ECOST

Effectiveness and Costs of ICD Follow-up Schedule with Telecardiology

Laurence Guédon-Moreau, European Heart Journal 2013

Estudio aleatorizado, intervencionista y multicéntrico
Comparación de la seguridad de BIOTRONIK Home Monitoring continua y el seguimiento ambulatorio convencional de CDI
433 pacientes en 43 centros de Francia

El seguimiento remoto con BIOTRONIK Home Monitoring® es un seguimiento ambulatorio tan seguro como convencional.

El estudio ECOST muestra que BIOTRONIK Home Monitoring de CDI es una alternativa segura a los seguimientos en la consulta. Además, tiene un impacto positivo en los resultados de los pacientes, sobre todo, cuando se trata de reducir el riesgo de descargas inadecuadas: una experiencia muy desagradable.
El valor de BIOTRONIK Home Monitoring para la monitorización remota continua, a través de sus transmisiones diarias, es esencial para que las clínicas puedan gestionar mejor el estado de salud de sus pacientes.

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
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