Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: ST elevation myocardial infarction (STEMI).
Treatment: Zoll Life Vest, code K0606.
The insurer denied coverage for Zoll Life Vest, code K0606.
The denial is upheld.

The patient is a male with coronary artery disease, hyperlipidemia, and myocardial infarction (MI). He suffered an ST (interval on an ECG) elevation myocardial infarction (STEMI) involving the left anterior descending coronary artery. He underwent primary percutaneous coronary intervention. He received a 4.0 x 15 mm (millimeter) drug-eluting stent. Post-procedure he remained hypotensive and was diagnosed with cardiogenic shock. He was treated with an intra-aortic balloon pump and vasopressor medications. At the time, his ejection fraction was noted to be 25-30% with anterior segment hypokinesis and a dilated left ventricle. He was started on guideline-directed medical therapy, including metoprolol, losartan, spironolactone, aspirin, ticagrelor, and atorvastatin. He was prescribed a Life Vest at the time of discharge for prevention of sudden cardiac death. The patient was diagnosed with a left ventricular mural thrombus, and subsequently initiated on anticoagulation with Eliquis; aspirin was discontinued at this time. He was referred to and completed cardiac rehabilitation. Upon follow-up echocardiography the patient was noted to have improved ejection fraction of 51%.  
Based on randomized clinical trials, the use of Life Vest has not been proven conclusively to improve health outcomes following acute coronary syndrome and MI. 

The Life Vest is approved for use in patients with reduced left ventricular ejection fraction for the primary prevention of sudden cardiac death.

The patient suffered a STEMI and underwent primary percutaneous coronary intervention. The standard of care treatment for patients with newly diagnosed ischemic cardiomyopathy following STEMI is emergent coronary revascularization with guideline-directed medical therapy, which the patient was prescribed. There is a risk of inappropriate shocks with use of the Life Vest. Furthermore, from the Defibrillator in Acute Myocardial Infarction Trial (DINAMIT), early use of implantable defibrillators was associated with worse cardiovascular outcomes than in patients who were treated with guideline-directed medical therapy.

The Life Vest is Food and Drug Administration (FDA) approved for prevention of sudden cardiac death. This technology does not have evidence-based proven efficacy for prevention of sudden cardiac death; however, it may be used in certain clinical circumstances when an implantable cardioverter-defibrillator is inappropriate. Examples of this include infection requiring explantation of a prior indwelling defibrillator or if the patient is a candidate for a heart transplant, whereby the risk of infection for implantable defibrillator should be avoided. In this clinical instance, the use of Life Vest is not likely to be more beneficial than guideline-directed medical therapy for a patient with newly diagnosed ischemic cardiomyopathy following STEMI. 

The scientific evidence in peer-reviewed literature does not support a result of improvement in health outcome for this patient. The Life Vest is FDA approved for prevention of sudden cardiac death. The Zoll Life Vest is not the best available treatment for this patient at this time. 

This treatment is not likely to be more beneficial than any standard treatments for this patient's condition and the adverse risk are not substantially increased over standard treatments. 

The carrier's denial of coverage for Zoll Life Vest, code K0606 should be upheld.