Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Ischemic Cardiomyopathy.
Treatment: Wearable Cardioverter Defibrillator (LifeVest).

The insurer denied Wearable Cardioverter Defibrillator (LifeVest). The determination is upheld.

The patient presented to the hospital with the sudden onset of chest pain. He also has a long standing history of smoking and hypertension.
He had an abnormal electrocardiogram (ECG) with ST and T (segment deviations & T wave) changes and his troponin was elevated. The patient was taken to the catheterization lab urgently. He was diagnosed with 3 vessels coronary artery disease.
His echocardiogram revealed an ejection fraction (EF) of 20-25%. There was grade 3 diastolic dysfunction, grossly normal size right ventricle (RV) with decreased right ventricular systolic function (RVSF). The patient also noted to have NSVT (nonsustained ventricular tachycardia).
The patient was recommended for coronary artery bypass grafting (CABG). However, a chest computed tomography (CT) performed for pre-CABG screening revealed bilateral diffuse emphysematous changes, suggesting likely underlying undiagnosed chronic obstructive pulmonary disease (COPD), and pneumonia. The patient is a long standing smoker. Instead he underwent percutaneous coronary intervention (he was deemed not a surgical candidate). The patient was discharged from the hospital. A LifeVest was fitted upon discharge. His echocardiogram revealed an EF of 30%.
The patient was seen and it was noted that the patient was not completely revascularized and ICD was recommended for primary prevention of sudden cardiac death.
At issue is whether the Wearable Cardioverter 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.

The health service or treatment Wearable Cardioverter Defibrillator (LifeVest) is not likely to be more beneficial than any standard treatment or treatments for the insured's life threatening or disabling condition or disease.
This patient presented with congestive heart failure and newly diagnosed cardiomyopathy LVEF less than 35%. He is at risk for sudden cardiac death, and his risk is due to low LVEF. According to current guidelines by the American College of Cardiology (ACC) / American Heart Association (AHA) (1), this patient has indications for ICD implantation if his LVEF remains less than 35% after he is treated for at least 3 months with guidelines directed medical therapy. Many providers use a LifeVest in the interim, until the patient is a candidate for ICD (or LV function improves). However, the application of LifeVest in these circumstances is not supported by medical evidence and is not indicated.
The latest guidelines listed indications for WCD as class IIB with level of evidence C. The service classified as IIb indications with level of evidence C means, that benefit was not demonstrated and further studies are necessary. "Usefulness/efficacy is less well established by evidence/opinion". The service classified as IIb indications with level of evidence C.
Application of a LifeVest might appear to protect the patient from sudden death and gives comfort to a provider, however, it lacks any evidence of survival benefit and despite multiple trials failed to demonstrate clinically and statistically significant outcome.
No definitive data are available on comparative efficacy of LifeVest versus alternative (medical management).
Per Masri A, Altibi AM, Erqou S, et al. "All studies on the use of WCD, except the VEST trial, are observational studies, and many demonstrate poor methodology, selection bias, and confounding. VEST is the only randomized controlled trial evaluating the benefit of WCD in patients post-myocardial infarction and ejection fraction less than or equal to (<=) 35% as compared with medical therapy alone. It reported no difference in sudden cardiac death mortality, a scaled down primary endpoint from the original all-cause mortality. Current guidelines give a Class IIa recommendation for the use of WCD in secondary prevention when implantable cardioverter-defibrillator removal is required and a Class IIb recommendation for all other scenarios, including primary prevention in individuals considered at high risk. The current analysis reminds us that the vast majority of the studies do not provide rigorous evidence in favor or against the use of the WCD. Current prescription of WCD in primary prevention is not a reflection of the body of evidence, but rather, as the authors point out, the expression of finality of sudden death".