Diagnosis: Cardiac/Circulatory Problems- Congestive Heart Failure (CHF).
Treatment: Durable Medical Equipment (DME)-Wearable defibrillator.

The health plan denied the Durable Medical Equipment (DME)-Wearable defibrillator. The reviewer has upheld in whole the health plan's determination.

The patient underwent multiple surgeries as a child for D-transposition of the great arteries, including a Mustard procedure (atrial switch). His medical history was also remarkable for atrial fibrillation, transient ischemic attack and nonischemic cardiomyopathy. By echocardiogram, his left ventricular ejection fraction was 24% (per cent). He was on medical therapy with a beta-adrenergic receptor blocker. The patient had been previously evaluated by an electrophysiologist, and an implantable cardioverter defibrillator (ICD) for the primary prevention of sudden cardiac death was recommended. The patient had been told that the risk for complications from this procedure were increased due to his complex anatomy and was hesitant to proceed with device implantation.

Based on the documentation provided the LifeVest wearable cardioverter defibrillator was not medically necessary. This patient has a nonischemic cardiomyopathy and a severely depressed left ventricular ejection fraction (LVEF). Subset analyses of patients from the large multi-center randomized DEFINITE trial evaluating the use of ICDs in nonischemic cardiomyopathy for the primary prevention of sudden cardiac death have shown that even patients with recently diagnosed cardiomyopathy are at risk for serious ventricular arrhythmias. Accordingly, many physicians prescribe the LifeVest WCD as a "bridge" to potential ICD implantation in newly diagnosed patients. Unlike the ICD, however, one of the largest barriers to the overall effectiveness of the WCD is lack of compliance. Even fully compliant patients cannot wear the device 24/7, as it must be removed for bathing. Thus, the recommendation is for ICD implantation after 90 days of optimal medical therapy. This man's LVEF was noted to be severely depressed. He was more than 90 days post-diagnosis and was on maximally tolerated medical therapy. He would have been eligible for an ICD at that time. The WCD is not intended as a replacement for an ICD but, rather, as a "bridge" to potential ICD implantation for patients, who are at risk for malignant arrhythmias but not immediately eligible for an ICD. Unlike with the ICD, there are no data, that long-term use of the WCD improves cardiovascular outcomes. The records provided indicate that the patient elected to delay ICD implantation due to concerns regarding potential procedural complications. They do not indicate that there was a medical reason for use of the WCD rather than an ICD.