Patients' knowledge and concerns about using the implantable cardioverter defibrillator for the primary prevention of sudden cardiac death and its correlates: A cross‐sectional study

Abstract Background and Aims Sudden cardiac death (SCD) is one of the most common causes of mortality in heart failure (HF) patients with reduced ejection fraction. Patients have concerns about the disease and use the implantable cardioverter defibrillator (ICD) to reduce the effects of HF disease. The current study aims to evaluate the barriers and factors affecting the implantation of the ICD for primary prevention. Methods One hundred‐forty‐seven patients with HF were studied in public hospitals in southern Iran by using a cross‐sectional design from April 2018 to June 2019. Demographic, researcher‐made questionnaire, World Health Organization Quality of life‐BREF (WHOQOL‐BREF), general self‐efficacy questionnaires, and Multidimensional Scale of Perceived Social Support (MSPSS) were measured for investigating the barriers and impact factors in patent HF. Results Most participants were male (56.5%), married (88.4%), illiterate (54.1%), and unemployed (72.6%). 62.6% (n = 92) of the participants did not know about HF and ICD. The total score of patients' concerns about using ICD was 47.11 ± 11.26, which showed a moderate level. The scores of knowledge about HF and ICD had a significant positive poor correlation with self‐efficacy, perceived social support and QoL. Also, the score of concerns about the ICD had a significant negative poor correlation with perceived social support. Conclusion Understanding HF patients' issues and obstacles can help us prevent sudden death. Doctors' advice has a significant impact on patients' acceptance. Poor knowledge is the most important reason for nonparticipation. Intervention is necessary to inform patients to understand the advantages and disadvantages.


| BACKGROUND
HF is a progressive and debilitating disease, the most common cardiovascular disorder, a major health problem and an epidemic disorder in the United States. The disease affects about 26 million people worldwide and causes more than 1 million hospitalizations in the United States and Europe annually. 1 HF is one of the major causes of hospitalization in adults and the elderly, which is associated with increased morbidity and mortality and imposes a significant burden on the healthcare system. 2 Heart disease (67.9%) including HF has been the leading cause of sudden cardiac death (SCD) as well as a major health challenge. 3 Studies show sudden death in 25%-30% of HF patients with reduced cardiac output. 4 HF has a significant impact on all aspects of quality of life (QoL), including physical function, mental health and social domains. According to the New York Heart Association (NYHA), the QoL disruption in patients with HF is higher than those with other cardiovascular or noncardiac conditions. 5 Although many HF treatments have a positive impact on the QoL of patients, many limitations are still available in the QoL of HF patients. 6 These limitations are higher in HF patients with lower cardiac output. 7 More than 8.5 million Americans suffering HF experience depressive symptoms and poor QoL. 8 Chronic HF requiring self-care and symptom management caused 70%-80% of healthcare costs in Europe in 2013. 9 Failure in self-care leads to the use of health systems and increased health care costs. 10 Self-care in HF is a two-stage process: the first one involves self-care in everyday behaviors and the second one is self-care management, including knowing changes in behaviors and responding to them. The self-care process is affected by self-efficacy. 9 Many studies are being conducted to improve drug admission, reduce forgetfulness, and activate self-efficacy and motivation in patients.
However, social support is one part of the patients' health that affects the patient's family. Social support can improve the QoL and self-efficacy of patients. 11 As mentioned above, the risk of SCA in HF patients is high due to dysrhythmias. Implantable cardioverter defibrillator (ICD) implantation is one of the methods for SCD prevention and survival in HF patients. 12 ICD prevents cardiac arrest by evacuating electrical shock. ICD is more effective than medication for ending cardiac dysrhythmia. 13 In primary and secondary preventions, ICD is fundamental for preventing SCD. 14,15 The American Heart Association (AHA), the American College of Cardiology (ACC), and the Heart Rhythm Society (HRS) have recommended ICD for the primary prevention of SCD in patients with known criteria. 16 Previous studies have shown that the refusal to use ICD for primary prevention is common due to patients' negligence, low risk of SCD, and the lack of medical advice. 17 Although many guidelines have been published for embedding ICD for patients at risk, the embedding has been less done because of not being well-perceived. Many barriers are available to implant ICD including no recognition of ICD implications, the absence of a heart surgeon and necessary resources, the high cost of embedding ICD device, and doubts about the benefits of ICD. If cardiologists believe that embedding an ICD device is not very beneficial, they will not propose an ICD for the patient. 18 HF patients do not understand the risk well. Physicians must inform patients in a meaningful way and help them understand the purpose, risks and benefits of their treatment and reach an informed choice. 18 But using this device may be challenging for patients and their families. 19 The ICD affects some aspects of people's lives, including social and family relationships, physical activity, psychological state, lifestyle, and QoL. 13,20,21 No study in Iran was found on the primary prevention of ICD in patients at risk of SCD, especially those with HF and reduced cardiac output. Therefore, the present study was conducted with the following specific objectives. (a) the evaluation of knowledge about HF and ICD; (b) the evaluation of concerns about ICD; (c) assess the four variables of perceived symptoms, self-efficacy, perceived social support, and QoL; (d) the correlation among ICD barriers (knowledge and concerns) and perceived symptoms, selfefficacy, perceived social support, and QoL.

| Study design and setting
The present study had a cross-sectional design. We evaluated some barriers of the ICD implantation for the primary prevention of SCD in HF patients in southeast Iran.

| Sample size and sampling
A descriptive cross-sectional study was conducted among 147 HF patients with reduced ejection fraction. The HF patients were admitted to two public-educational hospitals in different wards cardiac care unit (CCU) in Ali Ibn Abitaleb hospital of Rafsanjan city and shafa hospital of Kerman city. They were discharged after receiving the necessary care in the critical care unit (CCU) in one of the southeastern cities of Iran. The inclusion criteria were patients aged ≥21 years old, diagnosed with HF and reduced cardiac output (Left ventricular ejection fraction <35%) based on NYHA criteria, the presence of a formal or informal caregiver, and signed written informed consent. Patients with visual and auditory processing disorders, severe neurological or psychiatric disorders (e.g., Parkinson's disease, Alzheimer's disease), and an uncompleted questionnaire were excluded from the study.

| Data collection
Two hundred questionnaires were distributed in the two hospitals over a 14-month period (From April 2018 to June 2019) and 170 copies were returned (response rate: 85%). After poorly completed questionnaires (e.g., they were not fully completed) were excluded, data from 147 participants were used in the final analyses. Thus, the sample had an appropriate size.

| Measurements
Four questionnaires were used to collect data. The first one consisted of demographic and disease profile information (gender, marital status, income, educational level, employment status, duration of heart failure, history of hospitalization, number of admissions, ejection fraction, functional class, and other illnesses).
The second questionnaire was a researcher-made one by previous with the total score of (10-40) used to predict adaptability after the transformations. High reliability, stability, and construct validity of the GSE-10 have confirmed in the study. 22 The Cronbach α coefficient of the GSE-10 scale in Iran was 0.844, which was standardized by Rajabi. 23 In the present study, the Cronbach's α for the GSE-10 scale was 0.94.
World Health Organization Quality of life-BRE (WHOQOL-BREF) with 26 items includes psychophysical health, social relationships, and environment as a QoL to measure health. Two items of health and QoL are unscored. The score for each item ranges from 1 to 5 (never, low, medium, high, and quite a lot). Internal consistency of the study was excellent (0.92) and test-retest reliability was good. 24 The Cronbach's α coefficient of WHOQOL-BREF in Iran was 0.78. 25 The short version should be converted to the long version, and then the QoL was interpreted from zero to 100. In the present study, Cronbach's α for the WHOQOL-BREF scale was 0.89.

Multidimensional Scale of Perceived Social Support (MSPSS)
contains 12 items based on seven-point Likert scale (very strongly disagree to very strongly agree). The MSPSS individually measures the PSS through three sources: significant others, family and friends.
The Cronbach's α coefficient of MSPSS in Iran was 0.93. 26 The score ranges from 12 to 72 points. In the present study, Cronbach's α for the MSPSS scale was 0.95.

| Data analysis
Data were analyzed using SPSS22 and descriptive and inferential statistical methods. Descriptive statistics, including frequency, percentage, mean and standard deviation were used to describe demographic characteristics and mean scores (knowledge about HF and ICD; concerns about ICD). Mean and standard deviation were used to describe self-efficacy, QoL, PSS. Analysis of variance and independent t-test, and in some cases Mann-Whitney U and Kruskal-Wallis tests were used to determine the relationship between demographic and disease profile information questionnaire, knowledge about HF and ICD, and concerns about ICD. Spearman correlation coefficient was used to determine the relationship between Knowledge about HF and ICD, Concerns about ICD, self-efficacy, QoL and PSS. Also, p value and 95% confidence intervals are reported. A significance level of 0.05 was considered.   Table 1). The results also showed a positive correlation among the knowledge about HF, ICD score, and the duration of HF (p < 0.05). In addition, the knowledge about HF and ICD scores of married participants were more than that of the widowers. The participants with more than monthly two million-toman income had much knowledge compared to others. Also, either retired or employed participants had much knowledge compared to selfemployed or unemployed ones. Among the demographic variables, only age was significantly correlated with the concerns about ICD score (p < 0.05) ( Table 1)  questionnaire was 48). The participants were mostly worried about high surgical cost, ICD malfunction, side effects of the ICD, limited use of microwave, being old, and being dependent on others (Table 3).

| Ethical considerations
The results showed that 52.3% (n = 77 of the 147 patients) of the participants, decided themselves about the ICD implantation, in particular, they decided not to proceed with an ICD implantation.   Table 4).
The mean total score of self-efficacy was 21.39 ± 7.05, which was lower than 25 (cutoff point = 25). Therefore, the self-efficacy of the participants was less than moderate. The mean total score of perceived social support was 4.08 ± 1.44, which was higher than the median score of the questionnaire (score = 3.5). The mean total score of QOL was 40.72 ± 12.47, which was lower than the median score of the questionnaire (score = 50.0).
Therefore, the QOL of the participants was less than moderate (Table 5).
T A B L E 2 Participants' knowledge about HF and ICD (n = 147).

T A B L E 3
The participants' concerns about using ICD (n = 147). Note: Data were presented as number (%).
T A B L E 5 Self-efficacy, PSS scores, and QOL among the participants (n = 147). The score of knowledge about HF and ICD had a significant positive poor correlation with self-efficacy, perceived social support, and QoL (p < 0.05). Also, the score of concerns about ICD had a significant negative poor correlation with perceived social support (p < 0.05) (

| DISCUSSION
Avoiding ICD implantation is common among patients who are candidates for the SCD primary prevention. 17 The current study aimed to study barriers to the ICD implantation among HF patients

| Limitations
The main limitation of this study was the very low educational level of the majority of the participants; educated patients may be more aware of HF as well as the ICD indication and procedure. Also, we did not interview the physicians to know doctor-related misperceptions and recommendations. In addition, this study had a cross-sectional design so that we could not interview patients who accepted the ICD implantation and had valid knowledge and recognition regarding the ICD procedure and the reasons for using it.

| CONCLUSION
This study helps increasing knowledge about the barriers concerning ICD implantation in HF patients with an indication for primary

| Relevance to clinical practice
It is important to assess what patients think and concern about the risks of not inserting ICD, how much they are aware of these risks, and how important these therapeutic recommendations are for them.
It is helpful to investigate and remove the concerns and factors influencing the insertion of an ICD in patients. These results can help healthcare professionals choose the correct device as well as make the right decision when training the patients, and thus the chance of survival in patients increases.