Background-Monitoring performance of implantable cardioverter-defibrillator (ICD) generators and leads is important.Methods available are with in-person evaluations or by automatic remote home monitoring (HM). These were prospectively evaluated and compared in the TRUST trial. The HM technology tested performed daily self-checks and databasing with rapid event notifications for out-of-range (including asymptomatic) conditions. Methods and Results-Patients (nϭ1339) were randomly assigned after ICD implant 2:1 to HM or to conventional groups.Both groups underwent scheduled checks every 3 months and were followed for 15 months. In HM, in-person office visits were scheduled at 3 and 15 months. At 6, 9, and 12 months, HM only was used with subsequent office visits if necessary. Between these time points, ICDs triggered event notifications for system integrity problems.

AimsTo test recommended implantable cardioverter defibrillator (ICD) follow-up methods by ‘in-person evaluations’ (IPE) vs. ‘remote Home Monitoring’ (HM).Methods and resultsICD 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.ConclusionAutomatic remote monitoring better preserves patient retention and adherence to scheduled follow-up compared with IPE.Clinical trial registrationNCT00336284.

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AimsAssess whether automatic remote home monitoring (HM) permits same-day evaluation of implantable cardioverter defibrillator (ICD) system dysfunction.Methods and resultsCompromised ICD system integrity (generator/lead) demands prompt evaluation. Home monitoring promises earlier discovery but may be limited by technological differences and follow-up mechanism. We tested whether HM enabled event review within 24 h, and contrasted differing messaging mechanisms. Nine hundred and eight patients in the TRUST prospective multicentre trial were followed by HM for 15 months. ICD system problems automatically triggered notifications: repeatedly (‘redundant’) for impedance deviations and elective replacement indication (ERI), but only a single transmission for ‘30 J ineffective’. Detection time from event onset to physician evaluation was measured. Forty-three system-related alerts occurred; 42% were asymptomatic, 42% were actionable, and 22 of 43 (51%) were viewed within 24 h. Redundant notifications were: 1 ERI, 9 shock impedance, 2 ventricular and 6 atrial pacing impedance. Most (11/18; 61%) were detected in <24 h. Others elicited daily notifications without interruption until resolution. For single transmissions, 11 of 25 (44%) events were detected on the same day. Most (56%, 14/25) were detected between 1 and 39 days (mean 10.0 ± 13.0 days). Ten of 14 events were detected by HM and 4 at the time of office visits. These observations suggest single transmissions were vulnerable to detection failure. Mean detection time of redundant events was 1.1 ± 1.8 vs. single transmission 5.6 ± 10.9 days (P = 0.05). Hence, redundant notification avoided late detection.ConclusionSame-day discovery of ICD dysfunction, even if asymptomatic, was achievable. For those events not evaluated within 24 h, repetitive messaging promoted earlier discovery. Reorganization of clinical follow-up methods may maintain early reaction ability.Clinical Trials registration informationClinicalTrials.gov; NCT00336284.