Rationale and design of a prospective study of the efficacy of a remote monitoring system used in implantable cardioverter defibrillator follow-up: the Lumos-T Reduces Routine Office Device Follow-Up Study (TRUST) study

Abstract

Increased implantable cardioverter defibrillator (ICD) implant volumes (and product advisories/recalls) pose management challenges. Most device interrogations at 3- to 6-month routine follow-up visits are "nonactionable," that is, require no clinically significant reprogramming, lead revision, or initiation or up-titration of antiarrhythmic medications. Conversely, implanted devices collect important diagnostic data (eg, atrial fibrillation onset, system integrity) that remain concealed between device interrogations. Remote monitoring may resolve some of these challenges, but has not been studied in a large-scale clinical trial. Home Monitoring (HM) uses automatic (without patient intervention) data and electrogram transmissions with rapid (<24 hours) event notification of significant (including silent) events. The Lumos-T Reduces Routine Office Device Follow-Up Study (TRUST) is a multicenter, prospective, randomized study enrolling 1000 ICD patients designed to test whether HM can safely reduce the number of scheduled nonactionable office device interrogations by 50% and provide early detection and notification of cardiac and/or device problems. After enrollment, TRUST patients are randomized 2:1 to either HM or to control (ie, HM off) arms and are seen for an in-office follow-up 3 months postimplant. At subsequent 3-month intervals, control patients have conventional office visits, whereas in HM, patient data are remotely retrieved and evaluated. In HM patients, early notification may automatically occur between periodic checks for compromised system integrity (battery, lead parameters, high-voltage circuitry) or arrhythmia occurrence (eg, atrial fibrillation, ventricular arrhythmia). All study patients will have a final office visit 15 months after implant. The results of TRUST may confirm the role of remote monitoring as an intensive surveillance mechanism for device management.