Clinical experience with medical hypnosis as an adjunctive therapy in heart surgery.

Heart surgery patients are at high risk for psychological trauma and comorbid psychological disorders. Depression, anxiety, and post-traumatic stress disorders in this patient group are predictors of outcomes after cardiac surgery. Medical hypnosis is effective for non-pharmacologic prevention and treatment of psychological disorders and has been associated with improved health-related quality of life and better cardiovascular outcomes. This contribution makes note of evidence of the effectiveness of medical hypnosis in a discussion of the clinical experience with specific hypnotherapeutic tools and interventions from the perspective of the mental health team in one large cardiac center in Germany. Based on our experience, we encourage heart centers to educate their heart surgery care teams about the core concepts of medical hypnosis and to make hypnotherapeutic techniques available as an adjunctive therapy.

Professional Employment in Patients on Ventricular Assist Device Support-A National Multicenter Survey Study.

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.

High level of psychosocial adjustment in patients on ongoing ventricular assist device support in the years one to three after VAD implantation-A national multi-center Study.

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.

Health-Related Quality of Life in Patients With Ventricular Assist Device: Psychometric Evaluation of the German Version of the Quality of Life With a Ventricular Assist Device Questionnaire.

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.

Disturbance in bodily experience following ventricular assist device implantation.

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.

Donor and Donation Images (DDI)-A Scoping Review of What We Know and What We Don't.

Organ transplantation is associated with significant physical and psychological burden for the recipients. Qualitative reports indicate that organ recipients develop donor and donation images (DDI)-conceptions of the donor and/or the organ. A deeper understanding of DDI is needed in the care of transplant recipients. To present the current state of knowledge, we searched for and identified DDI-related publications in PubMed and Scopus. Inclusion criteria were (1) studies addressing transplant recipients, and (2) English or German language. Twenty-one studies of individuals with transplanted hearts, lungs, or kidneys were included in this scoping review. Prevalence for DDI ranged from 6% to 52.3%. DDI occurs both before and after transplantation and includes ideas about the donor as well as whether and how the recipient's personality may be altered by the transplanted organ. Some transplant recipients did indeed report personality changes following transplantation due to the adoption of assumed donor characteristics. One study showed a positive association between the presence of DDI and anxiety scores and one described a coping effect. DDI is understudied and should be systematically assessed to improve care for the vulnerable group of individuals undergoing organ transplantation. Current research gaps and future directions are discussed.

Preoperative Risk Factors and Early Outcomes of Delirium in Valvular Open-Heart Surgery.

BACKGROUND: Compared with coronary artery bypass grafting surgery, data regarding postoperative delirium are scant in valvular open-heart surgery. Therefore, the goal of this retrospective study was to investigate the incidence, preoperative risk factors, and early outcomes of delirium in a large group of patients undergoing valvular open-heart surgery. METHODS: In 13,229 patients with isolated valvular or combined valvular and bypass surgery, the incidence of postoperative delirium was assessed until discharge. Independent risk factors of delirium were evaluated by multivariable logistic regression analysis. Moreover, we assessed the multivariable-adjusted risk of prolonged intensive care unit (ICU) stay (>48 hours) and in-hospital mortality in patients with delirium. RESULTS: Overall, the incidence of postoperative delirium was 8.4%. The incidence in patients experiencing a postoperative stroke or seizure was 23.1 and 29.7%, respectively. Twelve preoperative risk factors, mostly nonmodifiable, were independently associated with the risk of delirium, including advanced age, renal impairment, stroke, the need for emergency surgery, and severe preoperative anemia (hemoglobin < 9 g/dL). Postoperative delirium was associated with an adjusted odds ratio (OR) of prolonged ICU stay of 9.48 (95% confidence interval [CI]: 7.96-11.30). Adjusted in-hospital mortality was, however, significantly lower in patients with delirium versus patients without delirium (OR, 0.56; 95% CI: 0.38-0.83). CONCLUSION: In valvular open-heart surgery, postoperative delirium is a frequent neurological complication that is associated with other postoperative neurological complications and several, mostly nonmodifiable, preoperative risk factors. Although postoperative delirium was associated with a significantly increased risk of prolonged ICU stay, this did not translate into an increased short-term mortality.

Perioperative Psychological Interventions in Heart Surgery­Opportunities and Clinical Benefit.

BACKGROUND: Heart surgery is a source of high levels of emotional distress for the patient. If the stress experience is not adequately compensated, it can have a negative impact on postoperative recovery, as can untreated comorbid mental disorders. METHODS: A selective literature review on emotional distress and mental comorbidities in heart surgery patients and a scoping review on the spectrum and effectiveness of perioperative psychological interventions to compensate and reduce the stress experience. RESULTS: Mental factors such as depressive symptoms or anxiety disorders are associated with an elevated risk of postoperative morbidity and mortality in patients treated for heart disease. Mental comorbidities occur more frequently in these patients than in the general population. Following the manifestation of chronic heart disease (CHD), for example, 15-20% of the patients display severe depressive disorders. A few psychotherapeutic interventions to reduce anxiety and depression, emotional distress, consumption of analgesics, and extubation time have been found effective, with low to moderate evidence quality. Many different psychological interventions have proved useful in clinical practice, including multimodal, multiprofessional interventions incorporating medications, education, sports, and exercise as well as psychosocial therapy including stress management. Individual psychotherapy during the period of acute inpatient treatment after myocardial infarction is also effective. CONCLUSION: Because psychosocial factors are important, the current guidelines recommend systematic screening for mental symptoms and comorbidities in advance of heart transplantation or the implantation of ventricular assist devices (VAD). Acute psychotherapeutic interventions to reduce mental symptoms can be offered in the perioperative setting.

Self-management for patients on ventricular assist device support: a national, multicentre study: protocol for a 3-phase study.

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.

Self-management with the therapeutic regimen in patients with ventricular assist device (VAD) support - a scoping review.

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.

[Psychosocial Evaluation of Transplant Patients - Recommendations for the Guidelines for Organ Transplantation]. / Psychosoziale Evaluation von Transplantationspatienten ­ Empfehlungen für die Richtlinien zur Organtransplantation.

For the last few years, the German Medical Association's guidelines for transplant medicine have been subject to an extensive revision process. The present contribution presents recommendations regarding the psychosocial evaluation of patients prior to organ transplantation, which were developed by experts from the Psychology/Psychosomatics committee of the German Transplant Society with the aim to incorporate the recommendations into the guidelines. The main objective is to establish a mandatory psychosocial evaluation for all patients prior to their admission to the transplant waiting list. Contents, potential contraindications, and the procedure of the evaluation are described. Furthermore, the qualification deemed necessary for the examiners is addressed in detail. Finally, the future need for action is determined.

Mental health interventions during ventricular assist device therapy: a scoping review.

OBJECTIVES: Because of the high prevalence of psychological disorders among ventricular assist device patients, mental health support is consensually recommended. No study as yet has provided an overview of recommended and reported mental health interventions. This article presents the results of a scoping review on these questions. METHODS: We searched standard databases for relevant search criteria and found 4 consensus guidelines and 13 publications with original research mentioning mental health interventions for ventricular assist device patients. These publications are synthesized and augmented with practical recommendations from our reports and from a single-centre experience of others. RESULTS: Consensus guidelines recommend mental health interventions in 4 areas: screening and diagnostics, assessment, support and treatment and education. Interventions vary across treatment phases and by device therapy strategy, as do typical sources of mental distress. A flow chart of interventions over the course of treatment summarizes these findings. CONCLUSIONS: The delivery of consensually recommended mental health support for ventricular assist device patients involves the performance of multiple, complex tasks that vary across treatment phases. Mental health professionals should have specialized skills and should interact frequently with other caregivers in care teams.

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

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.

Adherence of Heart Transplant Recipients to Prescribed Medication and Recommended Lifestyle Habits.

INTRODUCTION: Nonadherence may cause severe health problems in heart transplant (HTx) recipients. RESEARCH QUESTIONS: The present study aimed to investigate adherence to prescribed medication and recommended lifestyle habits in post-HTx patients and to assess associations between adherence, quality of life (QOL), and psychological well-being. DESIGN: A questionnaire package was sent to all HTx patients from our clinic (n = 858) to answer questions anonymously on medication adherence, dietary recommendations (avoidance of raw animal products and ice cream), pet keeping (risk of zoonosis), anxiety and depression, QOL, and posttraumatic stress disorders. RESULTS: Of the contacted patients, 524 (61%) responded and 505 fulfilled the inclusion criteria (age ≥18 years and ability to understand German). Of the study participants, 72.4% reported taking their medications very correctly, 72.2% stated consuming alcohol less often than once a week, 58.3% performed physical exercise at least once a week, one-third reported eating nonrecommended foods, 22.1% stated pet keeping, and 4.3% reported smoking. Adherence to prescribed medication was positively associated with age ( P < .001) and mental QOL ( P = .015) but was unrelated to eating nonrecommended foods ( P > .05). Depressiveness correlated inversely with physical QOL ( r = -0.232; P < .01) and mental QOL ( r = -0.411; P < .01). Stress disorders and minor stressful events were reported by 7.8% and 46.6%, respectively. Stress disorders correlated inversely with mental QOL ( r = -0.282; P < .01) and physical QOL ( r = -0.422; P < .01). DISCUSSION: Many HTx patients adhere to prescribed medications and health advice. Nevertheless, nonadherence is a problem, especially in younger HTx patients, indicating the need for a nonadherence crisis intervention program for long-term HTx patients.

Bypass surgery with psychological and spiritual support (the BY.PASS Study): results of a pragmatic trial based on patients' preference.

BACKGROUND: Some general hospitals within the German health system provide supportive interventions, psychological as well as spiritual, to their patients. It remains to be proven if these interventions are effective when used in routine clinical practice. AIM: To evaluate the effectiveness of psychological and spiritual interventions on improving recovery following bypass surgery. METHODS: The BY.PASS study is a pragmatic, patient preference trial (ISRCTN 07297983). Adult patients scheduled for elective coronary bypass surgery were enrolled. Patients were assigned to study conditions according to their personal preference: preference for psychological interventions, for spiritual interventions or for no intervention. Patients who were open for any kind of intervention were randomly assigned either to psychological or spiritual interventions. During a control period, patients were asked about their preference, but did not receive any interventions. Primary outcomes of the study were in-hospital morbidity and early mortality. Psychological measures served as secondary outcomes. RESULTS: A total of 847 patients were enrolled. Patients of the control (n = 260) and the intervention group (n = 269) who explicitly wanted to have interventions were compared. No significant treatment effects either for morbidity (d = 0.08, 95% CI -0.09 to 0.25), or for mortality (OR = 1.81; 95% CI 0.50-6.57) could be found. A reduction of negative mood resulted from both interventions. CONCLUSIONS: Although the effects observed were small, the study can serve as a basis to discuss methodological as well as theoretical aspects of a pragmatic trial, based upon patients' preferences.

Quality of life after aortic root surgery: reimplantation technique versus composite replacement.

BACKGROUND: Recent studies indicate the safety of the aortic valve reimplantation technique (David operation) in the long-term follow-up. The aim of this study was to compare the results of the David operation with those of the aortic composite replacement procedure, with the focus on quality of life (QoL). METHODS: Within a 6-year period, 143 patients received either an aortic composite replacement (composite group, n = 67) or the David-I operation (David group, n = 76). The QoL of 108 patients (87% of the living patients) was evaluated postoperatively by the 36-Item Short Form Health Survey. A subgroup analysis of QoL excluded patients with aortic stenosis and type A acute aortic dissection. RESULTS: Hospital survival rates (89.6% versus 97.4%, p = 0.102), as well as actuarial 1-year survival rate (86.6% versus 91.9%) and 3-year survival rate (81.1% versus 91.9%) proved more successful among the David group. Incidences of serious adverse events during the follow-up period (10.8% versus 28.3%, p = 0.008) were higher for patients of the composite group. The QoL was found to be compromised for patients of the composite group, in relation to all criteria outlined in the 36-Item Short Form Health Survey. Subgroup analysis without patients with dissection and aortic stenosis demonstrated a significantly better postoperative QoL for patients of the David group. Patients belonging to the composite group were more frequently compromised by prosthetic valve noise (p < 0.001). CONCLUSIONS: This study demonstrates the superiority of the aortic valve reimplantation compared with the aortic composite replacement, regarding both clinical outcome and postoperative QoL.

Suicide after ventricular assist device implantation.

Depression and anxiety are well documented in patients with end-stage heart failure and correlate with a higher risk of suicide. We report a 69-year-old depressed patient who committed suicide by disconnecting the driveline of his left ventricular assist device almost 3 years after implantation. We provide the medical, psychologic, and psychiatric background of this unique case. This report highlights the importance of pre-implant psychologic screening, the need for regular and long-term psychologic support for this vulnerable patient population, and the need for more qualitative research on patients' views on living with a left ventricular assist device, together with research exploring risk profiles for depression and suicide.

Bypass surgery with psychological and spiritual support (the By.pass study): study design and research methods.

Effects of psychological as well as spiritual interventions on outcome in cardiac surgery have mostly been studied with a focus on presurgical interventions. Systematically controlled analyses of the effects of psychological and spiritual interventions depending on the patients' preference have not been performed so far, although these studies would help to assign patients to an adequate support. The By.pass study is a bi-center, controlled trial of patients undergoing coronary bypass surgery and coronary bypass surgery combined with valve replacement surgery in 2 different German hospitals. Patients are assigned to 1 of 5 conditions, mainly according to their personal therapeutic preference: preference for psychological interventions (group 1), preference for spiritual interventions (group 2), or preference for no intervention (group 5). Patients who are open for any kind of intervention are randomly assigned either to psychological (group 3) or spiritual interventions (group 4). Six months before the start and 6 months after the end of the treatment phase, patients were assigned to the control groups. These were asked about their subjective preference (psychological, spiritual, no intervention, or no specific preference) as well but received no interventions. Patients will be enrolled from October 2006 to December 2009. The 6-month follow-up will be completed in July 2010.