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 - Funding Information:
We would like to thank the SMART Registry Investigators (see Supplementary Table 2 for full list of Investigators) and Study Coordinators for all of their contribution to the study. The authors would like to acknowledge Sam Watcha, MS, Statistician and Susan M. Bezenek, RN BA MPH, Senior Medical Writer for editorial support. They both received salary support from Penumbra Inc. for this work.
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
UR - http://www.scopus.com/inward/record.url?scp=85104981015&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85104981015&partnerID=8YFLogxK
U2 - 10.3389/fneur.2021.637551
DO - 10.3389/fneur.2021.637551
M3 - Article
AN - SCOPUS:85104981015
VL - 12
JO - Frontiers in Neurology
JF - Frontiers in Neurology
SN - 1664-2295
M1 - 637551
ER -