Long-Term Continuous Ambulatory ECG Monitors and External Cardiac Loop Recorders for Cardiac Arrhythmia: A Health Technology Assessment.

BACKGROUND: Ambulatory electrocardiography (ECG) monitors are often used to detect cardiac arrhythmia. For patients with symptoms, an external cardiac loop recorder will often be recommended. The improved recording capacity of newer Holter monitors and similar devices, collectively known as longterm continuous ambulatory ECG monitors, suggests that they will perform just as well as, or better than, external loop recorders. This health technology assessment aimed to evaluate the effectiveness, cost-effectiveness, and budget impact of longterm continuous ECG monitors compared with external loop recorders in detecting symptoms of cardiac arrhythmia.

METHODS: Based on our systematic search for studies published up to January 15, 2016, we did not identify any studies directly comparing the clinical effectiveness of longterm continuous ECG monitors and external loop recorders. Therefore, we conducted an indirect comparison, using a 24-hour Holter monitor as a common comparator. We used a meta-regression model to control for bias due to variation in device-wearing time and baseline syncope rate across studies. We conducted a similar systematic search for cost-utility and cost-effectiveness studies comparing the two types of devices; none were found. Finally, we used historical claims data (2006-2014) to estimate the future 5-year budget impact in Ontario, Canada, of continued public funding for both types of longterm ambulatory ECG monitors.

RESULTS: Our clinical literature search yielded 7,815 non-duplicate citations, of which 12 cohort studies were eligible for indirect comparison. Seven studies assessed the effectiveness of longterm continuous monitors and five assessed external loop recorders. Both types of devices were more effective than a 24-hour Holter monitor, and we found no substantial difference between them in their ability to detect symptoms (risk difference 0.01; 95% confidence interval -0.18, 0.20). Using GRADE for network meta-analysis, we evaluated the quality of the evidence as low. Our budget impact analysis showed that use of the longterm continuous monitors has grown steadily in Ontario since they became publicly funded in 2006, particularly since 2011 when monitors that can record for 14 days or longer became funded, and the use of external cardiac loop recorders has correspondingly declined. The analysis suggests that, with these trends, continued public funding of both types of longterm ambulatory ECG testing will result in additional costs ranging from $130,000 to $370,000 per year over the next 5 years.

CONCLUSIONS: Although both longterm continuous ambulatory ECG monitors and external cardiac loop recorders were more effective than a 24-hour Holter monitor in detecting symptoms of cardiac arrhythmia, we found no evidence to suggest that these two devices differ in effectiveness. Assuming that the use of longterm continuous monitors will continue to increase in the next 5 years, the public health care system in Ontario can expect to see added costs of $130,000 to $370,000 per year.