[Patients insuffisants cardiaques chroniques rarement adressés à un cardiologue libéral ou régulièrement suivis par un médecin généraliste et un cardiologue libéral : étude descriptive transversale (MIRROR-HF)]. / Patients with chronic heart failure infrequently referred to an officed-based cardiologist or regularly followed by a general practitioner and an officed-based cardiologist : a descriptive, cross-sectional study (MIRROR-HF).

BACKGROUND: French health authorities recommend implementing a strong coordination between general practitioners and office-based cardiologists for the care and management of patients with chronic heart failure. The aim of this study was to describe the characteristics of patients with chronic heart failure who were infrequently referred to an office-based cardiologist (either first time referral or last visit more than 12 months before study inclusion) by a general practitioner or other healthcare professional versus those who were regularly followed by a general practitioner and an office-based cardiologist (at least one visit to an office-based cardiologist in the last 12 months). METHODS: This was a non-interventional, cross-sectional study, conducted among office-based cardiologists in France during a single study visit. Descriptive statistics were performed. RESULTS: 1460 patients were included in the study with 37.1% in the group infrequently referred to an office-based cardiologist and 62.9% in the regularly followed group. The patients who were infrequently referred to an office-based cardiologist had relatively less heart failure with reduced ejection fraction (29.2% versus 36.6%), less prior chronic heart failure hospitalization (15.9% versus 31.4%), and less atrial fibrillation and ischemic heart failure as comorbidities (40.2% versus 50.5% and 39.3% versus 50.1%, respectively) than patients who were regularly followed by an office-based cardiologist and a general practitioner. They also received less clinical exams (25.5% versus 97.4%) and pharmacological (89.3% versus 98.4%) and non-pharmacological (17.3% versus 27.1%) heart failure treatments before the study visit. CONCLUSIONS: This study suggested that patients regularly followed by a general practitioner and an office-based cardiologist had globally a more severe chronic heart failure and a better medical monitoring and follow-up than other patients.

Early Switch From Tacrolimus to Everolimus After Liver Transplantation: Outcomes at 2 Years.

The observational CERTITUDE study follows liver transplant patients who completed the SIMCER trial. SIMCER randomized patients at month 1 after transplant to everolimus (EVR) with stepwise tacrolimus (TAC) withdrawal or to standard TAC, both with basiliximab induction and mycophenolic acid ± steroids. After completing SIMCER at 6 months after transplant, 65 EVR-treated patients and 78 TAC-treated patients entered CERTITUDE. At month 24 after transplant, 34/65 (52.3%) EVR-treated patients remained calcineurin inhibitor (CNI) free. Mean estimated glomerular filtration rate (eGFR) was significantly higher with EVR versus TAC during months 3-12. At month 24, eGFR values were 83.6 versus 75.3 mL/minute/1.73 m2 , respectively (P = 0.90) and adjusted mean change in eGFR from randomization was -8.0 versus -13.5 mL/minute/1.73 m2 (P = 0.15). At month 24, 45.9%, 31.1%, and 23.0% of EVR-treated patients had chronic kidney disease stages 1, 2, and 3, respectively, versus 25.7%, 45.7%, and 28.6% of TAC-treated patients (P = 0.05). Treated biopsy-proven acute rejection affected 4 EVR-treated patients and 2 TAC patients during months 6-24. Adverse events led to study discontinuation in 15.4% and 7.7% of EVR-treated and TAC-treated patients, respectively. Grade 3 or 4 hematological events were rare in both groups. A CNI-free EVR-based maintenance regimen appears feasible in approximately half of liver transplant patients. It preserves renal function effectively with good efficacy without compromising safety or hematological tolerance.

Nilotinib efficacy, safety, adherence and impact on quality of life in newly diagnosed patients with chronic myeloid leukaemia in chronic phase: a prospective observational study in daily clinical practice.

This observational, prospective study assessed, in a daily clinical practice, the molecular response, safety, quality of life (QoL) and treatment adherence in 183 patients with chronic myeloid leukaemia in chronic phase (CML-CP), receiving nilotinib as first-line treatment. Premature study termination before 24 months of follow-up occurred in 61 patients (33·3%), and was essentially due to nilotinib treatment discontinuation (n = 53; 29%), motivated by treatment intolerance (n = 29; 15·8%) and inefficacy (n = 19; 10·4%). After 24 months of treatment, 112/122 patients (91·8%) had a molecular assessment, 95·5% of whom achieved a major molecular response (MMR), 32·1% achieved uMR4 , defined as an undetectable molecular disease with 4-log molecular response sensitivity (≥10 000 ABL1 transcripts). The Morisky Green Levine Medication Adherence Scale was completed by 94/122 patients (77·0%), and 89·4% of these patients obtained a satisfactory level of treatment adherence, defined as a score ≥3. Patients' QoL was good at baseline and stable during the follow-up period. The two most common nilotinib-related adverse events (AEs) were pruritus (14·8%) and asthenia (13·7%). Seven patients (3·8%) experienced at least one cardiovascular ischaemic AE. This French nationwide cohort study provides relevant information in daily clinical practice indicating that nilotinib is a valuable first-line treatment option for CML-CP patients.

Dosing of Enteric-Coated Mycophenolate Sodium Under Routine Conditions: An Observational, Multicenter Study in Kidney Transplantation.

BACKGROUND Dosing of enteric-coated mycophenolate sodium (EC-MPS) should be adjusted to reflect concomitant immunosuppression, but it is largely undocumented whether such modifications are carried out during routine clinical practice. MATERIAL AND METHODS MyLIFE was an observational study of adult kidney-only or kidney-pancreas transplant patients starting -EC-MPS at 33 French transplant centers. Data were collected at first EC-MPS dose and 6 months later. The primary objective was to describe initial EC-MPS dosing according to concomitant immunosuppression. RESULTS There were 461 patients analyzed (174 started EC-MPS by month 1 post-transplant ['de novo'] and 287 started EC-MPS >1 month post-transplant ['maintenance']), receiving cyclosporine (CsA) (n=76), tacrolimus (n=363), or a mammalian target of rapamycin (mTOR) inhibitor (n=22). Mean (SD) starting dose was 1130 (511) mg/day, 1006 (441) mg/day, and 769 (300) mg/day in the CsA, tacrolimus, and mTOR inhibitor groups, respectively (p=0.003). In the de novo subpopulation, the starting dose was 1440 mg/day in 66.7% (14/21) of CsA-treated patients and 71.9% (110/153) of tacrolimus-treated patients, with an intensified dose of 2160 mg/day in 28.6% (6/21) and 8.5% (13/153), respectively. There was a non-significant trend to a higher rate of biopsy-proven acute rejection in patients receiving CsA versus tacrolimus or an mTOR inhibitor (p=0.082). Adverse events with a suspected relation to EC-MPS occurred in 21.0%, 23.1%, and 9.1% of the CsA, tacrolimus, and mTOR inhibitor subpopulations, respectively. CONCLUSIONS EC-MPS is usually initiated at the dose recommended for de novo CsA-treated kidney transplant patients, then titrated downwards as required. An early intensified regimen is not used frequently. The EC-MPS dose is modified in <20% of de novo patients to account for concomitant tacrolimus therapy instead of CsA administration.

Longitudinal and integrative biomodeling of effector and memory immune compartments after inactivated influenza vaccination.

Most vaccines, including those against influenza, were developed by focusing solely on humoral response for protection. However, vaccination activates different adaptive compartments that might play a role in protection. We took advantage of the pandemic 2009 A(H1N1) influenza vaccination to conduct a longitudinal integrative multiparametric analysis of seven immune parameters in vaccinated subjects. A global analysis underlined the predominance of induction of humoral and CD4 T cell responses, whereas pandemic 2009 A(H1N1)-specific CD8 responses did not improve after vaccination. A principal component analysis and hierarchical clustering of individuals showed a differential upregulation of influenza vaccine-specific immunity including hemagglutination inhibition titers, IgA(+) and IgG(+) Ab-secreting cells, effector CD4 or CD8 T cell frequencies at day 21 among individuals, suggesting a fine-tuning of the immune parameters after vaccination. This is related to individual factors including the magnitude and quality of influenza-specific immune responses before vaccination. We propose a graphical delineation of immune determinants that would be essential for a better understanding of vaccine-induced immunity in vaccination strategies.

Quality control of an image-scoring method for nuchal translucency ultrasonography.

OBJECTIVE: The objective of the study was to describe a new image-scoring method (NISM) for the measurement of nuchal translucency and crown-rump length on ultrasound scans and to establish interreviewer reliability. STUDY DESIGN: This NISM was based on 8 criteria on a scale of 4 levels (1-4) established on clearly defined ultrasound reference marks. Ten reviewers assessed the same images of 30 fetuses. After a short training period, the same images and those of 30 new fetuses were scored by these 10 reviewers. RESULTS: The differences in scores among the 10 reviewers were significant for 4 of 45 pairwise comparisons before training, but no pairwise comparison was significant after training. Interreviewer variance was significantly lower after training (P = .045). The intraclass correlations before and after training were 0.75 and 0.82. For each criterion, the scores were dichotomized into 2 categories (1-2 vs 3-4). Kappa values for each criterion were substantial (0.61 to 0.80) or even almost perfect (0.81 to 1.00). CONCLUSION: This NISM was highly reliable for the total scores and for each criterion evaluating the image of nuchal translucency and crown-rump length and provides a relevant quality control tool for ultrasound operators.