Appeal type: Experimental/Investigational
Decision: Overturned

The patient is a male with a history of tobacco abuse.  He developed heart failure with reduced ejection fraction (HFrEF), and subsequent workup revealed severe 3 vessel coronary artery disease and ischemic cardiomyopathy, with left ventricular ejection fraction (LVEF) 10-15% on multiple echocardiograms and on magnetic resonance imaging (MRI) (12%). Cardiac MRI also revealed a left anterior descending artery (LAD) not amenable to percutaneous coronary intervention (PCI), but viable myocardium was noted in that territory, and he subsequently underwent coronary artery bypass grafting (CABG) x1 involving the left internal mammary artery (LIMA) to the LAD, with incidental excision of the left atrial appendage. Electrophysiology recommended automated implantable cardiac defibrillator (AICD) if LVEF did not improve after CABG.
Appropriate medical therapy, including aspirin, atorvastatin, lisinopril, carvedilol, spironolactone, and furosemide was in place throughout, other than during a brief perioperative period when he required balloon pump and pressor support. Postoperative LVEF was unchanged, and electrophysiology recommended a LifeVest (an automatic external defibrillator, or AED) for the initial postoperative period, with consideration for AICD if LVEF did not improve within that time. AICD is contraindicated during the first three months after a revascularization procedure, as the hope is that LVEF will improve to greater than (>) 35% during that period, making the AICD and its associated risk unnecessary.
This review is focused on the use of the AED.
CentraCare Health, in Minneapolis MN, the facility in which the AED was placed, included the Medicare/CMS guidelines for use of AED, which is relevant for procedures performed and therefore applicable to the care of this patient. Those guidelines cover the use of an AED to prevent sudden cardiac death if any of certain conditions are met. Number three in this list of conditions includes dilated cardiomyopathy with LVEF < 36%, which does apply to this patient, as well as a requirement that the patient has been evaluated face to face within 6 months of the AED use, which also applies to this patient.
The records submitted for review include Hauptman's article in support of the use of AEDs, although it is concerned with the benefits of beta (B)-blockers (which this patient received in the form of carvedilol) for preventing the need for AICD in ischemic cardiomyopathy. An editorial by Kadish indicates the benefits of ICD for persistent ischemic cardiomyopathy, but mentions the fact that ICD use immediately after myocardial infarction (MI) has no protective benefit. This editorial references two landmark trials, SCD-HEFT and DEFINITE, which demonstrated the benefits of ICD in patients with ischemic cardiomyopathy.
None of these references support the use of an AED, however, or of any form of defibrillator during the early postoperative period. Brady's article showed that patients who survived an anterior wall MI (which was not the case in this patient), there was no mortality benefit to an AED. The WEARIT and BIROAD studies , with a total of approximately (~)300 patients, showed that an AED was safe and effective in terminating ventricular tachycardia (ventricular tachycardia (VT))/ventricular fibrillation (VF), but these studies were not powered to demonstrate differences in mortality, and compliance was low, which may have confounded the outcomes.
Note that many of these studies apply to populations after MI, which are not specifically relevant to this patient, although it is not unreasonable to generalize the findings in these studies to any form of ischemic cardiomyopathy.
The Excellus narrative includes mention of the WEARIT-II trial, which showed similar findings. The DINAMIT study, in which AICDs were implanted in the early post-MI period for patients with ischemic cardiomyopathy, showed no survival benefit, and the MADIT II (secondary analysis) showed a similar finding, as did the VEST trial. Note that the DINAMIT trial did show an improvement in arrhythmia-related deaths with AICD, but not overall death, as other causes of death were increased. Excellus' conclusion is that there is no evidence of improved clinical outcomes with an AED.
Excellus submitted their medical policy regarding AICDs (#7.01.06), which was not directly relevant to this patient's use of an AED. However, they also submitted their policy regarding AEDs (1.01.42), which are indicated for patients who meet the criteria for AICD but who have contraindications to their use.
Zoll (the makers of LifeVest, the AED in used in this case), submitted documentation indicating an ACC/AHA class IIb indication for AED in high-risk ischemic cardiomyopathy patients such as the patient in this case. They also point to Kadish, DEFINITE, WEARIT-II. They indicate that three patients a day have their life saved by a LifeVest.

The health plan's determination is upheld.

Based on the available data, there is evidence that an AED offers the following benefits: It is safe and effective for identifying and treating ventricular tachyarrhythmias in high risk patients, such as the patient in this case. It was presumably for this reason (and perhaps to help guide future decisions regarding the need for an AICD) that an AED was recommended and utilized for this patient, presumably with the best of intentions.
However, there is no evidence that the benefits provided by an AED lead to improved overall mortality. There are also no compelling data demonstrating improvement in other meaningful outcomes with AED, when compared to optimal medical therapy alone, as indicated by the literature review above. This patient was receiving appropriate medical therapy.
There is therefore no evidence that the service is likely to be more beneficial than any standard treatment for this patient based on the peer-reviewed literature.