130 Internacional Journal of Cardiovascular Sciences. 2015;28(2):130-138 ORIGINAL MANUSCRIPT Evaluation of the Impact to the Treatment of Heart Failure in the Brazilian Public Health System Frederico Augusto de Lima e Silva1, Guilherme Emilio Ferreira2, Ezequiel Aguiar Parente2, Eduardo Cesar Rios Neto2 Hospital de Messejana Dr. Carlos Alberto Studart Gomes – Serviço de Cardiologia – Fortaleza, CE – Brazil Centro Universitário Christus – Curso de graduação em Medicina - Fortaleza, CE – Brazil 1 2 Resumo Background: Heart failure (HF) is a worldwide health problem with the prospect of further increasing its prevalence due to population growth and increased life expectancy. The clinical treatment of patients with HF is the use of drugs, devices and procedures that improve cardiac performance, relieve symptoms and prolong survival. Objective: To evaluate the impact of treatment of heart failure in Hospital de Messejana (HM), Fortaleza, CE, Brazil. Methods: This is an observational, retrospective and quantitative study. In this study, 635 adult patients admitted in the Cardiac Units of HM from January 2011 to July 2013 were evaluated through the analysis of medical records. The study evaluated aspects related to mortality rates, treatment effectiveness and the number of readmissions. It also investigated the incidence of hospital infections and the percentage of patients whose treatment was heart transplantation. Results: Concerning the clinical treatment, 88.3% used anticoagulants, 80.8% used diuretics, 74.2% used beta-blockers, 48.7% used angiotensin-converting enzyme inhibitors and 19.25% used angiotensin receptor blocker. About the surgery, 11% had valvuloplasty or valve replacement, 9.3% had heart transplantation, 2.2% had pacemaker implant and 4.7%, coronary artery bypass grafting surgery. Conclusion: Patients treated with HF in HM received the classic therapy recommended, including the use of surgical devices and procedures such as heart transplantation and had a satisfactory outcome in most cases, despite a high rate of in-hospital mortality. Keywords: Treatment intention analysis; Survival analysis; Heart failure; Hospital mortality; Hospitalization Introduction Heart failure (HF) is a major public health problem that affects about 23 million people worldwide and five million in the United States1 alone. This is a complex clinical syndrome that characterizes the final stage of various heart diseases. Changes in function or cardiac structure lead to impairment of ventricular ability to fill or eject blood2. Data show that, in Brazil, HF is the third leading cause of hospitalization and the most common reason for hospitalization among the elderly, and is the most common cardiovascular disease among them3. According to Nogueira et al.4, in Brazil there are approximately two million patients with HF. About 240,000 cases are diagnosed per year. Records show that the prevalence of HF increases with age from the age of 655, and the Framingham study found that the incidence of HF, in turn, doubles every decade of life6. Population aging and life extension in patients with heart disease by modern therapy, which uses powerful drugs combined with efficient devices, have increased the incidence of HF2. Corresponding author: Frederico Augusto de Lima e Silva Av. Frei Cirilo, 3480 - Messejana - 60840-285 - Fortaleza, CE - Brazil E-mail: fredsil47@yahoo.com.br DOI: 10.5935/2359-4802.20150018 Manuscript received on November 20, 2014; approved on March 23, 2015; revised on April 12, 2015. Int J Cardiovasc Sci. 2015;28(2):130-138 Original Manuscript Systolic and diastolic ventricular dysfunction are the two most important mechanisms for reducing cardiac output and establishment of HF2. However, there is an important variability among the records of HF due to diastolic dysfunction defined by a normal left ventricular (LV) ejection fraction. The PREVEND7 study recently showed that among 8 592 patients, 4.4% develop HF in 11 years of follow-up, with 34.0% for diastolic dysfunction and 66.0% for systolic dysfunction7. The risk of developing HF at age 40 is 1:5 individuals, regardless of sex, while mortality, around 16.4:1 000, still shows a tendency to increase and low survival rates after hospitalization, which is 30% lower in patients with diastolic dysfunction6,8,9. Predisposing factors for HF have been identified in several studies, especially coronary artery disease, smoking, hypertension, obesity, diabetes mellitus and valvular heart disease10. Coronary artery disease, idiopathic dilated cardiomyopathy, hypertension and valvular disease are the major causes of heart failure due to systolic dysfunction. In diastolic dysfunction, hypertension, coronary artery disease and the restrictive and hypertrophic cardiomyopathies are the most prevalent causes11,12. The diagnostic approach in HF, thoroughly discussed and guided by a number of guidelines, should include a detailed medical history, thorough physical examination and a set of indispensable complementary tests: electrocardiogram, chest X-ray, blood leukocyte dosages, hemoglobin, creatinine, glucose, liver and thyroid tests, pro-BNP dosage, echocardiography (this must be done in all patients with suspected HF), exercise testing, cardiac catheterization, cardiovascular magnetic resonance imaging and endomyocardial biopsy; these are intended to confirm the diagnosis, determine the degree of severity and the probable etiology of the syndrome13. In the evolution of patients with HF, it is observed that the need for hospitalization is an important marker of a bad prognosis, with increased mortality after hospitalization, especially in the first month after hospital discharge. Similarly, failure to follow the drug treatment and diet are the most important factors Silva et al. Evaluation of the Treatment of Heart Failure contributing to readmissions and consequent increase in mortality14-17. 131 ABREVIATURAS E ACRÔNIMOS •EF — ejection fraction The Framingham study found that, after 1990, the annual mortality from HF was •HF — heart failure 28.0% for men and 24.0% for women. • HM — Hospital de Messejana Mortality due to HF in five years was 59.0% for men and 45.0% for women14,16,18,19. The most important causes of death observed in patients with HF were sudden death or arrhythmic death, described as death within the first hour after cardiac arrest in previously stable patients, or progressive failure of the heart20,21. Ventricular tachycardia degenerating into ventricular fibrillation is the most common cause of sudden death in patients with HF22. The treatment of HF has been the subject of numerous consensus, protocols and guidelines, with specific approaches for acute and chronic cases23. All treatment guidelines state that the main HF treatment objectives are the clinical improvement of symptoms, reduced risk of hospitalization, reduction or reversal of impairment of myocardial function and reduced mortality13,24-26. The pharmacological treatment protocol of HF in Hospital de Messejana Dr. Carlos Alberto Studart Gomes, Fortaleza, CE, Brazil includes several drugs which, in addition to improving the symptoms, can increase the survival of patients: diuretics, beta-blockers, angiotensinconverting enzyme inhibitors (ACE), angiotensin II receptor blockers, hydralazine + nitrates and aldosterone antagonists13,23. The high number of patients with HF admitted to HM, with the most varied etiologies in different functional classes and several long-term re-admissions encouraged the performance of this study to analyze the quality of HF treatment offered by HM. Methods This is an observational, retrospective, quantitative study held at HM, in Fortaleza, CE, in the neighborhood of Messejana, from August 2013 to July 2014. From January 2011 to July 2013, 762 patients were admitted to the Cardiac Units (B, C, G and I) of HM. However, only 635 adult patients were located and evaluated through their medical records. The therapeutic plan adopted for each patient was mainly observed. 132 Silva et al. Evaluation of the Treatment of Heart Failure Int J Cardiovasc Sci. 2015;28(2):130-138 Original Manuscript The patients included in the study had been diagnosed with heart failure, with the following criteria: signs and symptoms, chest radiography and echocardiography. In addition, patients with both preserved ejection fraction (EF) and decreased EF participated in the study. There was also some required data recorded in the medical records. The study excluded the following patients: those with pacemakers admitted to the HM ICU using mechanical ventilator, patients under 18 with HF, patients with clinical picture of cardiogenic shock, post-transplant patients diagnosed with HF. Regarding readmissions of patients in this period, only the first visit was used. The main limitation found by the researchers was to achieve a statistically significant number of medical records that contained all the necessary information. In this study, p values ≤ 0.05 were considered statistically significant. The study was approved by the Research Ethics Committee of Hospital de Messejana Doutor Carlos Alberto Studart Gomes, under No. 600.762-0, in line with all the ethical principles set out in Resolution CNS 466/12. The Researcher’s Instrument of Liability for using medical records was signed by the researchers, assuring them that the use of medical records would serve exclusively for this research project and also on maintaining the anonymity of the patients involved, in addition to the Instrument of Bona Fide Custodian signed by HM medical archive clerk. Results Aspects related to mortality rates, treatment effectiveness and the number of hospital readmissions were firstly evaluated. Secondly, the incidence of hospital infections and the percentage of patients whose treatment was heart transplantation were investigated. Furthermore, there was a comparison between patients with and without infection, patients transplanted or not, and the outcome of patients. The study included 635 patients: 427 (67.2%) males and 208 (32.8%) females. The age distribution ranged from 18 to 95 years, with mean age of 59.85±16.05 years. The mean hospital stay time was 4.71±1.76 weeks, ranging from 1-30 weeks. Regarding the number of readmissions, a variation of 0-19 was found, averaging 1.08±3.52. The ejection fraction averaged 40.88± 15.84%, ranging from 8.0-83.0% (Table 1). The information collected was compiled into a database managed by the statistical software IBM SPSS Statistics 20 and Microsoft Office 2013 Excel program. Initially, a standard descriptive statistics was taken: central tendency calculation and frequency distribution. The Mann-Whitney test was used to check the association of the independent variables on the outcomes of the study. The distribution of the etiology of HF among the patients studied showed that idiopathic dilated cardiomyopathy was most prevalent (34.8%), followed by ischemic cardiomyopathy (32.4%), valvular heart disease (20.3%), Chagas cardiomyopathy (6.3%), alcoholic cardiomyopathy (4.3%), hypertrophic cardiomyopathy (1.7%) and peripartum cardiomyopathy (0.2%) (Table 2). Table 1 General characteristics of the patients studied Mean±SD Minimum-maximum values 59.85±16.05 18-95 Length of stay (weeks) 4.71±1.76 0-19 Readmissions (number) 1.08±3.52 1-30 40.88±15.84 8-83 Age (years) Ejection fraction (%) SD — standard deviation Int J Cardiovasc Sci. 2015;28(2):130-138 Original Manuscript Silva et al. Evaluation of the Treatment of Heart Failure The analysis of predisposing factors for HF showed that hypertension was the most prevalent (62.4%) followed by smoking (42.7%), valvular heart disease (35.9%), diabetes mellitus (33.7%), coronary artery disease (32.8%) and obesity (8.3%) (Table 2). Table 2 Etiology, risk factors and tests performed by the patients studied % Etiology Risk factors Tests Idiopathic cardiomyopathy 34.8 Ischemic cardiomyopathy 32.4 Valvular heart disease 20.3 Chagas cardiomyopathy 6.3 Alcoholic cardiomyopathy 4.3 Hypertrophic cardiomyopathy 1.7 Peripartum cardiomyopathy 0.2 Hypertension 62.4 Smoking 42.7 Valve diseases 35.9 Diabetes mellitus 33.7 Coronary artery disease 32.8 Obesity 8.3 In the diagnostic approach of HF, all patients underwent electrocardiogram and chest X-ray. Echocardiography was performed in 99.2% of patients, followed by complete blood count in 98.6%, hemodynamic study in 40.6%, Holter in 14.8%, pro-BNP dosage in 1.4% and exercise test in 1.1%. On echocardiogram, there was an average EF of 40.88±15.84%, ranging from 8 to 83%. By assessing the physical examination upon admission, dyspnea was present in 95.6% of patients, being the most prevalent symptom. Other findings on physical examination were edema (47.2%), abnormal cardiac auscultation (47.1%), abnormal breath sounds (43.9%), jugular venous distension (4.3%) and hepatosplenomegaly (2.8%). Electrocardiogram 100.0 Chest X-ray 100.0 Electrocardiogram 99.2 Complete blood count 98.6 Hemodynamic study 40.6 Holter 14.8 Pro-BNP 1.4 Cardiac stress test 1.1 With regard to infection, 37.8% of patients showed some expression: 69.2% occurred in the respiratory system, 15.0% in the cardiovascular system, 6.7% in the urinary system, 6.7% in the dermatological system and 2.4% in the gastrointestinal system. Stratifying patients into two groups, with and without infection, there was a significant difference in the length of stay (p < 0.0001), in which the group with infection took longer to receive hospital discharge (Table 3). Concerning the clinical treatment, 88.3% used anticoagulants, 80.8% used diuretics, 74.2% used betablockers, 48.7% used angiotensin-converting enzyme inhibitors (ACEI) and 19.25% used angiotensin receptor blockers (ARB). All patients received low-sodium diet. Table 3 Characteristics of hospitalized patients stratified by group: with and without infection With infection No infection (n=238) (n=397) 61.37±16.37 58.93±15.82 0.058 Readmissions (number) 1.15±1.72 1.04±1.74 0.333 Length of stay (weeks) 5.72±3.74 4.10±3.23 < 0.0001 40.09±15.71 41.35±15.92 0.326 Age (years) Ejection fraction (%) Values expressed as mean±standard deviation p 133 134 Silva et al. Evaluation of the Treatment of Heart Failure Int J Cardiovasc Sci. 2015;28(2):130-138 Original Manuscript Of those using diuretics, 67.8% used loop diuretics, 26.9% used potassium-sparing diuretics and 5.3% used thiazides. Of those who used beta-blockers, 80.7% took carvedilol, 8.9% took metoprolol, 6.3% took atenolol and 4.1% tool propranolol. Regarding percutaneous treatment, 5.4% underwent transluminal coronary angioplasty with stenting (Table 4). Surgical treatment was performed in 33.1% of patients. Of these, 11% underwent valvuloplasty or valve replacement, 9.3% had transplantation, 2.2% had pacemaker implant and 4.7%, coronary artery bypass grafting surgery. 12.8% had breast implants, 23.3% had bypass surgery and 63.9% both. Comparing patients who needed heart transplantation (Group 1) or not (Group 2), there was a significant difference in relation to age, length of stay, number of readmissions and ejection fraction (p < 0.0001). Group 1 showed lower average age, longer hospital stay, greater number of readmissions and lower ejection fraction than Group 2 (Table 5). In this study, the mortality rate was 18.9%. Comparing patients who had improved outcome (Group 3) with the group that died (Group 4), there was a significant difference in relation to the mean ejection fraction (p=0.001) and the mean number of readmissions (p=0.03). Group 4 had a higher average of readmissions and a lower mean ejection fraction than Group 3 (Table 6). Table 4 Treatments performed in the patients studied % Anticoagulant Low-sodium diet ARB ACEI Clinical treatment Diuretics Beta-blocker Percutaneous treatment Coronary artery bypass grafting Surgical treatment Yes 88.3 No 11.7 Yes 100.0 Yes 19.5 No 80.5 Yes 48.7 No 51.3 Loop 54.8 K+ sparing diuretics 21.7 Thiazide 4.3 Did not use 19.2 Carvedilol 59.8 Metrapolol 6.6 Atenolol 4.7 Propranolol 3.0 Did not use 25.8 Stent 4.3 Balloon 0.6 Both 0.5 Bypass surgery 1.1 Breast implant 0.6 Both 3.0 Heart transplant 9.3 Valve replacement Valvuloplasty 11.0 ICD 2.2 Other 5.9 ARB — angiotensin receptor blocker; ACEI — angiotensin-converting enzyme inhibitor; ICD — cardioverter Int J Cardiovasc Sci. 2015;28(2):130-138 Original Manuscript Silva et al. Evaluation of the Treatment of Heart Failure Table 5 Characteristics of the patients studied stratified by groups: transplanted and non-transplanted Transplanted Non transplanted (n=59) (n=576) 48.68±12.95 60.99±15.92 < 0.0001 Readmissions (number) 2.14±3.06 0.97±1.53 < 0.0001 Length of stay (weeks) 7.03±4.89 4.47±2.26 < 0.0001 Ejection fraction (%) 27.92±9.78 42.20±15.75 < 0.0001 Age (years) p Values expressed as mean±standard deviation Table 6 Characteristics of the patients studied stratified by groups: improved evolution and death Improved evolution Death (n=485) (n=120) 59.44±16.14 61.80±15.2 0.106 Readmissions (number) 1.02±1.81 1.22±1.62 0.030 Length of stay (weeks) 4.61±3.43 5.42±3.88 0.068 41.78±15.78 36.74±15.13 0.001 Age (years) Ejection fraction (%) p Values expressed as mean±standard deviation Discussion Because it is a public hospital and a local and regional reference for the treatment of cardiovascular diseases, Hospital de Messejana receives a large number of patients with various cardiovascular system diseases in different conditions and receiving various treatment regimens in which most do not have any etiological and/or syndromic diagnosis. Receiving all of them, diagnosing them correctly and quickly and initiating appropriate therapy is a constant challenge on the daily routine of the Hospital. In this study, we observed an average age of 59.85 years; in the study conducted by Stewart et al.27, the average was 55.0 years, which shows a possible difficulty in identifying affected patients at the primary care level. In this study, there was a prevalence of HF increased in men (67.2%) compared to women (32.8%). Previous epidemiological studies show, however, that despite a relative incidence of higher HF among men, about 50.0% of HF cases are observed in women, mainly due to the longer life expectancy of the female sex28,29. The therapeutic approach of HF seeks an accurate assessment of the etiology, investigation of factors that contribute to the worsening of clinical symptoms, in addition to the severity of the syndrome23. In this sample, the prevailing HF etiology was idiopathic cardiomyopathy (34.8%), confirming Felker et al.30, whose study showed a prevalence of 50.0%. The most prevalent mechanism was systolic dysfunction with 72.0% of cases; in the PREVEND study, systolic dysfunction (66.0%)7 prevailed. Hypertensive patients and smokers were the majority of patients with HF, while respiratory infections were the most prevalent ones. Correction of systemic factors, treatment of comorbidities, changes in life style, suspension of drugs that contribute 135 136 Silva et al. Evaluation of the Treatment of Heart Failure to HF, vaccination against influenza and pneumonia, treatment of underlying diseases, drug therapy, hospitalization when necessary, use of devices such as cardioverter defibrillator (ICD), resynchronization therapy, ventricular assist devices, coronary angioplasty, coronary artery bypass grafting and valve replacement, heart transplant, plus a home support program after discharge are the required strategies to achieve the best results in the treatment of patients with HF13,26. Pharmacological treatment of HF comprises several drugs that improve symptoms, such as digoxin (recommendation/ level of evidence --R/NE-IIa/B); moreover, they can increase the survival of patients, such as beta blockers (I A), ACE inhibitors (I A), angiotensin receptor blockers II (I A), hydralazine + nitrates (IIa B) and aldosterone antagonists (I A)13,24. In some cases, we can also observe the need to use antiarrhythmics, anticoagulants (I A in concomitant atrial fibrillation) and the treatment of anemia in order to optimize the therapy13,23. In this study, the records showed that the drug therapy was appropriately administered to most patients with HF, according to the ACCF/AHA24, observing, however, a high average of readmissions (1.08 weeks), which might be due to the non-adherence to treatment (medication changes, poor diet, alcohol consumption or inappropriate substances), new triggering factors (infection, uncontrolled type 2 diabetes mellitus, anemia, pregnancy, electrolyte disorders, thyroid dysfunction) or worsening of the underlying disease (new ischemic episode, uncontrolled hypertension, onset of atrial fibrillation, pulmonary embolism, worsening of secondary mitral insufficiency)13,23,24. Invasive treatment, in this sample, was applied to about 40.0% of patients with valve replacement surgery and heart transplants with greater expression. In relation to heart transplantation, the higher prevalence in younger patients (48.68 years on average) should be noted, since it is an invasive procedure that requires a good clinical response from the patient. According to Barroso31, heart transplant indications are for patients with dilated cardiomyopathies class III/IV from the New York Heart Association (NYHA), thus showing a more severe clinical picture of this group of individuals. Therefore, this study shows this greater severity through the longer hospitalization time, about seven weeks, due to the increased number of readmissions (average of 2.14 times) and low ejection fraction (27.92%). Mortality from HF remains high among patients who became symptomatic. However, there are records showing reduction in in-hospital mortality of 5.1% to 4.2% among Int J Cardiovasc Sci. 2015;28(2):130-138 Original Manuscript patients of Medicare-USA 32, contrasting with 11.0% mortality after 30 days reported by another study33; the Framingham study showed a 12.0% reduction trend in mortality due to HF per decade of life after 198034. The present series showed a mortality rate of 18.9%, considered high, since the Brazilian studies of Villacorta et al.35 and Rohde et al.36 showed a mortality rate of 10.6% and 11.0%, respectively. By analyzing the patients who died, there was a statistically significant association in the number of readmissions and ejection fraction. There was a higher number of admissions as well as lower EF, which is believed to be due to the greater severity of the underlying disease. By analyzing the infections in patients, there has been a greater incidence on those whose age is higher; but not statistically significant (p > 0.05), as well as a greater number of hospital admissions and lower ejection fraction with p = 0.333 and p = 0.326, respectively. However, there was a positive statistical significance in the length of stay (p < 0.001), mainly related to complications arising from the fact that the patient has to remain in bed rest for a long time, proven by the studies of Blanes et al.37 and Barretto et al.38. The limitations of this study relate primarily to data collection, due to lack of medical records some patients in hospital during the study period; the lack of patient data, the lack of an electronic database with all Hospital admissions and the lack of a functioning protocol in HM made it difficult to identify diagnostic criteria. The knowledge of this reality will certainly help improve and humanize the performance of physicians and the multidisciplinary team involved, and increase the awareness of our managers about the need for administrative strategies to ensure the best treatment for patients with this disease, which will be the most important one in the 21st century. Conclusion Patients with HF treated in HM received the classical therapy recommended, including the use of surgical devices and procedures such as heart transplantation and had a satisfactory outcome in most cases, despite a high rate of in-hospital mortality. Potential Conflicts of Interest No relevant potential conflicts of interest. Sources of Funding This study had no external funding sources. Academic Association This study is not associated with any graduate programs. Int J Cardiovasc Sci. 2015;28(2):130-138 Original Manuscript Silva et al. 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