Follow-up Results of the TRUST Trial: Interview with Niraj Varma, MD, PhD, FRCP

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 (PWhat 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. How often are scheduled checks needed using Home Monitoring? In this trial, follow-up checks occurred at 3, 6, 9, 12, and 15 months after implantation. Home Monitoring was used before office visits at 3 and 15 months in the Home Monitoring group. At 6, 9, and 12 months, only Home Monitoring was used, but was followed by office visits if necessary. Hence, scheduled checks occurred every 3 months as required by the guidelines, but most did not require patients to attend in person. What can you tell us about your experience with Home Monitoring in your patients? Has Home Monitoring reduced the number of your scheduled and unscheduled office visits with patients? I would say that the results that were seen in the TRUST study mirror the real-world situation with patients who have the Home Monitoring system. The TRUST protocol received FDA approval in 2009 for remote management of ICD patients. In our institution, we see patients once yearly in person, check them with remote monitoring in between, and call them for any unusual events detected — even ones they may be unaware of. Hence, we only see patients when necessary. This scheme has made our busy device clinic much more efficient and enables us to manage our large patient volume. When a clinically relevant status change or device integrity issue arises in a patient, how does the Home Monitoring system respond? Arrhythmias were the most common causes for event notifications and device integrity issues a minority, which speaks for the high reliability of implanted systems. However, TRUST showed that Home Monitoring could rapidly identify such integrity problems as and when they occurred. The ability for rapid self-reporting of fault detection may be potentially lifesaving, especially for silent problems (e.g., lead fracture or device dysfunction), which compromise the device’s ability to perform its function, and which the patient may be unaware of. In these events, the patient’s physician received a notification via website alert or email and a BIOTRONIK call center. The three most common status changes in our study were reprogramming changes (76.2%, including increasing pacing output of >1V; Home Monitoring versus conventional, 22 versus 10; P=NS), medication changes (24.8%), and lead/system revision was most infrequent (4.0%). Tell us about the factors that were indicative of patient confidence in remote management. This study did not directly assess patients’ perspectives on remote evaluation, but we can certainly make some assumptions. No patients crossed over from Home Monitoring to conventional care during the study, which also speaks volumes about their sense of well-being and confidence. At the end of the study, 98% of patients decided to continue with this form of follow up rather than revert to conventional care with frequent in-person attendance. How has remote monitoring of cardiac devices evolved over the years? Home Monitoring has the ability to maintain near continuous surveillance and rapid self-reporting of fault detection, without patient or physician action. This may very well be lifesaving for “silent problems” such as lead fracture. Previously, we had no way of knowing in real time about lead fracture. This is a huge improvement in the technology. In heart failure patients prone to clinical decompensation, early identification of asymptomatic triggers (e.g., nonsustained VT or AF) or markers of deterioration may enable preemptive treatment. These are the objectives of future studies, with great potential for reducing patient morbidity and mortality. Do you anticipate automatic remote monitoring will eventually replace conventional in-office follow-up? No, there is no substitute for physician/patient interaction. TRUST did not control how often patients saw their doctors, but only the management of their implanted devices to retrieve and use their data efficiently without undue burden to the patient or physician. This is important, because devices collect so much crucial information regarding a patient’s condition (and their own function). Doctors will always see their patients, but this technology can free patients from feeling chained to their devices and having to plan (e.g., family events) around a recurring doctor visit just for this. Remote monitoring changes the paradigm. With Home Monitoring, doctors see their patients faster when they need to be seen, but not unnecessarily when all is well. The continuous surveillance of Home Monitoring is a safety net that can only be reproduced by daily in-person checks, which of course, is impossible for doctor or patient. Disclosure: The TRUST Study was sponsored by Biotronik, Inc.; Dr. Varma has received research grants and honoraria from Biotronik and other manufacturers in this space.