Introduction: Implantation of a permanent cardiac pacemaker (PPM) improves recipients’ quality of life (QoL). However, psychiatric disturbance may adversely affect QoL and undermine clinical outcomes.

Aim: To explore impact of anxiety and depression on QoL of PPM recipients.

Materials and methods: A hundred and fifty PPM recipients were enrolled. Data collection was performed by completing the Hospital Anxiety and Depression Scale (HADS) and the SF-36 Health Survey (SF-36). Demographic characteristics were also included. The statistical significance level was p<0.05.

Results: Almost a quarter of the patients experienced anxiety (25.3%) and depression (26.0%). In terms of QoL, patients showed moderate to high levels in social functionality, energy/fatigue, emotional well-being and pain (median: 50, 60, 72, and 67.5, respectively) and poor levels in physical functioning, physical role and emotional role (medians: 22, 0, and 0 respectively). In addition, patients had moderate levels of general health (median 48.5). All QoL subscales were negatively associated with anxiety and depression of patients on a univariate level (p<0.05). Regarding demographic variables affecting QoL, age was statistically significantly associated with physical role (p=0.025), emotional role (p=0.005), social functioning (p=0.033), and pain (p=0.018). Furthermore, physical role was statistically significantly associated with number of children (p=0.024), emotional role with education level (p=0.011), social functioning with family status (p=0.018), and general health with residency (p=0.006).

Conclusions: Demographic characteristics and anxiety/depression are related with QoL. A better understanding of these associations may help clinicians in planning rational and cost-effective interventions.

anxiety, depression, quality of life, HADS, SF36, pacemaker

During recent decades, implantation rates of permanent cardiac pacemakers (PPMs) have increased dramatically mainly due to improvements in diagnosis of cardiac diseases^[1,2] and progress in pacing technology.^[3]

According to estimates, over one million PPMs are implanted globally every year^[4], out of which 250000 are implanted in the United States alone.^[5] In 2011, average implantation rate in Europe was 938 devices per million inhabitants while in Greece, it was 629 per million inhabitants.^[3]

Implantation rates are increasing markedly with advancing age. More in detail, 70%–80% of all PPMs are implanted in individuals aged more than 65 years while incidence rates for men exceed those for women.^[6] Demand of pacing therapy is anticipated to double within 25 years in accordance with population aging and differing etiologies of cardiac arrhythmias.^[6]

This electronic device improves patients’ quality of life (QoL) up to one year post implantation.^[7,8] QoL reflects patients’ perspective^[7,9] thus providing information alongside with the traditional physiologic measurements of health status.^[10] Furthermore, QoL is not only a key element to achieve patient-centred approach but also stimulates clinicians’ awareness of patient concerns. Moreover, QoL is acknowledged as a valuable tool to recognize effectiveness of pacing therapy on patients’ daily functioning.^[8] Needless to say, QoL has become more valued than extending life under limited or disabled conditions.^[7]

According to guidelines, monitoring of recipients is suggested in periods between 3 and 12 months post implantation.^[9] Each follow up visit includes assessment of device function and cardiovascular events, as well as evaluation of patients’ physical status.^[9] Therefore, the time of scheduled follow-up is the most suitable to explore QoL.^[9]

Anxiety and depression is not uncommon for PPM patients. Several factors may trigger this emotional burden such as fear of device malfunction or dependency on health professionals, necessary modifications in lifestyle, limitations in daily activities, physical discomfort or technical issues including battery depletion.^[1,2,11] Additionally, anxiety and depression contribute to low treatment adherence, lead to unhealthy life style^[1,2] and provoke feelings of lack of control of the management of the disease^[11]. Also may cause physiological changes in platelet function or blood coagulation and autonomic disbalance, thus deteriorating the already established cardiac disease.^[11] Last but not least, though patients perceive implantation as an extension of their life,¹¹ the life-saving device demands psychosocial adaptation.^[2]

Therefore, this psychiatric disturbance exerts a negative influence on patients’ QoL. Deeper insights are needed to comprehensively elucidate the impact of anxiety and depression on QoL of PPM patients.

Hence, the aim of this cross-sectional study was to explore the impact of anxiety and depression on QoL of PPM recipients, as well as the demographic characteristics associated with QoL.

According to the results of the present study, patients showed moderate to high levels of QoL in social functionality, energy/fatigue, emotional well-being, and pain whereas poor levels in physical functioning, role physical and emotional. In addition, patients had moderate levels of general health. Barros et al.,^[7] who explored 107 clinically stable patients (aged 69.3±12.6, 49.5% female) with an implantation time span of 3 up to 12 months showed the lowest SF-36 scores in physical aspects, and the highest ones in social aspects. Similarly, a prior study conducted by Oliveira et al.,^[15] who explored 139 clinically stable recipients (aged 59±14, 60.4% female) indicated the decline in functional class as the strongest determinant of low QoL. Moreover, improvements in all SF-36 domains, were observed at 3 and 12 months among 720 recipients of leadless device (aged 76±11 years, 41% female).^[16] A relevant research demonstrated QoL improvements in 75% of recipients but 40% expressed worries about the device.^[17]

Noteworthy, a great effort is noticed globally to improve all domains in QoL through incorporating measurements pre- and post-implantation in order to evaluate effectiveness of therapy. Furthermore, scheduled follow-up (face-to-face visits) in cardiology departments is prerequisite to maintain QoL and preferred by the majority of patients (83%).^[17] Meanwhile, the alternative method of remote monitoring may increase QoL six months post implantation.^[18] In contemporary times, remote follow-up among PPM patients is a cost-effective option which doesn’t demand attendance to cardiology services. From patients’ perspective, communicating with clinicians from home is acknowledged as a safe and convenient approach, thus indirectly improving QoL.^[19,20]

Results revealed that almost a quarter of participants had anxiety (25.3%) and depression (26.0%). A relevant recent study among 250 PPM recipients (median 71 years) showed that 27.2% and 14% experienced high levels of anxiety and depression, respectively. The same researchers also showed that 69.6% of participants described themselves as anxious while 19.6% and 23.2% reported that they experienced severe anxiety about device functioning and heart rate disorder, respectively.^[2] Psychiatric disturbance does not seem to be a recent issue in pacing therapy. A prior study showed that 19.1% (n=16) among 84 recipients had a psychiatric diagnosis. The most frequent diagnoses were adjustment disorder (5.9%) and major depressive episode (4.7%).^[21]

At the other end of the spectrum, implantation is a challenge for patients with mental illness. Depression is not an absolute contraindication to permanent cardiac pacing. Furthermore, the implanted device has beneficial effects on chronic bradycardia, which is associated with depression but follow-up and monitoring are needed. Strikingly, suicide attempts by intentionally removing the pacemaker system are rare, but they have adverse clinical outcomes.^[22]

Apart from physical functioning and role physical in depression, all remaining QoL subscales were associated with anxiety and depression. The potential influence of anxiety and depression on QoL is a notable aspect in the field of PPM. Interestingly, psychiatric comorbidity exerts a negative influence on recovery or elevates the risk of future cardiovascular events, which in turn affect QoL. A three month cardiac rehabilitation program significantly improves the triad: anxiety, depression, QoL in patients with various cardiac pathology, including implantation.^[23]

Another possible explanation for low QoL among PPM recipients who experience psychiatric disturbance is through indirect pathways, such as fatigue. For example, recipients with high levels of anxiety and depression feel more fatigue,^[2] while those who don’t experience QoL improvement after implantation, also report high levels of fatigue^[1].

Therefore, QoL measurement is beneficial when including both cardiovascular and psychological assessment. This approach helps clinicians who specialize in the field of cardiology to gain deeper understanding of the patients’ needs.^[10,24,25] QoL before implantation is significantly lower compared to the general population.^[26] Thus health care professionals are aware to take care of an already “vulnerable” population in terms of QoL.

In terms of demographic characteristics, results showed better QoL in physical and emotional role, social functioning, and in pain among participants younger than 50 years old. Possibly, the concept of QoL in younger age is more closely related to autonomy and independence than to the presence of disease. Minimization of the interval between the time of diagnosis (indication for pacing therapy) and implantation procedure might be a predictor for better QoL.^[27]

However, as the age is advancing, the QoL is worsening in terms of functional capacity. Notably, QoL measurement among the elderly is not always attainable due to their diminished life expectancy and comorbidities.^[7] Interestingly, age as a non-modifiable factor, which is inversely related to QoL, must be considered when implementing individualized interventions.^[7] However, patients in a waiting list for implantation are usually older than other comorbidity such as epilepsy or diabetes mellitus.^[26]

Regarding the other demographic characteristics related to QoL, results showed better physical role among patients having two or more children and better social functioning in married patients. This encouraging finding is largely attributed to support within family which is an already known area among cardiac patients.^[27–29] Contrariwise, patients without a partner display low QoL in the SF‐36 mental component.^[15] Family members, especially spouses, are the first to notice worsening of symptoms and generally provide a context of support in several daily aspects or practical issues. Also, family members may share common cultural background, which means appreciation of patients’ deeper perceptions while adherence to treatment is higher in patients from cohesive families.^[29] Notably, the more the support, the less the anxiety among cardiac patients.^[30]

According to the present results, almost a quarter of patients experienced anxiety and depression while poor QoL was found in physical functioning, role physical and emotional. Additionally, anxiety and depression were associated with QoL.

These results demonstrate the necessity to identify and treat the psychiatric disturbance and are also raising the issue of routine psychiatric evaluation before and after pacemaker implantation.

In clinical practice, QoL measurement can be useful for monitoring progress, and measuring clinical outcomes.

From a practical perspective, the present knowledge may help clinicians to provide a better and research-based care for this steadily increasing population.

Having as ultimate goal to improve QoL, then further studies need to research more on anxiety and depression and to examine ways to minimize this burden using a longitudinal design whereby patients are followed.