Mohammad A. Issa

Balloon Guide Catheter Improves Revascularization and Clinical Outcomes With the Solitaire Device Analysis of the North American Solitaire Acute Stroke Registry

Background and Purpose— Efficient and timely recanalization is an important goal in acute stroke endovascular therapy. Several studies demonstrated improved recanalization and clinical outcomes with the stent retriever devices compared with the Merci device. The goal of this study was to evaluate the role of the balloon guide catheter (BGC) and recanalization success in a substudy of the North American Solitaire Acute Stroke (NASA) registry. Methods— The investigator-initiated NASA registry recruited 24 clinical sites within North America to submit demographic, clinical, site-adjudicated angiographic, and clinical outcome data on consecutive patients treated with the Solitaire Flow Restoration device. BGC use was at the discretion of the treating physicians. Results— There were 354 patients included in the NASA registry. BGC data were reported in 338 of 354 patients in this subanalysis, of which 149 (44%) had placement of a BGC. Mean age was 67.3±15.2 years, and median National Institutes of Health Stroke Scale score was 18. Patients with BGC had more hypertension (82.4% versus 72.5%; P=0.05), atrial fibrillation (50.3% versus 32.8%; P=0.001), and were more commonly administered tissue plasminogen activator (51.6% versus 38.8%; P=0.02) compared with patients without BGC. Time from symptom onset to groin puncture and number of passes were similar between the 2 groups. Procedure time was shorter in patients with BGC (120±28.5 versus 161±35.6 minutes; P=0.02), and less adjunctive therapy was used in patients with BGC (20% versus 28.6%; P=0.05). Thrombolysis in cerebral infarction 3 reperfusion scores were higher in patients with BGC (53.7% versus 32.5%; P<0.001). Distal emboli and emboli in new territory were similar between the 2 groups. Discharge National Institutes of Health Stroke Scale score (mean, 12±14.5 versus 17.5±16; P=0.002) and good clinical outcome at 3 months were superior in patients with BGC compared with patients without (51.6% versus 35.8%; P=0.02). Multivariate analysis demonstrated that the use of BGC was an independent predictor of good clinical outcome (odds ratio, 2.5; 95% confidence interval, 1.2–4.9). Conclusions— Use of a BGC with the Solitaire Flow Restoration device resulted in superior revascularization results, faster procedure times, decreased need for adjunctive therapy, and improved clinical outcome.

North American Solitaire Stent Retriever Acute Stroke registry: post-marketing revascularization and clinical outcome results

Background Limited post-marketing data exist on the use of the Solitaire FR device in clinical practice. The North American Solitaire Stent Retriever Acute Stroke (NASA) registry aimed to assess the real world performance of the Solitaire FR device in contrast with the results from the SWIFT (Solitaire with the Intention for Thrombectomy) and TREVO 2 (Trevo versus Merci retrievers for thrombectomy revascularization of large vessel occlusions in acute ischemic stroke) trials. Methods The investigator initiated NASA registry recruited North American sites to submit retrospective angiographic and clinical outcome data on consecutive acute ischemic stroke (AIS) patients treated with the Solitaire FR between March 2012 and February 2013. The primary outcome was a Thrombolysis in Myocardial Ischemia (TIMI) score of ≥2 or a Treatment in Cerebral Infarction (TICI) score of ≥2a. Secondary outcomes were 90 day modified Rankin Scale (mRS) score, mortality, and symptomatic intracranial hemorrhage. Results 354 patients underwent treatment for AIS using the Solitaire FR device in 24 centers. Mean time from onset to groin puncture was 363.4±239 min, mean fluoroscopy time was 32.9±25.7 min, and mean procedure time was 100.9±57.8 min. Recanalization outcome: TIMI ≥2 rate of 83.3% (315/354) and TICI ≥2a rate of 87.5% (310/354) compared with the operator reported TIMI ≥2 rate of 83% in SWIFT and TICI ≥2a rate of 85% in TREVO 2. Clinical outcome: 42% (132/315) of NASA patients demonstrated a 90 day mRS ≤2 compared with 37% (SWIFT) and 40% (TREVO 2). 90 day mortality was 30.2% (95/315) versus 17.2% (SWIFT) and 29% (TREVO 2). Conclusions The NASA registry demonstrated that the Solitaire FR device performance in clinical practice is comparable with the SWIFT and TREVO 2 trial results.

Refining Angiographic Biomarkers of Revascularization: Improving Outcome Prediction After Intra-arterial Therapy

Background and Purpose— Angiographic revascularization grading after intra-arterial stroke therapy is limited by poor standardization, making it unclear which scale is optimal for predicting outcome. Using recently standardized criteria, we sought to compare the prognostic performance of 2 commonly used reperfusion scales. Methods— Inclusion criteria for this multicenter retrospective study were acute ischemic stroke attributable to middle cerebral artery M1 occlusion, intra-arterial therapy, and 90-day modified Rankin scale score. Post–intra-arterial therapy reperfusion was graded using the Thrombolysis in Myocardial Infarction (TIMI) and Modified Thrombolysis in Cerebral Infarction (mTICI) scales. The scales were compared for prediction of clinical outcome using receiver-operating characteristic analysis. Results— Of 308 patients, mean age was 65 years, and median National Institutes of Health Stroke Scale score was 17. The mean time from stroke onset to groin puncture was 305 minutes. There was no difference in the time to treatment between patients grouped by final TIMI (ie, 0 versus 1 versus 2 versus 3) or mTICI grades (ie, 0 versus 1 versus 2a versus 2b versus 3). Good outcome (modified Rankin scale, 0–2) was achieved in 32.5% of patients, and mortality rate was 25.3% at 90 days. There was a 6.3% rate of parenchymal hematoma type 2. In receiver-operating characteristic analysis, mTICI was superior to TIMI for predicting 90-day modified Rankin scale 0 to 2 (c-statistic: 0.74 versus 0.68; P<0.0001). The optimal threshold for identifying a good outcome was mTICI 2b to 3 (sensitivity 78.0%; specificity 66.1%). Conclusions— mTICI is superior to TIMI for predicting clinical outcome after intra-arterial therapy. mTICI 2b to 3 is the optimal biomarker for procedural success.

North American SOLITAIRE Stent-Retriever Acute Stroke Registry: choice of anesthesia and outcomes.

Background and Purpose— Previous work that predated the availability of the safer stent-retriever devices has suggested that general anesthesia (GA) may have a negative impact on outcomes in patients with acute ischemic stroke undergoing endovascular therapy. Methods— We reviewed demographic, clinical, procedural (GA versus local anesthesia [LA], etc), and site-adjudicated angiographic and clinical outcomes data from consecutive patients treated with the Solitaire FR device in the investigator-initiated North American SOLITAIRE Stent-Retriever Acute Stroke (NASA) Registry. The primary outcomes were 90-day modified Rankin Scale, mortality, and symptomatic intracranial hemorrhage. Results— A total of 281 patients from 18 centers were enrolled. GA was used in 69.8% (196/281) of patients. Baseline demographic and procedural factors were comparable between the LA and GA groups, except the former demonstrated longer time-to-groin puncture (395.4±254 versus 337.4±208 min; P=0.04), lower National Institutes of Health Stroke Scale (NIHSS; 16.2±5.8 versus 18.8±6.9; P=0.002), lower balloon-guide catheter usage (22.4% versus 49.2%; P=0.0001), and longer fluoroscopy times (39.5±33 versus 28±22.8 min; P=0.008). Recanalization (thrombolysis in cerebral infarction ≥2b; 72.94% versus 73.6%; P=0.9) and rate of symptomatic intracranial hemorrhage (7.1% versus 11.2%; P=0.4) were similar but modified Rankin Scale ⩽2 was achieved in more LA patients, 52.6% versus 35.6% (odds ratio, 1.4 [1.1–1.8]; P=0.01). In multivariate analysis, hypertension, NIHSS, unsuccessful revascularization, and GA use (odds ratio, 3.3 [1.6–7.1]; P=0.001) were associated with death. When only anterior circulation and elective GA patients were included, there was a persistent difference in good outcomes in favor of LA patients (50.7% versus 35.5%; odds ratio, 1.3 [1.01–1.6]; P=0.04). Conclusions— The NASA Registry has demonstrated that clinical outcomes and survival are significantly better in patients treated with LA, without increased symptomatic intracranial hemorrhage risk. Future trials should prospectively evaluate the effect of GA on outcomes.

Predictors of poor outcome despite recanalization: a multiple regression analysis of the NASA registry

Background Mechanical thrombectomy with stent-retrievers results in higher recanalization rates compared with previous devices. Despite successful recanalization rates (Thrombolysis in Cerebral Infarction (TICI) score ≥2b) of 70–83%, good outcomes by 90-day modified Rankin Scale (mRS) score ≤2 are achieved in only 40–55% of patients. We evaluated predictors of poor outcomes (mRS >2) despite successful recanalization (TICI ≥2b) in the North American Solitaire Stent Retriever Acute Stroke (NASA) registry. Methods Logistic regression was used to evaluate baseline characteristics and recanalization outcomes for association with 90-day mRS score of 0–2 (good outcome) vs 3–6 (poor outcome). Univariate tests were carried out for all factors. A multivariable model was developed based on backwards selection from the factors with at least marginal significance (p≤0.10) on univariate analysis with the retention criterion set at p≤0.05. The model was refit to minimize the number of cases excluded because of missing covariate values; the c-statistic was a measure of predictive power. Results Of 354 patients, 256 (72.3%) were recanalized successfully. Based on 234 recanalized patients evaluated for 90-day mRS score, 116 (49.6%) had poor outcomes. Univariate analysis identified an increased risk of poor outcome for age ≥80 years, occlusion site of internal carotid artery (ICA)/basilar artery, National Institute of Health Stroke Scale (NIHSS) score ≥18, history of diabetes mellitus, TICI 2b, use of rescue therapy, not using a balloon-guided catheter or intravenous tissue plasminogen activator (IV t-PA), and >30 min to recanalization (p≤0.05). In multivariable analysis, age ≥80 years, occlusion site ICA/basilar, initial NIHSS score ≥18, diabetes, absence of IV t-PA, ≥3 passes, and use of rescue therapy were significant independent predictors of poor 90-day outcome in a model with good predictive power (c-index=0.80). Conclusions Age, occlusion site, high NIHSS, diabetes, no IV t-PA, ≥3 passes, and use of rescue therapy are associated with poor 90-day outcome despite successful recanalization.

Influence of Age on Clinical and Revascularization Outcomes in the North American Solitaire Stent-Retriever Acute Stroke Registry

Background and Purpose— The Solitaire With the Intention for Thrombectomy (SWIFT) and thrombectomy revascularization of large vessel occlusions in acute ischemic stroke (TREVO 2) trial results demonstrated improved recanalization rates with mechanical thrombectomy; however, outcomes in the elderly population remain poorly understood. Here, we report the effect of age on clinical and angiographic outcome within the North American Solitaire-FR Stent-Retriever Acute Stroke (NASA) Registry. Methods— The NASA Registry recruited sites to submit data on consecutive patients treated with Solitaire-FR. Influence of age on clinical and angiographic outcomes was assessed by dichotomizing the cohort into ⩽80 and >80 years of age. Results— Three hundred fifty-four patients underwent treatment in 24 centers; 276 patients were ⩽80 years and 78 were >80 years of age. Mean age in the ⩽80 and >80 cohorts was 62.2±13.2 and 85.2±3.8 years, respectively. Of patients >80 years, 27.3% had a 90-day modified Rankin Score ⩽2 versus 45.4% ⩽80 years (P=0.02). Mortality was 43.9% and 27.3% in the >80 and ⩽80 years cohorts, respectively (P=0.01). There was no significant difference in time to revascularization, revascularization success, or symptomatic intracranial hemorrhage between the groups. Multivariate analysis showed age >80 years as an independent predictor of poor clinical outcome and mortality. Within the >80 cohort, National Institutes of Health Stroke Scale (NIHSS), revascularization rate, rescue therapy use, and symptomatic intracranial hemorrhage were independent predictors of mortality. Conclusion— Greater than 80 years of age is predictive of poor clinical outcome and increased mortality compared with younger patients in the NASA registry. However, intravenous tissue-type plasminogen activator use, lower NIHSS, and shorter revascularization time are associated with better outcomes. Further studies are needed to understand the endovascular therapy role in this cohort compared with medical therapy.

Stenting and Angioplasty for Idiopathic Intracranial Hypertension: A Case Series with Clinical, Angiographic, Ophthalmological, Complication, and Pressure Reporting

Previous studies have demonstrated that cerebral dural sinus stenosis (DSS) may be a potential patho‐physiological cause of idiopathic intracranial hypertension (IIH). Endovascular therapy for DSS is emerging as a potential alternative to treat IIH. Here, we present the results of our case series.

Predictors of Mortality in Acute Ischemic Stroke Intervention Analysis of the North American Solitaire Acute Stroke Registry

Background and Purpose— Failure to recanalize predicts mortality in acute ischemic stroke. In the North American Solitaire Acute Stroke registry, we investigated parameters associated with mortality in successfully recanalized patients. Methods— Logistic regression was used to evaluate baseline characteristics and recanalization parameters for association with 90-day mortality. A multivariable model was developed based on backward selection with retention criteria of P<0.05 from factors with at least marginal significance (P⩽0.10), then refit to minimize the number of excluded cases (missing data). Results— Successfully recanalized patients had lower mortality (25.2% [59/234] versus 46.9% [38/81] P<0.001). There was no difference in symptomatic intracranial hemorrhage between patients with successful versus failed recanalization (9% [21/234] versus 14% [11/79]; P=0.205). However, mortality was significantly higher in patients with symptomatic intracranial hemorrhage (72% [23/32] versus 26% [73/281]; P<0.001). Proximal occlusion (internal carotid artery or vertebrobasilar), initial National Institutes of Health Stroke Scale≥18, use of rescue therapy (P<0.05), and 3+ passes (P<0.10) were associated with mortality in recanalized patients. In the multivariate model with good predictive power (c index=0.72), proximal occlusion, initial National Institutes of Health Stroke Scale≥18, and use of rescue therapy remained significant independent predictors of 90-day mortality. Conclusions— Failure to recanalize and presence of symptomatic intracranial hemorrhage resulted in increased mortality. Despite successful recanalization, proximal occlusion, high National Institutes of Health Stroke Scale, and need for rescue therapy were predictors of mortality.

E-011 TICI Quantified: Automated Cerebral Revascularization Grading in Acute Ischemic Stroke

Introduction Cerebral angiographic revascularization grading is the primary method for measuring the angiographic success of acute ischemic stroke (AIS) endovascular therapy and is one of the strongest predictors for clinical outcome. Of the many reported scales, the modified Treatment in Cerebral Ischemia (mTICI) scale is the preferred grading scale for assessment of revascularization. Currently, mTICI grading is based on visual crude estimations by the operator, which may introduce error and bias in to the evaluation. Here, we present an update on our on-going study to automatize mTICI and provide a more accurate and precise grading tool: Quantified TICI (qTICI). Methods Phase one of the project is to develop a database of 15–30 patients with an aplastic/hypoplastic anterior cerebral artery (ACA) in order to establish the standard average and predicted 100% qTICI for the isolated middle cerebral artery (MCA) territory. To map the MCA territory, a retrospective review of patients between the ages of 18–85 was performed from our Digital Subtraction Angiography (DSA) database at the Medical College of Wisconsin. All consecutive cases with aplastic/hypoplastic ACA (to minimise contaminating blood flow from the ACA territory) are included in this study. Existing Siemens software is currently in use to estimate the territory of normal capillary blush and establish normal blood flow values in this database. Results We have identified 19 consecutive patients with aplastic/hypoplastic ACA between the ages of 18–85, from our DSA database of over 3000 cases. Nine patients had aplastic A1 and 10 had hypoplastic A1 segments of the ACA. Once normal capillary blush of the MCA territory has been established and automatized, we will use those normalised values per age to compare the capillary blush and blood flow of the pathological cases- a cohort of 20–25 patients who have stroke secondary to MCA occlusion. Values of qTICI will be compared and validated using standard visual estimation of mTICI. Clinical correlation of qTICI with outcome will also be performed. The goal is to establish software that will accurately grade mTICI on a continuous scale rather than using the current crude visual estimation with wide range 4 strata, which will eliminate the operator dependent bias and increase the precision and accuracy of the revascularization grading. Conclusion The qTICI Grading Software once developed will have the potential to revolutionise the way clinicians and interventionalists grade revascularization post AIS endovascular therapy. The clinical implications of establishing automatized and quantified revascularization scale is critical in improving treatment safety and efficacy. Disclosures A. Sattar: None. K. Asif: None. M. Teleb: None. A. Castonguay: None. M. Issa: None. O. Zaidat: None.

E-069 Validation of a New Modified Capillary Index Score Angiographic Real Time Assessment of Dead vs Salvable Tissue

Background The original capillary index score publication only included patients that had full digital subtraction angiograms (DSA) before stroke intervention. This CIS was a single center publication with no external validation. Many centers do not perform a full DSA to assess all collaterals before intervention. Hypothesis A modified capillary index score (mCIS) using only the ICA injection can predict outcome in MCA occlusions (only MCA occlusions included). Objective Validate the utility and use of a modified capillary index score (mCIS) to assess outcomes and improvement in acute stroke patients. Methods mCIS was assessed on all consecutive patients with an MCA occlusion with complete database information. NIHSS, recanalization (mTICI), and mRS before and after treatment were assessed. mCIS of 2–3 was considered favorable as per original publication. Correlation between favorable CIS, NIHSS improvement, and mRS (0–3 good) were assessed. Results 33 patients with MCA occlusion with complete data sets where assessed. 63.6% (21/33) had a favorable mCIS (2–3) and 36.4% had a poor mCIS(0–1). Recanalization of TICI 2b or greater was achieved in 42.9% (9/21) of patients with favorable mCIS and 58.3% (7/12) of patients with poor mCIS. Of those with favorable mCIS 28.6% (6/21) had a good mRS of ≤3 at discharge vs those with poor mCIS while those with a poor mCIS 33.3% had a good mRS at discharge. However, mortality was lower in favorable mCIS vs. poor mCIS (9.5 vs. 33.35, p = 0.09). Conclusions A modified CIS is did not predict the functional outcome but may be predictor of mortality. Small sample size, lack of long-term follow up, or the lower rate of recanalization of those with favorable mCIS could have contributed to the negative outcome. A prospective or larger study with long term follow up is needed for validation. References Al-Ali F, Jefferson A, Barrow T, et al. The capillary index score: rethinking the acute ischemic stroke treatment algorithm. Results from the Borgess Medical Center Acute Ischemic Stroke Registry. J Neurointerv Surg. 2013;5(2):139–143. doi:10.1136/neurintsurg-2011-010146 Capillary Index Score, Baseline Characteristics and Outcomes Favorable mCIS Unfavorable mCIS P Value Baseline NIHSS 14 + /-6.9 18.3 + /-3.9 0.051 Age 64.3 + /-16.6 68.8 + /-4.9 0.453 Good Recanalization (2b-3) 42.9% (9/21) 58.3% (7/12) 0.391 NIHSS at Discharge 10.8 + /-7.5 15 + /-2.5 0.099 NIHSS at Discharge in TICI 2b and higher 5.8 + /-4.2 13.4 + /-13.7 0.067 Mortality 2/21 (9.5%) 4/12 (33.33%) 0.093 Good Outcome (mRS < = 3) 28.6% (6/21) 33.33% (4/12) 0.775 Good Outcome in TICI2b or higher 12 mRS < = 3) 5/9 (55.6%) 4/7 (57.1%) 0.0949 Disclosures M. Teleb: None. M. Noufal: None. A. Sattar: None. W. Wazni: None. M. Issa: None. K. Asif: None. A. Gheith: None. A. Castonguay: None. O. Zaidat: 2; C; Penumbra, Stryker, Covidie. 3; C; Penumbra, Stryker, Covidien.