Aims To assess the proportion of patients with heart failure and reduced ejection fraction (HFrEF) who are eligible for sacubitril/valsartan (LCZ696) based on the European Medicines Agency/Food and Drug Administration (EMA/FDA) label, the PARADIGM‐HF trial and the 2016 ESC guidelines, and the association between eligibility and outcomes. Methods and results Outpatients with HFrEF in the ESC‐EORP‐HFA Long‐Term Heart Failure (HF‐LT) Registry between March 2011 and November 2013 were considered. Criteria for LCZ696 based on EMA/FDA label, PARADIGM‐HF and ESC guidelines were applied. Of 5443 patients, 2197 and 2373 had complete information for trial and guideline eligibility assessment, and 84%, 12% and 12% met EMA/FDA label, PARADIGM‐HF and guideline criteria, respectively. Absent PARADIGM‐HF criteria were low natriuretic peptides (21%), hyperkalemia (4%), hypotension (7%) and sub‐optimal pharmacotherapy (74%); absent Guidelines criteria were LVEF>35% (23%), insufficient NP levels (30%) and sub‐optimal pharmacotherapy (82%); absent label criteria were absence of symptoms (New York Heart Association class I). When a daily requirement of ACEi/ARB ≥ 10 mg enalapril (instead of ≥ 20 mg) was used, eligibility rose from 12% to 28% based on both PARADIGM‐HF and guidelines. One‐year heart failure hospitalization was higher (12% and 17% vs. 12%) and all‐cause mortality lower (5.3% and 6.5% vs. 7.7%) in registry eligible patients compared to the enalapril arm of PARADIGM‐HF. Conclusions Among outpatients with HFrEF in the ESC‐EORP‐HFA HF‐LT Registry, 84% met label criteria, while only 12% and 28% met PARADIGM‐HF and guideline criteria for LCZ696 if requiring ≥ 20 mg and ≥ 10 mg enalapril, respectively. Registry patients eligible for LCZ696 had greater heart failure hospitalization but lower mortality rates than the PARADIGM‐HF enalapril group.
Introduction: Decreased physical activity has been associated with poorer mental health and is a cause for concern during the COVID-19 pandemic. Objective: To compare groups of medical students (MS) who practiced different levels of moderate and vigorous physical activity (MVPA) during the COVID-19 pandemic, in relation to symptoms of anxiety and depression (BAI-BDI), sleep quality (PSQI), and physical activity (PA) - light, moderate, vigorous (LPA-MPA and VPA), and sedentary behavior (SB). Methods: This research is a cross-sectional study involving 218 MS. Data on the characteristics of the MS were collected through online forms: PA, SB, BAI, BDI, and PSQI. The Cohen's D (Effect Size - ES) and confidence interval (95% CI), Mann-Whitney test: Lower MVPA (Median=0 minute) and Higher MVPA (Median=390 minutes) were recorded. For the statistical analyses, we used: the Odds ratio (OR) for the presence of symptoms of high levels of anxiety and depression and poor sleep quality in the MS and MVPA. Results: We found a small ES for symptoms of depression (ES 0.26 95% CI 0.00 0.53 p=0.029), and significant differences (p<0.05) for symptoms of anxiety (ES 0.17 95% CI −0.09 0.44 p=0.037). There was also a significant tendency for sedentary behavior on weekdays (ES 0.27 95% CI 0.00 0.53 p = 0.051). The OR for MVPA and the presence of symptoms of high levels of anxiety was 0.407 (95% CI = 0.228 to 0.724). Conclusions: the MS who practiced higher MVPA presented less symptoms of anxiety and depression during the COVID-19 pandemic. Level of evidence III; Case-control study.
Background Despite the reduction in mortality and hospitalization rates, resynchronization therapy still has 30-40% of non-responders. Several studies are ongoing to evaluate if novel programming techniques such as multipoint pacing (MPP) increase the conversion rate of non-responder to responder to CRT. However, there is still lack of information about conversion to super-responders and the impact in quality of life of MPP. Purpose To evaluate the impact of MPP in conversion to super-responders and its impact in the quality of life of patients. Methods Randomized clinical trial of non-AF patients with indication for CRT and who implanted the Quartet™ quadripolar left ventricle (LV) lead. After implant, CRTs were programmed on biventricular pacing according to the latest activated area for 6 months. After a 6-month follow-up, patients were randomized in a 1:1 fashion to MPP ON or MPP OFF. MPP was programmed with the two widest spaced LV electrodes and with a LV1-LV2 to LV2-RV delay of 5ms. Patients were followed-up for 12 months with a 6-month evaluation of NTproBNP, echocardiographic remodeling criteria (LV end systolic volume (ESV) and LV ejection fraction), and quality of life (QoL) evaluated by EQ-5D, Minnesota Living with Heart Failure (MLWHF) questionnaire and 6-minute walk test (6MWT). Results 76 patients were included in this trial, 62 with a completed 12-month follow-up (average age 67.2 ± 10.2 years old, 32.3% female gender, dilated cardiomyopathy in 77.4%). Among these patients, 24 were randomized to MPP ON, 28 to MPP OFF. Six patients died and 4 were lost to follow-up. Baseline clinical and echocardiographic characteristics were similar between groups (p = NS). At 6 months, the overall response rate (reduction in ESV≥15%) was 75%. At twelve months, patients randomized to MPP ON had a super-response rate (reduction in ESV≥30%) higher than patients with MPP OFF (75% vs 39.3%, p = 0.01). Between 6-12 months, patients assigned to MPP ON had a higher reduction in ESV (93.4 ± 52.3mL to 82.1 ± 40.5mL, p = 0.04) and an improvement in LVEF (38.3 ± 9.8% to 45.1 ± 11.1%, p < 0.01) compared to patients with MPP OFF (92.2 ± 47.3mL to 95.4 ± 47.5mL, p = NS; 37.1 ± 12.0% to 40.2 ± 9.2%, p = NS). Additionally, QoL of patients with MPP ON improved during follow up (EQ-5D 78.3% to 86.3%, p < 0.01; MLWHF 12.1 to 6.6, p = 0.03, 6MWT 316m to 239m, p = NS; NTproBNP 1608 ± 2450pg/mL to 775 ± 914pg/mL, p = NS) and was unchanged in MPP OFF patients (76.6% to 74.2%; MLWHF 12.7 to 12.7; 6MWT 338m to 299m, NTproBNP 1112 ± 1442pg/mL to 1383 ± 2118pg/mL, for all p = NS). Conclusion In our population, patients with CRT programmed with MPP ON, when compared to MPP OFF, had an improvement in the super-response rate and in quality of life. These results may be consequence from a more favorable reverse remodeling due to MPP, with a higher reduction in the LV end systolic volume. Abstract Figure.
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