Tell us about the completion of the TRUST trial (Lumax-T/Lumos-T Safely RedUceS RouTine Office Device Follow-Up). What did final results show?
Post-implant monitoring is an essential part of the management of patients receiving implantable cardiac electronic devices but optimal method is uncertain. The TRUST trial tested and compared conventional monitoring with in-person evaluations to continuous remote Home Monitoring technology in a large patient population with freshly implanted ICDs. This is the first and largest study to test the ability of remote monitoring to maintain comprehensive surveillance and reduce unnecessary hospital evaluations, yet permit rapid detection of symptomatic and asymptomatic cardiac events in patients with implantable heart pacing and arrhythmia devices.

In total, 1,339 patients were randomized to Home Monitoring or to conventional follow-up. Conventional patients were evaluated with office visits only. Scheduled office visits and unscheduled evaluations, incidence of adverse events including patient morbidity and mortality, and time elapsed from first event occurrence in each patient to physician evaluation were tracked for each group.

Regarding demographics, the Home Monitoring and conventional patients were similar and typical of an ICD population from 2005-2008 (age, 63.3 ± 12.8 versus 64.0 ± 12.1 years; gender, 72.0% versus 73.1% male; New York Heart Association class II, 55.9% versus 60.4%; pathology: left ventricular ejection fraction, 29.0 ± 10.7% versus 28.5 ± 9.8%; coronary artery disease, 64.8% versus 71.7%; primary prevention indication, 72.2% versus 73.8%; and dual-chamber implants, 57.8% versus 56.6%).

The results showed that Home Monitoring reduced total in-hospital device evaluations by 45% without compromising patient safety. In the Home Monitoring group, 85.8% of all 6-, 9-, and 12-month follow-ups were performed remotely only, indicating that Home Monitoring provided sufficient assessment in the majority. At the same time, important events were evaluated in a median time of less than 2 days in the Home Monitoring group compared with 36 days in the conventional group (P<0.001).

What is significant about this trial? How were total hospital encounters reduced by Home Monitoring?
Our trial demonstrated a reduction of in-hospital evaluations by 45%. That is an enormous reduction in hospital visits. This is because the vast majority of regular checks do not require any adjustment in the patient’s device or medications, and can be quickly and easily checked online by the following physician or device specialist without having to call the patient in unnecessarily. This alleviates both patient and physician burden. Unscheduled assessments may also be facilitated (e.g., checks required between regularly scheduled evaluations may be performed online and patients reassured or asked to come in, as the case may be). Many patients found that the continuous monitoring provided peace of mind. Rather than rushing to the hospital, patients with Home Monitoring can call their cardiologist, who can put them at ease based on the constant flow of data from the Home Monitoring system. The cost savings from averted hospital visits is difficult to calculate, but not insignificant.