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.

AimsThe aim of the LAICA study was to evaluate the long-term effectiveness and safety of intermittent levosimendan infusion in patients with advanced heart failure (AdHF). Methods and resultsThis was a multicentre, randomized, double-blind, placebo-controlled clinical trial of intermittent levosimendan 0.1 μg/kg/min as a continuous 24-h intravenous infusion administered once monthly for 1 year in patients with AdHF. The primary endpoint [incidence of rehospitalization (admission to the emergency department or hospital ward for >12 h) for acute decompensated HF or clinical deterioration of the underlying HF] occurred in 23/70 (33%) of the levosimendan group (Group I) and 12/27 (44%) of the placebo group (Group II) (P = 0.286). The incidence of hospital readmissions for acute decompensated HF (Group I vs. Group II) at 1, 3, 6, and 12 months was 4.2% vs. 18.2% (P = 0.036); 12.8% vs. 33.3% (P = 0.02); 25.7% vs. 40.7% (P = 0.147); 32.8% vs. 44.4% (P = 0.28), respectively. In a secondary pre-specified time-to-event analysis no differences were observed in admission for acute decompensated HF between patients treated with levosimendan compared with placebo (hazard ratio 0.66; 95% CI, 0.32-1.32; P = 0.24). Cumulative incidence for the aggregated endpoint of acute decompensation of HF and/or death at 1 and 3 months were significatively lower in the levosimendan group than in placebo group [5.7% vs. 25.9% (P = 0.004) and 17.1% vs. 48.1% (P = 0.001), respectively], but not at 6 and 12 months [34.2% vs. 59.2% (P = 0.025); 41.4% vs. 66.6% (P = 0.022), respectively]. Survival probability was significantly higher in patients who received levosimendan compared with those who received placebo (log rank: 4.06; P = 0.044). There were no clinically relevant differences in tolerability between levosimendan and placebo and no new safety signals were observed. Conclusions In our study, intermittent levosimendan in patients with AdHF produced a statistically non-significant reduction in the incidence of hospital readmissions for acute decompensated HF, a significantly lower cumulative incidence of acute decompensation of HF and/or death at 1 and 3 month of treatment and a significant improvement in survival during 12 months of treatment.

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BackgroundAnkylosing spondylitis (AS) is a disease with very characteristic extraarticular organ involvements. Cardiac conduction disturbances and aortic root diseases are some of the most particular manifestations of this disease¹. The most frequent conduction disturbances are atrioventricular blocks (AVB), bundle branch blocks (BBB) and intraventricular conduction disturbances (IVCD)². The prevalence of AVB is 3% and 8% for IVCD in the general population³. In some cross-sectional studies of the AS population4,5 the prevalence was reported to be around 4.6%–9% for AVB and 4%–29% for IVCD. Some studies propose that there may be a relation between the conduction disturbances and the inflammation of the aortic root due to disease activity6,7,8.ObjectivesThis study aims to evaluate association between the electrocardiographic alterations (AVB, BBB, IVCD) and aortic root dilation in patients with AS.MethodsOut of a registry of 118 patients from a spondyloarthritis consultation, we selected patients with AS according to New York criteria. We included those patients who had underwent an electrocardiography (EKG) and an echocardiography, in ordeer to rule out heart disease or to check up because of long term AS. Demographical and clinical data (cardiovascular risk factors, past heart disease, presence of arthritis, enthesitis, dactylitis, uveitis and HLAB27) were collected. The EKG were reevaluated looking for IVCD, AVB or BBB by a blinded arrhythmologist. Echocardiographical data about aortic root dilation were collected using aortic root diameter adjusted by body surface area. We carried out chi squared analysis as well as a comparison of proportions. We summarised descriptive data of our sample in table 1.ResultsOut of 118 patients, 38 patients met inclusion criteria. Fourteen of them (36.8%) were women. The average age was 60.3 years old and mean disease duration was 19.62 years.Conduction disturbances was present in 12 (31.5%) patients of whom 4 were AVB (10.5%), 5 BBB (13.2%) and 3 IVCD (7.8%). Aortic root dilation was found in 6 (15.8%) of the 38 patients.The conduction disturbances showed a statistically significant association with aortic root dilation (chi square p=0.02). In comparison of two proportions, the prevalence of aortic root dilation in abnormal EKG group (0.67 IC95% 0.36%–0.97%) was significantly higher than normal EKG group (0.6 IC95% 0.36–0.97) p=0.02.Abstract FRI0197 – Table 1ConclusionsThe prevalence of aortic root dilation and conduction disturbances was higher in our sample than in the general population. In our sample the presence of aortic root dilation and conduction disturbances (AVB, BBB, IVCD) had a statistically significant association. The principal limitations of this study are the small sample size and the retrospective nature in patient selection.References[1]. ARD 2018;0:1–8.[2] Am J Cardiol2017;120:2226–2232.[3] Rev Esp Cardiol2005;58(6):657–65.[4] BMC Muscul Dis2013;14:237.[5] Scand J Rheumatol2010;39:38–41.[6] Joint Bone Spine2011;78:451–455.[7] Clin Rheumatol2015;34:995–998.[8] ...

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