Remote Monitoring of ICDs: The TRUST Study, Interview with Niraj Varma, MD, FRCP

The purpose of the TRUST (Lumos-T Safely Reduces Routine Office Device Follow Up) study is to test whether remote monitoring is safe and effective for ICD follow up. In this feature interview, we speak with Dr. Niraj Varma, TRUST principal investigator, Cleveland Clinic.

Tell us about the TRUST Study. What was the purpose of this study? The study endpoints are designed to show that with BIOTRONIK’s Home Monitoring (HM) technology, office visits for patients can be reduced without compromising the well-being of the patients, and at the same time facilitate early detection of significant clinical problems. The obvious benefit of this is a reduction in the clinic load for the physician, as well as decreasing the hassle of coming into the office for the patients.

Is enrollment complete? How many patients were enrolled? What was the patient inclusion criteria? Yes, enrollment completed on February 29, 2008. There were 1,516 patients enrolled at 105 sites in the U.S. and Canada. The patient inclusion criteria was implantation with a single or dual chamber ICD and those patients who were not pacemaker dependent.

Describe the BIOTRONIK Home Monitoring system and IEGM Online®. How does each technology work, and what makes them unique? In addition, are they only compatible with BIOTRONIK's Lumos and Lumax ICDs? Currently available remote monitoring technologies differ in operation. The earliest systems required patient-driven communication, whereby wand-derived data was relayed via telephone connections to following facilities. However, these are vulnerable to missing asymptomatic events. In contrast, a fully automatic transmission path not dependent on patient or physician interaction is advantageous. The implanted device wirelessly transmits stored data on a daily basis to a mobile communicator (typically placed on a nightstand), which then relays these data to a processing center, which passes trend data to the website available for review at any time by the following clinic. Critical event data (e.g., arrhythmia onset or device integrity) are transmitted separately and flagged for attention. Such a system has the ability to rapidly bring to attention significant data, enabling clinically appropriate intervention. Most manufacturers are moving towards this model, but published data for technical efficacy exists only for Biotronik HM.

Explain the study methods and design. This is a prospective, randomized study with two arms — HM and control. Patients are randomized in a 2:1 ratio to HM or conventional (HM off) groups. All patients have scheduled follow-ups at 3, 6, 9, 12 and 15 months post implant, and unscheduled (interim) evaluations as needed. Patients in the control arm are evaluated conventionally with in-office follow ups. Patients in the HM arm have HM checks followed by office visits at 3 and 15 months. At 6, 9, and 12 months and for interim visits, HM patients are evaluated using HM alone, and office visits only if the investigator deems this necessary. Scheduled and unscheduled OVs (including responses to HM event notifications) are quantified for each individual patient per year (pt yr) of follow up.

What are some of the benefits of the BIOTRONIK Home Monitoring system? Physicians would only need to see patients for needed events, and would also see them sooner for a detected event. Hence, unnecessary follow up is avoided and necessary in-office evaluation is facililated. This provides advantages for both the patient and physician.

What are some of the ways in which home ICD monitoring differs from office follow-up?  Currently implanted devices have extensive self-monitoring ability, and may diagnose and record important diagnostic information. When asymptomatic events occur (e.g., lead or device malfunctions, which are typically silent), these data remain in diagnostic memory and are accessed only at interrogation. Therefore, the weak link in the chain of events from event to physician evaluation is retrieval of retained data. Remote monitoring may provide the key to data access and enable prompt communication directly with follow-up services. Patients do not need to come to the hospital as often, and can feel secure that their devices are being monitored continuously and will notify services even if a silent, asymptomatic problem occurs.

In general, how often do ICD patients need to be interrogated? Current guidelines recommend every 3-6 months. TRUST demonstrates that office follow-up can be reduced to one per year safely. TRUST has demonstrated that HM safely reduces the number of office follow-ups by 43%, and is a safe alternative to conventional care.

When will this technology be available for use? Home Monitoring with IEGM Online is currently FDA-approved and available in BIOTRONIK pacemakers, ICD and CRT devices.

Is there anything else you’d like to add? HM also provides the benefit of improving adherence to scheduled follow-up checks, presumably because patient data may be monitored remotely anytime and from anywhere, as opposed to in the conventional arm, which relies on patients to present themselves physically in their physician's office. Additionally, HM reduces the time from onset to physician evaluation by as much as 75% for significant problems such as VF.