2.1. Study Design and Study Population
This prospective, observational study was conducted in the Cardiology Department of the “Bagdasar-Arseni” Emergency Hospital in Bucharest, Romania, during an enrollment period of 1 year and 6 months, from May 2021 to October 2022, and followed the patients’ evolution after discharge for 12 months, from May 2022 to April 2023. This study was conducted on a sample of 142 patients over 18 years old and diagnosed with preserved LVEF. The cohort comprised patients admitted with a diagnosis of heart failure with preserved ejection fraction (LVEF ≥ 50 percent).
In Romania, the public health system includes emergency hospitals, as well as hospitals for chronic diseases. In each of these, patients can be admitted for evaluation and treatment. The outpatient system does not have the capabilities to provide a complex evaluation (echocardiography, NT pro BNP dosage, lung X-Ray, other blood tests, etc.) for all patients in each of these hospitals. Thus, patients with compensated heart failure are scheduled for hospitalization to evaluate and monitor the evolution of the disease under treatment [
22,
23,
24,
25].
The follow-up was carried out via a phone call during the first year after discharge due to the difficulty of follow-up in the cardiology clinic in the context of the recent SARS-CoV-2 virus pandemic.
The inclusion criteria were as follows: (1) patients over 18 years old; (2) patients with signs/symptoms of heart failure; (3) patients with NT-proBNP ≥300 pg/mL; (4) patients with LVEF (left-ventricular ejection fraction) ≥50% objectified echocardiographically; (5) patients with only signs and symptoms specific to the disease; (6) patients with compensated or acute heart failure; and (7) patients who signed the informed consent form and agreed to the prospective follow-up and to participate in the evaluation via telephone.
The exclusion criteria were as follows: (1) patients with severe valvular diseases; (2) patients with severe neuropsychiatric diseases; (3) patients with severe liver, kidney, or lung diseases; (4) patients with ongoing infections; (5) patients diagnosed with autoimmune diseases or malignancy; (6) patients with moderate and severe anemia; and (7) patients with hope of survival of less than 1 year (as this study aimed to observe the evolution for 12 months after discharge, which may not have been feasible for these patients).
All the patients had venous blood samples collected within 30 min of admission. The NT-proBNP level was evaluated using the ELISA method with a PATHFAST compact autoanalyzer. The LVEF (left-ventricular ejection fraction) values were obtained using transthoracic echocardiography performed during hospitalization. The modified Simpson biplane method was used to calculate the left-ventricular end-systolic volumes (LVESVs) and end-diastolic volumes (LVEDVs) from 4- and 2-chamber views. The LV volumes were corrected for body surface area.
The demographic data included age, gender, emergency admission or appointment, NYHA class, normal or arterial hypertension, atrial fibrillation, and overweight and obesity. The mean, minimum, and maximum ages of the patients enrolled in this study were 73.1, 40, and 93, respectively (
Table 1).
In this study, only 13 patients were under 60 years old (
Figure 1), suggesting a prevalence of the disease in elderly patients, a characteristic of HFPEF.
The NYHA class distribution at presentation was 58% for NYHA class III, and 42% for NYHA class IV (
Table 2). Patients in NYHA class III/IV had typical signs and symptoms of acute decompensated HF.
The percentage of women with HFPEF was higher in the group of patients studied, as it is known that HFPEF is more frequent in women (
Figure 2).
The distribution of NT-proBNP levels revealed that most patients had relatively low values, ranging from 1.005 pg/mL to 5008 pg/mL, encompassing 75% of the sample (
Table 3). The remaining 25% (top quartile) had levels exceeding 4.716 pg/mL. The data also included outliers, with values exceeding 10.000 pg/mL and a maximum recorded value of 30.000 pg/mL (
Figure 3).
The tracked quality-of-life factors were as follows: a marked limitation of physical activity, edema, recent fatigue, the ability to exercise, palpitations, and sadness.
All the variables used were binary, as described in the following summary statistics table (
Table 4).
These variables were chosen to describe patients’ quality of life because they directly impact lifestyle and show the symptoms and limitations caused by heart failure decompensation. For example, the presence of pitting edema, marked limitation of physical activity, and fatigue at regular exertion indicate an exacerbation of the disease. These patients should be medically reassessed as soon as possible.
The inability to exercise daily is a parameter associated with the limitations of the disease and contributes to its unfavorable evolution.
Illness indicates physical and mental limitations, so we wanted to identify which patients were sad and could benefit from psycho-emotional support.
We considered it useful to use some parameters from the patients’ hospitalizations to determine if there was a relationship between them and their H2FPEF scores. One variable was the presence of palpitations. This parameter is a symptom of the disease and simultaneously contributes to the course of the disease. It suggests a possible cause—atrial fibrillation—which must be investigated and treated if present.
The distribution of the independent variable used in this research, the H2FPEF score, a specific indicator of heart failure with preserved ejection fraction, is presented below.
The distribution of the H2FPEF scores in the sample is illustrated in
Figure 4. The data reveal a concentration of scores between 4 and 6, characteristic of this patient population, with relatively few individuals scoring at the extremes of 3 or 9.
Patients admitted with HFPEF had a minimum hospital stay of 3 days, a maximum of 9 days, and an average of 5.9 days (
Table 5).
The patients received the following treatments during hospitalization and after discharge: intravenous loop diuretics and then oral loop diuretics, ACEIs (Angiotensin-converting enzyme inhibitors)/ARBs (Angiotensin receptor blockers), spironolactone, beta-blockers, and digoxin (
Table 6). In total, 24% of patients required intravenous loop diuretics.
2.2. Study Method
Quality-of-life data were obtained one year after discharge via a telephone interview in which patients answered the questions below. The average duration of the phone call was 15 min. We aimed to obtain data on the following variables that describe the quality of life: marked limitation of physical activity, pitting edema, recent fatigue, ability to exercise, palpitations, and sadness.
For the variables obtained from the answers provided during the phone interview, we recorded and analyzed data for 126 patients. The other 16 patients died within the first year after discharge.
The questions for the phone interview were as follows:
In the last month, have you breathed harder during physical efforts?
Do you have pitting edemas?
Are you feeling more tired lately?
Do you manage to exercise minimum 30 min/day, minimum 5 days/week?
Are you sad? Is your sadness caused by the cardiovascular disease?
Do you have palpitations?
Have you been admitted to a cardiology ward in the last year? If the answer was Yes, the reason for hospitalization was also specified.
Only the answers that were related to the evolution of heart failure were considered.
The questions were designed in such a way that the answers could be converted to Yes or No values, to ensure a fast data collection process and to be able to apply the linear regression statistical method, a suitable tool for the analysis of variables with binary values. The existing questionnaires (MLHFQ and KCCQ) that measure quality-of-life allow for multiple answers and would not have allowed for the type of analysis we intended to perform.
We tried to find a correlation between the answers provided and the H2FPEF score value from admission to be able to predict which patients were at higher risk and, thus, identify the vulnerable ones early. These patients require closer follow-up via frequent check-ups with a general practitioner or cardiologist. They and their families should be medically educated about the precipitating factors and the signs and symptoms of the disease’s decompensation to reach their doctor faster.
The questionnaire was developed and used exclusively for this study. It includes questions whose answers helped us test our working hypothesis that H2FPEF score can provide a prediction of quality-of-life factors. Developing a new standard questionnaire to assess quality of life was not within the scope of this study.
This study was conducted according to the guidelines of the Declaration of Helsinki and approved by the Ethics Committee of “Carol Davila” University of Medicine and Pharmacy, Bucharest, Romania (protocol code: PO-35-F-03; 1 October 2021).