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

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, SMART Registry Investigators, 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, SMART Registry Investigators

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.

Keywords: SMART COIL; embolization coil; intracranial aneurysm; intracranial fistula; intracranial malformations.

Conflict of interest statement

This study was funded by Penumbra Inc. (Alameda USA). Both the sponsor and authors were involved in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, and approval of the manuscript; and decision to submit the manuscript for publication. The reviewer AC declared a past co-authorship with one of the authors OZ to the handling editor.

Copyright © 2021 Spiotta, Park, Bellon, Bohnstedt, Yoo, Schirmer, DeLeacy, Fiorella, Woodward, Hawk, Nanda, Zaidat, Sunenshine, Liu, Kabbani, Snyder, Sivapatham, Dumont, Reeves, Starke and the SMART Registry Investigators.

Figures

Figure 1
Figure 1
Study flow diagram.

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