Appeal type: Experimental/Investigational
Decision: Overturned

Diagnosis: Cardiac/Circulatory Problems. 
Treatment: wearable cardiac defibrillator. 
The insurer denied wearable cardiac defibrillator

The denial is overturned.

This male presented to the emergency department with an acute anterior ST segment elevation myocardial infarction. Coronary angiography showed a totally occluded proximal left anterior descending coronary artery (LAD) and a 99% stenosis in the ramus intermedius artery. Both vessels were successfully treated with drug-eluting stents. The patient required hemodynamic support with an intra-aortic balloon pump post-procedure. An echocardiogram showed a left ventricular ejection fraction (LVEF) of 23-30%. The patient was started on guideline-directed medical therapy for heart failure with reduced ejection fraction. He was discharged from the hospital with a LifeVest wearable cardioverter defibrillator. His Entresto dose was increased.  An echocardiogram showed an LVEF of 45-50%. The subject under review is whether the Wearable Cardioverter Defibrillator is likely to be more beneficial for this patient than any standard treatment.

Sudden arrhythmic death is common in the early post-myocardial infarction period, especially in the first 30 days. The risk is highest in patients with heart failure, left ventricular dysfunction, or both. Accordingly, there has been considerable interest in interventions that might modify this risk. Studies using anti-arrhythmic drugs have been disappointing. The DINAMIT trial (Defibrillators in Acute Myocardial Infarction Trial) was a multicenter, randomized, prospective study designed to assess the impact of implantable cardioverter defibrillator (ICD) implantation, in addition to optimal medical therapy (OMT) vs OMT alone, on all-cause mortality in high-risk patients within 40 days after infarction. Of 14,609 patients, 903 died suddenly, and 164 were resuscitated after cardiac arrest. The risk was highest in the first 30 days - 1.4 percent. Patients, like this man, with a left ventricular ejection fraction of 30 percent or less were at highest risk in this early period. However, there was no significant difference in all-cause mortality between the two groups. While the risk of sudden arrhythmic death was significantly lower in patients randomized to the ICD arm of the study than in the control group, this reduced risk was offset by an increase in nonarrhythmic death in the ICD arm of the study, compared with the control group. It is for this reason that current guidelines do not support ICD implantation within the first 40 days after myocardial infarct or within 90 days of revascularization. A 40 to 90 day "waiting period" on optimal medical therapy is recommended, in hopes that time, medication and revascularization (if performed) might result in improved left ventricular function. In order to provide a "safety net" for high-risk post-infarction patients, many physicians recommend the use of a wearable cardioverter defibrillator (WCD) as a bridge to potential ICD implantation during the waiting period. No other medical interventions, such as antiarrhythmic drugs, have proven effective in decreasing sudden cardiac death in the early post-myocardial infarction period. Thus, the wearable cardioverter defibrillator was likely to be more beneficial than any alternative treatment options in this instance.