Aims: Implantable loop recorders (ILR) provide an opportunity to record ECG data from a spontaneous syncopal event. We conducted a randomized study to investigate the impact of the Reveal Plus ILR on an unselected population of patients with recurrent syncope. Initial follow-up (at least 6 months) did not demonstrate a reduction in syncopal events or an improvement in quality of life. We report the planned extension of follow-up to 18 months.
Methods and results: All patients presenting acutely with recurrent unexplained syncope over a 16-month period, following a basic clinical work-up, were randomized to receive the ILR or conventional investigation and management. A total of 421 patients presented, 201 were eligible, median age 74, (IQ range 61-81) 54% female, with median syncopes 3 (IQ range 2-6). Median follow-up 17 months (IQ range 9-23). 42 (43%) of ILR patients and 8 (6%) of conventional patients received an ECG diagnosis (hazard ratio 6.53, 95% CI 3.73-11.4, P<0.001). Time to second syncope was significantly longer for ILR patients, although of borderline significance (P=0.04). A greater variety of diagnoses and treatments were seen in ILR patients. ILR patients had fewer post-randomization investigations and fewer days in hospital; however, cost savings were not statistically significant. There was improved quality of life in the ILR group (visual analogue scales, P=0.03) for general wellbeing. Overall mortality was 12% with no difference between the two groups.
Conclusion: Investigation by the ILR significantly increases the diagnostic rate and ECG directed treatments in a typical unselected syncopal population. Long-term follow-up has demonstrated a significant subsequent reduction in syncopal events with improved quality of life.