Effectiveness and Costs of ICD Follow-up Schedule with Telecardiology

Laurence Guédon-Moreau, European Heart Journal 2013

Study Design

  • Randomized, interventional, multicenter study
  • Compares the safety of continuous BIOTRONIK Home Monitoring versus conventional ambulatory follow-up of ICDs
  • 433 patients at 43 centers in France

Key Result 1

Remote follow-up with BIOTRONIK Home Monitoring® is as safe as conventional ambulatory follow-up.

Proportion of Patients

Clinical Relevance

  • The ECOST study shows that BIOTRONIK Home Monitoring of ICDs is a safe alternative to in-office follow-ups. It positively impacts patient outcome, specially when it comes to reducing the risk of inappropriate shocks – a very unpleasant experience
  • The value of BIOTRONIK Home Monitoring for continuous remote monitoring, through its daily transmissions, is essential for clinics to better manage their patients health condition

Study Objective
  • Examination of the long-term safety and effectiveness of home monitoring (HM) of implantable cardioverter defibrillators
1° Endpoints
  • The proportion of patients who experienced ≥ 1 MAE, including death from any cause, cardiovascular and procedure or device related MAE
2° Endpoints
  • Appropriate and inappropriate shock deliveries
  • ICD capacitor charges
  • Impact on battery longevity
Clinical Sites
  • 43 centers
Sample Size
  • 433 patients
Inclusion Criteria
  • Indication for single or dual chamber ICD
Main Exclusion Criteria #1
  • NYHA class IV
  • Pregnant woman or woman who plan to become pregnant during the trial
  • Patient whose medical situation is not stable
  • Presence of any disease, other than patient's cardiac disease, associated with reduced likelihood of survival for the duration of the trial, e.g. cancer, uraemia (urea > 70mg/dl or creatinine >3mg/dl), liver failure, etc.
  • Age < 18 years
  • Patient unable to handle Home Monitoring system correctly
  • The patient is not willing and able to comply with the protocol
  • Change of residence expected during study
Main Exclusion Criteria #2
  • Insufficient GSM coverage at patient's home
  • Participation in another clinical study
  • Patient unwilling to sign the consent for participation
  • ICDs equipped with BIOTRONIK Home Monitoring
Study Flowchart
    Study Flowchart
    • 27 months follow-up
    Study Duration
    • January 2007 – October 2010
    Reference no.
    • NCT00989417
    Principal Investigators
    • Prof. Dr. Salem S. Kacet, CHRU de Lille – Hospital Cardiologique, France

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