Frontiers in Neurology (Apr 2021)

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,
  • The SMART Registry Investigators

DOI
https://doi.org/10.3389/fneur.2021.637551
Journal volume & issue
Vol. 12

Abstract

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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.

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