Appeal type: Experimental/Investigational
Decision: Overturned

Diagnosis: Cardiomyopathy
Treatment: LifeVest
The insurer denied the LifeVest.
The determination is upheld.

The patient had a recent onset of pre-syncope. He had a history of hypertension, hyperlipidemia and family history for coronary artery disease (CAD). His work up included an event monitor which revealed premature ventricular contractions (PVCs), couplets and short runs of non-sustained ventricular tachycardia (NSVT) and accelerated idioventricular rhythm. His coronary angiography revealed severe 3 vessel CAD and an ejection fraction of 30%. The patient underwent coronary artery bypass grafting (CABG). His postoperative period was unremarkable. The patient was discharged with a LifeVest.

The patient continued to recover from surgery without additional adverse events. He was followed by a cardiologist. The plan was to reassess his left ventricular ejection fraction (LVEF) 3 month post revascularization. If his ejection fraction (EF) improved to more than 40%, and he had no recurrent NSVT, he would not need any further work up. If his EF was still below 35%, he would have indications for implantable cardioverter defibrillator (ICD) implantation. If his EF was between 35-40%, then he would need an electrophysiologic (EP) study.

The LifeVest was requested for 3 months. At issue is whether the proposed health service or treatment, wearable cardiac defibrillator (WCD - LifeVest), was likely to be more beneficial than any standard treatment or treatments for the insured's life threatening or disabling condition or disease.

The proposed health service, WCD - LifeVest, was unlikely to be more beneficial than standard treatment of ischemic cardiomyopathy during the first 3 months post CABG. The patient was diagnosed with ischemic cardiomyopathy and underwent revascularization with CABG.

The patient had a low EF, less than 35%. He was at risk for sudden cardiac death. For sudden cardiac death prevention, ICD implantation has been shown to be effective. However, because there is likelihood that the guideline directed medical therapy (GDMT) for 90 days post CABG might be sufficient to improve left ventricular (LV) function, it is recommended to treat the patient for 90 days with GDMT, and repeat LV function assessment (echocardiogram) to determine if ICD implantation is still indicated, in 90 days.

LifeVest, or wearable defibrillator, could be applied during these 90 days for sudden death protection. However the benefit of LifeVest (in contrast to ICD) was never demonstrated in randomized clinical trials. There were no prospective randomized clinical trials which would clearly support benefit of LifeVest versus GDMT.

Based on the most current guidelines (see reference), WCD - LifeVest for primary sudden death prevention is considered class II (b). Therefore, a LifeVest should be considered not indicated for this patient.

Below is a paragraph from the first reference:
"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."