Multi-Centre Randomised Controlled Trial of a Smart Phone Based Event Recorder Alongside Standard Care Versus Standard Care for Patients Presenting to the Emergency Department with Palpitations and Pre-Syncope: The IPED (Investigation of Palpitations in the Ed) Study

Abstract

Background: Patients with palpitations and pre-syncope commonly present to Emergency Departments (EDs) but underlying rhythm diagnosis is often not possible during the initial presentation. This trial compares the symptomatic rhythm detection rate of a smart phone based event recorder (AliveCor) alongside standard care versus standard care alone, for participants presenting to the ED with palpitations and pre-syncope with no obvious cause evident at initial consultation. Methods: Multi-centre open label, randomised controlled trial. Participants ≥16 years old presenting to 10 UK hospital EDs were included. Participants were randomised to either (a) intervention group; standard care plus the use of a smart phone based event recorder or (b) control group; standard care alone. Primary endpoint was symptomatic rhythm detection rate at 90 days. Findings: 243 participants were recruited over an 18-month period. A symptomatic rhythm was detected at 90 days in 69 (n=124; 55.6%; 95% CI 46.9-64.4%) participants in the intervention group versus 11 (n=116; 9.5%; 95% CI 4.2-14.8) in the control group (p<0.0001). Mean time to symptomatic rhythm detection in the intervention group was 9.5 days (SD 16.1, range 0-83) versus 42.9 days (SD 16.0, range 12-66; p<0.0001) in the control group. Commonest symptomatic rhythms detected were sinus rhythm, sinus tachycardia and ectopic beats. A symptomatic cardiac arrhythmia was detected at 90 days in 11 (n=124; 8.9%; 95% CI 3.9-13.9%) participants in the intervention group versus 1 (n=116; 0.9%; 95% CI 0.0- 2.5%) in the control group (p=0.006). The overall median healthcare utilisation cost was £108 more per patient in the intervention group but £921 less per patient per symptomatic rhythm. Interpretation: Use of a smart phone based event recorder increased the symptomatic rhythm detection rate over five fold at 90 days and should form be considered as part of on-going care to all patients presenting to EDs with unexplained palpitations or pre-syncope. Clinical Trial Number: Trial registration number NCT02783898 (ClinicalTrials.gov). Funding Statement: This study was funded by research awards from Chest, Heart and Stroke Scotland (CHSS) and British Heart Foundation (BHF) which included funding for purchasing the devices. MR was supported by an NHS Research Scotland Career Researcher Clinician award Declaration of Interest: The authors declare that they have no competing interests and no financial interest in the device used in this study. AliveCor had no involvement in the study. Ethics Approval Statement: A favorable ethical opinion was obtained from the South East Scotland Research Ethics Committee 02 (REC reference: 16/SS/0074) and from the HRA.