Appeal type: Experimental/Investigational
Decision: Upheld

A 29-year-old male enrollee has requested ambulatory event monitor with real time analysis for treatment of his syncope. Findings:  Three physician reviewers found that there is limited data available in the medical literature regarding ambulatory cardiac event monitoring with real time analysis. At this time, there are no guidelines to assess the incremental diagnostic yield and subsequent improvement in clinical outcomes using this technology, especially in the initial evaluation of a first syncopal episode. The largest multi-center controlled trial to date using real time event monitoring included 266 patients with persistent symptoms who had previously undergone prior Holter monitoring which failed to diagnose an arrhythmia (Rothman and colleagues). They were then randomized to conventional external loop monitoring (self activated or loop activated monitor for symptoms) versus a real time continuous monitoring group. This did show a statistically significant difference in the diagnosis of arrhythmia in the real time monitoring group. Another retrospective analysis of 100 consecutive patients who were undergoing treatment for known arrhythmias using real time monitoring devices showed that a number of treatment changes were made based on findings from the real time monitors, but there was no follow-up to determine whether patient outcomes were improved as a result of this new information (Joshi and colleagues).No current guidelines/position statements specifically address the use of these real time devices for the initial evaluation and detection of infrequent arrhythmias or the appropriateness of their use relative to the non-real time monitoring alternatives (Strickberger and colleagues). The limited data currently available mostly involves patients who have had prior arrhythmia evaluations that have been negative and who have frequent persistent symptoms. The devices have also been used to monitor therapy following either drug or catheter ablation therapy for patients with known cardiac arrhythmias. The Agency for Healthcare Research and Quality in their review stated that, While this report did find evidence that certain remote cardiac monitoring technologies lead to changes in patient management, the available evidence was insufficient to allow conclusions about the impact of remote cardiac monitoring technologies on any patient-oriented outcomes. Future studies that focus on downstream patient-oriented outcomes would be useful for determining the true benefit of these technologies. Therefore, the use of an ambulatory event monitor with real time analysis in a patient without known prior arrhythmias, and when not used for monitoring the effectiveness of anti-arrhythmic drug or catheter ablation therapy, is not supported by the available scientific evidence. The initial standard of care remains Holter monitoring, if symptoms are frequent, or non-real time external event monitoring, if symptoms are infrequent. Subsequent consideration of ambulatory real time monitored devices might then be indicated in some patients if symptoms persist and no diagnosis is forthcoming from the conventional technologies. Such is not the case with this patient.