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.
The number of CABG increases despite the enlargement of PCI. The risk for isolated CABG given by EuroSCORE increases over years. The risk factors, significantly contributing to higher EuroSCORE are: older age, extracardiac arteriopathy, recent myocardial infarction and emergency operation.
During the last years, the results in isolated coronary surgery have considerably improved. The EuroSCORE overestimates operative risk. In order to improve its predictive value, the model should be recalibrated.
The EuroSCORE II might be considered a solid predictive tool for hospital mortality. Although, the EuroSCORE II employs more sophisticated calculation methods regarding the number and definition of risk factors included, it does not seem to significantly improve the performance of previous iterations.
During the last several years many authors have found that the European System for Cardiac Operative Risk Evaluation is useful in the prediction of not only postoperative mortality but also of the length of stay in the intensive care unit, complication rate and overall treatment expenses. This study included 329 patients who had undergone isolated surgical myocardial revascularization at our Department during the period from January 1st to June 6th, 2008. For the operative risk evaluation, the additive European System for Cardiac Operative Risk Evaluaion was used. In group I (low risk 0-2%) there were 144 patients (43.7%), whereas group II (medium risk 3-5%) and group III (high risk > or = 6%) included 141 (42.8%) and 44 (13.4%) patients, respectively. The length of stay in the intensive care unit was 25.56, 32.43 and 49.59 hours for groups I, II and III, respectively. The difference in the mean length of stay in the intensive care unit between the groups was highly statistically significant (p < 0.001) with a positive correlation (R = 0.193; p < 0.001). There is a positive correlation in patients who had undergone surgical myocardial revascularization in terms of operative risk expressed by the additive European System for Cardiac Operative Risk Evaluation and length of stay in the intensive care unit, total intubation period and development of early postoperative complications.
The additive and logistic European Systems for Cardiac Operative Risk Evaluation overestimate while the European System for Cardiac Operative Risk Evaluation II underestimates the risk in cardiac surgery. We believe that a locally derived model would be of great use in the everyday clinical practice since it would faithfully illustrate the actual state of patient population of the region where it was developed. At the same time it would provide the accurate prediction of surgical outcome.
RADO significantly changes left ventricular morphology, reverses remodeling of the heart, decreases sphericity of the left heart, improves hemodynamic function of both ventricles, and slows down progression of cardiac failure. We recommend RADO in the early stage of PDCM, immediately after the first decompensation, and as an important associated procedure in IDCM.
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