title: Fluid status telemedicine alerts for heart failure: a randomized controlled trial.
abstract: 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.
  
  
  
  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.
  
  
  
  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.
authors.affiliation: 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.
authors.forename: Michael
authors.initials: M
authors.lastname: Böhm
authors.affiliation: Department of Cardiology and Angiology, Hannover Medical School, Hannover, Germany.
authors.forename: Helmut
authors.initials: H
authors.lastname: Drexler
authors.affiliation: Department of Cardiology and Angiology, Hannover Medical School, Hannover, Germany.
authors.forename: Hanno
authors.initials: H
authors.lastname: Oswald
authors.affiliation: Kardiologische Praxis, Dessau, Germany.
authors.forename: Karin
authors.initials: K
authors.lastname: Rybak
authors.affiliation: Cardio Centrum Ludwigsburg-Bietigheim, Ludwigsburg, Germany.
authors.forename: Ralph
authors.initials: R
authors.lastname: Bosch
authors.affiliation: Herzzentrum Brandenburg, Bernau, Germany.
authors.forename: Christian
authors.initials: C
authors.lastname: Butter
authors.affiliation: Herz im Zentrum, Kardiologische Praxis, Hannover, Germany.
authors.forename: Gunnar
authors.initials: G
authors.lastname: Klein
authors.affiliation: Medtronic Bakken Research Center, Maastricht, The Netherlands.
authors.forename: Bart
authors.initials: B
authors.lastname: Gerritse
authors.affiliation: Medtronic PLC, Minneapolis, USA.
authors.forename: Joao
authors.initials: J
authors.lastname: Monteiro
authors.affiliation: Department of Internal Medicine - Cardiology, Evangelisches Krankenhaus Bielefeld, Bielefeld, Germany.
authors.forename: Carsten
authors.initials: C
authors.lastname: Israel
authors.affiliation: Department of Internal Medicine - Cardiology, Sankt Marien Hospital, Bonn, Germany.
authors.forename: Dieter
authors.initials: D
authors.lastname: Bimmel
authors.affiliation: Department of Medicine 1, Ludwig-Maximilians University Hospital, Munich, Germany.
authors.forename: Stefan
authors.initials: S
authors.lastname: Käab
authors.affiliation: Department of Internal Medicine - Cardiology, Marienhaus Klinikum, Neuwied, Germany.
authors.forename: Burkhard
authors.initials: B
authors.lastname: Huegl
authors.affiliation: Department of Internal Medicine II, Cardiology, Angiology and Pneumology, Klinikum Coburg GmbH, Coburg, Germany.
authors.forename: Johannes
authors.initials: J
authors.lastname: Brachmann
mesh_terms: D058406:Cardiac Resynchronization Therapy; D017147:Defibrillators, Implantable; D006333:Heart Failure; D006760:Hospitalization; D006801:Humans; D017216:Telemedicine; D016896:Treatment Outcome
keywords: Cardiac resynchronization therapy; Disease management; Heart failure; Implantable defibrillator; Telemedicine