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 case involves a male with a history of hyperlipidemia and active smoking who presented to the emergency room (ER) with severe chest pain  and was diagnosed with anterior ST-Elevation Myocardial Infarction (STEMI). The patient underwent emergent cardiac catheterization demonstrating acute occlusion of the proximal left anterior descending (LAD) and 99% occlusion of the Ramus artery. He underwent a drug-eluting stent (DES) placement to the proximal and mid LAD and DES to the Ramus. After percutaneous coronary intervention (PCI) the patient did well. Transthoracic echocardiogram, showed severely reduced left ventricular (LV) function 25 to 30% with regional wall motion abnormalities involving the LAD territory. The patient was treated appropriately with evidence-based guideline directed medical therapy for reverse remodeling indications and reduction of mortality post myocardial infarction (MI). The patient was prescribed a LifeVest (WCD) at the time of acute myocardial infarction (AMI) for protection of sudden cardiac death. Repeat echocardiogram, showed improved LV function to 45-50% and the WCD was discontinued at that time. The subject under review is whether the WCD is likely to be more beneficial than any standard treatment for this patient.

Yes, the WCD, as recommended for this patient in this case, is likely to be superior to any other standard treatment for this patient. This patient presented with acute myocardial infarction due to acute STEMI secondary to acute occlusion of the LAD and Ramus arteries that was successfully treated with PCI. Due to the patient's AMI and severe ischemic cardiomyopathy, this patient is considered high risk for sudden death due to lethal ventricular arrhythmias. The WCD is Food and Drug Administration (FDA) approved to protect this patient from sudden death during the 90-day waiting period post-revascularization when patient is ineligible to receive ICD implantation.
The current body of evidence supports the use of the WCD demonstrating both safety and efficacy in terminating ventricular arrhythmias. Results from the WEARIT-II Registry enrolled 2000 patients treated with the WCD with ischemic (number [n]=805, 40%), or nonischemic cardiomyopathy (n=927, 46%), or congenital/inherited heart disease (n=268) between August 2011 and February 2014 (1). The median wear time of the WCD was 90 days. There was a total of 120 sustained episodes of ventricular tachycardia (VT)/ventricular fibrillation (VF) in 41 patients and 54% received an appropriate WCD shock and only 0.5% patients received an inappropriate WCD shock. Additionally, the one-year mortality of the WEARIT-II Registry patients was also favorable in 1,846 patients wearing the WCD, 93% (2). The VEST trial published in 2018 randomized patients with newly diagnosed ischemic cardiomyopathy and reduced left ventricular ejection fraction (LVEF) less than (<) 35% post-MI patients in a 2:1 strategy to WCD with optimal medical therapy (n = 1,524) compared to optimal medical therapy alone (n = 778) (3). The primary outcome of the study evaluated the combined rate of sudden death and death due to ventricular tachyarrhythmias which occurred in 1.6% of the WCD group compared to 2.4% in the control arm, p = 0.18, not reaching statistical significance. However, in secondary outcomes analysis, all-cause mortality was significantly reduced in patients randomized to the WCD occurring 3.1% versus 4.9% in the control, p = 0.04. Furthermore, the 2017 American Heart Association (AHA)/American College of Cardiology (ACC)/Heart Rhythm Society (HRS) guideline for management of patients with ventricular arrhythmias and the prevention of sudden cardiac death supports the use of the WCD in this case to protect this patient at high risk for sudden death due to potentially lethal ventricular arrhythmias during the 90-day time period after revascularization (4).