Browsing by Author "Starke, Robert M."

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    Association of Noncontrast Computed Tomography and Perfusion Modalities with Outcomes in Patients Undergoing Late-Window Stroke Thrombectomy
    (American Medical Association, 2022-11-11) Porto, Guilherme B. F.; Chen, Ching-Jen; Al Kasab, Sami; Essibayi, Muhammed Amir; Almallouhi, Eyad; Hubbard, Zachary; Chalhoub, Reda; Alawieh, Ali; Maier, Ilko; Psychogios, Marios-Nikos; Wolfe, Stacey Q.; Jabbour, Pascal; Rai, Ansaar; Starke, Robert M.; Shaban, Amir; Arthur , Adam; Kim, Joon-Tae; Yoshimura, Shinichi; Grossberg, Jonathan; Kan , Peter; Fragata, Isabel; Polifka, Adam; Osbun, Joshua; Mascitelli, Justin; Levitt, Michael R .; Williamson, Richard, Jr.; Romano, Daniele G.; Crosa, Roberto; Gory, Benjamin; Mokin, Maxim; Limaye, Kaustubh S.; Casagrande, Walter; Moss, Mark; Grandhi, Ramesh; Yoo, Albert; Spiotta, Alejandro M.; Park, Min S.; Stroke Thrombectomy and Aneurysm Registry (STAR) Collaborators; Neurology, School of Medicine
    Importance There is substantial controversy with regards to the adequacy and use of noncontrast head computed tomography (NCCT) for late-window acute ischemic stroke in selecting candidates for mechanical thrombectomy. Objective To assess clinical outcomes of patients with acute ischemic stroke presenting in the late window who underwent mechanical thrombectomy stratified by NCCT admission in comparison with selection by CT perfusion (CTP) and diffusion-weighted imaging (DWI). Design, Setting, and Participants In this multicenter retrospective cohort study, prospectively maintained Stroke Thrombectomy and Aneurysm (STAR) database was used by selecting patients within the late window of acute ischemic stroke and emergent large vessel occlusion from 2013 to 2021. Patients were selected by NCCT, CTP, and DWI. Admission Alberta Stroke Program Early CT Score (ASPECTS) as well as confounding variables were adjusted. Follow-up duration was 90 days. Data were analyzed from November 2021 to March 2022. Exposures Selection by NCCT, CTP, or DWI. Main Outcomes and Measures Primary outcome was functional independence (modified Rankin scale 0-2) at 90 days. Results Among 3356 patients, 733 underwent late-window mechanical thrombectomy. The median (IQR) age was 69 (58-80) years, 392 (53.5%) were female, and 449 (65.1%) were White. A total of 419 were selected with NCCT, 280 with CTP, and 34 with DWI. Mean (IQR) admission ASPECTS were comparable among groups (NCCT, 8 [7-9]; CTP, 8 [7-9]; DWI 8, [7-9]; P = .37). There was no difference in the 90-day rate of functional independence (aOR, 1.00; 95% CI, 0.59-1.71; P = .99) after adjusting for confounders. Symptomatic intracerebral hemorrhage (NCCT, 34 [8.6%]; CTP, 37 [13.5%]; DWI, 3 [9.1%]; P = .12) and mortality (NCCT, 78 [27.4%]; CTP, 38 [21.1%]; DWI, 7 [29.2%]; P = .29) were similar among groups. Conclusions and Relevance In this cohort study, comparable outcomes were observed in patients in the late window irrespective of neuroimaging selection criteria. Admission NCCT scan may triage emergent large vessel occlusion in the late window.
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    Periprocedural safety of saccular aneurysm embolization with the Penumbra SMART Coil System: a SMART registry subset analysis
    (BMJ, 2021-02) Starke, Robert M.; Park, Min S.; Bellon, Richard; Bohnstedt, Bradley; Schirmer, Clemens M.; Leacy, Reade De; Fiorella, David; Yoo, Albert J.; Spiotta, Alejandro M.; Neurological Surgery, School of Medicine
    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.
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    The SMART Registry: Long-Term Results on the Utility of the Penumbra SMART COIL System for Treatment of Intracranial Aneurysms and Other Malformations
    (Frontiers Media, 2021-04-13) Spiotta, Alejandro M.; Park, Min S.; Bellon, Richard J.; Bohnstedt, Bradley N.; Yoo, Albert J.; Schirmer, Clemens M.; DeLeacy, Reade A.; Fiorella, David J.; Woodward, B. Keith; Hawk, Harris E.; Nanda, Ashish; Zaidat, Osama O.; Sunenshine, Peter J.; Liu, Kenneth C.; Kabbani, Mouhammed R.; Snyder, Kenneth V.; Sivapatham, Thinesh; Dumont, Travis M.; Reeves, Alan R.; Starke, Robert M.; SMART Registry Investigators; Neurological Surgery, School of Medicine
    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.