Michael Böhm1, Helmut Drexler2, Hanno Oswald2, Karin Rybak3, Ralph Bosch4, Christian Butter5, Gunnar Klein6, Bart Gerritse7, Joao Monteiro8, Carsten Israel9, Dieter Bimmel10, Stefan Käab11, Burkhard Huegl12, Johannes Brachmann13. 1. Department of Internal Medicine III, Cardiology, Angiology and Intensive Care Medicine, Saarland University Hospital, Kirrberger Strasse 1, Homburg/Saar 66424, Germany michael.boehm@uniklinikum-saarland.de. 2. Department of Cardiology and Angiology, Hannover Medical School, Hannover, Germany. 3. Kardiologische Praxis, Dessau, Germany. 4. Cardio Centrum Ludwigsburg-Bietigheim, Ludwigsburg, Germany. 5. Herzzentrum Brandenburg, Bernau, Germany. 6. Herz im Zentrum, Kardiologische Praxis, Hannover, Germany. 7. Medtronic Bakken Research Center, Maastricht, The Netherlands. 8. Medtronic PLC, Minneapolis, USA. 9. Department of Internal Medicine - Cardiology, Evangelisches Krankenhaus Bielefeld, Bielefeld, Germany. 10. Department of Internal Medicine - Cardiology, Sankt Marien Hospital, Bonn, Germany. 11. Department of Medicine 1, Ludwig-Maximilians University Hospital, Munich, Germany. 12. Department of Internal Medicine - Cardiology, Marienhaus Klinikum, Neuwied, Germany. 13. Department of Internal Medicine II, Cardiology, Angiology and Pneumology, Klinikum Coburg GmbH, Coburg, Germany.
Abstract
AIMS: Hospital admissions are frequently preceded by increased pulmonary congestion in heart failure (HF) patients. This study evaluated whether early automated fluid status alert notification via telemedicine improves outcome in HF patients. METHODS AND RESULTS: Patients recently implanted with an implantable cardioverter defibrillator (ICD) with or without cardiac resynchronization therapy were eligible if one of three conditions was met: prior HF hospitalization, recent diuretic treatment, or recent brain natriuretic peptide increase. Eligible patients were randomized (1:1) to have fluid status alerts automatically transmitted as inaudible text message alerts to the responsible physician or to receive standard care (no alerts). In the intervention arm, following a telemedicine alert, a protocol-specified algorithm with remote review of device data and telephone contact was prescribed to assess symptoms and initiate treatment. The primary endpoint was a composite of all-cause death and cardiovascular hospitalization. We followed 1002 patients for an average of 1.9 years. The primary endpoint occurred in 227 patients (45.0%) in the intervention arm and 239 patients (48.1%) in the control arm [hazard ratio, HR, 0.87; 95% confidence interval (CI), 0.72-1.04; P = 0.13]. There were 59 (11.7%) deaths in the intervention arm and 63 (12.7%) in the control arm (HR, 0.89; 95% CI, 0.62-1.28; P = 0.52). Twenty-four per cent of alerts were not transmitted and 30% were followed by a medical intervention. CONCLUSION: Among ICD patients with advanced HF, fluid status telemedicine alerts did not significantly improve outcomes. Adherence to treatment protocols by physicians and patients might be challenge for further developments in the telemedicine field. Published on behalf of the European Society of Cardiology. All rights reserved.
RCT Entities:
AIMS: Hospital admissions are frequently preceded by increased pulmonary congestion in heart failure (HF) patients. This study evaluated whether early automated fluid status alert notification via telemedicine improves outcome in HF patients. METHODS AND RESULTS:Patients recently implanted with an implantable cardioverter defibrillator (ICD) with or without cardiac resynchronization therapy were eligible if one of three conditions was met: prior HF hospitalization, recent diuretic treatment, or recent brain natriuretic peptide increase. Eligible patients were randomized (1:1) to have fluid status alerts automatically transmitted as inaudible text message alerts to the responsible physician or to receive standard care (no alerts). In the intervention arm, following a telemedicine alert, a protocol-specified algorithm with remote review of device data and telephone contact was prescribed to assess symptoms and initiate treatment. The primary endpoint was a composite of all-cause death and cardiovascular hospitalization. We followed 1002 patients for an average of 1.9 years. The primary endpoint occurred in 227 patients (45.0%) in the intervention arm and 239 patients (48.1%) in the control arm [hazard ratio, HR, 0.87; 95% confidence interval (CI), 0.72-1.04; P = 0.13]. There were 59 (11.7%) deaths in the intervention arm and 63 (12.7%) in the control arm (HR, 0.89; 95% CI, 0.62-1.28; P = 0.52). Twenty-four per cent of alerts were not transmitted and 30% were followed by a medical intervention. CONCLUSION: Among ICDpatients with advanced HF, fluid status telemedicine alerts did not significantly improve outcomes. Adherence to treatment protocols by physicians and patients might be challenge for further developments in the telemedicine field. Published on behalf of the European Society of Cardiology. All rights reserved.
Authors: T M Helms; M Stockburger; J O Schwab; G Hindricks; F Köhler; V Leonhardt; A Müller; K Rybak; S Sack; C Zugck; B Zippel-Schultz; C A Perings Journal: Herzschrittmacherther Elektrophysiol Date: 2019-09
Authors: David Duncker; Roman Michalski; Johanna Müller-Leisse; Christos Zormpas; Thorben König; Christian Veltmann Journal: Herzschrittmacherther Elektrophysiol Date: 2017-08-15