Prognostic value of discharge heart rate in acute heart failure patients: More relevant in atrial fibrillation?

Aims: The prognostic impact of heart rate (HR) in acute heart failure (AHF) patients is not well known especially in atrial fibrillation (AF) patients. The aim of the study was to evaluate the impact of admission HR, discharge HR, HR difference (admission-discharge) in AHF patients with sinus rhythm (SR) or AF on long- term outcomes. Methods: We included 1398 patients consecutively admitted with AHF between October 2013 and December 2014 from a national multicentre, prospective registry. Logistic regression models were used to estimate the association between admission HR, discharge HR and HR difference and one- year all-cause mortality and HF readmission. Results: The mean age of the study population was 72+/-12years. Of these, 594 (42.4%) were female, 655 (77.8%) were hypertensive and 655 (46.8%) had diabetes. Among all included patients, 745 (53.2%) had sinus rhythm and 653 (46.7%) had atrial fibrillation. Only discharge HR was associated with one year all-cause mortality (Relative risk (RR)=1.182, confidence interval (CI) 95% 1.024-1.366, p=0.022) in SR. In AF patients discharge HR was associated with one year all cause mortality (RR=1.276, CI 95% 1.115-1.459, p</=0.001). We did not observe a prognostic effect of admission HR or HRD on long-term outcomes in both groups. This relationship is not dependent on left ventricular ejection fraction. Conclusions: In AHF patients lower discharge HR, neither the admission nor the difference, is associated with better long-term outcomes especially in AF patients

Levosimendan Efficacy and Safety: 20 years of SIMDAX in Clinical Use

Levosimendan was first approved for clinic use in 2000, when authorisation was granted by Swedish regulatory authorities for the haemodynamic stabilisation of patients with acutely decompensated chronic heart failure. In the ensuing 20 years, this distinctive inodilator, which enhances cardiac contractility through calcium sensitisation and promotes vasodilatation through the opening of adenosine triphosphate-dependent potassium channels on vascular smooth muscle cells, has been approved in more than 60 jurisdictions, including most of the countries of the European Union and Latin America. Areas of clinical application have expanded considerably and now include cardiogenic shock, takotsubo cardiomyopathy, advanced heart failure, right ventricular failure and pulmonary hypertension, cardiac surgery, critical care and emergency medicine. Levosimendan is currently in active clinical evaluation in the US. Levosimendan in IV formulation is being used as a research tool in the exploration of a wide range of cardiac and non-cardiac disease states. A levosimendan oral form is at present under evaluation in the management of amyotrophic lateral sclerosis. To mark the 20 years since the advent of levosimendan in clinical use, 51 experts from 23 European countries (Austria, Belgium, Croatia, Cyprus, Czech Republic, Estonia, Finland, France, Germany, Greece, Hungary, Italy, the Netherlands, Norway, Poland, Portugal, Russia, Slovenia, Spain, Sweden, Switzerland, UK and Ukraine) contributed to this essay, which evaluates one of the relatively few drugs to have been successfully introduced into the acute heart failure arena in recent times and charts a possible development trajectory for the next 20 years

Omecamtiv mecarbil in chronic heart failure with reduced ejection fraction, GALACTIC‐HF: baseline characteristics and comparison with contemporary clinical trials

Aims: The safety and efficacy of the novel selective cardiac myosin activator, omecamtiv mecarbil, in patients with heart failure with reduced ejection fraction (HFrEF) is tested in the Global Approach to Lowering Adverse Cardiac outcomes Through Improving Contractility in Heart Failure (GALACTIC‐HF) trial. Here we describe the baseline characteristics of participants in GALACTIC‐HF and how these compare with other contemporary trials. Methods and Results: Adults with established HFrEF, New York Heart Association functional class (NYHA) ≥ II, EF ≤35%, elevated natriuretic peptides and either current hospitalization for HF or history of hospitalization/ emergency department visit for HF within a year were randomized to either placebo or omecamtiv mecarbil (pharmacokinetic‐guided dosing: 25, 37.5 or 50 mg bid). 8256 patients [male (79%), non‐white (22%), mean age 65 years] were enrolled with a mean EF 27%, ischemic etiology in 54%, NYHA II 53% and III/IV 47%, and median NT‐proBNP 1971 pg/mL. HF therapies at baseline were among the most effectively employed in contemporary HF trials. GALACTIC‐HF randomized patients representative of recent HF registries and trials with substantial numbers of patients also having characteristics understudied in previous trials including more from North America (n = 1386), enrolled as inpatients (n = 2084), systolic blood pressure &lt; 100 mmHg (n = 1127), estimated glomerular filtration rate &lt; 30 mL/min/1.73 m2 (n = 528), and treated with sacubitril‐valsartan at baseline (n = 1594). Conclusions: GALACTIC‐HF enrolled a well‐treated, high‐risk population from both inpatient and outpatient settings, which will provide a definitive evaluation of the efficacy and safety of this novel therapy, as well as informing its potential future implementation

Guidance on the management of left ventricular assist device (LVAD) supported patients for the non-LVAD specialist healthcare provider: executive summary

The accepted use of left ventricular assist device (LVAD) technology as a good alternative for the treatment of patients with advanced heart failure together with the improved survival of patients on the device and the scarcity of donor hearts has significantly increased the population of LVAD supported patients. Device-related, and patient-device interaction complications impose a significant burden on the medical system exceeding the capacity of LVAD implanting centres. The probability of an LVAD supported patient presenting with medical emergency to a local ambulance team, emergency department medical team and internal or surgical wards in a non-LVAD implanting centre is increasing. The purpose of this paper is to supply the immediate tools needed by the non-LVAD specialized physician - ambulance clinicians, emergency ward physicians, general cardiologists, and internists - to comply with the medical needs of this fast-growing population of LVAD supported patients. The different issues discussed will follow the patient's pathway from the ambulance to the emergency department, and from the emergency department to the internal or surgical wards and eventually back to the general practitioner

Multi-level factors are associated with immunosuppressant nonadherence in heart transplant recipients: the international bright study

Factors at the level of family/healthcare worker-, organization- and system are neglected in medication nonadherence research in heart transplantation (HTx). The four-continent, eleven-country cross-sectional BRIGHT study used multi-staged sampling to examine 36 HTx centers, including 36 HTx directors, 100 clinicians, and 1397 patients. Nonadherence to immunosuppressants-defined as any deviation in taking or timing adherence and/or dose reduction-was assessed using the BAASIS® interview. Guided by the Integrative Model of Behavioral Prediction and Bronfenbrenner's ecological model, we analyzed factors at these multiple levels using sequential logistic regression analysis (6 blocks). The nonadherence prevalence was 34.1%. Six multi-level factors were associated independently (either positively or negatively) with nonadherence: patient level: barriers to taking immunosuppressants (OR: 11.48); smoking (OR:2.19); family/healthcare provider level: frequency of having someone to help patients read health-related materials (OR:0.85); organization level: clinicians reporting non-adherent patients were targeted with adherence interventions (OR: 0.66); pick-up of medications at physician's office (OR: 2.31); and policy level: monthly out-of-pocket costs for medication (OR: 1.16). Factors associated with nonadherence are evident at multiple levels. Improving medication nonadherence requires addressing not only the patient, but also family/healthcare provider, organization, and policy levels. This article is protected by copyright. All rights reserved.status: accepte

Guidance on the management of left ventricular assist device (LVAD) supported patients for the non-LVAD specialist healthcare provider: executive summary

The accepted use of left ventricular assist device (LVAD) technology as a good alternative for the treatment of patients with advanced heart failure together with the improved survival of patients on the device and the scarcity of donor hearts has significantly increased the population of LVAD supported patients. Device-related, and patient-device interaction complications impose a significant burden on the medical system exceeding the capacity of LVAD implanting centres. The probability of an LVAD supported patient presenting with medical emergency to a local ambulance team, emergency department medical team and internal or surgical wards in a non-LVAD implanting centre is increasing. The purpose of this paper is to supply the immediate tools needed by the non-LVAD specialized physician - ambulance clinicians, emergency ward physicians, general cardiologists, and internists - to comply with the medical needs of this fast-growing population of LVAD supported patients. The different issues discussed will follow the patient's pathway from the ambulance to the emergency department, and from the emergency department to the internal or surgical wards and eventually back to the general practitioner

Multilevel factors are associated with immunosuppressant nonadherence in heart transplant recipients: The international BRIGHT study.

Factors at the level of family/healthcare worker, organization, and system are neglected in medication nonadherence research in heart transplantation (HTx). The 4-continent, 11-country cross-sectional Building Research Initiative Group: Chronic Illness Management and Adherence in Transplantation (BRIGHT) study used multistaged sampling to examine 36 HTx centers, including 36 HTx directors, 100 clinicians, and 1397 patients. Nonadherence to immunosuppressants-defined as any deviation in taking or timing adherence and/or dose reduction-was assessed using the Basel Assessment of Adherence to Immunosuppressive Medications Scale© (BAASIS© ) interview. Guided by the Integrative Model of Behavioral Prediction and Bronfenbrenner's ecological model, we analyzed factors at these multiple levels using sequential logistic regression analysis (6 blocks). The nonadherence prevalence was 34.1%. Six multilevel factors were associated independently (either positively or negatively) with nonadherence: patient level: barriers to taking immunosuppressants (odds ratio [OR]: 11.48); smoking (OR: 2.19); family/healthcare provider level: frequency of having someone to help patients read health-related materials (OR: 0.85); organization level: clinicians reporting nonadherent patients were targeted with adherence interventions (OR: 0.66); pickup of medications at physician's office (OR: 2.31); and policy level: monthly out-of-pocket costs for medication (OR: 1.16). Factors associated with nonadherence are evident at multiple levels. Improving medication nonadherence requires addressing not only the patient, but also family/healthcare provider, organization, and policy levels

Stosowanie digoksyny jest związane ze zwiększonym ryzykiem śmierci u pacjentów z niewydolnością serca leczonych beta-adrenolitykami. Dane z polskiej części ESC HF Long-Term Registry.

Background: Digoxin is used in the treatment of atrial fibrillation (AF) and heart failure (HF). It was reported to increase the risk of death in HF. Studies on digoxin are based mainly on patients treated some years ago, before the era of common b-blocker use. Aim: This study aims to show the influence of digoxin in a modern cohort of HF patients on top of the contemporary guideline-directed treatment. Methods: This study retrospectively analyses the Polish part of the European Society of Cardiology Heart Failure Long-Term Registry. It includes 912 patients treated for HF between February 2012 and January 2013, and followed until May 2014. At baseline, 19.1% took digoxin, 89.6% angiotensin convertase enzyme inhibitors or angiotensin receptor blockers, 91.9% b-blockers, and 69.4% mineralocorticoid receptor antagonists. Results: Digoxin is associated with increased risk of death after adjustment for significant covariates in patients who have HF with reduced ejection fraction (HFrEF) but no AF history (hazard ratio [HR] 2.52, 95% confidence interval [CI] 1.23–5.19; p = 0.011), and it does not influence significantly the risk of hospitalisation (adjusted HR 1.46, 95% CI 1.05–1.72; p = 0.11). Digoxin use shows no significant association with the risk of death or hospitalisation in patients with AF and HFrEF or HF with preserved ejection fraction (HFpEF). Patients on digoxin present a significantly worse clinical status with lower left ventricular ejection fraction and higher New York Heart Association class, and fewer of them received the guideline-directed treatment. Conclusions: Digoxin is associated with increased risk of death in HFrEF patients without AF history receiving the guideline- -directed treatment. Digoxin seems to be employed in patients with worse clinical status, which may at least partially explain its association with increased risk of death.Wstęp: Digoksyna jest używana w leczeniu migotania przedsionków i niewydolności serca. Pojawiają się doniesienia, że może zwiększać ryzyko zgonu u pacjentów z niewydolnością serca. Opracowania na temat digoksyny opierają się głównie na analizach populacji pacjentów leczonych wiele lat temu, przed epoką powszechnego stosowania beta-adrenolityków.   Cel: To badanie ma na celu ukazanie wpływu digoksyny na leczenie we współczesnej grupie chorych z niewydolnością serca leczonych według współczesnych wytycznych.   Metodyka: Jest to retrospektywna analiza polskiej części rejestru ESC HF Long-Term Registry. Właczono do niej 912 pacjentów leczonych z powodu niewydolności serca od lutego 2012 r. do stycznia 2013 r., których obserwowano do maja 2014 r. Spośród nich 19.1% zażywało digoksynę, 89.6% inhibitor konwertazy angiotensyny lub antagonistę receptorów angiotensynowych, 91.9% beta-adrenolityki i 69.4% antagonistów aldosteronu.   Wyniki: Zażywanie digoksyny było związane ze zwiększonym ryzykiem śmierci w analizie wieloczynnikowej z uwzględnieniem innych istotnych zmiennych u pacjentów z niewydolnością serca z obniżoną frakcją wyrzucania lewej komory i bez migotania przedsionków (HR 2.70; p=0.007), ale nie wpływa istotnie na ryzyko hospitalizacji (analiza jednoczynnikowa HR 1.84, p=0.005; wieloczynnikowa HR 1.46, p=0.11). Nie obserwowano istotnego związku z ryzykiem śmierci lub hospitalizacji w grupie pacjentów z migotaniem przedsionków, niezależnie od frakcji wyrzucania lewej komory. Pacjenci zażywający digoksynę byli w istotnie gorszym stanie klinicznym z niższą średnią frakcją wyrzucania lewej komory i wyższą średnią klasą NYHA.   Wnioski: Zażywanie digoksyny jest związane z wyższym ryzykiem zgonu u pacjentów z niewydolnością serca z obniżoną frakcją wyrzucania lewej komory i bez migotania przedsionków, leczonych według współczesnych wytycznych. Digoksyna wydaje się być używana głównie u pacjentów w gorszym stanie klinicznym, co może przynajmniej częściowo tłumaczyć jej związek ze zwiększonym ryzykiem zgonu.

Impact of digoxin on risk of death in heart failure patients treated with b-blockers. Results from Polish part of ESC Heart Failure Long-Term Registry

Background: Digoxin is used in the treatment of atrial fibrillation (AF) and heart failure (HF). It was reported to increase the risk of death in HF. Studies on digoxin are based mainly on patients treated some years ago, before the era of common b-blocker use. Aim: This study aims to show the influence of digoxin in a modern cohort of HF patients on top of the contemporary guideline-directed treatment. Methods: This study retrospectively analyses the Polish part of the European Society of Cardiology Heart Failure Long-Term Registry. It includes 912 patients treated for HF between February 2012 and January 2013, and followed until May 2014. At baseline, 19.1% took digoxin, 89.6% angiotensin convertase enzyme inhibitors or angiotensin receptor blockers, 91.9% b-blockers, and 69.4% mineralocorticoid receptor antagonists. Results: Digoxin is associated with increased risk of death after adjustment for significant covariates in patients who have HF with reduced ejection fraction (HFrEF) but no AF history (hazard ratio [HR] 2.52, 95% confidence interval [CI] 1.23–5.19; p = 0.011), and it does not influence significantly the risk of hospitalisation (adjusted HR 1.46, 95% CI 1.05–1.72; p = 0.11). Digoxin use shows no significant association with the risk of death or hospitalisation in patients with AF and HFrEF or HF with preserved ejection fraction (HFpEF). Patients on digoxin present a significantly worse clinical status with lower left ventricular ejection fraction and higher New York Heart Association class, and fewer of them received the guideline-directed treatment. Conclusions: Digoxin is associated with increased risk of death in HFrEF patients without AF history receiving the guideline- -directed treatment. Digoxin seems to be employed in patients with worse clinical status, which may at least partially explain its association with increased risk of death.Wstęp: Digoksyna jest używana w leczeniu migotania przedsionków i niewydolności serca. Pojawiają się doniesienia, że może zwiększać ryzyko zgonu u pacjentów z niewydolnością serca. Opracowania na temat digoksyny opierają się głównie na analizach populacji pacjentów leczonych wiele lat temu, przed epoką powszechnego stosowania beta-adrenolityków.   Cel: To badanie ma na celu ukazanie wpływu digoksyny na leczenie we współczesnej grupie chorych z niewydolnością serca leczonych według współczesnych wytycznych.   Metodyka: Jest to retrospektywna analiza polskiej części rejestru ESC HF Long-Term Registry. Właczono do niej 912 pacjentów leczonych z powodu niewydolności serca od lutego 2012 r. do stycznia 2013 r., których obserwowano do maja 2014 r. Spośród nich 19.1% zażywało digoksynę, 89.6% inhibitor konwertazy angiotensyny lub antagonistę receptorów angiotensynowych, 91.9% beta-adrenolityki i 69.4% antagonistów aldosteronu.   Wyniki: Zażywanie digoksyny było związane ze zwiększonym ryzykiem śmierci w analizie wieloczynnikowej z uwzględnieniem innych istotnych zmiennych u pacjentów z niewydolnością serca z obniżoną frakcją wyrzucania lewej komory i bez migotania przedsionków (HR 2.70; p=0.007), ale nie wpływa istotnie na ryzyko hospitalizacji (analiza jednoczynnikowa HR 1.84, p=0.005; wieloczynnikowa HR 1.46, p=0.11). Nie obserwowano istotnego związku z ryzykiem śmierci lub hospitalizacji w grupie pacjentów z migotaniem przedsionków, niezależnie od frakcji wyrzucania lewej komory. Pacjenci zażywający digoksynę byli w istotnie gorszym stanie klinicznym z niższą średnią frakcją wyrzucania lewej komory i wyższą średnią klasą NYHA.   Wnioski: Zażywanie digoksyny jest związane z wyższym ryzykiem zgonu u pacjentów z niewydolnością serca z obniżoną frakcją wyrzucania lewej komory i bez migotania przedsionków, leczonych według współczesnych wytycznych. Digoksyna wydaje się być używana głównie u pacjentów w gorszym stanie klinicznym, co może przynajmniej częściowo tłumaczyć jej związek ze zwiększonym ryzykiem zgonu.

Levosimendan Efficacy and Safety : 20 Years of SIMDAX in Clinical Use

Levosimendan was first approved for clinical use in 2000, when authorization was granted by Swedish regulatory authorities for the hemodynamic stabilization of patients with acutely decompensated chronic heart failure (HF). In the ensuing 20 years, this distinctive inodilator, which enhances cardiac contractility through calcium sensitization and promotes vasodilatation through the opening of adenosine triphosphate-dependent potassium channels on vascular smooth muscle cells, has been approved in more than 60 jurisdictions, including most of the countries of the European Union and Latin America. Areas of clinical application have expanded considerably and now include cardiogenic shock, takotsubo cardiomyopathy, advanced HF, right ventricular failure, pulmonary hypertension, cardiac surgery, critical care, and emergency medicine. Levosimendan is currently in active clinical evaluation in the United States. Levosimendan in IV formulation is being used as a research tool in the exploration of a wide range of cardiac and noncardiac disease states. A levosimendan oral form is at present under evaluation in the management of amyotrophic lateral sclerosis. To mark the 20 years since the advent of levosimendan in clinical use, 51 experts from 23 European countries (Austria, Belgium, Croatia, Cyprus, Czech Republic, Estonia, Finland, France, Germany, Greece, Hungary, Italy, the Netherlands, Norway, Poland, Portugal, Russia, Slovenia, Spain, Sweden, Switzerland, the United Kingdom, and Ukraine) contributed to this essay, which evaluates one of the relatively few drugs to have been successfully introduced into the acute HF arena in recent times and charts a possible development trajectory for the next 20 years