Neil Sulke1, Conn Sugihara2, Paul Hong2, Nik Patel2, Nick Freemantle3. 1. Cardiology Research Department, Eastbourne General Hospital, Kings Drive, East Sussex Healthcare NHS Trust, East Sussex BN21 2UD, UK neil.sulke@nhs.net. 2. Cardiology Research Department, Eastbourne General Hospital, Kings Drive, East Sussex Healthcare NHS Trust, East Sussex BN21 2UD, UK. 3. Department of Primary Care and Population Health, University College London, London, UK.
Abstract
AIMS: 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). METHODS AND 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. Published on behalf of the European Society of Cardiology. All rights reserved.
RCT Entities:
AIMS: 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). METHODS AND 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. Published on behalf of the European Society of Cardiology. All rights reserved.
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