title: The benefit of a remotely monitored implantable loop recorder as a first line investigation in unexplained syncope: the EaSyAS II trial.
abstract: OBJECTIVE
  This prospective randomized controlled study evaluated the first-line use of a novel remotely monitored implantable loop recorder (ILR) in the initial investigation of unexplained syncope, and compared this to conventional therapy and a dedicated Syncope Clinic (SC).
  
  
  RESULTS
  A total of 246 patients (mean age 70.3 years) were randomly allocated to conventional management, SC alone, ILR alone, or SC + ILR. Median follow-up was 20 months (IQR 15-25 months). Time to electrocardiogram (ECG) diagnosis was significantly shorter with ILR alone vs. conventional [hazard ratio (HR) 35.5, P = 0.0004] and with SC vs. conventional (HR 25.6, P = 0.002). Seventy-four per cent of first syncopal events documented in the SC groups occurred during provocative tilt testing. Twenty-two per cent of patients who received an ILR were found to have a bradycardia indication for permanent pacing, compared with 3% of patients who did not. Overall, more investigative tests were undertaken in the conventional group than in any other. Only patients who received an ILR had a significant increase in time to second syncope (P = 0.02), suggesting successful diagnosis and management of treatable causes of syncope.
  
  
  CONCLUSIONS
  Implantable loop recorder monitoring achieved a more rapid diagnosis in unexplained syncope than usual care. Conventional management of syncope failed to achieve an ECG diagnosis despite a large number of investigative tests. Syncope Clinic and provocative tilt testing delivered a rapid ECG diagnosis, but did not prevent recurrent syncope. Implantable loop recorders offered rapid diagnosis, increased the likelihood of syncope being reported, demonstrated a high rate of intermittent bradycardia requiring pacing, and reduced recurrent syncope.
authors.affiliation: Cardiology Research Department, Eastbourne General Hospital, Kings Drive, East Sussex Healthcare NHS Trust, East Sussex BN21 2UD, UK neil.sulke@nhs.net.
authors.forename: Neil
authors.initials: N
authors.lastname: Sulke
authors.affiliation: Cardiology Research Department, Eastbourne General Hospital, Kings Drive, East Sussex Healthcare NHS Trust, East Sussex BN21 2UD, UK.
authors.forename: Conn
authors.initials: C
authors.lastname: Sugihara
authors.affiliation: Cardiology Research Department, Eastbourne General Hospital, Kings Drive, East Sussex Healthcare NHS Trust, East Sussex BN21 2UD, UK.
authors.forename: Paul
authors.initials: P
authors.lastname: Hong
authors.affiliation: Cardiology Research Department, Eastbourne General Hospital, Kings Drive, East Sussex Healthcare NHS Trust, East Sussex BN21 2UD, UK.
authors.forename: Nik
authors.initials: N
authors.lastname: Patel
authors.affiliation: Department of Primary Care and Population Health, University College London, London, UK.
authors.forename: Nick
authors.initials: N
authors.lastname: Freemantle
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001919:Bradycardia / Q000175:diagnosis*; D015716:Electrocardiography, Ambulatory / Q000295:instrumentation*; D004567:Electrodes, Implanted; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010138:Pacemaker, Artificial; D016016:Proportional Hazards Models; D011446:Prospective Studies; D012008:Recurrence; D013575:Syncope / Q000209:etiology* / Q000628:therapy*; D018667:Tilt-Table Test; D006113:United Kingdom
keywords: Implantable loop recorder; Syncope