Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Myocardial infarction

Treatment: Automatic Wearable Defibrillator (Procedure code K0606)

The insurer denied coverage for the Automatic Wearable Defibrillator (Procedure code K0606).

The denial is upheld. 

This is a male patient who complained of left-sided chest pain. The patient had a cardiac arrest while in the ambulance being transported to the hospital. The patient was resuscitated in the Emergency Department (ED), intubated and immediately taken to the catheterization laboratory. The patient's past medical history included renal transplantation, diverticulitis, pancreatitis, hypertension, and benign prostatic hypertrophy (BPH). The patient had an emergent coronary angiogram done following Direct Current Cardioversion (DC shock) in the ED and administration of amiodarone. The patient's angiogram showed that the left main was large and had no stenosis. There was a significant stenosis in the proximal left anterior descending (LAD), which was treated with percutaneous coronary intervention (PCI). The conclusion stated that the patient had two vessel coronary artery disease (CAD) with anterior-lateral ST-elevation infarction with ventricular tachycardia (VT)/ Ventricular fibrillation (VF) arrest. The patient's echocardiogram showed that his left ventricular (LV) systolic function was reduced and was at 25-30%. This systolic function was worse than that noted on a prior study, when the ejection fraction was 35-40%. There was severe hypokinesis of the entire anterior, mid anterior septal, septal and apical myocardium regions noted. The discharge summary listed the principal diagnosis as cardiac arrest secondary to ST-segment elevation myocardial infarction (STEMI). Secondary diagnoses included systolic heart failure, history of supraventricular tachycardia (SVT), status post renal transplant, hypertension and BPH. The plan was to have the patient fitted with the LifeVest after he arrived at home.

A 2016 American Heart Association (AHA) Science Advisory states that despite their obvious benefits, current defibrillator technologies have limitations and risks. Wearable Cardioverter Defibrillators (WCDs) can serve as a temporary means of aborting arrhythmic death in patients with transient risk of sudden cardiac death (SCD) or those with indications for implantable cardioverter-defibrillator (ICD) implantation who have a transient barrier to permanent device implantation.  Further research, including randomized trials, is needed to better inform the optimal use of WCD therapy. 

The New England Journal of Medicine (2018) published the Vest Prevention of Early Sudden Death Trial (VEST). This study randomly assigned (in a 2:1 ratio) patients with acute myocardial infarction and an ejection fraction of 35% or less to receive a wearable cardioverter-defibrillator plus guideline-directed therapy (the device group) or to receive only guideline-directed therapy (the control group). The investigators concluded that among patients with a recent myocardial infarction and an ejection fraction of 35% or less, the wearable cardioverter-defibrillator did not lead to a significantly lower rate of the primary outcome of arrhythmic death than control.

This patient has CAD and had STEMI complicated by VF arrest. The patient's ejection fraction which had been 35% on admission decreased to 25 % at the time of discharge. Based on literature review, there is lack of support that there is benefit of the LifeVest in this type of patient. The VEST trial showed that this type of patient had no survival or event benefit from the LifeVest. There is no evidence that this patient had an ICD removed because of infection or lead displacement or was on a waiting list for a heart transplant. Thus, LifeVest is not likely to be more beneficial than any of the standard treatments/procedures for this patient.

The carrier's denial of coverage for the Automatic Wearable Defibrillator (Procedure code K0606) should be upheld.