AUTHOR=Spiotta Alejandro M. , Park Min S. , Bellon Richard J. , Bohnstedt Bradley N. , Yoo Albert J. , Schirmer Clemens M. , DeLeacy Reade A. , Fiorella David J. , Woodward B. Keith , Hawk Harris E. , Nanda Ashish , Zaidat Osama O. , Sunenshine Peter J. , Liu Kenneth C. , Kabbani Mouhammed R. , Snyder Kenneth V. , Sivapatham Thinesh , Dumont Travis M. , Reeves Alan R. , Starke Robert M. ,  The SMART Registry Investigators 

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

JOURNAL=Frontiers in Neurology

VOLUME=12

YEAR=2021

URL=https://www.frontiersin.org/journals/neurology/articles/10.3389/fneur.2021.637551

DOI=10.3389/fneur.2021.637551

ISSN=1664-2295

ABSTRACT=<p><bold>Introduction:</bold> 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.</p><p><bold>Materials and Methods:</bold> 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.</p><p><bold>Results:</bold> 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 (<italic>P</italic> &lt; 0.0001), balloon-assisted coiling (<italic>P</italic> = 0.0354), aneurysm size (<italic>P</italic> = 0.0071), and RROC III immediate post-procedure (<italic>P</italic> = 0.0086) in a model that also included bifurcation aneurysm (<italic>P</italic> = 0.7788). Predictors of aneurysm retreatment at 1-year was rupture status (<italic>P</italic> &lt; 0.0001).</p><p><bold>Conclusions:</bold> Lesions treated with SMART System coils achieved low long-term retreatment rates.</p><p><bold>Clinical Trial Registration:</bold><ext-link ext-link-type="uri" xlink:href="http://www.ClinicalTrials.gov" xmlns:xlink="http://www.w3.org/1999/xlink">https://www.clinicaltrials.gov/</ext-link>, identifier NCT02729740.</p>