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Prospective, multicenter, single-arm study of mechanical thrombectomy using Solitaire Flow Restoration in acute ischemic stroke.

ABSTRACT: Mechanical thrombectomy using stent retriever devices have been advocated to increase revascularization in intracranial vessel occlusion. We present the results of a large prospective study on the use of the Solitaire Flow Restoration in patients with acute ischemic stroke.Solitaire Flow Restoration Thrombectomy for Acute Revascularization was an international, multicenter, prospective, single-arm study of Solitaire Flow Restoration thrombectomy in patients with large vessel anterior circulation strokes treated within 8 hours of symptom onset. Strict criteria for site selection were applied. The primary end point was the revascularization rate (thrombolysis in cerebral infarction ?2b) of the occluded vessel as determined by an independent core laboratory. The secondary end point was the rate of good functional outcome (defined as 90-day modified Rankin scale, 0-2).A total of 202 patients were enrolled across 14 comprehensive stroke centers in Europe, Canada, and Australia. The median age was 72 years, 60% were female patients. The median National Institute of Health Stroke Scale was 17. Most proximal intracranial occlusion was the internal carotid artery in 18%, and the middle cerebral artery in 82%. Successful revascularization was achieved in 79.2% of patients. Device and procedure-related severe adverse events were found in 7.4%. Favorable neurological outcome was found in 57.9%. The mortality rate was 6.9%. Any intracranial hemorrhagic transformation was found in 18.8% of patients, 1.5% were symptomatic.In this single-arm study, treatment with the Solitaire Flow Restoration device in intracranial anterior circulation occlusions results in high rates of revascularization, low risk of clinically relevant procedural complications, and good clinical outcomes in combination with low mortality at 90 days.http://www.clinicaltrials.gov. Unique identifier: NCT01327989.

SUBMITTER: Pereira VM

PROVIDER: S-EPMC4138310 | biostudies-literature | 2013 Oct

REPOSITORIES: biostudies-literature

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Prospective, multicenter, single-arm study of mechanical thrombectomy using Solitaire Flow Restoration in acute ischemic stroke.

Pereira Vitor M VM Gralla Jan J Davalos Antoni A Bonafé Alain A Castaño Carlos C Chapot René R Liebeskind David S DS Nogueira Raul G RG Arnold Marcel M Sztajzel Roman R Liebig Thomas T Goyal Mayank M Besselmann Michael M Moreno Antonio A Moreno Alfredo A Schroth Gerhard G

Stroke 20130801 10

<h4>Background and purpose</h4>Mechanical thrombectomy using stent retriever devices have been advocated to increase revascularization in intracranial vessel occlusion. We present the results of a large prospective study on the use of the Solitaire Flow Restoration in patients with acute ischemic stroke.<h4>Methods</h4>Solitaire Flow Restoration Thrombectomy for Acute Revascularization was an international, multicenter, prospective, single-arm study of Solitaire Flow Restoration thrombectomy in ...[more]

PMID: 23908066

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Project description:BackgroundEmergent large vessel occlusion (ELVO) strokes are devastating ischemic vascular events for which novel treatment options are needed. Using vascular cell adhesion molecule 1 (VCAM1) as a prototype, the objective of this study was to identify proteomic biomarkers and network signaling functions that are potential therapeutic targets for adjuvant treatment for mechanical thrombectomy.MethodsThe blood and clot thrombectomy and collaboration (BACTRAC) study is a continually enrolling tissue bank and registry from stroke patients undergoing mechanical thrombectomy. Plasma proteins from intracranial (distal to clot) and systemic arterial blood (carotid) were analyzed by Olink Proteomics for N=42 subjects. Statistical analysis of plasma proteomics used independent sample t tests, correlations, linear regression, and robust regression models to determine network signaling and predictors of clinical outcomes. Data and network analyses were performed using IBM SPSS Statistics, SAS v 9.4, and STRING V11.ResultsIncreased systemic (p<0.001) and intracranial (p=0.013) levels of VCAM1 were associated with the presence of hypertension. Intracranial VCAM1 was positively correlated to both infarct volume (p=0.032; r=0.34) and edema volume (p=0.026; r=0.35). The %∆ in NIHSS from admittance to discharge was found to be significantly correlated to both systemic (p=0.013; r = -0.409) and intracranial (p=0.011; r = -0.421) VCAM1 levels indicating elevated levels of systemic and intracranial VCAM1 are associated with reduced improvement of stroke severity based on NIHSS from admittance to discharge. STRING-generated analyses identified biologic functional descriptions as well as function-associated proteins from the predictive models of infarct and edema volume.ConclusionsThe current study provides novel data on systemic and intracranial VCAM1 in relation to stroke comorbidities, stroke severity, functional outcomes, and the role VCAM1 plays in complex protein-protein signaling pathways. These data will allow future studies to develop predictive biomarkers and proteomic targets for drug development to improve our ability to treat a devastating pathology.

Project description:BackgroundDysphagia is a frequent symptom in acute ischemic stroke (AIS). Endovascular treatment (EVT) has become the standard of care for acute stroke secondary to large vessel occlusion. Although standardized guidelines for poststroke dysphagia (PSD) management exist, they do not account for this setting in which patients receive EVT under general anesthesia. Therefore, the aim of this study was to evaluate PSD prevalence and severity, as well as an appropriate time point for the PSD evaluation, in patients undergoing EVT under general anesthesia (GA).MethodsWe prospectively included 54 AIS patients undergoing EVT under GA. Fiberoptic Endoscopic Evaluation of Swallowing (FEES) was performed within 24 h post-extubation in all patients. Patients presenting significant PSD received a second FEES-assessment to determine the course of dysphagia deficits over time. Dysphagia severity was rated according the Fiberoptic Dysphagia Severity Scale (FEDSS).ResultsAt first FEES (FEES 1) assessment, performed in the median 13 h (IQR 5-17) post-extubation, 49/54 patients (90.7%) with dysphagia were observed with a median FEDSS of 4 (IQR 3-6). Severe dysphagia requiring tube feeding was identified in 28/54 (51.9%) subjects, whereas in 21 (38.9%) patients early oral diet with certain food restrictions could be initiated. In the follow up FEES examination conducted in the median 72 h (IQR 70-97 h) after initial FEES 34/49 (69.4%) patients still presented PSD. Age (p = 0.030) and ventilation time (p = 0.035) were significantly associated with the presence of PSD at the second FEES evaluation. Significant improvement of dysphagia frequency (p = 0.006) and dysphagia severity (p = 0.001) could be detected between the first and second dysphagia assessment.ConclusionsPSD is a frequent finding both immediately within 24 h after extubation, as well as in the short-term course. In contrast to common clinical practice, to delay evaluation of swallowing for at least 24 h post-extubation, we recommend a timely assessment of swallowing function after extubation, as 50% of patients were safe to begin oral intake. Given the high amount of severe dysphagic symptoms, we strongly recommend application of instrumental swallowing diagnostics due to its higher sensitivity, when compared to clinical swallowing examination. Furthermore, advanced age, as well as prolonged intubation, were identified as significant predictors for delayed recovery of swallowing function.

Dataset Information

Prospective, multicenter, single-arm study of mechanical thrombectomy using Solitaire Flow Restoration in acute ischemic stroke.

Publications

Prospective, multicenter, single-arm study of mechanical thrombectomy using Solitaire Flow Restoration in acute ischemic stroke.

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