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Background: Little is known about the disturbance in bodily experience (BE) following ventricular assist device (VAD) implantation. The level of disturbance in BE serves as an indicator of the status of the patients' adaptation process to the device. This process encompasses coping with both the more affective, psychological conflicts and the more cognitive, practical challenges of living with the VAD. To provide an economical screening tool for everyday clinical practice, we refined and validated a questionnaire on BE in VAD patients., Methods: Seven specific items were derived from clinical experience and presented to 365 VAD patients (85% male; time since implantation: 3-36 months). The item structure was examined using factor analyses and probabilistic test theory. Discriminant validity and change sensitivity were determined in relation to associated psychometric instruments., Results: Four items were found to constitute the unidimensional bodily experience scale (BE-S). Besides a high internal consistency of the scale (ω = 0.86), the RMSEA of >0.01 indicates a very good model fit. The BE-S has high convergent validity with related constructs (Hospital Anxiety and Depression Scale, Kansas City Cardiomyopathy Questionnaire). Change sensitivity analyses proved the BE-S alone to be significantly sensitive to the temporal dynamics of psychological adaptation processes following VAD implantation., Conclusion: The BE-S constitutes a valid and economical tool for clinical practice to assess patients' disturbance in BE after VAD implantation. It is a valuable tool for identifying patients with difficulties in adapting to the VAD. Subsequently, it enables early and focused therapeutic support for these patients at risk., (© 2024 The Author(s). Artificial Organs published by International Center for Artificial Organ and Transplantation (ICAOT) and Wiley Periodicals LLC.)

Background: Ventricular assist device (VAD) implantation has become an alternative treatment for patients with end-stage heart failure. In Germany, valid and reliable instruments to assess health-related quality of life in patients with VAD are lacking., Objective: The aim of this study was to present the psychometric validation of the German version of the Quality of Life with a Ventricular Assist Device questionnaire., Methods: In a multicenter, cross-sectional study, 393 participants (mean age, 58.3 years; 85.8% male, 60.3% bridge to transplant, and 72.8% living with VAD for ≤2 years) completed the German Quality of Life with a Ventricular Assist Device questionnaire of physical, emotional, social, cognitive, and meaning/spiritual domains. Item and confirmatory factor analyses were conducted to test item difficulty and discrimination and the underlying structure, respectively. To examine internal consistency, Cronbach α was assessed. Convergent construct validity was tested using the Kansas City Cardiomyopathy Questionnaire and the Patient Health Questionnaire-9. Readability was examined using Flesch Reading Ease index and Vienna Factual Text Formula., Results: The Quality of Life with a Ventricular Assist Device showed reasonable item difficulty ( Ptotal = .67) and mostly moderate to high discriminatory power ( rit > 0.30). In confirmatory factor analysis, root-mean-square error of approximation (0.07) was acceptable for model fit, but no other indices. Acceptable internal consistency was found ( α ≥ 0.79), with the exception of the cognitive domain ( α = 0.58). The overall questionnaire and single domains demonstrated convergent validity ( r ≥ 0.45, P < .001). The questionnaire showed adequate readability (Flesch Reading Ease, 64.11; Vienna Factual Text Formula, 6.91)., Conclusion: Findings indicate a promising standardized clinical instrument to assess health-related quality of life in patients with VAD., (Copyright © 2023 The Authors. Published by Wolters Kluwer Health, Inc.)

Background: Disturbance in bodily experience (BE) is a potential adverse consequence of ventricular assist device (VAD) implantation. The concept BE encompasses all cognitive and affective processes related to the subjective experience of one's own body., Methods: A cross-sectional, multicenter study was performed, involving 365 VAD patients (85% male; time postimplant: 3-36 months). Patients completed a BE questionnaire (BE-S, 5-point Likert scale), and the disturbance in BE was analyzed based on sex, time since implantation (in the first, second, or third years postimplant), and patient acuity (elective vs emergent implantation). Subsidiary, patients' gratitude was surveyed., Results: Disturbance in BE was not particularly pronounced (mean = 2.69, standard deviation = 1.17). Eighty-five percent of patients expressed high levels of gratitude. Disturbance in BE decreased (p = 0.04), while gratitude increased (p = 0.02) with time since implantation. Female patients showed more disturbance in BE (p = 0.01) and less gratitude (p = 0.01) compared to male patients. Among patients who underwent emergency implantation, the decrease in disturbance occurred predominantly in the third year, exceeding the level observed in elective implanted patients (p = 0.03)., Conclusions: Disturbance in BE following VAD implantation does generally not reach excessive levels and tends to decrease over time. Our data indicate more disturbance and less gratitude in female patients. In emergently implanted patients, disturbance in BE is prolonged. Screening for disturbance in BE is recommended during follow-up, especially for these at-risk groups, to ensure early and focused psychological support., (Copyright © 2024 International Society for the Heart and Lung Transplantation. Published by Elsevier Inc. All rights reserved.)

This study aimed to assess patients of working age returning to professional employment as a surrogate marker for functional recovery and psychosocial reintegration after ventricular assist device (VAD) implantation. A national, multicenter study considered professional employment and its relationship to sociodemographic, psychosocial, and clinical adverse outcomes in outpatients on VAD support. Patient-reported outcome measures were administered. The survey had a 72.7% response rate. Mean age of 375 subjects was 58 ± 11 years, 53 (14%) were female. Thirty-five patients (15.15%; 95% confidence interval [CI] = 10.9-20.6) were employed, and the majority of them (n = 29, 82.9%) were bridged to transplantation. A regression model after variable selection revealed younger age (odds ratio [OR] = 0.95; 95% CI = 0.91-0.98; p < 0.005), and higher education (OR = 3.05; 95% CI = 1.72-5.41; p < 0.001) associated with professional employment. Employed patients reported higher health-related quality of life (HRQoL) (Kansas City Cardiomyopathy Questionnaire [KCCQ] overall sum-score, OR = 1.04; 95% CI = 0.92-1.07; p < 0.007), the OR for those employed was 2.18 (95% CI = 0.89-5.41; p < 0.08) indicating no significant relation for employment and a history of adverse events. In this sample, professional employment was rather small; the likelihood of adverse events was not significantly different between groups. Those employed perceived better overall HRQoL, which may encourage clinicians to support professional employment for selected patients on VAD support., Competing Interests: Disclosure: The authors have no conflicts of interest to report., (Copyright © 2024 The Author(s). Published by Wolters Kluwer Health, Inc. on behalf of the ASAIO.)

Background: Advanced heart failure therapies such as durable ventricular assist device (VAD) support require psychosocial adjustment for those affected. Since VAD implantation has become an established treatment strategy, a focus on psychosocial factors is needed., Objectives: To investigate the construct of psychosocial adjustment and to further understand the role of social support., Methods: In a nation-wide, multi-center, cross-sectional study, we recruited 393 participants with ongoing VAD support (3mts-3yrs on device; clinicaltrials.gov ID: NCT04234230). Patient demographics, psychosocial adjustment (perceived social support, anxiety, depression, and quality of life), and major adverse events (thromboembolic events, bleeding, driveline infections) were assessed., Results: Overall, 85.8 % of the sample were male; mean age was 58.3 years (range 18-85). The majority of the sample (89.3 %) reported normal to high perceived social support. Participants expressed symptoms of anxiety within the normal range (M=6.0±3.9), mildly elevated depressive symptoms (HADS: M=7.6±2.9; PHQ-9: M=6.2±4.7), and good quality of life (KCCQ: M=65.3±17.9). Higher perceived social support was associated with lower levels of anxiety and depression, and higher levels of quality of life within our sample (all p<0.001). Driveline infection was the most prevalent adverse event (0.304 infections per person-years [32.6 % of patients]). Binary logistic regression models did not identify significant associations for the occurrence of adverse events and variables of psychosocial adjustment., Conclusion: Our sample perceived high levels of psychosocial adjustment. High perceived social support was associated with better outcomes in levels of anxiety, depression, and quality of life, demonstrating potential for the future development and evaluation of targeted multi-professional social support interventions including peer- and caregiver support., Competing Interests: Declaration of Competing Interest None., (Copyright © 2023 The Authors. Published by Elsevier Inc. All rights reserved.)

Aims: Ventricular assist device (VAD) implantation has become a well-established treatment strategy for patients suffering from advanced heart failure. Ventricular assist device treatment attempts to ameliorate the symptom burden but may create new challenges in patients' lives. Lacking are insights into perceived challenges and health-related needs of patients with VAD within their home environment. Our study aimed to explore the perceived health-related needs of patients living with a VAD in their home environment., Methods and Results: We used a qualitative approach based on a hermeneutic, directed content analysis design. Telephone-based interviews were conducted with 10 patients with VAD from a single cardiology centre in Germany. Data collection and analyses were carried out using content-structuring content analyses. Normalcy and safety were identified as overarching themes: participants expressed a need to balance daily activities between striving for normalcy and maintaining safety. Underlying necessities reflecting this balance were categorized as functional, social, and mental health-related needs. Learning by doing, social-, and peer support were described as relevant requisites. Fulfilling these health-related needs could aid patients living with VAD in achieving the sense of normalcy and safety they seek., Conclusion: Balancing health-related needs with striving for normalcy and safety, emerged as a new core concept for patients with VAD. Thus, being cognizant of this balance when caring for these patients, could facilitate coping after VAD implantation through increasing acceptance of limitations to daily functions by enhancing individual safety. A supportive social environment, including peer support, becomes vital in self-management programs preparing patients with VAD for their home environment., (© The Author(s) 2021. Published by Oxford University Press on behalf of the European Society of Cardiology.)

Introduction: Self-management (SM) may facilitate patient participation and involvement to become active and knowledgeable partners in the care of complex chronic conditions such as ventricular assist device (VAD) therapy. The 'SM model for patients on VAD support' will serve to distinguish between SM components, and will guide the development, implementation and evaluation of an evidence-based curriculum., Methods and Analysis: This is a 3-phase, multicentre study. In phase 1, a prevalence study will be performed. Phase 2 aims to develop an evidence-based, interprofessional curriculum for SM support for VAD patients. In phase 3, a non-blinded block-randomised controlled trial (RCT), allocation ratio 1:1, intervention group superiority, with an unblinded multifacetted intervention with assessments before (T1) and after (T2) the intervention, and two follow-up assessments at three (T3), and 12 (T4) months after VAD implantation, will be performed. The curriculum guides the intervention in the RCT. Patient recruitment will consider centre-related volume: power analyses require 384 patients for phase 1, and 142 patients for phase 3., Ethics and Dissemination: Ethical considerations will be continuously taken into account and approved by the institutional review boards. Central ethical review board approval has been obtained by the Albert-Ludwigs University Freiburg. This study will be performed in concordance with the Declaration of Helsinki and the European data protection law. Publications will exclusively report aggregated data and will be distributed in the scientific community, and patient support groups. Report languages will be German and English., Trial Registration Numbers: NCT04234230 and NCT04526964; Pre-results., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Background: Ventricular assist device (VAD) implantation has become an established treatment strategy for the increasing number of patients with advanced heart failure. Adequate patient self-management becomes essential to prevent adverse events, which could diminish expected outcomes and survival for patients on VAD support., Objectives: The aim of this study was to provide an overview of the current state of evidence concerning self-management in VAD patients through a systematized search and mapping of the literature., Methods: Following the scoping review process, a comprehensive literature search (PubMed, PsychInfo), tabular synthesis of included articles, and data analysis of synthesized findings were performed., Results: Overall, twenty articles were included. Results describe the complexity of regular self-management tasks and give direction for specific self-management training., Conclusions: This article represents the first comprehensive overview of available evidence suggesting the need for development and implementation of evidence-based, patient self-management curricula with therapeutic regimen for VAD patients., Competing Interests: Declaration of Competing Interest None., (Copyright © 2021 The Authors. Published by Elsevier Inc. All rights reserved.)

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., (Copyright © 2018 The Authors. Published by Elsevier Inc. All rights reserved.)

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., (Copyright © 2018 International Society for Heart and Lung Transplantation. Published by Elsevier Inc. All rights reserved.)

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.

Objective: Newer generation left ventricular assist devices (LVADs) are established for long-term support. The aim of this multi-modal intervention was to improve the body weight, exercise tolerance and psychosocial status in outpatients on long-term LVAD support., Methods: Seventy patients participated in this non-randomized intervention study [intervention group (IGr) n = 34; control group (CGr) n = 36] over 18 months (T1-T4); the baseline sample characteristics showed no differences between groups. Dietary counselling and weight management intervention was performed by a dietician based on a specific algorithm. Physical reconditioning followed a home ergometry protocol and was supplemented by psychosocial counselling. The outcomes were measured based on the body mass index (BMI), cardiopulmonary exercise testing and self-report [hospital anxiety and depression scale (HADS), SF-36]., Results: The intervention showed a strong positive effect on nutrition and weight management [95% confidence interval (CI): -0.71-0.69; effect size (ES): 0.907; P = 0.02)], resulting in the normal BMI (kg/m(2)) values in the IGr (T1: 24.0 ± 0.6; T4: 24.5 ± 1.1; P = 0.35) compared with a significant BMI increase in the CGr (T1: 23.8 ± 0.6; T4: 29.7 ± 0.8; P = 0.05). Significant differences appeared regarding exercise tolerance (VO(2)max/% predicted) in favour of IGr patients (IGr: 69 ± 2.9; CGr 62 ± 3.7; P = 0.04). This increase was reflected by patients' self-reporting based on the SF-36 physical component score (IGr: P = 0.04; CGr: P = 0.54). SF-36 psychosocial component scores showed no changes for both groups. However, CGr showed a tendency for increased anxiety scores relative to their counterparts (IGr: 4.95 ± 0.4; CGr: 6.6 ± 0.9; P = 0.03)., Conclusions: IGr patients showed a strong benefit from a multi-modal intervention, including dietary counselling, controlled exercise and psychosocial support. Dietary counselling holds potential to prevent obesity in this patient population.

Background: The aim of this study was to evaluate and compare health-related quality of life (HRQoL) and physical exercise tolerance in patients after heart transplantation (HTx) or implantation of a left ventricular assist device (LVAD)., Methods: A prospective, comparative design was used to characterize changes over time in HRQoL (SF-36) and exercise tolerance in patients after HTx (n = 54) and during LVAD support (n = 36). Nine LVAD patients were lost for follow-up. The majority of patients in both groups were male (97%); the LVAD cohort tended to be younger (p = 0.06)., Results: HRQoL improved significantly in HTx patients in the SF-36 physical (p = 0.02), but not in the psychosocial (p = 0.27) component score during follow-up. In the LVAD group, HRQoL showed improvements for both the SF-36 physical and psychosocial component scores (both p = 0.04). Between-group comparisons revealed better HRQoL for the HTx cohort than the LVAD cohort for 2 of 8 SF-36 subscales. Age-, gender- and body mass index (BMI)-adjusted exercise tolerance (workload; VO(2max)) showed significant improvements for both HTx (p = 0.01) and LVAD (p = 0.01) patients. Adjusted maximum oxygen consumption was higher for HTx patients (p = 0.05) relative to LVAD patients at 8 ± 1 months after implant., Conclusion: HRQoL and exercise capacity increased in both groups over the time-course of the study. After adjusting for relevant variables, HTx patients showed a higher exercise tolerance compared with the LVAD group during follow-up. Thus, future large-scale intervention studies should emphasize the specific needs of these patient cohorts., (Copyright © 2011 International Society for Heart and Lung Transplantation. Published by Elsevier Inc. All rights reserved.)

Patient satisfaction with left ventricular assist device (LVAD) external equipment has not yet been reported. We aimed to evaluate the quality of two different systems based on patients' perspective and its interrelationship with quality of life. Differential assessment of the HeartMate II axial flow pump (n = 17; Thoratec, Pleasanton, CA, USA) and the HVAD centrifugal pump (n = 10; HeartWare, Inc., Miramar, FL, USA) was obtained from 27 outpatients by a questionnaire 2 months to 2.9 years after device implantation. In addition, a health-related quality of life questionnaire (Short Form-36 [SF-36]) was completed. Overall patients' satisfaction was high. Severe limitations were attributed to the loudness of the power base unit in HeartMate II patients (P = 0.00), and HVAD patients were dissatisfied by the length of the driveline (P = 0.02). Between HVAD and HeartMate II patients, no significant differences in the quality of life (assessed by SF-36) were reported. While the overall satisfaction of outpatients on LVAD support was high, differences between the systems were found. Patients' perspectives may have an important impact on future modification of external components. Ultimately, this may also contribute to an improvement in the quality of life of chronic LVAD patients., (© 2010, Copyright the Authors. Artificial Organs © 2010, International Center for Artificial Organs and Transplantation and Wiley Periodicals, Inc.)