ECOST

ECOST

Effectiveness and Costs of ICD Follow-up Schedule with Telecardiology

Laurence Guédon-Moreau, European Heart Journal 2013

Link to Download Section

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
Devices
  • ICDs equipped with BIOTRONIK Home Monitoring
Study Flowchart
    Study Flowchart
    Follow-Up
    • 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

    Download Section

    A randomized study of remote follow-up of ICDs: safety and efficacy report of the ECOST trial
    Contributions of remote monitoring to the follow-up of implantable cardioverter– defibrillator leads under advisory
    Decreased Delivery of Inappropriate Shocks Achieved by Remote Monitoring of ICD: A Substudy of the ECOST Trial

    Related Products

    Tachycardia Therapy

    More Information

    BIOTRONIK offers an extensive product portfolio in the area of tachycardia therapy.

    Tachy Teaser
    Monitoring Teaser

    Cardiac Remote Monitoring

    More Information

    BIOTRONIK offers Home Monitoring for its complete product portfolio.