Superiority of automatic remote monitoring compared with in-person evaluation for scheduled ICD follow-up in the TRUST trial - testing execution of the recommendations

AIMS To test recommended implantable cardioverter defibrillator (ICD) follow-up methods by 'in-person evaluations' (IPE) vs. 'remote Home Monitoring' (HM). METHODS AND RESULTS ICD patients were randomized 2:1 to automatic HM or to Conventional monitoring, with follow-up checks scheduled at 3, 6, 9, 12, and 15 months post-implant. Conventional patients were evaluated with IPE only. Home Monitoring patients were assessed remotely only for 1 year between 3 and 15 month evaluations. Adherence to follow-up was measured. HM and Conventional patients were similar (age 63 years, 72% male, left ventricular ejection fraction 29%, primary prevention 73%, DDD 57%). Conventional management suffered greater patient attrition during the trial (20.1 vs. 14.2% in HM, P = 0.007). Three month follow-up occurred in 84% in both groups. There was 100% adherence (5 of 5 checks) in 47.3% Conventional vs. 59.7% HM (P < 0.001). Between 3 and 15 months, HM exhibited superior (2.2×) adherence to scheduled follow-up [incidence of failed follow up was 146 of 2421 (6.0%) in HM vs. 145 of 1098 (13.2%) in Conventional, P < 0.001] and punctuality. In HM (daily transmission success rate median 91%), transmission loss caused only 22 of 2275 (0.97%) failed HM evaluations between 3 and 15 months; others resulted from clinic oversight. Overall IPE failure rate in Conventional [193 of 1841 (10.5%) exceeded that in HM [97 of 1484 (6.5%), P < 0.001] by 62%, i.e. HM patients remained more loyal to IPE when this was mandated. CONCLUSION Automatic remote monitoring better preserves patient retention and adherence to scheduled follow-up compared with IPE. CLINICAL TRIAL REGISTRATION NCT00336284.