Impact of patient education on chronic heart failure in primary care (ETIC): a cluster randomised trial

International audienceBACKGROUND:The Education Thérapeutique des patients Insuffisants Cardiaques (ETIC; Therapeutic Education for Patients with Cardiac Failure) trial aimed to determine whether a pragmatic education intervention in general practice could improve the quality of life of patients with chronic heart failure (CHF) compared with routine care.RESULTS:This cluster randomised controlled clinical trial included 241 patients with CHF attending 54 general practitioners (GPs) in France and involved 19 months of follow-up. The GPs in the Intervention Group were trained during a 2-day interactive workshop to provide a patient education programme. The mean age of the patients was 74 years (±10.5), 62 % were men and their mean left-ventricular ejection fraction was 49.3 % (± 14.3). At the end of the follow-up period, the mean Minnesota Living with Heart Failure Questionnaire scores in the Intervention and Control Groups were 33.4 (± 22.1) versus 27.2 (± 23.3; P = 0.74, intra-cluster coefficient [ICC] = 0.11). At the end of the follow-up period, the 36-Item Short Form Health Survey (mental health and physical health) scores in the Intervention and Control Groups were 58 (± 22.1) versus 58.7 (± 23.9; P = 0.58, ICC = 0.01) and 52.8 (± 23.8) versus 51.6 (± 25.5; P = 0.57, ICC = 0.01), respectively.CONCLUSIONS:Patient education delivered by GPs to elderly patients with stable heart failure in the ETIC programme did not achieve an improvement in their quality of life compared with routine care. Further research on improving the quality of life and clinical outcomes of elderly patients with CHF in primary care is necessary.TRIAL REGISTRATION:The Education Thérapeutique des patients Insuffisants Cardiaques (ETIC; Therapeutic Education for Patients with Cardiac Failure) trial is a cluster randomised controlled trial registered with ClinicalTrials.gov (REGISTRATION NUMBER:NCT01065142 ) and the French Drug Agency (Agence Nationale de Sécurité du Médicament et des Produits de Santé;REGISTRATION NUMBER:2009-A01142-55)

153: Comparison of primary pacemaker implantations in the following transcatheter aortic valve implantation (TAVI) in the University Hospital of Clermont Ferrand, according to two types of valve

IntroductionAortic valve replacement is the definitive therapy for severe aortic stenosis (valve area<0.6cm2/m2). Elderly and the associated comorbidity represent an operative risk (estimated with the EuroSCORE). TAVI is an alternative to surgery or balloon valvuloplasty. Two valves were marketed: Edwards and CoreValve. The complications of TAVI are well known and similar for the both. Only the primary pacemaker implantations (PPI) are greater with CoreValves. The objectives are to compare the PPI after a TAVI in the CHU of Clermont Ferrand depending on the type of valve, then to explain this difference.MethodWe used the register FRANCE II to a retrospective analysis of all patients with a TAVI in the CHU of Clermont Ferrand. We only excluded patients who died within 24 hours post procedure and patients who were already a pacemaker. The search for a PPI, age, type of valve, diameter of the valve, surgical approach, presence of bundle branch block (BB), operator dependence and learning curve were analyzed.ResultsFrom January 2010 to March 2012, 78 were included in this study (66% of CoreValve and 34% of Edwards). Of the 22 PPI (22.9%), 100% complicated a Corevalve (p=0.00034). Age, operator, learning curve, surgical approach and diameter of the valve are not risk factors for PPI, in contrast to the presence of BB (p=0.025).ConclusionThis study confirms that CoreValves are more complicated PPI than Edwards. The presence of BB is a risk factor for primary implantation. The lack of power of this study does not reveal other risk factors such as the diameter of the valve or the learning curve effect

Feasibility of a Chronic Foreign Body Infection Model Studying the Influence of TiO2 Nanotube Layers on Bacterial Contamination

International audienceBacterial infections on the surface of medical devices are a significant problem in therapeutic approach , especially when implants are used in the living. In cardiology, pacemaker generator pocket surfaces, made in titanium alloy can be colonized by pathogen microorganism. This contamination represents a major risk of sepsis, endocarditis and localized infections for patients. A way to limit this bacterial contamination is to modify the surface topography using nano-structuration process of the titanium alloy surface of the implanted devices. The aim of this study is to evaluate the influence of TiO2 nanotube layers on bacterial infection in the living, considering the feasibility of an animal model of chronic foreign body infection. TiO2 nanotube layers prepared by electro-chemical anodization of Ti foil in 0.4 wt% hydrofluoric acid solution were implanted subcuta-neously in Wistar rats. Three weeks after implantation, TiO2 implants were contaminated by a Staphylococcus epidermilis strain using two different concentrations at 10 6 and 10 8 colony forming unit (CFU) in order to induce a sufficient infection level and to avoid unwanted over infection consequences on rats health during the experiments. After 28 days in the living, 75% of nanotube layers initially submitted to the 10 8 CFU inoculum were contaminated while only 25% nanotube layers initially submitted to the 10 6 CFU inoculum remained infected. This significant result underlines the influence of TiO2 nanotube layers in decreasing the infection level. Our in vitro experiments showed that the synthesized TiO2 nanotubes indeed decreased the Staphylcoccus epider-mis adhesion compared to unanodized Ti foil

Is there benefit in optimising heart failure treatment in over-80 year-old patients? (HF-80 study): study protocol for a randomized controlled trial

Abstract Background An aging population and better management of various heart diseases explain the exponential growth in incidence and prevalence of chronic heart failure, with poor prognosis and heavy health costs. Medical management is codified in international guidelines. The management of heart failure in over-80 year-old patients follows these guidelines, but no clinical trials have been able to confirm benefit. Moreover, registries show down-prescription of heart failure treatments in the elderly and over-80s. Methods/Design We present the design of the HF-80 ("Is there benefit in optimising heart failure treatment in over-80 year-old patients?") study, which is a prospective randomised open-label clinical trial with blinded end-points, designed to evaluate the effect of optimising management by adhering to guidelines in over-80 year-old heart failure patients. Patients over 80 years of age admitted with acute heart failure will be included. The primary endpoint is to assess quality of life at 6 months on the Minnesota questionnaire. The secondary endpoints are to assess the effect of optimised management on quality of life, mortality, readmission for acute heart failure, cardiac fibrosis and economic data at 12 months. 80 patients will be included, divided into 2 groups: group A, with usual heart failure management by general practitioners; and group B, with optimised management based on international guidelines. Discussion It is necessary to assess the benefit of guidelines in over-80 year-old heart failure patients because of the fragility of this population and the elevated risk of iatrogenic complications. Trial Registration Clinical trials.gov number: NCT01437371.</p

Low fibrosis biomarker levels predict cardiac resynchronization therapy response

Abstract Cardiac fibrosis is associated with heart failure and poor prognosis. Fibrosis biomarkers have been poorly evaluated as a tool to predict cardiac resynchronization therapy (CRT) response generating conflicting results. The present study assessed the predictive value of cardiac fibrosis biomarkers on CRT response. Patients underwent clinical examination, echocardiography and blood fibrosis biomarker evaluation prior to CRT implantation. At six months, a positive response to CRT was defined by a composite endpoint of no death or hospitalization for heart failure, and presence of left ventricular (LV) reverse remodeling (decrease in LV end-systolic volume ≥15%). Sixty patients were included in a multicenter study. At 6 months, 38 were positive responders to CRT and reached the response criteria (63%). Compared to non-responders, CRT responders displayed lower concentration levels of the fibrosis biomarkers procollagen type I C-terminal propeptide [PICP 135[99–166] ng/ml vs. 179[142–226]ng/ml, p = 0.001)] and procollagen type III N-terminal propeptide [PIIINP 5.50[3.66–8.96] ng/ml vs. 8.01[5.01–11.86]ng/ml, p = 0.014)] at baseline. In multivariate analysis, a PICP ≤ 163 ng/ml was associated with a positive CRT response [OR = 7.8(1.3–46.7), p = 0.023] independently of the presence of LBBB, QRS duration, LV lead position or non-ischemic cardiomyopathy. Altogether, the present findings show that a lower degree of cardiac fibrosis is associated with a positive response after CRT implantation. PICP evaluation before CRT implantation could help improve patient selection

Temporal Trends in Transcatheter Aortic Valve Replacement in France: FRANCE 2 to FRANCE TAVI

International audienceBackground - Transcatheter aortic valve replacement (TAVR) is standard therapy for patients with severe aortic stenosis who are at high surgical risk. However, national data regarding procedural characteristics and clinical outcomes over time are limited. Objectives - The aim of this study was to assess nationwide performance trends and clinical outcomes of TAVR during a 6-year period. Methods - TAVRs performed in 48 centers across France between January 2013 and December 2015 were prospectively included in the FRANCE TAVI (French Transcatheter Aortic Valve Implantation) registry. Findings were further compared with those reported from the FRANCE 2 (French Aortic National CoreValve and Edwards 2) registry, which captured all TAVRs performed from January 2010 to January 2012 across 34 centers. Results - A total of 12,804 patients from FRANCE TAVI and 4,165 patients from FRANCE 2 were included in this analysis. The median age of patients was 84.6 years, and 49.7% were men. FRANCE TAVI participants were older but at lower surgical risk (median logistic European System for Cardiac Operative Risk Evaluation [EuroSCORE]: 15.0% vs. 18.4%; p < 0.001). More than 80% of patients in FRANCE TAVI underwent transfemoral TAVR. Transesophageal echocardiography guidance decreased from 60.7% to 32.3% of cases, whereas more recent procedures were increasingly performed in hybrid operating rooms (15.8% vs. 35.7%). Rates of Valve Academic Research Consortium-defined device success increased from 95.3% in FRANCE 2 to 96.8% in FRANCE TAVI (p < 0.001). In-hospital and 30-day mortality rates were 4.4% and 5.4%, respectively, in FRANCE TAVI compared with 8.2% and 10.1%, respectively, in FRANCE 2 (p < 0.001 for both). Stroke and potentially life-threatening complications, such as annulus rupture or aortic dissection, remained stable over time, whereas rates of cardiac tamponade and pacemaker implantation significantly increased. Conclusions - The FRANCE TAVI registry provided reassuring data regarding trends in TAVR performance in an all-comers population on a national scale. Nonetheless, given that TAVR indications are likely to expand to patients at lower surgical risk, concerns remain regarding potentially life-threatening complications and pacemaker implantation. (Registry of Aortic Valve Bioprostheses Established by Catheter [FRANCE TAVI]; NCT01777828)