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BACKGROUND: Safety and feasibility of transcatheter aortic valve replacement (TAVR) without balloon aortic valvuloplasty (BAV) using the SAPIEN 3 balloon-expandable device has been previously demonstrated. The impact on long-term valve hemodynamic performances and outcomes remains however unknown. We evaluate long-term clinical and hemodynamic results according to the implant strategy (direct TAVR vs BAV pre-TAVR) in patients included in the DIRECTAVI randomized trial (NCT02729519). METHODS: Clinical and echocardiographic follow-up until January 2023 was performed for all patients included in the DIRECTAVI trial since 2016 (n = 228). The primary endpoint was incidence of moderate/severe hemodynamic valve deterioration (HVD), according to the Valve Academic Research defined Consortium-3 criteria (increase in mean gradient ≥10 mmHg resulting in a final mean gradient ≥20 mmHg, or new/worsening aortic regurgitation of 1 grade resulting in ≥ moderate aortic regurgitation). RESULTS: Median follow-up was 3.8 (2.2-4.7) years. Mean age at follow-up was 87 ± 6.7 years. No difference in incidence of HVD in the direct implantation group compared to the BAV group was found (incidence of 1.97 per 100 person-years and 1.45 per 100 person-years, respectively, P = 0.6). Prevalence of predicted prothesis-patient mismatch was low (n = 13 [11.4%] in the direct TAVR group vs n = 15 [13.2%] in BAV group) and similar between both groups (P = .7). Major outcomes including death, stroke, hospitalization for heart failure and pacemaker implantation were similar between both groups, (P = .4, P = .7, P = .3, and P = .3 respectively). CONCLUSION: Direct implantation of the balloon-expandable device in TAVR was not associated with an increased risk of moderate/severe HVD or major outcomes up to 6-year follow-up. These results guarantee wide use of direct balloon-expandable valve implantation, when feasible. CLINICAL TRIALS REGISTRATION NUMBER: NCT05140317.
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Insuficiencia de la Válvula Aórtica , Estenosis de la Válvula Aórtica , Valvuloplastia con Balón , Prótesis Valvulares Cardíacas , Reemplazo de la Válvula Aórtica Transcatéter , Humanos , Anciano de 80 o más Años , Reemplazo de la Válvula Aórtica Transcatéter/métodos , Válvula Aórtica/diagnóstico por imagen , Válvula Aórtica/cirugía , Estenosis de la Válvula Aórtica/cirugía , Estudios de Seguimiento , Insuficiencia de la Válvula Aórtica/cirugía , Resultado del Tratamiento , Factores de Tiempo , Diseño de Prótesis , Valvuloplastia con Balón/efectos adversosRESUMEN
Chronic hepatitis C Virus (HCV) infection presents a global health challenge, with significant morbidity and mortality worldwide. Despite remarkable progress in treatment options, achieving elimination targets by 2030, as set by the World Health Organization, remains elusive. Our study aimed to address this gap by integrating HCV screening into a national breast cancer screening program. Between March 2022 and March 2023, a prospective cross-sectional multicenter study was conducted in four radiology centers in Montpellier, France. We proposed HCV screening to consecutive women undergoing mammography, targeting 1,500 participants aged 50-74 years. A rapid diagnostic test (RDT) for HCV antibodies (HCV Ab) was performed on capillary whole blood, with positive cases undergoing serological and RNA confirmation. Participants also completed a questionnaire on demographic data and risk factors. Acceptance rates, HCV prevalence, and linkage to care were assessed. The acceptance rate for this integrated screening approach was 82.4%. Notably, the seroprevalence of HCV was found to be 0.65%. Linkage to care was prompt, and the cascade of care demonstrated successful treatment outcomes. Importantly, the majority of detected infections were successfully resolved. These findings underscore the feasibility and acceptability of integrating HCV screening with breast cancer screening programs providing updated prevalence data and valuable insights for refining future screening strategies.
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Detección Precoz del Cáncer , Anticuerpos contra la Hepatitis C , Mamografía , Humanos , Femenino , Persona de Mediana Edad , Anciano , Estudios Transversales , Estudios Prospectivos , Mamografía/métodos , Mamografía/estadística & datos numéricos , Anticuerpos contra la Hepatitis C/sangre , Detección Precoz del Cáncer/métodos , Tamizaje Masivo/métodos , Francia/epidemiología , Hepacivirus/inmunología , Hepacivirus/genética , Neoplasias de la Mama/diagnóstico , Neoplasias de la Mama/epidemiología , Hepatitis C Crónica/diagnóstico , Hepatitis C Crónica/epidemiología , Pruebas Diagnósticas de Rutina/métodos , Pruebas Diagnósticas de Rutina/estadística & datos numéricos , Estudios Seroepidemiológicos , Prevalencia , Hepatitis C/diagnóstico , Hepatitis C/epidemiología , Prueba de Diagnóstico RápidoRESUMEN
BACKGROUND: Aerobic fitness is a predictor of cardiovascular health which correlates with health-related quality of life in the general population. The aim is to evaluate the aerobic capacity by cardiopulmonary exercise test (CPET) in children with sickle cell disease in comparison with healthy matched controls. METHODS: Controlled cross-sectional study. RESULTS: A total of 72 children (24 with sickle cell disease and 48 healthy controls), aged 6-17 years old were enrolled. Children with sickle cell disease had a poor aerobic capacity, with median VO2max Z-score values significantly lower than matched controls (-3.55[-4.68; -2.02] vs. 0.25[-0.22; 0.66], P < 0.01, respectively), and a high proportion of 92% children affected by an impaired aerobic capacity (VO2max Z-score < -1.64). The VO2max decrease was associated with the level of anemia, the existence of a homozygote HbS/S mutation, restrictive lung disease and health-related quality of life. CONCLUSION: Aerobic capacity is poor in children with sickle cell disease. VO2max decrease is associated with the level of anemia, the existence of a homozygote HbS/S mutation, lung function, and health-related quality of life. These results represent a signal in favor of early initiation of cardiac rehabilitation in patients with sickle cell disease. CLINICAL TRIALS: NCT05995743. IMPACT: Aerobic fitness is a predictor of cardiovascular health which correlates with health-related quality of life in the general population. Aerobic capacity (VO2max) is poor in children with sickle cell disease, despite the absence of any pattern of heart failure. VO2max decrease was associated with the level of anemia, the existence of a homozygote HbS/S mutation, restrictive lung disease, and health-related quality of life. These results are in favor of early initiation of cardiac rehabilitation in children with sickle cell disease.
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BACKGROUND: Adherence to medication is estimated to be around 50% for chronically ill patients in high-income countries. Improving the effectiveness of adherence interventions could have a far greater impact on population health than any improvement in specific medical treatments. Mobile health (mHealth) is one of the most effective solutions for helping patients improve their medication intake, notably through the use of mobile apps with reminder systems. With more than 327,000 apps available in the mHealth field, it is difficult for health care professionals and patients alike to choose which apps to recommend and use. OBJECTIVE: We aim to carry out a systematic search of medication management smartphone apps available in France that send reminders to patients and assess their quality using a validated scale. METHODS: Mobile apps were identified in October and November 2022 after a systematic keyword search on the 2 main app download platforms: App Store (Apple Inc) and Google Play Store. Inclusion criteria were free availability, date of last update, and availability in French. Next, 2 health care professionals independently evaluated the included apps using the French version of the Mobile App Rating Scale (MARS-F), an objective scoring system validated for assessing the overall quality of apps in the mHealth field. An intraclass correlation coefficient was calculated to determine interrater reliability. RESULTS: In total, 960 apps were identified and 49 were selected (25 from the App Store and 24 from the Google Play Store). Interrater reliability was excellent (intraclass correlation coefficient 0.92; 95% CI 0.87-0.95; P<.001). The average MARS-F score was 3.56 (SD 0.49) for apps on the App Store and 3.51 (SD 0.46) for those on the Google Play Store, with 10 apps scoring above 4 out of 5. Further, 2 apps were tested in at least one randomized controlled trial and showed positive results. The 2 apps with the highest ratings were Mediteo rappel de médicaments (Mediteo GmbH) and TOM rappel medicaments, pilule (Innovation6 GmbH), available on both platforms. Each app's MARS-F score was weakly correlated with user ratings on the App Store and moderately correlated on the Google Play Store. CONCLUSIONS: To our knowledge, this is the first study that used a validated scoring system to evaluate medication management apps that send medication reminders. The quality of the apps was heterogeneous, with only 2 having been studied in a randomized controlled trial with positive results. The evaluation of apps in real-life conditions by patients is necessary to determine their acceptability and effectiveness. Certification of apps is also essential to help health care professionals and patients identify validated apps.
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Administración del Tratamiento Farmacológico , Aplicaciones Móviles , Humanos , Francia , Reproducibilidad de los Resultados , Teléfono InteligenteRESUMEN
BACKGROUND: Skin cancers are the most common group of cancers diagnosed worldwide. Aging and sun exposure increase their risk. The decline in the number of dermatologists is pushing the issue of dermatological screening back onto family doctors. Dermoscopy is an easy-to-use tool that increases the sensitivity of melanoma diagnosis by 60% to 90%, but its use is limited due to lack of training. The characteristics of "ideal" dermoscopy training have yet to be established. We created a Moodle (Moodle HQ)-based e-learning course to train family medicine residents in dermoscopy. OBJECTIVE: This study aimed to evaluate the evolution of dermoscopy knowledge among family doctors immediately and 1 and 3 months after e-learning training. METHODS: We conducted a prospective interventional study between April and November 2020 to evaluate an educational program intended for family medicine residents at the University of Montpellier-Nîmes, France. They were asked to complete an e-learning course consisting of 2 modules, with an assessment quiz repeated at 1 (M1) and 3 months (M3). The course was based on a 2-step algorithm, a method of dermoscopic analysis of pigmented skin lesions that is internationally accepted. The objectives of modules 1 and 2 were to differentiate melanocytic lesions from nonmelanocytic lesions and to precisely identify skin lesions by looking for dermoscopic morphological criteria specific to each lesion. Each module consisted of 15 questions with immediate feedback after each question. RESULTS: In total, 134 residents were included, and 66.4% (n=89) and 47% (n=63) of trainees fully participated in the evaluation of module 1 and module 2, respectively. This study showed a significant score improvement 3 months after the training course in 92.1% (n=82) of participants for module 1 and 87.3% (n=55) of participants for module 2 (P<.001). The majority of the participants expressed satisfaction (n=48, 90.6%) with the training course, and 96.3% (n=51) planned to use a dermatoscope in their future practice. Regarding final scores, the only variable that was statistically significant was the resident's initial scores (P=.003) for module 1. No measured variable was found to be associated with retention (midtraining or final evaluation) for module 2. Residents who had completed at least 1 dermatology rotation during medical school had significantly higher initial scores in module 1 at M0 (P=.03). Residents who reported having completed at least 1 dermatology rotation during their family medicine training had a statistically significant higher score at M1 for module 1 and M3 for module 2 (P=.01 and P=.001). CONCLUSIONS: The integration of an e-learning training course in dermoscopy into the curriculum of FM residents results in a significant improvement in their diagnosis skills and meets their expectations. Developing a program combining an e-learning course and face-to-face training for residents is likely to result in more frequent and effective dermoscopy use by family doctors.
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PURPOSE OF THE REPORT: Primary lymphedema (PLE) is a rare chronic disorder. Extremity lymphoscintigraphy offers access for dynamic and functional information on peripheral lymphatics and lymph nodes. We aimed to assess intraobserver and interobserver reliability of a new lymphoscintigraphy quantitative and qualitative scoring system in a homogeneous population of adult patients followed for PLE of the lower limb(s). PATIENTS AND METHODS: This is a monocentric retrospective study. Clinical files of patients who underwent a lymphoscintigraphy were reviewed for inclusion. Lymphoscintigraphies were interpreted twice by 2 observers with a washout period. To assess intraobserver and interobserver reliability for both lower limbs, Cohen κ and Gwet's AC1 reliability coefficients were calculated with 95% confidence interval and P value of the zero-reliability comparison test. To interpret reliability coefficients, we used the orders of magnitude reported by Landis and Koch. RESULTS: One hundred forty-four patients (288 limbs) with PLE were included. For intraobserver reliability, agreement range was 0.87-1 with an almost perfect agreement in all staging items of the score for both limbs with the lower limit of the 95% confidence interval ≥80%. Interobserver reliability was overall strong or almost perfect, ranging from 0.67 to 0.97. CONCLUSIONS: This new scoring system demonstrated excellent intraobserver reliability and a very good interobserver reliability. Lymphoscintigraphy, when performed in a referral center and interpreted by trained nuclear medicine physicians, is a reliable means of investigation in patients with PLE of the lower limbs. This reproducibility advocates for further use of lymphoscintigraphy in multicentric cohorts of PLE patients.
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Linfedema , Linfocintigrafia , Humanos , Linfocintigrafia/métodos , Linfedema/diagnóstico por imagen , Femenino , Masculino , Persona de Mediana Edad , Reproducibilidad de los Resultados , Adulto , Anciano , Variaciones Dependientes del Observador , Estudios Retrospectivos , Anciano de 80 o más AñosRESUMEN
INTRODUCTION: High-flow nasal cannula (HFNC) is commonly used as first step respiratory support in infants with moderate-to-severe acute viral bronchiolitis (AVB). This device, however, fails to effectively manage respiratory distress in about a third of patients, and data are limited on determinants of patient response. The respiratory rate-oxygenation (ROX) index is a relevant tool to predict the risk for HFNC failure in adult patients with lower respiratory tract infections. The primary objective of this study was to assess the relationship between ROX indexes collected before and 1 h after HFNC initiation, and HFNC failure occurring in the following 48 h in infants with AVB. METHOD: This is an ancillary study to the multicenter randomized controlled trial TRAMONTANE 2, that included 286 infants of less than 6 months with moderate-to-severe AVB. Collection of physiological variables at baseline (H0), and 1 h after HFNC (H1), included heart rate (HR), respiratory rate (RR), fraction of inspired oxygen (FiO2), respiratory distress score (modified Wood's Clinical Asthma Score [mWCAS]), and pain and discomfort scale (EDIN). ROX and ROX-HR were calculated as SpO 2 FiO 2 RR $\frac{\left(\frac{{\mathrm{SpO}}_{2}}{{\mathrm{FiO}}_{2}}\right)}{\mathrm{RR}}$ and 100 × ROX HR $100\times \frac{\mathrm{ROX}}{\mathrm{HR}}$ , respectively. Predefined HFNC failure criteria included increase in respiratory distress score or RR, increase in discomfort, and severe apnea episodes. The accuracies of ROX, ROX-HR indexes and clinical variable to predict HFNC failure were assessed using receiver operating curve analysis. We analyzed predictive factors of HFNC failure using multivariate logistic regressions. RESULT: HFNC failure occurred in 111 of 286 (39%) infants, and for 56 (50% of the failure) of them within the first 6 h. The area under the curve of ROX indexes at H0 and H1 were, respectively, 0.56 (95% confidence interval [CI] 0.48-0.63, p = 0.14), 0.56 (95% CI 0.49-0.64, p = 0.09). ROX-HR performances were better but remained poorly discriminant. HFNC failure was associated with higher mWCAS score at H1 (p < 0.01) and lower decrease in EDIN scale during the first hour of HFNC delivery (p = 0.02). In the multivariate analyses, age and mWCAS score were were found to be independent factors associated with HFNC failure at H0. At H1, weight and mWCAS were associated factors. CONCLUSION: In this study, neither ROX index, nor physiological variables usually collected in infants with AVB had early discriminatory capacity to predict HFNC failure.
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Bronquiolitis Viral , Bronquiolitis , Neumonía , Síndrome de Dificultad Respiratoria , Insuficiencia Respiratoria , Lactante , Adulto , Humanos , Cánula , Bronquiolitis Viral/terapia , Frecuencia Respiratoria , Terapia por Inhalación de Oxígeno , Bronquiolitis/terapia , Neumonía/terapia , Disnea/terapia , Síndrome de Dificultad Respiratoria/terapia , Insuficiencia Respiratoria/terapiaRESUMEN
Although current systemic therapies significantly improved the outcome of advanced melanoma, the prognosis of patient with central nervous system (CNS) metastases remains poor especially when clinically symptomatic. We aimed to investigate the efficiency of CNS targets and tolerance of second-line combined anti-PD1/dual-targeted anti-BRAF/anti-MEK therapy implemented in patients with CNS progression after initially efficient first-line combined targeted therapy in patients with BRAF-mutated melanoma in a real-life setting. A monocentric retrospective analysis including all such patients treated from January 2017 to January 2022 was conducted in our tertiary referral center. The response of CNS lesions to second-line triple therapy was assessed through monthly clinical and at least quarterly morphological (according to RECIST criteria) evaluation. Tolerance data were also collected. Seventeen patients were included with a mean follow-up of 2.59 (±2.43) months. Only 1 patient displayed a significant clinical and morphological response. No statistically significant difference was observed between patients receiving or not additional local therapy (mainly radiotherapy) as to response achievement. Immunotherapy was permanently discontinued in 1 patient owing to grade 4 toxicity. Mean PFS and OS after CNS progression were 2.59 and 4.12 months, respectively. In this real-life survey, the subsequent addition of anti-PD1 to combined targeted therapy in melanoma patients with upfront CNS metastases did not result in significant response of CNS targets in most BRAF mutated melanoma patients with secondary CNS progression after initially successful first-line combined targeted therapy.
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Neoplasias del Sistema Nervioso Central , Melanoma , Proteínas Proto-Oncogénicas B-raf , Neoplasias Cutáneas , Humanos , Melanoma/tratamiento farmacológico , Melanoma/genética , Melanoma/patología , Femenino , Masculino , Proteínas Proto-Oncogénicas B-raf/genética , Persona de Mediana Edad , Anciano , Estudios Retrospectivos , Neoplasias del Sistema Nervioso Central/secundario , Neoplasias del Sistema Nervioso Central/tratamiento farmacológico , Adulto , Neoplasias Cutáneas/tratamiento farmacológico , Neoplasias Cutáneas/genética , Neoplasias Cutáneas/patología , Inhibidores de Proteínas Quinasas/uso terapéutico , Inhibidores de Proteínas Quinasas/farmacología , Protocolos de Quimioterapia Combinada Antineoplásica/uso terapéutico , Inhibidores de Puntos de Control Inmunológico/uso terapéutico , Inhibidores de Puntos de Control Inmunológico/farmacología , Mutación , Receptor de Muerte Celular Programada 1/antagonistas & inhibidores , Anciano de 80 o más AñosRESUMEN
BACKGROUND: According to the World Health Organization, climate and ecological emergencies are already major threats to human health. Unabated climate change will cause 3.4 million deaths per year by the end of the century, and health-related deaths in the population aged ≥65 years will increase by 1540%. Planetary health (PH) is based on the understanding that human health and human civilization depend on flourishing natural systems and the wise stewardship of those natural systems. Health care systems collectively produce global emissions equivalent to those of the fifth largest country on earth, and they should take steps to reduce their environmental impact. Primary care in France accounts for 23% of greenhouse gas emissions in the health care sector. General practitioners (GPs) have an important role in PH. The course offers first-year GP residents of the Montpellier-Nîmes Faculty of Medicine a blended-learning course on environmental health. An e-learning module on PH, lasting 30 to 45 minutes, has been introduced in this course. OBJECTIVE: The objective of this study was to assess the impact of the e-learning module on participants' knowledge and behavior change. METHODS: This was a before-and-after study. The module consisted of 3 parts: introduction, degradation of ecosystems and health (based on the Intergovernmental Panel on Climate Change report and planetary limits), and ecoresponsibility (based on the Shift Project report on the impact of the health care system on the environment). The questionnaire used Likert scales to self-assess 10 points of knowledge and 5 points of PH-related behavior. RESULTS: A total of 95 participants completed the pre- and posttest questionnaires (response rate 55%). The mean scores for participants' pretest knowledge and behaviors were 3.88/5 (SD 0.362) and 3.45/5 (SD 0.705), respectively. There was no statistically significant variation in the results according to age or gender. The pretest mean score of participants who had already taken PH training was statistically better than those who had not taken the PH training before this course (mean 4.05, SD 0.16 vs mean 3.71, SD 0.374; P<.001). CONCLUSIONS: The PH module of the Primary Care Environment and Health course significantly improved self-assessment knowledge scores and positively modified PH behaviors among GP residents. Further work is needed to study whether these self-declared behaviors are translated into practice.