Point32 Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) Form
Sudden cardiac death (SCD)
Sudden cardiac death (SCD) is an unanticipated, sudden death caused by loss of heart function that occurs within one hour of the onset of acute symptoms. Sudden cardiac death causes about 325,000 adult deaths annually in the U.S. and is thought to account for 50-60% of all cardiovascular deaths. The majority of SCDs are believed to be caused by ventricular fibrillation or ventricular tachycardia, which are irregular heart rhythms brought about when the electrical system to the heart malfunctions.
Implantable cardioverter-defibrillators (ICDs) can reduce the risk of sudden cardiac arrest and sudden cardiac death associated with dangerous arrhythmias by detecting these irregular rhythms when they occur and delivering an electrical shock to the heart muscle to cause the heart to beat in a normal rhythm again.
Conventional transvenous ICDs (TV-ICDs) have leads (wires) lying within the right ventricle. The risks of placing these devices include pneumothorax, pericardial effusion, tamponade, infection, and thrombosis. The S-ICD system does not require transvenous insertion; instead the system electrode in placed under the skin and implanted outside of the rib cage. The S-ICD system includes an implantable lead, an implantable pulse generator, a lead insertion tool, and a programming device that communicates wirelessly with the pulse generator.
Clinical Guideline Coverage Criteria
The Plan may cover a subcutaneous implantable cardioverter defibrillator (S-ICD) for Members who require an implantable cardioverter-defibrillator to reduce the risk of sudden cardiac arrest and sudden cardiac death, and who meet one of the following criteria:
- History of infection or endocarditis associated with a conventional implantable cardioverter defibrillator device
- The Member’s provider has deemed him or her an unacceptable risk for thoracotomy/ transvenous lead placement
Limitations
The Plan will not cover a subcutaneous implantable cardioverter defibrillator for Members who have symptomatic bradycardia or continual (incessant) ventricular tachycardia that can be terminated with anti-tachycardia pacing, and/or patients who have unipolar pacemakers.