Introduction Recurrent vasovagal syncope (VVS) is associated with decreased quality-of-life and frequent use of emergency services. The evidence base for causality, diagnostic procedures and potential VVS treatments is poor. Scattered observations in the literature suggest a link between respiratory disturbances during sleep and VVS. Empirical observations lead us to further hypothesise that the appropriate management of sleep apnoea syndrome (SAS) may help resolve comorbid recurrent VVS in certain patients. We therefore designed this pilot study to provide a framework for the observation of changes in outcomes accompanying the deployment of SAS treatments in patients with VVS. Methods and analysis This is a multicentre, registry-based study whose primary objective is to evaluate the effect of SAS management on the number of syncope/presyncope episodes in a population suffering from both VVS and SAS. To this effect, syncope rates prior to the treatment of SAS will be compared with those occurring after the initiation of the latter. In addition, yearly assessments will collect data for echocardiography, polysomnography, Holter monitoring, table tilt tests, multiple sleep latency tests, SAS management parameters and questionnaires describing fatigue, depression and quality-of-life. Sixty patients will be included with a minimum follow-up period of 12 months. The primary analysis will use comparisons of centrality for paired data to describe the changes in syncope rates before versus after the initiation of SAS management. Longitudinal data will be analysed using mixed models with patients set as a random effect. Subgroup analyses will be performed for SAS-treatment adherence and efficacy. Ethics and dissemination The VVS-SAS registry was approved by an ethics committee (Comité pour la Protection des Personnes Ile-de-France VI, Reference number CPP/2-18) in accordance with French law. The princeps publication will present before–after SAS management results and longitudinal analyses. Trial registration number NCT04294524 . Pre-results.
Abstract Background and Aims It has been reported that patients without standard modifiable cardiovascular (CV) risk factors (SMuRFs—diabetes, dyslipidaemia, hypertension, and smoking) presenting with first myocardial infarction (MI), especially women, have a higher in-hospital mortality than patients with risk factors, and possibly a lower long-term risk provided they survive the post-infarct period. This study aims to explore the long-term outcomes of SMuRF-less patients with stable coronary artery disease (CAD). Methods CLARIFY is an observational cohort of 32 703 outpatients with stable CAD enrolled between 2009 and 2010 in 45 countries. The baseline characteristics and clinical outcomes of patients with and without SMuRFs were compared. The primary outcome was a composite of 5-year CV death or non-fatal MI. Secondary outcomes were 5-year all-cause mortality and major adverse cardiovascular events (MACE—CV death, non-fatal MI, or non-fatal stroke). Results Among 22 132 patients with complete risk factor and outcome information, 977 (4.4%) were SMuRF-less. Age, sex, and time since CAD diagnosis were similar across groups. SMuRF-less patients had a lower 5-year rate of CV death or non-fatal MI (5.43% [95% CI 4.08–7.19] vs. 7.68% [95% CI 7.30–8.08], P = 0.012), all-cause mortality, and MACE. Similar results were found after adjustments. Clinical event rates increased steadily with the number of SMuRFs. The benefit of SMuRF-less status was particularly pronounced in women. Conclusions SMuRF-less patients with stable CAD have a substantial but significantly lower 5-year rate of CV death or non-fatal MI than patients with risk factors. The risk of CV outcomes increases steadily with the number of risk factors.
The efficacy and safety of catheter ablation of accessory pathways (AP) was studied in 79 children (age, 4-16 years), using DC shocks (n = 25) or radiofrequency energy (n = 54). All patients had documented arrhythmias including ventricular fibrillation in four. Organic heart disease was present in four patients. AP locations were left lateral (n = 36), posteroseptal (n = 36), right lateral (n = 8), Mahaim fibres (n = 2) and right anteroseptal (n = 6). Seven patients had multiple AP. One patient had a preexcitation which appeared secondary to an atrio-infundibular connection (Fontan procedure). The ablation site of concealed or overt AP was identified by retrograde or anterograde conduction mapping, respectively. A mean of 2.6 +/- 1 cathodal shocks (80-160 J) was delivered to 25 patients over 29 sessions, resulting in initial AP ablation in all. Fulguration was uncomplicated in all except in one patient (4%) who developed a secondary complete AV block post-ablation. During a follow-up period of 30-69 months, intermittent preexcitation recurred in two asymptomatic patients, but no significant tachycardia was inducible at late electrophysiological study, including under isoproterenol infusion. Radiofrequency energy was applied to 54 patients during 62 sessions, using 20-40 watts for 30-60 s. AP ablation was initially achieved in all patients using a median of three impulses, without significant immediate side-effects. Two patients (4%) developed a short episode of blurred vision possibly due to a microembolism. After discharge, the follow-up period was 10 +/- 5 months (range 1 to 24). All patients but one (98%) were asymptomatic without any drug therapy.(ABSTRACT TRUNCATED AT 250 WORDS)
Background: Ticagrelor is a P2Y12-receptor antagonist frequently used for dual antiplatelet therapy in coronary artery disease. Cheyne–Stokes respiration with central sleep apnea has been previously reported in 4 patients following ticagrelor introduction. Objective: To analyze in VigiBase, the reported cases of sleep apnea syndrome (SAS) among ticagrelor users compared to other antiplatelet agents. Methods: All cases of SAS and dyspnea associated to ticagrelor were extracted from VigiBase. A disproportionality analysis was performed by calculating the reporting odds ratio (ROR) in a case-noncase study to confirm the relationship between the use of ticagrelor and SAS or dyspnea compared to other drugs. A ROR>2 with a number of cases ≥5 is considered significant. Results: 28 cases of SAS and 2 665 of dyspnea were reported with ticagrelor. The RORs for ticagrelor were significant for SAS (ROR [95%CI] = 4.16 [2.87-6.03]) and for dyspnea (8.26 [7.92-8.62]). This relationship was not found for the other antiplatelet agents: clopidogrel, prasugrel or aspirin. Conclusion: The P2Y12 receptor is expressed in the central nervous system including in the respiratory centers. Ticagrelor by P2Y12 antagonism induces respiratory drive deregulations that might explain the occurrence of dyspnea and SAS. Further studies should investigate the exact incidence, the sustainability and consequences of ticagrelor-induced central sleep apnea.
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