SummaryBackgroundStents are an alternative treatment to carotid endarterectomy for symptomatic carotid stenosis, but previous trials have not established equivalent safety and efficacy. We compared the safety of carotid artery stenting with that of carotid endarterectomy.MethodsThe International Carotid Stenting Study (ICSS) is a multicentre, international, randomised controlled trial with blinded adjudication of outcomes. Patients with recently symptomatic carotid artery stenosis were randomly assigned in a 1:1 ratio to receive carotid artery stenting or carotid endarterectomy. Randomisation was by telephone call or fax to a central computerised service and was stratified by centre with minimisation for sex, age, contralateral occlusion, and side of the randomised artery. Patients and investigators were not masked to treatment assignment. Patients were followed up by independent clinicians not directly involved in delivering the randomised treatment. The primary outcome measure of the trial is the 3-year rate of fatal or disabling stroke in any territory, which has not been analysed yet. The main outcome measure for the interim safety analysis was the 120-day rate of stroke, death, or procedural myocardial infarction. Analysis was by intention to treat (ITT). This study is registered, number ISRCTN25337470.FindingsThe trial enrolled 1713 patients (stenting group, n=855; endarterectomy group, n=858). Two patients in the stenting group and one in the endarterectomy group withdrew immediately after randomisation, and were not included in the ITT analysis. Between randomisation and 120 days, there were 34 (Kaplan-Meier estimate 4·0%) events of disabling stroke or death in the stenting group compared with 27 (3·2%) events in the endarterectomy group (hazard ratio [HR] 1·28, 95% CI 0·77–2·11). The incidence of stroke, death, or procedural myocardial infarction was 8·5% in the stenting group compared with 5·2% in the endarterectomy group (72 vs 44 events; HR 1·69, 1·16–2·45, p=0·006). Risks of any stroke (65 vs 35 events; HR 1·92, 1·27–2·89) and all-cause death (19 vs seven events; HR 2·76, 1·16–6·56) were higher in the stenting group than in the endarterectomy group. Three procedural myocardial infarctions were recorded in the stenting group, all of which were fatal, compared with four, all non-fatal, in the endarterectomy group. There was one event of cranial nerve palsy in the stenting group compared with 45 in the endarterectomy group. There were also fewer haematomas of any severity in the stenting group than in the endarterectomy group (31 vs 50 events; p=0·0197).InterpretationCompletion of long-term follow-up is needed to establish the efficacy of carotid artery stenting compared with endarterectomy. In the meantime, carotid endarterectomy should remain the treatment of choice for patients suitable for surgery.FundingMedical Research Council, the Stroke Association, Sanofi-Synthélabo, European Union.
Myocarditis encompasses both primary and secondary processes causing inflammation of the myocardium. Viral infections are a common secondary cause of myocarditis with important clinical relevance. Viral myocarditis has a varied clinical presentation, potentially resulting in significant morbidity and mortality. Acutely, systolic dysfunction and sudden cardiac death may ensue; chronically, myocarditis may result in a dilated cardiomyopathy requiring heart transplantation. Myocarditis is thought to be one of the most common causes of myocardial infarction with nonobstructive coronary arteries (MINOCA), with important consequences for cardiovascular outcomes. Patients with myocarditis are currently underdiagnosed. Cardiac MRI has evolved as the noninvasive test of choice, with cardiac MRI‐specific diagnostic requirements defined in the Lake Louise Criteria (LLC). Detecting the presence of tissue edema, hyperemia, and necrosis in both acute and chronic stages form the foundation of the LLC. Cardiac MR for chronic myocarditis (greater than 8 weeks from symptom onset) has decreased sensitivity for diagnosis. Emerging sequences such as T1 and T2 parametric maps provide tissue characterization regarding inflammation without reliance on reference tissue, overcoming limitations of the LLC. Beyond diagnostic criteria, these imaging techniques have proven useful in further characterizing the diseased tissue, prognostication, and clinical decision‐making. This review describes the utility and evolving use of cardiac MRI in clinical practice. Level of Evidence: 1 Technical Efficacy Stage: 5 J. Magn. Reson. Imaging 2018;47:1061–1071.
Objective:Commotio cordis, sudden death with chest impact, occurs clinically despite chest wall protectors worn in sports. In an experimental model of commotio cordis, commercially available chest wall protectors failed to prevent ventricular fibrillation (VF). The goal of the current investigation was to develop a chest wall protector effective in the prevention of commotio cordis.Design:In the Tufts experimental model of commotio cordis the ability of chest protectors to prevent VF was assessed. Impacts were delivered with a 40-mph lacrosse ball, timed to the vulnerable period for VF.Intervention:A chest wall protector or no chest wall protector (control) was randomly assigned to be placed over the chest. Four iterative series of 2 to 4 different chest wall material combinations were assessed. Materials included 3 different foams (Accelleron [Unequal Technologies, Glen Mills, PA], closed cell high density foam; Airilon [Unequal Technologies, Glen Mills, PA], closed cell low density soft foam; and an open cell memory foam) that were adhered to a layer of TriDur (Unequal Technologies, Glen Mills, PA), a flexible elastomeric coated aramid that was bonded to a semirigid polypropylene polymer (ImpacShield, Unequal Technologies, Glen Mills, PA).Main Outcome Measure:Induction of VF by chest wall impact was the primary outcome.Results:Of 80 impacts without chest protectors, 43 (54%) resulted in VF. Ventricular fibrillation with chest protectors ranged from a high of 60% to a low of 5%. Of 12 chest protectors assessed, only 3 significantly lowered the risk of VF compared with impacts without chest protectors. These 3 chest protectors were combinations of Accelleron, Airilon, TriDur, and ImpacShield of different thicknesses. Protection increased linearly with the thicker combinations.Conclusions:Effective protection against VF with chest wall protection can be achieved in an experimental model of commotio cordis.Clinical Relevance:Chest protector designs incorporating these novel materials will likely be effective in the prevention of commotio cordis on the playing field.
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