Sexual activity in patients with left ventricular assist devices and their partners: impact of the device on quality of life, anxiety and depression

Sexual activity in patients with left ventricular assist devices and their partners: impact of... Abstract OBJECTIVES Prolonged support with a left ventricular assist device (LVAD) has evolved as an alternative treatment strategy for patients with end-stage heart disease. This requires a shift in focus on sexual activity and psychosocial outcomes in patients with an LVAD and their partners. METHODS This cross-sectional study was designed to capture Sexual Activities in Left Ventricular Assist Device Patients Or PaRtners (SALVADOR) perceptions on illness-related changes in the quality of sexual activity and its impact on quality of life, anxiety and depression using standardized patient-reported outcome scales (Sexual Adjustment Scale, 36-Item Short Form Health Survey, Hospital Anxiety and Depression Scale). A total of 72 patients with LVADs (50% response rate) along with 48 partners participated. RESULTS For patients with an LVAD (median age 60 years; 84.7% male), median time on the device was 650 days; 69.5% stayed in long-term partnerships (median 23 years). Prevalence rates for illness-related changes in the quality of sexual activity were 58.3% for patients and 52.1% for partners. Device-related disturbances in sexual activities occurred due to battery pockets (patients/partners: 59.2%/37.6%; P = 0.006) and the driveline (46.3%/37.5%; P = 0.033) and led to significantly increased distress in patients/partners (battery pockets: 53.5%/41.3%; P = 0.006; driveline 54.9%/37.5%; P = 0.004). Disturbances in sexual activity were independently associated with higher rates of depression (odds ratio 1.33, 95% confidence interval 1.14–1.55; P = 0.001) in patients and lower mental quality of life (odds ratio 6.18, 95% confidence interval 1.13–33.98; P = 0.036) in partners. CONCLUSIONS Disturbances in sexual activity are common in patients with an LVAD and their partners while the patients are on durable long-term support. Counselling on long-term adjustment should provide a platform for information seeking on illness-related changes in the quality of sexual activity. Left ventricular assist devices, Sexual activity, Anxiety, Depression, Quality of life, Partners INTRODUCTION Demographic developments imply a steadily increasing number of patients with end-stage heart disease. Numbers of patients whose medical heart failure treatment options have been exhausted increase, whereas donor organs for heart transplantation continue to be limited [1]. Consequently, left ventricular assist device (LVAD) support has evolved as an alternative treatment strategy [1]. Advancements in newer generation axial and centrifugal devices were designed to prolong survival and to improve quality of life (QoL) [2] but also led to substantially prolonged support time while decreasing the incidence of comorbid conditions. In its review, the EUROMACS registry reported on 2500 registered ventricular assist device implantations and almost 10 000 follow-up records [1]. German numbers reached 915 LVAD implantations in 2015, representing a 36.6% increase in comparison with 2005 [3]. Within the framework of patient-reported outcomes research [4], the concept of QoL needs to be defined for LVAD cohorts as an ‘individual’s perception of the impact of the disease and treatment on his/her life’ [2]. Because QoL is second to survival when estimating the success of treatment outcome, representation of the dynamic and multidimensional nature of the construct by robust and psychometrically sound measurement instruments is of upmost importance. Patient-reported outcomes instruments qualified to represent an individual’s health perception can be either generic or disease-specific [5, 6]. However, these need to adequately display LVAD therapy-related lifestyle adjustments and symptoms that might be associated with the individual’s QoL [2, 7]. Instruments used to date capture disease-specific heart failure adjustments and symptoms [8–10]. As the durability of LVADs improves, it becomes important to study their influence on life roles. Sexuality is an important aspect and is recommended for consideration [2, 11, 12]. A recent consensus document explicitly asks that information and counselling on illness-related changes in the quality of sexuality be incorporated in the treatment plan [13]. However, empirical studies assessing patients with LVADs in this regard are based primarily on small sample sizes (8–26 subjects), lack response rates and use non-standardized surveys, limiting generalizability and comparability to build an evidence base [14–16]. Sexual activity in patients on LVAD support might be hampered by the driveline exit site or battery pockets [15] or self-image associated with device parts. No studies on LVAD partners’ perspectives in regard to sexuality were found. The goal of this study was to fill this gap and to assess (i) prevalence rates regarding perceptions of illness-related changes in the quality of sexuality in patients with LVADs and their partners, (ii) associations of sexuality with QoL and psychosocial outcomes and (iii) the needs of patients with LVADs and their partners’ needs or information with respect to illness-related changes in the quality of sexuality. MATERIALS AND METHODS Design and setting The present investigation was a cross-sectional, observational study at a single site. Patients with implantable LVADs on long-term outpatient support and partners were considered. Data collection methods were carefully designed to respect the sensitivity of the topic under investigation and to reduce the number of non-responses and missing values for this study [5]. Stable patients with LVADs and their partners were sent invitation letters and were invited to participate. To ensure privacy and to allow each individual to decide autonomously whether to participate, separate invitation letters and study pamphlets were sent to patients and their partners. The invitation letters were accompanied by detailed information materials explaining the purposes of the study, consent forms with duplicates, a battery of questionnaires with written instructions and prestamped, preaddressed envelopes. Confidentiality was assured to all participants. Active recruitment was performed between May 2015 and May 2016. The study protocol was approved by the institutional review board. Data on this trial were reported in concordance with the STROBE Statement [17]. Study participants ‘Patients with LVADs’ qualified for this study when they were discharged home and were medically stable after successful LVAD implantation, were a minimum of 3 months postimplant, were aged 18 years or older and had sufficient language skills to answer the questionnaires. Patients were excluded when they showed symptoms of neurocognitive deficits, major psychic disorders or severe communication impairments. ‘Partners’ were defined as spouse or significant other and having a close relationship with the patient with an LVAD. To be eligible, partners should be 18 years or older and have sufficient language and neurocognitive skills. Partners were approached using the contact data from the patients’ charts. Patients and partners became participants after they had voluntarily agreed to this study invitation by signing and returning the written consent forms. During the data collection period, 6 patients died. The participating patient response rate was 50.0% (72 of 144). Non-responders were not different from responders with respect to age (median 57 years; IQR 42–62 years), gender (86%; n = 62 male) and time on device (median 701 days; IQR 240–959 days), respectively. Instruments and measures Patient-reported outcome measures Following the US Department of Health and Human Services Food and Drug Administration updated report (2006), measurement of patient-reported outcomes should be performed using psychometrically robust instruments [4]. Accordingly, the following instruments were used for this study: Sexual adjustment scale This 6-item subscale of the Psychosocial Adjustment to Illness Scale (PAIS) was designed to capture illness-related changes in the quality of sexuality (sexual interest, frequency of sexual activity, pleasure and satisfaction) and relationship (intimacy and discussion) during the last 4 weeks [18]. Likert-scaled item responses were cumulated in a total score, ranging from 6 to 24, whereby lower scores indicated less disturbance. Psychometric properties have been established for different chronic populations including those with chronic heart failure [19]. Internal consistency proved to be satisfactory and was (Cronbach’s alpha) α = 0.907 for patients with LVADs and α = 0.884 for partners. Sexual Activities in Left Ventricular Assist Device Patients or PaRtners The Sexual Activities in Left Ventricular Assist Device Patients Or PaRtners (SALVADOR) scale was specifically developed for this study. Items and scale structure were designed by a multidisciplinary expert panel with clinical and methodological expertise in LVAD populations and psychometrics research [5]. The initial instrument was pretested by patients not partaking in this study, which resulted in slight modifications in wording and layout. The scale captures 16 items and contains 3 dimensions: the first dimension asked whether the LVAD had an influence on sexual activity (1 item). In the second dimension, participants were asked to grade 5 items each on the ‘occurrence’ of device-related disturbances (no, minor to severe) with regard to illness-related changes in the quality of sexual activity and the associated ‘distress’ for each item (no, minor to severe). Items of this second dimension captured (each ‘occurrence’ and ‘distress’) impairment by battery pockets, emotional disengagement, decreased attractiveness because of the driveline exit site (patient only), disability and disturbance by driveline (10 items). The subscales in the second dimension on device-related disturbances showed a strong internal consistency for ‘occurrence’ (α = 0.968) and ‘distress’ (α = 0.975) scales. For the purposes of this study, the answer categories yes (minor to severe) were portrayed. In the third dimension, the need for additional information and information strategies was captured based on 5 categorical items. The 36-Item Short Form Health Survey The 36-Item Short Form Health Survey (SF-36) is a 36-item scale constructed as a general health survey and has been extensively validated in different populations with chronic conditions including patients with LVADs [20, 21]. The SF-36 assesses 8 health concepts along 8 scales that can be merged into 2 component scores: summary measures of physical and mental health, the physical component score and the mental component score are calculated from the 8 scales using algorithms recommended by the developers. All scores range between 0 and 100; higher scores indicate better QoL perceptions. A German version was provided by Bullinger and Kirchberger [22]. Hospital Anxiety and Depression Scale The Hospital Anxiety and Depression Scale (HADS) is a well-established screening instrument designed to measure the presence and severity of symptoms of anxiety and depression. The HADS has been proven to be valid in different populations with chronic conditions including patients with LVADs [21]. The instrument consists of the 2 scales, anxiety and depression, each scale containing 7 items. Scores range from 0 to 21; higher scores indicate more severe anxiety and depressive symptoms. A German validated version of the instrument was provided [23]. Work Performance Index The Work Performance Index (WPI) represents a 6-item index covering current employment status (full-time, part-time), unemployment and associated reasons (illness-related, other) or retirement status (illness-related, age-related) and has been shown to be reliable to assess the professional occupation status in patients after transplant [24]. In addition, relevant ‘sociodemographic’ (age, gender, time living with partner, family status) and ‘clinical’ [implant indication, type and time on LVAD, hospital length of stay postimplant, relevant comorbidities and medications, cardiac output by New York Heart Association (NYHA, Class I–IV)] classification, left ventricular ejection fraction (%), body mass index (kg/m2) and smoking (current, history, no) variables have been collected as part of the questionnaire or retrieved with permission from patients’ charts. Statistics Analyses were performed using SPSS version 23 (IBM Corp., Armonk, NY, USA). All test statistics were 2-tailed; the level of significance was set at P-value ≤0.05. Descriptive data were presented as median and interquartile range (IQR) or as percentages unless stated otherwise. Prevalence rates were outlined as percentages with 95% confidence intervals (CIs). Data were presented outlining missing values at the item level. No imputations were performed. Binary logistic regression analyses, with sexual adjustment (dichotomized Sexual Adjustment Scale sum score using the median at 15) as the dependent outcome variable, were fitted with the independent variables sexual disturbance related to the device (SALVADOR items), QoL (SF-36 subscales), symptoms of anxiety and depression (HADS), age, gender, living with a partner, time since LVAD implant, prescription of medications causing sexual dysfunction as a common side effect and smoking (current/history versus no) as predictive factors or potential confounders. Binary logistic regression models with the stepwise backward likelihood method were calculated as 2 separate models: 1 for patients and 1 for partners. Stepwise backward variable selections were performed using significance levels of 0.10 for entering a variable in the model. Data were reported in concordance with the guidelines for the European Journal of Cardio-Thoracic Surgery and Interactive Cardiovascular and Thoracic Surgery [25]. RESULTS Sample characteristics In our sample, the median age for patients with LVADs was 60 (IQR 51–68) years and 61 (IQR 48–67) years for partners. Sample characteristics include relevant sociodemographic variables for both cohorts and clinical variables for patients (Table 1). Table 1: Sample characteristics Variables  Patients with LVADs (n = 72)  Partners (n = 48)  Sociodemographic variables       Age (years), median (IQR)  60 (51–68)  61 (48–67)   Gender, % (n)    Male  84.7 (61)  14.6 (7)   Living with partner (years), median (IQR)  23 (11–44.5)  23 (14–45)   No response, % (n)  5.5 (4)  4.2 (2)   Family status, % (n)    Single  6.9 (5)  0 (0)    Married or living with partner  69.5 (50)  93.7 (45)    Divorced or widowed  23.6 (17)  6.3 (3)   Professional status based on WPI,a % (n)    Employed (full-time or part-time)  12.5 (9)  50 (24)    Unemployed (illness related or other)  5.6 (4)  6.3 (3)    Retired age related  30.6 (22)  29.2 (14)    Retired illness related  47.2 (34)  12.5 (6)    No response  4.1 (3)  1.9 (1)  Clinical variables       Indication, % (n)      DCM  51.4 (37)  n. a.    ICM  45.8 (33)      Other  2.8 (2)     LVAD type, % (n)  n. a.    HeartMate II®  20.8 (15)      HeartWare®  76.4 (55)      Other/Thoratec®  2.8 (2)     Time on LVAD (days), median (IQR)  650 (434–1233)  n. a.   Hospitalization postimplant (days), median (IQR)  44 (28–56)  n. a.   Relevant comorbidities (yes), % (n)  n. a.    Diabetes  27.8 (20)      Neurological diseases  11.1 (8)      Hypertension  94.4 (68)      Depression  16.7 (12)      ICD/CRT/PM  72.2 (52)     Relevant medications (%, yes), % (n)  n. a.    ß-blockers  83.3 (60)      ACE inhibitors  44.4 (32)      Diuretics  93.1 (67)      Antidepressants  15.3 (11)      Sildenafil  30.6 (22)     Cardiac output, % (n)  n. a.    NYHA III  29.2 (21)      NYHA IV  70.9 (51)     LVEF at implant (%), median (IQR)  20 (15–25)  n. a.   BMI at implant (kg/m2), median (IQR)  26.9 (24.4–29.8)  n. a.  Smoking (%, yes), % (n)  n. a.    Current  4.2 (3)      History  52.8 (38)    Variables  Patients with LVADs (n = 72)  Partners (n = 48)  Sociodemographic variables       Age (years), median (IQR)  60 (51–68)  61 (48–67)   Gender, % (n)    Male  84.7 (61)  14.6 (7)   Living with partner (years), median (IQR)  23 (11–44.5)  23 (14–45)   No response, % (n)  5.5 (4)  4.2 (2)   Family status, % (n)    Single  6.9 (5)  0 (0)    Married or living with partner  69.5 (50)  93.7 (45)    Divorced or widowed  23.6 (17)  6.3 (3)   Professional status based on WPI,a % (n)    Employed (full-time or part-time)  12.5 (9)  50 (24)    Unemployed (illness related or other)  5.6 (4)  6.3 (3)    Retired age related  30.6 (22)  29.2 (14)    Retired illness related  47.2 (34)  12.5 (6)    No response  4.1 (3)  1.9 (1)  Clinical variables       Indication, % (n)      DCM  51.4 (37)  n. a.    ICM  45.8 (33)      Other  2.8 (2)     LVAD type, % (n)  n. a.    HeartMate II®  20.8 (15)      HeartWare®  76.4 (55)      Other/Thoratec®  2.8 (2)     Time on LVAD (days), median (IQR)  650 (434–1233)  n. a.   Hospitalization postimplant (days), median (IQR)  44 (28–56)  n. a.   Relevant comorbidities (yes), % (n)  n. a.    Diabetes  27.8 (20)      Neurological diseases  11.1 (8)      Hypertension  94.4 (68)      Depression  16.7 (12)      ICD/CRT/PM  72.2 (52)     Relevant medications (%, yes), % (n)  n. a.    ß-blockers  83.3 (60)      ACE inhibitors  44.4 (32)      Diuretics  93.1 (67)      Antidepressants  15.3 (11)      Sildenafil  30.6 (22)     Cardiac output, % (n)  n. a.    NYHA III  29.2 (21)      NYHA IV  70.9 (51)     LVEF at implant (%), median (IQR)  20 (15–25)  n. a.   BMI at implant (kg/m2), median (IQR)  26.9 (24.4–29.8)  n. a.  Smoking (%, yes), % (n)  n. a.    Current  4.2 (3)      History  52.8 (38)    a WPI less than 100% refers to missing data. ACE: angiotensin-converting enzyme; BMI: body mass index; CRT: cardiac resynchronization therapy; DCM: dilative cardiomyopathy; ICD: implantable cardioverter–defibrillator; ICM: ischaemic cardiomyopathy; IQR: interquartile range; LVAD: left ventricular assist device; LVEF: left ventricular ejection fraction; NYHA: New York Heart Association; n. a.: item not applicable for this group; PM: pacemaker; WPI: Work Performance Index. Prevalence rates regarding perceptions of illness-related changes in the quality of sexuality in patients with left ventricular assist devices and their partners The majority of patients [42 (58.3%), 95% CI 47.2–69.4%] and parters [25 (52.1%), 95% CI 37.5–66.7%] reported negative illness-related changes in the quality of sexual activity related to the LVAD. A total of 12 (16.3%) patients and 9 (18.8%) partners chose not to answer this question. Significant differences for patients’ versus partners’ self-report appeared for ‘occurrence’ (P = 0.033) and ‘distress’ (P = 0.004) of device-related sexual disturbances (Fig. 1A and B). Non-response rates for patients ranged from 27.9% to 30.6% for occurrence and from 30.6% to 33.3% for distress, whereas partners more willingly answered this set of questions: Non-response rates varied between 8.3% and 22.9% for occurrence items and 16.7% and 22.9% for distress items. Figure 1: View largeDownload slide Patients with LVADs and their partners’ ‘occurrence’ of device-related disturbances (A) and associated distress in sexuality (B) based on the Sexual Activities in Left Ventricular Assist Device Patients Or PaRtners (SALVADOR) scale. The asterisk indicates that item ‘attractiveness by driveline’ was exclusively provided to patients with LVADs. LVAD: left ventricular assist device. Figure 1: View largeDownload slide Patients with LVADs and their partners’ ‘occurrence’ of device-related disturbances (A) and associated distress in sexuality (B) based on the Sexual Activities in Left Ventricular Assist Device Patients Or PaRtners (SALVADOR) scale. The asterisk indicates that item ‘attractiveness by driveline’ was exclusively provided to patients with LVADs. LVAD: left ventricular assist device. Illness-related changes in the quality of sexuality, as measured with the median total score of the Sexual Adjustment Scale, were 15 (IQR 11–18) for patients and 15 (IQR 13–20) for partners (Fig. 2A and B). Information about those participants not responding to this set of items is included. For ‘sexual performance’, patients’ and partners’ responses appeared to be significantly different (P = 0.004). All other illness-related changes in the quality of sexuality showed no significant differences between patients’ and partners’ perceptions. Figure 2: View largeDownload slide Patients with LVADs (A) and their partners’ (B) illness-related changes in the quality of sexuality based on the Sexual Adjustment Scale. The asterisk indicates the ratings of patients with LVADs differed significantly from those of their partners for ‘sexual performance’ (P = 0.004); all other items showed no significant differences in patients’ versus partners’ ratings based on Mann–Whitney U-test results. LVAD: left ventricular assist device. Figure 2: View largeDownload slide Patients with LVADs (A) and their partners’ (B) illness-related changes in the quality of sexuality based on the Sexual Adjustment Scale. The asterisk indicates the ratings of patients with LVADs differed significantly from those of their partners for ‘sexual performance’ (P = 0.004); all other items showed no significant differences in patients’ versus partners’ ratings based on Mann–Whitney U-test results. LVAD: left ventricular assist device. Associations of illness-related changes in the quality of sexuality on quality of life and psychosocial outcomes in patients with left ventricular assist devices and partners Self-reported ratings of QoL (SF-36) and psychosocial outcomes in terms of symptoms of anxiety and depression (HADS) are depicted in Table 2. Patients with LVADs showed significantly impaired QoL ratings in physical functioning (38.5 ± 27.6) in comparison with their partners (67.7 ± 31.7; P = 0.001). Symptoms of anxiety were significantly lower in patients (6 ± 4) in comparison with partners (8 ± 4; P = 0.021). Table 2: Health-related quality of life and psychosocial outcomes in patients with LVADs and their partners Variables (mean ± SD)  Patients with LVADs (n = 72)  Partners (n = 48)  Group comparisona (P-value)  SF-36         Physical functioning  38.5 ± 27.6  67.7 ± 31.7  <0.001   Role physical  34.6 ± 39.6  64.7 ± 38.9  <0.001   Bodily pain  67.5 ± 31.7  70.8 ± 32.2  0.58   General health perceptions  44.6 ± 21.0  58.9 ± 22.1  0.001   Vitality  44.2 ± 23.5  50.5 ± 24.5  0.18   Social function  62.3 ± 35.6  70.3 ± 28.9  0.10   Role emotional  49.4 ± 54.2  72.6 ± 38.8  0.013   Mental health  62.1 ± 24.1  62.7 ± 24.9  0.88   Physical component score  38.9 ± 32.4  44.6 ± 12.9  0.034   Mental component score  44.2 ± 14.5  45.1 ± 13.1  0.74  HADS         HADS–anxiety  6 ± 4  8 ± 4  0.021   HADS–depression  7 ± 5  7 ± 5  0.95  Variables (mean ± SD)  Patients with LVADs (n = 72)  Partners (n = 48)  Group comparisona (P-value)  SF-36         Physical functioning  38.5 ± 27.6  67.7 ± 31.7  <0.001   Role physical  34.6 ± 39.6  64.7 ± 38.9  <0.001   Bodily pain  67.5 ± 31.7  70.8 ± 32.2  0.58   General health perceptions  44.6 ± 21.0  58.9 ± 22.1  0.001   Vitality  44.2 ± 23.5  50.5 ± 24.5  0.18   Social function  62.3 ± 35.6  70.3 ± 28.9  0.10   Role emotional  49.4 ± 54.2  72.6 ± 38.8  0.013   Mental health  62.1 ± 24.1  62.7 ± 24.9  0.88   Physical component score  38.9 ± 32.4  44.6 ± 12.9  0.034   Mental component score  44.2 ± 14.5  45.1 ± 13.1  0.74  HADS         HADS–anxiety  6 ± 4  8 ± 4  0.021   HADS–depression  7 ± 5  7 ± 5  0.95  a Univariate analysis of variance; SF-36 score ranges from 0 to 100, with higher scores indicating better quality-of-life ratings. HADS ranges from 0 to 21, with higher scores relating to higher number of symptoms. HADS: Hospital Anxiety and Depression Scale; LVAD: left ventricular assist device; SF-36: 36-Item Short Form Health Survey; SD: standard deviation. Binary logistic regression analyses, using the median total score (15) of the Sexual Adjustment Scale, were computed for patients with LVADs and partners separately to explain potentially predicting variables of disturbances in sexuality (Table 3). The final adjusted model for patients with LVADs provided 46.5% of the proportion of the variance based on Nagelkerke’s pseudo-R2 and revealed that patients with symptoms of depression faced a 1.33-fold increased odds for disturbances in sexuality (odds ratio 1.33, 95% CI 1.11–1.59; P = 0.002). In partners, the final adjusted model explained 60.2% of its variance. For partners, perceived disturbances in sexuality were associated with an increased odds for impairments in the mental component score (odds ratio 6.18, 95% CI 1.13–33.98; P = 0.036). Table 3: Predicting variables of sexuality on health-related quality-of-life issues and psychosocial outcomes in patients with LVADs and their partners Patients with LVADs   Partners   Variables  OR  95% CI  P-value  Variables  OR  95% CI  P-value  Binary logistic regression modela   SF-36 PCS  1.10  0.99–1.22  0.055  SF-36 MCS  6.18  1.13–33.9  0.036   HADS–depression  1.33  1.14–1.55  <0.001  HADS–depression  1.23  1.04–1.45  0.011   Sildenafil  0.16  0.03–0.71  0.016  Age (years)  1.16  0.99–1.35  0.054   BMI (kg/m2)  3.26  1.05–10.0  0.040          Patients with LVADs   Partners   Variables  OR  95% CI  P-value  Variables  OR  95% CI  P-value  Binary logistic regression modela   SF-36 PCS  1.10  0.99–1.22  0.055  SF-36 MCS  6.18  1.13–33.9  0.036   HADS–depression  1.33  1.14–1.55  <0.001  HADS–depression  1.23  1.04–1.45  0.011   Sildenafil  0.16  0.03–0.71  0.016  Age (years)  1.16  0.99–1.35  0.054   BMI (kg/m2)  3.26  1.05–10.0  0.040          a Binary logistic regression model with stepwise backward likelihood method predicting variables of sexuality based on the dichotomized SAS median (dependent variable) on health-related quality of life (SF-36), psychosocial outcomes (HADS) and clinical variables in patients (e.g. BMI, Sildenafil) were assessed by calculating 2 separate regression models: 1 for patients and 1 for partners. BMI: body mass index; CI: confidence interval; HADS: Hospital Anxiety and Depression Scale; LVAD: left ventricular assist device; MCS: mental component score; OR: odds ratio; PCS: physical component score; SAS: Sexual Adjustment Scale; SF-36: 36-Item Short Form Health Survey. Need for information with respect to sexuality in patients with left ventricular assist devices and their partners A total of 18.1% of patients with LVADs considered counselling in one-on-one sessions as the preferred method to receive information about sexuality, whereas 22.9% of the partners preferred written materials. The majority of both cohorts did not answer this set of questions (Table 4). Two patients and 1 partner did recommend information from seminars, web page sites and peer support groups. Two patients explicitly asked for information about medication-related side effects and sexual dysfunction. Table 4: Needs for information with respect to sexuality of patients with LVADs and their partners Variables  Patients with LVADs (n = 72)  Partners (n = 48)  Group comparison (P-value)  Information needs (%, yes), n  59.7 (n = 43)  64.6 (n = 31)  0.54   Counselling sessions 1: 1a  18.1 (13)  12.5 (6)     Counselling sessions with partnera  12.5 (9)  20.8 (10)     Group sessionsa  1.4 (1)  −//-     Written materialsa  13.9 (10)  22.9 (11)     Othersb  9.7 (7)  8.3 (4)     No answer  40.3 (29)  35.4 (17)    Variables  Patients with LVADs (n = 72)  Partners (n = 48)  Group comparison (P-value)  Information needs (%, yes), n  59.7 (n = 43)  64.6 (n = 31)  0.54   Counselling sessions 1: 1a  18.1 (13)  12.5 (6)     Counselling sessions with partnera  12.5 (9)  20.8 (10)     Group sessionsa  1.4 (1)  −//-     Written materialsa  13.9 (10)  22.9 (11)     Othersb  9.7 (7)  8.3 (4)     No answer  40.3 (29)  35.4 (17)    a Multiple answers possible. b Field offered open answer option. LVAD: left ventricular assist device. DISCUSSION This cross-sectional study investigated perceptions of SALVADOR independently in a sample of 72 patients and 48 partners using standardized and validated self-report instruments. The majority of patients and partners reported perceived illness-related changes in the quality of sexuality from device disturbance and that the occurrence of these disturbances caused considerable distress. Patients with LVADs with symptoms of depression faced a 1.33-fold increased risk for disturbances in sexuality. Anxiety scores were higher in partners than in patients. Partner-perceived disturbances in sexuality were associated with an increased probability for impairments in the mental component, which reflected their QoL. Counselling sessions and written materials represented the preferred methods to inform patients with LVADs and their partners regarding changes in sexuality, respectively. Patients with LVADs and their partners reported marked disturbances in their sexuality related to the device, which included perceived impairments caused by the battery pockets and the driveline but also feelings of less attractiveness by the patient and emotional disengagement on both sides. Despite the steadily increasing body of knowledge indicating that LVAD placement has the potential to significantly improve the QoL of patients and partners for the long term [2, 7, 20, 21], our findings indicate that these advancements can be diminished, at least in part, by device-related sexual disturbances. Counselling on sexuality should be initiated and incorporated into the regular follow-up care for this population [26]. It should be offered to patients, partners or the couple, depending on their preferences. Education and training for all those involved in the follow-up care [27] might represent a step forward in supporting health care professionals, patients and partners to engage in respectful discussions about sexual concerns [14, 15]. An introductory question for counselling and information could be ‘how satisfied’ a person is regarding his or her day-to-day and sexual life, which might shift the focus from a discussion of ‘what is no longer possible’ to a discussion of what ‘can be done’. Patients with LVADs reported significantly lower scores in 3 of 4 SF-36 subscales capturing the physical dimension of QoL in comparison to their partners. Also, ‘role emotional’ was lower in patients than in partners. These findings indicate that exploring family dynamics and associated role changes might be a way to better support patients and partners while the patient is on long-term LVAD support. However, these findings might be interpreted to mean that patients and partners may need time and support not just to cope with the physical recovery postimplant but also to adjust emotionally. Consequently, follow-up visits should focus on discussions with the patient of psychological and sexual issues in addition to somatic issues. In our study, partners felt less impacted in their sexuality, the majority being women over the age of 60 years. A recent study investigating attitudes towards sexuality in 728 Germans over 60 years of age suggested that relationship-oriented aspects, for example confidence and communication with the partner, became more important than sexual activity and physical attractiveness [28]. Findings in this study might be cautiously interpreted in this regard; however, future research seems necessary to better understand partners’ attitudes towards sexuality of patients supported by LVADs. Partners reported higher depression levels and lower QoL in the mental component in comparison to patients with LVADs. These data are in line with those from an early study by Bunzel et al. [9], suggesting that a change in life roles and expectations (the majority of partners were professionally employed) may have influenced the outcome. Herein, partners also showed higher anxiety scores as measured with the HADS in comparison to predominantly male patients with LVADs. Similarly, Brouwers et al. [7] conducted an exploratory study on psychological distress in patients with LVADs and their partners. Prevalence rates of anxiety were significantly higher in partners compared to those in patients with LVADs after the implant procedure and at the 3-month follow-up examination [7]. Limitations Our study has several limitations. First, data were drawn from a single site and from a relatively small, homogeneous sample size with respect to age and gender. Nevertheless, centre-related factors not controlled for in this study might have impacted the response rate and the answers provided by the participants. Second, the cross-sectional design of this study does not allow a comparison of how this cohort perceived their quality of sexual activity before the LVAD implant. Also, no information on patients’ perceptions of the quality of their sexual activity before the LVAD was implanted, nor information on pre-existing diseases known to affect sexual performance, was available. Third, this study focused on a sensitive topic, perhaps one considered taboo by a considerable number of participants, which might have biased our data to some extent. The relatively high rates of missing data and no responses, ranging between 27.8% and 33.3% for patients and between 8.3% and 22.9% for partners, support this idea. Consequently, the numbers of non-answered items have been reported. However, several precautions were initiated as part of the preparations for this study in an attempt to provide maximum privacy and confidentiality for the individuals participating. Fourth, this study covers long-term survivors only, so patients who died for any reason were excluded from the analysis, resulting in a possible bias in regard to the total number of psychological problems after implant of an LVAD. Finally, written additional comments provided by participating patients and partners support this strategic attempt because several participants offered their gratitude for being consulted on this issue. CONCLUSION In conclusion, this study provides the largest sample of patients with LVADs and their partners to date, reporting that LVAD placement for the long-term is associated with illness-related changes in the quality of sexuality in a considerable number of patients. Sexuality as a relevant part of QoL can be disturbed by the device. Occurrence of device-related disturbances can independently cause remarkable distress in patients and partners. Partners might feel under pressure because they reported higher anxiety scores and diminished QoL for the mental component score. Despite patients with LVADs being qualified as stable and the investigation taking place after recovery from the LVAD implant procedure, patients reported significantly impaired QoL ratings for 4 of 8 SF-36 scales in comparison with their partners. The needs of LVAD patients and partners for information seeking about sexual issues should be considered a part of clinical and psychological counselling. Future research seems necessary to develop a better understanding on how patients and partners cope in terms of sexual adjustment to long-term assist device placement and which professional interventions might facilitate individual coping styles. Conflict of interest: none declared. REFERENCES 1 EUROMACS Report. http://www.euromacs.org/files/13/file/EUROMACS_NEWSLETTER_No_10.pdf ( 27 July 2016, date last accessed). 2 MacIver J, Ross HJ. Quality of life and left ventricular assist device support. Circulation  2012; 126: 866– 74. Google Scholar CrossRef Search ADS PubMed  3 Beckmann A, Funkat AK, Lewandowski J, Frie M, Ernst M, Hekmat K et al.   Cardiac surgery in Germany during 2014: a report on behalf of the German Society for Thoracic and Cardiovascular Surgery. Thorac Cardiovasc Surg  2015; 63: 258– 69. Google Scholar CrossRef Search ADS PubMed  4 Guidance for Industry: Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labelling Claims. http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/ Guidances/default.htm (30 October 2013, date last accessed). 5 Tourangeau R, Rips LJ, Rasinski K. The Psychology of Survey Response . Cambridge, United Kingdom: Cambridge University Press, 2000. Google Scholar CrossRef Search ADS   6 Fayers PM, Machin D. Quality of Life: the Assessment, Analysis and Reporting of Patient-Reported Outcomes . 3rd edn. Chester West Sussex, United Kingdom: Wiley Blackwell, 2016. 7 Brouwers C, Denollet J, Caliskan K, de Jonge N, Constantinescu A, Young Q et al.   Psychological distress in patients with a left ventricular assist device and their partners: an exploratory study. Eur J Cardiovasc Nurs  2015; 14: 53– 62. Google Scholar CrossRef Search ADS PubMed  8 Brouwers C, Denollet J, De Jonge N, Caliskan K, Kealy J, Pedersen SS. Patient-reported outcomes in left ventricular assist device therapy: a systematic review and recommendations for clinical research and practice. Circ Heart Fail  2011; 4: 714– 23. Google Scholar CrossRef Search ADS PubMed  9 Bunzel B, Laederach-Hofmann K, Wieselthaler G, Roethy W, Drees G. 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J Cardiovasc Nurs  2016; 31: 53– 61. Google Scholar CrossRef Search ADS PubMed  28 Gunzelmann T, Rusch BD, Brähler E. Attitudes towards erotism and sexuality in the elderly over 60 years of age. Gesundheitswesen  2004; 66: 15– 20. Google Scholar CrossRef Search ADS PubMed  © The Author 2017. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved. http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png European Journal of Cardio-Thoracic Surgery Oxford University Press

Sexual activity in patients with left ventricular assist devices and their partners: impact of the device on quality of life, anxiety and depression

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Abstract

Abstract OBJECTIVES Prolonged support with a left ventricular assist device (LVAD) has evolved as an alternative treatment strategy for patients with end-stage heart disease. This requires a shift in focus on sexual activity and psychosocial outcomes in patients with an LVAD and their partners. METHODS This cross-sectional study was designed to capture Sexual Activities in Left Ventricular Assist Device Patients Or PaRtners (SALVADOR) perceptions on illness-related changes in the quality of sexual activity and its impact on quality of life, anxiety and depression using standardized patient-reported outcome scales (Sexual Adjustment Scale, 36-Item Short Form Health Survey, Hospital Anxiety and Depression Scale). A total of 72 patients with LVADs (50% response rate) along with 48 partners participated. RESULTS For patients with an LVAD (median age 60 years; 84.7% male), median time on the device was 650 days; 69.5% stayed in long-term partnerships (median 23 years). Prevalence rates for illness-related changes in the quality of sexual activity were 58.3% for patients and 52.1% for partners. Device-related disturbances in sexual activities occurred due to battery pockets (patients/partners: 59.2%/37.6%; P = 0.006) and the driveline (46.3%/37.5%; P = 0.033) and led to significantly increased distress in patients/partners (battery pockets: 53.5%/41.3%; P = 0.006; driveline 54.9%/37.5%; P = 0.004). Disturbances in sexual activity were independently associated with higher rates of depression (odds ratio 1.33, 95% confidence interval 1.14–1.55; P = 0.001) in patients and lower mental quality of life (odds ratio 6.18, 95% confidence interval 1.13–33.98; P = 0.036) in partners. CONCLUSIONS Disturbances in sexual activity are common in patients with an LVAD and their partners while the patients are on durable long-term support. Counselling on long-term adjustment should provide a platform for information seeking on illness-related changes in the quality of sexual activity. Left ventricular assist devices, Sexual activity, Anxiety, Depression, Quality of life, Partners INTRODUCTION Demographic developments imply a steadily increasing number of patients with end-stage heart disease. Numbers of patients whose medical heart failure treatment options have been exhausted increase, whereas donor organs for heart transplantation continue to be limited [1]. Consequently, left ventricular assist device (LVAD) support has evolved as an alternative treatment strategy [1]. Advancements in newer generation axial and centrifugal devices were designed to prolong survival and to improve quality of life (QoL) [2] but also led to substantially prolonged support time while decreasing the incidence of comorbid conditions. In its review, the EUROMACS registry reported on 2500 registered ventricular assist device implantations and almost 10 000 follow-up records [1]. German numbers reached 915 LVAD implantations in 2015, representing a 36.6% increase in comparison with 2005 [3]. Within the framework of patient-reported outcomes research [4], the concept of QoL needs to be defined for LVAD cohorts as an ‘individual’s perception of the impact of the disease and treatment on his/her life’ [2]. Because QoL is second to survival when estimating the success of treatment outcome, representation of the dynamic and multidimensional nature of the construct by robust and psychometrically sound measurement instruments is of upmost importance. Patient-reported outcomes instruments qualified to represent an individual’s health perception can be either generic or disease-specific [5, 6]. However, these need to adequately display LVAD therapy-related lifestyle adjustments and symptoms that might be associated with the individual’s QoL [2, 7]. Instruments used to date capture disease-specific heart failure adjustments and symptoms [8–10]. As the durability of LVADs improves, it becomes important to study their influence on life roles. Sexuality is an important aspect and is recommended for consideration [2, 11, 12]. A recent consensus document explicitly asks that information and counselling on illness-related changes in the quality of sexuality be incorporated in the treatment plan [13]. However, empirical studies assessing patients with LVADs in this regard are based primarily on small sample sizes (8–26 subjects), lack response rates and use non-standardized surveys, limiting generalizability and comparability to build an evidence base [14–16]. Sexual activity in patients on LVAD support might be hampered by the driveline exit site or battery pockets [15] or self-image associated with device parts. No studies on LVAD partners’ perspectives in regard to sexuality were found. The goal of this study was to fill this gap and to assess (i) prevalence rates regarding perceptions of illness-related changes in the quality of sexuality in patients with LVADs and their partners, (ii) associations of sexuality with QoL and psychosocial outcomes and (iii) the needs of patients with LVADs and their partners’ needs or information with respect to illness-related changes in the quality of sexuality. MATERIALS AND METHODS Design and setting The present investigation was a cross-sectional, observational study at a single site. Patients with implantable LVADs on long-term outpatient support and partners were considered. Data collection methods were carefully designed to respect the sensitivity of the topic under investigation and to reduce the number of non-responses and missing values for this study [5]. Stable patients with LVADs and their partners were sent invitation letters and were invited to participate. To ensure privacy and to allow each individual to decide autonomously whether to participate, separate invitation letters and study pamphlets were sent to patients and their partners. The invitation letters were accompanied by detailed information materials explaining the purposes of the study, consent forms with duplicates, a battery of questionnaires with written instructions and prestamped, preaddressed envelopes. Confidentiality was assured to all participants. Active recruitment was performed between May 2015 and May 2016. The study protocol was approved by the institutional review board. Data on this trial were reported in concordance with the STROBE Statement [17]. Study participants ‘Patients with LVADs’ qualified for this study when they were discharged home and were medically stable after successful LVAD implantation, were a minimum of 3 months postimplant, were aged 18 years or older and had sufficient language skills to answer the questionnaires. Patients were excluded when they showed symptoms of neurocognitive deficits, major psychic disorders or severe communication impairments. ‘Partners’ were defined as spouse or significant other and having a close relationship with the patient with an LVAD. To be eligible, partners should be 18 years or older and have sufficient language and neurocognitive skills. Partners were approached using the contact data from the patients’ charts. Patients and partners became participants after they had voluntarily agreed to this study invitation by signing and returning the written consent forms. During the data collection period, 6 patients died. The participating patient response rate was 50.0% (72 of 144). Non-responders were not different from responders with respect to age (median 57 years; IQR 42–62 years), gender (86%; n = 62 male) and time on device (median 701 days; IQR 240–959 days), respectively. Instruments and measures Patient-reported outcome measures Following the US Department of Health and Human Services Food and Drug Administration updated report (2006), measurement of patient-reported outcomes should be performed using psychometrically robust instruments [4]. Accordingly, the following instruments were used for this study: Sexual adjustment scale This 6-item subscale of the Psychosocial Adjustment to Illness Scale (PAIS) was designed to capture illness-related changes in the quality of sexuality (sexual interest, frequency of sexual activity, pleasure and satisfaction) and relationship (intimacy and discussion) during the last 4 weeks [18]. Likert-scaled item responses were cumulated in a total score, ranging from 6 to 24, whereby lower scores indicated less disturbance. Psychometric properties have been established for different chronic populations including those with chronic heart failure [19]. Internal consistency proved to be satisfactory and was (Cronbach’s alpha) α = 0.907 for patients with LVADs and α = 0.884 for partners. Sexual Activities in Left Ventricular Assist Device Patients or PaRtners The Sexual Activities in Left Ventricular Assist Device Patients Or PaRtners (SALVADOR) scale was specifically developed for this study. Items and scale structure were designed by a multidisciplinary expert panel with clinical and methodological expertise in LVAD populations and psychometrics research [5]. The initial instrument was pretested by patients not partaking in this study, which resulted in slight modifications in wording and layout. The scale captures 16 items and contains 3 dimensions: the first dimension asked whether the LVAD had an influence on sexual activity (1 item). In the second dimension, participants were asked to grade 5 items each on the ‘occurrence’ of device-related disturbances (no, minor to severe) with regard to illness-related changes in the quality of sexual activity and the associated ‘distress’ for each item (no, minor to severe). Items of this second dimension captured (each ‘occurrence’ and ‘distress’) impairment by battery pockets, emotional disengagement, decreased attractiveness because of the driveline exit site (patient only), disability and disturbance by driveline (10 items). The subscales in the second dimension on device-related disturbances showed a strong internal consistency for ‘occurrence’ (α = 0.968) and ‘distress’ (α = 0.975) scales. For the purposes of this study, the answer categories yes (minor to severe) were portrayed. In the third dimension, the need for additional information and information strategies was captured based on 5 categorical items. The 36-Item Short Form Health Survey The 36-Item Short Form Health Survey (SF-36) is a 36-item scale constructed as a general health survey and has been extensively validated in different populations with chronic conditions including patients with LVADs [20, 21]. The SF-36 assesses 8 health concepts along 8 scales that can be merged into 2 component scores: summary measures of physical and mental health, the physical component score and the mental component score are calculated from the 8 scales using algorithms recommended by the developers. All scores range between 0 and 100; higher scores indicate better QoL perceptions. A German version was provided by Bullinger and Kirchberger [22]. Hospital Anxiety and Depression Scale The Hospital Anxiety and Depression Scale (HADS) is a well-established screening instrument designed to measure the presence and severity of symptoms of anxiety and depression. The HADS has been proven to be valid in different populations with chronic conditions including patients with LVADs [21]. The instrument consists of the 2 scales, anxiety and depression, each scale containing 7 items. Scores range from 0 to 21; higher scores indicate more severe anxiety and depressive symptoms. A German validated version of the instrument was provided [23]. Work Performance Index The Work Performance Index (WPI) represents a 6-item index covering current employment status (full-time, part-time), unemployment and associated reasons (illness-related, other) or retirement status (illness-related, age-related) and has been shown to be reliable to assess the professional occupation status in patients after transplant [24]. In addition, relevant ‘sociodemographic’ (age, gender, time living with partner, family status) and ‘clinical’ [implant indication, type and time on LVAD, hospital length of stay postimplant, relevant comorbidities and medications, cardiac output by New York Heart Association (NYHA, Class I–IV)] classification, left ventricular ejection fraction (%), body mass index (kg/m2) and smoking (current, history, no) variables have been collected as part of the questionnaire or retrieved with permission from patients’ charts. Statistics Analyses were performed using SPSS version 23 (IBM Corp., Armonk, NY, USA). All test statistics were 2-tailed; the level of significance was set at P-value ≤0.05. Descriptive data were presented as median and interquartile range (IQR) or as percentages unless stated otherwise. Prevalence rates were outlined as percentages with 95% confidence intervals (CIs). Data were presented outlining missing values at the item level. No imputations were performed. Binary logistic regression analyses, with sexual adjustment (dichotomized Sexual Adjustment Scale sum score using the median at 15) as the dependent outcome variable, were fitted with the independent variables sexual disturbance related to the device (SALVADOR items), QoL (SF-36 subscales), symptoms of anxiety and depression (HADS), age, gender, living with a partner, time since LVAD implant, prescription of medications causing sexual dysfunction as a common side effect and smoking (current/history versus no) as predictive factors or potential confounders. Binary logistic regression models with the stepwise backward likelihood method were calculated as 2 separate models: 1 for patients and 1 for partners. Stepwise backward variable selections were performed using significance levels of 0.10 for entering a variable in the model. Data were reported in concordance with the guidelines for the European Journal of Cardio-Thoracic Surgery and Interactive Cardiovascular and Thoracic Surgery [25]. RESULTS Sample characteristics In our sample, the median age for patients with LVADs was 60 (IQR 51–68) years and 61 (IQR 48–67) years for partners. Sample characteristics include relevant sociodemographic variables for both cohorts and clinical variables for patients (Table 1). Table 1: Sample characteristics Variables  Patients with LVADs (n = 72)  Partners (n = 48)  Sociodemographic variables       Age (years), median (IQR)  60 (51–68)  61 (48–67)   Gender, % (n)    Male  84.7 (61)  14.6 (7)   Living with partner (years), median (IQR)  23 (11–44.5)  23 (14–45)   No response, % (n)  5.5 (4)  4.2 (2)   Family status, % (n)    Single  6.9 (5)  0 (0)    Married or living with partner  69.5 (50)  93.7 (45)    Divorced or widowed  23.6 (17)  6.3 (3)   Professional status based on WPI,a % (n)    Employed (full-time or part-time)  12.5 (9)  50 (24)    Unemployed (illness related or other)  5.6 (4)  6.3 (3)    Retired age related  30.6 (22)  29.2 (14)    Retired illness related  47.2 (34)  12.5 (6)    No response  4.1 (3)  1.9 (1)  Clinical variables       Indication, % (n)      DCM  51.4 (37)  n. a.    ICM  45.8 (33)      Other  2.8 (2)     LVAD type, % (n)  n. a.    HeartMate II®  20.8 (15)      HeartWare®  76.4 (55)      Other/Thoratec®  2.8 (2)     Time on LVAD (days), median (IQR)  650 (434–1233)  n. a.   Hospitalization postimplant (days), median (IQR)  44 (28–56)  n. a.   Relevant comorbidities (yes), % (n)  n. a.    Diabetes  27.8 (20)      Neurological diseases  11.1 (8)      Hypertension  94.4 (68)      Depression  16.7 (12)      ICD/CRT/PM  72.2 (52)     Relevant medications (%, yes), % (n)  n. a.    ß-blockers  83.3 (60)      ACE inhibitors  44.4 (32)      Diuretics  93.1 (67)      Antidepressants  15.3 (11)      Sildenafil  30.6 (22)     Cardiac output, % (n)  n. a.    NYHA III  29.2 (21)      NYHA IV  70.9 (51)     LVEF at implant (%), median (IQR)  20 (15–25)  n. a.   BMI at implant (kg/m2), median (IQR)  26.9 (24.4–29.8)  n. a.  Smoking (%, yes), % (n)  n. a.    Current  4.2 (3)      History  52.8 (38)    Variables  Patients with LVADs (n = 72)  Partners (n = 48)  Sociodemographic variables       Age (years), median (IQR)  60 (51–68)  61 (48–67)   Gender, % (n)    Male  84.7 (61)  14.6 (7)   Living with partner (years), median (IQR)  23 (11–44.5)  23 (14–45)   No response, % (n)  5.5 (4)  4.2 (2)   Family status, % (n)    Single  6.9 (5)  0 (0)    Married or living with partner  69.5 (50)  93.7 (45)    Divorced or widowed  23.6 (17)  6.3 (3)   Professional status based on WPI,a % (n)    Employed (full-time or part-time)  12.5 (9)  50 (24)    Unemployed (illness related or other)  5.6 (4)  6.3 (3)    Retired age related  30.6 (22)  29.2 (14)    Retired illness related  47.2 (34)  12.5 (6)    No response  4.1 (3)  1.9 (1)  Clinical variables       Indication, % (n)      DCM  51.4 (37)  n. a.    ICM  45.8 (33)      Other  2.8 (2)     LVAD type, % (n)  n. a.    HeartMate II®  20.8 (15)      HeartWare®  76.4 (55)      Other/Thoratec®  2.8 (2)     Time on LVAD (days), median (IQR)  650 (434–1233)  n. a.   Hospitalization postimplant (days), median (IQR)  44 (28–56)  n. a.   Relevant comorbidities (yes), % (n)  n. a.    Diabetes  27.8 (20)      Neurological diseases  11.1 (8)      Hypertension  94.4 (68)      Depression  16.7 (12)      ICD/CRT/PM  72.2 (52)     Relevant medications (%, yes), % (n)  n. a.    ß-blockers  83.3 (60)      ACE inhibitors  44.4 (32)      Diuretics  93.1 (67)      Antidepressants  15.3 (11)      Sildenafil  30.6 (22)     Cardiac output, % (n)  n. a.    NYHA III  29.2 (21)      NYHA IV  70.9 (51)     LVEF at implant (%), median (IQR)  20 (15–25)  n. a.   BMI at implant (kg/m2), median (IQR)  26.9 (24.4–29.8)  n. a.  Smoking (%, yes), % (n)  n. a.    Current  4.2 (3)      History  52.8 (38)    a WPI less than 100% refers to missing data. ACE: angiotensin-converting enzyme; BMI: body mass index; CRT: cardiac resynchronization therapy; DCM: dilative cardiomyopathy; ICD: implantable cardioverter–defibrillator; ICM: ischaemic cardiomyopathy; IQR: interquartile range; LVAD: left ventricular assist device; LVEF: left ventricular ejection fraction; NYHA: New York Heart Association; n. a.: item not applicable for this group; PM: pacemaker; WPI: Work Performance Index. Prevalence rates regarding perceptions of illness-related changes in the quality of sexuality in patients with left ventricular assist devices and their partners The majority of patients [42 (58.3%), 95% CI 47.2–69.4%] and parters [25 (52.1%), 95% CI 37.5–66.7%] reported negative illness-related changes in the quality of sexual activity related to the LVAD. A total of 12 (16.3%) patients and 9 (18.8%) partners chose not to answer this question. Significant differences for patients’ versus partners’ self-report appeared for ‘occurrence’ (P = 0.033) and ‘distress’ (P = 0.004) of device-related sexual disturbances (Fig. 1A and B). Non-response rates for patients ranged from 27.9% to 30.6% for occurrence and from 30.6% to 33.3% for distress, whereas partners more willingly answered this set of questions: Non-response rates varied between 8.3% and 22.9% for occurrence items and 16.7% and 22.9% for distress items. Figure 1: View largeDownload slide Patients with LVADs and their partners’ ‘occurrence’ of device-related disturbances (A) and associated distress in sexuality (B) based on the Sexual Activities in Left Ventricular Assist Device Patients Or PaRtners (SALVADOR) scale. The asterisk indicates that item ‘attractiveness by driveline’ was exclusively provided to patients with LVADs. LVAD: left ventricular assist device. Figure 1: View largeDownload slide Patients with LVADs and their partners’ ‘occurrence’ of device-related disturbances (A) and associated distress in sexuality (B) based on the Sexual Activities in Left Ventricular Assist Device Patients Or PaRtners (SALVADOR) scale. The asterisk indicates that item ‘attractiveness by driveline’ was exclusively provided to patients with LVADs. LVAD: left ventricular assist device. Illness-related changes in the quality of sexuality, as measured with the median total score of the Sexual Adjustment Scale, were 15 (IQR 11–18) for patients and 15 (IQR 13–20) for partners (Fig. 2A and B). Information about those participants not responding to this set of items is included. For ‘sexual performance’, patients’ and partners’ responses appeared to be significantly different (P = 0.004). All other illness-related changes in the quality of sexuality showed no significant differences between patients’ and partners’ perceptions. Figure 2: View largeDownload slide Patients with LVADs (A) and their partners’ (B) illness-related changes in the quality of sexuality based on the Sexual Adjustment Scale. The asterisk indicates the ratings of patients with LVADs differed significantly from those of their partners for ‘sexual performance’ (P = 0.004); all other items showed no significant differences in patients’ versus partners’ ratings based on Mann–Whitney U-test results. LVAD: left ventricular assist device. Figure 2: View largeDownload slide Patients with LVADs (A) and their partners’ (B) illness-related changes in the quality of sexuality based on the Sexual Adjustment Scale. The asterisk indicates the ratings of patients with LVADs differed significantly from those of their partners for ‘sexual performance’ (P = 0.004); all other items showed no significant differences in patients’ versus partners’ ratings based on Mann–Whitney U-test results. LVAD: left ventricular assist device. Associations of illness-related changes in the quality of sexuality on quality of life and psychosocial outcomes in patients with left ventricular assist devices and partners Self-reported ratings of QoL (SF-36) and psychosocial outcomes in terms of symptoms of anxiety and depression (HADS) are depicted in Table 2. Patients with LVADs showed significantly impaired QoL ratings in physical functioning (38.5 ± 27.6) in comparison with their partners (67.7 ± 31.7; P = 0.001). Symptoms of anxiety were significantly lower in patients (6 ± 4) in comparison with partners (8 ± 4; P = 0.021). Table 2: Health-related quality of life and psychosocial outcomes in patients with LVADs and their partners Variables (mean ± SD)  Patients with LVADs (n = 72)  Partners (n = 48)  Group comparisona (P-value)  SF-36         Physical functioning  38.5 ± 27.6  67.7 ± 31.7  <0.001   Role physical  34.6 ± 39.6  64.7 ± 38.9  <0.001   Bodily pain  67.5 ± 31.7  70.8 ± 32.2  0.58   General health perceptions  44.6 ± 21.0  58.9 ± 22.1  0.001   Vitality  44.2 ± 23.5  50.5 ± 24.5  0.18   Social function  62.3 ± 35.6  70.3 ± 28.9  0.10   Role emotional  49.4 ± 54.2  72.6 ± 38.8  0.013   Mental health  62.1 ± 24.1  62.7 ± 24.9  0.88   Physical component score  38.9 ± 32.4  44.6 ± 12.9  0.034   Mental component score  44.2 ± 14.5  45.1 ± 13.1  0.74  HADS         HADS–anxiety  6 ± 4  8 ± 4  0.021   HADS–depression  7 ± 5  7 ± 5  0.95  Variables (mean ± SD)  Patients with LVADs (n = 72)  Partners (n = 48)  Group comparisona (P-value)  SF-36         Physical functioning  38.5 ± 27.6  67.7 ± 31.7  <0.001   Role physical  34.6 ± 39.6  64.7 ± 38.9  <0.001   Bodily pain  67.5 ± 31.7  70.8 ± 32.2  0.58   General health perceptions  44.6 ± 21.0  58.9 ± 22.1  0.001   Vitality  44.2 ± 23.5  50.5 ± 24.5  0.18   Social function  62.3 ± 35.6  70.3 ± 28.9  0.10   Role emotional  49.4 ± 54.2  72.6 ± 38.8  0.013   Mental health  62.1 ± 24.1  62.7 ± 24.9  0.88   Physical component score  38.9 ± 32.4  44.6 ± 12.9  0.034   Mental component score  44.2 ± 14.5  45.1 ± 13.1  0.74  HADS         HADS–anxiety  6 ± 4  8 ± 4  0.021   HADS–depression  7 ± 5  7 ± 5  0.95  a Univariate analysis of variance; SF-36 score ranges from 0 to 100, with higher scores indicating better quality-of-life ratings. HADS ranges from 0 to 21, with higher scores relating to higher number of symptoms. HADS: Hospital Anxiety and Depression Scale; LVAD: left ventricular assist device; SF-36: 36-Item Short Form Health Survey; SD: standard deviation. Binary logistic regression analyses, using the median total score (15) of the Sexual Adjustment Scale, were computed for patients with LVADs and partners separately to explain potentially predicting variables of disturbances in sexuality (Table 3). The final adjusted model for patients with LVADs provided 46.5% of the proportion of the variance based on Nagelkerke’s pseudo-R2 and revealed that patients with symptoms of depression faced a 1.33-fold increased odds for disturbances in sexuality (odds ratio 1.33, 95% CI 1.11–1.59; P = 0.002). In partners, the final adjusted model explained 60.2% of its variance. For partners, perceived disturbances in sexuality were associated with an increased odds for impairments in the mental component score (odds ratio 6.18, 95% CI 1.13–33.98; P = 0.036). Table 3: Predicting variables of sexuality on health-related quality-of-life issues and psychosocial outcomes in patients with LVADs and their partners Patients with LVADs   Partners   Variables  OR  95% CI  P-value  Variables  OR  95% CI  P-value  Binary logistic regression modela   SF-36 PCS  1.10  0.99–1.22  0.055  SF-36 MCS  6.18  1.13–33.9  0.036   HADS–depression  1.33  1.14–1.55  <0.001  HADS–depression  1.23  1.04–1.45  0.011   Sildenafil  0.16  0.03–0.71  0.016  Age (years)  1.16  0.99–1.35  0.054   BMI (kg/m2)  3.26  1.05–10.0  0.040          Patients with LVADs   Partners   Variables  OR  95% CI  P-value  Variables  OR  95% CI  P-value  Binary logistic regression modela   SF-36 PCS  1.10  0.99–1.22  0.055  SF-36 MCS  6.18  1.13–33.9  0.036   HADS–depression  1.33  1.14–1.55  <0.001  HADS–depression  1.23  1.04–1.45  0.011   Sildenafil  0.16  0.03–0.71  0.016  Age (years)  1.16  0.99–1.35  0.054   BMI (kg/m2)  3.26  1.05–10.0  0.040          a Binary logistic regression model with stepwise backward likelihood method predicting variables of sexuality based on the dichotomized SAS median (dependent variable) on health-related quality of life (SF-36), psychosocial outcomes (HADS) and clinical variables in patients (e.g. BMI, Sildenafil) were assessed by calculating 2 separate regression models: 1 for patients and 1 for partners. BMI: body mass index; CI: confidence interval; HADS: Hospital Anxiety and Depression Scale; LVAD: left ventricular assist device; MCS: mental component score; OR: odds ratio; PCS: physical component score; SAS: Sexual Adjustment Scale; SF-36: 36-Item Short Form Health Survey. Need for information with respect to sexuality in patients with left ventricular assist devices and their partners A total of 18.1% of patients with LVADs considered counselling in one-on-one sessions as the preferred method to receive information about sexuality, whereas 22.9% of the partners preferred written materials. The majority of both cohorts did not answer this set of questions (Table 4). Two patients and 1 partner did recommend information from seminars, web page sites and peer support groups. Two patients explicitly asked for information about medication-related side effects and sexual dysfunction. Table 4: Needs for information with respect to sexuality of patients with LVADs and their partners Variables  Patients with LVADs (n = 72)  Partners (n = 48)  Group comparison (P-value)  Information needs (%, yes), n  59.7 (n = 43)  64.6 (n = 31)  0.54   Counselling sessions 1: 1a  18.1 (13)  12.5 (6)     Counselling sessions with partnera  12.5 (9)  20.8 (10)     Group sessionsa  1.4 (1)  −//-     Written materialsa  13.9 (10)  22.9 (11)     Othersb  9.7 (7)  8.3 (4)     No answer  40.3 (29)  35.4 (17)    Variables  Patients with LVADs (n = 72)  Partners (n = 48)  Group comparison (P-value)  Information needs (%, yes), n  59.7 (n = 43)  64.6 (n = 31)  0.54   Counselling sessions 1: 1a  18.1 (13)  12.5 (6)     Counselling sessions with partnera  12.5 (9)  20.8 (10)     Group sessionsa  1.4 (1)  −//-     Written materialsa  13.9 (10)  22.9 (11)     Othersb  9.7 (7)  8.3 (4)     No answer  40.3 (29)  35.4 (17)    a Multiple answers possible. b Field offered open answer option. LVAD: left ventricular assist device. DISCUSSION This cross-sectional study investigated perceptions of SALVADOR independently in a sample of 72 patients and 48 partners using standardized and validated self-report instruments. The majority of patients and partners reported perceived illness-related changes in the quality of sexuality from device disturbance and that the occurrence of these disturbances caused considerable distress. Patients with LVADs with symptoms of depression faced a 1.33-fold increased risk for disturbances in sexuality. Anxiety scores were higher in partners than in patients. Partner-perceived disturbances in sexuality were associated with an increased probability for impairments in the mental component, which reflected their QoL. Counselling sessions and written materials represented the preferred methods to inform patients with LVADs and their partners regarding changes in sexuality, respectively. Patients with LVADs and their partners reported marked disturbances in their sexuality related to the device, which included perceived impairments caused by the battery pockets and the driveline but also feelings of less attractiveness by the patient and emotional disengagement on both sides. Despite the steadily increasing body of knowledge indicating that LVAD placement has the potential to significantly improve the QoL of patients and partners for the long term [2, 7, 20, 21], our findings indicate that these advancements can be diminished, at least in part, by device-related sexual disturbances. Counselling on sexuality should be initiated and incorporated into the regular follow-up care for this population [26]. It should be offered to patients, partners or the couple, depending on their preferences. Education and training for all those involved in the follow-up care [27] might represent a step forward in supporting health care professionals, patients and partners to engage in respectful discussions about sexual concerns [14, 15]. An introductory question for counselling and information could be ‘how satisfied’ a person is regarding his or her day-to-day and sexual life, which might shift the focus from a discussion of ‘what is no longer possible’ to a discussion of what ‘can be done’. Patients with LVADs reported significantly lower scores in 3 of 4 SF-36 subscales capturing the physical dimension of QoL in comparison to their partners. Also, ‘role emotional’ was lower in patients than in partners. These findings indicate that exploring family dynamics and associated role changes might be a way to better support patients and partners while the patient is on long-term LVAD support. However, these findings might be interpreted to mean that patients and partners may need time and support not just to cope with the physical recovery postimplant but also to adjust emotionally. Consequently, follow-up visits should focus on discussions with the patient of psychological and sexual issues in addition to somatic issues. In our study, partners felt less impacted in their sexuality, the majority being women over the age of 60 years. A recent study investigating attitudes towards sexuality in 728 Germans over 60 years of age suggested that relationship-oriented aspects, for example confidence and communication with the partner, became more important than sexual activity and physical attractiveness [28]. Findings in this study might be cautiously interpreted in this regard; however, future research seems necessary to better understand partners’ attitudes towards sexuality of patients supported by LVADs. Partners reported higher depression levels and lower QoL in the mental component in comparison to patients with LVADs. These data are in line with those from an early study by Bunzel et al. [9], suggesting that a change in life roles and expectations (the majority of partners were professionally employed) may have influenced the outcome. Herein, partners also showed higher anxiety scores as measured with the HADS in comparison to predominantly male patients with LVADs. Similarly, Brouwers et al. [7] conducted an exploratory study on psychological distress in patients with LVADs and their partners. Prevalence rates of anxiety were significantly higher in partners compared to those in patients with LVADs after the implant procedure and at the 3-month follow-up examination [7]. Limitations Our study has several limitations. First, data were drawn from a single site and from a relatively small, homogeneous sample size with respect to age and gender. Nevertheless, centre-related factors not controlled for in this study might have impacted the response rate and the answers provided by the participants. Second, the cross-sectional design of this study does not allow a comparison of how this cohort perceived their quality of sexual activity before the LVAD implant. Also, no information on patients’ perceptions of the quality of their sexual activity before the LVAD was implanted, nor information on pre-existing diseases known to affect sexual performance, was available. Third, this study focused on a sensitive topic, perhaps one considered taboo by a considerable number of participants, which might have biased our data to some extent. The relatively high rates of missing data and no responses, ranging between 27.8% and 33.3% for patients and between 8.3% and 22.9% for partners, support this idea. Consequently, the numbers of non-answered items have been reported. However, several precautions were initiated as part of the preparations for this study in an attempt to provide maximum privacy and confidentiality for the individuals participating. Fourth, this study covers long-term survivors only, so patients who died for any reason were excluded from the analysis, resulting in a possible bias in regard to the total number of psychological problems after implant of an LVAD. Finally, written additional comments provided by participating patients and partners support this strategic attempt because several participants offered their gratitude for being consulted on this issue. CONCLUSION In conclusion, this study provides the largest sample of patients with LVADs and their partners to date, reporting that LVAD placement for the long-term is associated with illness-related changes in the quality of sexuality in a considerable number of patients. Sexuality as a relevant part of QoL can be disturbed by the device. Occurrence of device-related disturbances can independently cause remarkable distress in patients and partners. Partners might feel under pressure because they reported higher anxiety scores and diminished QoL for the mental component score. Despite patients with LVADs being qualified as stable and the investigation taking place after recovery from the LVAD implant procedure, patients reported significantly impaired QoL ratings for 4 of 8 SF-36 scales in comparison with their partners. The needs of LVAD patients and partners for information seeking about sexual issues should be considered a part of clinical and psychological counselling. Future research seems necessary to develop a better understanding on how patients and partners cope in terms of sexual adjustment to long-term assist device placement and which professional interventions might facilitate individual coping styles. Conflict of interest: none declared. 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Journal

European Journal of Cardio-Thoracic SurgeryOxford University Press

Published: Apr 1, 2018

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