ESC Congress 2016 - 16

clINIcAl TRIAl HIgHlIgHTs (HF) services, it is not likely that weekly remote monitoring of cardiac implantable electronic devices (CIEDs; ie, implantable cardioverter defibrillator [ICD]; cardiac resynchronization therapy implantable cardioverter defibrillator [CRT-D], cardiac resynchronization therapy pacemaker [CRT-P]) will significantly improve patient outcomes. Despite therapeutic advances, patients with HF remain at high risk of death and hospitalization. Many of these patients have CIEDs that are capable of providing data about a patient's condition through remote monitoring. The purpose of the REM-HF study was to evaluate the clinical and economic value of weekly remote monitoring of data collected from CIEDs compared with usual care. This was a multicenter, randomized (1:1), nonblinded, parallel trial conducted in 9 cardiac centers in the United Kingdom between September 2011 and March 2014. The study included adult HF patients who were stable on optimal medical therapy for ≥ 6 weeks before recruitment and had a CIED implanted for ≥ 6 months that was functionally optimized and capable of being remotely monitored [Morgan JM et al. Eur J Heart Fail. 2014]. Study participants were randomized to weekly remote monitoring of the physiologic information available from their CIED (Table 1) plus usual care (n = 826) or usual care alone (n = 824) and followed for a median of 2.8 years. Table 1. Physiologic Variable Measure by CIED and Used to Guide Interventions Medtronic Boston Scientific St Jude Medical Biventricular pacing % Biventricular pacing % Biventricular pacing % Nocturnal heart rate - - Thoracic impedance - Thoracic impedance (if programmed on) Activity levels Activity levels Activity levels AT/AF burden AT/AF burden AT/AF burden Ventricular arrhythmias Ventricular arrhythmias Ventricular arrhythmias Therapy from device Therapy from device Therapy from device Heart rate variability Heart rate variability (SDANN) - Table 2. Actions Taken in Response to Remote Monitoring No. of Incidences No. of Subjects Impacted (%) 3534 599 (72.5) Phoned patient 2378 520 (62.9) Discussed download with clinician 1390 409 (49.4) Medication change by remote monitor without medical contact 226 134 (16.2) Advised patient to contact general practitioner 206 124 (15.0) Advised patient to visit heart failure clinic 8 113 (13.7) Remote monitor took action Action(s) taken* Lead integrity Lead integrity Lead integrity 202 (24.5) Device programming Device programming Advised patient to attend device clinic 328 Device programming V-V interval at time of D/L V-V interval at time of D/L V-V interval at time of D/L Advised patient to visit cardiovascular outpatient clinic 178 109 (21.5) Other advice to patient 632 274 (33.3) AF, atrial fibrillation; AT, atrial tachycardia; CIED, cardiac implantable electronic devices; D/L, download; SDANN, measure of changes in heart rate due to cycles > 5 minutes; V-V, interventricular delay. 16 The primary study endpoint was time to first event of allcause death or unplanned hospitalization for cardiovascular (CV) reasons. Secondary endpoints included the individual components of the primary outcomes, death from CV reasons, unplanned all-cause hospitalization, composite of death from CV reasons or unplanned hospitalization for CV reasons. Study participants had a mean age 69 years, 86% were men, mean left ventricular ejection fraction was about 30%, and the majority of participants (70%) had a prior history of coronary artery disease as well as NYHA class II symptoms. Types of CIEDs included ICD (33%), CRT-D (about 54%), and CRT-P (about 13%). More than 90% of patients were receiving an angiotensin-converting enzyme inhibitor or angiotensin receptor blockers as well as ß-blockers and about 53% were receiving an aldosterone antagonist. Based on CIED monitoring, there were 3534 clinical actions in 599 of 824 subjects (72.5%; Table 2). Despite these actions, the rates of the primary endpoint of all-cause mortality or CV hospitalization were not significantly different from those seen in patients receiving usual care only (HR, 1.01; 95% CI, 0.87 to 1.18; P = .87). Nor was there any meaningful difference in the components of the primary endpoint, including mortality (HR, 0.83; 95% CI, 0.66 to 1.05; P = .12) and unplanned CV hospitalization (HR, 1.07; 95% CI, 0.91 to 1.25; P = .42). There were no significant differences between the 2 groups on any of the secondary endpoints and there was no suggestion that any subgroup would benefit from weekly remote-monitoring guided therapy. October 2016 *Not mutually exclusive categories. medicom-publishers.com/mcr http://www.medicom-publishers.com/mcr

Table of Contents for the Digital Edition of ESC Congress 2016