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1.
Blood Adv ; 4(19): 4632-4639, 2020 10 13.
Artículo en Inglés | MEDLINE | ID: mdl-33002131

RESUMEN

Anticoagulant treatment of pediatric central venous catheter-related venous thromboembolism (CVC-VTE) has not been specifically evaluated. In EINSTEIN-Jr, 500 children with any VTE received rivaroxaban or standard anticoagulants. A predefined analysis of the CVC-VTE cohort was performed. Children with CVC-VTE (age, birth to 17 years) were administered rivaroxaban or standard anticoagulants during the 1-month (children <2 years) or 3-month (all other children) study period. Predefined outcomes were recurrent VTE, change in thrombotic burden on repeat imaging, and bleeding. Predictors for continuation of anticoagulant therapy beyond the study period were evaluated. One hundred twenty-six children with symptomatic (n = 76, 60%) or asymptomatic (n = 50, 40%) CVC-VTE received either rivaroxaban (n = 90) or standard anticoagulants (n = 36). There was no recurrent VTE (0%; 95% confidence interval [CI], 0.0%-2.8%). Three children had the principal safety outcome: none had major bleeding and 3 children had clinically relevant nonmajor bleeding (2.4%; 95% CI, 0.7%-6.5%), all in the rivaroxaban arm. Complete or partial vein recanalization occurred in 57 (55%) and 38 (37%) of 103 evaluable children, respectively. Results were similar for symptomatic and asymptomatic CVC-VTE. Continuation of anticoagulant therapy beyond the study period occurred in 61 (48%) of children and was associated with residual VTE but only in children <2 years (odds ratio [OR], 20.9; P = .003) and continued CVC use (OR, 6.7; P = .002). Anticoagulant therapy appeared safe and efficacious and was associated with reduced clot burden in most children with symptomatic or asymptomatic CVC-VTE. Residual VTE and continued CVC use were associated with extended anticoagulation. This trial was registered at www.clinicaltrials.gov as #NCT02234843.


Asunto(s)
Tromboembolia , Trombosis de la Vena , Anticoagulantes/efectos adversos , Niño , Hemorragia/inducido químicamente , Humanos , Rivaroxabán/efectos adversos
2.
Arch Cardiovasc Dis ; 113(8-9): 492-502, 2020.
Artículo en Inglés | MEDLINE | ID: mdl-32461091

RESUMEN

The population of patients with congenital heart disease (CHD) is continuously increasing, and a significant proportion of these patients will experience arrhythmias because of the underlying congenital heart defect itself or as a consequence of interventional or surgical treatment. Arrhythmias are a leading cause of mortality, morbidity and impaired quality of life in adults with CHD. Arrhythmias may also occur in children with or without CHD. In light of the unique issues, challenges and considerations involved in managing arrhythmias in this growing, ageing and heterogeneous patient population and in children, it appears both timely and essential to critically appraise and synthesize optimal treatment strategies. The introduction of catheter ablation techniques has greatly improved the treatment of cardiac arrhythmias. However, catheter ablation in adults or children with CHD and in children without CHD is more technically demanding, potentially causing various complications, and thus requires a high level of expertise to maximize success rates and minimize complication rates. As French recommendations regarding required technical competence and equipment are lacking in this situation, the Working Group of Pacing and Electrophysiology of the French Society of Cardiology and the Affiliate Group of Paediatric and Adult Congenital Cardiology have decided to produce a common position paper compiled from expert opinions from cardiac electrophysiology and paediatric cardiology. The paper details the features of an interventional cardiac electrophysiology centre that are required for ablation procedures in adults with CHD and in children, the importance of being able to diagnose, monitor and manage complications associated with ablations in these patients and the supplemental hospital-based resources required, such as anaesthesia, surgical back-up, intensive care, haemodynamic assistance and imaging. Lastly, the need for quality evaluations and French registries of ablations in these populations is discussed. The purpose of this consensus statement is therefore to define optimal conditions for the delivery of invasive care regarding ablation of arrhythmias in adults with CHD and in children, and to provide expert and - when possible - evidence-based recommendations on best practice for catheter-based ablation procedures in these specific populations.


Asunto(s)
Arritmias Cardíacas/cirugía , Procedimientos Quirúrgicos Cardíacos , Cardiólogos/normas , Servicio de Cardiología en Hospital/normas , Ablación por Catéter/normas , Competencia Clínica/normas , Criocirugía/normas , Cardiopatías Congénitas/cirugía , Adolescente , Adulto , Factores de Edad , Arritmias Cardíacas/diagnóstico , Arritmias Cardíacas/mortalidad , Arritmias Cardíacas/fisiopatología , Procedimientos Quirúrgicos Cardíacos/efectos adversos , Procedimientos Quirúrgicos Cardíacos/mortalidad , Ablación por Catéter/efectos adversos , Ablación por Catéter/mortalidad , Niño , Preescolar , Consenso , Criocirugía/efectos adversos , Criocirugía/mortalidad , Técnicas Electrofisiológicas Cardíacas/normas , Cardiopatías Congénitas/diagnóstico por imagen , Cardiopatías Congénitas/mortalidad , Cardiopatías Congénitas/fisiopatología , Frecuencia Cardíaca , Humanos , Lactante , Recién Nacido , Factores de Riesgo , Sobrevivientes , Resultado del Tratamiento , Adulto Joven
3.
J Thromb Haemost ; 18(7): 1672-1685, 2020 07.
Artículo en Inglés | MEDLINE | ID: mdl-32246743

RESUMEN

BACKGROUND: Recently, the randomized EINSTEIN-Jr study showed similar efficacy and safety for rivaroxaban and standard anticoagulation for treatment of pediatric venous thromboembolism (VTE). The rivaroxaban dosing strategy was established based on phase 1 and 2 data in children and through pharmacokinetic (PK) modeling. METHODS: Rivaroxaban treatment with tablets or the newly developed granules-for-oral suspension formulation was bodyweight-adjusted and administered once-daily, twice-daily, or thrice-daily for children with bodyweights of ≥30, ≥12 to <30, and <12 kg, respectively. Previously, these regimens were confirmed for children weighing ≥20 kg but only predicted in those <20 kg. Based on sparse blood sampling, the daily area under the plasma concentration-time curve [AUC(0-24)ss ] and trough [Ctrough,ss ] and maximum [Cmax,ss ] steady-state plasma concentrations were derived using population PK modeling. Exposure-response graphs were generated to evaluate the potential relationship of individual PK parameters with recurrent VTE, repeat imaging outcomes, and bleeding or adverse events. A taste-and-texture questionnaire was collected for suspension-recipients. RESULTS: Of the 335 children (aged 0-17 years) allocated to rivaroxaban, 316 (94.3%) were evaluable for PK analyses. Rivaroxaban exposures were within the adult exposure range. No clustering was observed for any of the PK parameters with efficacy, bleeding, or adverse event outcomes. Results were similar for the tablet and suspension formulation. Acceptability and palatability of the suspension were favorable. DISCUSSION: Based on this analysis and the recently documented similar efficacy and safety of rivaroxaban compared with standard anticoagulation, we conclude that bodyweight-adjusted pediatric rivaroxaban regimens with either tablets or suspension are validated and provide for appropriate treatment of children with VTE.


Asunto(s)
Rivaroxabán , Tromboembolia Venosa , Adolescente , Adulto , Anticoagulantes/efectos adversos , Coagulación Sanguínea , Niño , Preescolar , Hemorragia/inducido químicamente , Humanos , Lactante , Recién Nacido , Rivaroxabán/efectos adversos , Tromboembolia Venosa/diagnóstico , Tromboembolia Venosa/tratamiento farmacológico
4.
Int J Cardiol Heart Vasc ; 27: 100489, 2020 Apr.
Artículo en Inglés | MEDLINE | ID: mdl-32154361

RESUMEN

BACKGROUND: Recent advances in the field of congenital heart disease (CHD) have significantly improved the overall prognosis. Now more attention is being given to health-related quality of life (HRQoL) and promotion of physical activity. Non-invasive relaxation therapy may be effective in cardiac patients concerned with exercise-induced dyspnoea. The SOPHROCARE randomised trial aims to assess the impact of Caycedian Sophrology on cardiopulmonary fitness in adolescents and young adults with CHD. METHODS: The SOPHROCARE trial is a nationwide, multicentre, randomised, controlled study in CHD patients aged from 13 to 25 years old. Patients will be randomised into 2 groups (8 Sophrology group sessions vs. no intervention). The primary outcome is the change in percent predicted maximum oxygen uptake (VO2max) between baseline and 12-month follow-up. A total of 94 patients in each group is required to observe a significant increase of 10% in VO2max with a power of 80% and an alpha risk of 5%. The secondary outcomes are: clinical outcomes, cardiopulmonary exercise test parameters (VE/VCO2 slope, ventilatory anaerobic threshold, oxygen pulse, respiratory response to hypercapnia), health-related quality of life score (PedsQL), physical and psychological status. CONCLUSION: After focusing on the survival in CHD, current research is opening on secondary prevention and patient-related outcomes. We sought to assess in the SOPHROCARE trial, if a Sophrology program, could improve exercise capacity and quality of life in youth with CHD. TRIAL REGISTRATION: Clinicaltrials.gov (NCT03999320).

5.
Lancet Haematol ; 7(1): e18-e27, 2020 Jan.
Artículo en Inglés | MEDLINE | ID: mdl-31699660

RESUMEN

BACKGROUND: Treatment of venous thromboembolism in children is based on data obtained in adults with little direct documentation of its efficacy and safety in children. The aim of our study was to compare the efficacy and safety of rivaroxaban versus standard anticoagulants in children with venous thromboembolism. METHODS: In a multicentre, parallel-group, open-label, randomised study, children (aged 0-17 years) attending 107 paediatric hospitals in 28 countries with documented acute venous thromboembolism who had started heparinisation were assigned (2:1) to bodyweight-adjusted rivaroxaban (tablets or suspension) in a 20-mg equivalent dose or standard anticoagulants (heparin or switched to vitamin K antagonist). Randomisation was stratified by age and venous thromboembolism site. The main treatment period was 3 months (1 month in children <2 years of age with catheter-related venous thromboembolism). The primary efficacy outcome, symptomatic recurrent venous thromboembolism (assessed by intention-to-treat), and the principal safety outcome, major or clinically relevant non-major bleeding (assessed in participants who received ≥1 dose), were centrally assessed by investigators who were unaware of treatment assignment. Repeat imaging was obtained at the end of the main treatment period and compared with baseline imaging tests. This trial is registered with ClinicalTrials.gov, number NCT02234843 and has been completed. FINDINGS: From Nov 14, 2014, to Sept 28, 2018, 500 (96%) of the 520 children screened for eligibility were enrolled. After a median follow-up of 91 days (IQR 87-95) in children who had a study treatment period of 3 months (n=463) and 31 days (IQR 29-35) in children who had a study treatment period of 1 month (n=37), symptomatic recurrent venous thromboembolism occurred in four (1%) of 335 children receiving rivaroxaban and five (3%) of 165 receiving standard anticoagulants (hazard ratio [HR] 0·40, 95% CI 0·11-1·41). Repeat imaging showed an improved effect of rivaroxaban on thrombotic burden as compared with standard anticoagulants (p=0·012). Major or clinically relevant non-major bleeding in participants who received ≥1 dose occurred in ten (3%) of 329 children (all non-major) receiving rivaroxaban and in three (2%) of 162 children (two major and one non-major) receiving standard anticoagulants (HR 1·58, 95% CI 0·51-6·27). Absolute and relative efficacy and safety estimates of rivaroxaban versus standard anticoagulation estimates were similar to those in rivaroxaban studies in adults. There were no treatment-related deaths. INTERPRETATION: In children with acute venous thromboembolism, treatment with rivaroxaban resulted in a similarly low recurrence risk and reduced thrombotic burden without increased bleeding, as compared with standard anticoagulants. FUNDING: Bayer AG and Janssen Research & Development.


Asunto(s)
Anticoagulantes/uso terapéutico , Rivaroxabán/uso terapéutico , Tromboembolia Venosa/tratamiento farmacológico , Adolescente , Niño , Preescolar , Femenino , Humanos , Lactante , Masculino , Factores de Riesgo
6.
Eur J Cardiovasc Nurs ; 18(2): 163-170, 2019 02.
Artículo en Inglés | MEDLINE | ID: mdl-30230358

RESUMEN

BACKGROUND: The use of hypnosis in children has been described more than two centuries ago, with a more recent research and clinical application. There is currently a good level of evidence for the efficacy of clinical hypnosis in children for minor surgery, medical procedures or pain management. The use of clinical hypnosis, in paediatric cardiology, for invasive procedures such as transesophageal echocardiography, has not been reported. AIMS: This study evaluated the feasibility of clinical hypnosis in children undergoing transesophageal echocardiography. METHOD: This prospective, non-randomised, cross-sectional study was carried out over 24 months in a paediatric cardiology referral centre. All children aged 10-18 years requiring a transesophageal echocardiography examination, outside the operating room and the catheterisation laboratory, were eligible for the study. Children and families could choose between transesophageal echocardiography under clinical hypnosis or under general anaesthesia (<15 years) or sedation (⩾15 years). RESULTS: We included 16 children aged 11-18 years (seven girls, mean age 14.1±2.5 years). The hypnotic state was achieved for 15 out of the 16 participating children (94%). The transesophageal echocardiography examination could be completely achieved with a full diagnosis for 15 out of 16 children (94%). In all cases, a transesophageal echocardiography examination under clinical hypnosis provided a complete diagnosis. CONCLUSION: This study demonstrated that hypnosis was feasible and effective for transesophageal echocardiography in adolescents and might be a good alternative to general anaesthesia. Further study with larger numbers of subjects and more diverse congenital cardiac conditions are needed to confirm the results in a more diverse sample.


Asunto(s)
Ecocardiografía Transesofágica/normas , Cardiopatías Congénitas/diagnóstico , Hipnosis/métodos , Pediatría/normas , Guías de Práctica Clínica como Asunto , Adolescente , Niño , Estudios Transversales , Estudios de Factibilidad , Femenino , Humanos , Masculino , Estudios Prospectivos
7.
Pediatr Pulmonol ; 53(5): 559-566, 2018 05.
Artículo en Inglés | MEDLINE | ID: mdl-29493875

RESUMEN

BACKGROUND: Asthma is the most common chronic disease in pediatrics. Along with the usual drug therapy using corticosteroids and bronchodilators, some interest has been shown for adjuvant therapies, such as sophrology. However, the level of evidence for non-pharmaceutical therapies in asthma remains low, especially in children. This study aimed to assess whether in children with asthma, peak expiratory flow (PEF) improved more after a sophrology session alongside standard treatment than after standard treatment alone. METHODS: We carried out a prospective randomized controlled clinical trial among 74 children aged 6-17 years old, hospitalized for an asthma attack. Group 1: conventional treatment (oxygen, corticosteroids, bronchodilators, physiotherapy) added to one session of sophrology. Group 2: conventional treatment alone. The primary outcome was the PEF variation between the initial and final evaluations (PEF2 -PEF1 ). RESULTS: Demographic and clinical characteristics were similar in both groups at baseline. Measures before and after the sophrology session showed that the PEF increased by mean 30 L/min in the sophrology group versus 20 L/min in the control group (P = 0.02). Oxygen saturation increased by 1% versus 0% (P = 0.02) and the dyspnea score with visual analogue scale improved by two points point (P = 0.01). No differences were observed between the two groups in terms of duration of hospitalization, use and doses of conventional medical treatment (oxygen, corticosteroids, and bronchodilators), and quality of life scores. CONCLUSIONS: Sophrology appears as a promising adjuvant therapy to current guideline-based treatment for asthma in children.


Asunto(s)
Corticoesteroides/uso terapéutico , Asma/fisiopatología , Asma/terapia , Broncodilatadores/uso terapéutico , Ápice del Flujo Espiratorio/fisiología , Terapia por Relajación , Adolescente , Niño , Niño Hospitalizado , Terapia Combinada , Femenino , Humanos , Masculino , Modalidades de Fisioterapia , Estudios Prospectivos , Calidad de Vida , Resultado del Tratamiento
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