Abstract 3513: Homemonitoring in MADIT II Patients: A Prospective Randomized Multicenter Comparison Against a Standard Follow-Up (REFORM Trial)
Background: The number of patients with ICD implantation for primary prevention is increasing. A conventional 3 monthly follow-up regimen may exceed healthcare resources. The REFORM trial is a prospective, randomized multicenter study comparing a simplified homemonitoring ICD follow-up against a conventional regimen in MADIT II patients.
Methods: 147 patients (90% men, 10% women; 62+/−10 Jahre) with coronary artery disease (previous myocardial infarction > 1 month) and an EF<30% received ICD implantation for primary prevention. All ICDs were equipped with homemonitoring technology. 3 months after implantation the patients were randomized towards a simplified homemonitoring based follow-up (12M = one consultation in the ICD clinic per year only) or a conventional follow-up (3M = one consultation in the ICD clinic per 3 months). The primary endpoint analyzed the number of additional unplanned consultations in the ICD clinic in each group. The secondary endpoints studied total follow-up costs, patients’ quality of life (SF-36) and total mortality.
Resultate: The average follow-up time measured 364 days (29–793 days). Left ventricular ejection fraction was 25+/−6%. Distribution between NYHA class I to IV was as followed: NYHA I = 6%; NYHA II = 52%; NYHA III = 42%; NYHA IV = 0%. During the study period 151 additional unplanned consultations in the ICD clinic occurred. Of those 76 occurred in the 3M group and 75 in the 12M group (p=0.152). Of the 151 unplanned consultations 20 were initiated by the patient and 131 by the supervising physician (p=0.001). Of the 20 patient initiated additional follow-up visits 9 occurred in the 3M group and 11 in the 12M group (p=0.082). Of the 131 physician initiated additional follow up visits 67 occurred in the 3M group and 64 in the 12M group (p=0.125). Mortality was not significantly different between the 2 groups.
Conclusions: A simplified 12 monthly homemonitoring based ICD follow-up does not create a significantly higher number of additional unplanned consultations in the ICD clinic than a conventional 3 monthly follow-up regimen and by that could significantly reduce the follow-up burden in patients with ICD implantation for primary prevention following MADIT II.