Efficacy and Safety of Automatic Remote Monitoring for Implantable Cardioverter-Defibrillator Follow-Up

Abstract

Background-Monitoring implantable cardiac device function and patient condition is important. The Lumos-T SafelyReduces Routine Office Device Follow-Up (TRUST) trial tested the hypothesis that remote home monitoring with automatic daily surveillance (HM) is safe and effective for implantable cardioverter-defibrillator follow-up for 1 year and enables rapid physician evaluation of significant events. Methods and Results-In total, 1339 patients were randomized 2:1 to HM or conventional follow-up. Follow-up checks occurred at 3, 6, 9, 12, and 15 months after implantation. HM was used before office visits at 3 and 15 months in the HM group. At 6, 9, and 12 months, HM only was used but was followed by office visits if necessary. Conventional patients were evaluated with office visits only. Scheduled office visits and unscheduled evaluations, incidence of morbidity, and time elapsed from first event occurrence in each patient to physician evaluation were tracked for each group. HM and conventional patients were similar (age, 63.3Ϯ12. 2 However, clinical practice is inconsistent. Follow-up schedules vary according to facility, physician preference, and available resources. Expert consensus advocates 3-to 6-month clinic checks with increased frequency in response to product advisories and recalls. 2 Efficacy of this schedule with regard to patient safety, adherence, incidence of unscheduled encounters, and rate of problem detection remains untested. A major limitation of conventional follow-up, regardless of frequency, is the absence of monitoring between hospital interrogations, which accounts for the majority of the time. Hence, recorded data remain concealed for extended periods. This is important if clinical intervention based on these data would preempt patient morbidity/mortality, as may be the case with product advisories. Increased frequency of evaluation of a large patient population with a low incidence of problems challenges both patient compliance and clinic follow-up capacity. A mechanism for performing continuous surveillance and rapid problem identification notification, without overburdening device clinics, is desirable. Editorial see p 319 Clinical Perspective on p 332Currently available remote technologies differ operationally. Some rely on patient-initiated communication on a scheduled calendar basis. 5-7 These risk missing interim asymptomatic problems. In contrast, remote home monitoring (HM) performs daily self-checks with a fully automatic transmission path independent of patient or physician interaction. 8 -10 Stored ICD data are relayed every 24 hours and delivered as trend data for Web site review. Critical events (eg, arrhythmia onset or compromised device integrity) are transmitted separately and flagged for attention. Technical reliability (preservation of data integrity during transmission and early notification ability) of HM and feasibility for remote follow-up have been demonstrated in preliminary evaluations. 8,9 This system offers the advantages of providing nearly continuous arrhyt...

Remote patient management using implantable devices

“…The clinical value of remote monitoring using wireless ICDs was evaluated recently in a randomized control trial [5]. The TRUST trial was a prospective (non-inferiority) trial, which compared the safety and efficacy of the Biotronik remote home monitoring with quarterly in-office evaluation in a cohort of 1,450 non-pacemaker-dependent patients following single-or dual-chamber ICD implantation.…”

Cardiolaminopathies from bench to bedside: challenges in clinical decision-making with focus on arrhythmia-related outcomes

“…Several trials demonstrated that remote control is safe and reduces delay in detection of events such as atrial fibrillation and worsening heart failure [63,65,66]. The MORE CARE randomized trial revealed a median 27-day reduction in delay from actionable event detection to medical decision in the device group with remote control compared to a control group without remote data transmission [63].…”

2013 ESC Guidelines on Cardiac Pacing and Cardiac Resynchronization Therapy

“…Este Grupo de Trabajo respalda ese documento y considera que hay evidencia suficiente para hacer la siguiente recomendación [174][175][176] .…”