Diagnosis: LV (left ventricle) dysfunction
Treatment: LifeVest (automatic wearable automatic cardiac defibrillator)
The insurer denied the Life Vest (automatic wearable automatic cardiac defibrillator).
The denial is overturned.

The patient is a woman. She presented with dyspnea over a six-week period and was diagnosed with severe LV (left ventricle) dysfunction and an LV ejection fraction of 10% with severe mitral regurgitation. Echocardiogram also revealed severe tricuspid valve regurgitation and severe pulmonary hypertension with an estimated RVSP (right ventricular systolic pressure) of 62 mmHg (millimeters of mercury). Cardiac catheterization was performed and revealed normal coronary arteries without obstruction. Telemetry monitor revealed non-sustained ventricular tachycardia.

The patient was treated with guideline directed anti-congestive therapy and an external LifeVest defibrillator. Plans were made to reassess left ventricular ejection fraction following three months of medical therapy.

Yes, the LifeVest is medically necessary.

An external LifeVest defibrillator for a patient presenting with newly diagnosed congestive heart failure with a severely reduced LVEF (left ventricle ejection fraction) (10%) is medically necessary and in the best interest of the patient. Such therapy is both safe and efficacious.

The SCD HFT (Sudden Cardiac Death in Heart Failure Trial) clearly demonstrated that such patients have a significant risk of sudden cardiac death and benefit from ICD (implantable cardioverter defibrillator) therapy (Reference 1). Prior to implanting an ICD, patients must be treated with guideline directed medical therapy for at least three 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 (Reference 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 (References 3-5). In a real-world study of patients treated with external LifeVest defibrillators, almost 5% of subjects received lifesaving therapy (Reference 6).

This patient was at high risk for sudden cardiac death due to a severely depressed LVEF, severe pulmonary hypertension, and nonsustained VT (ventricular tachycardia) noted on telemetry monitor. In conclusion, the wearable LifeVest defibrillator is in the best interest of the patient and is medically necessary.