Therapeutic use of ultrasound in patients with cerebrovascular diseases.

Background: Sonolysis is an important factor in therapeutic use of ultrasound in patients with cerebrovascular diseases, it is ultrasound induced lysis of thrombus or embolus. The aim of this work was to asses safety and efficacy of therapeutic ultrasound effect (sonolysis) in acute stroke patients and in patients undergoing carotid artery intervention. First partial aim of this work was to confirm the safety and efficacy of endovascular sonolysis by using the EkoSonic Endovascular System in subjects with acute ischemic stroke. Second partial aim of this work was to test the clinical efficacy of sonolysis for reducing the risk of incidence of new brain ischaemic lesions detected on brain magnetic resonance imaging in patients undergoing elective CEA or CAS for severe internal carotid stenosis. In addition, we assessed the effects of sonolysis on cognitive function, morbidity, and mortality at 30 days post-surgery. Methods: Patients with acute ischemic stroke and occlusion of the middle cerebral artery or basilar artery were enrolled consecutively to the prospective study tested safety and efficacy of endovascular sonolysis using the EkoSonic Endovascular System (EKOS) in patients with acute stroke. The control group (44 MCA and 12 BA occlusions) was selected from historical controls. EkoSonic...Úvod: Sonolýza patří k terapeutickým ultrazvukovým metodám. Jedná se o ultrazvukem navozenou lýzu trombu nebo trombembolu. Cílem této práce bylo ověřit bezpečnost a účinnost terapeutického vlivu ultrazvuku (sonolýzy) u pacientů s akutní cévní mozkovou příhodou a u pacientů podstupujících intervenční výkon na karotické tepně. Prvním dílčím cílem práce bylo zhodnotit bezpečnost a účinnost endovaskulární sonolýzy systémem EkoSonic Endovascular System (EKOS) u pacientů s akutní ischemickou cévní mozkovou příhodou. Druhým dílčím cílem bylo zhodnotit bezpečnost a účinnost transkraniální sonolýzy během intervenčního výkonu na redukci vzniku nových, ischemických mozkových infarktů, zobrazitelných pomocí magnetické rezonance mozku s posouzením vlivu na kognitivní funkce, u pacientů podstupujících karotickou endarterektomii nebo karotickou angioplastiku a stenting pro významnou stenózu vnitřní karotidy. Metodika: Do prospektivní studie testující bezpečnost a účinnost endovaskulární sonolýzy systémem EKOS u pacientů s akutní cévní mozkovou příhodou byli zařazováni pacienti s akutní cévní mozkovou příhodou s okluzí velké mozkové tepny (ACM nebo AB). Kontrolní skupina (44 ACM a 12 AB okluzí) byla vytvořena z historických kontrol. Terapie endovaskukární sonolýzou pomocí EkoSonic Endovascular Systému byla...Neurologická klinika 1. LF UK a VFN v PrazeDepartment of Neurology First Faculty of Medicine and General University Hospital in PragueFirst Faculty of Medicine1. lékařská fakult

Status Update and Interim Results from the Asymptomatic Carotid Surgery Trial-2 (ACST-2)

Objectives: ACST-2 is currently the largest trial ever conducted to compare carotid artery stenting (CAS) with carotid endarterectomy (CEA) in patients with severe asymptomatic carotid stenosis requiring revascularization. Methods: Patients are entered into ACST-2 when revascularization is felt to be clearly indicated, when CEA and CAS are both possible, but where there is substantial uncertainty as to which is most appropriate. Trial surgeons and interventionalists are expected to use their usual techniques and CE-approved devices. We report baseline characteristics and blinded combined interim results for 30-day mortality and major morbidity for 986 patients in the ongoing trial up to September 2012. Results: A total of 986 patients (687 men, 299 women), mean age 68.7 years (SD ± 8.1) were randomized equally to CEA or CAS. Most (96%) had ipsilateral stenosis of 70-99% (median 80%) with contralateral stenoses of 50-99% in 30% and contralateral occlusion in 8%. Patients were on appropriate medical treatment. For 691 patients undergoing intervention with at least 1-month follow-up and Rankin scoring at 6 months for any stroke, the overall serious cardiovascular event rate of periprocedural (within 30 days) disabling stroke, fatal myocardial infarction, and death at 30 days was 1.0%. Conclusions: Early ACST-2 results suggest contemporary carotid intervention for asymptomatic stenosis has a low risk of serious morbidity and mortality, on par with other recent trials. The trial continues to recruit, to monitor periprocedural events and all types of stroke, aiming to randomize up to 5,000 patients to determine any differential outcomes between interventions. Clinical trial: ISRCTN21144362. © 2013 European Society for Vascular Surgery. Published by Elsevier Ltd. All rights reserved

Therapeutic use of ultrasound in patients with cerebrovascular diseases.

Background: Sonolysis is an important factor in therapeutic use of ultrasound in patients with cerebrovascular diseases, it is ultrasound induced lysis of thrombus or embolus. The aim of this work was to asses safety and efficacy of therapeutic ultrasound effect (sonolysis) in acute stroke patients and in patients undergoing carotid artery intervention. First partial aim of this work was to confirm the safety and efficacy of endovascular sonolysis by using the EkoSonic Endovascular System in subjects with acute ischemic stroke. Second partial aim of this work was to test the clinical efficacy of sonolysis for reducing the risk of incidence of new brain ischaemic lesions detected on brain magnetic resonance imaging in patients undergoing elective CEA or CAS for severe internal carotid stenosis. In addition, we assessed the effects of sonolysis on cognitive function, morbidity, and mortality at 30 days post-surgery. Methods: Patients with acute ischemic stroke and occlusion of the middle cerebral artery or basilar artery were enrolled consecutively to the prospective study tested safety and efficacy of endovascular sonolysis using the EkoSonic Endovascular System (EKOS) in patients with acute stroke. The control group (44 MCA and 12 BA occlusions) was selected from historical controls. EkoSonic..

Second asymptomatic carotid surgery trial (ACST-2) : a randomised comparison of carotid artery stenting versus carotid endarterectomy

Background: Among asymptomatic patients with severe carotid artery stenosis but no recent stroke or transient cerebral ischaemia, either carotid artery stenting (CAS) or carotid endarterectomy (CEA) can restore patency and reduce long-term stroke risks. However, from recent national registry data, each option causes about 1% procedural risk of disabling stroke or death. Comparison of their long-term protective effects requires large-scale randomised evidence. Methods: ACST-2 is an international multicentre randomised trial of CAS versus CEA among asymptomatic patients with severe stenosis thought to require intervention, interpreted with all other relevant trials. Patients were eligible if they had severe unilateral or bilateral carotid artery stenosis and both doctor and patient agreed that a carotid procedure should be undertaken, but they were substantially uncertain which one to choose. Patients were randomly allocated to CAS or CEA and followed up at 1 month and then annually, for a mean 5 years. Procedural events were those within 30 days of the intervention. Intention-to-treat analyses are provided. Analyses including procedural hazards use tabular methods. Analyses and meta-analyses of non-procedural strokes use Kaplan-Meier and log-rank methods. The trial is registered with the ISRCTN registry, ISRCTN21144362. Findings: Between Jan 15, 2008, and Dec 31, 2020, 3625 patients in 130 centres were randomly allocated, 1811 to CAS and 1814 to CEA, with good compliance, good medical therapy and a mean 5 years of follow-up. Overall, 1% had disabling stroke or death procedurally (15 allocated to CAS and 18 to CEA) and 2% had non-disabling procedural stroke (48 allocated to CAS and 29 to CEA). Kaplan-Meier estimates of 5-year non-procedural stroke were 2·5% in each group for fatal or disabling stroke, and 5·3% with CAS versus 4·5% with CEA for any stroke (rate ratio [RR] 1·16, 95% CI 0·86-1·57; p=0·33). Combining RRs for any non-procedural stroke in all CAS versus CEA trials, the RR was similar in symptomatic and asymptomatic patients (overall RR 1·11, 95% CI 0·91-1·32; p=0·21). Interpretation: Serious complications are similarly uncommon after competent CAS and CEA, and the long-term effects of these two carotid artery procedures on fatal or disabling stroke are comparable