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.
Background: The Interventional Management of Stroke III (IMS-III) trial demonstrated no benefit for intravenous recombinant tissue plasminogen activator (IV rt-PA) followed by endovascular therapy versus IV rt-PA alone. However, IMS-III mostly included earlier generation devices. The recent thrombectomy trials have incorporated the stent-retriever technology, but their generalizability remains unknown. Methods: The North American Solitaire Acute Stroke (NASA) registry recruited patients treated with the Solitaire FR™ device between March 2012 and February 2013. The NASA-IMS-III-Like Group (NILG baseline NIHSS score ≥10 who received IV rt-PA) was compared to the IV rt-PA and IV + intra-arterial (IA)-IMS-III groups and the MR CLEAN, ESCAPE, SWIFT Prime, and REVASCAT trial controls to assess the stent-retriever treatment in the ‘real-world' setting. The NILG was also compared to non-IV rt-PA NASA patients to evaluate the impact of IV rt-PA on thrombectomy. Results: A total of 136 of the 354 NASA patients fulfilled criteria for the NILG. Baseline characteristics were well balanced across groups. Time from onset to puncture was higher in NILG than IV+IA-IMS-III patients (274 ± 112 vs. 208 ± 47 min, p < 0.0001). Occlusions involving the intracranial ICA, MCA-M1, or basilar arteries were more common in NILG than IV+IA-IMS-III patients (91.2 vs. 47.2%, p < 0.00001). Modified thrombolysis in cerebral infarction ≥2b reperfusion was higher in NILG than IV+IA-IMS-III patients (74.3 vs. 39.6%, p < 0.00001). A 90-day modified Rankin Scale score ≤2 was more frequent in the NILG than IV+IA-IMS-III patients (51.9 vs. 40.8%, p = 0.03) and MR CLEAN (51.9 vs. 19.1%, p < 0.00001), ESCAPE (51.9 vs. 29.3%, p = 0.0002), SWIFT Prime (51.9 vs. 35.5%, p = 0.02), and REVASCAT (51.9 vs. 28.2%, p = 0.0003) controls. Symptomatic intracranial hemorrhage definitions varied across the different studies with rates ranging from 2.7% (ESCAPE) to 11.9% (NILG). The NILG 90-day mortality (24.4%) was higher than in SWIFT Prime but comparable to all other groups. IV rt-PA was an independent predictor of good outcome in NASA (OR = 2.3, 95% CI 1.2-4.7). Conclusion: Our results support the ‘real-world' applicability of the recent thrombectomy trials.
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.
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.
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.
Background: Recanalization of the occluded artery is a powerful predictor of good outcome in acute ischemic stroke secondary to large artery occlusions. Mechanical thrombectomy with stent-trievers results in higher recanalization rates and better outcomes compared to previous devices. However, despite successful recanalization rates (Treatment in Cerebral Infarction, TICI, score ≥ 2b) between 70 and 90%, good clinical outcomes assessed by modified Rankin Scale (mRS) ≤ 2 is present in 40-50% of patients . We aimed to evaluate predictors of poor outcomes (mRS > 2) despite successful recanalization (TICI ≥ 2b) in the acute stroke patients treated with the Solitaire device of the North American Solitaire Stent Retriever Acute Stroke (NASA) registry. Methods: The NASA registry is a multicenter, non-sponsored, physician-conducted, post-marketing registry on the use of SOLITAIRE FR device in 354 acute, large vessel, ischemic stroke patients. Logistic regression was used to evaluate patient characteristics and treatment parameters for association with 90-day mRS score of 0-2 (good outcome) versus 3-6 (poor outcome) within patients who were recanalized successfully (Thrombolysis in Cerebral Infarction or TICI score 2b-3). Univariate tests were followed by development of a multivariable model based on stepwise selection with entry and retention criteria of p < 0.05 from the set of factors with at least marginal significance (p ≤ 0.10) on univariate analysis. The c-statistic was calculated as a measure of predictive power. Results: Out of 354 patients, 256 (72.3%) were successfully recanalized (TICI ≥ 2b). Based on 90-day mRS score for 234 of these patients, there were 116 (49.6%) with mRS > 2. Univariate analysis identified increased risk of mRS > 2 for each of the following: age ≥ 80 years (upper quartile of data), occlusion site other than M1/M2, NIH Stroke Scale (NIHSS) score ≥ 18 (median), history of diabetes mellitus (DM), TICI = 2b, use of rescue therapy, not using a balloon-guided catheter (BGC) or intravenous tissue plasminogen activator (IV t-PA), and time to recanalization > 30 minutes (all p ≤ 0.05). Three or more passes was marginally significant (p=0.097). In multivariable analysis, age ≥ 80 years, site other than M1/M2, initial NIHSS ≥18, DM, absence of IV t-PA, use of rescue therapy and three or more passes 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, not receiving IV t-PA, use of rescue therapy and three or more passes, were associated with poor 90-day outcome despite successful recanalization.
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.
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.
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.
Methods: We retrospectively reviewed clinical data on patients admitted at a single institution for possible stroke between 2004 and 2007, and selected subjects who underwent angiography of the neck. We classified subjects as having vertebral artery origin stenosis (VAOS) by ‘moderate’ to ‘severe’ (≥50%) occlusion. Age, sex, and race-matched control subjects were selected from our study population as having no evidence of VAOS on angiography. Long-term follow-up data was collected and death certificates were searched for comparison among cases and controls. A Kaplan-Meier curve was plotted based on time to event (stroke or death). Results: The proportion of subjects that were found to have VAOS was 58 per 358 cases, or 16.2%. Four subjects were excluded because of stenting, so a total of 54 cases and 54 matched controls were included for long-term follow-up analysis. In our study population, we calculated the relative risk of having a stroke or dying in patients with VAOS to be 6.0 times that of patients without VAOS ( p <0.02). The observed 5-year survival for patients with VAOS was 67% (36/54) compared to 89% (48/54) in control subjects ( p <0.01). Conclusions: Patients with vertebral artery origin stenosis are at a significantly higher risk of having a stroke or dying. Subsequent prospective, multicenter studies are needed to validate our results.
Background: Tissue reperfusion is a critical determinant of outcomes after intra-arterial therapy (IAT). However, there is no standardized method for grading angiographic reperfusion. We sought to compare the two most commonly used reperfusion scales, TIMI and modified TICI (m-TICI), for predicting good long-term outcome following IAT. Methods: From a multicenter database, we evaluated acute stroke patients presenting with middle cerebral artery (MCA) M1 occlusions who underwent IAT. Clinical and angiographic data were collected. Reperfusion for each case was graded using the TIMI and m-TICI scales. The primary distinction between these scales is that partial reperfusion (TIMI 2) is sub-divided into minor (m-TICI 2A: <50%) and major (m-TICI 2B: 50-99%) grades in the m-TICI system. The performance of these scales for predicting a good 90-day outcome (mRS 0-2) was evaluated using the c-statistic. Results: There were 313 acute stroke patients with MCA M1 segment occlusions who underwent IAT at 6 academic centers; 171 (54.6%) were female. Mean age was 65.3±16.5 years. There were 157 (50.2%) right-sided strokes. Median baseline NIHSS score was 17 (IQR 15-20). Good outcome at 90 days was achieved in 32.5%. For predicting good outcome, the c-statistic was significantly higher for m-TICI (0.74 vs. 0.68; p<0.0001). The threshold that maximized predictive accuracy was m-TICI ≥2B (sensitivity 78%, specificity 65%; figure). Conclusions: The modified TICI scale is superior to the TIMI scale for predicting clinical outcome after IAT, and should be the standard tool for grading angiographic reperfusion. An m-TICI score ≥2B (≥50% reperfusion) is the optimal biomarker for successful reperfusion.
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.
We sought to determine the long-term survival and natural history of vertebral artery origin stenosis (VAOS) as it relates to stroke. Methods: We retrospectively reviewed clinical data on patients admitted at a single institution for possible stroke between 2004 and 2007 and selected subjects who underwent angiography of the neck. We classified VAOS subjects as having "moderate'' to "severe'' (>= 50%) occlusion. Age-, sex-, and race-matched control subjects with no evidence of VAOS on angiography were selected from our study population. Long-term follow-up data were collected and death certificates were searched for comparison among cases and controls. A Kaplan-Meier curve was plotted based on time to event (stroke or death). Results: Fifty-eight of the 358 subjects were found to have VAOS (16.2%). Four subjects were excluded because of stenting; therefore, 54 cases and 54 matched controls were included for long-term follow-up analysis. In our study population, we calculated that the relative risk of having a stroke or dying in patients with VAOS was 6 times that of patients without VAOS (P < .02). The observed 5-year survival rate for patients with VAOS was 67% (36/54) compared to 89% (48/54) in control subjects (P < .01). Conclusions: Patients with VAOS are at a significantly higher risk of having a stroke or dying. Subsequent prospective, multicenter studies are needed to validate our results.
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. (Stroke. 2014;45:141-145.)
BACKGROUNDPrevious 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.METHODWe prospectively collected angiographic and manometric data on patients that underwent angioplasty/stenting for IIH. All patients had failed maximal medical therapy (MMT) and had confirmed sinus stenosis. Demographic, clinical and radiological presentation, and outcomes were collected retrospectively.RESULTSA total of 18 patients underwent 25 procedures. Demographics revealed a mean age of 30 (range 15-59), 83% (15/18) were female, 72% (13/18) were white, and mean body mass index of 36 (range 23-59.2). All patients presented with classic IIH. Symptom improvement or resolution was reported in 94% (17/18) of patients. All patients had resolution and/or stabilization/improvement of their papilledema. Headaches related to increased pressure improved in 56% (10/18). Re-stenosis and retreatment occurred in 33% (6/18). No procedural related complications were reported.CONCLUSIONDural sinus angioplasty and stenting is relatively safe, feasible, and clinically efficacious for patients with symptomatic sinus stenosis who have failed standard therapy. The long-term durability of patency and clinical improvement remains unknown.
Objective: To evaluate correlation between ECASS defined hemorrhage and clinical outcome in acute ischemic stroke after endovascular therapy. Background Post thrombolytic hemorrhagic transformation (HT) of acute ischemic strokes can be characterized radiologically by European Cooperative Acute Stroke Study (ECASS) criteria and clinically by NINDS criteria. Despite a previous analysis of ECASS I and II demonstrating early neurologic deterioration and increased 90 day mortality associated with parenchymal hemorrhage, the correlation between ECASS radiologic classification and 90 day clinical outcome in patients undergoing endovascular therapy remains unclear. Design/Methods: Retrospective review of 34 acute stroke patients enrolled in clinical trials at our institute. Data was collected prospectively for all patients. CT head was performed 18-36 hours post procedure. intracranial bleeding was graded as follows based on ECASS definition: Grade: 0=no hemorrhage, 1=H1(petechial hemorrhage), 2=H2 (petechial hemorrhage), 3=PH1(parenchymal hemorrhage), 4=PH2(parenchymal hemorrhage), 5=symptomatic ICH (sICH). MRS>2 was defined as poor outcome, while mRS≤2 was defined as good outcome. Multivariate analysis was performed using the following variables: initial NIHSS, discharge and 3 month MRS, ECASS hemorrhage score. Results: 24/34 (71%) received IV thrombolysis, and all patients underwent endovascular treatment with either mechanical thrombectomy and/or intra-arterial thrombolysis. 21 (62%) were female. Mean patient age was 63. No hemorrhage occurred in 16 (47%) of patients, while HT was detected in 18 (53%): 11 (32%) with HI1, 0 (0%) with HI2, 5 (15%) with PH1, 2 (6%) with PH2 and 0 (0%) with sICH. All 34 patients had baseline mRS≤2. At 3 months, 21/34 patients (62%) had mRS>2, while 13 (38%) had mRS≤2. Multivariate analysis did not reveal ECASS defines hemorrhage as an independent predictor of outcome. Conclusions: In our cohort of patients post endovascular therapy, ECASS hemorrhage score did not correlate with functional outcome at 3 months after controlling for severity of stroke. Disclosure: Dr. Sweis has nothing to disclose. Dr. Malaiyandi has nothing to disclose. Dr. Issa has nothing to disclose. Dr. Jani has nothing to disclose. Dr. Taqi has nothing to disclose. Dr. Zaidat has received personal compensation for activities with Boston Scientific Corporation and Micrus Inc.
Background: Both balloon remodeling and stent placement techniques are used for coil embolization of the large neck aneurysms. Comparison of safety and efficacy of these two endovascular approaches has not been reported in the past. We aimed to compare the risk of thromboembolic event (TEE), intra-operative rupture (IOP)and recanalization rates between the two techniques. Methods: A review of a retrospectively collected database was performed, and all aneurysms treated with stent or balloon assistance between 07/2005 to 12/2010 were identified. Cases with a combined use of stent and balloon were excluded. Pearson Chi square 2x2 tables were used to calculate the odds ratio and p-value Results: Among 791 aneurysms treated by endovascular cerebral aneurysm embolization (EAE), 81(10.3%) cases used balloon and 275 (35%) cases used stent assistance. Mean age and large neck (> 4 mm ) were not significantly different between the two groups. Balloon remodeling was used more commonly in ruptured aneurysm compare to stent-assistance ( 41% versus 15%; OR 3.7 CI 2.1-6.4; p value 0.0001). Both symptomatic and asymptomatic angiographically proven TEE occurred in 11 (14%) cases treated with a balloon and in 26 (9.5%) cases treated with stent-assistance (OR 1.5 CI 0.7-3.2; p-value 0.3). These TEEs were symptomatic in 2 (2.5%) cases treated with a balloon, and in 2 (0.7%) cases treated with stent-assistance. The rate of symptomatic and asymptomatic intraoperative rupture in balloon-remodeled cases was 1/81(1.2%) compare to 13/275 (4.7%) in stent-assisted cases (OR 4 CI 0.5-30). Symptomatic IOP occurred in 1/81(1.2%) and 1/275 (0.4%) case respectively (OR 3.4 CI 0.2-55). After excluding patient with lack of follow up imaging; 8/66 (12%) of balloon remodeled and 23/201(11.5%) of stent assisted cases had recanalization of the aneurysm defined as any filling of the sac or class 3 per Raymond classification. (OR 1.06 CI 0.4-2.5 p-value 0.8). Conclusion: Balloon remodeling was more commonly used in ruptured aneurysm compared to stent assistance. No statistically significant difference was found in the risk of TEE, IOP or recanalization between the two techniques.