Appeal type: Experimental/Investigational
Decision: Upheld

The enrollee requested authorization and coverage, and reimbursement, for an automatic external defibrillator, with integrated electronic cardiogram analysis, garment type. The enrollee was admitted acutely on with new-onset, severe left ventricular dysfunction with fluid overload. The enrollee has longstanding left bundle branch block and no evidence of coronary artery disease or acute myocarditis. Cardiology indicated the enrollee can switch from angiotensin-converting enzyme inhibitors to angiotensin II receptor blockers to allow for a transition to Entresto if needed, and to minimize the side effect of cough. The enrollee was discharged home with an automatic external defibrillator due to being considered high risk for sudden cardiac arrest. Medical records indicate an implantable cardioverter defibrillator is contraindicated, due to the mandatory 90-day medical optimization period in which the strategies used to manage newly-diagnosed heart failure are evaluated and time is allowed for left ventricular remodeling. However, the enrollee required protection of the automatic external defibrillator during that time. The need for an implantable cardioverter defibrillator would be assessed with repeat cardiac testing. The enrollees ejection fraction was 10-15%. Coronary angiogram showed no occlusive disease. Her exam did not show jugular venous distention. There were no murmurs, rubs or gallops described. An electrocardiogram described a normal sinus rhythm and a complete left bundle branch block. The assessment and plan indicates she has new onset left ventricular systolic dysfunction. The etiologies considered were inflammatory versus viral syndrome.  It clinically appears less likely to be inflammatory. There was no evidence of coronary artery disease or acute myocarditis. The myocardial biopsy showed left ventricular hypertrophy and did not show any inflammatory process. A professional society science advisory notes current defibrillator technologies have limitations and risks.  Further research, including randomized trials, is needed to determine the optimal use of automatic external defibrillators. Because there had been a paucity of prospective data supporting the use of the automatic external defibrillators, the recommendations provided in the advisory were not intended to be prescriptive or to suggest an evidence-based approach to the management of enrollees with approved indications for use. Instead, these recommendations were offered to provide clinicians direction when discussing this therapy with enrollees. This advisory rated the use of the automatic external defibrillators as reasonable when there is a clear indication for an implanted/permanent device, accompanied by a transient contraindication or interruption in implanted cardioverter defibrillator care, such as infection. A professional society conducted a randomized controlled trial of enrollees with acute myocardial infarction and an ejection fraction of 35% or less. The device group received an automatic external defibrillator plus guideline-directed therapy, and the control group received only guideline-directed therapy. The investigators concluded that among individuals with a recent myocardial infarction and an ejection fraction of 35% or less, the automatic external defibrillator did not lead to a significantly lower rate of the primary outcome of arrhythmic death than the control methods. This enrollee was admitted to the hospital with the acute onset of congestive heart failure symptoms and volume overload. With the information provided, it appears the enrollee had an episode of symptomatic heart failure, but it is not clear that her myocardial disease was new. The complete left bundle branch block, with its unknown duration, the left ventricular hypertrophy on myocardial biopsy, and the thickening of the mitral valve all indicate that her myocardial disease was not new. There is no clinical research evidence documenting an incremental benefit of this technology over conventional medical therapy in the prevention of sudden cardiac death. Final Result: Two of the three reviewers determined that the requested services were not, and are not, likely to have been, or likely to be, more beneficial than any available standard therapy for treatment of the enrollees medical condition. Credentials/Qualifications: Three reviewers are board certified in cardiovascular disease and are actively practicing.  All three reviewers are experts in the treatment of the enrollees medical condition and knowledgeable about the proposed treatment through recent or current actual clinical experience treating those with the same or a similar medical condition.