European Heart Journal Advance Access originally published online on November 28, 2005
European Heart Journal 2006 27(3):351-356; doi:10.1093/eurheartj/ehi602
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The clinical impact of implantable loop recorders in patients with syncope
1Department of Cardiology, Eastbourne District General Hospital, King's Drive, Eastbourne, East Sussex, UK
2Department of Primary Care and General Practice, University of Birmingham, UK
Received 29 November 2004; revised 21 September 2005; accepted 29 September 2005; online publish-ahead-of-print 28 November 2005.
* Corresponding author. Tel: +44 1323 417400; fax: +44 1323 414993. E-mail address: djfarwell{at}bigfoot.com
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.
Key Words: Syncope • Implantable loop recorder • Cost effectiveness
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