Search

Summary Progression of chronic heart failure depends on various additional pathophysiologic factors like blood pressure, arrhythmias, congestion. Early detection of any alteration using telemonitoring of multiple vital parameters may avoid severe decompensation requiring hospital admission. The feasibility and the clinical outcome using a new telemonitoring device for recording multiple vital parameters and allowing communication on individual state of health is investigated. Twenty-four patients with chronic heart failure (mean age 65 years, mean LV ejection fraction 35%) requiring at least one hospital admission during the past year were investigated. Twice a day, the vital-parameters were measured (weight, blood pressure, heart rate and rhythm, oxygen saturation, respiration rate) and patients information on well being, shortness of breath, medication, and request for contact were received. Intra-individual comparison was carried out between the 12 month before inclusion in this study and 12 month under telemonitoring surveillance (extrapolated, if necessary). Performing over 10 500 measurements during 5751 patient days, critical events were diagnosed for 55 events concerning relative weight gain (43 episodes), blood pressure (6), decrease in oxygen saturation (3), new onset of atrial fibrillation with tachyarrhymia (3). Of these, 45 events were controlled on an outpatient basis by changing medication or external cardioversion. Only 10 patients required re-admission. Thus, the number of admission to the hospital could be reduced by 62%, those of days spent in hospital by 69%. Non-invasive telemonitoring of multiple vital parameters combined with patients statements on their health condition and out-patient treatment on the basis of these findings is found to be an effective and reliable approach to avoid hospital readmission for patients with chronic heart failure. [ABSTRACT FROM AUTHOR]

Aims: Recent trial data demonstrate beneficial effects of active rhythm management in patients with atrial fibrillation (AF) and support the concept that a low arrhythmia burden is associated with a low risk of AF-related complications. The aim of this document is to summarize the key outcomes of the 9th AFNET/EHRA Consensus Conference of the Atrial Fibrillation NETwork (AFNET) and the European Heart Rhythm Association (EHRA)., Methods and Results: Eighty-three international experts met in Münster for 2 days in September 2023. Key findings are as follows: (i) Active rhythm management should be part of the default initial treatment for all suitable patients with AF. (ii) Patients with device-detected AF have a low burden of AF and a low risk of stroke. Anticoagulation prevents some strokes and also increases major but non-lethal bleeding. (iii) More research is needed to improve stroke risk prediction in patients with AF, especially in those with a low AF burden. Biomolecules, genetics, and imaging can support this. (iv) The presence of AF should trigger systematic workup and comprehensive treatment of concomitant cardiovascular conditions. (v) Machine learning algorithms have been used to improve detection or likely development of AF. Cooperation between clinicians and data scientists is needed to leverage the potential of data science applications for patients with AF., Conclusions: Patients with AF and a low arrhythmia burden have a lower risk of stroke and other cardiovascular events than those with a high arrhythmia burden. Combining active rhythm control, anticoagulation, rate control, and therapy of concomitant cardiovascular conditions can improve the lives of patients with AF., Competing Interests: Conflict of interest The 9th AFNET/EHRA consensus conference was partially supported by the European Union MAESTRIA project (grant agreement 965286) to AFNET. The following participants and authors are employees of companies active in cardiovascular health as indicated in their affiliations: M.D.M., E.D., C.E., G.H., L.H.H., T.H., R.H.v.L., M.W., and H.W. P.K. was partially supported by the European Union AFFECT-AF (grant agreement 847770) and MAESTRIA (grant agreement 965286), German Center for Cardiovascular Research supported by the German Ministry of Education and Research (DZHK, grant numbers DZHK FKZ 81X2800182, 81Z0710116, and 81Z0710110), German Research Foundation (Ki 509167694), and Leducq Foundation. He receives research support for basic, translational, and clinical research projects from several drug and device companies active in AF and has received honoraria from several such companies in the past, but not in the last 3 years. He is listed as an inventor on two issued patents held by the University of Hamburg (Atrial Fibrillation Therapy WO 2015140571, Markers for Atrial Fibrillation WO 2016012783). J.G.A. was partially supported by the Canadian Arrhythmia Network and the Michael Smith Foundation for Health Research, Baylis Medical. He receives consulting fees/honoraria from Bayer, BMS/Pfizer Alliance, Servier, and Medtronic Inc. E.A. receives consulting fees/honoraria from Biosense Webster and Bayer. G.B. receives consulting fees/honoraria from Bayer, BMS, Boston Scientific, Daiichi Sankyo, Sanofi, and Janssen. A.J.C. receives consulting fees/honoraria from Bayer, Pfizer/BMS, Daiichi Sankyo, Menarini, Sanofi, Boston Scientific, Biosense Webster, Abbott, Acesion Pharma, Huya Bio, and Milestone. V.C. receives consulting fees/honoraria from Bayer, Boehringer Ingelheim, and Ever Pharma (paid to the institution of employment). W.D. receives consulting fees/honoraria from Reata and research grants from MicroPort, Boston Scientific, and Abbott. S.Z.D. receives consulting fees from BMS/Pfizer, Cortrium, and Acesion Pharma and speaker fees from MS/Pfizer and Bayer. He is listed as a medical advisor for Vital Beats. Dobromir D. receives consulting fees/honoraria from Elsevier, Springer Healthcare Ltd, and Daiichi Sankyo and research grants as follows: four NIH grants (partially) from Baylor College of Medicine, Houston; one NIH grant from UC Davis, one NIH grant from the University of Minnesota, and one EU-Project H2020. David D. receives consulting fees/honoraria from Abbott, Astra Zeneca, Biotronik, Boehringer Ingelheim, Boston Scientific, BMS/Pfizer, CVRx, Medtronic, MicroPort, and Zoll and research grants from Roche, CVRx, and Zoll. L.E. has received lecture fees from various companies in AF in the past but none related to the present work. L.F. receives consulting fees/honoraria from Roche (paid to the institution of employment). She is currently employed at the UKE and previously at the University of Birmingham. She was partially supported by the European Union AFFECT-EU (grant agreement 847770), MAESTRIA (grant agreement 965286), CATCH ME (grant agreement 633196), and the British Heart Foundation (AA/18/2/3218). D.F.-R. receives research grants from Abbott. He is listed as an inventor on two issued patents: EP3636147A1 (method for the identification of cardiac fibrillation drivers and/or the footprint of rotational activations) and PCT/EP2022/071364 (system and method of assessment of electromechanical remodelling). A.G. receives consulting fees/honoraria from Daiichi Sankyo, Bayer, BMS/Pfizer, Medtronic, Abbott, and Boston Scientific and was partially supported by the European Union MAESTRIA (grant agreement 965286). K.G.H. receives consulting fees/honoraria from Abbott, Alexion, Amarin, Astra Zeneca, Bayer Healthcare, Biotronik, Boehringer Ingelheim, Boston Scientific, BMS/Pfizer, Daiichi Sankyo, Edwards Lifesciences, Medtronic, Novaris, Portola, Premier Research, Sanofi, SUN Pharma, and W. L. Gore and Associates. J.S.H. receives speaking fees from BMS/Pfizer, Bayer, Servier, and Boston Scientific and consulting fees from Bayer and Boston Scientific. He receives research grants from BMS/Pfizer, Servier, Novartis, Boston Scientific, and Medtronic. H.H. receives lecture and consulting fees from Bayer, Biotronik, BMS/Pfizer, Daiichi Sankyo, Milestone Pharmaceuticals, Centrix India, C.T.I. Germany, ESC, Medscape, and Springer Healthcare Ltd. He receives research grants (paid to the institution of employment, University of Antwerp and/or University of Hasselt) from Abbott, Bayer, Biosense Webster, Boston Scientific, Daiichi Sankyo, Fibricheck/Qompium, Medtronic, and BMS/Pfizer. Z.H. receives consulting fees/honoraria from Boehringer Ingelheim, BMS/Pfizer, and Roche Diagnostics. He was partially supported by The Swedish Society for Medical Research (S17-0133), Hjärt-Lungfonden (The Swedish Heart-Lung Foundation, 20200722), and the institution he is currently employed at (Uppsala University Hospital). L.H.-M. receives research grants from the Spanish Ministry of Science and Innovation (PID2020-116927RB-C21) and Fondo Europeo de Desarrollo Regional (FEDER). D.K. receives consulting fees/honoraria from Bayer, Amomed, and Protherics Medicines Development. He receives research grants from the National Institute for Health Research (NIHR CDF-2015-08-074 RAE-AF; NIHR130280 DaRe2THINK; NIHR13274 D2T-NeuroVascular; and NIHR203326 Biomedical Research Centre), the British Heart Foundation (PG/17/55/33087, AA/182/3218, and FS/CDRF/21/21032), the EU/EFPIA Innovative Medicines Initiative (BigData@Heart 116074), EU Horizon and UKRI (HYPERMARKER 101095480) UK National Health Service—Data for R&D-Subnational Secure Data Environment programme, UK Department for Business, Energy Industrial Strategy Regulators Pioneer Fund, the Cook & Wolstenholme Charitable Trust, and the European Society of Cardiology supported by educational grants from Boehringer Ingelheim, BMS/Pfizer, Alliance, Bayer, Daiichi Sankyo, Boston Scientific, the NIHR/University of Oxford Biomedical Research Centre, and the British Hear Foundation, the University of Birmingham Accelerator Award (STEEER-AF). J.L.M. receives consulting fees/honoraria from Biotronik, Medtronic, MicroPort, and Milestone Pharmaceuticals. A.M. receives consulting fees/honoraria from Medtronic, Biosense Webster, and Boston Scientific and lecture fees from Medtronic, Boston Scientific, Biosense Webster, BMS, and Bayer. L.M. receives consulting fees/honoraria from Abbott, Medtronic, Boston Scientific, and Johnson & Johnson. G.A.N. receives lecture fees from AliveCor, consultant fees from Biosense Webster, and research grants from Abbott and Biosense Webster. H.P. receives consulting fees/honoraria from Abbott, Boston Scientific, Biosense Webster, Medtronic, Daiichi Sankyo, Bayer, and Pfizer. P.S. receives consulting fees/honoraria from Medtronic, Boston Scientific, Abbott, CathRx, and PaceMate (paid to the institution of employment). He is currently employed at the University of Adelaide, which receives research grants from Medtronic, Boston Scientific, and Becton-Dickenson. R.B.S. receives consulting fees/honoraria from BMS/Pfizer. She was partially supported by the European Union Horizon 2020 research and innovation programme (grant agreement 648131 and 847770), German Center for Cardiovascular Research supported by the German Ministry of Education and Research (DZHK, grant numbers 81Z1710103 and 81Z0710114), German Ministry of Research and Education (BMBF 01ZX1408A), ERACoSysMed3 (031L0239), Wolfgang Seefried project funding German Heart Foundation. U.S. receives consulting fees/honoraria from University Svizzerra Italiana, Stanford, and Johnson & Johnson and research grants from the European Union, Dutch Heart Foundation, Roche, and EP Solution. He is a shareholder of YourRhythmics B.V. T.T. receives consulting fees/honoraria from Boston Scientific and Medtronic. I.C.v.G. receives consulting fees/honoraria from Bayer (paid to the institution of employment). She is currently employed at the University of Groningen. K.V. receives consulting fees/honoraria from Abbott, Philips, Medtronic, Biosense Webster, and Boston Scientific and research grants from Medtronic and Biosense Webster. R.W. receives consulting fees/honoraria from Boehringer Ingelheim, BMS/Pfizer, Daiichi Sankyo, Boston Scientific, Biotronik, Abiomed, and Zoll and a research grant from Boston Scientific, BMS/Pfizer, and Abiomed. S.W. receives consulting fees/honoraria from Boehringer Ingelheim, Boston Scientific, Abbott, and Bayer Vital and a research grant from Boston Scientific. All remaining authors (G.B., J.C.N., T.D.P., N.D., M.F., E.G., S.H., S.K., D.L., K.M.-R., M.O., A.S.P., U.R., M.R., D.S., C.S., G.S., D.S., S.T., R.H.v.L., and S.Z.) have declared no conflicts of interest., (© The Author(s) 2024. Published by Oxford University Press on behalf of the European Society of Cardiology.)

Purpose: A setting-sensitive instrument for assessing Quality of Life (QoL) in Telemedicine (TM) was unavailable. To close this gap, a content-valid "add-on" measure was developed. In parallel, a brief index was derived featuring six items that summarise the main content of the multidimensional assessment. After pre- and pilot-testing, the psychometric performance of the final measures was investigated in an independent validation study., Methods: The questionnaires were applied along with other standardised instruments of similar concepts as well as associated, yet disparate concepts for validation purposes. The sample consisted of patients with depression or heart failure, with or without TM (n = 200). Data analyses were aimed at calculating descriptive statistics and testing the psychometric performance on item, scale, and instrument level, including different types of validity and reliability., Results: The proposed factor structure of the multidimensional Tele-QoL measure has been confirmed. Reliability coefficients for internal consistency, split-half, and test-retest reliability of the subscales and index reached sufficient values. The Tele-QoL subscales and the index demonstrated Rasch scalability. Validity of both instruments can be assumed. Evidence for discriminant construct validity was provided. Known-groups validity was indicated by respective score differences for various classes of disease severity., Conclusion: Both measures show convincing psychometric properties. The final multidimensional Tele-QoL assessment consists of six outcome scales and two impact scales assessing (un-)intended effects of TM on QoL. In addition, the Tele-QoL index provides a short alternative for outcome assessment. The Tele-QoL measures can be used as complementary modules to existing QoL instruments capturing healthcare-related aspects of QoL from the patients' perspective., (© 2023. The Author(s).)

Despite marked progress in the management of atrial fibrillation (AF), detecting AF remains difficult and AF-related complications cause unacceptable morbidity and mortality even on optimal current therapy. This document summarizes the key outcomes of the 8th AFNET/EHRA Consensus Conference of the Atrial Fibrillation NETwork (AFNET) and the European Heart Rhythm Association (EHRA). Eighty-three international experts met in Hamburg for 2 days in October 2021. Results of the interdisciplinary, hybrid discussions in breakout groups and the plenary based on recently published and unpublished observations are summarized in this consensus paper to support improved care for patients with AF by guiding prevention, individualized management, and research strategies. The main outcomes are (i) new evidence supports a simple, scalable, and pragmatic population-based AF screening pathway; (ii) rhythm management is evolving from therapy aimed at improving symptoms to an integrated domain in the prevention of AF-related outcomes, especially in patients with recently diagnosed AF; (iii) improved characterization of atrial cardiomyopathy may help to identify patients in need for therapy; (iv) standardized assessment of cognitive function in patients with AF could lead to improvement in patient outcomes; and (v) artificial intelligence (AI) can support all of the above aims, but requires advanced interdisciplinary knowledge and collaboration as well as a better medico-legal framework. Implementation of new evidence-based approaches to AF screening and rhythm management can improve outcomes in patients with AF. Additional benefits are possible with further efforts to identify and target atrial cardiomyopathy and cognitive impairment, which can be facilitated by AI., Competing Interests: Conflict of interest: RBS has received lecture fees and advisory board fees from BMS/Pfizer outside this work and has received funding from the European Research Council (ERC) under the European Union's Horizon 2020 research and innovation programme under the grant agreement No 648131, from the European Union's Horizon 2020 research and innovation programme under the grant agreement No 847770 (AFFECT-EU) and German Center for Cardiovascular Research (DZHK e.V.) (8121710103); German Ministry of Research and Education (BMBF 01ZX1408A) and ERACoSysMed3 (031L0239).EAM is employee of Daiichi Sankyo Europe GmbH producing and marketing an oral anticoagulant (edoxaban). EA has received consulting / speaker fees for Biosense Webster. GB has received speaker's fees of small amount from Boston, Bayer, Daiichi, Boehringer. SB is consultant for Medtronic, Boston Scientific, Microport, and Zoll. JC has received consulting fees / honoraria fees from Acesion, Allergan, Alta Thera, Arca, lncarda, Menarini, Milestone, Sanofi, Bayer, Daiichi Sankyo, Pfizer, Abbott, Biosense Webster, Biotronik, Boston Scientific, Lilly, Medtronic, Johnson and Johnson. BC has received in kind contribution for research Support from iRhythm. WC has received advisory board fees for Roche Diagnostics AG. MDM is employee of Medtronic. SZB has received fees as member of Advisory Board in Bristol Myers Squibb-Pfizer. DD has received fees from Abbott, Astra Zenica, Bayer, Bosten Scientific, Bristol Myers Squibb-Pfizer, Medtonic, Zoll. LE has received lecture Honoria from Medtronic, Biotronik, Boston Scientific, Boehringer Ingelheim, Daiichy Sankyo, Bayer, MMS, Pfizer, Sanofi and received research grants from DFG and DGK. CE is employee of Preventicus GmbH. LF has received institutional research grants and non-financial support from European Union, DFG, British Heart Foundation, Medical Research Council (UK), NIHR, and several biomedical companies. The Institute of Cardiovascular Research, University of Birmingham, has received an Accelerator Award by the British Heart Foundation M/18/2/34218. LF is listed as inventor of two patents held by University of Birmingham (Atrial Fibrillation Therapy WO 2015140571, Markers for Atrial Fibrillation WO 2016012783). BF receiving fees from Bristol-Myers Squibb and Pfizer Alliance, Bayer, Daiichi Sankyo, Omron. (largely speaker fees and travel support for speaking at session or official satellites of large international/continental society meetings) and investigator-initiated research grants to the institution from Bristol-Myers and Squibb and Pfizer Alliance and Ownership / Employee of Nil. LG and AZ are employees of Roche Diagnostics International Ltd. AG has received funding from Daiichi Sankyo, Astra Zenica, Bayer, Bristol Myers Squibb-Pfizer, Viola, Medtonic, Berlin Charitè. JHS has received Advisory board fees in Medtronic and Speaker fee from Medtronic. KGH has received fees from Abbott, Alexion, AMARIN, AstraZeneca, Bayer, Biotronik, Boehringer Ingelheim, Bristol-Myers-Squibb, Daiichi Sankyo, Edwards Lifesciences, Medtronic, Pfizer, Premier Research, SUN Pharma and W. L. Gare & Associates and Research Grants from Bayer Vital, Sanofi-Aventis. JSH received fees from Boston Scientific, Servier, Bayer, Myokardia, Bristol-Myers-Squibb, Pfizer, and research grants from Medtronic, Boston Scientific, Bristol-Myers-Squibb, Abbott. HH has received lecture and consultancy fees from Abbott, Biotronik, Bristol-Myers-Squibb- Pfizer, Medscape, Daiichi Sankyo, Springer Healthcare Ltd and receive un conditional research grants through the Univerity of Antwerp and/or University of Hasselt from Abbott, Bayer, Biotronik, Biosense-Webster, Fibrickeck/Qompium, Medtronic, Bristol-Myers-Squibb- Pfizer, Boston Scientific, Daiichi Sankyo and Boehringer Ingelheim. RH has received speacker fees from BI, Bayer and Bristol-Myers-Squibb- Pfizer and AZ. TH is CEO of Preventicus GmbH. DK has received funding from Bayer, AtriCure, Protherics Medicines Development and Myokardia and Research grant from rants from the National Institute for Health Research (NIHR CDF-2015-08-074 RATE-AF; NIHR HTA-130280 DaRe2THINK; NIHR EME- 132974 D2T-NV), the British Heart Foundation (PG/17/55/33087 and AA/18/2/34218), EU/EFPIA IMI (BigData@Heart 116074),the European Society of Cardiology supported by educationalgrants from Boehringer Ingelheim/BMS-Pfizer Alliance/Bayer/Daiichi Sankyo/Boston Scientific, the NIHR/the University of Ox- ford Biomedical Research Centre, and British Heart Foundation/ the University of Birmingham Accelerator Award (STEEER-AF NCT04396418), Amomed Pharma, and IRCCS San Raffaele/Menarini (beta-blockers in Heart Failure Collaborative Group NCT0083244). MK is employee of Bristol-Myers and Squibb. CL has received fees from medtonic, Boston Scientific, Biotronik and Bristol-Myers and Squibb- Pfizer and research grants from Rennes Univerity, Metronik, Biotonik and Boston Scientific. DL has received research grant for EHRA-PATHS, NovoNordisk Young Investigator Award. MLL has received lecture fees from Bristol-Myers and Squibb and research grant from H2020 AFFECT-EU (grant No. 847770). SM has received research grant from Daiichi Sankyo (EPDAURUS IIT) and Bristol-Myers and Squibb (APPROACH ACS AF IIT). JLM has received Abbott, Boston Scientific, Biotronik, Boehringer Ingelheim, Sanofi, Microport and received research grants from Medtronic, Abbott, Microport, Biosense. RM is employee of Medtronic. LM is Stockholder for Galgomedical and Corify and receiving consuting fees from Abbott, Biosense-Webster, Bosten Scientific, Medtronik and receiving research grants from Abbott, Biosense-Webster, Bosten Scientific, Medtronik. LN has received consulting fees from Bristol-Myers and Squibb- Pfizer. GP is employee of Bayer AG. HP has received consulting fees from Abbott, Biosense-Webster, Bosten Scientific, Medtronik and receiving research grants from Abbott, Bayer, Biosense-Webster, Bosten Scientific, Medtronik, Bristol-Myers and Squibb- Pfizer. MR has received consulting fees for Medtonic, Arca BiopharmaInc, Roche and received research grants from Dutch Heart Foundation: RACE V, RED-CVD, CVON-AI, DECISION studies; grant from SJM/Abbott to institution: VIP-HF study; Grant for Medtronic to institution: Cryoballoon AF registry/biobank study. The other authors declare that there is no conflict of interest.LR has received research grants from Canadian Insititute of Health research and Byer Inc. U.S. received consultancy fees or honoraria from Università della Svizzera Italiana (USI, Switzerland), Roche Diagnostics (Switzerland), EP Solutions Inc. (Switzerland), Johnson & Johnson Medical Limited, (United Kingdom), Bayer Healthcare (Germany). U.S. is co-founder and shareholder of YourRhythmics BV, a spin-off company of the University Maastricht and Research grant from the Dutch Heart Foundation (CVON RACE V, CVON2014–09) European Union's Horizon 2020 Research and Innovation Program granted to MS under the Marie Sklodowska-Curie grant agreement #813716 (TRAIN-HEART Innovative Training Network), and various other programs of the European Union granted to US (ITN Network Personalize AF: Personalized Therapies for Atrial Fibrillation: a translational network – grant #860974; CATCH ME: Characterizing Atrial fibrillation by Translating its Causes into Health Modifiers in the Elderly – grant #633196; MAESTRIA: Machine Learning Artificial Intelligence Early Detection Stroke Atrial Fibrillation – grant #965286; REPAIR: Restoring cardiac mechanical function by polymeric artificial muscular tissue – grant #952166). DS has received consultation fees from Biosense Webster, Abbott, Boston Scientific, Consultant with stock option: SentiAR, Arga Medtech. RS is employee of Daiichi Sankyo Europe GmbH. DS has received consultation fees from Boston Scientific, Abbott and Research grant from Biosense Webster. ES has received lecture fees from Bayer, Bristol-Myers and Squibb- Pfizer, Boehringer Ingelheim, Johnson & Johnson, Merck Sharp & Dohme and Sanofi. DT has received lecture fees from Bayer Vital, Bristol-Myers and Squibb- Pfizer, Daiichi Sankyo, Medtonic, Zoll CMS, Sanofi, St. Jude Medical and research grant from Daiichi Sankyo. MTH is employee/owner of American Foundation of women's Health /StopAfib.org and employee/owner of True Hills Inc.. BV is employee of Bayer AG. RW has received consultation fees from Boston Scientific, Biotronic, Pfizer, Daiichi Sankyo, Bayer, Adagio Medical and Research grant from Bristol-Myers and Squibb- Pfizer, Boston Scientific. CW has received consulation fees from Biotronik, Boston Scientific, Novartis and research grant from BMBF, AFNET, DZHK, Biotronik. MW is employee and shareholder of Sanofi. SW has received Consulting fees from Boston Scientific, Abbott, Bayer, Bristol-Myers and Squibb- Pfizer, Boehringer Ingelheim and research grant from Boston Scientific. HW is employee and stockholder of Pfizer Germany. MDZ has received advisory and speaker fee from Bristol-Myers and Squibb- Pfizer. PK reports grants and non-financial support from BMBF (German Ministry of Education and Research), grants from Sanofi and Abbott, grants and non-financial support from EHRA (European Heart Rhythm Association), and grants from German Heart Foundation and DZHK (German Center for Cardiovascular Research), during the conduct of the study, and grants from European Union, British Heart Foundation, Leducq Foundation, Medical Research Council (UK), and non-financial support from German Centre for Heart Research, outside the submitted work; in addition, P.K. has a patent Atrial Fibrillation Therapy WO 2015140571 issued to University of Birmingham and a patent Markers for Atrial Fibrillation WO 2016012783 issued to University of Birmingham., (© The Author(s) 2022. Published by Oxford University Press on behalf of European Society of Cardiology.)

Aims: Atrial fibrillation (AF) is associated with a high risk of cardiovascular and non-cardiovascular death, even on anticoagulation. It is controversial, which conditions-including concomitant diseases and AF itself-contribute to this mortality. To further clarify these questions, major determinants of long-term mortality and their contribution to death were quantified in an unselected cohort of AF patients., Methods and Results: We established a large nationwide registry comprising 8833 AF-patients with a median follow-up of 6.5 years (45 345 patient-years) and central adjudication of adverse events. Baseline characteristics of the patients were evaluated as predictors of mortality using Cox regression and C-indices for determination of predictive power. Annualized mortality was highest in the first year (6.2%) and remained high thereafter (5.2% in men and 5.5% in women). Thirty-eight percent of all deaths were cardiovascular, mainly due to heart failure or sudden death. Sex-specific age was the strongest predictor of mortality, followed by concomitant cardiovascular and non-cardiovascular conditions. These factors accounted for 25% of the total mortality beyond age and sex and for 84% of the mortality differences between AF types. Thus, the electrical phenotype of the disease at baseline contributed only marginally to prediction of mortality., Conclusion: Mortality is high in AF patients and arises primarily from heart failure, peripheral artery disease, chronic obstructive lung disease, chronic kidney disease, and diabetes mellitus, which, therefore, should be targeted to lower mortality. Parameters related to the electrical manifestation of AF did not have an independent impact on long-term mortality in our representative cohort., (Published on behalf of the European Society of Cardiology. All rights reserved. © The Author(s) 2021. For permissions, please email: journals.permissions@oup.com.)

Quality of life (QoL) is a core patient-reported outcome in healthcare research, alongside primary clinical outcomes. A conceptual, operational, and psychometric elaboration of QoL in the context of TM is needed, because standardized instruments to assess QoL do not sufficiently represent essential aspects of intended outcomes of telemedical applications (TM). The overall aim is to develop an instrument that can adequately capture QoL in TM. For that purpose, an extended working model of QoL will be derived. Subsequently, an instrument will be developed and validated that captures those aspects of QoL that are influenced by TM. The initial exploratory study section includes (a) a systematic literature review, (b) a qualitative survey for concept elicitation, and (c) pre-testings using cognitive debriefings with patients and an expert workshop. The second quantitative section consists of an online expert survey and two patient surveys for piloting and validation of the newly developed instrument. The resulting questionnaire will assess central experiences of patients regarding telemedical applications and its impact on QoL more sensitively. Its use as adjunct instrument will lead to a more appropriate evaluation of TM and contribute to the improvement of care tailored to patients' individual needs.

Background: Although telemedical applications are increasingly used in the area of both mental and physical illness, there is no quality of life (QoL) instrument that takes into account the specific context of the healthcare setting. Therefore, the aim of this study was to determine a concept of quality of life in telemedical care to inform the development of a setting-sensitive patient-reported outcome measure., Methods: Overall, 63 semi-structured single interviews and 15 focus groups with 68 participants have been conducted to determine the impact of telemedical care on QoL. Participants were patients with chronic physical or mental illnesses, with or without telemedicine supported healthcare as well as telemedical professionals. Mayring's content analysis approach was used to encode the qualitative data using MAXQDA software., Results: The majority of aspects that influence the QoL of patients dealing with chronic conditions or mental illnesses could be assigned to an established working model of QoL. However, some aspects that were considered important (e. g. perceived safety) were not covered by the pre-existing domains. For that reason, we re-conceptualized the working model of QoL and added a sixth domain, referred to as healthcare-related domain., Conclusion: Interviewing patients and healthcare professionals brought forth specific aspects of QoL evolving in telemedical contexts. These results reinforce the assumption that existing QoL measurements lack sensitivity to assess the intended outcomes of telemedical applications. We will address this deficiency by a telemedicine-related re-conceptualization of the assessment of QoL and the development of a suitable add-on instrument based on the resulting category system of this study.

Background: Remote patient management in patients with heart failure might help to detect early signs and symptoms of cardiac decompensation, thus enabling a prompt initiation of the appropriate treatment and care before a full manifestation of a heart failure decompensation. We aimed to investigate the efficacy of our remote patient management intervention on mortality and morbidity in a well defined heart failure population., Methods: The Telemedical Interventional Management in Heart Failure II (TIM-HF2) trial was a prospective, randomised, controlled, parallel-group, unmasked (with randomisation concealment), multicentre trial with pragmatic elements introduced for data collection. The trial was done in Germany, and patients were recruited from hospitals and cardiology practices. Eligible patients had heart failure, were in New York Heart Association class II or III, had been admitted to hospital for heart failure within 12 months before randomisation, and had a left ventricular ejection fraction (LVEF) of 45% or lower (or if higher than 45%, oral diuretics were being prescribed). Patients with major depression were excluded. Patients were randomly assigned (1:1) using a secure web-based system to either remote patient management plus usual care or to usual care only and were followed up for a maximum of 393 days. The primary outcome was percentage of days lost due to unplanned cardiovascular hospital admissions or all-cause death, analysed in the full analysis set. Key secondary outcomes were all-cause and cardiovascular mortality. This study is registered with ClinicalTrials.gov, number NCT01878630, and has now been completed., Findings: Between Aug 13, 2013, and May 12, 2017, 1571 patients were randomly assigned to remote patient management (n=796) or usual care (n=775). Of these 1571 patients, 765 in the remote patient management group and 773 in the usual care group started their assigned care, and were included in the full analysis set. The percentage of days lost due to unplanned cardiovascular hospital admissions and all-cause death was 4·88% (95% CI 4·55-5·23) in the remote patient management group and 6·64% (6·19-7·13) in the usual care group (ratio 0·80, 95% CI 0·65-1·00; p=0·0460). Patients assigned to remote patient management lost a mean of 17·8 days (95% CI 16·6-19·1) per year compared with 24·2 days (22·6-26·0) per year for patients assigned to usual care. The all-cause death rate was 7·86 (95% CI 6·14-10·10) per 100 person-years of follow-up in the remote patient management group compared with 11·34 (9·21-13·95) per 100 person-years of follow-up in the usual care group (hazard ratio [HR] 0·70, 95% CI 0·50-0·96; p=0·0280). Cardiovascular mortality was not significantly different between the two groups (HR 0·671, 95% CI 0·45-1·01; p=0·0560)., Interpretation: The TIM-HF2 trial suggests that a structured remote patient management intervention, when used in a well defined heart failure population, could reduce the percentage of days lost due to unplanned cardiovascular hospital admissions and all-cause mortality., Funding: German Federal Ministry of Education and Research., (Copyright © 2018 Elsevier Ltd. All rights reserved.)

There are major challenges ahead for clinicians treating patients with atrial fibrillation (AF). The population with AF is expected to expand considerably and yet, apart from anticoagulation, therapies used in AF have not been shown to consistently impact on mortality or reduce adverse cardiovascular events. New approaches to AF management, including the use of novel technologies and structured, integrated care, have the potential to enhance clinical phenotyping or result in better treatment selection and stratified therapy. Here, we report the outcomes of the 6th Consensus Conference of the Atrial Fibrillation Network (AFNET) and the European Heart Rhythm Association (EHRA), held at the European Society of Cardiology Heart House in Sophia Antipolis, France, 17-19 January 2017. Sixty-two global specialists in AF and 13 industry partners met to develop innovative solutions based on new approaches to screening and diagnosis, enhancing integration of AF care, developing clinical pathways for treating complex patients, improving stroke prevention strategies, and better patient selection for heart rate and rhythm control. Ultimately, these approaches can lead to better outcomes for patients with AF.

At least 30 million people worldwide carry a diagnosis of atrial fibrillation (AF), and many more suffer from undiagnosed, subclinical, or 'silent' AF. Atrial fibrillation-related cardiovascular mortality and morbidity, including cardiovascular deaths, heart failure, stroke, and hospitalizations, remain unacceptably high, even when evidence-based therapies such as anticoagulation and rate control are used. Furthermore, it is still necessary to define how best to prevent AF, largely due to a lack of clinical measures that would allow identification of treatable causes of AF in any given patient. Hence, there are important unmet clinical and research needs in the evaluation and management of AF patients. The ensuing needs and opportunities for improving the quality of AF care were discussed during the fifth Atrial Fibrillation Network/European Heart Rhythm Association consensus conference in Nice, France, on 22 and 23 January 2015. Here, we report the outcome of this conference, with a focus on (i) learning from our 'neighbours' to improve AF care, (ii) patient-centred approaches to AF management, (iii) structured care of AF patients, (iv) improving the quality of AF treatment, and (v) personalization of AF management. This report ends with a list of priorities for research in AF patients., (Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2015. For permissions please email: journals.permissions@oup.com.)

Background: Anticoagulation using vitamin K antagonists (VKAs) significantly reduces the risk of recurrent stroke in stroke patients with atrial fibrillation (AF) and is recommended by guidelines., Methods: The German Competence NETwork on Atrial Fibrillation established a nationwide prospective registry including 9,574 AF patients, providing the opportunity to analyse AF management according to German healthcare providers., Results: On enrolment, 896 (9.4 %) patients reported a prior ischaemic stroke or transient ischaemic attack. Stroke patients were significantly older, more likely to be female, had a higher rate of cardiovascular risk factors, and more frequently received anticoagulation (almost exclusively VKA) than patients without prior stroke history. Following enrolment, 76.4 % of all stroke patients without VKA contraindications received anticoagulation, which inversely associated with age (OR 0.95 per year; 95 % CI 0.92-0.97). General practitioners/internists (OR 0.40; 95 % CI 0.21-0.77) and physicians working in regional hospitals (OR 0.47; 95 % CI 0.29-0.77) prescribed anticoagulation for secondary stroke prevention less frequently than physicians working at university hospitals (reference) and office-based cardiologists (OR 1.40; 95 % CI 0.76-2.60). The impact of the treating healthcare provider was less evident in registry patients without prior stroke., Conclusions: In the AFNET registry, anticoagulation for secondary stroke prevention was prescribed in roughly three-quarters of AF patients, a significantly higher rate than in primary prevention. We identified two factors associated with withholding oral anticoagulation in stroke survivors, namely higher age and-most prominently-treatment by a general practitioner/internist or physicians working at regional hospitals.

The management of atrial fibrillation (AF) has seen marked changes in past years, with the introduction of new oral anticoagulants, new antiarrhythmic drugs, and the emergence of catheter ablation as a common intervention for rhythm control. Furthermore, new technologies enhance our ability to detect AF. Most clinical management decisions in AF patients can be based on validated parameters that encompass type of presentation, clinical factors, electrocardiogram analysis, and cardiac imaging. Despite these advances, patients with AF are still at increased risk for death, stroke, heart failure, and hospitalizations. During the fourth Atrial Fibrillation competence NETwork/European Heart Rhythm Association (AFNET/EHRA) consensus conference, we identified the following opportunities to personalize management of AF in a better manner with a view to improve outcomes by integrating atrial morphology and damage, brain imaging, information on genetic predisposition, systemic or local inflammation, and markers for cardiac strain. Each of these promising avenues requires validation in the context of existing risk factors in patients. More importantly, a new taxonomy of AF may be needed based on the pathophysiological type of AF to allow personalized management of AF to come to full fruition. Continued translational research efforts are needed to personalize management of this prevalent disease in a better manner. All the efforts are expected to improve the management of patients with AF based on personalized therapy.

Background: Current recommendations for anticoagulation management during cardioversion are largely based on historical data and expert consensus., Methods and Results: To characterize current practice of anticoagulation during and after elective cardioversion for AF and the risk of stroke and bleeding events, all patients enrolled into the Flec-SL trial were analyzed for stroke/transient ischemic attack and major bleeds after cardioversion. Flec-SL (ISRCTN62728743, NCT00215774) enrolled 635 patients (mean age 63.7 ± 10.9, 66% male). 629 (99.1%) patients received periprocedural anticoagulation, 556 (87.6%) were adequately anticoagulated following current recommendations. 202 (31.8%) patients underwent transesophageal echocardiography-guided cardioversion. Electrical cardioversion was used in 508 patients (80.0%), pharmacological cardioversion in 127 (20%). Six patients suffered from stroke (n = 5) or transient ischemic attack (3 TIAs in 1 patient, event rate 0.9%, 95% CI 0.4-2.1), five others from major bleeds (event rate 0.8%, 95% CI 0.3-1.9), consistent with the low reported event rates in prior studies. Three strokes occurred in the first 5 days after cardioversion. Events were independent of type of cardioversion or the use of TEE to exclude thrombi., Conclusion: Strokes are rare in this large, prospectively followed cohort of patients undergoing cardioversion for AF and receiving antithrombotic therapy following local routine. These results support adherence to current recommendations for anticoagulation during cardioversion of AF., (© 2013.)

Introduction: Flecainide is a class Ic antiarrhythmic agent available in Europe since 1982. The clinical development program of flecainide provided good data on its antiarrhythmic effect for the prevention of ventricular and supraventricular arrhythmias. The Cardiac Arrhythmia Suppression Trial (CAST), conducted to test whether the arrhythmia suppression translates into prevention of sudden death, assessed the impact of flecainide and encainide therapy in patients with frequent ventricular ectopics and reduced left ventricular function who had survived an infarction. In that population, flecainide and encainide increased mortality. Consequently, sodium channel blockers are now rarely used to prevent sudden death and are not recommended in patients with heart failure. Current European and North American guidelines recommend the use of flecainide in carefully selected patients with atrial fibrillation (AF) and no documented structural heart disease., Areas Covered: The aim of this review is to evaluate the available data on efficacy and safety of flecainide in all the spectrum of its indications including cardioversion of recent-onset AF, sinus rhythm maintenance in paroxysmal AF and management of ventricular tachyarrhythmias., Expert Opinion: In the setting of AF and in carefully selected patients without structural heart disease, flecainide has shown a good efficacy and safety for both cardioversion and sinus rhythm maintenance.

Atrial fibrillation (AF) patients may receive treatment from specialists or from general medicine physicians representing different levels of care within a structured health care system. This "choice" is influenced by patient flow within a health care system, patient preference, and individual access to health care resources. We analysed how the postgraduate training and work environment of treating physicians affects management decisions in AF patients. Patient characteristics and treatment decisions were analysed at the time of enrolment into the registry of the German Atrial Fibrillation NETwork (AFNET). A total of 9,577 patients were enrolled from 2004 to 2006 in 191 German centres that belonged to the following four levels of care: 13 tertiary care centres (TCC) enrolled 3,795 patients (39.6%), 58 district hospitals (DH) enrolled 2,339 patients (24.4%), 62 office-based cardiologists (OC) enrolled 2,640 patients (27.6%), and 58 general practitioners or internists (GP) enrolled 803 patients (8.4%). Patients with new-onset AF were often treated in DH. TCC treated younger patients who more often presented with paroxysmal AF. Older patients and patients in permanent AF more often received outpatient care. Consistent with recommendations, younger patients and patients with non-permanent AF received rhythm control therapy more often. In addition, the type of centre affected the decision for rhythm control. Stroke risk was similar between centre types (mean CHADS2 scores 1.6 -1.9). TCC (68.8%) and OC (73.6%) administered adequate antithrombotic therapy more often than DH (55.1%) or GP (52.0%, p<0.001 between groups). Upon multivariate analysis, enrolment by TCC or OC was associated with a 1.60 (1.20-2.12, p=0.001) fold chance for adequate antithrombotic treatment. This difference between centre types was consistent irrespective of the type of stroke risk estimation (ESC 2001 guidelines, CHADS2 score), and also consistent when the recently suggested CHA2DS2-VASc score was used to estimate stroke risk. In conclusion, management decisions in AF are influenced by the education and clinical background of treating physicians in Germany. Inpatients receive more rhythm control therapy. Adequate antithrombotic therapy is more often administered in specialist (cardiologist) centres.

The German Competence Network on Atrial Fibrillation (AFNET) is a national interdisciplinary research network funded by the Federal Ministry of Education and Research (BMBF). AFNET was initiated in 2003 and aims at improving treatment of atrial fibrillation (AF), the most frequent sustained cardiac arrhythmia. AFNET has established a nationwide patient registry on diagnostics, therapy, course and complications of AF in Germany. The data analyzed to date demonstrate that patients with AF are likely to have multiple co-morbidities, such as hypertension, valvular heart disease, coronary artery disease, diabetes mellitus and advanced age. Oral anticoagulation is provided to the majority of patients in accordance with the recommendations given by guidelines. Further areas of research deal with the optimal duration of antiarrhythmic therapy following electrical cardioversion of atrial fibrillation and the value of strategies to prevent arrhythmogenic changes, such as fibrosis in the atria, for prevention of further episodes of atrial fibrillation. Additional registry projects were established for patients with catheter-based interventional therapy of atrial fibrillation and surgical ablation to define success, complications and long term results of these recently developed procedures more clearly. Data and insights gathered from these projects were used to further develop standards of care in two international conferences.

Background: Telemonitoring can improve the medical care, quality of life, and prognosis of chronically ill patients. This review article summarizes the current status of health services research on telemonitoring, focusing on patients with chronic congestive heart failure., Method: The Medline database was selectively searched for articles appearing from June 2001 to May 2008, with an emphasis on randomized, controlled trials., Results: The available scientific data on vital signs monitoring are limited, yet there is evidence for a positive effect on some clinical endpoints, particularly mortality. Nonetheless, any possible improvement of patient-reported outcomes, such as the quality of life, still remains to be demonstrated., Conclusions: The data suggest that telemonitoring is effective, yet there is no evidence for superior outcomes with any particular model of care incorporating telemonitoring (i.e., monitoring of vital signs versus structured telephone monitoring). A valid criticism is that the individual components of home telemonitoring have not yet been separately tested in order to compare their individual effects.

The great epidemiological significance and costs associated with chronic heart failure pose a challenge to health systems in Western industrial countries. In the past few years, controlled randomised studies have shown that patients with chronic heart failure benefit from telemedical monitoring; specifically, telemonitoring of various vital parameters combined with a review of the symptoms, drug compliance and patient education. In Germany, various telemedical monitoring projects for patients with chronic heart failure have been initiated in the past few years; seven of them are presented here. Currently 7220 patients are being monitored in the seven selected projects. Most patients (51.1%) are in NYHA stage II, 26.3% in NYHA stage III, 14.5% in NYHA stage I and only 6.6% in NYHA stage IV respectively. Most projects are primarily regional. Their structure of telemedical monitoring tends to be modular and uses stratification according to the NYHA stages. All projects include medical or health economics assessments. The future of telemedical monitoring projects for patients with chronic heart failure will depend on the outcome of these assessments. Only of there is statistical evidence for medical benefit to the individual patient as well as cost savings will these projects continue.

Aims: The aim of this study was to describe the characteristics of patients with atrial fibrillation (AF) enrolled in the Central Registry of the German Competence NETwork on Atrial Fibrillation (AFNET) and to assess current medical practice in patients treated at various levels of medical care in Germany., Methods and Results: From February 2004 to March 2006, 9582 ambulatory and hospitalized patients with ECG-documented AF were enrolled by 194 participating study centres from all levels of medical care in Germany. Clinical type of AF was reported as paroxysmal in 2893, persistent in 1873, and permanent in 3134 patients or classified as a first episode in 1035 patients. Predisposing conditions were common and present in 87.6% of the patients. Most patients were symptomatic with AF (75.1%). Rhythm control in persistent AF was provided to 53.4% of the symptomatic patients and to 47.8% of the patients without symptoms. Anticoagulation for stroke prevention was given to 71.4% of the patients considered eligible by applicable guidelines and to 48.4% of patients with low risk where guidelines do not recommend anticoagulation., Conclusion: This registry provides insight into current medical care of patients with AF in Germany. The use of oral anticoagulation in eligible patients was among the highest reported, whereas decisions on rate and rhythm control often do not follow current recommendations.

The German Competence Network on Atrial Fibrillation (AFNET) is an interdisciplinary national research network funded by the Federal Ministry of Education and Research (BMBF) since 2003. The AFNET aims at improving treatment of atrial fibrillation (AF), the most frequent sustained arrhythmia of the heart. The AFNET has established a nationwide patient registry on manifestation, diagnostics, and therapy of AF in Germany. The data analyzed to date demonstrate that patients with AF are likely to have multiple comorbidities (hypertension, valvular heart disease, coronary artery disease, diabetes mellitus) and an advanced age. Regarding oral anticoagulation, guideline adherence is very high. Basic research has identified specific changes in atrial tissue during AF-induced remodeling providing the rationale for novel therapeutic interventions. Clinical trials are being carried out to optimize pharmacological and nonpharmacological treatments. The ANTIPAF trial is designed to prove that angiotensin II receptor blockers reduce the incidence of paroxysmal AF. The Flec-SL trial tests the efficacy of a short-term treatment with antiarrhythmic drugs after cardioversion. The Gap-AF trial investigates the impact of complete pulmonary vein (PV) isolation versus incomplete circumferential PV ablation on AF recurrences. The effect of preventive pacing on the recurrence of paroxysmal AF is studied in the BACE-PACE trial.

In order to obtain greater insights into the molecular mechanisms accompanying hormonal aging the effects of growth hormone (GH), insulin-like growth factor-I (IGF-I), 17beta-estradiol, progesterone and dehydroepiandrosterone were tested as single agents in concentrations corresponding to 20- and 60-year-old females on human SZ95 sebocytes and fibroblasts. Cell proliferation and viability were measured by 4-methylumbelliferyl heptanoate and lactate dehydrogenase microassays, respectively, whereas lipid accumulation was documented via nile red microassay and fluorescence microscopy. mRNA and protein expression were evaluated via real-time RT-PCR and Western blotting or ELISA, accordingly. Our results depict the importance of IGF-I for lipid synthesis in SZ95 sebocyte and demonstrate the lack of 17beta-estradiol, dehydroepiandrosterone and progesterone activity on lipid synthesis and SZ95 sebocyte proliferation suggesting that the action of these hormones in vivo may be implemented through indirect pathways. Fibroblast showed to be more susceptible to 17beta-estradiol treatment, while IGF-I could significantly stimulate fibroblast proliferation in a dose-dependent manner. Furthermore, an interplay between the 17beta-estradiol and IGF-I signaling pathway was documented in both cell types. In conclusion, IGF-I is a key regulator of human skin aging and declining IGF-I levels with age may play a significant role in the reduction of skin surface lipids and thickness.

The changes in the demographic structure, the increasing multi-morbidity in connection with a rise in the number of chronic illnesses and the absence of an effective coordination of the different levels of health care services with its discontinuous processes and redundancies will increase the economic burdens in the health care system. The latest developments and appropriate logistic premises nowadays offer a realistic basis for implementing telemonitoring as a central service and information tool as well as an instrument controlling the information- and data-flow between patient, hospital and medical practitioner.

Changes in the demographic structure, increasing multimorbidity in connection with a rise in the number of chronic illnesses and the absence of an effective coordination of the different levels of healthcare services with its discontinuous processes and redundancies will increase the economic burdens in the German health-care system. Recent developments and appropriate logistic premises nowadays offer a realistic basis for implementing remote medicine as a central service and information tool as well as an instrument controlling the information and data flow between patient, hospital and medical practitioner. This article highlights current and future strategies including diagnostic and therapeutic options. The focus will concentrate on patients with heart rhythm disturbances, advanced congestive heart failure, and patients with implantable devices, i.e., pacemaker and implantable cardioverter defibrillator (ICD).

ECG telemonitoring is the application of single- or multichannel ECGs transmitted by telephone to the physician or an expert center. This enables the control of the health status despite the spatial separation of patient and physician. Cardiac arrhythmias, palpitations of unknown causes, the outcome of antiarrhythmic drug therapy or interventional ablation therapy can be diagnosed using ECG telemonitoring. Even asymptomatic arrhythmias, e.g. paroxysmal atrial fibrillation, may be detected. The use of a multichannel ECG facilitates the early prehospital diagnosis of an acute coronary syndrome and thus helps to optimize the chain of rescue. The telemonitoring of the ECG and additional physiological data enables the tele-care of patients with chronic heart failure. New types of implanted pacemaker or cardioverter/defibrillator devices allow telemonitoring of device data or ECG data for close control.

The Atrial Fibrillation Competence Network is an interdisciplinary national research network funded by the Federal Ministry of Education and Research (BMBF). The aim of the network--founded in 2003--is to improve the treatment of atrial fibrillation, the most common clinically important arrhythmia of the heart. A decentralized patient registry has been established. This registry, which comprises the manifestation, diagnostics and therapy of atrial fibrillation in Germany, is being used as a data basis for epidemiologic clinical studies. Epidemiologic projects are being conducted to study, e.g., the prevalence of atrial fibrillation as well as the occurrence of complications. Four multicenter clinical trials have been started to optimize pharmacological treatments (ANTIPAF trial, Flec-SL trial), preventive pacing (BACE-PACE trial) and catheter-based ablation (GAP-AF trial). Other clinical projects are being conducted to study the risk of neurologic complications and to develop new diagnostic imaging techniques. Experimental basic research projects are focusing on different aspects of atrial remodeling in order to find out in which way the molecular mechanisms can be manipulated by new methods of treatment. First results are presented.

Progression of chronic heart failure depends on various additional pathophysiologic factors like blood pressure, arrhythmias, congestion. Early detection of any alteration using telemonitoring of multiple vital parameters may avoid severe decompensation requiring hospital admission. The feasibility and the clinical outcome using a new telemonitoring device for recording multiple vital parameters and allowing communication on individual state of health is investigated. Twenty-four patients with chronic heart failure (mean age 65 years, mean LV ejection fraction 35%) requiring at least one hospital admission during the past year were investigated. Twice a day, the vital-parameters were measured (weight, blood pressure, heart rate and rhythm, oxygen saturation, respiration rate) and patients information on well being, shortness of breath, medication, and request for contact were received. Intra-individual comparison was carried out between the 12 month before inclusion in this study and 12 month under telemonitoring surveillance (extrapolated, if necessary). Performing over 10 500 measurements during 5751 patient days, critical events were diagnosed for 55 events concerning relative weight gain (43 episodes), blood pressure (6), decrease in oxygen saturation (3), new onset of atrial fibrillation with tachyarrhymia (3). Of these, 45 events were controlled on an outpatient basis by changing medication or external cardioversion. Only 10 patients required re-admission. Thus, the number of admission to the hospital could be reduced by 62%, those of days spent in hospital by 69%. Non-invasive telemonitoring of multiple vital parameters combined with patients statements on their health condition and out-patient treatment on the basis of these findings is found to be an effective and reliable approach to avoid hospital readmission for patients with chronic heart failure.

Aims: In patients with persistent atrial fibrillation (AF), the efficacy and safety of two anti-arrhythmic drugs in preventing the recurrence of AF after successful direct current (DC) cardioversion was prospectively assessed in a multi-centre double-blind, placebo-controlled, randomised trial using daily trans-telephonic monitoring., Methods and Results: 1182 patients with persistent AF were prospectively enrolled, 848 patients were successfully cardioverted and then randomised to either sotalol (383 patients), quinidine plus verapamil (377 patients) or placebo (88 patients). The primary outcome parameter was AF recurrence or death. All patients received an event recorder (Tele-ECG) and had to record and transmit via telephone at least one ECG per day during follow-up. The mean follow-up period was 266 days. A total of 191,103 Tele-ECGs were recorded and transmitted. The primary outcome parameter (AF recurrence of any kind or death) was observed in 572 patients (67%) in whom at least one episode of AF recurrence was documented during follow-up, in 348 patients (41%) AF recurrence was persistent. The recurrence rates after one year for any AF were 83% for placebo, 67% for sotalol and 65% for quinidine plus verapamil, the latter being statistically superior to placebo but not different from sotalol. The recurrence rates for the secondary outcome parameter persistent AF were 77%, 49% and 38%, respectively. Quinidine plus verapamil was significantly superior to placebo and to sotalol. About 95% of all AF recurrences were initially detected in the daily Tele-ECG, about 70% of all AF recurrences occurred completely asymptomatic. Adverse events on sotalol and quinidine plus verapamil were comparable with the exception that all torsade de pointes tachycardias occurred on sotalol., Conclusion: Anti-arrhythmic treatment after DC cardioversion of persistent AF significantly decreases the recurrence rates of persistent AF compared to placebo with superiority of quinidine plus verapamil compared to sotalol. Symptoms were not reliable as clinical surrogates to detect episodes of AF.

Sebaceous glands may be involved in a pathway conceptually similar to that of the hypothalamic-pituitary-adrenal (HPA) axis. Such a pathway has been described and may occur in human skin and lately in the sebaceous glands because they express neuropeptide receptors. Corticotropin-releasing hormone (CRH) is the most proximal element of the HPA axis, and it acts as central coordinator for neuroendocrine and behavioral responses to stress. To further examine the probability of an HPA equivalent pathway, we investigated the expression of CRH, CRH-binding protein (CRH-BP), and CRH receptors (CRH-R) in SZ95 sebocytes in vitro and their regulation by CRH and several other hormones. CRH, CRH-BP, CRH-R1, and CRH-R2 were detectable in SZ95 sebocytes at the mRNA and protein levels: CRH-R1 was the predominant type (CRH-R1/CRH-R2 = 2). CRH was biologically active on human sebocytes: it induced biphasic increase in synthesis of sebaceous lipids with a maximum stimulation at 10(-7) M and up-regulated mRNA levels of 3 beta- hydroxysteroid dehydrogenase/Delta(5-4) isomerase, although it did not affect cell viability, cell proliferation, or IL-1 beta-induced IL-8 release. CRH, dehydroepiandrosterone, and 17 beta-estradiol did not modulate CRH-R expression, whereas testosterone at 10(-7) M down-regulated CRH-R1 and CRH-R2 mRNA expression at 6 to 24 h, and growth hormone (GH) switched CRH-R1 mRNA expression to CRH-R2 at 24 h. Based on these findings, CRH may be an autocrine hormone for human sebocytes that exerts homeostatic lipogenic activity, whereas testosterone and growth hormone induce CRH negative feedback. The findings implicate CRH in the clinical development of acne, seborrhea, androgenetic alopecia, skin aging, xerosis, and other skin disorders associated with alterations in lipid formation of sebaceous origin.

Background: The identification of patients at increased risk for ventricular tachycardia or ventricular fibrillation (VT/VF) and sudden cardiac death has consequences for therapeutic options and thus may reduce mortality in patients with coronary artery disease (CAD)., Hypothesis: We hypothesized that the intra-QRS fragmentation in magnetocardiographic recordings is increased in patients with CAD and with a history of VT/VF., Methods: Multichannel magnetocardiography (MCG) was carried out in 34 healthy controls, 42 patients with CAD without a history of VT/VF, and 43 patients with CAD and with a history of VT/VF. The intra-QRS fragmentation was quantified by a new fragmentation score. Its spatial distribution was investigated using two-dimensional (2-D) contour maps according to the sensor position of the 49-channel magnetogradiometer., Results: Patients with CAD and with a history of VT/VF had significantly increased QRS fragmentation compared with patients with CAD without VT/VF or controls (72.9+/-37.5, 48.5+/-14.3, and 42.5+/-7.8, respectively: p <0.05). The area of high fragmentation in 2-D contour maps was twice as large in patients with than in those without a history of VT/VF (represented by the number of MCG channels with high fragmentation: 26.3+/-15.5 vs. 12.4+/-9.9, p<0.0001). Patients prone to VT/VF could be identified with a sensitivity of 64% and a specificity of 90%., Conclusion: In patients with CAD and with a history of VT/VF, intra-QRS fragmentation is increased and the area of high fragmentation in 2-D contour maps is enlarged. These findings may be helpful in identifying patients with CAD at risk for malignant tachyarrhythmias.

The variability of electric and magnetic signals from the heart during the depolarization phase is investigated. A signal processing method is developed, which provides estimates for the beat-to-beat variability of the QRS-complex. The method is based on the decomposition of the depolarization signal into bandpass signals by means of the Morlet wavelet transform. The beat variability of the depolarization signal is estimated by normalized variances of the envelope and instantaneous frequency of bandpass signals. Time intervals of the bandpass filtered depolarization signals having a high signal-to-noise ratio are selected applying an analysis based on phase statistics. The method was tested by computer simulation and experimental data taken from electrocardiographic and magnetocardiographic measurements of healthy persons and patients prone to malignant ventricular tachycardia (VT) or ventricular fibrillation (VF). Results suggest that the calculated variance parameters permit the characterization of beat variable depolarization signals and distinguish VT/VF patients from healthy persons.

The variability of electric and magnetic signals from the heart during the depolarization phase is investigated. A signal processing method is developed which provides estimates for the beat-to-beat variability of the QRS-complex. The method is based on the decomposition of the depolarization signal into bandpass signals by means of the Morlet wavelet transform. The beat variability of the depolarization signal is estimated by normalized variances of the envelope and instantaneous frequency of bandpass signals. Time intervals of the bandpass filtered depolarization signals having a high signal-to-noise ratio are selected by applying an analysis based on phase statistics. The method was tested by experimental data taken from ECG and MCG measurements of healthy persons and patients prone to malignant ventricular tachycardia (VT) or ventricular fibrillation (VF). Results suggest that the calculated variance parameters permit the characterization of beat variable depolarization signals and distinguish VT/VF patients from healthy persons. The method developed can be used to obtain additional information concerning abnormal heart signals which is attenuated when applying signal averaging.

We report our experience of pacemaker treatment in a premature infant of 830 g with congenital complete atrioventricular block due to maternal Sjögren's Syndrome. The infant was delivered by cesarean section at an estimated gestational age of 26 weeks because of fetal bradycardia, decreasing fetal movements, and hydrops. Immediate postnatal transesophageal ventricular pacing was not successful, whereas transthoracic pacing with self-adhesive patch electrodes adapted to body size resulted in an effective increase of the infant's heart rate until operative application of temporary epimyocardial pacing wires allowed external stimulation of the heart.

The ectopic atrial tachycardia is diagnosed in approx. 10 to 15% of supraventricular tachycardias. Since medical therapy is often shown to be ineffective, ablative procedures became especially important in this disease. Localization of the arrhythmia foci seems to be concentrated at anatomical preformations like the crista terminalis, right or left atrial appendage orifice or at the superior pulmonary veins. The P-wave vector in the surface ECG is predictive for focus localization: a positive or biphasic P-wave in a VL for right atrial foci, a positive P-wave in V1 for left atrial foci. Catheter ablation therapy is also shown to be very effective in this kind of supraventricular tachycardia.

It has been shown that regional ventricular repolarization properties can be reflected in body surface distributions of electrocardiographic QRST deflection areas (integrals). We hypothesize that these properties can be reflected also in the magnetocardiographic QRST areas and that this may be useful for predicting vulnerability to ventricular tachyarrhythmias. Magnetic field maps were obtained during sinus rhythm from 49 leads above the anterior chest in 22 healthy (asymptomatic) control subjects (group A) and in 29 patients with ventricular arrhythmias (group B). In each subject, the QRST deflection area was calculated for each lead and displayed as an integral map. The mean value of maximum was significantly larger in the control group A than in the patient group B (1,626+/-694 pTms vs. 582+/-547 pTms, P<0.0001). To quantitatively assess intragroup variability in the control group A and intergroup variability of the control and patient groups, we used the correlation coefficient r and covariance sigma. These indices showed significantly less intragroup than intergroup variation (e.g., in terms of sigma, 28.0x10(-6)+/-12.3x10(-6) vs. 3.4x10(-6)+/-12.5x10(-6), P<0.0001). Each QRST integral map was also represented as a weighted sum of 24 basis functions (eigenvectors) by means of Karhunen-Loeve transformation to calculate the contribution of the nondipolar eigenvectors (all eigenvectors beyond the third). This percentage nondipolar content of magnetocardiographic QRST integral maps was significantly higher in the patient group B than in the control group A (13.0%+/-9.1 % vs. 2.6%+/-2.0%, P<0.0001). Discriminations between control subjects and patients with ventricular arrhythmias based on magnitude of the maximum, covariance sigma, and nondipolar content were 90.2%, 90.2%, and 86.3% accurate, with a sensitivity of 89.7%, 93.1%, and 75.9%, and a specificity of 90.9%, 86.4%, and 100%. We have shown that magnitude of the maximum and indices of variability and nondipolarity of the magnetocardiographic QRST integral maps may predict arrhythmia vulnerability. This finding is in agreement with earlier studies that used body surface potential mapping and suggests that magneticfield mapping may also be a useful diagnostic tool for risk analysis.

The objective of this case report is to determine the accurate localization of a malignant ventricular tachycardia (VT) focus by combining multichannel magnetocardiographic (MCG) information with morphologic data. The localization was obtained by calculating the three-dimensional current density distribution (3D-CDD) on the left ventricular surface. To estimate the accuracy of this localization technique, examinations of a healthy volunteer were additionally performed. The MCG-signals were recorded in a magnetically shielded room by a 49-channel magnetogradiometer. The corresponding morphologic information was recorded by magnetic resonance tomography (MRT). The coordinate systems were matched with the help of markers. The 3D-CDD was calculated by the Philips CURRY software package. The origin of a malignant VT determined by X-ray images of the ablation catheter position during the electrophysiological examination (EPE), was used as the gold standard. This was then compared with the localization results obtained by the 3D-CDD. It was found that the localization coordinates showed a difference of less than 10 mm.

The spatial distribution of high-frequency components in magnetic signals during the QRS complex of the human heartbeat was investigated. Cardiomagnetic signals were recorded simultaneously using 49 first-order magnetogradiometer channels of a multi-SQUID system with a low noise power density. The QRS fragmentation score S, as a measure of the fragmentation of the bandpass-filtered QRS complex, was examined for its sensitivity and specificity to discriminate 34 healthy volunteers, 42 post-myocardial infarction patients and 43 patients with coronary heart disease and with a history of malignant sustained ventricular tachycardia or ventricular fibrillation. The multichannel information was visualized by two-dimensional mapping of the score values of the single channels. By averaging the score values for the seven central channels, S7, the score values of all 49 channels, S49, and calculating the standard deviation for all 49 channels, D49, a higher sensitivity and specificity for detecting patients with ventricular tachycardia (VT) or ventricular fibrillation (VF) was reached than by analysis of a single channel. Combination of these parameters furnishes a sensitivity of 90% and a specificity of 70% for identifying patients prone to VT/VF. The results were compared with diagnostic information obtained from the QRS duration of the signal as well as with results obtained by modified QRS integral mapping.

The structure of high-frequency components of electric and magnetic signals from the heart during the depolarisation phase is investigated. After averaging and broadband filtering with a binomial bandpass filter (37 Hz-90 Hz), the fragmentation of the QRS-complex is quantified. The number of extrema M and a new score value S are calculated from the signals of three electrical leads and one magnetic lead of 23 healthy subjects, 23 patients with coronary heart disease (CHD) without reported event of ventricular tachycardia or fibrillation at the time of measurement, and eight patients with CHD who have suffered from malignant tachycardia. For the parameter M, the sensitivity and specificity for healthy subjects against patients with CHD and ventricular tachycardia for the magnetic lead (the best electric lead) are 100% (75%) and 100% (100%). For the magnetic lead (best electric lead) and parameter S, the sensitivity and specificity are 100% (75%) and 95.6% (100%).

Unlabelled: Fragmented and delayed activation of ventricular myocardium can cause malignant tachyarrhythmias. By detection of ventricular late potentials only a severely delayed depolarisation is registered, but not the intra QRS-activation. The aim of this study was to examine the complete phase of ventricular depolarisation, to detect and to quantify abnormal electrical activation by magnetocardiography and to estimate in a small group of patients with coronary heart disease the prognostic significance.In 26 healthy subjects, 32 patients after myocardial infarction without malignant ventricular arrhythmias and 10 patients with coronary heart disease and a history of sustained, monomorph ventricular tachycardia magnetocardiography was performed in a magnetically shielded room. To quantify the fragmentation of QRS a fragmentation-index (FI) was calculated. Besides signal averaged ECG, in patients with coronary heart disease cardiac catheterisation and in patients with arrhythmias electrophysiological testing was performed. The FI for the three groups was significantly different (p<0,005). The mean FI in the group of healthy subjects was 20,4+/-5,4, in the group of postinfarction-patients without arrhythmias 27+/-12,1 and in the group of patients with coronary heart disease and ventricular arrhythmias 49,5+/-17,9. Dichotomized at 36 the sensitivity was 80%, the specifity 93%, the positive predictive value was 66% and the negative predictive value 96%. The FI was correlated to the extent of regional wall-motion-irregularity and global ejection fraction.Analyzing late potentials, the values for sensitivity and positive predictive value were surprisingly low (20% and 50%, respectively). The specifity was 96%, the negative predictive value was 88%. Calculating the FI on the basis of electrical signals only an insufficient discrimination of the groups was possible.In the follow-up period of two years one post-infarctional patient was resusciated because of ventricular fibrillation. The FI of this patient was 17.One patient with coronary 3-vessel-disease and left ventricular ejection fraction of 50% died due to acute myocardial infarction, his FI was 39., Conclusion: By means of magnetocardiography fragmented ventricular activation in patients with coronary heart disease was demonstrated even within the QRS-complex and could be correlated to ventricular tachyarrhythmias.

Magnetocardiographic mapping opens new perspectives for three-dimensional localization of cardiac electrical activation. Using a 37-channel SQUID magnetometer equipment with high shielding, the origin of abnormal ventricular activation was investigated in 18 patients with Wolff-Parkinson-White syndrome prior to catheter ablation and in 5 of 31 patients with coronary artery disease having a sufficient number of monomorphic ventricular extrasystoles to enable evaluation. In all WPW-patients, the site of the earliest delta-wave activation was projected onto the AV-valve plane in accordance with the MR images. The result of magnetocardiographic localization was then compared to the site of successful catheter ablation determined by digital imaging processing. After optimization of the algorithms, both sites were in the various planes at the following distance from each other: X-plane: 0.8 +/- 0.9 cm, Y-plane: 1.1 +/- 1.0 cm and Z-plane: 1.5 +/- 1.0 cm. In three-dimensional projection, the mean difference in space between both positions was calculated to be 2.1 +/- 1.7 cm. After this validation ventricular premature beats were localized in another group of patients. In 4 of 5 patients their origin was found at the border of infarct areas. In each case, the progression of the ventricular activation could be pursued. The detected structure of the magnetic field distribution of the VBP's exhibited a stable bipolar pattern, which is comparable to that of ventricular tachycardia, and its algorithms may be used to localize the origin of ventricular tachycardia.(ABSTRACT TRUNCATED AT 250 WORDS)