Appeal type: Experimental/Investigational
Decision: Upheld

Nature of Statutory Criteria/ Case Summary:  The enrollee requested reimbursement for the wearable cardioverter defibrillator LifeVest. According to the records, the enrollee has a past medical history of coronary artery disease, diabetes mellitus type 2, hyperlipidemia, and ischemic cardiomyopathy with ejection fraction (EF) of 30%. A previous angiogram showed severe disease in the left anterior descending (LAD) artery (100%)/obtuse marginal (OM2) (90%). The enrollee was put on a LifeVest for sudden cardiac death (SCD) prevention and recommended to undergo surgical revascularization of his coronary arteries of Impella assisted complete percutaneous coronary intervention (PCI). The requesting provider noted the enrollee needed to be medically optimized and reassessed after the waiting period as to the need for automated implantable cardioverter defibrillator (AICD). A transesophageal echo report showed left ventricular ejection fraction of 45%; mildly depressed left ventricular systolic function; moderate diastolic dysfunction and post coronary artery bypass graft, improved left ventricular function. The LifeVest is FDA approved for prevention of sudden cardiac death; however the use of LifeVest for the dates under review was not likely to be more beneficial in this case. The enrollee was diagnosed with ischemic cardiomyopathy, with ejection fraction of 45%, according to the transesophageal echo report. The use of LifeVest technology has not been shown to be more beneficial compared with standard-of-care medical therapy for prevention of sudden cardiac death in patients with newly diagnosed cardiomyopathy, in particular for patients with mild left ventricular systolic dysfunction with ejection fraction >35%. There is no evidence in the clinical research documenting incremental benefit of this technology over conventional medical therapy in prevention of sudden cardiac death. Left ventricular systolic function had improved with optimal medical management prior to revascularization and there is no evidence that it worsened after surgery, thus increasing his risk for sudden cardiac death. Scientific evidence in peer reviewed literature does not support post-operative use of a LifeVest in this enrollee. This is supported by a lack of benefit in a randomized study of 900 patients with an ejection fraction <36% who underwent bypass surgery and had an AICD implanted prophylactically. Survival was the same whether an AICD was implanted or the enrollee was treated medically only after surgery.Final Result: Three of the three reviewers determined that the requested services are not likely to be more beneficial than any available standard therapy for treatment of the enrollees medical condition. Credentials/Qualifications: Two reviewers are board certified in cardiovascular disease and interventional cardiology, one reviewer is board certified in cardiovascular disease and are actively practicing.  All three reviewers are experts in the treatment of the enrollees medical condition and knowledgeable about the proposed treatment through recent or current actual clinical experience treating those with the same or a similar medical condition.