[The German Transplant Registry - An Analysis of Legacy Data 2006-2016]. / Das Deutsche Transplantationsregister ­ eine Analyse der Altdaten 2006­2016.

INTRODUCTION: In 2018, medical transplant data from three institutions were merged to create a German transplant registry. Since June 2021, access to data of the registry has been available. It was planned to analyze the registry data in order to compare special allocation rules with regular allocation for heart, liver, lung, and kidney transplantation. Our approach led to a quality analysis of the registry. METHODS: Upon request, legacy data (2006-2016) of the registry was provided, divided into 61 elements. From these elements, the user had to compile the required dataset. Data checks were performed for completeness, correct allocation of information, and consistency among different sources. Software used for these tasks included R, SQL, and Excel. RESULTS: The initial elements ("waiting list" elements) of the four types of transplantations contained data from a total of 80,259 originally listed patients. However, these patients were only partially present in other elements resulting in complete datasets reflecting waiting time in only 23%, 30%, 50%, and 96%, and for post-transplantation outcomes in 14%, 11%, 38%, and 13% (heart, liver, lung, and kidney transplantation, respectively). The linking of urgency information with clinical data was successful in only a small proportion, with only 6% for heart transplantation. Incorrect and thus implausible allocations in the case of special allocation rules indicated incorrect entries in the registry. Data from different data providers were inconsistent. DISCUSSION: The incompleteness and incorrect data allocation raise doubts about the reliability of scientific studies based on the transplant registry. The complex structure also hinders the compilation of a reliable dataset, which is uncommon internationally. New data (acquisition since 2017) has only been available since December 2023. CONCLUSION: The transplant registry urgently needs restructuring. Competent clinical data management, involving transplant medical expertise, and continuous quality controls are essential in this process.

Hemodynamic markers of pulmonary vasculopathy for prediction of early right heart failure and mortality after heart transplantation.

BACKGROUND: Elevated pulmonary vascular resistance (PVR) is broadly accepted as an imminent risk factor for mortality after heart transplantation (HTx). However, no current HTx recipient risk score includes PVR or other hemodynamic parameters. This study examined the utility of various hemodynamic parameters for risk stratification in a contemporary HTx population. METHODS: Patients from seven German HTx centers undergoing HTx between 2011 and 2015 were included retrospectively. Established risk factors and complete hemodynamic datasets before HTx were analyzed. Outcome measures were overall all-cause mortality, 12-month mortality, and right heart failure (RHF) after HTx. RESULTS: The final analysis included 333 patients (28% female) with a median age of 54 (IQR 46-60) years. The median mean pulmonary artery pressure was 30 (IQR 23-38) mm Hg, transpulmonary gradient 8 (IQR 5-10) mm Hg, and PVR 2.1 (IQR 1.5-2.9) Wood units. Overall mortality was 35.7%, 12-month mortality was 23.7%, and the incidence of early RHF was 22.8%, which was significantly associated with overall mortality (log-rank HR 4.11, 95% CI 2.47-6.84; log-rank p < .0001). Pulmonary arterial elastance (Ea) was associated with overall mortality (HR 1.74, 95% CI 1.25-2.30; p < .001) independent of other non-hemodynamic risk factors. Ea values below a calculated cutoff represented a significantly reduced mortality risk (HR 0.38, 95% CI 0.19-0.76; p < .0001). PVR with the established cutoff of 3.0 WU was not significant. Ea was also significantly associated with 12-month mortality and RHF. CONCLUSIONS: Ea showed a strong impact on post-transplant mortality and RHF and should become part of the routine hemodynamic evaluation in HTx candidates.

Microembolic signal monitoring in patients with HeartMate 3 and HeartWare left ventricular assist devices: Association with antithrombotic treatment and cerebrovascular events.

BACKGROUND: In patients with left ventricular assist devices (LVADs), ischemic and hemorrhagic stroke are dreaded complications. Predictive markers for these events are lacking. This study aimed to investigate the prevalence and predictive value of microembolic signals (MES) for stroke, detected by Transcranial Doppler sonography (TCD) in patients with HeartMate 3 (HM 3) or HeartWare (HW). METHODS: A thirty-minute bilateral TCD monitoring of the middle cerebral artery (MCA) was performed in 62 outpatients with LVAD (HM 3 N = 31, HW N = 31) and 31 healthy controls. Prevalence and quantity of MES were investigated regarding clinical and laboratory parameters. Cerebrovascular events (CVE) were recorded on follow-up at 90 and 180 days. RESULTS: MES were detected in six patients with HM 3, three patients with HW, and three controls. Within the LVAD groups, patients on monotherapy with vitamin-K-antagonist (VKA) without antiplatelet therapy were at risk for a higher count of MES (negative binomial regression: VKA: 1; VKA + ASA: Exp(B) = 0.005, 95%CI 0.001-0.044; VKA + clopidogrel: Exp(B) = 0.012, 95%CI 0.002-0.056). There was no association between the presence of MES and CVE or death on follow-up (p > 0.05). CONCLUSION: For the first time, the prevalence of MES was prospectively investigated in a notable outpatient cohort of patients with HM 3 and HW. Despite optimized properties of the latest LVAD, MES remain detectable depending on antithrombotic therapy. No association between MES and CVE could be detected.

Heart transplantation across preformed donor-specific antibody barriers using a perioperative desensitization protocol.

Heart transplantation across preformed donor-specific HLA-antibody barriers is associated with impaired short- and long-term survival. Therefore, in recipients with preformed anti-HLA antibodies, waiting for crossmatch-negative donors is standard practice. As an alternative strategy, recipients with preformed anti-HLA donor specific antibodies have been managed at our institutions with a perioperative desensitization regimen. A retrospective analysis was performed comparing heart transplant recipients with preformed donor-specific HLA-antibodies to recipients without donor-specific antibodies. Recipients with a positive virtual crossmatch received a perioperative desensitization protocol including tocilizumab intraoperatively, plasma exchange and rituximab followed by a six-month course of IgGAM. Among the 117 heart-transplanted patients, 19 (16%) patients underwent perioperative desensitization, and the remaining 98 (84%) patients did not. Cold ischemic time, posttransplant extracorporeal life support for primary graft dysfunction, and intensive care unit stay time did not differ between groups. At 1-year follow-up, freedom from pulsed steroid therapy for presumed rejection and biopsy-confirmed acute cellular or humoral rejection did not differ between groups. One-year survival amounted to 94.7% in the treated patients and 81.4% in the control group. Therefore, heart transplantation in sensitized recipients undergoing a perioperative desensitization appears safe with comparable postoperative outcomes as patients with a negative crossmatch.

Ex-Vivo Preservation with the Organ Care System in High Risk Heart Transplantation.

OBJECTIVE: Ex vivo organ perfusion is an advanced preservation technique that allows graft assessment and extended ex situ intervals. We hypothesized that its properties might be especially beneficial for high-risk recipients and/or donors with extended criteria. METHODS: We reviewed the outcomes of 119 consecutive heart transplant patients, which were divided into two groups: A (OCS) vs. B (conventional). Ex vivo organ perfusion was performed using the Organ Care System (OCS). Indications for OCS-usage were expected ischemic time of >4 h or >2 h plus given extended donor criteria. RESULTS: Both groups included mostly redo cases (A: 89.7% vs. B: 78.4%; p = 0.121). Incidences of donors with previous cardiac arrest (%) (A: 32.4 vs. B: 22.2; p < 0.05) or LV-hypertrophy (%) (A: 19.1 vs. B: 8.3; p = 0.119) were also increased in Group A. Ex situ time (min) was significantly longer in Group A (A: 381 (74) vs. B: 228 (43); p < 0.05). Ventilation time (days) (A: 10.0 (19.9) vs. B: 24.3 (43.2); p = 0.057), postoperative need for ECLS (%) (A: 25.0 vs. B: 39.2; p = 0.112) and postoperative dialysis (chronic) (%) (A: 4.4 vs. B: 27.5; p < 0.001) were numerically better in the OCS group, without any difference in the occurrence of early graft rejection. The 30-d-survival (A: 92.4% vs. B: 90.2%; p = 0.745) and mid-term survival were statistically not different between both groups. CONCLUSIONS: OCS heart allowed safe transplantation of surgically complex recipients with excellent one-year outcomes, despite long preservation times and unfavourable donor characteristics. Furthermore, we observed trends towards decreased ventilation times and fewer ECLS treatments. In times of reduced organ availability and increasing recipient complexity, OCS heart is a valuable instrument that enables otherwise infeasible allocations and contributes to increase surgical safety.

Effectiveness of wearable devices as a support strategy for maintaining physical activity after a structured exercise intervention for employees with metabolic syndrome: a randomized controlled trial.

BACKGROUND: Metabolic syndrome (MetS) is associated with an increased risk for cardiovascular events and high socioeconomic costs. Despite lifestyle interventions focusing on exercise are effective strategies to improve parameters of the above aspects, many programs fail to show sustained effects in the long-term. METHODS: At visit 2 (V2) 129 company employees with diagnosed MetS, who previously participated in a 6-month telemonitoring-supported exercise intervention, were randomized into three subgroups for a 6-month maintenance treatment phase. A wearable activity device was provided to subgroup A and B to assess and to track physical activity. Further subgroup A attended personal consultations with individual instructions for exercise activities. Subgroup C received neither technical nor personal support. 6 months later at visit (V3), changes in exercise capacity, MetS severity, work ability, health-related quality of life and anxiety and depression were compared between the subgroups with an analysis of variance with repeated measurements. RESULTS: The total physical activity (in MET*h/week) declined between visit 2 and visit 3 (subgroup A: V2: 48.0 ± 33.6, V3: 37.1 ± 23.0; subgroup B: V2: 52.6 ± 35.7, V3: 43.8 ± 40.7, subgroup C: V2: 51.5 ± 29.7, V3: 36.9 ± 22.8, for all p = 0.00) with no between-subgroup differences over time (p = 0.68). In all three subgroups the initial improvements in relative exercise capacity and MetS severity were maintained. Work ability declined significantly in subgroup C (V2: 40.3 ± 5.0, V3: 39.1 ± 5.7; p < 0.05), but remained stable in the other subgroups with no between-subgroup differences over time (p = 0.38). Health-related quality of life and anxiety and depression severity also showed no significant differences over time. CONCLUSIONS: Despite the maintenance of physical activity could not be achieved, most of the health related outcomes remained stable and above baseline value, with no difference regarding the support strategy during the maintenance treatment phase. Trial registration The study was completed as a cooperation project between the Volkswagen AG and the Hannover Medical School (ClinicalTrials.gov Identifier: NCT02029131).

Chronic unilateral arm lymphedema correlates with increased intima-media thickness in the brachial artery.

Drainage of the arterial wall via adventitial lymphatic vessels has been shown to play a pivotal role for vessel wall homeostasis. Also, retrograde cholesterol transport is ensured via this route, but no studies exist to demonstrate that lymphatic stasis would represent a mechanism to initiate atherosclerotic lesion formation in human arteries. To test this hypothesis, we embarked on a simple clinical experiment, assessing wall thickness in limb arteries with lymphedema after surgical intervention, with the contralateral limb serving as control. Using ultrasound imaging, the differential thickness was assessed separately for the three arterial wall layers. The potential of disease progression by lymphostasis was addressed by depiction of longitudinal results according to the time after lymph dissection.

Sympathetic vasoconstrictor activity before and after left ventricular assist device implantation in patients with end-stage heart failure.

AIMS: Sympathetic overactivity, which predicts poor outcome in patients with heart failure, normalizes following cardiac transplantation. We tested the hypothesis that haemodynamic improvement following left ventricular assist device (LVAD) implantation is also associated with reductions in centrally generated sympathetic activity. METHODS AND RESULTS: In eight patients with heart failure (two women, six men, age 44-66 years), we continuously recorded electrocardiogram, beat-to-beat finger blood pressure, respiration, and muscle sympathetic nerve activity (MSNA) before and after implantation of the continuous-flow LVAD devices HeartWare HVAD (n = 4) and HeartMate II (n = 2), and the non-continuous-flow device HeartMate 3 (n = 2). LVAD implantation increased cardiac output by 1.29 ± 0.88 L/min (P = 0.060) and mean arterial pressure by 16.2 ± 7.9 mmHg (P < 0.001), while reducing pulse pressure by 25.3 ± 9.8 mmHg (P < 0.001). LVAD implantation did not change MSNA burst frequency (-1.3 ± 7.5 bursts/min, P = 0.636), total activity (+0.62 ± 1.83 au, P = 0.369), or normalized activity (+0.63 ± 4.23, P = 0.685). MSNA burst incidence was decreased (-7.8 ± 9.3 bursts/100 heart beats, P = 0.049). However, cardiac ectopy altered MSNA bursting patterns that could be mistaken for sympatholysis. CONCLUSION: Implantation of current design LVAD does not consistently normalize sympathetic activity in patients with end-stage heart failure despite haemodynamic improvement.

Simultaneous heart-kidney transplantation results in respectable long-term outcome but a high rate of early kidney graft loss in high-risk recipients - a European single center analysis.

BACKGROUND: In spite of renal graft shortage and increasing waiting times for transplant candidates, simultaneous heart and kidney transplantation (HKTx) is an increasingly performed procedure established for patients with combined end-stage cardiac and renal failure. Although data on renal graft outcome in this setting is limited, reports on reduced graft survival in comparison to solitary kidney transplantation (KTx) have led to an ongoing discussion of adequate organ utilization. METHODS: This retrospective study was conducted to evaluate prognostic factors and outcomes of 27 patients undergoing HKTx in comparison to a matched cohort of 27 patients undergoing solitary KTx between September 1987 and October 2019 in one of Europe's largest transplant centers. RESULTS: Median follow-up was 100.33 (0.46-362.09) months. Despite lower five-year kidney graft survival (62.6% versus 92.1%; 111.73 versus 183.08 months; p = 0.189), graft function and patient survival (138.90 versus 192.71 months; p = 0.128) were not significantly inferior after HKTx in general. However, in case of prior cardiac surgery requiring sternotomy we observed significantly reduced early graft and patient survival (57.00 and 94.09 months, respectively) when compared to patients undergoing solitary KTx (183.08 and 192.71 months; p < 0.001, respectively) or HKTx without prior cardiac surgery (203.22 and 203.22 months; p = 0.016 and p = 0.019, respectively), most probably explained by the significantly increased rate of primary nonfunction (33.3%) and in-hospital mortality (25.0%). CONCLUSIONS: Our data demonstrates the increased rate of early kidney graft loss and thus significantly inferior graft survival in high-risk patients undergoing HKTx. Thus, we advocate for a "kidney-after-heart" program in such patients to ensure responsible and reasonable utilization of scarce resources in times of ongoing organ shortage crisis.

Relationship quality, dyadic coping, and depression in couples with left ventricular assist device implantation.

AIMS: Living with a left ventricular assist device (LVAD) can be associated with many burdens and worries for patients. They are often dependent on the support of their spouses. This can also be a burden on the spouses and the relationship. However, the relationships quality of LVAD couples has so far scarcely been investigated. Couple's mutual coping with stress (dyadic coping, DC), as well as depression are important factors influencing relationship quality. To examine patients' with an LVAD and their partners' ability to cope with stress and levels of depression, and the impact these have on relationship quality. METHODS AND RESULTS: The study investigates relationship satisfaction in couples after LVAD implantation as well as influencing factors such as DC or depression. Differences in relationship quality, DC, and depression between patients and spouses are examined using validated questionnaires. N = 39 heterosexual couples with male patients participated. Relationship quality of patients was higher than that of their spouses. The actor-partner-interdependence model provided for spouses actor effects on relationship satisfaction of their own DC, partner DC, and depression. For patients, actor effects of partner DC and depression as well as a partner effect of depression were found. In addition, DC of patients was estimated by both partners to be lower than DC of spouses. CONCLUSION: The results indicate a high rate of depression among LVAD patients and spouses. This study contributes to the knowledge about the mental state of LVAD couples and demonstrates that the spouses should be considered during treatment.

Five-year outcomes of patients supported with HeartMate 3: a single-centre experience.

OBJECTIVES: The HeartMate 3 left ventricular assist device was first implanted in 2014 and received the Conformité Européenne mark in 2015. Since then, several trials demonstrated its high haemocompatibility associated with good survival and low adverse events rates. Herein, we report our institutional experience with patients supported with HeartMate 3 for 5 years. METHODS: This prospective cohort study included patients receiving a HeartMate 3 implantation in 2014 as part of the HeartMate 3 Conformité Européenne Mark clinical trial. Patients had follow-up visits every 3 months while on left ventricular assist device support, and all patients completed the 5-year follow-up. The primary end point was survival at 5 years. Secondary end points included adverse events, health status and quality of life. RESULTS: Eight patients (men: 75%) aged 59 years (min-max: 52-66 years) were enrolled. At 5 years, survival was 100%. Patients remained on support for a median time of 1825 days (min-max: 101-1825 days); 2 patients successfully received cardiac transplants. No right heart failure, haemolysis, pump thrombosis, pump malfunction or neurological events occurred in any patients. A driveline infection was observed in 6 patients (0.25 events/patient-year). Compared to baseline, a significant improvement in quality of life and in New York Heart Association functional class was noted after the implant and for the whole follow-up time. A slight decline in kidney function and in the 6-min walk test results occurred after 3 years. CONCLUSIONS: This study reports the longest single-centre follow-up of the HeartMate 3, showing excellent haemocompatibility over time with high survival and low complication rates at 5 years.

Depression, anxiety, fear of progression, and emotional arousal in couples after left ventricular assist device implantation.

AIMS: Left ventricular assist device (LVAD) is a common treatment option for patients with heart failure waiting for a donor heart. Living with an LVAD is associated with many burdens and worries. Patients often depend on the support of their relatives, usually their spouses. This can also put a strain on the spouses and be associated with psychological stress for both. In couples, communication proves to be an important form of emotional support. Besides verbal aspects of communication, the extent of emotional arousal (f0 ) that is vocally encoded plays an essential role as a non-verbal aspect of communication. This study aims to investigate the psychological impact of LVAD on couples in investigating to what extent depression, anxiety, and fear of progression (FoP) differ between patients and partners, the intrapersonal and interpersonal associations of anxiety, depression, and FoP, and differences in emotional arousal. METHODS AND RESULTS: In this cross-sectional study, male LVAD patients and their female partners (N = 21 couples) responded to self-report questionnaires on depression, anxiety, and FoP. Emotional arousal (f0 ) was evaluated during social support interactions between both spouses. Female partners experienced more anxiety than male patients (P = 0.016). No differences occurred in depression (P = 0.967) and FoP (P = 0.084). Regarding intrapersonal associations, for patients, correlations appeared between anxiety and depression (r = 0.859, P = 0.000), anxiety and FoP (r = 0.730, P = 0.000), and depression and FoP (r = 0.608, P = 0.004). For caregivers, correlations appeared between anxiety and depression (r = 0.906, P = 0.000), anxiety and FoP (r = 0.665, P = 0.001), and depression and FoP (r = 0.734, P = 0.000). Regarding interpersonal associations, correlations were found between patient's anxiety and caregiver's anxiety (r = 0.461, P = 0.041), caregiver's depression (r = 0.510, P = 0.018), and caregiver's FoP (r = 0.524, P = 0.015). Non-significant correlations were found for caregiver's anxiety and patient's FoP (r = 0.404, P = 0.078) and patient's depression (r = 0.286, P = 0.236). Patient's depression was associated with caregiver's FoP (r = 0.526, P = 0.017), but not with caregiver's depression (r = 0.337, P = 0.146). No significant correlations were found between caregiver's depression and patient's FoP (r = 0.386, P = 0.084) and patient's depression (r = 0.337, P = 0.146). Patient's and caregiver's FoP showed significant associations (r = 0.482, P = 0.027). Patient's and partner's f0 were interrelated. Patient's f0 was positively related with his own and his partner's psychological distress. Partner's f0 showed associations to her own depression and FoP. CONCLUSIONS: Findings indicate that women of LVAD patients are burdened similarly or even to a greater extent than men themselves. Women's psychological distress has an impact on patients' psychological distress and vice versa. Early interventions for both patient and partner represent a necessary intervention target.

Effects of six month personalized endurance training on work ability in middle-aged sedentary women: a secondary analysis of a randomized controlled trial.

BACKGROUND: To test the effects of guided endurance training on work ability in middle-aged female hospital workers of various occupations. METHODS: We randomized 265 healthy, sedentary, middle-aged women (45-65 years) to an endurance training group (EG 210 min/week) or a wait-list control group (CG). At baseline and at 6-month follow-up, we assessed work ability (Work Ability Index [WAI]), physical activity (Freiburger activity questionnaire) and peak oxygen uptake (VO2peak) by cardiopulmonary exercise testing. To examine the influence of baseline work ability, participants were divided into poor-moderate (WAI 1, 7-36 points, n = 83), good (WAI 2, 37-43 points, n = 136) and excellent (WAI 3, 44-49 points, n = 46) WAI subgroups. RESULTS: Cardiorespiratory fitness improved significantly after 6 months in the EG but not in the CG. The WAI total score increased significantly in the EG (38.3 ± 5.0 to 39.8 ± 4.9 points) but not in the CG (39.4 ± 4.7 to 39.3 ± 4.9 points), with a significant difference between groups (p < 0.01). In the EG, only the poor-moderate subgroup (WAI 1, 33.0 ± 2.9 to 36.6 ± 4.8 points, p < 0.05) increased the WAI total score, with this increase being significantly higher compared to the good (WAI 2, 40.2 ± 2.1 to, 40.4 ± 3.7 points) and excellent (WAI 3, 45.6 ± 1.5 to 45.7 ± 1.8 points) subgroup. CONCLUSIONS: A 6-month guided exercise training intervention significantly increases cardiorespiratory fitness with concomitant improvements in work ability in middle-aged previously sedentary hospital employees. Women with low baseline work ability seem to particularly benefit from the intervention, which implies that similar interventions may be particularly beneficial for this group of individuals. TRIAL REGISTRATION: German Clinical Trails Register Identifier: DRKS00005159. Registered 25 September 2013.

Upper-body cannulation for midterm mechanical circulatory support: A novel bridging strategy to cardiac retransplantation.

Heart retransplantation remains a controversial issue, due to the overall shortage of donor organs. Many patients put on the waiting list for retransplantation, decompensate rapidly, and do not survive. The use of veno-arterial extracorporeal life support remains an option in such emergency situations as bridge-to-recovery or bridge-to-transplantation therapy. In peripheral femoral configuration, veno-arterial extracorporeal life support improves the patient's condition by relieving low-cardiac output but immobilizes him or her for an uncertain period of time. The upper-body cannulation is an alternative approach, which allows to maintain the patient awake and mobile. We present two cases of midterm circulatory support as a bridge to heart retransplantation, using upper-body cannulation veno-arterial extracorporeal life support. Two male patients, presenting with progressive cardiac decompensation due to severe graft rejection, were placed on upper-body veno-arterial extracorporeal life support. The stabilization of hemodynamics and improvement of end-organ perfusion could be achieved after extracorporeal life support initiation. After 48 and 40 days, respectively, on extracorporeal life support with active physical therapy and no major adverse events, both patients received a cardiac retransplantation and were eventually discharged home. The presented cases are the first reported where a successful cardiac retransplant was performed following prolonged upper-body extracorporeal life support.

Should kidney allografts from old donors be allocated only to old recipients?

In several deceased donor kidney allocation systems, organs from elderly donors are allocated primarily to elderly recipients. The Eurotransplant Senior Program (ESP) was implemented in 1999, and since then, especially in Europe, the use of organs from elderly donors has steadily increased. The proportion of ≥60-year-old donors reported to the Collaborative Transplant Study (CTS) by European centers has doubled, from 21% in 2000-2001 to 42% in 2016-2017. Therefore, in the era of organ shortage it is a matter of debate whether kidney organs from elderly donors should only be allocated to elderly recipients or whether <65-year-old recipients can also benefit from these generally as "marginal" categorized organs. To discuss this issue, a European Consensus Meeting was organized by the CTS on April 12, 2018, in Heidelberg, in which 36 experts participated. Based on available evidence, it was unanimously concluded that kidney organs from 65- to 74-year-old donors can also be allocated to 55- to 64-year-old recipients, especially if these organs are from donors with no history of hypertension, no increased creatinine, no cerebrovascular death, and no other reasons for defining a marginal donor, such as diabetes or cancer.

Valor pronóstico del índice de riesgo nutricional para los candidatos a implante de un dispositivo de asistencia ventricular izquierda de flujo continuo / Prognostic value of the nutritional risk index in candidates for continuous flow left ventricular assist device therapy

Introducción y objetivos: La desnutrición influye en la evolución clínica de los pacientes con insuficiencia cardiaca. El objetivo es analizar el impacto del estado nutricional preoperatorio evaluado mediante el índice de riesgo nutricional (IRN) en el pronóstico de los pacientes que recibieron dispositivos de asistencia ventricular izquierda de flujo continuo (DAVI-fc). Métodos: Estudio retrospectivo de 279 pacientes tratados con implante de DAVI-fc entre 2009 y 2015 en el centro. Se calculó el IRN preoperatorio y se realizó un seguimiento del primer año tras el implante. Se analizó mediante regresión la asociación entre el IRN preoperatorio y los eventos clínicos posoperatorios. Resultados: Las prevalencias de riesgo nutricional grave (IRN<83,5), moderado (83,5 ≤ IRN<97,5) y leve (97,5 ≤ IRN <100) fueron del 5,4, el 21,5 y el 9,3%. Las tasas de mortalidad a 1 año después del implante en estas 3 categorías fueron del 53,3, el 31,7 y el 23,1%, frente al 18,0% (p <0,001) de los pacientes con IRN normal. Un IRN preoperatorio normal se identificó como predictor independiente de riesgo de muerte por cualquier causa durante el seguimiento (HRa por unidad=0,961; IC95%, 0,941-0,981; p <0,001) y predictor de menor riesgo de infección (ORa=0,968; IC95%, 0,946-0,991; p=0,007), insuficiencia respiratoria (ORa=0,961; IC95%, 0,936-0,987; p=0,004) e insuficiencia cardiaca derecha (ORa=0,963; IC95%, 0,934-0,992; p=0,014) posoperatorias. Conclusiones: Los pacientes desnutridos tienen mayor riesgo de complicaciones posoperatorias y muerte después del implante de un DAVI-fc. La evaluación del riesgo nutricional puede contribuir a mejorar la selección de pacientes e iniciar un apoyo nutricional precoz

Introduction and objectives: Malnutrition has been shown to affect clinical outcomes in patients with heart failure. The aim of this study was to analyze the impact of preoperative nutritional status assessed by the nutritional risk index (NRI) on the prognosis of patients with a continuous-flow left ventricular assist device (cf-LVAD). Methods: We performed a retrospective study of 279 patients who underwent cf-LVAD implantation between 2009 and 2015 in our center. Preoperative NRI was calculated and the patients were followed-up for 1 year. The association between preoperative NRI and postoperative clinical events was analyzed using multivariable logistic regression. Results: The prevalence of severe (NRI <83.5), moderate (83.5 ≤ NRI <97.5) and mild (97.5 ≤ NRI <100) nutritional risk was 5.4%, 21.5%, and 9.3%. Mortality rates 1 year after cf-LVAD implantation in these 3 categories were 53.3%, 31.7%, 23.1% vs 18.0% (P <.001) in patients with a normal IRN. A normal preoperative NRI value was an independent predictor of lower risk of death from any cause during follow-up (aHR per 1 unit, 0.961; 95%CI, 0.941-0.981; P <.001) was and a predictor for a lower risk of postoperative infections (aOR, 0.968; 95%CI, 0.946-0.991; P=.007), respiratory failure (aOR, 0,961; 95%CI, 0.936-0.987; P=.004), and right heart failure (aOR, 0.963; 95%CI, 0.934-0.992; P=.014). Conclusions: Malnourished patients are at increased risk for postoperative complications and death after cf-LVAD implantation. Assessment of nutritional risk could improve patient selection and the early initiation of nutritional support

Telemonitoring-supported exercise training, metabolic syndrome severity, and work ability in company employees: a randomised controlled trial.

BACKGROUND: Metabolic syndrome is a predisposing factor for cardiovascular and metabolic disease, but also has socioeconomic relevance by affecting the health and productivity of workers. We tested the effect of regular telemonitoring-supported physical activity on metabolic syndrome severity and work ability in company employees. METHODS: This was a prospective, randomised, parallel-group, and assessor-blind study done in workers in the main Volkswagen factory (Wolfsburg, Germany). Volunteers with diagnosed metabolic syndrome according to American Heart Association/National Heart, Lung, and Blood Institute criteria were randomly assigned (1:1) to a 6-month lifestyle intervention focusing on regular exercise (exercise group), or to a waiting-list control group, using a computer-based assignment list with variable block length. Participants in the exercise group received individual recommendations for exercise at face-to-face meetings and via a smartphone application, with the aim of doing 150 min physical activity per week. Activities were supervised and adapted using activity-monitor data, which were transferred to a central database. Participants in the control group continued their current lifestyle and were informed about the possibility to receive the supervised intervention after study completion. The primary outcome was the change in metabolic syndrome severity (metabolic syndrome Z score) after 6 months in the intention-to treat population. This trial is registered with ClinicalTrials.gov, number NCT03293264, and is closed to new participants. FINDINGS: 543 individuals were screened between Oct 10, 2017, and Feb 27, 2018, of whom 314 (mean age 48 years [SD 8]) were randomly assigned to receive the intervention (n=160; exercise group) or to a waiting list (n=154; control group). The mean metabolic syndrome Z score for the exercise group was significantly reduced after the 6-month intervention period (0·93 [SD 0·63] before and 0·63 [0·64] after the intervention) compared with the control group (0·95 [0·55] and 0·90 [0·61]; difference between groups -0·26 [95% CI -0·35 to -0·16], p<0·0001). We documented 11 adverse events in the exercise group, with only one event (a twisted ankle) regarded as directly caused by the intervention. INTERPRETATION: A 6-month exercise-focused intervention using telemonitoring systems reduced metabolic syndrome severity. This form of intervention shows significant potential to reduce disease risk, while also improving mental health, work ability, and productivity-related outcomes for employees at high risk for cardiovascular and metabolic disease. FUNDING: Audi BKK health insurance and the German Research Foundation through the Cluster of Excellence REBIRTH.

Comparing everolimus-based immunosuppression with reduction or withdrawal of calcineurin inhibitor reduction from six months after heart transplantation: the randomized MANDELA study.

In the 12-month, open-label MANDELA study, patients were randomized at month 6 after heart transplantation to (i) convert to calcineurin inhibitor (CNI)-free immunosuppression with everolimus (EVR), mycophenolic acid and steroids (CNI-free, n=71), or to (ii) continue reduced-exposure CNI, with EVR and steroids (EVR/redCNI, n=74). Tacrolimus was administered in 48.8% of EVR/redCNI patients and 52.6% of CNI-free patients at radomization. Both strategies improved and stabilized renal function based on the primary endpoint (estimated GFR at month 18 post-transplant post-randomization) with superiority of the CNI-free group versus EVR/redCNI : mean 64.1mL/min/1.73m2 versus 52.9mL/min/1.73m2 ; difference +11.3mL/min/1.73m2 (p<0.001). By month 18, estimated GFR had increased by ≥10mL/min/1.732 in 31.8% and 55.2% of EVR/redCNI and CNI-free patients, respectively, and by ≥25 mL/min/1.73m2 in 4.5% and 20.9%. Rates of biopsy-proven acute rejection (BPAR) were 6.8% and 21.1%; all cases were without hemodynamic compromise. BPAR was less frequent with EVR/redCNI versus the CNI-free regimen (p=0.015); 6/15 episodes in CNI-free patients occurred with EVR concentration <5ng/mL. Rates of adverse events and associated discontinuations were comparable EVR/redCNI from month 6 achieved stable renal function with infrequent BPAR. One-year renal function can be improved by early conversion to EVR-based CNI-free therapy but requires close EVR monitoring. This article is protected by copyright. All rights reserved.

Novel Cytokine Score and Cardiac Allograft Vasculopathy.

To date, there are no established noninvasive biomarkers available for prediction of cardiac allograft vasculopathy (CAV) after orthotopic heart transplantation (OHT). Inflammatory processes are supposed to play a central role in the pathogenesis of CAV. Recent studies have suggested that immune mediators could serve as biomarkers for cardiovascular diseases. We hypothesized particular cytokines or a combination thereof may serve as noninvasive biomarkers for CAV. Plasma cytokines were screened from 27 patients with CAV and 27 patients without CAV after OHT. The concentrations of interleukins-4, -6, -10, -21, -23, -31, -33, interferon gamma, tumor necrosis factor alpha, and the soluble activation marker CD40 ligand were determined using Luminex-based multiplex analyses. Although concentrations of all cytokines except interferon gamma were on average higher in the CAV group, there were no significant differences between the groups for any 1 cytokine. Using a binary logistic regression model, we were able to develop a probability score for detecting patients at elevated risk for advanced CAV with a sensitivity of 92.31% and a specificity of 60.71% (receiver-operating characteristic area under the curve 0.799 ± 0.06; p<0.0001). In conclusion, analyzing the concentration of specific inflammatory cytokines could be meaningfully included in evaluation of CAV after OHT.