Appeal type: Experimental/Investigational
Decision: Overturned

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

The patient has a history of presyncope, hypertension, and hyperlipidemia and underwent a cardiac evaluation with a coronary angiogram for premature ventricular contractions (PVCs) and was found to have multi-vessel coronary artery disease and severe ischemic cardiomyopathy. A left ventricular ejection fraction was severely reduced. The patient underwent a multi-vessel coronary artery bypass graft (CABG), then started on reverse remodeling medical therapy to treat his newly diagnosed severe ischemic cardiomyopathy. Post revascularization, the patient was prescribed a wearable cardiac defibrillator (WCD - LifeVest) for protection against sudden cardiac death during the waiting period prior to reassessment of the left ventricular ejection fraction (LVEF) in 3 month's time. A cardiac magnetic resonance imaging (MRI) scan showed moderately decreased systolic dysfunction with LVEF 31%. The patient was then referred to an electrophysiologist (EP) for consideration of primary prevention implantable cardioverter defibrillator (ICD), but the decision was for continued aggressive medical therapy, use of the LifeVest, and monitoring for LVEF recovery. At issue is whether the proposed health service or treatment, 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 proposed health service or treatment, 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 WCD has been Food and Drug Administration (FDA) approved since 2001 to protect patients from sudden death due to potentially lethal ventricular tachyarrhythmias. The Prospective Registry of Patients Using the Wearable Defibrillator (WEARIT-II) Registry enrolled 2000 patients with both ischemic and non-ischemic cardiomyopathies who were prescribed the WCD [1]. The WEARIT-II registry results demonstrated that there were a total of 120 episodes of sustained ventricular tachyarrhythmias in 41 patients and approximately half received an appropriate device shock. Use of the WCD demonstrated a good safety profile, with only 10 patients (0.5%) experiencing an inappropriate shock. Furthermore, the incidence of sustained ventricular tachyarrhythmias by 3 months of enrollment was 3% among patients with ischemic cardiomyopathy and congenital/inherited heart disease indicative of a high risk patient profile likely to benefit from the WCD.

The more recent Vest Prevention of Early Sudden Death Trial (VEST) published in 2018 in the New England Journal of Medicine randomized patients with newly diagnosed cardiomyopathy post-myocardial infarction (MI) with a LVEF less than (<) 35% to either WCD plus optimal medical therapy compared to medical therapy alone [2]. The primary outcome of the study, the combined rate of sudden cardiac death and death due to ventricular tachyarrhythmia, occurred in 1.6% in the WCD group compared to 2.4% with medical therapy alone (probability [p] = 0.18). On secondary outcome analysis, all-cause mortality was significantly reduced in patients randomized to the WCD compared to medical therapy alone, 3.1% versus [vs] 4.9%, probability [p] = 0.04.

Based on the published medical literature demonstrating the effectiveness of the WCD to terminate ventricular tachyarrhythmias along with its good safety profile, the 2017 American Heart Association/American College of Cardiology/Heart Rhythm Society (AHA /ACC/HRS) guideline for management of patients with ventricular arrhythmias and the prevention of sudden cardiac death indicates that the WCD may be considered to protect against sudden cardiac death in patients who are not ineligible for ICD therapy, including patients in the 90-day waiting period post revascularization (Class of Recommendation [COR], IIb) [3]. For these reasons, treatment with the WCD is likely to benefit this patient and reduce his risk of all-cause mortality given his high cardiovascular risk profile highlighted by his severe ischemic cardiomyopathy and non-sustained ventricular tachycardia.