The REDUCE FMR Trial: A Randomized Sham-Controlled Study of Percutaneous Mitral Annuloplasty in Functional Mitral Regurgitation

Objectives This study sought to evaluate the effects of the Carillon device on mitral regurgitation severity and left ventricular remodeling. Background Functional mitral regurgitation (FMR) complicates heart failure with reduced ejection fraction and is associated with a poor prognosis. Methods In this blinded, randomized, proof-of-concept, sham-controlled trial, 120 patients receiving optimal heart failure medical therapy were assigned to a coronary sinus-based mitral annular reduction approach for FMR or sham. The pre-specified primary endpoint was change in mitral regurgitant volume at 12 months, measured by quantitative echocardiography according to an intention-to-treat analysis. Results Patients (69.8 ± 9.5 years of age) were randomized to either the treatment (n = 87) or the sham-controlled (n = 33) arm. There were no significant differences in baseline characteristics between the groups. In the treatment group, 73 of 87 (84%) had the device implanted. The primary endpoint was met, with a statistically significant reduction in mitral regurgitant volume in the treatment group compared to the control group (decrease of 7.1 ml/beat [95% confidence interval [CI]: −11.7 to −2.5] vs. an increase of 3.3 ml/beat [95% CI: −6.0 to 12.6], respectively; p = 0.049). Additionally, there was a significant reduction in left ventricular volumes in patients receiving the device versus those in the control group (left ventricular end-diastolic volume decrease of 10.4 ml [95% CI: −18.5 to −2.4] vs. an increase of 6.5 ml [95% CI: −5.1 to 18.2]; p = 0.03 and left ventricular end-systolic volume decrease of 6.2 ml [95% CI: −12.8 to 0.4] vs. an increase of 6.1 ml [95% CI: −1.42 to 13.6]; p = 0.04). Conclusions The Carillon device significantly reduced mitral regurgitant volume and left ventricular volumes in symptomatic patients with functional mitral regurgitation receiving optimal medical therapy. (Carillon Mitral Contour System for Reducing Functional Mitral Regurgitation [REDUCE FMR]; NCT02325830

A randomized double-blind trial of an interventional device treatment of functional mitral regurgitation in patients with symptomatic congestive heart failure-Trial design of the REDUCE FMR study

The Carillon Mitral Contour System has been studied in 3 nonrandomized trials in patients with symptomatic congestive heart failure and functional mitral regurgitation. The REDUCE FMR study is a uniquely designed, double-blind trial evaluating the impact of the Carillon device on reducing regurgitant volume, as well as assessing the safety and clinical efficacy of this device. Carillon is a coronary sinus-based indirect annuloplasty device. Eligible patients undergo an invasive venogram to assess coronary sinus vein suitability for the Carillon device. If the venous dimensions are suitable, they are randomized on a 3:1 basis to receive a device or not. Patients and assessors are blinded to the treatment assignment. The primary end point is the difference in regurgitant volume at 1 year between the implanted and nonimplanted groups. Other comparisons include clinical parameters such as heart failure hospitalizations, 6-minute walk test, Kansas City Cardiomyopathy Questionnaire (KCCQ), and other echocardiographic parameters. An exercise echo substudy will also be included

Progression from new methicillin-resistant Staphylococcus aureus colonisation to infection: An observational study in a hospital cohort

10.1186/1471-2334-13-491BMC Infectious Diseases131-BIDM

Multi-drug resistance, inappropriate initial antibiotic therapy and mortality in Gram-negative severe sepsis and septic shock: A retrospective cohort study

INTRODUCTION: The impact of in vitro resistance on initially appropriate antibiotic therapy (IAAT) remains unclear. We elucidated the relationship between non-IAAT and mortality, and between IAAT and multi-drug resistance (MDR) in sepsis due to Gram-negative bacteremia (GNS). METHODS: We conducted a single-center retrospective cohort study of adult intensive care unit patients with bacteremia and severe sepsis/septic shock caused by a gram-negative (GN) organism. We identified the following MDR pathogens: MDR P. aeruginosa, extended spectrum beta-lactamase and carbapenemase-producing organisms. IAAT was defined as exposure within 24 hours of infection onset to antibiotics active against identified pathogens based on in vitro susceptibility testing. We derived logistic regression models to examine a) predictors of hospital mortality and b) impact of MDR on non-IAAT. Proportions are presented for categorical variables, and median values with interquartile ranges (IQR) for continuous. RESULTS: Out of 1,064 patients with GNS, 351 (29.2%) did not survive hospitalization. Non-survivors were older (66.5 (55, 73.5) versus 63 (53, 72) years, P = 0.036), sicker (Acute Physiology and Chronic Health Evaluation II (19 (15, 25) versus 16 (12, 19), P <0.001), and more likely to be on pressors (odds ratio (OR) 2.79, 95% confidence interval (CI) 2.12 to 3.68), mechanically ventilated (OR 3.06, 95% CI 2.29 to 4.10) have MDR (10.0% versus 4.0%, P <0.001) and receive non-IAAT (43.4% versus 14.6%, P <0.001). In a logistic regression model, non-IAAT was an independent predictor of hospital mortality (adjusted OR 3.87, 95% CI 2.77 to 5.41). In a separate model, MDR was strongly associated with the receipt of non-IAAT (adjusted OR 13.05, 95% CI 7.00 to 24.31). CONCLUSIONS: MDR, an important determinant of non-IAAT, is associated with a three-fold increase in the risk of hospital mortality. Given the paucity of therapies to cover GN MDRs, prevention and development of new agents are critical

Cross-sectional survey of older peoples' views related to influenza vaccine uptake

BACKGROUND: The population's views concerning influenza vaccine are important in maintaining high uptake of a vaccine that is required yearly to be effective. Little is also known about the views of the more vulnerable older population over the age of 74 years. METHODS: A cross-sectional survey of community dwelling people aged 75 years and over wh, previous participant was conducted using a postal questionnaire. Responses were analysed by vaccine uptake records and by socio-demographic and medical factors. RESULTS: 85% of men and 75% of women were vaccinated against influenza in the previous year. Over 80% reported being influenced by a recommendation by a health care worker. The most common reason reported for non uptake was good health (44%), or illness considered to be due to the vaccine (25%). An exploration of the crude associations with socio-economic status suggested there may be some differences in the population with these two main reasons. 81% of people reporting good health lived in owner occupied housing with central heating vs. 63% who did not state this as a reason (p = 0.04), whereas people reporting ill health due to the vaccine was associated with poorer social circumstances. 11% lived in the least deprived neighbourhood compared to 36% who did not state this as a reason (p = 0.05) and were less likely to be currently married than those who did not state this as a reason (25% vs 48% p = 0.05). CONCLUSION: Vaccine uptake was high, but non uptake was still noted in 1 in 4 women and 1 in 7 men aged over 74 years. Around 70% reported they would not have the vaccine in the following year. The divergent reasons for non-uptake, and the positive influence from a health care worker, suggests further uptake will require education and encouragement from a health care worker tailored towards the different views for not having influenza vaccination. Non-uptake of influenza vaccine because people viewed themselves as in good health may explain the modest socio-economic differentials in influenza vaccine uptake in elderly people noted elsewhere. Reporting of ill-health due to the vaccine may be associated with a different, poorer background

The usefulness of arbekacin compared to vancomycin

The bacteriological efficacy response (improved, arbekacin vs. vancomycin; 71.2% vs. 79.5%) and clinical efficacy response (improved, arbekacin vs. vancomycin; 65.3% vs. 76.1%) were not statistically different between the two groups. The complication rate was significantly higher in the vancomycin group (32.9%) compared to the arbekacin group (15.1%) (p = 0.019). Arbekacin was not inferior to vancomycin, and it could be a good alternative drug for vancomycin in methicillin-resistant Staphylococcus aureus (MRSA) treatment

Predictors of hospital mortality among septic ICU patients with Acinetobacter spp. bacteremia: A cohort study

BACKGROUND: We hypothesized that among septic ICU patients with Acinetobacter spp. bacteremia (Ac-BSI), carbapenem-resistant Acinetobacter spp. (CRAc) increase risk for inappropriate initial antibiotic therapy (non-IAAT), and non-IAAT is a predictor of hospital death. METHODS: We conducted a retrospective cohort study of adult septic ICU patients with Ac-BSI. Non-IAAT was defined as exposure to initially prescribed antibiotics not active against the pathogen based on in vitro susceptibility testing, and having no exposure to appropriate antimicrobial treatment within 24 hours of drawing positive culture. We compared patients who died to those who survived, and derived regression models to identify predictors of hospital mortality and of non-IAAT. RESULTS: Out of 131 patients with Ac-BSI, 65 (49.6%) died (non-survivors, NS). NS were older (63 [51, 76] vs. 56 [45, 66] years, p = 0.014), and sicker than survivors (S): APACHE II (24 [19, 31] vs. 18 [13, 22], p < 0.001) and Charlson (5 [2, 8] vs. 3 [1, 6], p = 0.009) scores. NS were also more likely than S to require pressors (75.4% vs. 42.4%, p < 0.001) and mechanical ventilation (75.4% vs. 53.0%, p = 0.008). Both CRAc (69.2% vs. 47.0%, p = 0.010) and non-IAAT (83.1% vs. 59.1%, p = 0.002) were more frequent among NS than S. In multivariate analyses, non-IAAT emerged as an independent predictor of hospital death (risk ratio [RR] 1.42, 95% confidence interval [CI] 1.10-1.58), while CRAc was the single strongest predictor of non-IAAT (RR 2.66, 95% CI 2.43-2.72). CONCLUSIONS: Among septic ICU patients with Ac-BSI, non-IAAT predicts mortality. Carbapenem resistance appears to mediate the relationship between non-IAAT and mortality

An international multicenter retrospective study of Pseudomonas aeruginosa nosocomial pneumonia: Impact of multidrug resistance

Introduction: Pseudomonas aeruginosa nosocomial pneumonia (Pa-NP) is associated with considerable morbidity, prolonged hospitalization, increased costs, and mortality. Methods: We conducted a retrospective cohort study of adult patients with Pa-NP to determine 1) risk factors for multidrug-resistant (MDR) strains and 2) whether MDR increases the risk for hospital death. Twelve hospitals in 5 countries (United States, n = 3; France, n = 2; Germany, n = 2; Italy, n = 2; and Spain, n = 3) participated. We compared characteristics of patients who had MDR strains to those who did not and derived regression models to identify predictors of MDR and hospital mortality. Results: Of 740 patients with Pa-NP, 226 patients (30.5%) were infected with MDR strains. In multivariable analyses, independent predictors of multidrug-resistance included decreasing age (adjusted odds ratio [AOR] 0.91, 95% confidence interval [CI] 0.96-0.98), diabetes mellitus (AOR 1.90, 95% CI 1.21-3.00) and ICU admission (AOR 1.73, 95% CI 1.06-2.81). Multidrug-resistance, heart failure, increasing age, mechanical ventilation, and bacteremia were independently associated with in-hospital mortality in the Cox Proportional Hazards Model analysis. Conclusions: Among patients with Pa-NP the presence of infection with a MDR strain is associated with increased in-hospital mortality. Identification of patients at risk of MDR Pa-NP could facilitate appropriate empiric antibiotic decisions that in turn could lead to improved hospital survival