Appeal type: Experimental/Investigational
Decision: Overturned

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

The patient was evaluated for recurrent near syncopal spells. An echocardiogram showed a left ventricular ejection fraction of 25-30% with regional wall motion abnormalities. Electrocardiographic monitoring showed runs of nonsustained ventricular tachycardia. Cardiac catheterization showed multi-vessel disease. The patient underwent coronary artery bypass graft surgery. At discharge, a LifeVest wearable cardioverter defibrillation (WCD) was prescribed. At issue is whether the WCD (LifeVest) is likely to be more beneficial than any standard treatment or treatments for the insured's life threatening or disabling condition or disease.

The wearable cardiac defibrillator (LifeVest) is likely to be more beneficial than any standard treatment or treatments for the insured's life threatening or disabling condition or disease.

Depressed left ventricular systolic function is a risk factor for, and powerful predictor of, sudden arrhythmic death. Consequently, implantation of an implantable cardioverter defibrillator (ICD) for the primary prevention of sudden cardiac death is a widespread practice, proven to be beneficial to heart failure patients with a variety of cardiac diagnoses. Current guidelines support implantable cardioverter defibrillator (ICD) implantation in patients, such as this patient, with cardiomyopathy and left ventricular ejection fractions of 35% or less. However, given that this depressed left ventricular systolic often improves with revascularization, a waiting period of 90 days post-revascularization is recommended. If, at the end of that 90 day period, the left ventricular ejection fraction (LVEF) remained less than or equal to 35%, ICD implantation is then recommended. However, the degree to which revascularization mitigates the risk for serious ventricular arrhythmias during this 90 day period is unclear. Accordingly, many physicians prescribe the LifeVest wearable cardioverter defibrillator (WCD) as a "bridge" to ICD implantation in these patients.

The efficacy of the WCD in terminating serious ventricular arrhythmias compares favorably to that of the implanted device. In one large retrospective study of patients with left ventricular ejection fractions (LVEFs) of 35% or less after coronary artery bypass graft surgery (CABG) or percutaneous intervention, "the WCD was associated with a lower 90-day mortality in patients after coronary artery bypass graft (CABG) (no WCD: 7% versus (vs) WCD: 3%) and after PCI (no WCD: 10% vs WCD: 2%)." [2] In the 2016 Science Advisory from the American Heart Association, Piccini, et al state, "Patients with LVEF less than or equal to 35% are at increased postoperative risk following CABG compared to those with preserved LVEF, and of those who die in the postoperative period, half have sudden cardiac death. On the other hand, up to 50% of patients will demonstrate significant improvement in LVEF after CABG. Improved survival in the immediate post-CABG period has not been demonstrated with the ICD. There are even fewer data on ICD placement after percutaneous coronary intervention (PCI), but the issues of potential improvement in LVEF are similar. Therefore, the Centers for Medicare & Medicaid Services mandated a 90-day waiting period for placement of a primary prevention ICD after revascularization with either CABG or PCI. However, patients with multiple risk factors or high risk features may ultimately require an ICD after 90 days. Given the presumed risk of sudden cardiac death (SCD) for these individuals during the waiting period, the WCD may provide a bridge of protection in patients within 90 days of CABG or percutaneous coronary intervention (PCI)."