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.

Does Anxiety Affect Survival in Patients with Coronary Heart Disease?

INTRODUCTION: Behavioral and physiological risk factors worsen the prognosis of coronary heart disease (CHD). Anxiety is known to be a psychological predictor of CHD. In this study, we investigated whether this factor is associated with all-cause mortality in CHD patients in the long term. METHODS: We studied 180 patients (mean age 60.6 SD 9.2 years, 26% women) with CHD from the Berlin Anxiety Trial (BAT) and the Stepwise Psychotherapy Intervention for Reducing Risk in Coronary Artery Disease (SPIRR-CAD) study. Their cardiac and psychological risk profile was represented by standardized procedures, including the Hospital Anxiety and Depression Scale (HADS) questionnaire. Mortality outcomes were assessed using a community-based registry. RESULTS: Of 180 patients, we obtained information on all-cause mortality in 175 (96.7%) after a mean follow-up of 12.2 years (range 10.4-16.6 years). Of all participants, 54.4% had prior myocardial infarction, 95.3% had percutaneous transluminal coronary angioplasty and 22.2% had prior coronary artery bypass graft. Most of the patients (98.4%) had New York Heart Association class I and II, 25.6% had diabetes and 38.2% were smokers. Patients had a mean HADS anxiety score of 9.7 SD 4.1 at study entrance. We found the highest HADS anxiety quartile all-cause mortality in 14%, 30.2% in the middle quartiles and 58.7% in the lowest quartile (chi2 20.8, p = 0.001). Related to psychological mechanisms, a low level of anxiety, seemed to be a significant predictor of all-cause mortality. We found no advantage for patients who had received psychosocial therapy in terms of survival. CONCLUSION: These first data confirmed our hypothesis about the association of psychological risk factors with the long-term outcome of CAD patients. Future studies will clarify whether the severity of disease, age or a particular type of coping or denial mechanism are associated with the presented outcome in low-anxious patients.

Pre-surgery optimization of patients' expectations to improve outcome in heart surgery: Study protocol of the randomized controlled multi-center PSY-HEART-II trial.

The PSY-HEART-I trial indicated that a brief expectation-focused intervention prior to heart surgery improves disability and quality of life 6 months after coronary artery bypass graft surgery (CABG). However, to investigate the clinical utility of such an intervention, a large multi-center trial is needed to generalize the results and their implications for the health care system. The PSY-HEART-II study aims to examine whether a preoperative psychological intervention targeting patients' expectations (EXPECT) can improve outcomes 6 months after CABG (with or without heart valve replacement). EXPECT will be compared to Standard of Care (SOC) and an intervention providing emotional support without targeting expectations (SUPPORT). In a 3-arm multi-center randomized, controlled, prospective trial (RCT), N = 567 patients scheduled for CABG surgery will be randomized to either SOC alone or SOC and EXPECT or SOC and SUPPORT. Patients will be randomized with a fixed unbalanced ratio of 3:3:1 (EXPECT: SUPPORT: SOC) to compare EXPECT to SOC and EXPECT to SUPPORT. Both psychological interventions consist of 2 in-person sessions (à 50 minute), 2 phone consultations (à 20 minute) during the week prior to surgery, and 1 booster phone consultation post-surgery 6 weeks later. Assessment will occur at baseline approx. 3-10 days before surgery, preoperatively the day before surgery, 4-6 days later, and 6 months after surgery. The study's primary end point will be patients' illness-related disability 6 months after surgery. Secondary outcomes will be patients' expectations, subjective illness beliefs, quality of life, length of hospital stay and blood sample parameters (eg, inflammatory parameters such as IL-6, IL-8, CRP). This large multi-center trial has the potential to corroborate and generalize the promising results of the PSY-HEART-I trial for routine care of cardiac surgery patients, and to stimulate revisions of treatment guidelines in heart surgery.

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.

Association of certification, improved quality and better oncological outcomes for rectal cancer in a specialized colorectal unit.

PURPOSE: Centralization of cancer care is expected to yield superior results. In Germany, the national strategy is based on a voluntary certification process. The effect of centre certification is difficult to prove because quality data are rarely available prior to certification. This observational study aims to assess outcomes for rectal cancer patients before and after implementation of a certified cancer centre. PATIENTS AND METHODS: All consecutive patients treated for rectal cancer in our certified centre from 2009 to 2017 were retrieved from a prospective database. The dataset was analyzed according to a predefined set of 19 quality indicators comprising 36 quality goals. The results were compared to an identical cohort of patients, treated from 2000 to 2008 just before centre implementation. RESULTS: In total, 1059 patients were included, 481 in the 2009-2017 interval and 578 in the 2000-2008 interval. From 2009 to 2017, 25 of 36 quality goals were achieved (vs. 19/36). The proportion of anastomotic leaks in low anastomoses was improved (13.5% vs. 22.1%, p = 0.018), as was the local 5-year recurrence rate for stage (y)pIII rectal cancers (7.7% vs. 17.8%, p = 0.085), and quality of mesorectal excision (0.3% incomplete resections vs. 5.5%, p = 0.002). Furthermore, a decrease of abdominoperineal excisions was noted (47.1% vs. 60.0%, p = 0.037). For the 2009-2017 interval, local 5-year recurrence rate in stages (y)p0-III was 4.6% and 5-year overall survival was 80.2%. CONCLUSIONS: Certification as specialized centre and regular audits were associated with an improvement of various quality parameters. The formal certification process has the potential to enhance quality of care for rectal cancer patients.

Advanced Ulcerated Squamous Cell Carcinoma of the Hand with Locoregional Axillary Lymph Node Metastasis - Case Report and Literature Review.

BACKGROUND: Cutaneous squamous cell carcinoma (SCC) of the hand is the most common soft-tissue malignancy in this particular region. A literature survey suggested a higher rate of metastases in advanced SCC of the hand compared to head-and-neck cutaneous SCC. CASE REPORT: An 84-year-old man presented with an ulcerated firm tumour on the dorsum of his right hand. A diagnostic biopsy confirmed the diagnosis SCC. Imaging suggested an involvement of the tendons of digits 3 and 4. A diagnostic ultrasound suggested a loco-regional axillary lymph node metastasis. After discussion in the interdisciplinary tumour board, amputation of the affected digits followed by lymph node excision was recommended. CONCLUSIONS: Advanced SCC of the hand requires interdisciplinary management. Amputation is part of the surgical spectrum in advanced cases.

Exploring the developmental tasks of emerging adults after paediatric heart transplantation: a cross-sectional case control study.

OBJECTIVE: Paediatric heart transplantation (PHTX) comprises 12% of all cardiac transplants and many of the children now survive into adulthood. Only a few studies have investigated the long-term psychosocial well-being of young adult patients after PHTX; no studies have investigated developmental tasks of emerging adulthood in different domains (family, social environment, education and profession, partnership, social environment). SETTING: Specialised heart centre in Germany. PARTICIPANTS: Thirty-eight young adults aged 22.11 years (SD=4.7) who underwent PHTX and a control group of 46 participants with no known chronic diseases, aged 22.91 years (SD=1.8), participated in the study. OUTCOME MEASURES: All participants completed the following questionnaires: sociodemographic, the F-SozU, to measure perceived social support, the Gießener Beschwerde-Bogen to measure subjective complaints experienced by patients, the KIDSCREEN-27 to measure well-being and the SF-36 to measure health-related quality of life (QoL). RESULTS: 'Family': the quality of the relationship with the parents was found to be equal in both groups, while PHTX patients stayed in closer spatial proximity to their parents. 'Social environment': PHTX patients reported lower social support by peers than the control group. 'Education and profession': PHTX patients most often worked full-time (23%), had no job and/or received a pension (21%). In comparison, most of the healthy controls did an apprenticeship (40%) and/or worked part time (32%). 'Partnership': fewer of the PHTX patients had a partner than the control group while relationship duration did not differ. In exploratory regression analyses, social support by peers predicted physical QoL, whereas physical complaints and the physical role predicted mental QoL in PHTX patients. CONCLUSIONS: Our exploratory findings highlight important similarities and differences in specific developmental tasks between PHTX patients and healthy controls. Future studies should focus on developmental tasks of PHTX patients in this age group more systematically, investigating their role in physical and mental well-being in a confirmatory manner.

[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.

Body image after heart transplantation compared to mechanical aortic valve insertion.

OBJECTIVE: Heart transplantation (HT) obviously affects body image and integrity. However, there are very few empirical data post-transplant. METHODS: In a cross-sectional study, 57 HT patients were compared with 47 subjects with mechanical aortic valve replacement (AVR) using the Dresden-Body-Image questionnaire (DKB) and specific questions regarding integration of the organ/device. In addition, affective symptoms and quality of life (QoL) were assessed (12-Item Short-Form Health Survey and Hospital Anxiety and Depression Scale, HADS). RESULTS: DKB-35 scores did not differ. HT patients scored higher than AVR on specific questions regarding integration of the organ/device. AVR patients showed more affective disturbance and lower mental QoL than HT subjects. Affective scores correlated negatively with body image scores. Seventeen percent of all patients showed psychological distress (HADS scores >8). CONCLUSIONS: HT patients integrated the new organ well - and even better than AVR subjects did with the device. In general, our data corroborate a good adaptation process, in particular in HT patients. Similar to other reported data, a subgroup of 15-20% of patients shows stronger mental distress, including body image problems. These must be identified and treated by professionals. Patients with AVR deserve more attention in the future.

Adherence with immunosuppression in heart transplant recipients.

PURPOSE OF REVIEW: Nonadherence is a major problem in heart transplantation (htx) and a challenge for clinical practice and research. In heart transplant recipients, nonadherence could cause chronic rejection of the transplanted heart followed by difficult clinical course and/or death of the patient. RECENT FINDINGS: Main topics are the relationship between psychological aspects and adherence, risk factors and prediction of nonadherence, strategies for improving adherence like single-dose immunosuppressant therapy and follow-up studies. SUMMARY: There is a lack of behavioral intervention studies. So-called targeted interventions should be defined for clinical practice and research with randomized controlled studies.

Direct identification of bacteria in urine samples by matrix-assisted laser desorption/ionization time-of-flight mass spectrometry and relevance of defensins as interfering factors.

Standard methods for the identification of uropathogens that are based on the determination of metabolic activity require cultivation on agar plates, which often takes more than 1 day. If microbial growth on agar plates is slow, or if metabolic activity is impaired by adverse interactions resulting from the patient's condition or from medical treatment, the application of standard methods may lead to delayed or erroneous identification of bacteria. In recent studies, matrix-assisted laser desorption/ionization time-of-flight mass spectrometry (MALDI-TOF MS) has proven to be able to rapidly identify bacteria obtained from cultures. We tested the applicability of this analytical technique for the rapid identification of bacteria collected directly from urine samples and compared the results with those of conventional identification methods, such as the Vitek system, the MicroScan WalkAway system and the API system, and in some cases with the gas chromatographic determination of the bacterial long-chain fatty acid pattern. We analysed a total of 107 urine samples with bacterial counts ranging from 10(2) to ≥10(5) c.f.u. ml(-1). Mass spectrometric identification of bacteria was accomplished for 62 of these samples. In the mass spectra obtained from 40 of the 45 urine samples for which no identification result was achieved, a triplet of very intense peaks corresponding to the human α-defensins 1, 2 and 3 occurred at m/z values of around 3440 Da. This signal suppressed the intensity of the bacterial protein peaks and thus impaired database matching. Our results show that MALDI-TOF MS allows the reliable direct identification of bacteria in urine samples at concentrations as low as 10(3) c.f.u. ml(-1). In a subset of samples, human defensins may occur and impair the mass spectrometric identification of bacteria.

Determination of trimethylbismuth in the human body after ingestion of colloidal bismuth subcitrate.

Biological methylation and hydride formation of metals and metalloids are ubiquitous environmental processes that can lead to the formation of chemical species with significantly increased mobility and toxicity. Whereas much is known about the interaction of metal(loid)s with microorganisms in environmental settings, little information has been gathered on respective processes inside the human body as yet. Here, we studied the biotransformation and excretion of bismuth after ingestion of colloidal bismuth subcitrate (215 mg of bismuth) to 20 male human volunteers. Bismuth absorption in the stomach and upper intestine was very low, as evidenced by the small quantity of bismuth eliminated via the renal route. Total bismuth concentrations in blood increased rapidly in the first hour after ingestion. Most of the ingested bismuth was excreted via feces during the study period. Trace levels of the metabolite trimethylbismuth [(CH(3))(3)Bi] were detected via low temperaturegas chromatography/inductively coupled plasma-mass spectrometry in blood samples and in exhaled air samples. Concentrations were in the range of up to 2.50 pg/ml (blood) and 0.8 to 458 ng/m(3) (exhaled air), with high interindividual variation being observed. Elimination routes of bismuth were exhaled air (up to 0.03 per thousand), urine (0.03-1.2%), and feces. The site of (CH(3))(3)Bi production could not be identified in the present study, but the intestinal microflora seems to be involved in this biotransformation if accompanying ex vivo studies are taken into consideration.

[Symptoms of depression and anxiety in patients with coronary heart disease: natural course and results of a psychotherapeutic pilot study]. / Depressivität und Angstlichkeit bei Patienten mit koronarer Herzerkrankung: Spontanverlauf und Ergebnisse einer psychotherapeutischen Pilotstudie.

OBJECTIVES: In this pilot study we examined the natural course of depressive and anxiety symptoms in patients with coronary heart disease over a period of 1(1/2) years. Additionally, we examined patients' interest in participation in a group-psychotherapy. The intervention and its effects on symptom reduction were tested in a subgroup of patients. METHODS: Assessment of anxiety and depression (HADS) in 58 cardiology inpatients at 3 time points (t1 after one year, t2 after 1(1/2) years). N = 9 patients were additionally included in a 6-month psychotherapy intervention and compared to N = 14 untreated patients. RESULTS: 79 % of the patients were interested in beginning a psychotherapy intervention. Without psychotherapeutic treatment, the average psychological strain remained stable over the time of investigation. Intervention-group patients, however, achieved a significant (60 %) reduction in depression and anxiety scores. Implications for the clinical practice and further investigations are discussed.