@article{StoerkBernhardtBoehmetal.2022, author = {St{\"o}rk, Stefan and Bernhardt, Alexandra and B{\"o}hm, Michael and Brachmann, Johannes and Dagres, Nikolaos and Frantz, Stefan and Hindricks, Gerd and K{\"o}hler, Friedrich and Zeymer, Uwe and Rosenkranz, Stephan and Angermann, Christiane and Aßmus, Birgit}, title = {Pulmonary artery sensor system pressure monitoring to improve heart failure outcomes (PASSPORT-HF): rationale and design of the PASSPORT-HF multicenter randomized clinical trial}, series = {Clinical Research in Cardiology}, volume = {111}, journal = {Clinical Research in Cardiology}, number = {11}, doi = {10.1007/s00392-022-01987-3}, url = {http://nbn-resolving.de/urn:nbn:de:bvb:20-opus-324026}, pages = {1245-1255}, year = {2022}, abstract = {Background Remote monitoring of patients with New York Heart Association (NYHA) functional class III heart failure (HF) using daily transmission of pulmonary artery (PA) pressure values has shown a reduction in HF-related hospitalizations and improved quality of life in patients. Objectives PASSPORT-HF is a prospective, randomized, open, multicenter trial evaluating the effects of a hemodynamic-guided, HF nurse-led care approach using the CardioMEMS™ HF-System on clinical end points. Methods and results The PASSPORT-HF trial has been commissioned by the German Federal Joint Committee (G-BA) to ascertain the efficacy of PA pressure-guided remote care in the German health-care system. PASSPORT-HF includes adult HF patients in NYHA functional class III, who experienced an HF-related hospitalization within the last 12 months. Patients with reduced ejection fraction must be on stable guideline-directed pharmacotherapy. Patients will be randomized centrally 1:1 to implantation of a CardioMEMS™ sensor or control. All patients will receive post-discharge support facilitated by trained HF nurses providing structured telephone-based care. The trial will enroll 554 patients at about 50 study sites. The primary end point is a composite of the number of unplanned HF-related rehospitalizations or all-cause death after 12 months of follow-up, and all events will be adjudicated centrally. Secondary end points include device/system-related complications, components of the primary end point, days alive and out of hospital, disease-specific and generic health-related quality of life including their sub-scales, and laboratory parameters of organ damage and disease progression. Conclusions PASSPORT-HF will define the efficacy of implementing hemodynamic monitoring as a novel disease management tool in routine outpatient care. Trial registration ClinicalTrials.gov; NCT04398654, 13-MAY-2020.}, language = {en} } @article{LadwigLederbogenAlbusetal.2014, author = {Ladwig, Karl-Heinz and Lederbogen, Florian and Albus, Christian and Angermann, Christiane and Borggrefe, Martin and Fischer, Denise and Fritzsche, Kurt and Haass, Markus and Jordan, Jochen and J{\"u}nger, Jana and Kindermann, Ingrid and K{\"o}llner, Volker and Kuhn, Bernhard and Scherer, Martin and Seyfarth, Melchior and V{\"o}ller, Heinz and Waller, Christiane and Herrmann-Lingen, Christoph}, title = {Position paper on the importance of psychosocial factors in cardiology: Update 2013}, series = {GMS German Medical Science}, volume = {12}, journal = {GMS German Medical Science}, doi = {10.3205/000194}, url = {http://nbn-resolving.de/urn:nbn:de:bvb:20-opus-121196}, year = {2014}, abstract = {Background: The rapid progress of psychosomatic research in cardiology and also the increasing impact of psychosocial issues in the clinical daily routine have prompted the Clinical Commission of the German Heart Society (DGK) to agree to an update of the first state of the art paper on this issue which was originally released in 2008. Methods: The circle of experts was increased, general aspects were implemented and the state of the art was updated. Particular emphasis was dedicated to coronary heart diseases (CHD), heart rhythm diseases and heart failure because to date the evidence-based clinical knowledge is most advanced in these particular areas. Differences between men and women and over the life span were considered in the recommendations as were influences of cognitive capability and the interactive and synergistic impact of classical somatic risk factors on the affective comorbidity in heart disease patients. Results: A IA recommendation (recommendation grade I and evidence grade A) was given for the need to consider psychosocial risk factors in the estimation of coronary risks as etiological and prognostic risk factors. Furthermore, for the recommendation to routinely integrate psychosocial patient management into the care of heart surgery patients because in these patients, comorbid affective disorders (e.g. depression, anxiety and post-traumatic stress disorder) are highly prevalent and often have a malignant prognosis. A IB recommendation was given for the treatment of psychosocial risk factors aiming to prevent the onset of CHD, particularly if the psychosocial risk factor is harmful in itself (e.g. depression) or constrains the treatment of the somatic risk factors. Patients with acute and chronic CHD should be offered anti-depressive medication if these patients suffer from medium to severe states of depression and in this case medication with selective reuptake inhibitors should be given. In the long-term course of treatment with implanted cardioverter defibrillators (ICDs) a subjective health technology assessment is warranted. In particular, the likelihood of affective comorbidities and the onset of psychological crises should be carefully considered. Conclusions: The present state of the art paper presents an update of current empirical evidence in psychocardiology. The paper provides evidence-based recommendations for the integration of psychosocial factors into cardiological practice and highlights areas of high priority. The evidence for estimating the efficiency for psychotherapeutic and psychopharmacological interventions has increased substantially since the first release of the policy document but is, however, still weak. There remains an urgent need to establish curricula for physician competence in psychodiagnosis, communication and referral to ensure that current psychocardiac knowledge is translated into the daily routine.}, language = {en} }