Implantable Cardioverter Defibrillators (ICDs)

CMS NCA document | source_status=Closed | review_type=New | public_comment_open=False | document_id=CAG-00157N

CMS determines that the evidence is adequate to conclude that an implantable defibrillator is reasonable and necessary for patients with A documented episode of cardiac arrest due to ventricular fibrillation (VF), not due to a transient or reversible cause; Documented sustained ventricular tachyarrhythmia, either spontaneous or induced by an electrophysiology (EP) study, not associated with myocardial infarction (MI) and not due to a transient or reversible cause; Documented familial or inherited conditions with a high risk of life-threatening ventricular tachyarrhythmias, such as long QT syndrome or hypertrophic cardiomyopathy; Coronary artery disease with a documented prior myocardial infarction, a measured left ventricular ejection fraction ≤ 0.35, and inducible, sustained ventricular tachycardia (VT) or VF at EP study. (The myocardial infarction must have occurred more than 4 weeks prior to implantable defibrillator insertion. The EP test must be performed more than 4 weeks after the qualifying myocardial infarction.) CMS determines that the evidence is adequate to conclude that an implantable defibrillator is reasonable and necessary for patients with a documented prior myocardial infarction and a measured left ventricular ejection fraction ≤ 0.30 and a QRS duration of > 120 milliseconds. Patients must not have: New York Heart Association classification IV; Cardiogenic shock or symptomatic hypotension while in a stable baseline rhythm; have Had a coronary artery bypass graft (CABG) or percutaneous transluminal coronary angioplasty (PTCA) within past 3 months; Had an enzyme-positive MI within past month; Clinical symptoms or findings that would make them a candidate for coronary revascularization; or Irreversible brain damage from preexisting cerebral disease; Any disease, other than cardiac disease (e.g. cancer, uremia, liver failure), associated with a likelihood of survival less than one year; and patients must be able to give informed consent. Myocardial infarctions must be documented by elevated cardiac enzymes or Q-waves on an electrocardiogram. Ejection fractions must be measured by angiography, radionuclide scanning or echocardiography. CMS determines that the evidence is not adequate to conclude that an implantable defibrillator is reasonable and necessary for all patients with a prior myocardial infarction, a left ventricular ejection fraction ≤ 0.30, and a QRS > 120 ms. All other indications are also noncovered.