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INTRODUCTION: The optimal regional anticoagulation (RA) of dialysis filters in patients at risk of bleeding remains elusive. Inducing hypocalcemia within the filter by using a calcium-free dialysate has emerged as an easy-to-use heparin-free RA, including in critically ill patients, but comparative studies are lacking. METHODS: We conducted a multicentre, randomized, crossover trial to compare the efficacy and tolerance of two RAs (heparin-coated membrane (HCM) or calcium free dialysate with calcium reinjection according to ionic dialysance (CFD)) in patients requiring hemodialysis and at risk of bleeding. During the study period, each patient received two dialysis sessions (one with each RA in a randomly assigned order). The primary endpoint was the proportion of dialysis sessions completed (≥ 240 min). RESULTS: 94 patients were included in the intention-to-treat analysis, including 16 critically ill patients (17.0%). Coagulation and inflammation parameters, as well as hemodynamic status at baseline, were balanced between groups. Premature coagulation of the filter occurred in 19 HCM (20.9%) compared to 3 (3.2%) CFD sessions. In half of the sessions with premature termination, coagulation occurred before 180 minutes. The proportion of patients who completed the CFD session while failing to complete the HCM session (n = 17) was significantly higher than the proportion of patients who completed the HCM session while failing to complete the CFD session (n = 1; p < 0.001). Hemodynamic and metabolic tolerance were not different between groups. CONCLUSIONS: In individuals at risk of bleeding, RA with calcium-free dialysate significantly reduces the incidence of premature dialysis termination compared to heparin-coated membrane without safety concerns. Trial registration and statistical analysis plan: ClinicalTrials.gov identifier: NCT03842657.
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AIMS: Correlations between malignant ventricular arrhythmias and the COVID waves have never been investigated. METHODS AND RESULTS: Prevalence of malignant ventricular arrhythmias/sudden cardiac death has been correlated to the four COVID waves between the onset of pandemic and end 2021. No significant correlation was present in the temporal evolution of both COVID patients/positive tests and incidence of malignant ventricular arrhythmias, which tended to decrease after vaccination onset. CONCLUSION: We present evidence of complex higher-order periodicities and the co-existence of such regions with stable non-chaotic areas in ex vivo human hearts. We infer that the oscillation of the calcium cycling machinery is the primary mechanism of higher-order dynamics. These higher-order regions may act as niduses of instability and may provide targets for substrate-based ablation of VF.
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COVID-19 , Pandemias , Humanos , COVID-19/epidemiología , COVID-19/complicaciones , Arritmias Cardíacas/diagnóstico , Arritmias Cardíacas/epidemiología , Arritmias Cardíacas/etiología , Corazón , Muerte Súbita Cardíaca/epidemiologíaRESUMEN
OBJECTIVE: The aim of this study was to examine the external applicability of the COMPASS and the VOYAGER-PAD trials in patients with lower extremity artery disease (LEAD) in the real world. METHODS: This was a multicentre retrospective analysis of prospectively collected COPART data, a French multicentre registry of patients hospitalised for symptomatic LEAD. The proportion of patients eligible for the combination of rivaroxaban 2.5 mg twice daily plus aspirin based on either COMPASS or VOYAGER-PAD criteria is reported. The one year cumulative incidence of outcomes between eligible and non-eligible patients, as well as eligible patients vs. control arms of the COMPASS (LEAD patient subgroup) and the VOYAGER-PAD trials were compared. Analyses were performed using Cox models. RESULTS: Of 2 259 evaluable patients, only 679 (30.1%) were eligible for a low dose rivaroxaban plus aspirin regimen. Others were not eligible because of the need for anticoagulant (48.5% and 38.9% of patients meeting COMPASS and VOYAGER-PAD exclusion criteria, respectively) or dual antiplatelet therapy use (15.7% and 16.5%, respectively), high bleeding risk (14.4% and 11.6%, respectively), malignancy (26.1% and 21.0%, respectively), history of ischaemic/haemorrhagic stroke (21.1% and 19.8%, respectively), and severe renal failure (13.2% and 10.5%, respectively). COMPASS and VOYAGER-PAD eligible and ineligible patients were at higher risk of ischaemic events than participants in these trials. The one year cumulative incidences were 6.0% (95% CI 4.3 - 8.1) in the COMPASS eligible subset vs. 3.5% (95% CI 2.9 - 4.3) in the COMPASS control arm for major adverse cardiovascular events, and 27.9% (95% CI 19.9 - 38.3) in the VOYAGER-PAD eligible subset vs. 6.0% (95% CI 5.3 - 6.9) in the VOYAGER-PAD control arm for major adverse limb events. CONCLUSION: Many patients hospitalised for symptomatic LEAD in France are not eligible for the low dose rivaroxaban plus aspirin combination. In turn, those eligible may potentially have greater absolute benefit because of higher risk than those enrolled in the trials.
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Aspirina/uso terapéutico , Inhibidores del Factor Xa/uso terapéutico , Isquemia/prevención & control , Extremidad Inferior/irrigación sanguínea , Enfermedad Arterial Periférica/tratamiento farmacológico , Inhibidores de Agregación Plaquetaria/uso terapéutico , Rivaroxabán/uso terapéutico , Adolescente , Adulto , Anciano , Anciano de 80 o más Años , Esquema de Medicación , Quimioterapia Combinada , Femenino , Francia , Hospitalización , Humanos , Incidencia , Isquemia/epidemiología , Isquemia/etiología , Extremidad Inferior/patología , Masculino , Persona de Mediana Edad , Enfermedad Arterial Periférica/fisiopatología , Guías de Práctica Clínica como Asunto , Ensayos Clínicos Controlados Aleatorios como Asunto , Sistema de Registros , Estudios Retrospectivos , Resultado del Tratamiento , Adulto JovenRESUMEN
Increased fruit and vegetable (FV) intake is associated with reduced blood pressure (BP). However, it is not clear whether the effect of FV on BP depends on the type of FV consumed. Furthermore, there is limited research regarding the comparative effect of juices or whole FV on BP. Baseline data from a prospective cohort study of 10 660 men aged 50-59 years examined not only the cross-sectional association between total FV intake but also specific types of FV and BP in France and Northern Ireland. BP was measured, and dietary intake assessed using FFQ. After adjusting for confounders, both systolic BP (SBP) and diastolic BP (DBP) were significantly inversely associated with total fruit, vegetable and fruit juice intake; however, when examined according to fruit or vegetable sub-type (citrus fruit, other fruit, fruit juices, cooked vegetables and raw vegetables), only the other fruit and raw vegetable categories were consistently associated with reduced SBP and DBP. In relation to the risk of hypertension based on SBP >140 mmHg, the OR for total fruit, vegetable and fruit juice intake (per fourth) was 0·95 (95 % CI 0·91, 1·00), with the same estimates being 0·98 (95 % CI 0·94, 1·02) for citrus fruit (per fourth), 1·02 (95 % CI 0·98, 1·06) for fruit juice (per fourth), 0·93 (95 % CI 0·89, 0·98) for other fruit (per fourth), 1·05 (95 % CI 0·99, 1·10) for cooked vegetable (per fourth) and 0·86 (95 % CI 0·80, 0·91) for raw vegetable intakes (per fourth). Similar results were obtained for DBP. In conclusion, a high overall intake of fruit, vegetables and fruit juice was inversely associated with SBP, DBP and risk of hypertension, but this differed by FV sub-type, suggesting that the strength of the association between FV sub-types and BP might be related to the type consumed, or to processing or cooking-related factors.
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Presión Sanguínea , Dieta , Frutas , Infarto del Miocardio/epidemiología , Verduras , Citrus , Culinaria , Estudios Transversales , Francia , Frutas/clasificación , Jugos de Frutas y Vegetales , Humanos , Hipertensión/epidemiología , Hipertensión/prevención & control , Masculino , Persona de Mediana Edad , Irlanda del Norte , Oportunidad Relativa , Estudios Prospectivos , Verduras/clasificaciónRESUMEN
BACKGROUND: The main underlying risk factors associated with coronary heart disease (CHD) are modifiable and oxidative injury and systemic inflammatory damage represent key aetiological factors associated with the development and progression of CHD and premature mortality. OBJECTIVE: To examine associations of plasma antioxidant status with all-cause mortality and fatal or non-fatal cardiovascular events. DESIGN: The PRIME study prospectively evaluated 9709 men aged 50-59 years between 1991 and 1993 in Northern Ireland and France who were free of CHD at recruitment and followed annually for deaths and cardiovascular events for 10 years. Serum concentrations of vitamin C, retinol, two forms of vitamin E (α- and γ-tocopherol) and six carotenoids were quantified by high-performance liquid chromatography. Baseline conventional risk factors were considered, as well as socioeconomic differences and lifestyle behaviours including diet, smoking habit, physical activity, and alcohol consumption through Cox regression analyses. RESULTS: At 10 years, there were 538 deaths from any cause and 440 fatal or non-fatal cardiovascular events. After adjustment for country, age, systolic blood pressure, diabetes, body mass index, cholesterol, high density lipoprotein cholesterol, triglycerides, height, total physical activity, alcohol consumption and smoking habit, higher levels of all antioxidants were associated with significantly lower risk of all-cause mortality, with the exception of γ-tocopherol. Only retinol was significantly associated with decreased risk of cardiovascular events in a fully adjusted model. CONCLUSIONS: Low antioxidant levels contribute to the gradient of all-cause mortality and cardiovascular incidence independent of lifestyle behaviours and traditional cardiovascular and socioeconomic risk factors.
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Antioxidantes , Enfermedad Coronaria , Enfermedad Coronaria/epidemiología , Francia/epidemiología , Humanos , Masculino , Persona de Mediana Edad , Irlanda del Norte/epidemiología , Factores de RiesgoRESUMEN
BACKGROUND A small proportion of familial hypercholesterolemia (FH) patients can adequately control this condition, although achieving the recommended targets for low-density lipoprotein cholesterol (LDL-c) levels remains a challenge. Proprotein convertase subtilisin/kexin type 9 inhibitors (PCSK9i) are new and potent lipid-lowering drugs. However, there is scarce literature on real-world data about their use in patients with FH. MATERIAL AND METHODS We examined the reduction in LDL-c levels from the baseline, after PCSK9i initiation in heterozygous familial hypercholesterolemia patients referred for lipoprotein apheresis in our regional lipid clinic. The study was conducted from March 2018 to September 2019, the period immediately after PCSK9i reimbursement was available in France. PCSK9i was added on top of the patients' maximal tolerated lipid-lowering regimens. RESULTS The study had 123 patients with heterozygous FH. The mean age of the patients was 59±11 years. The mean baseline LDL-c for all the participants was 277±78 mg/dl. It was 283±81 mg/dl in the PCSK9i monotherapy group (n=83), 247±68 mg/dl in the PCSK9i plus ezetimibe group (n=12), and 264±78 mg/dl in the PCSK9i plus statin and ezetimibe group (n=28). The mean decrease observed in the LDL-c level from baseline was 136±70 mg/dl (n=123), 125±60 mg/dl (n=83), 103±77 mg/dl (n=12), and 175±70 mg/dl (n=28), respectively. CONCLUSIONS An overall reduction of 49.1% from the baseline LDL-c was observed in the heterozygous FH population after PCSK9i initiation in a real-world experience. The group treated with PCSK9i ezetimibe plus statin showed further reduction of their LDL-c levels with a better responder rate, achieving the target 50% reduction in LDL-c from the baseline.
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Hiperlipoproteinemia Tipo II/tratamiento farmacológico , Hipolipemiantes/uso terapéutico , Inhibidores de PCSK9 , Subtilisinas/uso terapéutico , Eliminación de Componentes Sanguíneos/métodos , LDL-Colesterol/metabolismo , Estudios de Cohortes , Femenino , Humanos , Inhibidores de Hidroximetilglutaril-CoA Reductasas/uso terapéutico , Hiperlipoproteinemia Tipo II/metabolismo , Metabolismo de los Lípidos/efectos de los fármacos , Lípidos , Lipoproteínas/metabolismo , Masculino , Persona de Mediana EdadRESUMEN
Ultra-high-density mapping allows very accurate characterization of circuits/mechanisms in atrial tachycardia (AT). Whether these advantages will translate into a better procedural or long-term clinical outcome is unknown. Sixty consecutive AT ablation procedures using ultra-high-density mapping (Rhythmia™, group 1) were retrospectively compared to 60 consecutive procedures using standard high-density mapping (Carto/NavX™, group 2) (total 209 AT, 79% left AT). A higher number of maps were performed in group 1 (4.8 ± 2.5 vs 3.2 ± 1.7, p = 0.0001) with similar acquisition duration (12 ± 5 vs 13 ± 6 min per map, p = ns), although with a greater number of activation points (10,543 ± 5854 vs 689 ± 1827 per map, p < 0.0001). AT location remained undetermined in 5 AT in group 1 vs 10 (p = 0.1). Mechanism remained undetermined in 5 AT from group 1 vs 11 (p = 0.06). Acute complete success was achieved in 77%, in both groups. At 1-year follow-up, AT recurred in 37% in group 1 vs 50% in group 2 (p = 0.046). There are less long-term recurrences after AT ablation using ultra-high-density mapping system compared to standard high-density 3D mapping, possibly because of a better comprehensive approach of AT mechanisms.
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Mapeo del Potencial de Superficie Corporal/instrumentación , Ablación por Catéter , Sistema de Conducción Cardíaco/cirugía , Taquicardia Supraventricular/diagnóstico , Taquicardia Supraventricular/cirugía , Anciano , Técnicas Electrofisiológicas Cardíacas , Femenino , Humanos , Modelos Logísticos , Masculino , Persona de Mediana Edad , Imagen Multimodal , Radiografía Intervencional , Recurrencia , Estudios Retrospectivos , Resultado del TratamientoRESUMEN
Aims: Very narrow QRS have been reported in sudden death survivors but prevalence and prognosis role of narrow QRS is unknown. Methods and results: 546 healthy men between 50 and 60 years (group 1) and 373 similar patients with coronary artery disease (368 men, group 2) underwent signal averaged ECG (SA-ECG) allowing precise measurement of QRS duration. All cause-mortality was determined after 18 ± 3 years follow-up. Mean QRS duration was 97 ± 13 ms in group 1 and 103 ± 16 ms in group 2. Tenth percentile was 84 ms in group 1 and 85 ms in group 2. All cause-mortality in group 1 was 10.4% (57/546): 6/85 in case of QRS <85 ms (7%) and 2/23 (9%) in case of QRS >120 ms (ns). HR for all-cause mortality was 0.75 (95% CI 0.32-1.76, P = 0.52) for QRS <85 ms and 0.86 (95% CI 0.21-3.53, P = 0.84) for QRS >120 ms. All cause mortality in group 2 was 29% (109/373): 7/44 in case of QRS <85 ms (16%) and 22/44 (50%) in case of QRS >120 ms (P = 0.002). HR for all-cause mortality was 0.65 (95% CI 0.29-1.45, P = 0.29) for QRS <85 ms and 1.73 (95% CI 1.02-2.94, P = 0.05) for QRS >120 ms. Conclusion: QRS duration <80-85 ms can be observed in a significant proportion of middle-aged healthy males and in similar patients with ischemic heart disease. Narrow QRS were not linked to prognosis in any group.
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Potenciales de Acción , Arritmias Cardíacas/epidemiología , Muerte Súbita Cardíaca/epidemiología , Sistema de Conducción Cardíaco/fisiopatología , Frecuencia Cardíaca , Isquemia Miocárdica/epidemiología , Arritmias Cardíacas/diagnóstico , Arritmias Cardíacas/mortalidad , Arritmias Cardíacas/fisiopatología , Estudios de Casos y Controles , Electrocardiografía , Francia/epidemiología , Humanos , Masculino , Persona de Mediana Edad , Isquemia Miocárdica/diagnóstico , Isquemia Miocárdica/mortalidad , Isquemia Miocárdica/fisiopatología , Irlanda del Norte/epidemiología , Prevalencia , Pronóstico , Estudios Prospectivos , Factores de Riesgo , Factores de TiempoRESUMEN
BACKGROUND: The role of occupational stressors (OS) on blood pressure (BP) is often suspected, but asserting its impact remains uncertain. Our goal was to evaluate their impact on BP increase and on incident cases of hypertension over a 5-year period. METHODS: One thousand, one hundred and fifty-six men and women from the French prospective VISAT study were followed up over five-years (T1 to T2). Exposures to a large panel of OS (physical, organizational, psychosocial and employment categories) were collected. Linear and logistic regressions were used to assess associations between OS and T2-T1 SBP difference and incident cases of hypertension. They were performed to determine the role of OS first considered separately, then in combination, in crude and adjusted models for main cardiovascular risk factors (gender, age, education, BMI, lifestyle habits and medical history). RESULTS: For initial SBP level < 130 mmHg, carrying loads, intense noise exposure, working more than 48 h/week, active and high strain tended to be associated with an SBP difference increase, while job recognition was associated with a decrease. After adjustment, only significant associations with job strain and job recognition persisted. For initial SBP level ≥ 130 mmHg, being exposed to an active job strain was positively associated with T2-T1 SBP difference only in unadjusted model. Considering all the OS, the recognition of completed tasks had a major protective role. No impact of OS on incident cases of hypertension was observed. CONCLUSION: Associations between OS and SBP were observed mainly when initial SBP is within the normal range, and are mainly explained by cardiovascular factors, requiring physician's particular attention to people exposed to these OS. VISAT study is registered in "LE PORTAIL EPIDEMIOLOGIE - FRANCE- AVIESAN -ID 3666".
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Presión Sanguínea , Hipertensión/epidemiología , Estrés Laboral/epidemiología , Adulto , Femenino , Estudios de Seguimiento , Francia/epidemiología , Humanos , Hipertensión/fisiopatología , Masculino , Persona de Mediana Edad , Estrés Laboral/fisiopatología , Lugar de TrabajoAsunto(s)
Derivación Portosistémica Intrahepática Transyugular/clasificación , Índice de Severidad de la Enfermedad , Anciano , Femenino , Humanos , Masculino , Persona de Mediana Edad , Intervención Coronaria Percutánea/métodos , Derivación Portosistémica Intrahepática Transyugular/métodos , Derivación Portosistémica Intrahepática Transyugular/mortalidadRESUMEN
BACKGROUND: Epidemiological and observational studies have established that high-density lipoprotein cholesterol (HDL-C) is an independent negative cardiovascular risk factor. However, simple measurement of HDL-C levels is no longer sufficient for cardiovascular risk assessment. Therefore, there is a critical need for novel non-invasive biomarkers that would display prognostic superiority over HDL-C. Cell surface ecto-F1-ATPase contributes to several athero-protective properties of HDL, including reverse cholesterol transport and vascular endothelial protection. Serum inhibitory factor 1 (IF1), an endogenous inhibitor of ecto-F1-ATPase, is an independent determinant of HDL-C associated with low risk of coronary artery disease (CAD). This work aimed to examine the predictive value of serum IF1 for long-term mortality in CAD patients. Its informative value was compared to that of HDL-C. METHOD: Serum IF1 levels were measured in 577 male participants with stable CAD (age 45-74 years) from the GENES (Genetique et ENvironnement en Europe du Sud) study. Vital status was yearly assessed, with a median follow-up of 11 years and a 29.5 % mortality rate. Cardiovascular mortality accounted for the majority (62.4 %) of deaths. RESULTS: IF1 levels were positively correlated with HDL-C (r s = 0.40; P < 0.001) and negatively with triglycerides (r s = -0.21, P < 0.001) and CAD severity documented by the Gensini score (r s = -0.13; P < 0.01). Total and cardiovascular mortality were lower at the highest quartiles of IF1 (HR = 0.55; 95 % CI, 0.38-0.89 and 0.50 (0.28-0.89), respectively) but not according to HDL-C. Inverse associations of IF1 with mortality remained significant, after multivariate adjustments for classical cardiovascular risk factors (age, smoking, physical activity, waist circumference, HDL-C, dyslipidemia, hypertension, and diabetes) and for powerful biological and clinical variables of prognosis, including heart rate, ankle-brachial index and biomarkers of cardiac diseases. The 10-year mortality was 28.5 % in patients with low IF1 (<0.42 mg/L) and 21.4 % in those with high IF1 (≥0.42 mg/L, P < 0.02). CONCLUSIONS: We investigated for the first time the relation between IF1 levels and long-term prognosis in CAD patients, and found an independent negative association. IF1 measurement might be used as a novel HDL-related biomarker to better stratify risk in populations at high risk or in the setting of pharmacotherapy.
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Enfermedad de la Arteria Coronaria/sangre , Enfermedad Coronaria/sangre , Proteínas/análisis , Anciano , Biomarcadores/sangre , HDL-Colesterol/metabolismo , Europa (Continente) , Humanos , Masculino , Persona de Mediana Edad , Mitocondrias/metabolismo , Pronóstico , Medición de Riesgo , Factores de Riesgo , Proteína Inhibidora ATPasaRESUMEN
BACKGROUND: Measurement of expired-air carbon monoxide (EACO) is commonly used to ascertain non-smoking status, although it can also reflect exposures not related to smoking. Our aim was to assess 16-year mortality according to EACO measured at baseline, in a general population. METHODS: Our analysis was based on the Third French MONICA population survey (1994-1997). Causes of death were obtained 16 years after inclusion, and assessment of determinants of mortality was based on Cox modeling. RESULTS: EACO was measured in 2232 apparently healthy participants aged 35-64. During follow-up, 195 deaths occurred (19% were due to cardio-vascular (CV) causes and 49% to cancer). At baseline, the mean EACO was 11.8 (±7.4)ppm, 4.6 (±2.5)ppm, 4.3 (±2.2)ppm for current, former and never smokers, respectively (P<0.001). After adjustment for main mortality risk factors and smoking, the hazard ratio (HR) for total mortality was 1.03[95% confidence interval: 1.01-1.06] per 1-unit increase in EACO, and it was 1.04[1.01-1.07] for cancer mortality. Adjusted HR for CV mortality was 1.05[1.01-1.10] but did not remain significant after additional adjustment for smoking (0.98[0.91-1.04]). Interactions between EACO and smoking were not significant. CONCLUSIONS: In a general population, baseline EACO is an independent predictor of 16-year all-cause and cancer mortality, after adjustment for confounders including smoking. Given that the effect of EACO is similar among smokers and non-smokers, EACO is probably not solely related to smoking but could also be a marker of inhaled ambient carbon monoxide and/or endogenous production. Besides, smoking better predicts CV mortality than EACO.
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Monóxido de Carbono/análisis , Enfermedades Cardiovasculares/mortalidad , Neoplasias/mortalidad , Adulto , Biomarcadores/sangre , Pruebas Respiratorias , Causas de Muerte , Femenino , Francia/epidemiología , Humanos , Masculino , Persona de Mediana Edad , Factores de Riesgo , Fumar/efectos adversos , Encuestas y CuestionariosRESUMEN
OBJECTIVE: Despite cardioprotective properties, studies investigating adiponectin as a cardiovascular disease marker led to conflicting results. We investigated in participants with stable coronary artery disease (CAD) and controls whether serum adiponectin was associated with long-term mortality, considering varying degrees of CAD severity. METHODS AND RESULTS: A case-control design with prospective median follow-up of 8.1 years was used. Survival rates among 715 CAD men (aged 45-74 years) in increasing quartiles of serum adiponectin values were 87.5%, 85.6%, 76.4%, and 67.6%, respectively (P<0.001). Survival rates in 782 controls with adiponectin <9.1 µg/mL and ≥9.1 µg/mL (third quartile) were 95.3% and 91.0%, respectively (P=0.035). Adiponectin concentration above the highest quartile was associated with an increased risk of total and cardiovascular disease mortality in CAD patients (P=0.001 and P=0.001) and controls (P=0.02 and P=0.004). The associations among high adiponectin, total mortality, and cardiovascular disease mortality remained significant after multivariate adjustments for metabolic, cardiac, and CAD severity variables. No significant interaction was found among CAD patients, controls, and the relationship of adiponectin with mortality. CONCLUSIONS: High serum adiponectin is a predictor of mortality, particularly from cardiovascular disease. This prognostic value remains significant whatever the severity of the CAD and the metabolic status and is not different among people with and without CAD.
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Adiponectina/sangre , Enfermedad de la Arteria Coronaria/sangre , Enfermedad de la Arteria Coronaria/mortalidad , Anciano , Biomarcadores/sangre , Estudios de Casos y Controles , Causas de Muerte , Distribución de Chi-Cuadrado , Enfermedad de la Arteria Coronaria/diagnóstico , Enfermedad de la Arteria Coronaria/fisiopatología , Progresión de la Enfermedad , Estudios de Seguimiento , Francia , Humanos , Estimación de Kaplan-Meier , Masculino , Persona de Mediana Edad , Análisis Multivariante , Pronóstico , Modelos de Riesgos Proporcionales , Estudios Prospectivos , Medición de Riesgo , Factores de Riesgo , Índice de Severidad de la Enfermedad , Factores de Tiempo , Regulación hacia ArribaRESUMEN
BACKGROUND: This phase II trial sought to be the first of its kind to estimate the success rate of endermology in reducing breast cancer-related lymphedema. PATIENTS AND METHODS: ELOCS is a French, monocentric, randomized, open-label phase II trial. Patients were randomized to receive the following over a 5-day treatment period: standard intensive decongestant treatment (IDT) (bandages and manual lymphatic drainage MLD) (group 1); IDT including bandages, MLD, and Cellu M6 (group 2); and IDT including bandages and Cellu M6 (Group 3). The main endpoint was the success rate in each group, (reduction of at least 30% in the excess volume). We estimated that endermology treatment (groups 2 and 3) would be of interest successes occurred in at least 21 out of 31 patients. RESULTS: A total of 93 patients were included (31 patients in each of the 3 groups). The median age was 64.5 years (IQR: [56.4-71.3]). Patients were treated with mastectomy (n = 35), axillary lymphadenectomy (n = 80), radiotherapy (n = 91), and chemotherapy (n = 68). The mean relative reduction in excess volume was 38% in group 1, 33% in group 2, and 34% in group 3. Success rate was 58.1% in group 1 (18/31, P = ,0237), 51.6% (16/31, P = ,5) in group 2, and 64.5% (20/31, P = ,075) in group 3. In the LPG groups (2 and 3), 10/62 (16%) patients found LPG painful and 9/62 (15%) patients considered it to be unpleasant. CONCLUSION: Even though the critical threshold of 21 successes was not met, this study was the first to validate a standardized and reproducible endermology protocol.
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Linfedema del Cáncer de Mama , Neoplasias de la Mama , Humanos , Femenino , Persona de Mediana Edad , Anciano , Neoplasias de la Mama/terapia , Neoplasias de la Mama/complicaciones , Neoplasias de la Mama/patología , Linfedema del Cáncer de Mama/terapia , Drenaje Linfático Manual/métodos , Mastectomía/efectos adversos , Escisión del Ganglio Linfático/efectos adversos , Vendajes , Resultado del Tratamiento , Linfedema/etiología , Linfedema/terapiaRESUMEN
BACKGROUND: The true incidence of sudden death remains undetermined, with controversial results from various publications over time and countries. AIM: To investigate if different estimations would reach the values usually reported for France. METHODS: Three different kinds of estimations were used. First, the number of resuscitated sudden deaths and necropsies for sudden death in the Haute-Garonne French administrative department (i.e. county) over the last 10years was expanded to the national level. Second, sudden death coding of death certificates was collected at the national level. Third, the total number of out-of-hospital cardiac arrests leading to any emergency call (with/without intervention) in Haute-Garonne over the last 10years was expanded to the national level. RESULTS: There was a mean of 26 resuscitated sudden deaths and 145 necropsies for sudden death each year in Haute-Garonne, i.e. 12 to 14 sudden deaths for 100,000 inhabitants, and 7700 to 9400 sudden deaths yearly when related to the whole French population, according to the year of inclusion. Based on death certificates, a mean of 6584 sudden deaths was registered each year in France. Finally, there were about 600 yearly calls/interventions for out-of-hospital cardiac arrests in Haute-Garonne, i.e. 40 to 50 sudden deaths for 100,000 inhabitants, and 16,000 to 27,000 sudden deaths yearly for the whole French territory, according to the year of inclusion. CONCLUSIONS: The incidence of sudden death ranges from 6500 to 27,000 in France according to the calculation methods. This huge difference raises the question of the true current incidence of sudden death, which may have been overestimated previously or may be underestimated in France. More straight prospective surveys are needed to solve this question, because of relevant implications for priorities that should be given to sudden death.
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Paro Cardíaco Extrahospitalario , Humanos , Paro Cardíaco Extrahospitalario/diagnóstico , Paro Cardíaco Extrahospitalario/epidemiología , Paro Cardíaco Extrahospitalario/terapia , Incidencia , Estudios Prospectivos , Muerte Súbita , Francia/epidemiología , Muerte Súbita Cardíaca/epidemiología , Muerte Súbita Cardíaca/prevención & controlRESUMEN
BACKGROUND: Because rotational atherectomy (RA) is associated with arterial trauma and platelet activation, patients treated with RA may benefit from more potent antiplatelet drugs. The aim of this trial was to assess the superiority of ticagrelor over clopidogrel in reducing post procedure troponin release. METHODS: TIRATROP (TIcagrelor in Rotational Atherectomy to reduce TROPonin enhancement) is a multicenter double-blind randomized controlled trial that included 180 patients with severe calcified lesions requiring RA who received either clopidogrel (300 mg loading dose, then 75 mg/d) or ticagrelor (loading dose 180 mg then 90 mg twice daily). Blood samples were collected at the beginning (T0), and 6, 12, 18, 24 and 36 h after the procedure. Primary end point was troponin release within the first 24 h using area under the curve analysis (troponin level as a function of time). RESULTS: The mean age of patients was 76 ± 10 years, 35% had diabetes. RA was used to treat 1, 2 or 3 calcified lesions in 72%, 23% and 5% of patients, respectively. Troponin release within the first 24 h was similar in both the ticagrelor (adjusted mean ±SD of ln AUC 8.85 ± 0.33) and the clopidogrel (8.77 ± 0.34, p = 0.60) arms. Independent predictors for troponin enhancement were acute coronary syndrome presentation, renal failure, elevated C-Reactive protein and multiple lesions treated with RA. CONCLUSION: Troponin release did not differ among treatment arms. Our results suggest that greater platelet inhibition does not affect periprocedural myocardial necrosis in the setting of RA.
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AIMS: Factors underlying clinical tolerance and hemodynamic consequences of monomorphic sustained ventricular tachycardia (VT) need to be clarified. METHODS: Intra-arterial pressures (IAP) during VT were collected in patients admitted for VT ablation and correlated to clinical, ECG and baseline echocardiographical parameters. RESULTS: 114 VTs from 58 patients were included (median 67 years old, 81% ischemic heart disease, median left ventricular ejection fraction 30%). 61 VTs were untolerated needing immediate termination (54%). VT tolerance was tightly linked to the evolution of IAPs. Faster VT rates (p<0.0001), presence of resynchronization therapy (p = 0.008), previous anterior myocardial infarction (p = 0.009) and more marginally larger baseline QRS duration (p = 0.1) were independently associated with VT tolerance. Only an inferior myocardial infarction was more often present in patients with only tolerated VTs vs patients with only untolerated VTs in multivariate analysis (OR 3.7, 95% CI 1.4-1000, p = 0.03). In patients with both well-tolerated and untolerated VTs, a higher VT rate was the only variable independently associated with untolerated VT (p = 0.02). Two different patterns of hemodynamic profiles during VT could be observed: a regular 1:1 relationship between electrical (QRS) and mechanical (IAP) events or some dissociation between both. VT with the second pattern were more often untolerated compared to the first pattern (78% vs 29%, p<0.0001). CONCLUSION: This study helps to explain the large variability in clinical tolerance during VT, which is clearly related to IAP. VT tolerance may be linked to resynchronization therapy, VT rate, baseline QRS duration and location of myocardial infarction.
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Ablación por Catéter , Infarto del Miocardio , Taquicardia Ventricular , Humanos , Anciano , Volumen Sistólico , Función Ventricular Izquierda , Infarto del Miocardio/complicaciones , EcocardiografíaRESUMEN
BACKGROUND: Data on recurrence after the end of anticoagulation for a first event of cancer-associated venous thromboembolism (VTE) are scarce. OBJECTIVES: Our aim was to assess predictors of VTE recurrence during a 1-year follow-up period. METHODS: This study is an analysis of RIETE, an international, multicenter, prospective cohort study of patients diagnosed with VTE. Patients had to have active cancer at the time of VTE and to have withdrawn from anticoagulation after 3 months of full treatment. Analyses were performed using Fine and Gray models, with death as a competing risk, and multiple imputation of missing data was performed by chained equations. RESULTS: Among 14 318 patients with cancer-associated VTE, 3414 had undergone time-limited anticoagulation for at least 3 months. The cumulative incidence function for recurrent VTE was 10.2% (95% CI, 9.1-11.5) at 1 year. Chronic kidney disease (a subhazard ratio [sHR] of 1.08 for 10-mL/min decrease in glomerular filtration rate; 95% CI, 1.02-1.14); cancer of the lung, brain, stomach, esophagus, liver, or ovary (sHR, 3.56; 95% CI, 1.07-11.80; compared with cancer of the oropharynx, larynx, or melanoma); cancer of the pancreas, the biliary tract, or of unknown origin (sHR, 6.86; 95% CI, 1.89-24.85); inferior vena cava filter (sHR, 3.16; 95% CI, 1.75-5.71); postthrombotic syndrome (sHR, 2.09; 95% CI, 1.06-4.15); and residual pulmonary thrombotic obstruction (sHR, 2.58; 95% CI, 1.38-4.82) were predictive of recurrence. Surgery during the 2 months before VTE was predictive of absence of recurrence (sHR, 0.60; 95% CI, 0.40-0.92). CONCLUSION: One year after anticoagulant cessation for cancer-associated VTE, approximately 10% of patients experienced recurrence. Discontinuing anticoagulant therapy seems safe, mainly in surgery-associated VTE.
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Neoplasias , Tromboembolia Venosa , Femenino , Humanos , Anticoagulantes/uso terapéutico , Neoplasias/complicaciones , Estudios Prospectivos , Recurrencia , Factores de Riesgo , Tromboembolia Venosa/diagnóstico , Tromboembolia Venosa/tratamiento farmacológico , Tromboembolia Venosa/epidemiologíaRESUMEN
BACKGROUND: Data on cardiogenic shock in adults with congenital heart disease (ACHD) are scarce. AIM: We sought to describe cardiogenic shock in ACHD patients in a nationwide cardiogenic shock registry. METHODS: From the multicentric FRENSHOCK registry (772 patients with cardiogenic shock from 49 French centres between April and October 2016), ACHD patients were compared with adults without congenital heart disease (non-ACHD). The primary outcome was defined by all-cause mortality, chronic ventricular assist device or heart transplantation at 1year. RESULTS: Out of the 772 patients, seven (0.9%) were ACHD, who were younger (median age: 56 vs. 67years), had fewer cardiovascular risk factors, such as hypertension (14.3% vs. 47.5%) and diabetes (14.3% vs. 28.3%), and no previous ischaemic cardiopathy (0 vs. 61.5%). Right heart catheterization (57.1% vs. 15.4%), pacemakers (28.6% vs. 4.6%) and implantable cardioverter-defibrillators (28.6% vs. 4.8%) were indicated more frequently in the management of ACHD patients compared with non-ACHD patients, whereas temporary mechanical circulatory support (0 vs. 18.7%) and invasive mechanical ventilation (14.3% vs. 38.1%) were less likely to be used in ACHD patients. At 1year, the primary outcome occurred in 85.7% (95% confidence interval: 42.1-99.6) ACHD patients and 52.3% (95% confidence interval: 48.7-55.9) non-ACHD patients. Although 1-year mortality was not significantly different between ACHD patients (42.9%) and non-ACHD patients (45.4%), ventricular assist devices and heart transplantation tended to be more frequent in the ACHD group. CONCLUSIONS: Cardiogenic shock in ACHD patients is rare, accounting for only 0.9% of an unselected cardiogenic shock population. Despite being younger and having fewer co-morbidities, the prognosis of ACHD patients with cardiogenic shock remains severe, and is similar to that of other patients.