OBJECTIVE: To evaluate the effectiveness and safety of sonolysis using a low intensity 2 MHz pulsed wave ultrasound beam during carotid endarterectomy. DESIGN: Multicentre, phase 3, double blind, randomised controlled trial. SETTING: 16 European centres. PARTICIPANTS: 1004 patients (mean age 68 years; 312 (31%) female) were enrolled in the study between 20 August 2015 and 14 October 2020 until the interim analysis was performed. INTERVENTIONS: Sonolysis (n=507) versus sham procedure (n=497). MAIN OUTCOME MEASURES: The primary endpoint was the composite incidence of ischaemic stroke, transient ischaemic attack, and death within 30 days. The incidence of new ischaemic lesions on follow-up brain magnetic resonance imaging was the main substudy endpoint, and incidence of intracranial bleeding was the main safety endpoint. RESULTS: The results favoured the sonolysis group for the primary endpoint (11 (2.2%) v 38 (7.6%); risk difference -5.5%, 95% confidence interval (CI) -8.3% to -2.8%; P<0.001), as well as in the substudy for magnetic resonance imaging detected new ischaemic lesions (20/236 (8.5%) v 39/224 (17.4%); risk difference -8.9%, -15% to -2.8%; P=0.004). Sensitivity analysis resulted in a risk ratio for sonolysis of 0.25 (95% CI 0.11 to 0.56) for ischaemic stroke and 0.23 (0.07 to 0.73) for transient ischaemic attack within 30 days. Sonolysis was found to be safe, and 94.4% of patients in the sonolysis group were free from serious adverse events 30 days after the procedure. CONCLUSION: Sonolysis was safe for patients undergoing carotid endarterectomy and resulted in a significant reduction in the composite incidence of ischaemic stroke, transient ischaemic attack, and death within 30 days. TRIAL REGISTRATION: Clinicaltrials.gov NCT02398734.

• MeSH
• dvojitá slepá metoda MeSH
• ischemická cévní mozková příhoda epidemiologie   prevence a kontrola   etiologie   MeSH
• karotická endarterektomie * metody   škodlivé účinky   MeSH
• lidé středního věku MeSH
• lidé MeSH
• magnetická rezonanční tomografie MeSH
• senioři MeSH
• stenóza arteria carotis * chirurgie   terapie   MeSH
• tranzitorní ischemická ataka epidemiologie   etiologie   prevence a kontrola   MeSH
• ultrazvuková terapie * metody   škodlivé účinky   MeSH
• výsledek terapie MeSH
• Check Tag
• lidé středního věku MeSH
• lidé MeSH
• mužské pohlaví MeSH
• senioři MeSH
• ženské pohlaví MeSH
• Publikační typ
• časopisecké články MeSH
• klinické zkoušky, fáze III MeSH
• multicentrická studie MeSH
• randomizované kontrolované studie MeSH
• Geografické názvy
• Evropa epidemiologie   MeSH

BACKGROUND: Carotid endarterectomy (CEA) is a beneficial procedure for selected patients with an internal carotid artery (ICA) stenosis. Surgical risk of CEA varies from between 2 and 15%. The aim of the study is to demonstrate the safety and effectiveness of sonolysis (continual transcranial Doppler monitoring, TCD) using a 2-MHz diagnostic probe with maximal diagnostic energy on the reduction of the incidence of stroke, transient ischemic attack (TIA) and brain infarction detected using magnetic resonance imaging (MRI) by the activation of the endogenous fibrinolytic system during CEA. METHODS/DESIGN: Design: a multicenter, randomized, double-blind, sham-controlled trial. SCOPE: international, multicenter trial for patients with at least 70% symptomatic or asymptomatic ICA stenosis undergoing CEA. INCLUSION CRITERIA: patients with symptomatic or asymptomatic ICA stenosis of at least 70% are candidates for CEA; a sufficient temporal bone window for TCD; aged 40-85 years, functionally independent; provision of signed informed consent. Randomization: consecutive patients will be assigned to the sonolysis or control (sham procedure) group by computer-generated 1:1 randomization. Prestudy calculations showed that a minimum of 704 patients in each group is needed to reach a significant difference with an alpha value of 0.05 (two-tailed) and a beta value of 0.8 assuming that 10% would be lost to follow-up or refuse to participate in the study (estimated 39 endpoints). ENDPOINTS: the primary endpoint is the incidence of stroke or TIA during 30 days after CEA and the incidence of new ischemic lesions on brain MRI performed 24 h after CEA in the sonolysis and control groups. Secondary endpoints are occurrence of death, any stroke, or myocardial infarction within 30 days, changes in cognitive functions 1 year post procedure related to pretreatment scores, and number of new lesions and occurrence of new lesions ≥0.5 mL on post-procedural brain MRI. ANALYSIS: descriptive statistics and linear/logistic multiple regression models will be performed. Clinical relevance will be measured as relative risk reduction, absolute risk reduction and the number needed to treat. DISCUSSION: Reduction of the periprocedural complications of CEA using sonolysis as a widely available and cheap method may significantly increase the safety of CEA and extend the indication criteria for CEA. TRIAL REGISTRATION: ClinicalTrials.gov, NCT02398734 . Registered on 20 March 2015.

• Klíčová slova
• Brain infarction, Carotid, Endarterectomy, Sonolysis, Stroke,
• MeSH
• arteria carotis interna diagnostické zobrazování   chirurgie   MeSH
• časové faktory MeSH
• cerebrální infarkt diagnostické zobrazování   etiologie   prevence a kontrola   MeSH
• dospělí MeSH
• dvojitá slepá metoda MeSH
• fibrinolýza * MeSH
• karotická endarterektomie * škodlivé účinky   MeSH
• klinické protokoly MeSH
• lidé středního věku MeSH
• lidé MeSH
• magnetická rezonanční tomografie MeSH
• prediktivní hodnota testů MeSH
• rizikové faktory MeSH
• senioři nad 80 let MeSH
• senioři MeSH
• stenóza arteria carotis krev   komplikace   diagnostické zobrazování   chirurgie   MeSH
• ultrasonografie dopplerovská transkraniální * MeSH
• ultrazvuková terapie metody   MeSH
• výsledek terapie MeSH
• výzkumný projekt MeSH
• Check Tag
• dospělí MeSH
• lidé středního věku MeSH
• lidé MeSH
• mužské pohlaví MeSH
• senioři nad 80 let MeSH
• senioři MeSH
• ženské pohlaví MeSH
• Publikační typ
• časopisecké články MeSH
• multicentrická studie MeSH
• práce podpořená grantem MeSH
• randomizované kontrolované studie MeSH
• Geografické názvy
• Česká republika MeSH

Here, we examined whether intraoperative sonolysis can alter the risk of new ischemic lesions in the insonated brain artery territory during coronary artery bypass grafting (CABG) or valve surgery.Silent brain ischemic lesions could be detected in as many as two-thirds of patients after CABG or valve surgery.Patients indicated for CABG or valve surgery were allocated randomly to sonolysis (60 patients, 37 males; mean age, 65.3 years) of the right middle cerebral artery (MCA) during cardiac surgery and control group (60 patients, 37 males; mean age, 65.3 years). Neurologic examination, cognitive function tests, and brain magnetic resonance imaging (MRI) were conducted before intervention as well as 24 to 72 hours and 30 days after surgery.New ischemic lesions on control diffusion-weighted MRI in the insonated MCA territory ≥0.5 mL were significantly less frequent in the sonolysis group than in the control group (13.3% vs 26.7%, P = 0.109). The sonolysis group exhibited significantly reduced median volume of new brain ischemic lesions (P = 0.026). Stenosis of the internal carotid artery ≥50% and smoking were independent predictors of new brain ischemic lesions ≥0.5 mL (odds ratio = 5.685 [1.272-25.409], P = 0.023 and 4.698 [1.092-20.208], P = 0.038, respectively). Stroke or transient ischemic attack occurred only in 2 control patients (P = 0.496). No significant differences were found in scores for postintervention cognitive tests (P > 0.05).This study provides class-II evidence that sonolysis during CABG or valve surgery reduces the risk of larger, new ischemic lesions in the brain.www.clinicaltrials.gov (NCT01591018).

• MeSH
• arteria cerebri media diagnostické zobrazování   MeSH
• difuzní magnetická rezonance MeSH
• kognitivní dysfunkce diagnóza   etiologie   prevence a kontrola   MeSH
• koronární bypass škodlivé účinky   MeSH
• lidé středního věku MeSH
• lidé MeSH
• mozkový infarkt diagnostické zobrazování   etiologie   prevence a kontrola   MeSH
• neuropsychologické testy MeSH
• neurozobrazování MeSH
• peroperační komplikace diagnostické zobrazování   etiologie   prevence a kontrola   MeSH
• prospektivní studie MeSH
• senioři MeSH
• ultrasonografie dopplerovská MeSH
• ultrazvuková terapie * MeSH
• Check Tag
• lidé středního věku MeSH
• lidé MeSH
• mužské pohlaví MeSH
• senioři MeSH
• ženské pohlaví MeSH
• Publikační typ
• časopisecké články MeSH
• randomizované kontrolované studie MeSH

BACKGROUND AND PURPOSE: Sonolysis is a new therapeutic procedure for arterial recanalization. The aim of this study was to confirm the safety and efficacy of endovascular sonolysis by using the EkoSonic Endovascular System in subjects with acute ischemic stroke. MATERIALS AND METHODS: Patients with acute ischemic stroke with occlusion of the middle cerebral artery or basilar artery were enrolled consecutively in this prospective study. The control group (44 MCA and 12 BA occlusions) was selected from historical controls. EkoSonic Endovascular System was started within 8 hours after stroke onset. The NIHSS score at hospital admission, after 24 hours, and at 7 days; arterial recanalization; early neurologic improvement; symptomatic intracerebral hemorrhage; and favorable 3-month clinical outcome defined as a modified Rankin Scale score of 0-2 were evaluated by statistical means. RESULTS: Fourteen patients (10 men; mean age, 65.1 ± 11.2 years; median NIHSS score, 16.5) underwent EkoSonic endovascular sonolysis. Arterial recanalization after endovascular treatment was achieved in 6 of 7 (85.7%) patients with MCA occlusion (4 complete recanalizations) and in all 7 (100%) patients with BA occlusion (6 complete recanalizations). No (0%) symptomatic intracerebral hemorrhage or periprocedural complications occurred. Seven (50%) patients were independent at 3 months (median mRS score, 2). Early neurologic improvement and favorable clinical outcome were significantly more frequent in patients with MCA occlusion undergoing EkoSonic endovascular sonolysis than in controls (100% and 71.4% versus 4.6% and 13.6% of patients; P = .0001 and P = .003, respectively). Three-month mortality was significantly lower in patients with BA occlusion undergoing EkoSonic endovascular sonolysis than in controls (0% versus 66.7% patients, P = .013). CONCLUSIONS: In this small study, EkoSonic endovascular sonolysis allowed safe and potentially effective revascularization in patients experiencing acute ischemic stroke.

• MeSH
• angioplastika metody   MeSH
• bezpečnost MeSH
• časové faktory MeSH
• cévní mozková příhoda terapie   MeSH
• endovaskulární výkony metody   MeSH
• fibrinolytika terapeutické užití   MeSH
• infarkt arteria cerebri media terapie   MeSH
• ischemie mozku terapie   MeSH
• lidé středního věku MeSH
• lidé MeSH
• mechanická trombolýza přístrojové vybavení   metody   MeSH
• míra přežití MeSH
• následné studie MeSH
• neurologické vyšetření MeSH
• obnova funkce fyziologie   MeSH
• prospektivní studie MeSH
• recidiva MeSH
• revaskularizace mozku přístrojové vybavení   metody   MeSH
• senioři nad 80 let MeSH
• senioři MeSH
• stenty MeSH
• studie případů a kontrol MeSH
• vertebrobazilární insuficience terapie   MeSH
• vibrace ultrazvukové přístrojové vybavení   metody   MeSH
• výsledek terapie MeSH
• Check Tag
• lidé středního věku MeSH
• lidé MeSH
• mužské pohlaví MeSH
• senioři nad 80 let MeSH
• senioři MeSH
• ženské pohlaví MeSH
• Publikační typ
• časopisecké články MeSH
• práce podpořená grantem MeSH
• srovnávací studie MeSH
• Názvy látek
• fibrinolytika MeSH

D-dimers are one of the basic laboratory markers of fibrinolytic system activity. The aim of this prospective study was to detect changes in D-dimer levels in acute stroke patients as a function of the time of artery recanalization and the therapy used. During a 12-month period, 80 acute ischemic stroke patients admitted to the hospital within a 6-h time window were consecutively enrolled in the study. The clinical neurologic examination, brain computed tomography, neurosonologic examination, and biochemical and hematological blood tests (including D-dimers and fibrinogen) were performed on all patients on admission. The control examinations of D-dimer and fibrinogen blood levels were performed 3 (optional), 6, and 24 h after stroke onset. The Mann-Whitney test, Kruskal-Wallis test, ANOVA test, multiple comparison test, and Pearson test were used for statistical evaluation. Application of intravenous thrombolysis significantly increased the D-dimer levels and decreased the fibrinogen level 6 h after stroke onset in comparison with patients treated with antiplatelets or anticoagulants (P < 0.01), with normalization of blood levels over a 24 h period. The use of sonothrombotripsy showed a tendency to increase the D-dimer levels (P = 0.09) with a significant decrease of the fibrinogen level 6 h after stroke onset (P < 0.05). A significant increase in the D-dimer levels was detected in patients with strokes of cardioembolic and atherothrombotic etiologies, and patients with occlusion of cervical or large intracranial arteries (P < 0.05). There was no correlation between the changes in D-dimer or fibrinogen levels and age, gender, time to artery recanalization, risk factors, and the seriousness of neurologic deficits on admission (P > 0.05). D-dimer levels significantly increased during the first 6 h after stroke onset in patients with large artery occlusion and patients treated using intravenous thrombolysis. However, this increase was independent on the time of artery recanalization thus cannot be used as its marker.

• MeSH
• akutní nemoc MeSH
• biologické markery analýza   krev   MeSH
• časové faktory MeSH
• cévní mozková příhoda * krev   chirurgie   MeSH
• dospělí MeSH
• fibrin-fibrinogen - produkty degradace analýza   MeSH
• intrakraniální arteriální nemoci * krev   chirurgie   MeSH
• ischemie mozku * krev   chirurgie   MeSH
• lidé středního věku MeSH
• lidé MeSH
• prediktivní hodnota testů MeSH
• senioři nad 80 let MeSH
• senioři MeSH
• Check Tag
• dospělí MeSH
• lidé středního věku MeSH
• lidé MeSH
• mužské pohlaví MeSH
• senioři nad 80 let MeSH
• senioři MeSH
• ženské pohlaví MeSH
• Publikační typ
• časopisecké články MeSH
• klinické zkoušky MeSH
• multicentrická studie MeSH
• práce podpořená grantem MeSH
• srovnávací studie MeSH
• Názvy látek
• biologické markery MeSH
• fibrin fragment D MeSH Prohlížeč
• fibrin-fibrinogen - produkty degradace MeSH