PMID- 33593799 OWN - NLM STAT- MEDLINE DCOM- 20220120 LR - 20220206 IS - 1759-8486 (Electronic) IS - 1759-8478 (Print) IS - 1759-8478 (Linking) VI - 14 IP - 1 DP - 2022 Jan TI - Periprocedural safety of saccular aneurysm embolization with the Penumbra SMART Coil System: a SMART registry subset analysis. LID - neurintsurg-2020-016943 [pii] LID - 10.1136/neurintsurg-2020-016943 [doi] AB - BACKGROUND: Using data from the SMART registry, we report on periprocedural safety of the Penumbra SMART Coil System for endovascular coil embolization of saccular intracranial aneurysms. METHODS: The SMART registry was a prospective, multi-center registry of site standard of care endovascular coiling procedures performed using at least 75% Penumbra SMART Coil, PC400, and/or POD coils. This subset analysis reports on the periprocedural safety outcomes of the saccular intracranial aneurysm cohort. Predictors of rupture/re-rupture or perforation (RRP), thromboembolic complications, and device- or procedure-related adverse events (AEs) were determined in univariate and multivariate analysis. RESULTS: Between June 2016 and August 2018, 851 saccular aneurysm patients (31.0%, 264/851 ruptured) were enrolled across 66 North American centers. Clinically significant (ie, a serious adverse event) RRP occurred in 2.0% (17/851) of cases - 1.9% (5/264) for the ruptured cohort and 2.0% (12/587) for the un-ruptured cohort. Clinically significant thromboembolic events occurred in 3.1% (26/851) of cases - 5.3% (14/264) for the ruptured cohort and 2.0% (12/587) for the un-ruptured cohort. Multivariate predictors of periprocedural RRP were increased packing density and adjunctive treatment with a balloon. For periprocedural thromboembolic events, multivariate predictors were bifurcation location and ruptured status. For device- or procedure-related AEs, multivariate predictors were bifurcation location and adjunctive treatment with stent or balloon. CONCLUSION: The low rates of thromboembolic complications and RRP events demonstrate the adequate safety profile of the SMART Coil System to treat cerebral aneurysms in routine clinical practice. TRIAL REGISTRATION NUMBER: NCT02729740. CI - (c) Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. FAU - Starke, Robert M AU - Starke RM AD - Neurological Surgery, University of Miami Hospital, Miami, Florida, USA. FAU - Park, Min S AU - Park MS AD - Neurosurgery, University of Virginia, Charlottesville, Virginia, USA. FAU - Bellon, Richard AU - Bellon R AD - Interventional Neuroradiology, Radiology Imaging Associates, Englewood, Colorado, USA. FAU - Bohnstedt, Bradley AU - Bohnstedt B AUID- ORCID: 0000-0001-6254-2313 AD - Department of Neurological Surgery, Oklahoma University Medical Center, Oklahoma City, Oklahoma, USA. FAU - Schirmer, Clemens M AU - Schirmer CM AD - Neurosurgery, Geisinger Health System, Danville, Pennsylvania, USA. FAU - De Leacy, Reade AU - De Leacy R AUID- ORCID: 0000-0001-9447-5338 AD - Neurosurgery and Radiology, Icahn School of Medicine at Mount Sinai, New York City, New York, USA. FAU - Fiorella, David AU - Fiorella D AUID- ORCID: 0000-0002-2677-8780 AD - Neurosurgery, Stony Brook University Medical Center, Stony Brook, New York, USA. FAU - Yoo, Albert J AU - Yoo AJ AD - Interventional Neuroradiology, Texas Stroke Institute, Dallas-Fort Worth, Texas, USA. FAU - Spiotta, Alejandro M AU - Spiotta AM AD - Neurosurgery, Medical University of South Carolina, Charleston, South Carolina, USA spiotta@musc.edu. CN - SMART Registry Investigators LA - eng SI - ClinicalTrials.gov/NCT02729740 GR - KL2 TR002737/TR/NCATS NIH HHS/United States GR - R01 NS111119/NS/NINDS NIH HHS/United States GR - UL1 TR002736/TR/NCATS NIH HHS/United States PT - Journal Article DEP - 20210216 PL - England TA - J Neurointerv Surg JT - Journal of neurointerventional surgery JID - 101517079 SB - IM MH - *Aneurysm, Ruptured/diagnostic imaging/therapy MH - *Embolization, Therapeutic/adverse effects MH - Humans MH - *Intracranial Aneurysm/diagnostic imaging/therapy MH - Prospective Studies MH - Registries MH - Retrospective Studies MH - Stents MH - Treatment Outcome PMC - PMC8785012 OTO - NOTNLM OT - aneurysm OT - coil OT - complication OT - device OT - intervention COIS- Competing interests: RMS: research support - NREF, Joe Niekro Foundation, Brain Aneurysm Foundation, Bee Foundation, and National Institute of Health (R01NS111119-01A1) and (UL1TR002736, KL2TR002737) through the Miami Clinical and Translational Science Institute, from the National Center for Advancing Translational Sciences and the National Institute on Minority Health and Health Disparities. Consulting - Penumbra, Abbott, Medtronic, InNeuroCo, and Cerenovus. Teaching - Penumbra, Abbott, Medtronic, InNeuroCo, and Cerenovus; MSP: other from Penumbra, during the conduct of the study; CMS: research support -Penumbra. Shareholder - Neurotechnology Investors; RD: personal fees from Penumbra, personal fees from Imperative Care, personal fees from Siemens, and personal fees from Cerenovus, outside the submitted work; DF: consultant - Balt, Marblehead, Medtronic, Stryker, Microvention, Stryker, Penumbra, and Cerenovus. Research support - Cerenovus, Medtronic, Siemens, Stryker, Microvention, and Penumbra; AJY: grants and personal fees from Penumbra, grants and personal fees from Cerenovus, grants from Medtronic, grants from Stryker, and personal fees from Genentech, outside the submitted work. Equity interest in Galaxy Therapeutics and Insera Therapeutics; AMS: consulting for Stryker, Penumbra, and Terumo. Research support Stryker, Penumbra, and Medtronic. EDAT- 2021/02/18 06:00 MHDA- 2022/01/21 06:00 PMCR- 2022/01/24 CRDT- 2021/02/17 05:43 PHST- 2020/09/28 00:00 [received] PHST- 2020/12/30 00:00 [revised] PHST- 2021/01/19 00:00 [accepted] PHST- 2021/02/18 06:00 [pubmed] PHST- 2022/01/21 06:00 [medline] PHST- 2021/02/17 05:43 [entrez] PHST- 2022/01/24 00:00 [pmc-release] AID - neurintsurg-2020-016943 [pii] AID - 10.1136/neurintsurg-2020-016943 [doi] PST - ppublish SO - J Neurointerv Surg. 2022 Jan;14(1):neurintsurg-2020-016943. doi: 10.1136/neurintsurg-2020-016943. Epub 2021 Feb 16.