Introduction
End-stage heart failure (HF) is the dominant cause of death worldwide, and long-term mechanical circulatory support (MCS), mainly left ventricular assist devices (LVAD), is one of the well-established surgical treatments for advanced HF [1]. Available one-year survival data of patients receiving modern continuous-flow LVADs is comparable to that of cardiac transplantation. However, post-implantation complications negatively influence patients’ quality of life (QoL) with LVAD [2]. From the viewpoint of patients living with LVAD, QoL includes 5 domains (physical, cognitive, meaning/spiritual, emotional, and social) [3]. An interpretation of QoL in patients living with an LVAD has been settled as: ‘Being well enough to do and enjoy day-to-day activities that are important to me’ [3, 4].
The literature review highlights the crucial role of psychosocial factors in functional adaptation to illness for patients and caregivers [5]. Living with an LVAD is complex and requires dedicated around-the-clock patient care. Caregiver responsibilities range from simple tasks to complex procedures, causing significant stress and possibly affecting their health and QoL [6, 7]. Studies have emphasised that LVAD caregivers often suffer from stress and unpredictability and are exposed to poor psychological outcomes. The literature also indicates high levels of caregiver strain in VAD caregivers, who are known to sacrifice relationships, jobs, and livelihoods, straining their physical and emotional health [8, 9]. The 2018 International Society for Heart and Lung Transplantation consensus recommendations for evaluating potential recipients for heart transplantation and LVAD support define social support as a critical prerequisite for successful psychosocial adaptation, identifying it as a risk factor affecting patient outcomes [10]. A high level of social support can reduce stress and improve QoL among LVAD recipients and their caregivers [11].
Aim of the research
Evaluation of the depressive and anxiety symptoms in conjunction with QoL and social support among LVAD recipients and their caregivers.
Material and methods
Study design and study group
The study was a cross-sectional study. The study was conducted at the Clinical Department of Cardiovascular Surgery and Transplantology of Saint John Paul II Specialist Hospital in Krakow from 1.01.2022 to 31.12.2022. The study protocol complied with the Declaration of Helsinki and received a positive opinion from the Bioethics Committee KBKA/23/O/2021.
Study group
Patients and their caregivers meeting the following criteria were enrolled in the study: Age > 18 years, good cognitive status, co-residence with the patient/caregiver, first hospitalisation after LVAD implantation completed, and informed consent to participate. The exclusion criteria included age < 18 years, poor cognitive health, no caregiver, first hospitalisation after LVAD implantation, and participation in other clinical trials. In total, 54 patient-caregiver couples were enrolled in the study.
Research method
Diagnostic survey with standardised questionnaires:
- SF-12 is a short-form health survey questionnaire. It includes a 12-item Physical Component Summary (PCS) and a Mental Component Summary (MCS). Scores for the 8 scales are calculated using the transformed scores (range: 0–100). The higher the score, the better the perceived health [12]. A license for the SF-12v2 was acquired from QualityMetric Incorporated (QM0557070, August 2021). Cronbach’s coefficient alpha was 0.84 for PCS and 0.78 for MCS.
- The Hospital Anxiety and Depression Scale (HADS) score range is 0–21; higher scores indicate greater anxiety and depression [13]. A score from 0 to 7 indicates a standard value; 8–10 points suggests the ceiling; from 11 to 21 is considered abnormal. Cronbach’s coefficient alpha was 0.83 for anxiety, 0.62 for depression, and 0.75 for irritability.
- The Berlin Social-Support Scales (BSSS) is a multidimensional measure of social support. The BSSS has 6 subscales: perceived emotional support, perceived instrumental support, need for support, support seeking, received support, and protective buffering. Scores are obtained by adding item responses (sum scores) or generating the scale mean score [14]. Cronbach’s coefficient a ranged from 0.94 to 0.71.
Statistical analysis
Statistical analysis was performed in R software version 4.3.1. Values comparison of groups’ qualitative variables (not expressed in numbers) was done with the c2 test (with Yates correction) or Fisher’s exact test. A comparison of the values of quantitative variables (expressed in numbers) in 2 groups was done using the Mann-Whitney test. Correlations among quantitative variables were analysed with Spearman’s correlation coefficient. Multivariate analysis of potential predictors’ impact on a quantitative variable was done using linear regression. Results are presented as regression parameters with 95% confidence intervals. A significance level of 0.05 was adopted. SF-12 quality of life was calculated in PROCoRE Smart Measurement System Version 2.0.7653.27808.
Results
Patient and caregiver demographics
The dominant patient gender was male (96.3%) and female (96.3%) among caregivers. The median patient age was 61 years and 59 for caregivers. Patients were statistically significantly older than caregivers. The HeartMate II (HM, Thoratec Corporation, Pleasanton, CA, USA) was implanted in 37 patients and HeartWare (HW, Framingham, MA, USA) in 17. The mean duration of mechanical support was 3.11 ±1.84 years. Table 1 presents the demographic data.
Descriptive findings of quality of life, social support, and depression and anxiety
The Physical Component Summary (PCS) measured patients’ physical QoL at 41.87. For caregivers, PCS was significantly higher, at 55.94. The patients’ Mental Component Summary (MCS) was higher (48.98) than the PCS, while in caregivers it was lower (45.58) than the PCS. The MCS was significantly higher in caregivers than in patients.
Among patients, perceived instrumental support predominated. Caregivers reported more emotional support. Patients had significantly higher levels of instrumental support and a greater need for support than caregivers. Patients’ support-seeking was also higher. Symptoms of depression or anxiety were absent, but these issues were significantly greater for patients than for caregivers. Irritability was stronger in patients. Table 2 gives detailed results.
Impact of depression and anxiety on the QoL and social support in patients
Analysis of depression and anxiety’s impact on QoL and social support showed that anxiety intensity significantly correlated (p < 0.05) negatively (r > 0) with MCS, perceived instrumental support, and protective buffering support, indicating that higher anxiety leads to lower MCS and support. Similarly, depression symptoms significantly correlated (p < 0.05) negatively (r > 0) with MCS and perceived instrumental support, indicating that greater depression results in lower MCS and support.
The impact of depression and anxiety on QoL and social support in caregivers
Caregiver anxiety correlates significantly (p < 0.05) and positively (r > 0) with protective buffering support, indicating that higher anxiety leads to increased protective buffering. Conversely, anxiety correlates significantly (p < 0.05) and negatively (r > 0) with perceived instrumental support, suggesting that greater anxiety results in lower perceived instrumental support.
Type of implanted device and QoL and symptoms of depression
QoL and symptoms of depression were analysed depending on the type of implanted device. MCS was significantly higher in patients with HM than those with HW (p < 0.05).
QoL and type of social support among patients and caregivers
PCS correlates significantly (p < 0.05) and negatively (r > 0) with currently received information support; higher PCS indicates lower information support. MCS correlates significantly (p < 0.05) and positively (r > 0) with perceived emotional and instrumental support, indicating that higher MCS corresponds to greater emotional and instrumental support in patients. For caregivers, PCS correlates significantly (p < 0.05) and positively (r > 0) with currently provided instrumental support, indicating that higher PCS leads to more instrumental support. MCS correlates significantly (p < 0.05) and positively (r > 0) with protective buffering support, indicating that higher MCS results in greater protective buffering. MCS correlates significantly (p < 0.05) and negatively (r > 0) with perceived instrumental support, indicating that higher MCS is associated with lower perceived instrumental support.
Quality of life predictors
PCS in patients
,br>The multivariate linear regression model showed that PCS increased by an average of 1.6 points yearly after LVAD implantation (Table 3).
MCS in patients
The multivariate linear regression model showed MCS reduced by an average of 0.64 points for each point on the depression scale (regression parameter is –0.64). The HW device lowers MCS by an average of 4.96 points (t regression parameter is –4.96) compared to the HM device (Table 4).
PCS and MCS in caregivers
The multivariate linear regression model showed that each additional year of life reduces PCS by an average of 0.16 points, and PCS increases yearly after LVAD implantation by an average of 1.18 points. Professional activity increases MCS by an average of 6.86 points; after LVAD implantation, MCS is reduced by an average of 1.45 points yearly.
Discussion
The study provides the first data on the experience of depressive symptoms, QoL, and social support of patients and caregivers of patients with LVAD in Poland.
The study found depression and anxiety symptoms to reduce patients’ mental QoL and influence the choice of social support. The symptoms lowered perceived instrumental and protective buffering support. In caregivers, higher anxiety levels increased the need for protective buffering support while reducing perceived instrumental support. Patients’ QoL predictors have included time since LVAD implantation, which enhanced physical QoL but decreased mental QoL. Depression and device type (HW) lowered mental QoL; among caregivers, years of life reduced physical QoL, while it increased yearly post-implantation. Professional activity boosted mental QoL but decreased yearly post-LVAD implantation.
INTERMACS Registry results showed that nearly one-third of patients died or had a persistently poor QoL during the year after LVAD [15]. Modica et al. found that early postimplant findings showed constantly lower PCS than the ordinary population [16]. Our study’s PCS and MCS scores were also lower than those of the general population, but the patients had better results in both QoL components. Patients had low scores in general health and high rates of bodily pain. Comparing the QoL of patients with LVAD and HF, Schmalz et al. found that PCS was 34.9 ±8.8 and MCS was 48.8 ±12.6 among LVAD patients [17]. Their PCS scale results were higher, and their MCS results were lower than ours. Suzuki et al. showed that patients rated PCS very low at 37.7 (29.1–49.9) and MCS high at 48.6 56.9 (52.4–64.5) [18]. Our study did not confirm this data. Kirkpatrick et al. explored the burdens and QoL of caregivers of patients with LVAD-destination therapy. They found that the psychological component had the lowest average QoL score, followed by the social, spiritual, and physical subscales. The mean QoL scores were highest among the caregivers aged < 40 and ≥ 70 years [7]. In our study, we did not observe an association with age. Kato et al. showed no statistically significant modification in caregivers’ PCS scores during the distant observation (before 52.7 ±7.1; at 3 months, 49.7 ±6.5; at 6 months, 50.7 ±6.4, n = 20) [5]. In our study, caregivers’ MCS were similar (48.98), and the scores were lower than in the general population (norm = 50), but this domain decreased yearly post-LVAD implantation. In our study, we saw no symptoms of depression and anxiety. Modica et al. found that 50% of the patients had HADS scores indicated for both depression and anxiety [19]. Jesus et al. showed that depression was a stronger predictor of QoL than anxiety [20]. In our study, depression was a QoL predictor for patients in the MCS domain. A candidate for LVAD implantation should live with a caregiver. Family, social, and emotional support must be evaluated before LVAD therapy [21]. No study has comprehensively assessed social support needs among LVAD recipients and caregivers. Our research found that perceived social support was greater among patients, while perceived emotional support was more pronounced among caregivers. Patients reported significantly higher levels of perceived instrumental support and a greater need for support than caregivers. Support-seeking was also higher among patients. We identified relationships between QoL, depression, anxiety, and social support; specifically, the availability of a systematic review shows that support from family and friends greatly enhances HRQoL for LVAD patients [22]. Spielmann et al. found that most patients reported average to high perceived social support. Higher perceived social support was associated with lower levels of anxiety and depression and higher levels of QoL [23]. In our study, perceived instrumental support alone was positively associated with anxiety and depression. The mental domain of QoL correlated significantly and positively with perceived emotional support and perceived instrumental support. In our study, the time since LVAD implantation and the type of support received predicted QoL. The type of device used influenced patients’ QoL with MCS significantly more in those with HM than in those with HW. Comparative studies indicate that HW devices have a higher incidence of strokes and are an independent risk factor [24]. In 2021, the company ceased distribution and sale of the HW System.
The study’s limitations include several factors. First, as a single-centre study, the results may only reflect this centre’s effectiveness in enhancing caregivers’ QoL, limiting their applicability to the LVAD population in other centres. Second, the convenience sampling technique may have introduced bias that a randomised selection could have avoided; more burdened caregivers might have been excluded from the study due to their perception of excessive burden.
Conclusions
QoL after LVAD implantation improves in the physical domain but worsens in the mental domain, influenced by depression symptoms and support device type. Caregivers’ physical QoL life decreases yearly and increases yearly post-implantation. In the mental domain, professional activity predicts improvement, whereas each year after LVAD implantation reduces this domain. Strategies monitoring QoL and depression are essential for managing patients enduring long-term support or facing unpleasant symptoms from support-related complications. Strengthening the social support system is crucial to enhance patients’ and caregivers’ roles and activities post-discharge.
Funding
No external funding.
Ethical approval
Approval number: KBKA/23/O/2021.
Conflict of interest
The authors declare no conflict of interest.
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