TY - JOUR
T1 - The SMART Registry
T2 - Long-Term Results on the Utility of the Penumbra SMART COIL System for Treatment of Intracranial Aneurysms and Other Malformations
AU - The SMART Registry Investigators
AU - Spiotta, Alejandro M.
AU - Park, Min S.
AU - Bellon, Richard J.
AU - Bohnstedt, Bradley N.
AU - Yoo, Albert J.
AU - Schirmer, Clemens M.
AU - DeLeacy, Reade A.
AU - Fiorella, David J.
AU - Woodward, B. Keith
AU - Hawk, Harris E.
AU - Nanda, Ashish
AU - Zaidat, Osama O.
AU - Sunenshine, Peter J.
AU - Liu, Kenneth C.
AU - Kabbani, Mouhammed R.
AU - Snyder, Kenneth V.
AU - Sivapatham, Thinesh
AU - Dumont, Travis M.
AU - Reeves, Alan R.
AU - Starke, Robert M.
N1 - Publisher Copyright:
© 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.
PY - 2021/4/13
Y1 - 2021/4/13
N2 - 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.
AB - 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.
KW - SMART COIL
KW - embolization coil
KW - intracranial aneurysm
KW - intracranial fistula
KW - intracranial malformations
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U2 - 10.3389/fneur.2021.637551
DO - 10.3389/fneur.2021.637551
M3 - Article
AN - SCOPUS:85104981015
SN - 1664-2295
VL - 12
JO - Frontiers in Neurology
JF - Frontiers in Neurology
M1 - 637551
ER -