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  • 1
    In: Stroke, Ovid Technologies (Wolters Kluwer Health), Vol. 45, No. 5 ( 2014-05), p. 1396-1401
    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. 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.
    Type of Medium: Online Resource
    ISSN: 0039-2499 , 1524-4628
    RVK:
    Language: English
    Publisher: Ovid Technologies (Wolters Kluwer Health)
    Publication Date: 2014
    detail.hit.zdb_id: 1467823-8
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  • 2
    In: Stroke, Ovid Technologies (Wolters Kluwer Health), Vol. 46, No. 8 ( 2015-08), p. 2305-2308
    Abstract: 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.
    Type of Medium: Online Resource
    ISSN: 0039-2499 , 1524-4628
    RVK:
    Language: English
    Publisher: Ovid Technologies (Wolters Kluwer Health)
    Publication Date: 2015
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  • 3
    In: Journal of NeuroInterventional Surgery, BMJ, Vol. 6, No. 8 ( 2014-10), p. 584-588
    Type of Medium: Online Resource
    ISSN: 1759-8478 , 1759-8486
    Language: English
    Publisher: BMJ
    Publication Date: 2014
    detail.hit.zdb_id: 2506028-4
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  • 4
    In: Journal of NeuroInterventional Surgery, BMJ, Vol. 8, No. 3 ( 2016-03), p. 224-229
    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. 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.
    Type of Medium: Online Resource
    ISSN: 1759-8478 , 1759-8486
    Language: English
    Publisher: BMJ
    Publication Date: 2016
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  • 5
    In: Interventional Neurology, S. Karger AG, Vol. 7, No. 1-2 ( 2018), p. 26-35
    Abstract: 〈 b 〉 〈 i 〉 Background: 〈 /i 〉 〈 /b 〉 Various techniques are used to enhance the results of mechanical thrombectomy with stent-retrievers, including proximal arrest with balloon guide catheter (BGC), conventional large bore proximal catheter (CGC), or in combination with local aspiration through a large-bore catheter positioned at the clot interface (Aspiration-Retriever Technique for Stroke [ARTS]). We evaluated the impact of ARTS in the North American Solitaire Acute Stroke (NASA) registry. 〈 b 〉 〈 i 〉 Summary: 〈 /i 〉 〈 /b 〉 Data on the use of the aspiration technique were available for 285 anterior circulation patients, of which 29 underwent ARTS technique, 131 CGC, and 125 BGC. Baseline demographics were comparable, except that ARTS patients are less likely to have hypertension or atrial fibrillation. The ARTS group had more ICA occlusions (41.4 vs. 22% in the BGC, 〈 i 〉 p 〈 /i 〉 = 0.04 and 26% in CGC, 〈 i 〉 p 〈 /i 〉 = 0.1) and less MCA/M1 occlusions (44.8 vs. 68% in BGC and 62% in CGC). Time from arterial puncture to reperfusion or end of procedure with ARTS was shorter than with CGC (54 vs. 91 min, 〈 i 〉 p 〈 /i 〉 = 0.001) and was comparable to the BGC time (54 vs. 67, 〈 i 〉 p 〈 /i 〉 = 0.11). Final degree of reperfusion was comparable among the groups (TICI [modified Thrombolysis in Cerebral Infarction] score 2b or higher was 72 vs. 70% for CGC vs. 78% for BGC). Procedural complications, mortality, and good clinical outcome at 90 days were similar between the groups. 〈 b 〉 〈 i 〉 Key Messages: 〈 /i 〉 〈 /b 〉 The ARTS mechanical thrombectomy in acute ischemic stroke patients appears to yield better results as compared to the use of CGCs with no significant difference when compared to BGC. This early ARTS technique NASA registry data are limited by the earlier generation distal large bore catheters and small sample size. Future studies should focus on the comparison of ARTS and BGC techniques.
    Type of Medium: Online Resource
    ISSN: 1664-9737 , 1664-5545
    Language: English
    Publisher: S. Karger AG
    Publication Date: 2018
    detail.hit.zdb_id: 2662855-7
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  • 6
    In: Journal of NeuroInterventional Surgery, BMJ, Vol. 9, No. 4 ( 2017-04), p. 366-369
    Abstract: Time to reperfusion following endovascular treatment (ET) predicts outcomes after acute ischemic stroke (AIS). Objective To assess the time–outcome relationship within reperfusion grades in the North American Solitaire Acute Stroke registry. Methods We identified patients given ET for anterior circulation ischemic stroke within 8 h from onset and in whom reperfusion was achieved. Together with clinical and outcome data, site-adjudicated modified Thrombolysis in Cerebral Ischemia (TICI) was recorded. We assessed the impact of time to reperfusion (onset to procedure completion time) on good outcome (modified Rankin Scale 0–2 at 3 months) in patients who achieved TICI 2 or higher reperfusion in multivariable models. We further assessed this relationship within strata of reperfusion grades. A p 〈 0.05 was considered significant. Results Independent predictors of good outcome at 3 months among those achieving TICI ≥2a reperfusion (n=188) were initial National Institutes of Health Stroke Scale score (adjusted OR=0.90, 95% CI 0.85 to 0.95), symptomatic hemorrhage (adj. OR=0.16, 95% CI 0.05 to 0.60), TICI grade (TICI 3: adj. OR=11.52, 95% CI 3.34 to 39.77; TICI 2b: adj. OR=5.14, 95% CI 1.61 to 16.39), and time to reperfusion per 30 min interval (adj. OR=0.91, 95% CI 0.82 to 0.99). There was an interaction between final TICI grade and 30 min time to reperfusion intervals (p=0.001) such that the effect of time was strongest in TICI 2a patients. Conclusions Time to reperfusion was a strong predictor of outcome following ET for AIS. However, the effect varied by TICI grade such that its greatest effect was in those achieving TICI 2a reperfusion.
    Type of Medium: Online Resource
    ISSN: 1759-8478 , 1759-8486
    Language: English
    Publisher: BMJ
    Publication Date: 2017
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  • 7
    In: Journal of NeuroInterventional Surgery, BMJ, Vol. 10, No. Suppl 1 ( 2018-07), p. i45-i49
    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. 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.
    Type of Medium: Online Resource
    ISSN: 1759-8478 , 1759-8486
    Language: English
    Publisher: BMJ
    Publication Date: 2018
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  • 8
    In: Stroke, Ovid Technologies (Wolters Kluwer Health), Vol. 45, No. 12 ( 2014-12), p. 3631-3636
    Abstract: 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.
    Type of Medium: Online Resource
    ISSN: 0039-2499 , 1524-4628
    RVK:
    Language: English
    Publisher: Ovid Technologies (Wolters Kluwer Health)
    Publication Date: 2014
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  • 9
    In: Stroke, Ovid Technologies (Wolters Kluwer Health), Vol. 49, No. 3 ( 2018-03), p. 660-666
    Abstract: In acute ischemic stroke, fast and complete recanalization of the occluded vessel is associated with improved outcomes. We describe a novel measure for newer generation devices: the first pass effect (FPE). FPE is defined as achieving a complete recanalization with a single thrombectomy device pass. Methods— The North American Solitaire Acute Stroke Registry database was used to identify a FPE subgroup. Their baseline features and clinical outcomes were compared with non-FPE patients. Clinical outcome measures included 90-days modified Rankin Scale score, National Institutes of Health Stroke Scale score, mortality, and symptomatic intracranial hemorrhage. Multivariate analyses were performed to determine whether FPE independently resulted in improved outcomes and to identify predictors of FPE. Results— A total of 354 acute ischemic stroke patients underwent thrombectomy in the North American Solitaire Acute Stroke registry. FPE was achieved in 89 out of 354 (25.1%). More middle cerebral artery occlusions (64% versus 52.5%) and fewer internal carotid artery occlusions (10.1% versus 27.7%) were present in the FPE group. Balloon guide catheters were used more frequently with FPE (64.0% versus 34.7%). Median time to revascularization was significantly faster in the FPE group (median 34 versus 60 minutes; P =0.0003). FPE was an independent predictor of good clinical outcome (modified Rankin Scale score ≤2 was seen in 61.3% in FPE versus 35.3% in non-FPE cohort; P =0.013; odds ratio, 1.7; 95% confidence interval, 1.1–2.7). The independent predictors of achieving FPE were use of balloon guide catheters and non-internal carotid artery terminus occlusion. Conclusions— The achievement of complete revascularization from a single Solitaire thrombectomy device pass (FPE) is associated with significantly higher rates of good clinical outcome. The FPE is more frequently associated with the use of balloon guide catheters and less likely to be achieved with internal carotid artery terminus occlusion.
    Type of Medium: Online Resource
    ISSN: 0039-2499 , 1524-4628
    RVK:
    Language: English
    Publisher: Ovid Technologies (Wolters Kluwer Health)
    Publication Date: 2018
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  • 10
    In: Stroke, Ovid Technologies (Wolters Kluwer Health), Vol. 45, No. 1 ( 2014-01), p. 141-145
    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. 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.
    Type of Medium: Online Resource
    ISSN: 0039-2499 , 1524-4628
    RVK:
    Language: English
    Publisher: Ovid Technologies (Wolters Kluwer Health)
    Publication Date: 2014
    detail.hit.zdb_id: 1467823-8
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