alejandro M. Spiotta, Min S. Park, Richard J. Bellon, Bradley N. Bohnstedt, Albert J. Yoo, Clemens M. Schirmer, Reade A. DeLeacy, David J. Fiorella, B. Keith Woodward, Harris E. Hawk, Ashish Nanda, Osama O. Zaidat, Peter J. Sunenshine, Kenneth C. Liu, Mouhammed R. Kabbani, Kenneth V. Snyder, Thinesh Sivapatham, Travis M. Dumont, Alan R. Reeves, Robert M. Starke, and The SMART Registry Investigators
- Subjects
embolization coil ,intracranial aneurysm ,SMART COIL ,intracranial fistula ,intracranial malformations ,Neurology. Diseases of the nervous system ,RC346-429 - 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.
- Published
- 2021
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