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INTRODUCTION: Aneurysmal subarachnoid hemorrhage (aSAH) patients are given calcium channel blockers (CCBs) to prevent brain vessel vasospasm. We hypothesized that preinjury antihypertensive use may protect against vasospasm. It remains unclear whether the timing of in-hospital CCB initiation affects the vasospasm risk in this population. METHODS: This retrospective cohort study included aSAH patients (≥18 y/o) at a Comprehensive Stroke Center (1/18-11/21). Patients taking prehospital antihypertensives [CCBs, Angiotensin-converting enzyme (ACE) inhibitors or Angiotensin II receptor blockers (ARBs)] were compared to those who were not. Results were stratified by patients receiving vasospasm prophylaxis ('in-hospital CCBs') ≤1.2 h of arrival vs. >1.2 h from arrival. Outcomes included vasospasm, hospital length of stay (LOS), and mortality. RESULTS: Of 251 patients, 18% were taking prehospital antihypertensives. Patients were comparable in baseline characteristics. There was no difference in the rate of vasospasm when compared by prehospital antihypertensive use. For those on prehospital antihypertensives, the time to in-hospital CCBs was significantly longer for patients who developed vasospasm than for those who did not (1.2 vs. 4.9 h, respectively, p = 0.02). For those on prehospital antihypertensives, receipt of in-hospital CCBs within 1.2 h of arrival was associated with a significantly lower vasospasm rate (6% vs. 39%, p = 0.03) and LOS (14 vs. 20 d, p = 0.01) when compared to receiving in-hospital CCBs > 1.2 h of arrival, respectively. The mortality rate (50% vs. 26%, p = 0.06) was statistically similar between groups, respectively. These results were not observed among patients who were not on prehospital antihypertensives. The timing to in-hospital CCB initiation had no effect on vasospasm (p = 0.23), death (p = 0.08), or LOS (p = 0.31) for patients not on prehospital antihypertensives. CONCLUSIONS: Enhancing the efficiency of in-hospital CCB initiation for patients on prehospital antihypertensives may decrease the occurrence of vasospasm and lead to a shorter LOS.
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Antagonistas de Receptores de Angiotensina , Inibidores da Enzima Conversora de Angiotensina , Bloqueadores dos Canais de Cálcio , Hemorragia Subaracnóidea , Vasoespasmo Intracraniano , Humanos , Hemorragia Subaracnóidea/complicações , Hemorragia Subaracnóidea/tratamento farmacológico , Vasoespasmo Intracraniano/etiologia , Vasoespasmo Intracraniano/prevenção & controle , Feminino , Masculino , Pessoa de Meia-Idade , Estudos Retrospectivos , Inibidores da Enzima Conversora de Angiotensina/uso terapêutico , Inibidores da Enzima Conversora de Angiotensina/administração & dosagem , Bloqueadores dos Canais de Cálcio/administração & dosagem , Bloqueadores dos Canais de Cálcio/uso terapêutico , Idoso , Antagonistas de Receptores de Angiotensina/administração & dosagem , Antagonistas de Receptores de Angiotensina/uso terapêutico , Resultado do Tratamento , Adulto , Anti-Hipertensivos/administração & dosagem , Anti-Hipertensivos/uso terapêutico , Tempo de Internação/estatística & dados numéricos , Fatores de TempoRESUMO
BACKGROUND AND OBJECTIVES: The effect of endovascular therapy (EVT) for large vessel occlusion stroke on cognitive outcomes is not well understood. We evaluated the effect of EVT on cognitive function in the Endovascular Treatment for Small Core and Anterior Circulation Proximal Occlusion With Emphasis on Minimizing CT to Recanalization Times (ESCAPE) trial. METHODS: Patient data from the ESCAPE randomized trial were analyzed. Cognitive assessments completed at 90 days after stroke were the Montreal Cognitive Assessment (MoCA), the Sunnybrook Neglect Assessment Procedure (SNAP), the Boston Naming Test (BNT), Trail-making test A (Trails A), and Trail-making test B (Trails B). We used logistic regression to evaluate the association between EVT and favorable cognitive outcome on the 5 separate tests, adjusting for demographic and clinical factors. We used generalized estimating equations and ordinal regression to determine the odds of favorable outcome with EVT on global cognition incorporating the 5 tests. We added final infarct volume (FIV) to the models to assess the relationship of FIV with cognitive outcome. RESULTS: The ESCAPE trial included 315 patients, 165 randomized to EVT and 150 randomized to control. There was higher odds of favorable outcome with EVT for MoCA (adjusted odds ratio [aOR] 2.32, 95% CI 1.30-4.16), SNAP (aOR 3.85, 95% CI 2.00-7.45), BNT (aOR 2.33, 95% CI 1.30-4.17), trails A (aOR 3.50, 95% CI 1.93-6.36), and trails B (aOR 2.56, 95% CI 1.46-4.48). There was higher odds of favorable outcome with EVT on global binary (aOR 2.57, 95% CI 1.67-3.94) and ordinal analyses (aOR 2.83, 95% CI 1.68-4.76) of cognitive function. After adding FIV to the models, both FIV and EVT were significantly associated with cognitive outcome. There was a significant correlation between global cognitive performance and mRS at day 90 (r = -0.78, p < 0.001), with the largest reductions in favorable cognitive outcome from mRS score 4 to 5 and from mRS 2 to 3. DISCUSSION: In this secondary analysis of the ESCAPE trial, EVT was associated with favorable outcome on 5 separate cognitive tests and in global analyses of cognitive benefit. These results provide novel evidence for the effect of EVT on cognition and support the global benefit of treatment with EVT. CLASSIFICATION OF EVIDENCE: This study provides Class II evidence that in patients with acute ischemic stroke due to intracranial internal carotid artery (ICA) or M1 segment MCA occlusion, including tandem extracranial ICA occlusions, EVT compared with best medical therapy increased odds of favorable cognitive outcome.
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Procedimentos Endovasculares , AVC Isquêmico , Trombectomia , Humanos , Masculino , Feminino , AVC Isquêmico/cirurgia , AVC Isquêmico/terapia , Procedimentos Endovasculares/métodos , Idoso , Trombectomia/métodos , Pessoa de Meia-Idade , Resultado do Tratamento , Cognição/fisiologia , Testes Neuropsicológicos , Idoso de 80 Anos ou maisRESUMO
BACKGROUND AND PURPOSE: To assess cost-effectiveness of late time-window endovascular treatment (EVT) in a clinical trial setting and a "real-world" setting. METHODS: Data are from the randomized ESCAPE trial and a prospective cohort study (ESCAPE-LATE). Anterior circulation large vessel occlusion patients presenting > 6 hours from last-known-well were included, whereby collateral status was an inclusion criterion for ESCAPE but not ESCAPE-LATE. A Markov state transition model was built to estimate lifetime costs and quality-adjusted life-years (QALYs) for EVT in addition to best medical care vs. best medical care only in a clinical trial setting (comparing ESCAPE-EVT to ESCAPE control arm patients) and a "real-world" setting (comparing ESCAPE-LATE to ESCAPE control arm patients). We performed an unadjusted analysis, using 90-day modified Rankin Scale(mRS) scores as model input and analysis adjusted for baseline factors. Acceptability of EVT was calculated using upper/lower willingness-to-pay thresholds of 100,000 USD/50,000 USD/QALY. RESULTS: Two-hundred and forty-nine patients were included (ESCAPE-LATE:n = 200, ESCAPE EVT-arm:n = 29, ESCAPE control-arm:n = 20). Late EVT in addition to best medical care was cost effective in the unadjusted analysis both in the clinical trial and real-world setting, with acceptability 96.6%-99.0%. After adjusting for differences in baseline variables between the groups, late EVT was marginally cost effective in the clinical trial setting (acceptability:49.9%-61.6%), but not the "real-world" setting (acceptability:32.9%-42.6%). CONCLUSION: EVT for LVO-patients presenting beyond 6 hours was cost effective in the clinical trial setting and "real-world" setting, although this was largely related to baseline patient differences favoring the "real-world" EVT group. After adjusting for these, EVT benefit was reduced in the trial setting, and absent in the real-world setting.
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BACKGROUND: The Neuroform Atlas Stent System is an established treatment modality for unruptured anterior and posterior circulation intracranial aneurysms. Location-specific results are needed to guide treatment decision-making. However, it is unclear whether there are differences in safety and efficacy outcomes between carotid and more distal anterior circulation aneurysms. METHODS: The ATLAS IDE trial was a prospective, multicenter, single-arm, open-label interventional study that evaluated the safety and efficacy of the Neuroform Atlas Stent System. We compared differences in efficacy and safety outcomes of proximal internal carotid artery (ICA) versus distal and bifurcation anterior circulation aneurysms. RESULTS: Of 182 cases, there were 70 aneurysms in the ICA and 112 in the distal anterior circulation (including ICA terminus/bifurcation). There were no significant differences in the primary efficacy endpoint (85.5% vs 83.9%, p=0.78) and complete aneurysm occlusion rates (88.7% vs 87.9%, p=0.78) between proximal ICA aneurysms and distal aneurysms, respectively. Complications were more often encountered in distal and bifurcation aneurysms, but the overall rate of major safety events was low and comparable between the two groups (1.4% vs 6.3%, p=0.14). Recanalization and retreatment rates were also similar between the groups. CONCLUSION: The results of this study suggest that the Neuroform Atlas Stent System is a safe and efficacious treatment modality for unruptured anterior circulation intracranial aneurysms, regardless of aneurysm location. TRIAL REGISTRATION NUMBER: NCT02340585.
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BACKGROUND: We describe the first-in-human experience using the Balloon Occlusion Stroke Sheath (BOSSTM) balloon-guide catheter to perform stroke thrombectomy in 50 consecutive patients enrolled in the Flow Arrest Safety and Technical success with balloon-guide catheters trial. This aspiration system includes a novel 9.4F balloon-guide catheter conduit for the insertion and guidance of catheters with a balloon providing temporary flow arrest. METHODS: The Flow Arrest Safety and Technical success with balloon-guide catheter trial is a single-arm, prospective, multi-center, non-randomized, observational registry evaluating the use of the market-released BOSSTM balloon-guide catheter in adult patients diagnosed with an acute ischemic stroke attributable to large vessel occlusion. The purpose of the current trial was to assess the safety and technical success associated with the use of the BOSSTM balloon-guide catheter. RESULTS: Fifty patients met inclusion criteria with a mean baseline National Institutes of Health Stroke Scale (NIHSS) of 16. Treatment devices, including aspiration and stent retriever devices, were used in a total of 88 passes. The BOSSTM balloon-guide catheter was compatible with all stroke thrombectomy treatment devices used in 98% (49/50) of procedures. Balloon inflation and flow arrest were achieved in 100% (50/50) and 98% (49/50) of cases, respectively. Balloon deflation and retraction were observed in 100% (50/50) of cases. Successful reperfusion (modified thrombolysis in cerebral infarction score > 2b) was achieved in 100% of cases with single-pass reperfusion achieved in 62% (31/50) of cases. CONCLUSIONS: The BOSSTM balloon-guide catheter is a safe and technically effective adjunctive device for mechanical thrombectomy of acute ischemic stroke due to large vessel occlusion.
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BACKGROUND: The pipeline embolization device (PED; Medtronic) has presented as a safe and efficacious treatment for small- and medium-sized intracranial aneurysms. Independently adjudicated long-term results of the device in treating these lesions are still indeterminate. We present 3-year results, with additional application of a flow diverter specific occlusion scale. METHODS: PREMIER (prospective study on embolization of intracranial aneurysms with pipeline embolization device) is a prospective, single-arm trial. Inclusion criteria were patients with unruptured wide-necked intracranial aneurysms ≤12 mm. Primary effectiveness (complete aneurysm occlusion) and safety (major neurologic event) endpoints were independently monitored and adjudicated. RESULTS: As per the protocol, of 141 patients treated with a PED, 25 (17.7%) required angiographic follow-up after the first year due to incomplete aneurysm occlusion. According to the Core Radiology Laboratory review, three (12%) of these patients progressed to complete occlusion, with an overall rate of complete aneurysm occlusion at 3 years of 83.3% (115/138). Further angiographic evaluation using the modified Cekirge-Saatci classification demonstrated that complete occlusion, neck residual, or aneurysm size reduction occurred in 97.1%. The overall combined safety endpoint at 3 years was 2.8% (4/141), with only one non-debilitating major event occurring after the first year. There was one case of aneurysm recurrence but no cases of delayed rupture in this series. CONCLUSIONS: The PED device presents as a safe and effective modality in treating small- and medium-sized intracranial aneurysms. The application of a flow diverter specific occlusion classification attested the long-term durability with higher rate of successful aneurysm occlusion and no documented aneurysm rupture. TRIAL REGISTRATION: NCT02186561.
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Embolização Terapêutica , Aneurisma Intracraniano , Humanos , Angiografia Cerebral/métodos , Embolização Terapêutica/métodos , Seguimentos , Aneurisma Intracraniano/diagnóstico por imagem , Aneurisma Intracraniano/terapia , Aneurisma Intracraniano/etiologia , Estudos Prospectivos , Estudos Retrospectivos , Resultado do TratamentoRESUMO
OBJECTIVES: Treatment of ischemic stroke with endovascular thrombectomy (EVT) leads to improved outcomes compared to IV tPA. The neutrophil-lymphocyte ratio (NLR), a marker of inflammation, has been proposed to predict outcomes in ischemic stroke patients and may be used to identify patients at risk for poor outcomes after EVT. MATERIALS AND METHODS: This was a retrospective study of adult ischemic stroke patients undergoing EVT between 1/1/2018 and 12/31/2020. Outcomes were successful reperfusion (TICI score ≥2B), favorable discharge NIHSS (≤4), favorable discharge and 3-month mRS (≤2), and symptomatic intracranial hemorrhage (sICH). The primary exposure was NLR, measured pre- and post-EVT. Other variables collected included demographics and timing of stroke onset, arrival, groin puncture, tPA, and recanalization. RESULTS: A total of 592 patients were included. The most common vessel involved was the middle cerebral artery (73%). Lower admission NLR was associated with favorable discharge NIHSS and favorable discharge and 3-month mRS (all P < 0.01). NLRs measured after EVT were associated with all the primary outcomes. Improvements in NLR after EVT were associated with favorable discharge (P = 0.02) and 3-month mRS (P = 0.02) and lower incidence of sICH (P = 0.01). CONCLUSIONS: Because of the long-term functional deficits that can persist after ischemic stroke, it is vital to identify patients with higher probability for these outcomes. The results from this study showed that favorable NLR measures, as well as favorable trends in NLR over time, are associated with improved outcomes, indicating that NLR is a useful marker to identify patients at risk for poor functional outcomes.
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Isquemia Encefálica , Procedimentos Endovasculares , AVC Isquêmico , Acidente Vascular Cerebral , Humanos , Isquemia Encefálica/diagnóstico , Isquemia Encefálica/terapia , Isquemia Encefálica/complicações , Neutrófilos , AVC Isquêmico/diagnóstico , AVC Isquêmico/terapia , Estudos Retrospectivos , Resultado do Tratamento , Reperfusão/efeitos adversos , Trombectomia/efeitos adversos , Trombectomia/métodos , Acidente Vascular Cerebral/diagnóstico , Acidente Vascular Cerebral/terapia , Acidente Vascular Cerebral/etiologia , Hemorragias Intracranianas/etiologia , Linfócitos , Procedimentos Endovasculares/efeitos adversos , Procedimentos Endovasculares/métodosRESUMO
INTRODUCTION: The purpose of this study was to report our initial experience of using a large-bore (0.096â³ inner diameter) access catheter in neurovascular interventions. METHODS: Data were retrospectively collected from 5 sites in the US for neurovascular procedures performed using a large-bore access catheter. The effectiveness outcome was technical success, defined as the access catheter's successfully reaching its target vessel without conversion to direct carotid puncture or to a smaller-bore access catheter and successfully completing the intended neurointervention. RESULTS: One hundred and thirteen procedures performed in 112 patients were included in this study. The mean age of the patients was 67.5 years (SD 16.2), and about half (49.1%) were female. The most common primary access sites were the femoral (64.6%) or radial (32.7%) artery. Challenging anatomic variations included severe vessel tortuosity (26/81, 32.1%), type II aortic arch (17/88, 19.3%), type III aortic arch (14/88, 15.9%), bovine arch (16/104, 15.4%), severe angle (<30°) between the subclavian and target vessel (11/74, 14.9%), and subclavian loop (7/79, 8.9%). The median access time to branch view was 18 min (IQR 11-28, N = 75). The technical success rate was 94.7%. Two dissections (1.8%) were related to the large-bore access catheter. Access site complications occurred in 2 patients (1.8%). Four additional symptomatic periprocedural complications not related to the large-bore access catheter occurred (7.1%). CONCLUSION: For neurovascular interventions, a 0.096â³ inner diameter access catheter could be used with both femoral and radial arterial approaches, had a high technical success rate, and had a low rate of periprocedural complications.
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BACKGROUND: There is conflicting evidence on the utility of intravenous (IV) alteplase in patients with emergent large vessel occlusion (ELVO) treated with mechanical thrombectomy (MT). METHODS: This was a post hoc analysis of the COMPASS: a trial of aspiration thrombectomy versus stent retriever thrombectomy as first-line approach for large vessel occlusion. We compared clinical, procedural and angiographic outcomes of patients with and without prior IV alteplase administration. RESULTS: In the COMPASS trial, 235 patients had presented to the hospital within the first 4 hours of stroke symptom onset and were eligible for analysis. On univariate analysis, administration of IV alteplase prior to MT was found to be significantly associated with favorable outcomes (modified Rankin scale (mRS) 0-2 at 3 months; 55.6% vs 40.0% in the MT-only group, P=0.037). However, on multivariate analysis, only baseline (pre-stroke) mRS, admission National Institutes of Health Stroke Scale (NIHSS) score and age were identified as independent predictors of favorable outcomes at 3 months. We found higher final thrombolysis in cerebral infarction (TICI) 2b/3 rates in patients without the use of alteplase prior to the aspiration first approach (100.0% vs 87.9% in IV altepase +aspiration first MT, P=0.03). In the stent retriever first group, final TICI 2b/3 rates were identical in patients with and without IV alteplase administration (87.5% and 87.5%, P=1.0). CONCLUSIONS: Prior administration of IV alteplase may adversely affect the efficacy of aspiration, but does not seem to influence the stent retriever first approach to MT in patients with anterior circulation ELVO.
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Acidente Vascular Cerebral , Trombectomia , Ativador de Plasminogênio Tecidual , Isquemia Encefálica/etiologia , Infarto Cerebral/etiologia , Humanos , Lactente , Recém-Nascido , Estudos Retrospectivos , Stents/efeitos adversos , Acidente Vascular Cerebral/diagnóstico por imagem , Acidente Vascular Cerebral/tratamento farmacológico , Acidente Vascular Cerebral/cirurgia , Trombectomia/efeitos adversos , Trombectomia/métodos , Ativador de Plasminogênio Tecidual/uso terapêutico , Resultado do TratamentoRESUMO
BACKGROUND: Stent-assisted coiling of wide-necked intracranial aneurysms (IAs) using the Neuroform Atlas Stent System (Atlas) has shown promising results. OBJECTIVE: To present the primary efficacy and safety results of the ATLAS Investigational Device Exemption (IDE) trial in a cohort of patients with posterior circulation IAs. METHODS: The ATLAS trial is a prospective, multicenter, single-arm, open-label study of unruptured, wide-necked, IAs treated with the Atlas stent and adjunctive coiling. This study reports the results of patients with posterior circulation IAs. The primary efficacy endpoint was complete aneurysm occlusion (Raymond-Roy (RR) class I) on 12-month angiography, in the absence of re-treatment or parent artery stenosis >50%. The primary safety endpoint was any major ipsilateral stroke or neurological death within 12 months. Adjudication of the primary endpoints was performed by an imaging core laboratory and a Clinical Events Committee. RESULTS: The ATLAS trial enrolled and treated 116 patients at 25 medical centers with unruptured, wide-necked, posterior circulation IAs (mean age 60.2±10.5 years, 81.0% (94/116) female). Stents were placed in all patients with 100% technical success rate. A total of 95/116 (81.9%) patients had complete angiographic follow-up at 12 months, of whom 81 (85.3%) had complete aneurysm occlusion (RR class I). The primary effectiveness outcome was achieved in 76.7% (95% CI 67.0% to 86.5%) of patients. Overall, major ipsilateral stroke and secondary persistent neurological deficit occurred in 4.3% (5/116) and 1.7% (2/116) of patients, respectively. CONCLUSIONS: In the ATLAS IDE posterior circulation cohort, the Neuroform Atlas Stent System with adjunctive coiling demonstrated high rates of technical and safety performance. Trial registration number https://clinicaltrials.gov/ct2/show/NCT02340585.
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Embolização Terapêutica , Aneurisma Intracraniano , Idoso , Angiografia Cerebral , Feminino , Humanos , Aneurisma Intracraniano/diagnóstico por imagem , Aneurisma Intracraniano/cirurgia , Pessoa de Meia-Idade , Estudos Prospectivos , Estudos Retrospectivos , Stents , Resultado do TratamentoRESUMO
BACKGROUND: It is not clear whether the COVID-19 pandemic and subsequent Society of Neurointerventional Surgery (SNIS) recommendations affected hospital stroke metrics. METHODS: This retrospective cohort study compared stroke patients admitted to a comprehensive stroke center during the COVID-19 pandemic April 1 2020 to June 30 2020 (COVID-19) to patients admitted April 1 2019 to June 30 2019. We examined stroke admission volume and acute stroke treatment use. RESULTS: There were 637 stroke admissions, 52% in 2019 and 48% during COVID-19, with similar median admissions per day (4 vs 3, P=0.21). The proportion of admissions by stroke type was comparable (ischemic, P=0.69; hemorrhagic, P=0.39; transient ischemic stroke, P=0.10). Acute stroke treatment was similar in 2019 to COVID-19: tPA prior to arrival (18% vs, 18%, P=0.89), tPA treatment on arrival (6% vs 7%, P=0.85), and endovascular therapy (endovascular therapy (ET), 22% vs 25%, P=0.54). The door to needle time was also similar, P=0.12, however, the median time from arrival to groin puncture was significantly longer during COVID-19 (38 vs 43 min, P=0.002). A significantly higher proportion of patients receiving ET were intubated during COVID-19 due to SNIS guideline implementation (45% vs 96%, P<0.0001). There were no differences by study period in discharge mRS, P=0.84 or TICI score, P=0.26. CONCLUSIONS: The COVID-19 pandemic did not significantly affect stroke admission volume or acute stroke treatment utilization. Outcomes were not affected by implementing SNIS guidelines. Although there was a statistical increase in time to groin puncture for ET, it was not clinically meaningful. These results suggest hospitals managing patients efficiently can implement practices in response to COVID-19 without impacting outcomes.
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COVID-19 , Acidente Vascular Cerebral , Benchmarking , Humanos , Pandemias , Estudos Retrospectivos , SARS-CoV-2 , Acidente Vascular Cerebral/tratamento farmacológico , Acidente Vascular Cerebral/terapia , Trombectomia , Terapia Trombolítica/métodos , Tempo para o Tratamento , Resultado do TratamentoRESUMO
BACKGROUND: Cerebral vasospasm (CV) after aneurysmal subarachnoid hemorrhage (aSAH) is linked to worse neurological outcomes. The NeVa VS is a novel cerebral dilation device based on predicate stent retrievers. We report the results of the Vesalio NeVa VS for the Treatment of Symptomatic Cerebral Vasospasm following aSAH (VITAL) Study. METHODS: This was a single-arm prospective multicenter trial to assess the safety and probable benefit of the NeVa VS device to treat CV. Patients were screened and treated if they had CV >50% on non-invasive imaging confirmed by cerebral angiography. The vessel diameters were measured before and after treatment by an independent core laboratory. The primary endpoint was ≥50% vessel diameter immediately after treatment with the NeVa VS device. RESULTS: Thirty patients with a mean age of 52±11 years and mean Hunt-Hess grade of 3.1±0.9 were enrolled. A total of 74 vessels were treated with an average of 1.3 deployments per vessel (95 deployments total). The mean pre-treatment narrowing of the target vessel (n=74) was 65.6% with reduction of the narrowing to 29.4% after treatment. The primary endpoint was achieved in 64 of 74 vessels (86.5%). In three of 95 total deployments (3.2%), thrombus at the site of deployment was observed during the procedure without apparent neurological sequelae. CONCLUSIONS: The NeVa VS device appears to be a safe treatment to regain vessel diameter in severely narrowed intracranial arteries secondary to CV associated with aSAH. This treatment offers a new tool that allows for controlled vessel expansion to treat CV.
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Aneurisma , Hemorragia Subaracnóidea , Vasoespasmo Intracraniano , Adulto , Aneurisma/complicações , Angiografia Cerebral , Humanos , Pessoa de Meia-Idade , Estudos Prospectivos , Hemorragia Subaracnóidea/complicações , Hemorragia Subaracnóidea/diagnóstico por imagem , Hemorragia Subaracnóidea/cirurgia , Vasoespasmo Intracraniano/complicações , Vasoespasmo Intracraniano/etiologiaRESUMO
BACKGROUND: Heterogeneous effect of endovascular aneurysm therapy has been observed across different anatomic locations. There is a paucity of data for stent-assisted coiling of middle cerebral artery (MCA) aneurysms. OBJECTIVE: To present the results of the MCA aneurysm group from the Neuroform Atlas (Stryker Neurovascular) investigational device exemption (IDE) trial. METHODS: The Atlas IDE trial is a prospective, multicenter, single-arm, open-label study of wide-neck aneurysms (neck ≥ 4 mm or dome-to-neck ratio < 2) in the anterior circulation treated with the Neuroform Atlas Stent and approved coils. Follow-up was obtained immediately postprocedure and 2, 6, and 12 mo postoperatively. We herein describe safety and efficacy outcomes, and functional independence of the subjects with aneurysms from all segments of MCA. RESULTS: A total of 35 patients were included (27 MCA bifurcation, 5 M1, 3 M2). The mean aneurysm size was 6.0 ± 1.8 mm, and the mean neck was 4.4 ± 1.2 mm. Technical procedural success was achieved in all patients. A total of 26 patients had follow-up digital subtraction angiography available at 12 mo, with 80.8% (21/26) having complete aneurysm occlusion. Twelve-month safety data were collected for 91.4% (32/35), 8.5% (3/35) had primary safety endpoint, all 3 major ischemic strokes. Mortality occurred in 2 patients beyond 30 d unrelated to procedure (1 gallbladder cancer and 1 fentanyl intoxication). At 1 yr, modified Rankin Score was 0 to 2 in 84.4% (27/32), 3 in 9.4%, and 3 patients were missing. Approximately 5.7% (2/35) of patients were retreated at 12 mo. CONCLUSION: Stent-assisted coiling with the Neuroform Atlas Stent is a viable alternative to clipping for selected MCA aneurysms. Complete aneurysm occlusion rates have improved compared to historical data. Proper case selection can lead to acceptable endovascular results.
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Aneurisma da Aorta Abdominal , Embolização Terapêutica , Aneurisma Intracraniano , Stents , Implante de Prótese Vascular , Angiografia Cerebral , Procedimentos Endovasculares , Humanos , Aneurisma Intracraniano/diagnóstico por imagem , Aneurisma Intracraniano/cirurgia , Estudos Prospectivos , Estudos Retrospectivos , Resultado do TratamentoRESUMO
BACKGROUND: The COVID-19 pandemic led to profound changes in the organization of health care systems worldwide. AIMS: We sought to measure the global impact of the COVID-19 pandemic on the volumes for mechanical thrombectomy, stroke, and intracranial hemorrhage hospitalizations over a three-month period at the height of the pandemic (1 March-31 May 2020) compared with two control three-month periods (immediately preceding and one year prior). METHODS: Retrospective, observational, international study, across 6 continents, 40 countries, and 187 comprehensive stroke centers. The diagnoses were identified by their ICD-10 codes and/or classifications in stroke databases at participating centers. RESULTS: The hospitalization volumes for any stroke, intracranial hemorrhage, and mechanical thrombectomy were 26,699, 4002, and 5191 in the three months immediately before versus 21,576, 3540, and 4533 during the first three pandemic months, representing declines of 19.2% (95%CI, -19.7 to -18.7), 11.5% (95%CI, -12.6 to -10.6), and 12.7% (95%CI, -13.6 to -11.8), respectively. The decreases were noted across centers with high, mid, and low COVID-19 hospitalization burden, and also across high, mid, and low volume stroke/mechanical thrombectomy centers. High-volume COVID-19 centers (-20.5%) had greater declines in mechanical thrombectomy volumes than mid- (-10.1%) and low-volume (-8.7%) centers (p < 0.0001). There was a 1.5% stroke rate across 54,366 COVID-19 hospitalizations. SARS-CoV-2 infection was noted in 3.9% (784/20,250) of all stroke admissions. CONCLUSION: The COVID-19 pandemic was associated with a global decline in the volume of overall stroke hospitalizations, mechanical thrombectomy procedures, and intracranial hemorrhage admission volumes. Despite geographic variations, these volume reductions were observed regardless of COVID-19 hospitalization burden and pre-pandemic stroke/mechanical thrombectomy volumes.
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COVID-19 , Saúde Global , Hospitalização/tendências , Hemorragias Intracranianas/terapia , Acidente Vascular Cerebral/terapia , Trombectomia/tendências , Estudos Transversais , Hospitais com Alto Volume de Atendimentos/tendências , Hospitais com Baixo Volume de Atendimentos/tendências , Humanos , Hemorragias Intracranianas/diagnóstico , Hemorragias Intracranianas/epidemiologia , Sistema de Registros , Estudos Retrospectivos , Acidente Vascular Cerebral/diagnóstico , Acidente Vascular Cerebral/epidemiologia , Fatores de TempoRESUMO
BACKGROUND: Clot density (Hounsfield units, HU) and perviousness (post-contrast increase in the HU of clot) are thought to be associated with clot composition. We evaluate whether these imaging characteristics were associated with angiographic outcomes of aspiration and stent retriever thrombectomy in COMPASS: a trial of aspiration thrombectomy versus stent retriever thrombectomy as first-line approach for large vessel occlusion. METHODS: Clot density and perviousness were measured by two independent operators who were blind to all the final angiographic and clinical outcomes. The association of clot density and perviousness with the Thrombolysis In Cerebral Infarction (TICI) scale after first pass was assessed using univariate and multivariate analysis. RESULTS: Among all patients enrolled in COMPASS, 165 were eligible for the post-hoc analysis (81 patients in the aspiration first and 84 in the stent retriever first groups). Overall mean perviousness of clot was significantly higher in patient with mTICI 2b-3 after first pass (28.6±22.9 vs 20.3±19.2, p=0.017). Mean perviousness among patients who achieved TICI 2c/3 versus TICI 2b versus TICI 0-2a in the aspiration first group varied significantly (32.6±26.1, 35.3±24.4, and 17.7±13.1, p=0.013). The association of perviousness with first pass success was not significant in the stent retriever group. Using multivariate analysis, high perviousness (defined as cut-off >27.6) was an independent predictor of TICI 2b-3 (OR 3.82, 95% CI 1.10 to 13.19; p=0.034). CONCLUSIONS: Clot perviousness is associated with first pass angiographic success in patients treated with the aspiration first approach for thrombectomy.
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Stents , Trombectomia/métodos , Trombose/diagnóstico por imagem , Trombose/cirurgia , Idoso , Idoso de 80 Anos ou mais , Infarto Cerebral/diagnóstico por imagem , Infarto Cerebral/etiologia , Infarto Cerebral/cirurgia , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Stents/tendências , Acidente Vascular Cerebral/diagnóstico por imagem , Acidente Vascular Cerebral/etiologia , Acidente Vascular Cerebral/cirurgia , Trombose/complicações , Resultado do TratamentoRESUMO
BACKGROUND AND PURPOSE: Stent-assisted coil embolization using the new generation Neuroform Atlas Stent System has shown promising safety and efficacy. The primary study results of the anterior circulation aneurysm cohort of the treatment of wide-neck, saccular, intracranial, aneurysms with the Neuroform Atlas Stent System (ATLAS trial [Safety and Effectiveness of the Treatment of Wide Neck, Saccular Intracranial Aneurysms With the Neuroform Atlas Stent System]) are presented. METHODS: ATLAS IDE trial (Investigational Device Exemption) is a prospective, multicenter, single-arm, open-label study of wide-neck (neck ≥4 mm or dome-to-neck ratio <2) intracranial aneurysms in the anterior circulation treated with the Neuroform Atlas Stent and approved coils. The primary efficacy end point was complete aneurysm occlusion (Raymond-Roy class 1) on 12-month angiography, in the absence of retreatment or parent artery stenosis (>50%) at the target location. The primary safety end point was any major stroke or ipsilateral stroke or neurological death within 12 months. Adjudication of the primary end points was performed by an independent Imaging Core Laboratory and the Clinical Events Committee. RESULTS: A total of 182 patients with wide-neck anterior circulation aneurysms at 25 US centers were enrolled. The mean age was 60.3±11.4 years, 73.1% (133/182) women, and 80.8% (147/182) white. Mean aneurysm size was 6.1±2.2 mm, mean neck width was 4.1±1.2 mm, and mean dome-to-neck ratio was 1.2±0.3. The most frequent aneurysm locations were the anterior communicating artery (64/182, 35.2%), internal carotid artery ophthalmic artery segment (29/182, 15.9%), and middle cerebral artery bifurcation (27/182, 14.8%). Stents were placed in the anticipated anatomic location in all patients. The study met both primary safety and efficacy end points. The composite primary efficacy end point of complete aneurysm occlusion (Raymond-Roy 1) without parent artery stenosis or aneurysm retreatment was achieved in 84.7% (95% CI, 78.6%-90.9%) of patients. Overall, 4.4% (8/182, 95% CI, 1.9%-8.5%) of patients experienced a primary safety end point of major ipsilateral stroke or neurological death. CONCLUSIONS: In the ATLAS IDE anterior circulation aneurysm cohort premarket approval study, the Neuroform Atlas stent with adjunctive coiling met the primary end points and demonstrated high rates of long-term complete aneurysm occlusion at 12 months, with 100% technical success and <5% morbidity. Registration: URL: https://www.clinicaltrials.gov. Unique identifier: NCT02340585.
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Embolização Terapêutica/instrumentação , Procedimentos Endovasculares/instrumentação , Aneurisma Intracraniano/terapia , Stents , Adulto , Idoso , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Resultado do TratamentoRESUMO
BACKGROUND: Enrollment in time-sensitive endovascular stroke trials can be challenging because of an inability to consent a debilitated patient. Often the legally authorized representative is not on site. Remote consent procedures in the US are inconsistent with the majority of sites shunning these approaches. The current pandemic with visitor restrictions highlights the need for enhancing these options. METHODS: Remote electronic and phone consent procedures specifically for endovascular stroke trials from two comprehensive stroke centers (CSC) are presented. An overview of the genesis of informed consent procedures in the US is also included. RESULTS: The two CSCs identified as Institution-1 and Institution-2 are large tertiary systems. Institution-1 is a non-profit university-affiliated academic medical center in rural geography. Institution-2 is an HCA hospital in an urban environment. Both serve patients through a spoke-and-hub network, have participated in multiple randomized endovascular stroke trials, and have successfully used these remote options for enrollment. A tiered approach is employed at both institutions with an emphasis on obtaining informed consent in person and resorting to alternatives methods when efforts to that are unsuccessful. A rationale for electronic and phone consent is included, followed by step-by-step illustration of the process at each institution. CONCLUSION: Two examples of remote electronic or phone consent procedures from institutions in different geographic environments and organization structures demonstrate that these options can be successfully used for enrollment in stroke trials. The current pandemic highlights the need to enhance these approaches while maintaining appropriate adherence to ethical and legal frameworks.
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Betacoronavirus , Ensaios Clínicos como Assunto/métodos , Infecções por Coronavirus/epidemiologia , Consentimento Livre e Esclarecido , Pneumonia Viral/epidemiologia , Acidente Vascular Cerebral/epidemiologia , Telemedicina/métodos , Centros Médicos Acadêmicos/métodos , COVID-19 , Telefone Celular , Infecções por Coronavirus/diagnóstico , Infecções por Coronavirus/terapia , Humanos , Pandemias , Seleção de Pacientes , Pneumonia Viral/diagnóstico , Pneumonia Viral/terapia , SARS-CoV-2 , Acidente Vascular Cerebral/diagnóstico , Acidente Vascular Cerebral/terapiaRESUMO
OBJECTIVE: Cerebral venous thrombosis (CVT) is a rare type of stroke whose pathophysiology differs from arterial stroke. CVT is treated with systemic anticoagulant therapy even in the setting of intracerebral hemorrhage. Patients who do not respond adequately may require decompressive surgery. The study objective was to examine the timing of anticoagulation in patients with CVT who require decompressive surgery through systematic literature review and consecutive case series. METHODS: A review of the literature was performed through PubMed using key word search to identify case series and cohort studies examining timing of anticoagulation following decompressive surgery. Our case series included 4 patients who had decompressive surgery for hemorrhagic CVT between 1 January, 2015 and 31 December, 2016 at our comprehensive stroke center. RESULTS: The literature review summarizes 243 patients from 15 studies whose timing of anticoagulation varied. The review suggests anticoagulation can be safely resumed at 48 hours postoperatively based on larger series and as early as 12 hours in smaller series, especially when delivered as a half or prophylactic dose. In our case series, timing of anticoagulation varied slightly but was started or resumed within 38-44 hours postoperatively in 3 patients and was started at the time of decompressive surgery without interruption in 1 patient. No patient had worsening hemorrhage or new hemorrhage while 2 patients rethrombosed. CONCLUSIONS: Despite the lack of high-quality studies, this systematic review of patients with CVT requiring decompressive surgery indicates that anticoagulation can be safely initiated or resumed around 24-48 hours postoperatively; our series supports the existing literature.
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Anticoagulantes/administração & dosagem , Craniectomia Descompressiva/métodos , Heparina/administração & dosagem , Trombose dos Seios Intracranianos/terapia , Adulto , Anticoagulantes/efeitos adversos , Angiografia Cerebral , Hemorragia Cerebral/induzido quimicamente , Procedimentos Endovasculares , Feminino , Heparina/efeitos adversos , Antagonistas de Heparina/uso terapêutico , Humanos , Masculino , Pessoa de Meia-Idade , Hemorragia Pós-Operatória/induzido quimicamente , Período Pós-Operatório , Protaminas/uso terapêutico , Trombectomia , Terapia Trombolítica , Fatores de TempoRESUMO
BACKGROUND: Nerinetide, an eicosapeptide that interferes with post-synaptic density protein 95, is a neuroprotectant that is effective in preclinical stroke models of ischaemia-reperfusion. In this trial, we assessed the efficacy and safety of nerinetide in human ischaemia-reperfusion that occurs with rapid endovascular thrombectomy in patients who had an acute ischaemic stroke. METHODS: For this multicentre, double-blind, randomised, placebo-controlled study done in 48 acute care hospitals in eight countries, we enrolled patients with acute ischaemic stroke due to large vessel occlusion within a 12 h treatment window. Eligible patients were aged 18 years or older with a disabling ischaemic stroke at the time of randomisation, had been functioning independently in the community before the stroke, had an Alberta Stroke Program Early CT Score (ASPECTS) greater than 4, and vascular imaging showing moderate-to-good collateral filling, as determined by multiphase CT angiography. Patients were randomly assigned (1:1) to receive intravenous nerinetide in a single dose of 2·6 mg/kg, up to a maximum dose of 270 mg, on the basis of estimated or actual weight (if known) or saline placebo by use of a real-time, dynamic, internet-based, stratified randomised minimisation procedure. Patients were stratified by intravenous alteplase treatment and declared endovascular device choice. All trial personnel and patients were masked to sequence and treatment allocation. All patients underwent endovascular thrombectomy and received alteplase in usual care when indicated. The primary outcome was a favourable functional outcome 90 days after randomisation, defined as a modified Rankin Scale (mRS) score of 0-2. Secondary outcomes were measures of neurological disability, functional independence in activities of daily living, excellent functional outcome (mRS 0-1), and mortality. The analysis was done in the intention-to-treat population and adjusted for age, sex, baseline National Institutes of Health Stroke Scale score, ASPECTS, occlusion location, site, alteplase use, and declared first device. The safety population included all patients who received any amount of study drug. This trial is registered with ClinicalTrials.gov, NCT02930018. FINDINGS: Between March 1, 2017, and Aug 12, 2019, 1105 patients were randomly assigned to receive nerinetide (n=549) or placebo (n=556). 337 (61·4%) of 549 patients with nerinetide and 329 (59·2%) of 556 with placebo achieved an mRS score of 0-2 at 90 days (adjusted risk ratio 1·04, 95% CI 0·96-1·14; p=0·35). Secondary outcomes were similar between groups. We observed evidence of treatment effect modification resulting in inhibition of treatment effect in patients receiving alteplase. Serious adverse events occurred equally between groups. INTERPRETATION: Nerinetide did not improve the proportion of patients achieving good clinical outcomes after endovascular thrombectomy compared with patients receiving placebo. FUNDING: Canadian Institutes for Health Research, Alberta Innovates, and NoNO.
Assuntos
Isquemia Encefálica/tratamento farmacológico , Fármacos Neuroprotetores/uso terapêutico , Peptídeos/uso terapêutico , Acidente Vascular Cerebral/tratamento farmacológico , Trombectomia , Doença Aguda , Idoso , Idoso de 80 Anos ou mais , Isquemia Encefálica/complicações , Proteína 4 Homóloga a Disks-Large/efeitos dos fármacos , Método Duplo-Cego , Procedimentos Endovasculares , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Fármacos Neuroprotetores/efeitos adversos , Peptídeos/efeitos adversos , Acidente Vascular Cerebral/etiologia , Resultado do TratamentoRESUMO
BACKGROUND: To determine the clinical outcomes of perimesencephalic subarachnoid hemorrhages based on the computed tomography (CT) bleeding patterns. METHODS: This retrospective cohort study included: (1) patients (≥18 years) admitted to a comprehensive stroke center (January 2015-May 2018), (2) with angiography-negative, nontraumatic subarachnoid hemorrhage in a perimesencephalic or diffuse bleeding pattern, and (3) had CT imaging performed in ≤ 72 hours of symptom onset. Patients were stratified by location of bleeding on CT: Peri-1: focal prepontine hemorrhage; Peri-2: prepontine with suprasellar cistern +/- intraventricular extension; and diffuse. RESULTS: Of the 39 patients included, 13 were Peri-1, 11 were Peri-2, and 15 were diffuse. The majority were male (nâ¯=â¯26), with a mean (standard deviation) age of 55.3 (11.3) years, who often presented with headache (nâ¯=â¯37) and nausea (nâ¯=â¯28). Overall, patients in Peri-1 were significantly less likely to have hydrocephalus compared to Peri-2 and dSAH (P= .003), and 4 patients required an external ventricular drain. Five patients developed symptomatic vasospasm. Patients in Peri-1, compared to Peri-2 and diffuse, had a significantly shorter median neuro critical care unit length of stay (LOS) and hospital LOS. Most patients (nâ¯=â¯35) had a discharge modified Rankin Score between 0 and 2 with no significant differences found between groups. CONCLUSION: These data suggest that patients with the best clinical course were those in Peri-1, followed by Peri-2, and then diffuse. Because these patients often present with similar clinical signs, stratifying by hemorrhage pattern may help clinicians predict which patients with perimesencephalic subarachnoid hemorrhage develop complications.