Objective: The main limitations of the treatment with tissue plasminogen activator (tPA) include low recanalization efficacy and the risk of intracerebral hemorrhage. The aim of this study was to test new dosing of intravenous tPA. Methodology: This is a prospective, non-randomized open-label study with 3 groups of patients (n = 12) with acute ischemic stroke due to artery occlusion. Three dosing regimes of tPA were: 0.8 mg/kg/60 min; 1.0 mg/kg/90 min, and 1.2 mg/kg/120 min. during treatment, recanalization was monitored with transcranial color-coded sonography (TCCd). Thrombolytic treatment was to be if full recanalization was diagnosed. The primary safety endpoint was the incidence of sICH within 36 hours. The main efficiency endpoint was the rate of complete recanalization at 120 minutes after treatment initiation. Results: In the 0.8 mg/kg dose group, no recanalization was achieved in the first six patients and, therefore, recruitment was stopped due to a lack of efficacy. In the 1.0 mg/kg/90 min and 1.2 mg/kg/120 min groups, 12 patients were enrolled. In each of these cohorts, one complete recanalization was achieved and one sICH was diagnosed. In two patients (in the 1.2 mg/kg group), treatment was terminated after recanalization within 30 minutes but reocclusion occurred in one of them. Favorable outcome at three months was predicted by the baseline NIHSS (or 0.6, 95% CI 0.4–0.9) and systolic flow velocity in the affected artery at 120th minute (or 1.1, 95% CI 1.01–1.2). Conclusions: The aim of tPA treatment is to achieve adequate flow velocity in the affected artery but this objective was not achieved by a different tPA dosing. Autoři deklarují, že v souvislosti s předmětem studie nemají žádné komerční zájmy. The authors declare they have no potential conflicts of interest concerning drugs, products, or services used in the study. Redakční rada potvrzuje, že rukopis práce splnil ICMJE kritéria pro publikace zasílané do biomedicínských časopisů. The editorial Board declares that the manuscript met the ICMJe “uniform requirements” for biomedical papers. R. Mikulík1, M. Reif1, M. Bar2, D. Goldemund1, J. Brichta1, D. Školoudík2, M. Kuliha2, M. Roubec2 1 Mezinárodní centrum klinického výzkumu, Neurologická klinika FN u sv. Anny v Brně 2 Neurologická klinika FN ostrava * MUDr. Robert Mikulík, Ph.D. Mezinárodní centrum klinického výzkumu Neurologická klinika FN u sv. Anny Pekařská 53 656 91 Brno e-mail: mikulik@hotmail.com Přijato k recenzi: 11. 5. 2012 Přijato do tisku: 22. 6. 2012
Aim: The aim of the pilot study was to assess correlation between three diagnostic methods - contrast transesophageal echocardiography (cTEE), contrast transcranial Doppler (cTCD) and Flow detection system AnazenTM (FDS) - in detecting right-to-left shunts in young patients aged under 55 years with ischemic stroke or transient ischemic attack (TIA). Patients and methods: All consecutive patients presenting with acute ischemic stroke or TIA aged 18-55 years and able to perform sufficient Valsalva maneuver who signed informed consent were enrolled to the study from 8/2014 to 4/2015. Brain-computed tomography or magnetic resonance imaging as well as detection of right-to-left shunt using the cTEE, cTCD and FDS were performed in all patients after an onset of stroke/TIA. Correlations of the results between the methods and sensitivity, specificity, positive and negative predictive values of cTCD and FDS compared to cTEE as a gold standard were statistically evaluated. Results: In total, 30 patients (21 males, mean age 46.2 +/- 8.5 years) were included in the study. Right-to-left shunt was detected in the same eight (26.7%) patients using the cTEE and cTCD, and in one additional patient (totally nine, 30.0%) using FDS. Spearman's coefficient for cTEE and FDS was 0.92 and for cTEE and cTCD 1.00. Interclass correlation coefficient was 0.975. Sensitivity, specificity, positive and negative predictive values were 100%, 100%, 100%, 100%, respectively, for cTCD and 100%, 95.5%, 88.9%, 100%, respectively, for FDS. Conclusion: Correlation between cTCD and FDS as a new method with cTEE as a gold standard in right-to-left shunt detection appear to be high. Considering the ease of their use, both cTCD and FDS appear as suitable screening methods.
OBJECTIVE: To evaluate safety and efficacy of percutaneous transluminal angioplasty (PTA) and mechanical embolectomy (ME) in the treatment of acute middle cerebral artery occlusion (MCAo), including bridging therapy (intravenous thrombolysis [IVT] with subsequent endovascular treatment [EVT]). BACKGROUND: In the treatment of acute MCAo, IVT has only limited effectiveness, while EVT represents an alternative treatment method. EVT comprises also "older" PTA and "up-to-date" ME. Nevertheless, only limited data with controversial results is available regarding the comparison of their safety and efficacy (including bridging therapy). DESIGN/METHODS: In the retrospective study, data from the national multicenter registry of cerebral mechanical recanalizations was analyzed. The set consisted of 126 acute ischemic stroke patients (64 males; mean age 68.0 ± 13.3 years) with radiologically confirmed MCAo. Following data was collected: baseline characteristics, risk factors, pre-event treatment with antithrombotics, treatment with statins, neurologic deficit at time of treatment, time to therapy, recanalization rate (with successful recanalization defined as Thrombolysis in Cerebral Infarction score 2-3), post-treatment imaging findings. 90-day outcome was assessed using modified Rankin scale with good clinical outcome defined as 0-2 points. RESULTS: Good 90-day clinical outcome was achieved more frequently in patients treated with ME+IVT (56.4[percnt]) than with PTA+IVT (33.3[percnt]) (p=0.04). Other differences found between the particular groups (PTA, ME, PTA+IVT, ME+IVT) were not statistically significant: successful recanalization in 89.1[percnt], 93.1[percnt], 86.7[percnt] and 91.4[percnt], resp., and good 90-day clinical outcome in 41.1[percnt], 51.0[percnt], 33.3[percnt] and 56.4[percnt], resp. (p>0.05 in all cases). CONCLUSIONS: Data from this national multicenter registry showed that both PTA and ME represent safe and effective recanalization methods of acute MCAo. Bridging therapy was associated with better clinical outcome in the case of ME+IVT than PTA+IVT combination. Study Supported by: the grants of the Internal Grant Agency of Ministry of Health of the Czech Republic number NT/11046-6/2010, NT/11386-5/2010, NT/13498-4/2012, and NT/14288-3/2013.
AIMS:Previous case series have detected silent brain infarctions in as many as one-third of patients after carotid endarterectomy (CEA) and in up to two-thirds of patients after carotid angioplasty and stenting (CAS). Sonolysis employs ultrasound to facilitate disruption of thrombi and has been shown to be safe and effective for improving long-term outcomes following acute stroke. Here, we examined whether intraoperative sonolysis alters the risk of new brain ischaemic lesions during CEA or CAS. METHODS AND RESULTS:All consecutive patients with internal carotid stenosis ≥70% indicated for CEA/CAS were screened in this prospective study. Patients were allocated randomly to sonolysis and control groups. Neurological examination, cognitive function tests, and brain magnetic resonance imaging (MRI) were conducted before intervention and at 24 and 30 days post-surgery. Of the 487 screened patients, 121 (87 males; mean age, 66.65 ± 7.17 years) were allocated to the sonolysis group and 121 (75; 66.02 ± 8.11 years) to the control group. New brain ischaemic lesions on post-procedure MRI were significantly less frequent in the sonolysis group than in the control group (31.4% of patients vs. 47.1%; P = 0.018). Sonolysis and CEA were identified as independent predictors of reduced brain ischaemic risk [sonolysis: odds ratio (OR) = 0.450 (0.215-0.942), P = 0.034 and CEA: OR = 0.208 (0.087-0.495), P < 0.001]. Stroke or transient ischaemic attack occurred in one sonolysis patient and three control patients (P = 0.372). No significant group differences were found in post-intervention cognitive test scores (P > 0.3). CONCLUSION:This study provides Class II evidence that sonolysis during CEA or CAS reduces the risk of new brain ischaemic lesions. CLINICAL TRIAL REGISTRATION:http://www.clinicaltrials.gov (NCT01591005).
Background: Acute cerebral artery occlusion is the most common cause of ischemic stroke. Early recanalization is associated with a significantly higher chance of achieving patient self-sufficiency and reducing mortality. Over the recent years, pharmacological recanalization methods were joined by mechanical methods. The aim of the registry is to map geographic availability and to assess safety and efficacy of mechanical recanalization techniques in routine clinical practice. Methods: All consecutive acute ischemic stroke patients treated with mechanical recanalization techniques in selected comprehensive cerebrovascular and stroke centers in the Czech Republic have been prospectively registered. Demographic data, stroke severity, grade of recanalization, patient clinical outcome and frequency of symptomatic intracranial hemorrhage (SICH) were analyzed in the pilot study and are presented. Results: A total of 353 patients (210 men, mean age 66.0 +/- 13.1 years) with acute ischemic stroke and acute occlusion of the carotid or intracranial artery, treated using mechanical technique were consecutively registered to a multicentre registry between January 1, 2006 and September 21, 2014. The median of baseline NIHSS score was 16 points. Recanalization (TICI 2b-3) was achieved in 58.6% and self-sufficiency after three months (modified Rankin Scale, mRS 0-2) in 45.3% patients. SICH occurred in 4.2% patients and 3-month mortality was 26.1%. Conclusion:The organization of care for ischemic stroke patients in the Czech Republic is at a good level with availability of intravenous thrombolysis as well as mechanical recanalization methods. Endovascular procedures appear to be safe and highly effective with respect to arterial recanalization.
Background: Heart surgery is burdened with a significant risk of ischemic stroke. Asymptomatic cerebral infarctions can be detected in as many as 32% of patients after heart surgery. The aim of this study is to prove the efficacy of sonolysis (continual transcranial Doppler (TCD) monitoring) during open-heart surgery to decrease the risk of new brain infarctions detected by magnetic resonance imaging (MRI). Material and methods: Patients indicated to isolated coronary artery bypass or isolated one heart valve surgery were included in the study. Patients were randomized to a sonolysis group (TCD monitoring), and to a control group without sonolysis. All patients underwent brain MRI before and 24 hours after the surgery and the presence of new ischemic lesions was evaluated. Results: During 16 months, 78 patients (48 males, mean age 63.7 +/- 15.8 years) were enrolled to the study. Thirty five patients were randomized to the sonolysis group and 43 to the control group. In the sonolysis group, new brain infarctions were found in eight (23%) patients in the right (TCD-monitored) MCA territory in five patients (14%) but > 0.5 cm(3) in two (6%) patients only. In the control group, new infarctions were found in 10 patients (23%) in the right (TCD-monitored) MCA in eight (19%) patients and > 0.5 cm(3) in five (12 %) (p > 0.05 in all cases). Conclusion: Pilot study results showed a trend towards reduction in a number and volume of new brain ischemic lesions in patients treated with sonolysis during heart surgery.
BACKGROUND:Silent infarction in the brain can be detected in around 34 per cent of patients after carotid endarterectomy (CEA) and 54 per cent after carotid angioplasty and stenting (CAS). This study compared the risk of new infarctions in the brain in patients undergoing CEA or CAS.METHODS:Consecutive patients with internal carotid artery (ICA) stenosis exceeding 70 per cent were screened for inclusion in this prospective study. Patients with indications for intervention, and eligible for both methods, were allocated randomly to CEA or CAS. Neurological examination, cognitive function tests and MRI of the brain were undertaken before and 24 h after intervention.RESULTS:Of 150 randomized patients, 73 (47 men; mean age 64·9(7·1) years) underwent CEA and 77 (58 men; 66·4(7·5) years) had CAS. New infarctions on MRI were found more frequently after CAS (49 versus 25 per cent; P = 0·002). Lesion volume was also significantly greater after CAS (P = 0·010). Multiple logistic regression analyses identified intervention in the right ICA as the only independent predictor of brain infarction (odds ratio 2·10, 95 per cent c.i. 1·03 to 4·25; P = 0·040). Stroke or transient ischaemic attack occurred in one patient after CEA and in two after CAS. No significant differences were found in cognitive test results between the groups.CONCLUSION:These data confirm a higher risk of silent infarction in the brain on MRI after CAS in comparison with CEA, but without measurable change in cognitive function.REGISTRATION NUMBER:NCT01591005 ( http://www.clinicaltrials.gov).
withdrawn EP2212 The evaluation of aggregation activity of platelets in patients with ischemic stroke after i.v. thrombolysis and its influence on reocclusion after successful recanalization therapy M. Domashenko, M. Gafarova, M. Loskutnikov, A. Nikonov, M. Kostyreva, M. Maksimova Research Center of Neurology, Russian Academy of Medical Sciences, Moscow, Russian Federation Introduction: The i.v. thrombolysis is effective in selected patients with acute ischemic stroke (IS). However there is a high percent of reocclusion after successful recanalization therapy. The mechanisms of reocclusion and ways for its prevention are unclear. Methods: 60 patients (42 males; age 61±11 years, mean NIHSS 14±4) with IS were treated with i.v. rt-PA thrombolysis according to ESO recommendations. The recanalization and early reocclusion rates documented by MR angiography were 51.7% and 22.6%. 60 patients with IS (39 males; age 64±12 years; mean NIHSS 12±4) were included in the control group. We evaluated the ADPinduced (ADP-A) and adrenalin-induced (Adr-A) platelets’ aggregation 24 hours after stroke onset. Results: The ADP-A and Adr-A in patients after i.v. thrombolysis were 39.6±8.8% and 42.6±11.5%, greater than in patients of control group where ADP-A and Adr-A were 29.1±9.7% and 28.5±12.3% (p<0.05). The ADP-A and Adr-A in patients after i.v. thrombolysis with reocclusion were 45,9±10,5% and 47.1±14.2%, greater than in patients without reocclusion where ADP-A and Adr-A were 36.2±9.3% and 39.5±10.2% (p<0.05). Conclusions: We demonstrated the increase of platelets’ aggregation activity in patients after i.v. thrombolysis compared to control as well as in patients with reocclusion compared to those without reocclusion after i.v. thrombolysis. This may reflect the platelets’ activation after thrombolysis. Additional data is needed to prove the necessity for antiplatelet therapy earlier than 24 hours after i.v. thrombolysis. Disclosure: Nothing to disclose