Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Syncope. 
Treatment: LifeVest (K0606) Wearable Cardiac Defibrillator. 

The insurer denied the LifeVest (K0606) Wearable Cardiac Defibrillator. 
The denial is overturned. 

The patient is a female with a past medical history significant for ventricular fibrillation arrest, CAD (coronary artery disease), status post STEMI (ST-elevation myocardial infarction), status post Impella-assisted PCI (percutaneous coronary intervention) of LAD (left anterior descending), CVA (cerebrovascular accident), DVT (deep venous thrombosis), gastric sleeve surgery, with possible chronic leak, prior admission with ventricular tachycardia. She was admitted following a syncope episode, suspicious for recurrent ventricular arrhythmia. 

The patient was admitted for cardiac work-up and was planned to undergo an EP (electrophysiology) study for risk stratification and possible AICD (automatic implantable cardioverter defibrillator) implantation. Her course, however was complicated by a finding of an abdominal abscess, and she required percutaneous drainage by interventional radiology. The patient was started on IV (intravenous) antibiotics and was subsequently transitioned to oral antibiotics. The EP (electrophysiology) study and ICD (implantable cardioverter defibrillator) implantation were postponed pending resolution of infection. 

The patient was discharged on Life Vest Wearable Cardioverter Defibrillator for prevention of sudden cardiac death. 

Yes, the LifeVest (K0606) Wearable Cardiac Defibrillator was medically necessary. 

The LifeVest is a wearable cardioverter defibrillator (WCD) used on an outpatient basis. The LifeVest is designed to perform the same functions as an automatic implantable cardioverter defibrillator (ICD), but is worn outside the body and therefore is noninvasive. Two pivotal studies were designed to examine the safety and efficacy of the LifeVest WCD (wearable cardioverter defibrillator) system. The WEARIT study enrolled ambulatory patients typical of those awaiting a heart transplant and who had an LEVEF (left ventricle ejection fraction) < 30% and New York Heart Association (NYHA) functional Class III or IV heart failure. These patients went on to receive the heart transplant, implantation of an ICD (implantable cardioverter defibrillator), or a circulatory assist device. 

The BIROAD study enrolled patients who were waiting for four months for implantation of an ICD (implantable cardioverter defibrillator), and included patients who had experienced a recent MI (myocardial infarction) or received a coronary artery bypass graft (CABG). Additional inclusion criteria for the BIROAD study were complication of the CABG (coronary artery bypass graft) or MI (myocardial infarction) with ventricular tachyarrhythmias within 48 hours of the event, an LEVEF (left ventricle ejection fraction) < 30% at least three days after the event; a Killip Class III or IV three days following the infarction and syncopal ventricular tachyarrhythmias two days postinfarction. Although the BIROAD and WEARIT studies were initiated independently performed in a total of 18 centers in the United States and one center in Germany, the FDA (United State Food and Drug Administration) requested that the two studies be combined with each group being considered as a subpopulation. 

Another study supporting the utility of a wearable cardioverter/defibrillator is a retrospective review of a database of 3,569 patients (mean age 59 years) who received a WCD (wearable cardioverter defibrillator) in 2002-2006. Survival of these patients was compared to that of patients who received an implantable cardioverter-defibrillator (ICD). In this study, short-term survival in patients with a WCD (wearable cardioverter defibrillator) was similar to that of patients with an ICD (implantable cardioverter defibrillator). The conclusion was that WCD (wearable cardioverter defibrillator) provides very useful temporary protection from death due to VT/VF (ventricular tachycardia/ventricular fibrillation) in ICD (implantable cardioverter defibrillator) candidates who require 'bridging therapy,' for example, in the first 40 days after a large myocardial infarction or when an ICD (implantable cardioverter defibrillator) is explanted because of infection. 

In this specific case, the patient had known ischemic coronary disease with a history of MI (myocardial infarction), large myocardial scar, and prior ventricular fibrillation as well as ventricular tachycardia episodes, who presented with new onset syncope suspicious for recurrent ventricular arrhythmia. EP (electrophysiology) study and implantation of AICD (automatic implantable cardioverter defibrillator) could not be performed in this case due to finding of an intra-abdominal infection, which required drainage and treatment with a prolonged course of antibiotic. Given the infectious contraindication to AICD (automatic implantable cardioverter defibrillator), as well as high risk for sudden cardiac death due to ventricular arhhythmia, it would be consistent with the currently accepted standards of care to use a LifeVest wearable cardioverter defibrillator for SCD (sudden cardiac death) prevention as a bridge to definitive therapy, once the infection source is controlled and adequately treated. Therefore, based on the information submitted for review, the use of LifeVest wearable cardioverter defibrillator in this clinical setting would be medically necessary in this specific case.