Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Ischemic cardiomyopathy.
Treatment: Wearable Cardioverter Defibrillator (LifeVest).

The insurer denied Wearable Cardioverter Defibrillator (LifeVest). The determination is overturned.

The patient had a non-ST segment elevation myocardial infarction that was complicated by hemodynamic compromise and required intra-aortic balloon pump support. Cardiac catheterization showed severe three vessel disease. By echocardiogram, the patient's left ventricular ejection fraction was 20-25%. He was not deemed to be a candidate for surgical revascularization. He underwent stent implantation in the proximal left anterior descending coronary artery. He was treated with guideline-directed medical therapy for congestive heart failure. He was discharged with a LifeVest wearable cardioverter defibrillator (WCD). At issue is whether the proposed health service or treatment Wearable Cardioverter Defibrillator (LifeVest) is likely to be more beneficial than any standard treatment or treatments for the insured's life threatening or disabling condition or disease.
The Wearable Cardioverter Defibrillator (LifeVest) is likely to be more beneficial than any standard treatment or treatments for the insured's life threatening or disabling condition or disease
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) versus 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 after-1.4 percent. Patients, like this patient, with a left ventricular ejection fractions 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. A 90 day "waiting period" after revascularization is also recommended, in hopes that healing 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 WCD in the early post-infarction period. These devices have been shown to be highly effective in terminating ventricular tachyarrhythmias, with close to a 100% efficacy, resulting in "aborted sudden death" as opposed to sudden death. Data culled from manufacturer-controlled databases show that, in a cohort of 8453 patients who used the device for periods between 40 days and three months post-infarction, malignant ventricular arrhythmias occurred and were successfully treated by the WCD in 1.4%.
In the Wearit II registry, which included 805 patients with ischemic cardiomyopathy, the rate of potentially life-threatening ventricular tachyarrhythmias was 3% over a 3 month period. All episodes that were treated by the WCD were successfully terminated, suggesting that these patients had aborted sudden death versus actual sudden death. The VEST (Vest Prevention of Early Sudden Death Trial) trial was a randomized controlled trial designed to evaluate the efficacy of WCD use in high risk post infarction patients. This trial enrolled 2302 patients with recent myocardial infarction and severe left ventricular systolic dysfunction who were randomized to therapy with a WCD versus without a WCD. Over a mean follow-up of 84 days, the rate of sudden death was 1.6% in the group receiving the WCD, versus 2.4% in the control group. While the result was not statistically significant, the trend was positive, with a 33% relative reduction in sudden death. Moreover, the total mortality was 3.1% in the treatment group versus 4.9% in the control group (probability [P]=0.04). Thus, there was a 36% relative risk reduction in total mortality that did reach statistical significance. While it is true that the decrease in sudden death in the treatment group did not reach statistical significance, the trend suggests a signal of efficacy. Moreover, the results were somewhat confounded by patient noncompliance with wearing the WCD, which was higher than previously reported. Of the 25 patients in the treatment group who were adjudicated as having had sudden death, only 8 were wearing the WCD at the time of their death. In summary, use of the WCD in this situation is the only treatment that has been shown to have a favorable effect on sudden cardiac death over and above that seen with standard therapy for heart failure. Antiarrhythmic drugs have proven ineffective.