Outcomes of Mechanical Thrombectomy for Patients With Stroke Presenting With Low Alberta Stroke Program Early Computed Tomography Score in the Early and Extended Window

Importance: Limited data are available about the outcomes of mechanical thrombectomy (MT) for real-world patients with stroke presenting with a large core infarct. Objective: To investigate the safety and effectiveness of MT for patients with large vessel occlusion and an Alberta Stroke Program Early Computed Tomography Score (ASPECTS) of 2 to 5. Design, setting, and participants: This retrospective cohort study used data from the Stroke Thrombectomy and Aneurysm Registry (STAR), which combines the prospectively maintained databases of 28 thrombectomy-capable stroke centers in the US, Europe, and Asia. The study included 2345 patients presenting with an occlusion in the internal carotid artery or M1 segment of the middle cerebral artery from January 1, 2016, to December 31, 2020. Patients were followed up for 90 days after intervention. The ASPECTS is a 10-point scoring system based on the extent of early ischemic changes on the baseline noncontrasted computed tomography scan, with a score of 10 indicating normal and a score of 0 indicating ischemic changes in all of the regions included in the score. Exposure: All patients underwent MT in one of the included centers. Main outcomes and measures: A multivariable regression model was used to assess factors associated with a favorable 90-day outcome (modified Rankin Scale score of 0-2), including interaction terms between an ASPECTS of 2 to 5 and receiving MT in the extended window (6-24 hours from symptom onset). Results: A total of 2345 patients who underwent MT were included (1175 women [50.1%]; median age, 72 years [IQR, 60-80 years]; 2132 patients [90.9%] had an ASPECTS of ≥6, and 213 patients [9.1%] had an ASPECTS of 2-5). At 90 days, 47 of the 213 patients (22.1%) with an ASPECTS of 2 to 5 had a modified Rankin Scale score of 0 to 2 (25.6% [45 of 176] of patients who underwent successful recanalization [modified Thrombolysis in Cerebral Ischemia score ≥2B] vs 5.4% [2 of 37] of patients who underwent unsuccessful recanalization; P = .007). Having a low ASPECTS (odds ratio, 0.60; 95% CI, 0.38-0.85; P = .002) and presenting in the extended window (odds ratio, 0.69; 95% CI, 0.55-0.88; P = .001) were associated with worse 90-day outcome after controlling for potential confounders, without significant interaction between these 2 factors (P = .64). Conclusions and relevance: In this cohort study, more than 1 in 5 patients presenting with an ASPECTS of 2 to 5 achieved 90-day functional independence after MT. A favorable outcome was nearly 5 times more likely for patients with low ASPECTS who had successful recanalization. The association of a low ASPECTS with 90-day outcomes did not differ for patients presenting in the early vs extended MT window

P-047 Multimodal endovascular treatment of wide-necked aneurysms: safety and occlusion outcomes from the sterling registry

PurposeWe present core-lab adjudicated immediate post-procedural angiographic outcomes following endovascular treatment of side wall and bifurcation wide-necked aneurysms using MICRUSFRAME and GALAXY coils and various adjunctive devices within the STERLING registry.MethodsSTERLING is an ongoing single-arm prospective post-market surveillance registry evaluating ruptured/unruptured aneurysms treated with MICRUSFRAME and GALAXY coils (Cerenovus, Irvine, CA). All cases of wide-neck aneurysm treatment (neck > 4 mm or dome-to-neck ratio 5mm and 13 mm. The average procedure time was 1.74 hours (SD 0.99) and the average fluoroscopy time was 49.7 minutes (SD 29.6).Aneurysms were treated using the following modalities: coiling alone (58.3%), stent-assisted coiling (24.4%), coiling plus flow diversion (8.3%), Pulserider-assisted coiling (4.2%), balloon-assisted coiling (1.2%), other adjunctive devices (1.8%), and multiple adjunctive devices (1.8%). Across the entire cohort, 82.1% of patients achieved adequate occlusion, defined as mRR class I or II. Angiographic outcomes according to treatment modality are summarized in table 1.Abstract P-047 Table 1Core-lab adjudicated immediate post-procedural occlusion scores Modified Raymond-Roy Outcome Coils Only (N=98) Stent-Assisted Coiling (N=41) Coils + Flow Diverter (N=14) Pulserider (N=7) Balloon Assisted Coiling (N=2) Other Adjunctive Devices (N=3) Multiple Adjunctive Devices (N=3) Total (N=168) Class I 50/98 (51.0%) 23/41 (56.1%) 1/14 (7.1%) 3/7 (42.9%) 2/2 (100.0%) 0 2/3 (66.7%) 81/168 (48.2%) Class II 42/98 (42.9%) 11/41 (26.8%) 1/14 (7.1%) 2/7 (28.6%) 0 0 1/3 (33.3%) 57/168 (33.9%) Class III 6/98 (6.1%) 7/41 (17.1%) 12/14 (85.7%) 2/7 (28.6%) 0 3/3 (100.0%) 0 30/168 (17.9%) IIIa 0 1/7 (2.5%) 0 0 0 0 0 1/168 (0.6%) IIIb 6/98 (6.1%) 6/7 (14.6%) 12/14 (85.7%) 2/7 (28.6%) 0 3/3 (100.0%) 0 29/168 (17.3%) Adequate occlusion (I or II ) 92/98 (93.9%) 34/41 (82.9%) 2/14 (14.3%) 5/7 (71.4%) 2/2 (100.0%) 0 3/3 (100.0%) 138/168 (82.1%) Procedure-related adverse events occurred in 7 cases (4.2%). These included 3 intraprocedural ruptures (1 ruptured, 2 unruptured at baseline), 1 cerebrovascular accident, and 3 asymptomatic thromboembolic events. There were no deaths.ConclusionEndovascular treatment of wide-neck aneurysms using MICRUSFRAME and GALAXY coils is safe and effective when used alone or in conjunction with currently available adjunctive devices.Disclosures R. De Leacy: 6; C; Non-financial support from Penumbra, Cerenovus, and Siemens. A. Puri: 1; C; Received research grants from Medtronic Neurovascular and Stryker Neurovascular. 2; C; Serves as consultant for Medtronic Neurovascular and Stryker Neurovascular. R. Starke: 2; C; Serves as consultant for Medtronic Neurovascular, Penumbra, Cerenovus, and Abbott. B. Jankowitz: 2; C; Serves as consultant for Medtronic and Stryker. A. Yoo: 1; C; Receives research grants from Medtronic, Cerenovus, Penumbra, Stryker, and Genentech. 2; C; Serves as consultant for Cerenovus, Penumbra, and Zoll. 4; C; Has equity interest in Insera Therapeutics.. G. Pero: None. C. Chivot: None. T. Yao: 2; C; Serves as consultant/proctor for Medtronic. O. Zaidat: 2; C; Serves as a consultant for Neuravi, Stryker, Penumbra, and Medtronic

E-125 Impact of COVID related restrictions on clinical trials – Insights from the sterling registry

IntroductionThe STERLING registry is a prospective collection of aneurysms treated with endovascular techniques. The primary intention is to assess the efficacy and safety of Galaxy and MicrusFrame coils (Cerenovus, Irvine, CA). The Covid pandemic has the potential to alter the delivery of medical care or trial enrollment. Changes to regional or hospital specific research infrastructure will likely affect trials for the worse.MethodsA retrospective review of STERLING sites and patients was undertaken to better understand regional variation in adapting to the pandemic and how enrollment was affected.Results45 global sites currently take part in the STERLING registry. 28 sites began enrolling pre-Covid. 34% of U.S. sites were required to halt research, enrollment or elective surgery, whereas only 8% of EU and none of the Japanese sites were required to significantly change their research protocols respectively. At the 10 (9 US, 1 EU) sites required to put a hold on research, rates of enrollment dropped from an average of 0.6 subjects/month in the US (0.5 in EU) to 0 in the first month and 0.1 subjects/month in the second month of Covid-related restrictions. At the time of this analysis (1/2021), the average rate of enrollment across those sites partially recovered to 0.2 subjects/month in the US and 0.2 in EU, although 5 of the 10 sites (all US) had not enrolled any subjects post Covid. Overall, mean actual vs. projected enrollment rates decreased more in the U.S. than in the EU and Japan. The percent of ruptured aneurysms in the per-protocol analysis increased from 23% to 40%, while the percent of unruptured aneurysms decreased from 76% to 60%. There were no significant changes to occlusion rates or adverse events pre/post Covid.Abstract E-125 Table 1Post-COVID differences in actual vs. projected monthly enrollment rates by region Region Actual (mean ± SD) Projected(mean ± SD) Mean Diff. 95% CI US 5.92 ± 3.53 9.58 ± 0.51 3.67 1.53; 5.80 EU 3.83 ± 2.04 5.83 ± 1.34 2.00 0.54; 3.46 Japan 1.25 ± 1.60 2.17 ± 0.39 0.92 -0.07; 1.90 Global 3.67 ± 1.61 5.86 ± 0.67 2.19 1.15; 3.24 ConclusionThe Covid pandemic has the potential to dramatically alter how research is conducted worldwide. U.S. sites faced tougher restrictions than their EU and Japan counterparts. Particularly within the U.S., moratoriums on research and elective surgery may be the driving factor in reducing overall enrollment and increasing the percentage of ruptured aneurysm enrollment. Fortunately, these changes did not appear to negatively affect occlusion rates or adverse events.Disclosures R. De Leacy: 6; C; Reports other and non-financial support from Penumbra; and non-financial support from Cerenovus and Siemens. A. Puri: 1; C; Has received research grants from Medtronic Neurovascular and Stryker Neurovascular.. 2; C; Serves as a consultant for Medtronic Neurovascular Stryker Neurovascular. R. Starke: 2; C; Serves as a consultant for for Medtronic Neurovascular, Penumbra, Cerenovus, and Abbott. B. Jankowitz: 2; C; Serves as a consultant for Medtronic and Stryker. A. Yoo: 1; C; Receives research grants from Medtronic, Cerenovus, Penumbra, Stryker, and Genentech. 2; C; Serves as a consultant for Cerenovus, Penumbra, and Zoll.. 4; C; Has equity interest in Insera Therapeutics.. G. Pero: None. C. Chivot: None. T. Yao: 2; C; Serves as a consultant/proctor for Medtronic. O. Zaidat: 2; C; Serves as a consultant for Neuravi, Stryker, Penumbra, and Medtronic

Differential Subsampling with Cartesian Ordering–MRA for Classifying Residual Treated Aneurysms

Background and purposeDifferential Subsampling with Cartesian Ordering (DISCO), an ultrafast high-spatial-resolution head MRA, has been introduced. We aimed to determine the diagnostic performance of DISCO-MRA in grading residual aneurysm in comparison with TOF-MRA in patients with treated intracranial aneurysms.Materials and methodsPatients with endovascular treatment and having undergone DISCO-MRA, TOF-MRA, and DSA were included for review. The voxel size and acquisition time were 0.75 × 0.75 × 1 mm3/6 seconds for DISCO-MRA and 0.6 × 0.6 × 1 mm3/6 minutes for TOF-MRA. Residual aneurysms were determined using the Modified Raymond-Roy Classification on TOF-MRA and DISCO-MRA by 2 neuroradiologists independently and were compared against DSA as the reference standard. Statistical analysis was performed using the κ statistic and the χ2 test.ResultsSixty-eight treated intracranial aneurysms were included. The intermodality agreement was κ = 0.82 (95% CI, 0.67-0.97) between DISCO and DSA and 0.44 (95% CI, 0.28-0.61) between TOF and DSA. Modified Raymond-Roy Classification scores matched DSA scores in 60/68 cases (88%; χ2 = 144.4, P < .001 for DISCO and 46/68 cases (68%; χ2 = 65.0, P < .001) for TOF. The diagnostic accuracy for the detection of aneurysm remnants was higher for DISCO (0.96; 95% CI, 0.88-0.99) than for TOF (0.79; 95% CI, 0.68-0.88).ConclusionsIn patients with endovascularly treated intracranial aneurysms, DISCO-MRA provides superior diagnostic performance in comparison with TOF-MRA in delineating residual aneurysms in a fraction of the time

MR Perfusion to Determine the Status of Collaterals in Patients with Acute Ischemic Stroke: A Look Beyond Time Maps.

BACKGROUND AND PURPOSE: Patients with acute stroke with robust collateral flow have better clinical outcomes and may benefit from endovascular treatment throughout an extended time window. Using a multiparametric approach, we aimed to identify MR perfusion parameters that can represent the extent of collaterals, approximating DSA. MATERIALS AND METHODS: Patients with anterior circulation proximal arterial occlusion who had baseline MR perfusion and DSA were evaluated. The volume of arterial tissue delay (ATD) at thresholds of 2-6 seconds (ATD2-6 seconds) and >6 seconds (ATD>6 seconds) in addition to corresponding values of normalized CBV and CBF was calculated using VOI analysis. The association of MR perfusion parameters and the status of collaterals on DSA were assessed by multivariate analyses. Receiver operating characteristic analysis was performed. RESULTS: Of 108 patients reviewed, 39 met our inclusion criteria. On DSA, 22/39 (56%) patients had good collaterals. Patients with good collaterals had significantly smaller baseline and final infarct volumes, smaller volumes of severe hypoperfusion (ATD>6 seconds), larger volumes of moderate hypoperfusion (ATD2-6 seconds), and higher relative CBF and relative CBV values than patients with insufficient collaterals. Combining the 2 parameters into a Perfusion Collateral Index (volume of ATD2-6 seconds × relative CBV2-6 seconds) yielded the highest accuracy for predicting collateral status: At a threshold of 61.7, this index identified 15/17 (88%) patients with insufficient collaterals and 22/22 (100%) patients with good collaterals, for an overall accuracy of 94.1%. CONCLUSIONS: The Perfusion Collateral Index can predict the baseline collateral status with 94% diagnostic accuracy compared with DSA

Defining Ischemic Core in Acute Ischemic Stroke Using CT Perfusion: A Multiparametric Bayesian-Based Model.

BACKGROUND AND PURPOSE: The Bayesian probabilistic method has shown promising results to offset noise-related variability in perfusion analysis. Using CTP, we aimed to find optimal Bayesian-estimated thresholds based on multiparametric voxel-level models to estimate the ischemic core in patients with acute ischemic stroke. MATERIALS AND METHODS: Patients with anterior circulation acute ischemic stroke who had baseline CTP and achieved successful recanalization were included. In a subset of patients, multiparametric voxel-based models were constructed between Bayesian-processed CTP maps and follow-up MRIs to identify pretreatment CTP parameters that were predictive of infarction using robust logistic regression. Subsequently CTP-estimated ischemic core volumes from our Bayesian model were compared against routine clinical practice oscillation singular value decomposition-relative cerebral blood flow <30%, and the volumetric accuracy was assessed against final infarct volume. RESULTS: In the constructed multivariate voxel-based model, 4 variables were identified as independent predictors of infarction: TTP, relative CBF, differential arterial tissue delay, and differential mean transit time. At an optimal cutoff point of 0.109, this model identified infarcted voxels with nearly 80% accuracy. The limits of agreement between CTP-estimated ischemic core and final infarct volume ranged from -25 to 27 mL for the Bayesian model, compared with -61 to 52 mL for oscillation singular value decomposition-relative CBF. CONCLUSIONS: We established thresholds for the Bayesian model to estimate the ischemic core. The described multiparametric Bayesian-based model improved consistency in CTP estimation of the ischemic core compared with the methodology used in current clinical routine

O-025 Outcomes of rescue endovascular treatment of acute ischemic stroke in patients with underlying intracranial atherosclerosis – insights from star registry

IntroductionMechanical Thrombectomy (MT) is the standard of care for patients presenting with emergent large vessel occlusion (ELVO) with salvageable tissue. A subgroup of ELVO is refractory to reperfusion due to underlying intracranial atherosclerosis (ICAS), often requiring rescue therapy with balloon angioplasty, stenting or both. Whether such rescue therapy is safe and effective remains to be established. The purpose of this study is to investigate the safety, efficacy, and long-term outcomes of MT for ELVO related ICAS.MethodsWe queried the databases of 11 thrombectomy-capable centers in the US and Europe included in STAR (Stroke Thrombectomy and Aneurysm Registry). In this analysis, we included patients who underwent rescue therapy (balloon angioplasty and/or stenting) in the setting of ELVO due to underlying ICAS. A matched sample was produced by matching on the variables of age, admission NIHSS, and location of the occlusion.ResultsOut of 2827 thrombectomy patients included in STAR at the time of this analysis, 190 patients required rescue therapy for ELVO with underlying ICAS. Balloon angioplasty was performed on 116 patients, and 113 patients had intracranial stenting. On multivariate analysis, after controlling for age, sex, race, hypertension, diabetes, prior stroke, NIHSS on admission and location of occlusion; compared to angioplasty alone, or stenting alone, combination therapy with angioplasty and stenting was associated with higher odds of favorable long-term functional outcome (mRS 0–2) (OR 4.404, 95% CI 1.318–9.712; P=0.021).in the matched analysis, 161 rescue therapy patients matched to a similar number of controls. There was no difference in age, race, sex, rate of IV tPA administration, ASPECTS score, or onset to groin time. Successful first attempt rate was lower (52% vs. 22%, p=0.001) and procedural time was longer in the rescue therapy group (47 min vs. 31 min, p≤0.001). There was no difference in symptomatic intracranial hemorrhage (7.5% vs. 5.6%, p=0.49), or favorable long term functional outcome (modified Rankin scale 0–2) (42.2% vs. 50.9%, p=0.118) between patients in the rescue therapy and control groups.Abstract O-025 Table 1Baseline features, procedural metrics and outcomes in the 2 treatment groups (rescue theraly vs. matched control)ConclusionIn patients with ELVO with underlying ICAS requiring rescue therapy, despite longer procedural time and lower rate of first pass revascularization, rescue therapy appears to be safe with similar rate of favorable long-term functional outcomes compared to patients with large vessel occlusion from embolic source.Disclosures S. Al Kasab: None. E. Almallouhi: None. I. Maier: None. A. Arthur: None. J. Kim: None. R. De Leacy: None. A. Rai: None. S. Keyrouz: None. K. Fargen: None. T. Dumont: None. P. Kan: None. R. Starke: None. A. Spiotta: None