Appeal type: Experimental/Investigational
Decision: Overturned

Diagnosis: Non-sustained polymorphic ventricular tachycardia.
Treatment: Automatic external defibrillator with integrated electrocardiogram analysis garment type (wearable vest that automatically delivers treatment shock when a life-threatening heart rhythm is detected). 
The insurer denied coverage for the automatic external defibrillator with integrated electrocardiogram analysis garment type (wearable vest that automatically delivers treatment shock when a life-threatening heart rhythm is detected). 
The denial is overturned. 

This is a male patient who presented to the hospital with ST segment elevation myocardial infarction requiring revascularization of the right and mid left anterior descending coronary arteries.  Following revascularization echocardiogram revealed a left ventricular ejection fraction (LVEF) of 35%.  His blood pressure was deemed to be too low to begin therapy with afterload reducing agents such as ACE-inhibitors [Angiotensin-converting enzyme (ACE) inhibitors].  While hospitalized he was noted to have non-sustained polymorphic ventricular tachycardia (VT) on telemetry.  He was prescribed an external life vest defibrillator for three months.

External life vest defibrillator for a patient presenting with a depressed LVEF of 35% or less following acute myocardial infarction would not be considered experimental or investigational by the general medical community.  Such therapy is both safe, efficacious and FDA [Food and Drug Administration] approved. The SCD HFT [Sudden Cardiac Death in Heart Failure Trial] trial clearly demonstrated that such patients have a significant risk of sudden cardiac death and benefit from implantable cardioverter defibrillator (ICD) therapy.(1)  Prior to implanting an ICD [implantable cardioverter defibrillator], patients must be treated with guideline directed medical therapy for at least 3 months in an attempt to allow for ventricular remodeling and improve LVEF.  If medical therapy is effective then patients often do not require device implantation.(2)  During this period of treatment, patients are at risk for sudden cardiac death and must be protected.  External LifeVest defibrillator therapy provides such protection. Guideline statements from the Heart Rhythm Society/American Heart Association and the American College of Cardiology specify that external LifeVest defibrillator therapy should be utilized during periods when patients are at risk of sudden cardiac death and require further cardiac workup/treatment.(3-5)  A real world study of patients treated with external LifeVest defibrillators, almost 5% of subjects received lifesaving therapy.(6) The VEST [Vest Prevention of Early Sudden Death Trial] trial specifically studied patients at risk of sudden cardiac death following myocardial infarction.  In an as treated analysis wearing a LifeVest defibrillator was associated with a 57% reduction in arrhythmic death and a 74% reduction in mortality.(7) 

In this case, medications that would allow for left ventricular remodeling through afterload reduction were not prescribed due to low blood pressure.  In addition, non-sustained polymorphic VT was noted on telemetry following revascularization.  These factors are likely to contribute to a higher risk profile than the typical patient that can tolerate ACE inhibitor therapy without ventricular arrhythmia. 

In conclusion external LifeVest defibrillator therapy is the best available treatment for this patient at this time.  It is likely to be more beneficial for the enrollee than any available standard therapy.  Without the protection of an external LifeVest defibrillator, the adverse risks would be increased in this case.

The carrier's denial of coverage for an automatic external defibrillator with integrated electrocardiogram analysis garment type (wearable vest that automatically delivers treatment shock when a life-threatening heart rhythm is detected) should be overturned.