Appeal type: Experimental/Investigational
Decision: Upheld

Cardiac/Circulatory Problems/Coronary Artery Disease/CAD
Surgical Services (All)/Intracardiac Ischemia Monitoring System
The health plan denied the requested treatment as experimental/investigational. The health plan's determination is upheld.

This case involves a male with prior coronary artery disease (CAD), non-ST elevation myocardial infarction (NSTEMI), percutaneous coronary intervention (PCI), hypertension (HTN), hyperlipidemia, left bundle branch block (LBBB), and a previously implanted with intracardiac coronary ischemic monitoring system (AngelMed Guardian device) for coronary ischemia monitoring and early detection of acute coronary syndrome (ACS) events, given the patient's high risk cardiovascular status.

At issue is whether the proposed health service or treatment of insertion or replacement of Intracardiac Ischemia Monitoring System with Monitor, Cardiac, Including Intracardiac Lead and All System Componentsis likely to be more beneficial than any standard treatment or treatments for the insured's life threatening or disabling condition or disease.

I recommend that the health plan's determination be upheld, in whole, on the grounds the intracardiac coronary ischemia monitoring system in this case is of unproven benefit in this patient with LBBB and given the currently available limited published efficacy data.

Based upon the currently available published evidence on the efficacy of the AngelMed Guardian intracardiac coronary ischemia monitoring system, I do not believe it will more beneficial over current standards of care for treatment of this patient's ischemic heart disease.

The AngelMed intracardiac ischemic monitoring device is Food and Drug Administration (FDA) approved for use in patients who have had prior acute coronary events and remain at high risk for recurrent events. Published data from the ALERTS (AngeLmed Early Recognition and Treatment of STEMI) clinical trial, patients at high risk for recurrent ACS events were randomized to control (Alarms OFF) or treatment groups (Alarm ON) for 6 months. Patients with the alarms turned ON showed reduced delays to emergency department (ED) arrival, with 55% (95% confidence interval [CI]: 46% to 63%) of ED visits for ACS events < 2 hours compared with 10% (95% CI: 2% to 27%) in patients with Alarms OFF ((clinical significance) p < 0.0001). [1] In an additional analysis from the ALERTS multicenter, randomized trial, the primary safety endpoint was absence of system-related complications (>90%). The combined primary efficacy endpoint included cardiac/unexplained death, new Q-wave myocardial infarction, or detection to presentation time >2 hours. The primary safety endpoint was achieved with 96.7% freedom from device complications. The combined primary efficacy endpoint for an ACS event was not significantly reduced in patients with alarms ON compared to controls (16 of 423 [3.8%] vs. 21 of 428 [4.9%], posterior probability = 0.786). However, within a 90-day treatment window, alarms did significantly reduce detection to arrival time (51 minutes vs. 30.6 hours; . [2] Furthermore, this device has not been evaluated in patients with baseline LBBB such as this patient. Overall, given the currently available limited published data as discussed above in addition to this patient having a known LBBB, it remains uncertain if the AngelMED intracardiac coronary ischemia monitoring system will be more beneficial over current standards of care for cardiovascular (CV) monitoring in this high-risk patient.