Factors influencing quality of life of patients with cardiovascular implantable electronic devices

Introduction

The number of cardiac implantable electronic device (CIED) procedures performed each year is growing, and it is one of the most frequently performed surgeries in invasive cardiology. On average, 1.7 million devices are implanted worldwide each year [1]. Several types of implantable cardiac devices can be distinguished, such as pacemaker (PM), implanted cardioverter-defibrillator (ICD), and resynchronization device (cardiac resynchronization therapy – CRT), each having a different purpose [2].
Pacemakers are implanted in patients who are at risk of bradycardia. The purpose of a PM is to monitor the patient’s own heart rhythm and, if insufficient heart rate is detected, the device provides an electrical impulse to stimulate the heart muscle [3].
Cardioverter-defibrillator has a dual function; it can provide pacing, but also has a function of delivering electrical discharge in the event of life-threatening ventricular arrhythmia [3, 4]. Devices with resynchronization function are a form of treatment for patients with heart failure (HF) and deteriorated left ventricular function. They provide biventricular pacing, and prevent the development of further symptoms of HF and abnormal remodeling of the heart structures [5].
Although CIEDs are life-saving devices, they are life-changing for the patient, creating both physical and psychological challenges. The procedure of implanting a PM or ICD can itself cause a great amount of stress or cause complications for the patient, including life-threatening conditions, such as cardiac tamponade, pneumothorax, infective endocarditis, lead perforation, or electrode dislocation [6, 7]. In addition, the implantation of CIED is associated with a psychological burden. Although these devices generally improve health-related quality of life (HR-QoL), up to 35% of CIED patients feel emotionally distressed or experience anxiety. This may be related to the patient’s awareness that their life depends on an implanted device. Furthermore, this can result in difficulties in returning to professional and social activities, which may also reduce the perceived quality of life [8, 9]. In patients with ICDs, the experience of an electrical discharge and awareness of being at risk of a life-threatening arrhythmia cause an additional significant psychological burden, which may contribute to the development of post-traumatic stress disorder [10, 11]. In cardiac patients, the psychological aspect plays an important role; it has been proven that stress or frequent exposure to negative feelings increase the risk of the occurrence or worsening of cardiovascular diseases [12].
It should also be noted that there are restrictions related to living with a CIED, which may also influence patients’ QoL, especially in first months after implantation. These limitations apply to sports activities, daily routines, driving, traveling, etc. Some patients may therefore be required to discontinue or change their workplace. Also, a lot depends on the patient attitude towards the device as well as family and medical staff support. Patients often are not aware as to why they had a CIED implanted, and perceive it as a useless device that only limits their daily life and negatively changes body image. At times, they see CIED as an unpleasant reminder of their illness. However, patients who understand that the device is intended to protect them from life-threatening arrhythmias feel safer and accept it as part of their body. If patients have supportive spouses and relatives, and received comprehensive information about the device from medical professionals, they adapt more easily to living with a CIED and associated limitations [13, 14].
Quality of life is a multidimensional concept that includes physical, emotional, and social functioning. Symptoms of a disease and effects of the applied treatment influence patients’ view about their QoL [15]. It is also worth noting that in case of patients with CIEDs, the perceived QoL depends on factors unrelated to the device itself, such as gender, personality, pre-existing psychological conditions, such as depression or anxiety, patients’ age, level of knowledge, and presence of other conditions [13, 16].
Considering all the consequences of having to live with an implanted cardiac device, special attention should be paid to health-related quality of life (HR-QoL) of this group of patients and influencing factors.
Therefore, the aim of this study was to assess the quality of life of patients with implanted cardiac devices.

Material and methods

Study design and population

The study was conducted among 101 patients of a cardiology outpatient clinic at the Independent Public Regional Hospital in Szczecin. The selection of the study group was purposive; only patients with implanted CIED, aged above 18 years, and agreed to participate in the study were included. The research was conducted from June to September 2022 after obtaining approval from the hospital management. The study was carried out in accordance with the Declaration of Helsinki and approved by the Bioethical Committee of Pomeranian Medical University in Szczecin (resolution No. KB-0012/46/01/2013). Participation in the study was anonymous and voluntary. Prior to the research, participants were informed about the study confidentiality, its purpose, and methodology as well as withdrawing from the study at any time without a reason. After obtaining an signed consent from the respondents, the study was conducted.

Research instruments

This research was a diagnostic survey study carried out with the use of a questionnaire technique. The tools used were a self-constructed questionnaire with 11 single-choice questions assessing patients’ socio-demographic and medical data, and the standardized World Health Organization Quality of Life – BREF (WHOQOL-BREF) questionnaire to analyze QoL in four aspects: 1. Physical health – performance of daily activities, experiencing fatigue, pain sensations, ability to work, medication and treatment used, and quality of sleep; 2. Psychological health – body image perception, self-esteem, religious beliefs, concentration, memory, and negative and positive emotions; 3. Social relationships – family relationships and receiving support; 4. Environment – finances, sense of security, ability to engage in hobby or recreational activities, home, and physical environment [17]. The questionnaire consisted of 26 questions, of which 24 related to domains of life described above. In each domain, scores ranged from 4 to 20, and the higher the score, the better the quality of life. First, the average score for all items in each of the four domains was calculated by adding the scores for each item, and dividing the sum by the number of items in the domain. This result was then multiplied by 4. The results obtained were transformed to a scale ranging from 0 to 100. The first step was to subtract the lowest possible score (i.e., 4) from the score obtained in each domain. Then, the number obtained was divided by ‘possible raw score range’, understood as the difference between the highest and lowest scores, which was 16 for all domains. This calculated value was then multiplied by 100, providing a transformed score for a given domain. In addition, the WHOQOL-BREF contains items analyzed separately: Question 1 (WHO1): individual overall perception of quality of life; Question 2 (WHO2): individual overall perception of one’s own health, scored on a scale from 1 to 5 [17]. Cronbach’s a coefficient was also calculated for each domain. The results are presented in Table 1.

Study group

The study group consisted of 101 patients, with mean age of 71.7 years (SD = 7.991). 61% of respondents were males, and majority of participants lived in cities of 10,000-100,000 inhabitants (32.7%) and in rural areas (31.7%). 10.9% of respondents resided in large cities with more than 100,000 inhabitants. Surveyed patients most often declared primary education (43.6%), followed by a relatively large group (34.7%) with basic vocational, while only 7.9% declared higher education. Vast majority (82.2%) were patients who had a pacemaker implanted. The most common reasons for a cardiac device implantation were sinus node disease (40.6%) and atrioventricular block (40.6%). In terms of comorbidities, more than half (50.5%) of respondents declared having hypertension. 92.1% of participants with ICD implanted never experienced an electrical discharge, while 5.9% of the study group had a one-time event, and 2% of patients reported several time events. The mean time since implantation of a cardiac device in the study group was 7.5 years (SD = 4.696).

Data analysis

Statistical analysis was performed using IBM SPSS Statistics version 25.0. Basic descriptive statistics of the quantitative study variables were calculated with Kolomogrov-Smirnov test. A series of frequency analyses were performed to assess the level of quality of life, respondents’ satisfaction with their health, and distribution of scores for each domain of the WHOQOL-BREF scale. To calculate the correlation between quality of life level and gender, a series of Student’s t tests were done. Pearson’s r correlation analyses were carried out to determine whether the subjects’ age and time since CIED implantation were associated with their quality of life. To assess the relationship between quality of life and place of residence, level of education, presence of comorbidities, reasons for CIED implantation, and types of cardiac device, Kruskal-Wallis tests were performed. For a statistically significant result, an analysis of post-hoc was employed using Dunn-Sidak test, while Cronbach’s a coefficient was used for reliability analysis of each domain.

Results

First, basic descriptive statistics of the quantitative variables were calculated with Kolmogorov-Smirnov tests for evaluating normality of distributions of these variables. All variables showed distributions different from the Gaussian ones. In such cases, skewness of the distribution of the analyzed variables should be implemented. If it falls within the range of ± 2, it can be assumed that the distribution of the analyzed variable is not significantly asymmetrical in relation to the mean. Here, this value was observed for all variables. Based on the results, it was decided that statistical analyses will be performed using parametric tests.
The patients’ overall quality of life on a scale of 1-5 averaged 3.48 ±0.94, indicating average to good level of their QoL. The average life satisfaction was 3.50 ±0.94, showing the subjects’ satisfaction with their health status. For each domain, the result was transformed into a 0-100 scale. The highest mean values of 62.25 points (SD = 16.23) were obtained within the psychological domain. Slightly lower mean values of 60.32 points (SD = 17.06) were shown within the environmental domain and social relationships domain – 60.13 points (SD = 18.54). The lowest mean values of 59.14 (SD = 17.81) were scored in the physical domain. The results are demonstrated in Table 2.
Subsequently, a series of tests were carried out to see if the quality of life of the subjects depended on individual socio-demographic characteristics. Firstly, correlation was determined for the gender, but no statistically significant differences were found. The results are presented in Table 3.
A series of analyses were performed to calculate the correlation between quality of life and age of the participants and the time since implantation. Similarly, no statistically significant correlations were observed for these variables. The data can be found in Table 4.
The correlation between quality of life and level of education, reasons for CIED implantation, comorbidities, place of residence, and type of implantable cardiac device was calculated, and significant associations were observed only for the latter two variables. No statistically significant differences were found for the level of education, implantation reason, and comorbidities. The data are presented in Tables 5-7.
The performed analysis showed a correlation between the level of quality of life in the physical and social relationships domains and the place of residence. Residents of rural areas had a worse perception of their quality of life in the physical dimension than those living in larger towns and cities. Additionally, it was noted that among respondents living in rural areas, the level of quality of life in the social domain was lower. The data are shown in Table 8 and Figure 1.
Next, statistically significant correlation was observed between the level of quality of life and the type of implanted device. It was shown that the level of psychological quality of life was lower in patients with an implanted resynchronization system. However, it must be taken into account that the group of CRT patients was very small, which significantly affected the reliability of results. The results are presented in Table 9 and Figure 2.

Discussion

Cardiac implantable electronic device CIED implantation in majority of patients, especially in the initial period after procedure, improves their QoL. CIEDs prevent bradycardia and ensure activity-based heart rate, prevent deterioration of the condition, increase the expected life-span, and reduce the number of patient hospitalizations [18]. The impact of the device type on patients’ QoL is also worth mentioning. Studies show that leadless pacemakers (LP) improve patients’ QoL to a greater extent than conventional PM. This is due to a less invasive implantation procedure, a lower incidence of long-term complications, and fewer post-implantation restrictions. LP patients are also less likely to report psychological discomfort after implantation. In addition, LPs are recommended for patients prone to infection, and these devises have been shown to have little adverse impact on the incidence of tricuspid regurgitation [19-21]. Nevertheless, the use of LPs is still limited because they usually allow single-chamber pacing, which may be insufficient in some patients [20]. It is also important to remember that every CIED implantation, including LP, has its risks and side effects. The perforation and vascular complications have been shown to be more common in short-term incidence. On the other hand, LP patients experience fewer long-term complications, e.g., one year after implantation [19, 22]. In the current study, no patients with LPs were enrolled, as the center where the study was conducted does not perform LP implantation.
However, LPs are not the only devices that enhance quality of life. Patients who receive cardiac resynchronization therapy (CRT) also report a significant QoL improvement, particularly in later period after implantation. This is specifically noticeable between ICD and CRT with defibrillator (CRT-D) patient groups. Those with CRT showed significant improvement in performing daily living activities and self-care in early period after implantation. Furthermore, in later period, patients reported less pain and a lower incidence of anxiety or depressive symptoms. The significant improvement of QoL in patients with CRT may be related to enhanced synchronization of the heart chambers and a reduction in symptoms associated with HF [23]. This study found that CRT patients reported worse quality of life in the psychological aspects than the other respondents; however, the CRT patients group was too small for the results to be considered valid.
Although the number of restrictions decreases over time, there are still some limitations that apply for the rest of patient’s life, such as regular visits to outpatient clinic, travelling restrictions, physical activity, and the use of devices involving electromagnetic fields [24]. Over time, the limitations associated with having a CIED create psychological strain, stress, and difficulties with acceptance of the disease and body image [25]. In addition, the type of CIED influences the number of restrictions patients need to obey and their perceiving of QoL. For instance, patients with ICDs are a special group of patients. They are at risk of life-threatening arrhythmias, the device is relatively large and can be seen under the skin and, most importantly, it can generate electrical discharges, which are potentially traumatic experiences. Studies show that electrical discharge is one of the most significant factors contributing to psychological burden. Those who experienced an electrical discharge from a device are more likely to have anxiety and depressive symptoms, regardless of whether high-energy therapy was adequate or not. However, patients with ICD who did not experienced an electrical shock still report negative feelings about having a CIED. Nonetheless, it is noticeable that the longer the time since implantation, the less frequent reporting on anxiety or depressive symptoms. The same correlation can be observed regarding acceptance of a device. Interestingly, compared with men, women experience anxiety more frequently after ICD implantation [13, 16, 22, 26]. In this study, no reduction in QoL was seen in patients with ICDs, possibly because there were few patients with these devices and most of them have never experienced an electrical discharge. Patients with CRT usually report an improvement in QoL, which may be due to the fact that CRT is one of the treatments for HF, a condition that can manifest by decreased exercise tolerance, difficulty breathing, oedema, or sleep problems, all of which can significantly affect QoL [27]. Implantation of a resynchronization therapy device alleviates these symptoms. Patients reported an improvement in QoL, especially if their quality of life was significantly reduced by HF symptoms prior to implantation. Previous studies demonstrated no significant differences in quality of life between patients with CRT-D and CRT pacemakers (CRT-P) [28, 29]. Furthermore, even if no significant changes are observed in an echocardiogram after implantation, a large group of patients report improved quality of life. The enhancement is seen in the overall QoL, mainly in physical aspects, although there are patients reporting improvements in psychological aspect and other domains. A factor that limits QoL improvement after CRT implantation is atrial fibrillation [29, 30]. However, our study did not demonstrate such correlation and the quality of life in patients with CRT was lower than in other patients. Conversely, the group of patients with a resynchronization device was very small, which could have affected the reliability of results.
The QoL assessment of patients with CIED is a very important aspect that can be used to evaluate the therapeutic impact on improving the patient’s physical and mental health. For this purpose, various standardized tools are used. In this study, the WHOQOL-BREF questionnaire was employed to analyze QoL in general and in four different aspects related to physical, psychological, social, and environmental functioning. The level of the overall QoL of the respondents in this study can be ranged between average and good. Very similar results were obtained in other studies conducted solely among patients with pacemakers or all kinds of CIEDs, where more than half of the respondents reported good QoL and satisfaction with life after implantation. This may be related to the cessation of symptoms related to bradycardia and other issues that were no longer experienced after CIED implantation [16, 25, 31]. In contrast, studies focusing solely on patients with ICDs noted a decrease in QoL in several or all domains, especially in patients who suffered an electrical discharge. Typically, the worst results were obtained in ICD patients regarding psychological aspect. In addition, a significantly higher level of anxiety was observed among these patients [8, 32, 33].
In this study, the participants scored the lowest in the physical domain, where their QoL was considered only average to good. The results of other studies often showed that post-implantation patients rated their physical QoL as quite good and were satisfied; they reported improvements in terms of self-care and activities of daily living. The group that was particularly satisfied with their activity level after the procedure were patients with LPs. Even though many patients reported undergoing pain around the area of implantation, this symptom was experienced in the early post-implantation period [16, 23, 34].
In our study, it was noted that the respondents’ quality of life in the psychological, environmental, and social relationships domains can be ranked as average to high; although in the social relationships’ domain, no patient obtained the maximum score.
In contrast, other studies showed a deterioration in patients’ psychological quality of life. This is the domain most poorly rated by patients, and they reported experiencing anxiety and depressive symptoms. These problems apply to all CIED patients, but a significantly lower QoL is noted in ICD patients. Also, whether the device was implanted in primary or secondary prevention makes a difference, but research results are not unanimous. However, electrical discharge of a device definitely has a negative impact on the psychological state of patients [35-37]. Whereas in relation to QoL in social aspects, an improvement or a neutral attitude is rather noticed [16, 35].
In this study, it was observed that the place of residence and type of CIED correspond with the level of QoL. This, to some extent, is in line with other studies. However, in other research, more correlations were seen between QoL and socio-demographic and medical data, including age, gender, marital status, education, and medical factors mainly related to pacemaker function, such as younger people, women, people with lower education and those who experienced problems with CIED functioning reported a poorer QoL [14, 38-40].
Moreover, many studies demonstrated correlations between QoL and the presence of comorbidities. These usually have a negative impact on patients’ QoL, as they cause CIED implantation to be less beneficial and complications may occur more frequently. This applies to both PM and ICD implantation [14, 41, 42]. In the present study, although patients reported having comorbidities, no correlation was proven. This may have been related to the nature of the conditions, where only hypertension and atrial fibrillation were reported, and AF was declared by about 24% of the patients.

Limitations

The study was conducted in a single center and included a relatively small group of patients, especially those with CRT. Also, the investigated cohort was considerably homogenous, with majority having pacemakers implanted. This study did not include the occurrence of complications, the NYHA class patients, or the level of patient knowledge about the implanted device. In future studies, using a questionnaire specifically designed for patients with implanted devices should be considered.

Conclusions

The study group rated their physical quality of life as mostly poor. It was shown that the place of residence influenced the patients’ quality of life. Conversely, the type of implanted cardiac device appeared to be a significant determinant of the patients’ quality of life in the psychological domain. Nonetheless, these findings should be viewed with caution, as the study group was dominated by patients with pacemakers. Further analyses with a larger and more diverse group of patients are required, while the current results confirm the need for further investigation of quality of life in patients with implanted cardiac devices.

Disclosures

This research received no external funding.
The study was conducted in accordance with the Declaration of Helsinki and approved by the Institutional Review Board of Bioethical Committee, Pomeranian Medical University in Szczecin (Resolution No. KB-0012/46/01/2013, January 2013).
The authors declare no conflict of interest.

References