Comorbidities and their implications in patients with and without type 2 diabetes mellitus and heart failure with preserved ejection fraction. Findings from the rica registry.

AIM: To determine if patients with heart failure and preserved ejection fraction (HFpEF) and type 2 diabetes mellitus (T2DM) have a higher comorbidity burden than those without T2DM, if other comorbidities are preferentially associated with T2DM and if these conditions confer a worse patient prognosis. METHODS AND RESULTS: Cohort study based on the RICA Spanish Heart Failure Registry, a multicentre, prospective registry that enrols patients admitted for decompensated HF and follows them for 1 year. We selected only patients with HFpEF, classified as having or not having T2DM and performed an agglomerative hierarchical clustering based on variables such as the presence of arrhythmia, chronic obstructive pulmonary disease, dyslipidemia, liver disease, stroke, dementia, body mass index, haemoglobin levels, estimated glomerular filtration rate and systolic blood pressure. A total of 1934 patients were analysed: 907 had T2DM (mean age 78.4 ± 7.6 years) and 1027 did not (mean age 81.4 ± 7.6 years). The analysis resulted in four clusters in patients with T2DM and three in the reminder. All clusters of patients with T2DM showed higher BMI and more kidney disease and anaemia than those without T2DM. Clusters of patients without T2DM had neither significantly better nor worse outcomes. However, among the T2DM patients, clusters 2, 3 and 4 all had significantly poorer outcomes, the worst being cluster 3 (HR 2.0, 95% CI 1.36-2.93, P = .001). CONCLUSIONS: Grouping our patients with HFpEF and T2DM into clusters based on comorbidities revealed a greater disease burden and prognostic implications associated with the T2DM phenotype, compared with those without T2DM.

Acute heart failure - an EFIM guideline critical appraisal and adaptation for internists.

BACKGROUND: Over the past two decades, several studies have been conducted that have tried to answer questions on management of patients with acute heart failure (AHF) in terms of diagnosis and treatment. Updated international clinical practice guidelines (CPGs) have endorsed the findings of these studies. The aim of this document was to adapt recommendations of existing guidelines to help internists make decisions about specific and complex scenarios related to AHF. METHODS: The adaptation procedure was to identify firstly unresolved clinical problems in patients with AHF in accordance with the PICO (Population, Intervention, Comparison and Outcomes) process, then conduct a critical assessment of existing CPGs and choose recommendations that are most applicable to these specific scenarios. RESULTS: Seven PICOs were identified and CPGs were assessed. There is no single test that can help clinicians in discriminating patients with acute dyspnoea, congestion or hypoxaemia. Performing of echocardiography and natriuretic peptide evaluation is recommended, and chest X-ray and lung ultrasound may be considered. Treatment strategies to manage arterial hypotension and low cardiac output include short-term continuous intravenous inotropic support, vasopressors, renal replacement therapy, and temporary mechanical circulatory support. The most updated recommendations on how to treat specific patients with AHF and certain comorbidities and for reducing post-discharge rehospitalization and mortality are provided. Overall, 51 recommendations were endorsed and the rationale for the selection is provided in the main text. CONCLUSION: Through the use of appropriate tailoring process methodology, this document provides a simple and updated guide for internists dealing with AHF patients.

The influence of comorbidities on the prognosis after an acute heart failure decompensation and differences according to ejection fraction: Results from the EAHFE and RICA registries.

OBJECTIVE: The role of comorbidities in heart failure (HF) outcome has been previously investigated, although mostly individually. We investigated the individual effect of 13 comorbidities on HF prognosis and looked for differences according to left-ventricular ejection fraction (LVEF), classified as reduced (HFrEF), mildly-reduced (HFmrEF) and preserved (HFpEF). METHODS: We included patients from the EAHFE and RICA registries and analysed the following comorbidities: hypertension, dyslipidaemia, diabetes mellitus (DM), atrial fibrillation (AF), coronary artery disease (CAD), chronic kidney disease (CKD), chronic obstructive pulmonary disease (COPD), heart valve disease (HVD), cerebrovascular disease (CVD), neoplasia, peripheral artery disease (PAD), dementia and liver cirrhosis (LC). Association of each comorbidity with all-cause mortality was assessed by an adjusted Cox regression analysis that included the 13 comorbidities, age, sex, Barthel index, New York Heart Association functional class and LVEF and expressed as adjusted Hazard Ratios (HR) with 95% confidence intervals (95%CI). RESULTS: We analysed 8,336 patients (82 years-old; 53% women; 66% with HFpEF). Mean follow-up was 1.0 years. Respect to HFrEF, mortality was lower in HFmrEF (HR:0.74;0.64-0.86) and HFpEF (HR:0.75;0.68-0.84). Considering patients all together, eight comorbidities were associated with mortality: LC (HR:1.85;1.42-2.42), HVD (HR:1.63;1.48-1.80), CKD (HR:1.39;1.28-1.52), PAD (HR:1.37;1.21-1.54), neoplasia (HR:1.29;1.15-1.44), DM (HR:1.26;1.15-1.37), dementia (HR:1.17;1.01-1.36) and COPD (HR:1.17;1.06-1.29). Associations were similar in the three LVEF subgroups, with LC, HVD, CKD and DM remaining significant in the three subgroups. CONCLUSION: HF comorbidities are associated differently with mortality, LC being the most associated with mortality. For some comorbidities, this association can be significantly different according to the LVEF.

Benefits of dapagliflozin in the whole spectrum of heart failure in clinical practice: the RICA registry.

Aims: To determine the projected benefits of dapagliflozin after an acute heart failure (HF) event in Spain. Methods: A multicenter and prospective study that included subjects aged 50 years or older consecutively admitted with HF to internal medicine departments in Spain. The projected clinical benefits of dapagliflozin were calculated via pooled analysis of the DAPA-HF and DELIVER trials. Results: A total of 5644 subjects were analyzed, of whom 79.2% were eligible for dapagliflozin, according to criteria of the DAPA-HF and DELIVER trials. Full implementation of dapagliflozin would imply a 1-year absolute risk reduction of 2.3% for death (number needed to treat = 43) and 5.7% (number needed to treat = 17) for HF rehospitalization. Conclusion: Treatment with dapagliflozin could significantly reduce HF burden in clinical practice.

Heart failure is a severe condition that is associated with a high risk of complications. This means that it is important to start using new therapies that have demonstrated a clinical benefit. Clinical trials have shown that dapagliflozin reduces the risk of developing these complications in patients with heart failure. However, it is important to find out whether the results of clinical trials are also seen in real-life populations. We estimated the potential benefits of dapagliflozin in people admitted to hospital more than once with heart failure. The study took place in Spain. Our data suggest that treatment with dapagliflozin could reduce the complications associated with heart failure in real-life patients.

Projected clinical benefits of dapagliflozin in patients with heart failure with preserved ejection fraction.

Aims: To address the projected clinical benefits of dapagliflozin among patients with heart failure (HF) with mildly reduced ejection fraction (HFmrEF) and preserved ejection fraction (HFpEF). Methods: A multicenter, prospective, cohort study of patients ≥50 years admitted with HF to Spanish internal medicine departments. The projected clinical benefits of dapagliflozin were calculated from the DELIVER trial. Results: A total of 4049 patients were included; 3271 (80.8%) were eligible for dapagliflozin treatment, according to DELIVER criteria. Within 1 year after discharge, 22.2% were rehospitalized for HF and 21.6% died. Implementation of dapagliflozin would translate into an absolute risk reduction of 1.3% for mortality and 5.1% for HF readmission. Conclusion: HF patients with preserved or mildly reduced ejection fraction have a high risk of events. The use of dapagliflozin could substantially reduce the HF burden.

Heart failure (HF) with preserved ejection fraction is frequent in clinical practice, particularly in the elderly. In HF with preserved ejection fraction, the heart still pumps a similar proportion of blood, but the heart muscle has become thicker. This means there is less space inside the heart to fill with blood, so too little is pumped out each time. Until very recently, no drugs had been shown to provide significant benefits on the outcome of the condition or the chance of recovery for these patients. Fortunately, recent clinical trials have demonstrated that treatment with drugs called SGLT2 inhibitors (e.g., dapagliflozin) could reduce the chance of being admitted to hospital or dying from HF. We investigated the benefits for patients who took dapagliflozin after being admitted to hospital and had HF with mildly reduced or preserved ejection fraction. We saw substantial benefits in this population.

Projected effectiveness of dapagliflozin in heart failure with reduced ejection fraction in clinical practice.

Aim: To estimate the projected effectiveness of dapagliflozin in subjects with heart failure (HF) with reduced ejection fraction in clinical practice in Spain. Materials & methods: This multicenter cohort study included subjects aged 50 years or older consecutively hospitalized for HF in internal medicine departments in Spain. The projected clinical benefits of dapagliflozin were estimated based on results from the DAPA-HF trial. Results: A total of 1595 patients were enrolled, of whom 1199 (75.2%) were eligible for dapagliflozin. Within 1 year after discharge, 21.6% of patients eligible for dapagliflozin were rehospitalized for HF and 20.5% died. Full implementation of dapagliflozin led to an absolute risk reduction of 3.5% for mortality (number needed to treat = 28) and 6.5% (number needed to treat = 15) for HF readmission. Conclusion: Treatment with dapagliflozin in clinical practice may markedly reduce mortality and readmissions for HF.

Heart failure with reduced ejection fraction is a severe disease with a high risk of hospitalization and mortality. With this condition, the heart muscle cannot pump properly. This means that not enough blood is pumped from the heart, reducing the amount of oxygen to the body. Fortunately, there are treatments that reduce this risk, in patients with heart failure. SGLT2 inhibitors, including dapagliflozin, are among the first therapies given to patients with heart failure. In this study, we investigated the potential benefits of adding dapagliflozin to the treatment of patients admitted to the hospital in Spain for heart failure with reduced ejection fraction. Our data showed that dapagliflozin was able to reduce the risk of further events (e.g., heart attack) in these patients.

Prognostic Impact of the UMIPIC Program in the Follow Up in Patients with Heart Failure and Cardiorenal Syndrome.

BACKGROUND: Individuals suffering from heart failure (HF) and cardiorenal syndrome (CRS) represent a special group of patients considering their age, multiple health issues, and treatment challenges. These factors make them more susceptible to frequent hospital stays and a higher mortality rate. UMIPIC is a multidisciplinary care model program for patients with heart failure follow up provided by internists and nurses who are experts in this entity. Our study delved into the effectiveness of this specialized care program (UMIPIC) in mitigating these risks for HF and CRS patients. METHODS: We analyzed the medical records of 3255 patients diagnosed with HF and CRS types 2 and 4, sourced from the RICA registry. These patients were divided into two distinct groups: those enrolled in the UMIPIC program (1205 patients) and those under standard care (2050 patients). Using propensity score matching, we ensured that both groups were comparable. The study focused on tracking hospital admissions and mortality rates for one year after an HF-related hospital stay. RESULTS: Patients in the UMIPIC group experienced fewer hospital readmissions due to HF compared to their counterparts (20% vs. 32%; Hazard Ratio [HR] = 0.48; 95% Confidence Interval [95% CI]: 0.40-0.57; p < 0.001). They also showed a lower mortality rate (24% vs. 36%; HR = 0.64; 95% CI: 0.54-0.75; p < 0.001). Furthermore, the UMIPIC group had fewer total hospital admissions (36% vs. 47%; HR = 0.58; 95% CI: 0.51-0.66; p < 0.001). CONCLUSIONS: The UMIPIC program, centered on holistic and ongoing care, effectively reduces both hospital admissions and mortality rates for HF and CRS patients after a one-year follow-up period.

Identifying the patient with heart failure to be treated with vericiguat.

The pathophysiology of heart failure with reduced ejection fraction (HFrEF) is a complex process in which a number of neurohormonal systems are involved. Targeting only some of these systems, but not all, translates into a partial benefit of HF treatment. The nitric oxide-soluble guanylate cyclase (sGC)-cGMP pathway is impaired in HF, leading to cardiac, vascular and renal disturbances. Vericiguat is a once-daily oral stimulator of sGC that restores this system. No other disease-modifying HF drugs act on this system. Despite guidelines recommendations, a substantial proportion of patients are not taking all recommended drugs or when taking them, they do so at low doses, limiting their potential benefits. In this context, treatment should be optimized considering different parameters, such as blood pressure, heart rate, renal function, or potassium, as they may interfere with their implementation at the recommended doses. The VICTORIA trial showed that adding vericiguat to standard therapy in patients with HFrEF significantly reduced the risk of cardiovascular death or HF hospitalization by 10% (NNT 24). Furthermore, vericiguat does not interfere with heart rate, renal function or potassium, making it particularly useful for improving the prognosis of patients with HFrEF in specific settings and clinical profiles.

Optimizing the management of patients with worsening heart failure: beyond heart failure hospitalization.

INTRODUCTION: Worsening heart failure (HF) is associated with a high risk of death and HF hospitalization. AREAS COVERED: A systematic search was conducted on PubMed (MEDLINE), using the MeSH terms [Heart failure] + [Worsening] + [Treatment] + [Vulnerable period] up to February 2023. Original data from clinical trials, and observational studies were critically analyzed. EXPERT OPINION: Although the vulnerable period has been traditionally limited to the first 6 months after HF hospitalization, the fact is that there are other clinical scenarios in which the patient is particularly vulnerable. These vulnerable patients may also include those that require parenteral administration of diuretics in the day hospital or emergency department, those in which the increase of oral diuretic dose in an outpatient setting is needed to relief congestive symptoms, as well as those that remain symptomatic despite treatment. On the other hand, HF is a complex disease in which different neurohormonal systems are involved. Therefore, to actually reduce the HF burden, a comprehensive management, targeting all the neurohormonal systems that are involved in the pathogenesis of HF, through the use of those drugs that have demonstrated to positively modify the clinical course of HF, is needed.

A cost-effectiveness analysis of patiromer for the treatment of hyperkalemia in chronic kidney disease patients with and without heart failure in Spain.

AIMS: Renin-angiotensin-aldosterone system inhibitors (RAASi) therapy is commonly used to reduce the risk of death and to slow down disease progression in patients with chronic kidney disease (CKD), heart failure (HF) and hypertension. However, the cardio-renal benefits of RAASi therapy are also associated with an increased risk of hyperkalemia (HK), which may lead to dose reduction or discontinuation of therapy. Patiromer has demonstrated to reduce the risk of HK, which enables to maintain optimal doses of RAASi therapy. This study aimed to assess the cost-effectiveness of patiromer for the management of HK in CKD patients with and without HF in Spain. METHODS: A Markov model was developed to evaluate the costs and benefits of patiromer for the management of HK in patients with CKD stages 3-4 with and without HF treated with RAASi over a lifetime horizon. The main outcomes included total direct costs (€2021), quality-adjusted life-years (QALYs), life-years gained (LYG) and incremental cost-effectiveness ratio (ICER). Deterministic one-way and probabilistic sensitivity analyses were performed to assess the robustness of the results. RESULTS: Patiromer was more effective compared to no patiromer (5.76 vs 5.57 QALYs; 7.73 vs 7.50 LYG), and resulted in an incremental cost of €3,574, yielding an ICER of €19,092/QALY gained and of €15,236/LYG. Sensitivity analyses suggested that the results were robust to changes in most input parameters. CONCLUSIONS: Patiromer is a cost-effective intervention in maintaining normokalemia and enabling optimal RAASi therapy in patients with CKD stages 3-4 with and without HF in Spain.

Effectiveness of sacubitril-varsartan versus angiotensin converting enzyme inhibitors in patients hospitalized for acute heart failure: a retrospective cohort study of the RICA registry.

BACKGROUND: Sacubitril-valsartan has been shown to reduce hospitalizations and mortality in patients with heart failure (HF) and reduced ejection fraction. The PIONEER-HF trial demonstrated that initiation of the drug during acute HF hospitalization reduced NT-proBNP levels and a post-hoc analysis of the trial found a reduction in HF hospitalizations and deaths. Real-life studies in the elderly population are scarce. The aim of our study was to assess the effectiveness of sacubitril-valsartan versus angiotensin converting enzyme inhibitors (ACEI) in elderly patients who initiate this treatment during hospitalization for acute HF. METHODS: We conducted a retrospective cohort study using the Spanish acute heart failure registry (RICA) comparing rehospitalizations and deaths at 3 months and 1 year among patients aged 70 years or older who had initiated treatment with sacubitril-valsartan during hospitalization for acute HF versus those treated with ACEI. RESULTS: One hundred and ninety-nine patients hospitalized between October 2016 and November 2020 were included, with a median age of 82 years and high rate of comorbidity. Of these, 107 were treated with sacubitril-valsartan and 92 with ACEI. The adjusted OR for readmission for HF at 3 months was 0.906 (95% CI: 0.241-3.404) and for the combined variable readmission for HF or death at 3 months was 0.696 (95% CI: 0.224-2.167). The adjusted OR for HF readmission at one year was 0.696 (95% CI: 0.224 -2.167). and for the combined variable HF readmission or death at one year 0.724 (95% CI: 0.325-1.612). CONCLUSION: Treatment with sacubitril-valsartan initiated early in hospitalization for HF in elderly patients with high comorbidity was associated with a trend towards a reduction in readmissions and death due to HF compared to treatment with ACEI, which did not reach statistical significance either at 3 months or 1 year of follow-up.

Clinical Characteristics and Prognostic Relevance of Different Types of Caregivers for Elderly Patients with Acute Heart Failure-Analysis from the RICA Registry.

Background: Patients with heart failure encompass a heterogeneous group, but they are mostly elderly patients with a large burden of comorbid conditions. Objective: The aim of this study was to compare the clinical characteristics and the prognostic impact on hospital admissions and mortality in a population of patients with HF with different types of caregivers (family members, professionals, and the patient himself). Methods: We conducted an observational study from a prospective registry. Patients from the National Registry of Heart Failure (RICA), which belongs to the Working Group on Heart Failure and Atrial Fibrillation of the Spanish Society of Internal Medicine (SEMI), were included. Patients with heart failure were classified, according to the type of main caregiver, into four groups: the patient himself/herself, a partner, children, or a professional caregiver. A bivariable analysis was performed between the clinical, analytical, therapeutic, and prognostic characteristics of the different groups. The endpoints of the study were all-cause mortality at 1 year; mortality at 120 days; and the readmission rate for HF at 30 days, 120 days, and 1 year of follow-up. In all cases, the level of statistical significance was set at p < 0.05. Results: A total of 2147 patients were enrolled in this study; women represented 52.4%, and the mean age was 81 years. The partner was the caregiver for 703 patients, children were caregivers for 1097 patients, 199 patients had a professional caregiver, and only 148 patients were their own caregivers. Women were more frequently cared for by their children (65.8%) or a professional caregiver (61.8%); men were more frequently cared for by their spouses (68.7%) and more frequently served as their own caregivers (59.5%) (p < 0.001). No statistically significant differences were observed in relation to readmissions or mortality at one year of follow-up between the different groups. A lower probability of readmission and death was observed for patients who received care from a partner or children/relative, with log-rank scores of 11.2 with p= 0.010 and 10.8 with p = 0.013. Conclusions: Our study showed that the presence of a family caregiver for elderly patients with heart failure was associated with a lower readmission rate and a lower mortality rate at 120 days of follow-up. Our study also demonstrated that elderly patients with good cognitive and functional status can be their own caregivers, as they obtained good health outcomes in terms of readmission and mortality. More prospective studies and clinical trials are needed to evaluate the impact of different types of caregivers on the outcomes of patients with heart failure.

[Influence of the degree of anaemia on the prognosis of older adults with heart failure (SPAN-HF study)]. / Influencia del grado de anemia en el pronóstico de los pacientes de edad avanzada con insuficiencia cardíaca (Estudio SPAN-HF).

OBJECTIVE: To assess whether a sustained optimal haemoglobin value in the 3 months after admission for heart failure (HF) decompensation reduces morbidity and mortality during the 12 months after admission for acute HF. PATIENTS AND METHOD: Retrospective study of the 1408 patients older than 65 years included in the RICA registry divided into 3 groups: no anaemia (group A), recovered anaemia (group B), and persistent anaemia (group C), according to haemoglobin levels on admission, and 3 months after discharge. Kaplan-Meier curves were constructed, comparing the groups using the log-rank test and a Cox regression model was performed to analyse survival. RESULTS: 578 (41.1%), 299 (21.2%) and 531 (37.7%) were included in groups A, B and C, respectively. We recorded a total of 768 deaths and readmissions. There were 23 (4%), 12 (4%) and 49 (9.2%), (p=.001) individuals who died due to HF and 154 (27%), 73 (24%) and 193 (36%) (P<.001) admissions for this pathology, respectively. Patients with persistent anaemia had a higher risk of death (RR 1.29, 95% CI 1.04-1.61, P=.024) or readmission (1.92, 95% CI 1.16-3, 19; P=.012) due to HF. CONCLUSIONS: Persistent anaemia in the months after admission for HF increases morbidity and mortality in the subsequent year.

Cognitive impairment in patients hospitalized for congestive heart failure: data from the RICA Registry.

The objective of this study is to determine the prevalence of cognitive impairment (CogI) in patients hospitalized for congestive heart failure, and the influence of CogI on mortality and hospital readmission. This is a multicenter cohort study of patients hospitalized for congestive heart failure enrolled in the RICA registry. The patients were divided into 3 groups according to their Short Portable Mental Status Questionnaire score: 0-3 errors (no CogI or mild CogI), 4-7 (moderate CogI) and 8-10 (severe CogI). A total of 3845 patients with a mean (SD) age of 79 (8.6) years were included; 2038 (53%) were women. A total of 550 (14%) patients had moderate CogI and 76 (2%) had severe CogI. Factors independently associated with severe CogI were age (OR 1.09, 95% CI 1.05-1.14 p < 0.001), male sex (OR 0.57, 95% CI 0.34-0.95, p = 0.031), heart rate (OR 1.01, 95% CI 1.00-1.02, p = 0.004), Charlson index (OR 1.16, 95% CI 1.06-1.27, p = 0.002), and history of stroke (OR 2.67, 95% CI 1.60-4.44, p < 0.001). Severe CogI was associated with higher mortality after one year (HR 3.05, 95% CI 2.25-4.14, p < 0.001). The composite variable of death/hospital readmission was higher in patients with CogI (log rank p < 0.001). Patients with heart failure and severe CogI are older and have a higher comorbidity burden, lower survival, and a higher rate of death or readmission at 1 year, compared to patients with no CogI.

Epidemiology of heart failure with preserved ejection fraction: Results from the RICA Registry. / Epidemiología de la insuficiencia cardiaca con fracción de eyección preservada: resultados del Registro RICA.

INTRODUCTION AND OBJECTIVES: There is great interest in better characterizing patients with heart failure (HF) with preserved ejection fraction (HF-PEF). The objective of this study is to determine the prevalence, progression over time and to describe the clinical and epidemiological characteristics of patients with HF-PEF. METHODS: From the National Registry of Heart Failure (RICA, prospective multicentre cohort study) we analysed patients consecutively admitted for HF in Internal Medicine wards over a period of 11 years (2008-2018). RESULTS: 4752 patients were included, 2957 (62.2%) with preserved ejection fraction. This prevalence remained constant from 2008 to 2019. Compared to patients with HF and reduced ejection fraction (HF-REF) patients with HF-PEF are older, more are female, there is a higher prevalence of hypertensive and valvular aetiology, they have a profile of different comorbidities and worse functional status. A high proportion of patients receive disease-modifying treatment for IC-REF (renin-angiotensin-aldosterone system inhibitors and beta-blockers). The overall mortality after one-year follow-up was 24% and 30% in the HF-PEF and the HF-REF, respectively. In the multivariate analysis, the risk of death was higher in patients with HF-REF compared to HF-PEF (OR: 1.84; 95% CI: [1.43-2.36]). The length of hospital stay was also lower in the HF-PEF patients but there were no differences in re-hospitalizations. CONCLUSIONS: Sixty percent of patients in the RICA registry have preserved ejection fraction. These patients have a higher comorbidity burden and a worse functional status, but lower mortality compared with HF-REF patients.

Budget impact of ferric carboxymaltose treatment in patients with chronic heart failure and iron deficiency in Spain.

OBJECTIVE: The treatment of iron deficiency (ID) with ferric carboxymaltose (FCM) improves the functional class and quality of life of chronic heart failure (CHF) patients with reduced left ventricular ejection fraction (LVEF), and reduces the rate of hospitalization due to worsening CHF. This study aims to evaluate the budget impact for the Spanish National Health System (SNHS) of treating ID in reduced LVEF CHF with FCM compared to non-iron treatment. METHODS: We simulated a hypothetical cohort of 1000 CHF patients with ID and reduced LVEF based on the Spanish population characteristics. A decision-analytic model was also built using the data from the largest FCM clinical trial (CONFIRM-HF) that lasted for a year. We considered the use of healthcare resources from a national prospective study. A deterministic sensitivity analysis was carried out varying the corresponding baseline data by ±25%. RESULTS: The cost of treating the simulated population with FCM was €2,570,914, while that of the non-iron treatment was €3,105,711, which corresponds to a cost saving of €534,797 per 1,000 patients in one year. Cost savings were mainly due to a decrease in the number of hospitalizations. All sensitivity analysis showed cost savings for the SNHS. CONCLUSIONS: FCM results in an annual cost saving of €534.80 per patient, and would thus be expected to reduce the economic burden of CHF in Spain.

Study design of Heart failure Events reduction with Remote Monitoring and eHealth Support (HERMeS).

AIMS: The role of non-invasive telemedicine (TM) combining telemonitoring and teleintervention by videoconference (VC) in patients recently admitted due to heart failure (HF) ('vulnerable phase' HF patients) is not well established. The aim of the Heart failure Events reduction with Remote Monitoring and eHealth Support (HERMeS) trial is to assess the impact on clinical outcomes of implementing a TM service based on mobile health (mHealth), which includes remote daily monitoring of biometric data and symptom reporting (telemonitoring) combined with VC structured, nurse-based follow-up (teleintervention). The results will be compared with those of the comprehensive HF usual care (UC) strategy based on face-to-face on-site visits at the vulnerable post-discharge phase. METHODS AND RESULTS: We designed a 24 week nationwide, multicentre, randomized, controlled, open-label, blinded endpoint adjudication trial to assess the effect on cardiovascular (CV) mortality and non-fatal HF events of a TM-based comprehensive management programme, based on mHealth, for patients with chronic HF. Approximately 508 patients with a recent hospital admission due to HF decompensation will be randomized (1:1) to either structured follow-up based on face-to-face appointments (UC group) or the delivery of health care using TM. The primary outcome will be a composite of death from CV causes or non-fatal HF events (first and recurrent) at the end of a 6 month follow-up period. Key secondary endpoints will include components of the primary event analysis, recurrent event analysis, and patient-reported outcomes. CONCLUSIONS: The HERMeS trial will assess the efficacy of a TM-based follow-up strategy for real-world 'vulnerable phase' HF patients combining telemonitoring and teleintervention.

Prevalence and outcome of diuretic resistance in heart failure.

Diuretic resistance (DR) is common in patients with decompensated heart failure (HF), and is associated with adverse outcomes. To determine the prevalence of DR and its impact on survival among patients with decompensated HF, we prospectively evaluated the prevalence and influence on prognosis of DR (defined as persistent congestion despite ≥ 80 mg of furosemide per day) in a cohort of elderly patients from the Spanish HF registry (RICA) admitted for an acute decompensation of HF. Patients with new-onset HF were excluded. From the global cohort of 2067 patients, 435 (21%; 95% CI 19.3%-22.7%) patients met criteria for DR. Patients with DR had more comorbidities (hypercholesterolemia, diabetes mellitus, valvular disease, chronic kidney disease, and cancer) and a worse functional status compared to patients without DR. In addition, patients with DR had a higher proportion of ischemic etiology, more advanced functional class and lower left ventricular ejection fraction values. After 1 year of follow-up, all-cause mortality was higher in patients with DR with an adjusted hazard ratio of 1.37 (95% CI 1.06-1.79; p = 0.018). The prevalence of DR in a cohort of elderly patients admitted for acute HF decompensation is 21%. DR is an independent predictor of 1-year mortality.

Influence of atrial fibrillation on the mortality of patients with heart failure with preserved ejection fraction. / Influencia de la fibrilación auricular en la mortalidad de los pacientes con insuficiencia cardiaca con fracción de eyección preservada.

INTRODUCTION AND OBJECTIVES: The impact of atrial fibrillation (AF) on the prognosis of heart failure with preserved ejection fraction (HFpEF) is still the subject of debate. We analysed the influence of AF on the prognosis on mortality and readmission in patients with HFpEF. METHODS: Prospective observational study in 1,971 patients with HFpEF, who were admitted for acute heart failure. Patients were divided into 2 groups according to the presence or absence of AF. We analysed mortality, readmissions and combined mortality/readmissions at one year follow-up. RESULTS: A total of 1,177 (59%) patients had AF, mean age 80.3 (7.8) years and 1,233 (63%) were women. Patients with HFpEF and AF were older, female, greater valvular aetiology and lower comorbidity measured by the Charlson index. At the one year follow-up, 430 (22%) patients had died and 840 (43%) had been readmitted. In the 2 groups analysed, there was no difference in all-cause mortality (22 vs. 21%; P=.739, AF vs. no-AF, respectively) or cardiovascular causes (9.6 vs. 8.2%; P=.739, AF vs. no-AF, respectively). In the multivariable analysis, factors associated with higher mortality were: age, male, valvular aetiology, uric acid, and comorbidity. In the analysis of the subgroup with HFpEF with AF, the presence of chronic AF compared to de novo AF was associated with higher mortality (HR 1,716; 95% CI 1,099-2,681; P=.018). CONCLUSIONS: In patients with HFpEF, the presence of AF is frequent. During the one-year follow-up, the presence of AF does not influence mortality or readmissions in patients with HFpEF.

The concentrations of soluble vascular cell adhesion molecule-1 and lipids are independently associated with venous thromboembolism.

BACKGROUND AND OBJECTIVES: Venous thromboembolism (VTE) involves inflammation and a relation with dyslipidemia which remains controversial. The vascular cell adhesion molecule-1 (VCAM-1) is a ligand expressed by activated endothelium (and recruits leukocytes) whose soluble form (sVCAM-1) increases in atherosclerosis, severe hypertriglyceridemia or deep vein thrombosis (DVT) in acute phase. We analyzed the association between VTE (> 6 months after), sVCAM-1 and lipid concentrations. DESIGN AND METHODS: Case-control study involving 126 consecutive patients (aged 25-80 years, 49% males) and 125 controls of similar age and gender. RESULTS: The patients had a more unfavorable lipid profile than controls [higher triglycerides (p<0.001), LDLc/HDLc ratio (p<0.01) or total cholesterol (TC) (p=0.07)] and higher sVCAM-1 concentration (p<0.01) even adjusting for arterial diseases. VTE was associated with extreme values of TC, LDL-c, triglycerides (>P90) and HDL-c (P90) (OR=4.2)(p<0.0001). The sVCAM-1 values were age-related (r=0.26, p<0.001) but independent of lipid levels. Hazards ratios from five-fold to ten-fold appeared when combining the sVCAM-1 top quartile (>970 ng/mL) with TC >250 mg/dL or HDL-c <45 mg/dL (p<0.01) irrespective of thrombophilic status. Recurrent or severe VTE cases (pulmonary embolism or proximal DVT vs. distal DVT) showed higher sVCAM-1 values (p<0.05). All the associations weakened among females. In stepwise logistic regression, obesity (p<0.001), sVCAM-1 (p<0.001) and LDL-c (p=0.004) in men and sVCAM-1 (p=0.02) and triglycerides (p=0.04) in women retained their independent association. INTERPRETATION AND CONCLUSIONS: Although the exact mechanisms linking abnormal lipid and sVCAM-1 concentrations to VTE await clarification, both seem to be independently associated.