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Introduction
Acute decompensated heart failure (ADHF) is a syndrome defined as the presentation of symptoms and signs of congestion and deterioration of systemic perfusion in the context of chronic heart failure (CHF), a condition induced by one or more precipitating factors1. About 46% of patients are hospitalized for decompensated CHF, while 39% are admitted for non-cardiovascular comorbidities2. In developed countries, the prevalence of heart failure (HF) in the adult population is approximately 1-2%, > 10% in people over 70. In Latin America, the burden of disease due to HF has not been fully characterized due to the lack of population studies to determine its prevalence and incidence; however, an incidence of 199 cases/100,000 person-years and a prevalence of 1% (95% confidence interval [CI] 0.1-2.7%)3.
In addition, HF has a considerable and growing economic burden on health systems, with hospital admission costs being shown to be the costliest element. Globally, annual fees based on HF prevalence range from eight hundred sixty-eight dollars for South Korea to twenty-five thousand five hundred thirty-two dollars for Germany. Similarly, the lifetime costs for a patient with HF have been estimated at approximately one hundred twenty-six thousand one hundred ninety-four dollars4. Although, the annual cost in Colombia is unknown, hospitalizations contribute to a significant proportion of these costs, primarily due to HF decompensation5. Tamayo et al. conducted a study on HF costs in two centers in Colombia where they determined an average of ten million four hundred thousand two hundred fourteen ± twenty-two million five hundred fifty-two thousand nine hundred fifty-four Colombian pesos per hospitalization and an average hospital stay of 8 ± 11 days6. Despite advances in the management of this disease, the incidence of re-hospitalization continues to be alarmingly high worldwide2.
The lack of representative data and the panorama of morbidity and mortality associated with admission for ADHF underline the value of this prospective cohort. Therefore, the aim of the Institutional aCute decompensAted HeaRt FailUre RegiStry (ICARUS) is to provide information on clinical characteristics, medical practice, patterns of treatment, and outcomes of patients hospitalized with ADHF, allowing a framework for future initiatives to improve care and results in this population.
Materials and methods
Design
A prospective cohort of patients with a medical diagnosis of ADHF (de novo or chronically decompensated) who attend the emergency department of the cardiovascular center.
Recruitment location
The cardiovascular center is in Floridablanca, Santander, Colombia. This is an institution accredited by the Joint Commission International (JCI), a national and international reference in the care of cardiovascular diseases for having centers of excellence in HF, acute myocardial infarction, myocardial revascularization, heart transplant, left ventricular assist devices and extracorporeal membrane oxygenation (ECMO) among others.
This institution’s HF Center of Excellence is the first to be founded in Colombia and accredited as a Center of Excellence by the JCI. It focuses on providing comprehensive, timely, and effective care in treating HF and being leaders in managing advanced HF, with therapies such as heart transplant, ECMO, and implantation of long-term ventricular assist devices.
Eligibility criteria
Patients with a medical diagnosis of ADHF aged ≥ 18 years hospitalized in any service were included. People of nationality other than Colombian were excluded.
Sample calculation and sampling
No sample size calculation was considered. All patients who met the eligibility criteria and did not have the exclusion criteria were included.
Measurements
PERSONAL DATA
Care code, medical record number, date of entry, date of birth, age at entry into the program, current age, sex, type of social security, level of education, marital status, municipality, department, and area of residence and informed consent.
CARDIOLOGY
Type of patient (new/old), previous left ventricular ejection fraction (LVEF), readmission to institution, treating physician, analysis by a multidisciplinary team, classification of HF according to American Heart association-AHA (A, B, C, D), New York Heart Association-NYHA (I, II, III, IV), international classification of diseases (ICD-10-CM) for medical diagnosis, LVEF during hospitalization, HF etiology, palliative management (yes/no), refractory (yes/no), comorbidities, Charlson Comorbidity index, medication history (pre-hospitalization), paraclinical findings on admission (glycated hemoglobin, potassium, creatine, TSH, Ferritin, transferrin saturation, natriuretic peptides), vital signs (heart rate [HR], systolic blood pressure [SBP] and diastolic [DBP]), do you know the animal ("pito," kissing bugs, reduviid bugs, "barbeiros," blood suckers) that transmits Chagas disease? (yes/no), when you were a child, did you live in houses with thatched roofs, dirt floors, or adobe walls? (yes/no), do you have a 1st° relative (father, mother, or siblings) with Chagas? (yes/no) and has any 1st° relative (father, mother, or siblings) died suddenly? (yes/no).
NURSING
Nursing domain and diagnosis according to altered North American Nursing Diagnosis Association, nursing intervention and outcome associated with each diagnosis, level of knowledge about the disease and treatment, number of educational sessions, Morisky-Green Test7, European HF Self-Care Behavior Scale8,9, Fatigue, Resistance, Ambulation, Illnesses, Loss of Weight10,11, quality of life measured with a Minnesota Living with HF (MLHFQ)12,13.
NUTRITION
Nutritional screening, nutritional diagnosis measured with the nutrition risk screening scale14,15, height, weight, body mass index, and dry weight.
SOCIAL WORk
Family typology, Family Functioning Test16, APGAR-Family Function Questionnaire17, socio-family risk (yes/no), vulnerability factors, AUDIT test18 and drug detection test-1019.
PSYCHOLOGY
Zung Self-Rating Depression scale for depression screening20,21, vulnerability factor, smoking index, Fagerström test22-24, psychiatric or psychological history.
Outcomes
The outcomes of interest to be evaluated are in-hospital mortality from all causes and at 30 days after hospital discharge, days of hospital stay, change at 30 days in MLHFQ score, re-hospitalization at 30 days due to HF, heart transplant, or insertion of ventricular assist devices.
Follow-up
Follow-up was carried out during the hospital stay by the interdisciplinary team of the HF Center of Excellence of the institution, and after discharge, telephone follow-up at three and 30 days after hospital discharge.
Data collection plan
Once the medical diagnosis of ADHF was confirmed, the patient was evaluated by the HF Center of Excellence interdisciplinary team. The information was recorded in the institutional clinical history and the "Heart Failure Center of Excellence - In-hospital" database pre-established in REDCap. This last database is managed by the Epidemiology Unit, which monitors the registered information, the quality of the registry, and missing data. All information is recorded by medical personnel and allied professionals who have been trained and who care for people with HF daily (Supplementary Fig. 1).
Statistical analysis
This report used descriptive statistics to synthesize baseline characteristics, clinical characteristics during hospitalization, and outcomes for the ICARUS population. Quantitative variables that presented a normal distribution according to the histogram and the ShapiroWilk test were described with the mean and standard deviation; otherwise, the median, first, and third quartiles were reported. Categorical variables were described with absolute and relative values. The cumulative incidence (CI) of the outcomes for the cohort was calculated with their respective 95% of CI. Variables with missing observations in < 15% of the total were subjected to multiple imputations using the mice statistical package, except for the outcomes of interest. A two-tailed p < 0.05 was considered statistically significant. All statistical analyses were performed using R (v4.3.1; R Core Team 2023) and STATA 17 (StataCorp LLC) statistical software.
Ethical aspects
The study was conducted according to the guidelines of the Declaration of Helsinki and national regulations, which is indicated in Resolution 008430 of October 4, 1993, of the Ministry of Health of Colombia, establishing the ethical principles of scientific, technical, and administrative standards for health research. Resolution 008430 of 1993 states this research is considered "without risk." In addition, the research protocol was submitted and approved by the institution’s Scientific Technical Committee and Research Ethics Committee with code 2022-05104.
Results
This report is based on an analysis of 1595 patients with ADHF from June 1, 2022, to September 1, 2023 (Supplementary Fig. 2). The median age of the patients was 68 years (Q1 = 58; Q3 = 76), and 69.28% were men. 68.53% belonged to the subsidized social security regime, followed by the contributory (25.08%) and others (6.39%). 74.23% were illiterate or had primary school education, 40.00% were married, and 90.72% lived in urban areas (Supplementary Fig. 3).
The most common medical history was high blood pressure (56.68%), coronary heart disease (26.08%), atrial fibrillation (24.64%), and diabetes mellitus (24.64%), among others. The etiology of HF in 38.31% was of ischemic origin, followed by idiopathic disease (25.45%), Chagas disease (21.25%), and valvular disease (14.92%). 16.36% had an implantable device, the most common being the implantable cardioverter-defibrillator, with 8.46%. Median HR was 74 beats/min (Q1 = 64; Q3 = 85), SBP 118 mmHg (Q1 = 101; Q3 = 136) and DBP 70 mmHg (Q1 = 61; Q3 = 82). Regarding the classification of HF, 81.25% were in AHA class C, 59.00% were in NYHA class III-IV, and the median LVEF was 30% (Q1 = 20; Q3 = 43). Other clinical characteristics can be seen in supplementary table 2. The pharmacological treatment for HF at hospital admission and discharge can be seen in figure 1.
Figure 1 Proportion of heart failure drug group at hospital admission and discharge in Institutional aCute decompensAted HeaRt FailUre RegiStry (n = 1595). ACEI: angiotensin-converting enzyme inhibitors; ARBs: angiotensin receptor blockers; ARNIs: angiotensin receptor-neprilysin inhibitors; MRAs: aldosterone receptor antagonists; SGLT2i: sodium-glucose cotransporter-2 inhibitors.
Concerning the outcomes, the median hospital stay was 6 days (Q1 = 4; Q3 = 11), with a cumulative incidence for re-hospitalization at 30 days of 8.70% (95% CI 7.18-10.40%), a cumulative incidence for hospital mortality of 4.33% (95% CI 3.38-5.44%) and a median change in the quality-of-life score (MLHFQ) at 30 days of −20 points (Q1 = −37; Q3 = −5) (Fig. 2).
Discussion
The ICARUS is one of the first studies in Latin America to evaluate the sociodemographic and clinical characteristics, as well as the treatment patterns and outcomes of a preliminary cohort of 1595 patients hospitalized for HF, mainly of ischemic origin in stage C (HF classification according to AHA) of the disease. Our results show that the percentage of patients receiving quadruple neurohormonal blockade therapy increased from admission to hospital discharge. The use of guideline-directed medical treatment for HF could have influenced the good results regarding in-hospital mortality, improvement in quality of life, and the percentage of short-term re-hospitalizations compared to similar cohorts, as we will discuss later.
Our population’s sociodemographic and clinical characteristics are similar to other studies in our region. This appreciation can be observed through a systematic review and meta-analysis of the disease burden of HF in Latin America3, in which around 143 studies were included, with a median of 257 patients. Most participants were male (61.07 ± 11.48%) with an average age of 60.34 ± 8.98 years, similar to our population, in which the majority was also male (69.28%) with a median age of 68 years. Regarding clinical characteristics, most studies included patients in NYHA functional class III-IV with a mean LVEF of 35.93 ± 8.58%, which is similar to our data (functional NYHA class III-IV, with a median LVEF of 30%, Q1 = 20; Q3 = 43). The most common comorbidity of our patients was arterial hypertension (56.68%), consistent with the data from the Latin American region (hypertension 62%). It is worth highlighting Chagas disease as one of the main etiologies causing HF in Latin America, being 13% versus 21.25% in our population.
The initial results of ICARUS demonstrate the feasibility of the registry program carried out to describe patients hospitalized for HF. At discharge, our study showed a combined use of β-blockers, ACEI/ARBs/ARNIs, and mineralocorticoid receptor antagonists above 70% compared to studies such as the Brazilian Registry of HF which was < 50%27 and the Romanian Acute Heart Failure Syndromes where only 56%, 66% and 54% of patients had a β-blocker, an ACE inhibitor/ARB and a mineralocorticoid receptor antagonist, respectively28. The inclusion of Sodium-Glucose cotransporter 2 inhibitors (SGLT2i) as the fourth pillar of HF treatment has also had an impact on the clinical outcomes of this population. Studies such as DAPA-HF29 showed a reduction in the risk of worsening HF (translated as new hospitalizations) in patients with an ejection fraction of < 40%, consistent with the clinical profile of our population group, which had a median LVEF of 30%. A modern registry that included SGLT2i, the EVOLUTION-HF study30, revealed interesting data, when comparing high-income countries, such as Japan, Sweden, the United Kingdom (UK), and the United States (US). Few patients were treated with the four fundamental therapies during the first hospitalization. The use of SGLT2i at discharge in Japan, Sweden, the UK, and the US was 3%, 4%, 1%, and 3%, respectively, versus 74.98% in our institution. Significantly, the utilization of quadruple neurohumoral blockade therapy 3 months post-discharge varied across countries, with rates of 7.1% in Japan, 11.3% in Sweden, 1.5% in the UK, and 1.5% in the USA as observed in EVOLUTION-HF. The proportion of patients in our study that had Guideline-Directed Medical Therapy in HF at discharge could have influenced the favorable outcomes for the present analysis.
Outcomes such as in-hospital mortality differ from those found in other investigations. In their systematic review and meta-analysis, Ciapponi et al. showed an in-hospital mortality of 11.7%, with a worse prognosis for those patients with ischemic or chagasic etiology3. Another study by Chaves et al. had an in-hospital mortality of up to 8.9%31. In our study, in-hospital mortality was considerably lower than observed in Latin America (4.33%) but similar to that reported by US registries such as OPTIMIZE-HF (3.8%)32 and ADHERE (4.0%)33. Besides, in studies with more contemporary data, such as the EVOLUTION-HF, the non-use of optimal treatment at the first hospital discharge implied higher mortality, hospital readmissions, and increases in the cost of medical care. This is emphasized by the substantial difference in the proportion of patients experiencing all-cause re-hospitalization 30 days after discharge between the US data of EVOLUTION-HF and our study (14% vs. 8.70%)30. The above further highlights our results, evidencing the pharmacological adherence of our patients, as well as the joint work of the HF Center of Excellence interdisciplinary team.
Our findings have relevant clinical implications for patients with ADHF. The observation at hospital discharge of an association between the prescription of guideline-directed medical therapy and the presence of lower mortality and hospital readmissions than other international registries highlights the usefulness of adherence to evidence-based practice. Furthermore, the sample size allows us to obtain potentially representative population data. It constitutes a basis for defining strategies to improve the care of these patients, with potential impact on mortality and costs. On the other hand, one of the most relevant limitations of the study is related to the process of entering the information, which is carried out by several individuals belonging to the interdisciplinary team of the HF Center of Excellence, which, being mechanical processes due to accumulation, could have implicit some source of bias. However, professionals dedicated to recording information have extensive and up-to-date knowledge of HF. They know the importance of data quality and recording, which mitigates the probability of typing errors. Furthermore, prospective studies are susceptible to loss of follow-up; however, three calls are made to patients to avoid this. Another limitation of the registry is the incomplete availability of angiograms to confirm the etiology of HF, since some were performed in other centers and there is only a history and record in the clinical history. This is because, at our institution, the main cause of hospitalization is decompensation of HF.
Conclusion
The results of the present study show that the use of Guideline-directed medical treatment for HF reduced in-hospital mortality, short-term re-hospitalizations and improved the quality of life of patients with ADHF at 30 days after discharge. The proportion of quadruple neurohormonal blockade therapy at hospital discharge is considerably higher than in other international cohorts; however, we still need to increase the prescription percentage. ICARUS shows an urgent need for earlier use of Guideline-directed medical treatment to improve the management and outcomes of HF patients. This ongoing study will continue to provide relevant information on ADHF, which will impact public health in the region.
