Adverse events after left ventricular assist device implantation linked to psychosocial risk in women and men.

BACKGROUND: Reasons for women's increased probability to experience adverse events (AEs) after left ventricular assist device (LVAD) implantation compared with men's remain uncertain. We explored the role of psychosocial risk in the experience of AEs in women and men. METHODS: INTERMACS patients receiving a primary continuous-flow LVAD between July 2006 and December 2017, median follow-up 13.6 months, were included (n = 20,123, 21.3% women). Time-to-event was calculated with cumulative incidence functions for 10 types of AEs separately (e.g., infection, device malfunction), each time accounting for the competing outcomes death, heart transplant, and device explant due to recovery. Event-specific Cox proportional hazard models were run with a binary psychosocial risk variable (including substance abuse, psychiatric diagnosis, limited social support, limited cognition, repeated noncompliance), controlled for covariates. RESULTS: Psychosocial risk was more prevalent in men than in women (21.4% vs 17.5%, p < 0.001). Seven out of 10 AEs were more likely in women than in men (e.g., infection 44.5% vs 39.2%, p < 0.001). The association of psychosocial risk with each AE was either stronger in women than in men (e.g., device malfunction HRadj 1.29, 95% confidence interval (CI) (1.06-1.56) vs HRadj 1.10, 95% CI (0.97-1.25); rehospitalization HRadj 1.15, 95% CI (1.02-1.29) vs HRadj 1.03, 95% CI (0.97-1.10) or similar between sexes. CONCLUSIONS: Independent of clinical parameters, the presence of psychosocial risk is associated with increases in AEs. This suggests that early modification of psychosocial risk factors may have the potential to lower the risk for AEs in this patient population.

Shared decision-making in routine breast cancer care in Germany-A cross-sectional study.

OBJECTIVE: Many preference-sensitive decisions have to be made in breast cancer care and little is known about the decision-making processes between breast cancer patients and the different health care professionals engaged in their treatment. METHODS: All female breast cancer patients who underwent surgery in four German breast centers between 07/2016 and 12/2018 were invited to fill in a survey. The decision-making process was evaluated using the 9-item Shared Decision Making Questionnaire (SDM-Q-9) and a German measure to assess satisfaction with care (ZAPA). The higher the total score (0-100), the higher the experienced degree of participation and satisfaction, respectively. Participants were asked to separately rate consultations with their inpatient hospital doctors, outpatient gynecologists, outpatient oncologists and primary care providers. An overall mean score for the degree of participation and the satisfaction with care was calculated for each patient across all consultations assessed. Differences between the 4 treating physician groups were analyzed as well. RESULTS: Of 1068 approached patients, 563 with a mean age of 62 and a standard deviation (SD) of 12.2 years filled in the survey (response rate: 53%). The overall SDM-Q-9 score was 73.8 (SD: 20.8). Older patients stated a higher level of participation than younger, different physician groups were rated quite similarly. Overall satisfaction with care was 87.4 (SD: 15.5). CONCLUSIONS: Overall, patients reported to have experienced a high level of shared decision-making (SDM) and were quite satisfied with their treatment. However, we do not know whether non-responders might have had different experiences.

Sex Differences in Recovery and Device Replacement After Left Ventricular Assist Device Implantation as Destination Therapy.

Background The relevance of sex and preimplant factors for clinical outcomes among patients with left ventricular assist devices intended for destination therapy is unclear. Methods and Results INTERMACS (Interagency Registry for Mechanically Assisted Circulatory Support) data (2006-2017) from 6771 men and 1690 women with left ventricular assist devices as destination therapy were analyzed to evaluate the contribution of preimplant clinical, demographic, and clinically judged psychosocial characteristics to time until death, heart transplant, device explant due to recovery, or complication-related device replacement. Associations of sex with time until each competing outcome were evaluated using cumulative incidence functions and event-specific Cox proportional hazards models. Women were younger, more likely to have nonischemic diagnoses, and reported less substance abuse but were more likely to be unmarried, not working for an income, overweight, and depressed than men. After 2 years, women had higher probabilities for recovery (3.7% versus 1.6%, P<0.001) and device replacement (12.1% versus 10%, P=0.019) than men but not for death and transplant (P>0.12). The sex differences remained after controlling for covariates (adjusted hazard ratio [HRadj] recovery, 1.85; 95% CI, 1.30-2.70; P<0.001; HRadj device replacement, 1.22; 95% CI, 1.04-1.33; P=0.015). Female-specific diagnoses (eg, postpartum heart failure) contributed to women's enhanced rate of recovery. Demographic and psychosocial factors were unrelated to women's increased event rates. Conclusions In destination therapy, women have higher rates of device replacement and recovery than men. The latter was partly explained by female-specific diagnoses. Standardized assessments of psychosocial characteristics are needed to elucidate their association with sex differences in outcomes.

Psychosocial Risk and Health Behaviors as Predictors of Clinical Events in Patients Wait-Listed for a New Heart: Results from 7 Years of Follow-Up.

We examined the long-term relationship of psychosocial risk and health behaviors on clinical events in patients awaiting heart transplantation (HTx). Psychosocial characteristics (e.g., depression), health behaviors (e.g., dietary habits, smoking), medical factors (e.g., creatinine), and demographics (e.g., age, sex) were collected at the time of listing in 318 patients (82% male, mean age = 53 years) enrolled in the Waiting for a New Heart Study. Clinical events were death/delisting due to deterioration, high-urgency status transplantation (HU-HTx), elective transplantation, and delisting due to clinical improvement. Within 7 years of follow-up, 92 patients died or were delisted due to deterioration, 121 received HU-HTx, 43 received elective transplantation, and 39 were delisted due to improvement. Adjusting for demographic and medical characteristics, the results indicated that frequent consumption of healthy foods (i.e., foods high in unsaturated fats) and being physically active increased the likelihood of delisting due improvement, while smoking and depressive symptoms were related to death/delisting due to clinical deterioration while awaiting HTx. In conclusion, psychosocial and behavioral characteristics are clearly associated with clinical outcomes in this population. Interventions that target psychosocial risk, smoking, dietary habits, and physical activity may be beneficial for patients with advanced heart failure waiting for a cardiac transplant.

Gender differences in psychosocial and clinical characteristics in the European Registry for Patients with Mechanical Circulatory Support.

BACKGROUND: Not much is known about psychosocial characteristics of men and women receiving continuous flow left ventricular assist devices (CF LVAD). OBJECTIVE: To investigate gender differences in clinical and psychosocial (demographic, behavioral, psychological) characteristics in CF LVAD recipients. METHODS: We analyzed European Registry for Patients with Mechanical Circulatory Support (EUROMACS) data (N=2395, 16.8% women; 2011 to 2017) and compared pre-implant characteristics in men and women intended for bridge-to-transplant (BTT) or destination therapy (DT). RESULTS: Women were underrepresented [DT (n=61): 13.4%; BTT (n=341): 17.6%]. They were more likely to be divorced/separated, widowed, in unstable clinical condition, and non-working (DT only), but less likely to be smokers, to have ischemic cardiomyopathy or diabetes, and younger (BTT only) than men. Missing data were abundant, especially those that reflect psychological characteristics (>87%). CONCLUSION: Gender differences were noted, some specific to device strategy. Improved collection of psychosocial characteristics is warranted to elucidate their relationship to future prognosis.

Modulation of startle and heart rate responses by fear of physical activity in patients with heart failure and in healthy adults.

Fear of physical activity (FoPA) has been suggested as a barrier to physical activity in patients with heart failure and might be associated with low adherence to exercise regimen despite medical guideline recommendations. The present study examined physiological indicators of FoPA by assessing startle modulation (via EMG at the orbicularis oculi muscle) and heart rate responses (derived from ECG) after affective priming with lexical stimuli of positive, neutral, and negative valence, as well as words related to physical activity as potentially phobic cues. After screening for FoPA in patients with heart failure and healthy adults, twenty participants each were assigned to one of three subsamples: a healthy control group and two cardiac patient groups scoring either low or high on FoPA. The high-FoPA group showed startle potentiation and more pronounced heart rate acceleration (than did controls) in the phobic prime condition, indicating defensive response mobilization. Among the patients, higher FoPA accounted for 30% of the startle potentiation by phobic priming, whereas general anxiety, depression, and disease severity were no significant predictors of startle modulation. These findings suggest that FoPA in patients with heart failure is associated with defensive responses on a physiological level that might be indicative of avoidance behavior, thereby contributing to low adherence to exercise regimen. Thus, FoPA presents a significant target for psychological interventions to foster physical activity in cardiac patients.

Designing a Randomized Trial with an Age Simulation Suit-Representing People with Health Impairments.

Due to demographic change, there is an increasing demand for professional care services, whereby this demand cannot be met by available caregivers. To enable adequate care by relieving informal and formal care, the independence of people with chronic diseases has to be preserved for as long as possible. Assistance approaches can be used that support promoting physical activity, which is a main predictor of independence. One challenge is to design and test such approaches without affecting the people in focus. In this paper, we propose a design for a randomized trial to enable the use of an age simulation suit to generate reference data of people with health impairments with young and healthy participants. Therefore, we focus on situations of increased physical activity.

The 2018 ISHLT/APM/AST/ICCAC/STSW Recommendations for the Psychosocial Evaluation of Adult Cardiothoracic Transplant Candidates and Candidates for Long-term Mechanical Circulatory Support.

The psychosocial evaluation is well-recognized as an important component of the multifaceted assessment process to determine candidacy for heart transplantation, lung transplantation, and long-term mechanical circulatory support (MCS). However, there is no consensus-based set of recommendations for either the full range of psychosocial domains to be assessed during the evaluation, or the set of processes and procedures to be used to conduct the evaluation, report its findings, and monitor patients' receipt of and response to interventions for any problems identified. This document provides recommendations on both evaluation content and process. It represents a collaborative effort of the International Society for Heart and Lung Transplantation (ISHLT) and the Academy of Psychosomatic Medicine, American Society of Transplantation, International Consortium of Circulatory Assist Clinicians, and Society for Transplant Social Workers. The Nursing, Health Science and Allied Health Council of the ISHLT organized a Writing Committee composed of international experts representing the ISHLT and the collaborating societies. This Committee synthesized expert opinion and conducted a comprehensive literature review to support the psychosocial evaluation content and process recommendations that were developed. The recommendations are intended to dovetail with current ISHLT guidelines and consensus statements for the selection of candidates for cardiothoracic transplantation and MCS implantation. Moreover, the recommendations are designed to promote consistency across programs in the performance of the psychosocial evaluation by proposing a core set of content domains and processes that can be expanded as needed to meet programs' unique needs and goals.

The 2018 ISHLT/APM/AST/ICCAC/STSW recommendations for the psychosocial evaluation of adult cardiothoracic transplant candidates and candidates for long-term mechanical circulatory support.

The psychosocial evaluation is well-recognized as an important component of the multifaceted assessment process to determine candidacy for heart transplantation, lung transplantation, and long-term mechanical circulatory support (MCS). However, there is no consensus-based set of recommendations for either the full range of psychosocial domains to be assessed during the evaluation, or the set of processes and procedures to be used to conduct the evaluation, report its findings, and monitor patients' receipt of and response to interventions for any problems identified. This document provides recommendations on both evaluation content and process. It represents a collaborative effort of the International Society for Heart and Lung Transplantation (ISHLT) and the Academy of Psychosomatic Medicine, American Society of Transplantation, International Consortium of Circulatory Assist Clinicians, and Society for Transplant Social Workers. The Nursing, Health Science and Allied Health Council of the ISHLT organized a Writing Committee composed of international experts representing the ISHLT and the collaborating societies. This Committee synthesized expert opinion and conducted a comprehensive literature review to support the psychosocial evaluation content and process recommendations that were developed. The recommendations are intended to dovetail with current ISHLT guidelines and consensus statements for the selection of candidates for cardiothoracic transplantation and MCS implantation. Moreover, the recommendations are designed to promote consistency across programs in the performance of the psychosocial evaluation by proposing a core set of content domains and processes that can be expanded as needed to meet programs' unique needs and goals.

Measuring Fear of Physical Activity in Patients with Heart Failure.

PURPOSE: Fear of physical activity (FoPA) has been suggested as a psychological barrier to exercise-based cardiac rehabilitation and everyday physical activity (PA) in patients with heart failure (HF). We evaluated the recently developed Fear of Activity in Situations-Heart Failure (FActS-HF) questionnaire that assesses affective/cognitive fear reactions to situations of varying PA intensities. METHODS: The FActS-HF was given to 132 ambulatory patients with stable HF (67 ± 12 years, 80% men). In 121 participants with valid FActS-HF data, the questionnaire's dimensionality was investigated. Psychometric properties were determined in terms of reliability and validity. We assessed convergent and discriminant correlations of FoPA with anxiety, kinesiophobia, and depression. External validation criteria encompassed clinical variables and objectively assessed accelerometer measures of everyday PA in a subsample of 61 participants. RESULTS: The FActS-HF measures a unidimensional construct (i.e., FoPA) based on items presenting varying PA intensities (i.e., the more intense the PA, the stronger the fear response). The scale demonstrated good 2-week stability (r tt = 0.82) and excellent internal consistency reliability (α = 0.97). FoPA was moderately to strongly associated with anxiety and kinesiophobia, and weakly to moderately associated with state/trait depression, supporting convergent and discriminant validity, respectively. High FoPA was associated with feeling uninformed about HF, comorbidities, non participitation to cardio fitness groups, and less stair climbing, as measured by accelerometry. CONCLUSION: The FActS-HF is a reliable and valid instrument to measure FoPA in patients with HF and provides a promising tool for further research and practice.

Role of Depression and Social Isolation at Time of Waitlisting for Survival 8 Years After Heart Transplantation.

BACKGROUND: We evaluated depression and social isolation assessed at time of waitlisting as predictors of survival in heart transplant (HTx) recipients. METHODS AND RESULTS: Between 2005 and 2006, 318 adult HTx candidates were enrolled in the Waiting for a New Heart Study, and 164 received transplantation. Patients were followed until February 2013. Psychosocial characteristics were assessed by questionnaires. Eurotransplant provided medical data at waitlisting, transplantation dates, and donor characteristics; hospitals reported medical data at HTx and date of death after HTx. During a median follow-up of 70 months (<1-93 months post-HTx), 56 (38%) of 148 transplanted patients with complete data died. Depression scores were unrelated to social isolation, and neither correlated with disease severity. Higher depression scores increased the risk of dying (hazard ratio=1.07, 95% confidence interval, 1.01, 1.15, P=0.032), which was moderated by social isolation scores (significant interaction term; hazard ratio = 0.985, 95% confidence interval, 0.973, 0.998; P=0.022). These findings were maintained in multivariate models controlling for covariates (P values 0.020-0.039). Actuarial 1-year/5-year survival was best for patients with low depression who were not socially isolated at waitlisting (86% after 1 year, 79% after 5 years). Survival of those who were either depressed, or socially isolated or both, was lower, especially 5 years posttransplant (56%, 60%, and 62%, respectively). CONCLUSIONS: Low depression in conjunction with social integration at time of waitlisting is related to enhanced chances for survival after HTx. Both factors should be considered for inclusion in standardized assessments and interventions for HTx candidates.

Smoking Status at Time of Listing for a Heart Transplant Predicts Mortality on the Waiting List: A Multicenter Prospective Observational Study.

OBJECTIVE: We examined the association of smoking status at time of listing with waitlist mortality among heart transplant (HTx) candidates. PARTICIPANTS AND DESIGN: Data were analyzed from 316 participants (aged 53 ± 11; 18% female) of the Waiting for a New Heart Study, a prospective observational study of patients newly listed for HTx at 17 hospitals. RESULTS: During the study period (April 2005 to March 2010), 14% of those who never smoked died, 18% among former smokers died, and almost half (42%) died among those who reported smoking at time of wait listing. Multivariate Cox regression models controlling for age, sex, and disease severity revealed smoking at time of listing was associated with significantly higher risk of mortality compared to never smoking (hazard ratio [HR] = 3.43; P = .03). The relationship between smoking and mortality risk appeared to follow a dose-dependent pattern: adjusted HRs were 1.80 for those who quit ≤1 year ago, 1.25 for those who quit >1 to 10 years ago, and 0.90 for those quit >10 years ago, compared to never smokers. Smoking at time of listing may increase risk of mortality during the waiting period, indicating the need for improved strategies to achieve smoking cessation as early as possible in the course of HTx.

Who makes use of Internet-delivered health information? The role of gender role self-concept in young men and women.

This study examined the contribution of gender role self-concept (expressiveness and instrumentality) on active interest in and use of Internet-delivered health information among young men and women. Four hundred and twenty university students reported health behaviours and perceived personal vulnerability regarding five diseases. We analysed active interest in receiving health-related information concerning these diseases (providing email address to receive a link to health-related websites) and actual use of provided websites two weeks afterwards. Usage of health-related information via the Internet was objectively assessed by recording log-ins on the website and obtaining individual click counts. In both sexes, higher expressiveness was independently associated with being more likely to show active interest in health-related information. Additionally, expressiveness was positively associated with website use in men independent of age, personal vulnerability and reported health behaviours. Thus, an expressive self-concept facilitates the use of health-related information, especially among men.

Physical activity and depression predict event-free survival in heart transplant candidates.

OBJECTIVE: This study prospectively evaluated the relationship of physical activity (PA), depression, and anxiety to event-free survival during waiting time for heart transplantation in ambulatory patients enrolled in the Waiting for a New Heart Study. METHOD: Data from 227 ambulatory patients newly listed for heart transplantation were analyzed. Everyday PA (number of activities, caloric expenditure), depression, and anxiety at time of listing were assessed via questionnaires. Events were defined as death, high-urgency transplantation, delisting due to clinical deterioration, and mechanical circulatory support device implantation. Associations of PA scores, depression, and anxiety with event-free survival were analyzed using Cox proportional hazards models. Covariates included age, sex, body mass index, and objective indicators of disease severity. RESULTS: After a median follow-up of 478 days (6-1,849 days), 132 events occurred (46 deaths, 20 mechanical circulatory support device implantations, 54 high-urgency transplantations, 12 delistings). A higher number of activities was significantly associated with a reduced hazard ratio (HR) to experience an event (HR = 0.88, 95% CI [0.81, 0.96]), and depression increased this risk (HR = 1.64, 95% CI [1.16, 2.32]). Both effects remained significant in multivariate analyses (HR = 0.91, 95% CI [0.83, 0.99]; HR = 1.60, 95% CI [1.12, 2.29], ps < .02). No significant interactions between PA scores and emotions were observed and anxiety was unrelated to survival. CONCLUSION: Both everyday PA and the absence of depression prolonged event-free survival in ambulatory heart transplant candidates. These findings were independent of objective measures of disease severity. Patients waiting for cardiac transplantation may benefit from interventions focused on increasing their everyday PA and reducing depressive symptoms.

Everyday physical activity in ambulatory heart transplant candidates: the role of expected health benefits, social support, and potential barriers.

BACKGROUND: Physical activity (PA) is recommended for stable patients with advanced heart failure (HF). PURPOSE: We evaluated expected health benefits of PA and social support as facilitators of PA, and physical symptom distress and psychological distress (depression, anxiety) as barriers to PA. Additionally, we investigated if facilitators of PA are of particular importance for patients who report barriers. METHOD: We analyzed data assessed at time of waitlisting in 231 ambulatory patients (53.4 ± 10.3 years, 18 % women) who were enrolled in the multisite Waiting for a New Heart Study in 1 Austrian and 16 German hospitals. Self-reported everyday PA scores (number of activities, duration of activities) was regressed on demographic characteristics and indicators of disease severity (ejection fraction, peak oxygen consumption), facilitators (expected health benefits of PA, perceived emotional support, perceived support for PA), and barriers to PA (physical symptom distress, psychological distress). Interaction terms of facilitators with barriers were also examined. RESULTS: PA was positively associated with higher peak oxygen consumption, validating self-reported PA. Regarding facilitators, expected health benefits of PA were independently associated with higher PA (p values < 0.001). There were no main effects for social support on PA. Regarding barriers, depression tended to be associated with fewer activities (p = 0.068). However, in the presence of barriers (depression, physical symptoms), feeling supported for being physically active was positively associated with PA (p values < 0.05). CONCLUSION: Interventions to improve PA may benefit from strengthening positive expectations of health outcomes associated with everyday PA and fostering PA-specific social support for those distressed by HF symptoms or depression.

Dietary habits are related to outcomes in patients with advanced heart failure awaiting heart transplantation.

BACKGROUND: Empirical evidence supporting the benefits of dietary recommendations for patients with advanced heart failure is scarce. We prospectively evaluated the relation of dietary habits to pre-transplant clinical outcomes in the multisite observational Waiting for a New Heart Study. METHODS AND RESULTS: A total of 318 heart transplant candidates (82% male, age 53 ± 11 years) completed a Food Frequency Questionnaire (foods high in salt, saturated fats, poly-/monounsaturated fats [PUFA+MUFA], fruit/vegetables/legumes, and fluid intake) at time of waitlisting. Cox proportional hazard models controlling for heart failure severity (eg, Heart Failure Survival Score, creatinine) estimated cause-specific hazard ratios (HRs) associated with each dietary habit individually, and with all dietary habits entered simultaneously. During follow-up (median 338 days, range 13-1,394), 54 patients died, 151 received transplants (110 in high-urgency status, 41 electively), and 45 became delisted (15 deteriorated, 30 improved). Two robust findings emerged: Frequent intake of salty foods, which correlated positively with saturated fat and fluid intake, was associated with transplantation in high-urgency status (HR 2.90, 95% confidence interval [CI] 1.55-5.42); and frequent intake of foods rich in PUFA+MUFA reduced the risk for death/deterioration (HR 0.49, 95% CI 0.26-0.92). CONCLUSIONS: These results support the importance of dietary habits for the prognosis of patients listed for heart transplantation, independently from heart failure severity.

Health behaviors contribute to quality of life in patients with advanced heart failure independent of psychological and medical patient characteristics.

BACKGROUND: Little is known about the contribution of health behaviors to quality of life (QoL) in heart transplant candidates. We examined physical activity, dietary habits, psychological, and medical patient characteristics as correlates of QoL among patients enrolled in the multisite Waiting for a New Heart Study. METHOD: QoL (Minnesota Living with Heart Failure Questionnaire), demographic variables, psychological variables (e.g., depression, coping styles), and health behaviors (physical activity, dietary habits) were assessed in 318 patients (82% male, 53 ± 11 years) at the time of wait-listing and analyzed in 312 patients (excluding six underweight patients). Eurotransplant provided BMI and medical variables to compute the Heart Failure Survival Score (HFSS). Hierarchical multiple regression models were used to assess the independent contribution of health behaviors to QoL. RESULTS: The HFSS was unrelated to QoL. As expected, psychological characteristics (depression, anxiety, vigilant coping style) contributed to impaired QoL, accounting for 22.9, 35.9, and 12.9% of the variance in total, emotional, and physical QoL, respectively. Physical inactivity further impaired QoL (total: 4.1%, p < 0.001; physical: 7.4%, p < 0.001). Dietary habits typically considered as unhealthy (i.e., infrequent consumption of fruits/vegetables/legumes; frequent intake of foods high in saturated fats) were related to enhanced physical QoL, but only among the overweight and obese patients. CONCLUSION: Lifestyle interventions to modify negative emotions and to increase physical activity could help to improve QoL in heart transplant candidates, regardless of their disease severity. The role of eating habits in QoL among obese and overweight patients needs further exploration.

Cardiac threat appraisal and depression after first myocardial infarction.

The present study investigated cardiac threat appraisal and its association with depression after first myocardial infarction (MI). A semi-structured interview allowing for DSM-IV-axis I diagnoses was administered to 36 patients after first MI. Patients completed self-reports 5-15 days after the MI (time 1), 6-8 weeks later (time 2), and again 6 months later (time 3). Assessments at time 1 included indices of cardiac threat appraisal, locus of control, coping, and depression while at time 2 and time 3 only measures of depression were obtained. Cardiac threat appraisal was significantly correlated with depression at time 1, but was unrelated to depression scores at time 2 and time 3. Furthermore, there was a significant inverse association between cardiac threat appraisal and the subscales "search for affiliation" and "threat minimization" of the coping questionnaire. Additionally, "search for affiliation" correlated negatively with depression scores at time 1 and time 3, and "threat minimization" negatively with depression scores at time 1 and time 2. These results suggest a significant association between cardiac threat appraisal and depressive symptoms shortly after MI. Practical implications for treatment are discussed.