[Show abstract][Hide abstract] ABSTRACT: 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.
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.
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).
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.
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Full-text · Article · Jan 2015 · Journal of Neurointerventional Surgery
[Show abstract][Hide abstract] ABSTRACT: 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.
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.
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.
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.
[Show abstract][Hide abstract] ABSTRACT: In light of the negative results of three randomised trials for endovascular acute ischemic stroke therapy, proper patient selection has become a critical area of focus for endovascular therapy. The Stroke Prognostication using Age and NIH Stroke Scale (SPAN) index, a score that combines age and NIHSS, demonstrated that SPAN-100 positive patients did not benefit from IV-tPA. Here, we sought to evaluate the predictive value of SPAN index in a real-life cohort of patients undergoing endovascular therapy.
No preview · Article · Jul 2014 · Journal of Neurointerventional Surgery
[Show abstract][Hide abstract] ABSTRACT: To describe the periprocedural results of the TARGET Registry, an on-going, prospective, non-randomised, multicenter, real-world study of patients with ruptured or unruptured intracranial aneurysms that are embolised with the new generation TARGET Coils. In particular, the aneurysm that were coiled with 100% 360 complex coils only were compared to the aneurysm that were coiled with mixed 360 and helical coil or helical coils only.
No preview · Article · Jul 2014 · Journal of Neurointerventional Surgery
[Show abstract][Hide abstract] ABSTRACT: The infarct core has been theorised to be an important indicator for treatment success from endovascular intervention in acute ischemic stroke from large vessel proximal occlusion. The objective of this study was to determine the extent to which it contributes to the number of patients needed to treat (NNT) to achieve long-term functional independence.
No preview · Article · Jul 2014 · Journal of Neurointerventional Surgery
[Show abstract][Hide abstract] ABSTRACT: 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 vessels, 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 recanalised 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 recanalised (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 (BCG) or intravenous tissue plasminogen activator (IV t-PA), and time to recanalization > 30 min (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 IVtPA, 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 IVtPA, use of rescue therapy and three or more passes, were associated with poor 90-day outcome despite successful recanalization.
Disclosures I. Linfante: None. G. Dabus: None. A. Starosciak: None. A. Castonguay: None. R. Gupta: None. C. Sun: None. C. Martin: None. W. Holloway: None. N. Mueller-Kronast: None. J. English: None. T. Malisch: None. F. Marden: None. H. Bozorgchami: None. A. Xavier: None. A. Rai: None. M. Froehler: None. A. Badruddin: None. T. Nguyen: None. M. Taqi: None. M. Abraham: None. V. Janardhan: None. H. Shaltoni: None. R. Novakovic: None. A. Yoo: None. O. Zaidat: None.
No preview · Article · Jul 2014 · Journal of Neurointerventional Surgery
[Show abstract][Hide abstract] ABSTRACT: 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.
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.
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).
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.
[Show abstract][Hide abstract] ABSTRACT: 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.
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.
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).
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.
[Show abstract][Hide abstract] ABSTRACT: 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.
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.
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).
The NASA registry demonstrated that the Solitaire FR device performance in clinical practice is comparable with the SWIFT and TREVO 2 trial results.
No preview · Article · Sep 2013 · Journal of Neurointerventional Surgery
[Show abstract][Hide abstract] ABSTRACT: Introduction/Purpose The recent results of the SWIFT and TREVO-2 trials demonstrated better recanalisation and efficacy rates with mechanical thrombectomy; however, its efficacy in the elderly population is 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 investigator-initiated NASA Registry recruited sites within North America to submit data on consecutive patients treated with Solitaire-FR. Good clinical outcome was defined as a 90-day mRS ≤2. Successful recanalisation was defined as TIMI ≥2. SICH was defined as any parenchymal haematoma, SAH, or IVH associated with a worsening of the NIHSS score by 4 or more within 24 hours. Age influence on outcomes was assessed by comparing the means between outcomes and dichotomising the age into ≤80 or ≥80 years of age. A standard medical care cohort was not available for comparison in this study.
Results 343 patients underwent treatment using the SOLITAIRE-FR device in 24 centres. The mean age for those with good clinical outcome at 90 days was 64.9 ± 15 versus 69.2 ± 14.4 years (P=0.02). Only 26.6% (17/64) of patients >80 years of age had a 90-day mRS ≤ 2 versus 45.3% (111/245) of those ≤80 years of age (p=0.007, OR 1.34, 95%CI 1.2-1.6). Mortality was 42.2% (27/64) and 27.4% (67/245) in the >80 and ≤80 age groups, respectively. No difference in good outcome or mortality between female and males was observed in this population (90-day mRS≤ 2 was 41.3% (62/150) with mortality of 28% (42/150) versus 42.1% (69/164) with mortality of 32.3% (53/164) in females and males, respectively). Multivariate logistic regression analysis (adjusting for age, sex, race, baseline-NIHSS, occlusion site, initial BP, time from symptoms onset to groin puncture, and revascularisation), showed age, baseline-NIHSS, initial systolic blood pressure and revascularisation status as an independent predictors of both good outcome and mortality.
Conclusions In the NASA registry, patients >80 years of age who were treated with the Solitaire-FR device demonstrated a significantly lower rate of good clinical outcome and increased mortality at 90-days, compared to the those in the ≤ 80 years of age group.
Disclosures A. Castonguay: None. R. Gupta: None. R. Nogueira: None. C. Martin: None. W. Holloway: None. N. Mueller-Kronast: None. T. Malisch: None. F. Marden: None. H. Bozorgchami: None. A. Xavier: None. A. Rai: None. A. Badruddin: None. M. Taqi: None. I. Linfante: None. G. Dabus: None. M. Abraham: None. H. Shaltoni: None. V. Janardhan: None. T. Nguyen: None. A. Abou-Chebl: None. P. Chen: None. A. Yoo: None. G. Britz: None. A. Nanda: None. O. Zaidat: None.
No preview · Article · Jul 2013 · Journal of Neurointerventional Surgery
[Show abstract][Hide abstract] ABSTRACT: Cell-based therapies are being investigated as an adjunct to IV thrombolysis or mechanical thrombectomy in ischemic stroke. This review summarizes the potential applications as well as challenges of intravascular cell delivery in ischemic stroke.
We conducted a search of Medline as well as the clinicaltrials.gov Web site for all ongoing human clinical studies using stem cells in ischemic stroke patients. Result: The pros and cons of the various donor cell types and routes of cell delivery, including intravascular delivery, in ischemic stroke are discussed. In addition, the potential challenges in translation from bench to bedside, the optimal techniques for intravascular cell delivery, and an updated comprehensive list of ongoing clinical trials in ischemic stroke are highlighted.
Stem cells have shown a promising role in ischemic stroke, in preclinical studies as well as initial pilot studies. Further studies are needed to assess intravascular cell therapy as a potential adjunct to thrombolysis or mechanical thrombectomy in ischemic stroke.
[Show abstract][Hide abstract] ABSTRACT: Guidelines have been established for the management of acute ischemic stroke; however, specific recommendations for endovascular revascularization therapy are lacking. Burgeoning investigation of endovascular revascularization therapies for acute ischemic stroke, rapid device development, and a diverse training background of the providers performing the procedures underscore the need for practice recommendations. This review provides a concise summary of the Society of Vascular and Interventional Neurology endovascular acute ischemic stroke roundtable meeting. This document was developed to review current clinical efficacy of pharmacologic and mechanical revascularization therapy, selection criteria, periprocedure management, and endovascular time metrics and to highlight current practice patterns. It therefore provides an outline for the future development of multisociety guidelines and recommendations to improve patient selection, procedural management, and organizational strategies for revascularization therapies in acute ischemic stroke.
[Show abstract][Hide abstract] ABSTRACT: To report our initial experience in setting up a neuroendovascular service in a university-based comprehensive stroke center.
We determined the rates of referral path, procedural type, and independently adjudicated 1-month outcomes (actual rates) in first 150 procedures (120 patients) and subsequently compared with rates derived from pertinent clinical trials after adjustment for procedural type (predicted rates).
The patients were referred from the emergency department (n= 44), transferred from another hospital (n= 13), or admitted for elective procedures from the clinic (n= 63). The procedures included treatment of acute ischemic stroke (n= 12); extracranial carotid stent placement (n= 33); extracranial vertebral artery stent placement (n= 13); intracranial angioplasty and/or stent placement (n= 12); embolization for intracranial aneurysms (n= 35), arteriovenous malformations (n= 5), and tumors (n= 10); cerebral vasospasm treatment (n= 26); and others (n= 4). The technical success rate was 100% for intracranial aneurysm obliteration and extracranial carotid artery stent placement, and 95% for those undergoing intracranial or vertebral artery stent placements; and partial or complete recanalization was achieved in 72% of patients undergoing intra-arterial thrombolysis. After adjusting for procedural type, the actual adverse event rate of 3% compared favorably with the predicted rate of 7% based on the results of clinical trials.
We provide estimates of procedure volumes and outcomes observed in the initial phase of setting up a neuroendovascular service with an active training program.
No preview · Article · Jul 2008 · Journal of neuroimaging: official journal of the American Society of Neuroimaging