Appeal type: Experimental/Investigational
Decision: Overturned

The patient is a male with a history of coronary artery disease (CAD), ischemic cardiomyopathy, congestive heart failure (CHF), and chronic tobacco abuse who underwent one vessel (left internal mammary artery [LIMA]-left anterior descending [LAD]) CABG during a hospitalization. Cardiac catheterization revealed multi-vessel, obstructive CAD (left main-30%, LAD-95% ostial, left circumflex [LCx]-50% proximal, right coronary artery (RCA)-90% mid, 80%-90% mid-distal). Echocardiogram revealed left ventricular ejection fraction (LVEF)=10-15% with severe, diffuse, left ventricular (LV) hypokinesis, mild mitral regurgitation (MR), and severe left atrial enlargement (LAE). The patient was evaluated by a cardiothoracic (CT) surgeon, who recommended cardiac magnetic resonance imaging (MRI) to evaluate myocardial viability. This test revealed scar in the inferior and inferolateral scar with viability noted in the other wall segments. It also revealed severe LV enlargement, LVEF=12% with severe, global, LV hypokinesis. The patient was evaluated by an electrophysiologist, to discuss implantable cardioverter defibrillator (ICD) placement for this patient in light of his cardiomyopathy. The patient had been on optimal medical therapy with Aspirin, Lipitor, Lasix, Lisinopril, spironolactone, and Coreg and was clinically stable with New York Heart Association (NYHA) Class I symptoms. He recommended consideration of single chamber implantable cardioverter defibrillator (ICD) placement for primary prevention of sudden cardiac death for this patient if there were no upcoming plans for coronary revascularization.
The patient was admitted to the hospital, and intra-aortic balloon pump (IABP) was placed prior to plans for one vessel CABG. The patient was re-evaluated by the electrophysiology service and stated that he "anticipated provision of a LifeVest on discharge." He also stated that "if LVEF fails to improve substantially at 3 months post-revascularization, implant of a primary prevention ICD will be recommended." The patient underwent successful one vessel, LIMA-LAD, CABG. He was discharged from the hospital on appropriate medical therapy and with LifeVest wearable cardioverter defibrillator (WCD) and plans for repeat echocardiogram to be performed in 3 months to reassess LVEF and need for permanent ICD.
At issue is whether the LifeVest wearable defibrillator was likely to be more beneficial for this patient's cardiac condition than any standard treatment. 

The health plan's determination is overturned.

Yes, the wearable external defibrillator was more beneficial than any other standard treatment for the patient's life threatening or disabling condition or disease.
According to the 2017 article by Sharma, et al., in European Heart Journal, "Clinical trials on sudden cardiac death have consistently demonstrated that the highest risk for sudden cardiac death (SCD) is among patients with severely depressed LV function. Thus, guidelines on primary prevention of SCD recommend implantation of an ICD in patients with severely depressed left ventricular ejection fraction (LVEF) of 35% or less with Class II/III heart failure (HF) symptoms (Class I recommendation). 1,2
Additionally, Piccini, et al., reported in a 2016 Circulation article that WCD use is reasonable when there is a clear indication for an ICD in the presence of a transient contraindication to an ICD. The transient contraindication to permanent ICD placement in this patient's case could be interpreted to be the timing of permanent ICD placement. Since the patient had recently undergone CABG in mid-December, a permanent ICD would not be indicated until 3 months status/post (s/p) coronary revascularization. Permanent ICD would then be indicated if the repeat echocardiogram demonstrated an LVEF=< 35%.
In order to ensure that the LV dysfunction is irreversible and the risk for sudden cardiac death (SCD) is permanent, current guidelines recommend a waiting period to allow for potential improvement in LV function on guideline directed medical therapy (GDMT). This waiting period depends on the cause for LV dysfunction. Among patients with ischemic cardiomyopathy (ICM) occurring as a result of a recent myocardial infarction (MI), a waiting period of least 3-months post-revascularization (percutaneous or surgical) and 40-days post-MI [American College of Cardiology (ACC)/American Heart Association (AHA)/Heart Rhythm Society (HRS) guidelines)] or 6 weeks [European Society of Cardiology (ESC) guidelines)] in patients without target vessel revascularization has been recommended. 1,2
After this patient was diagnosed with ischemic cardiomyopathy per cardiac catheterization, was noted to have viable anterior wall with inferior and inferolateral scarring with an LVEF=12% per cardiac MRI, and subsequently underwent one vessel CABG. At that point, the patient was re-evaluated by the electrophysiology service and LifeVest WCD was recommended for primary prevention of sudden cardiac death (SCD) for this patient with ischemic cardiomyopathy at the time of hospital discharge. After 3 months of guideline-directed medical therapy, a follow-up echocardiogram was also recommended by the electrophysiologic (EP) physician in order to re-evaluate patient's LVEF to determine if he would be a candidate at that time for a permanent ICD placement.
The patient had a documented history of ischemic cardiomyopathy with an LVEF of 12%. He was treated with guideline-directed medical therapy, underwent echocardiography, and cardiac MRI, was evaluated by EP and cardiothoracic surgery regarding his ischemic cardiomyopathy. Ultimately, he was recommended to undergo one vessel, LIMA-LAD, CABG and underwent this surgery. Per the articles and guidelines listed above, a LifeVest WCD was indicated for this patient for primary prevention of SCD.