Randomized trials have indicated that ICD therapy for
primary prevention of sudden death is effective in many populations. The current
indications for ICD insertion accepted by the Center for Medicare Services are
shown in Table below. The most recent trials have used entry criteria based
primarily on left ventricular ejection fraction (below 30% or 35%) and NYHA
functional class. Most primary prevention trials have reported relative risk
reductions in a range similar to those seen in the secondary prevention trials
(20–30%). The CABG-Patch Trial and the Defibrillators in Acute Myocardial
Infarction Trial (DINAMIT) failed to show benefit in patients who received their
ICD either at the time of coronary revascularization or within 40 days of an
acute myocardial infarction, respectively. These trials resulted in the specific
exclusion of these conditions in the current guidelines.
Indications and Contraindications for
Implantable Cardioverter Defibrillator Therapy
|
|
| I. Indications for
Secondary Prevention |
| A. Documented episode
of cardiac arrest due to ventricular fibrillation (VF), not due to a transient
or reversible cause |
| B. Documented sustained
ventricular tachyarrhythmia (VT), either spontaneous or induced by an
electrophysiology (EP) study, not associated with an acute myocardial infarction
(MI) and not due to a transient or reversible cause |
| II. Indications for
Primary Prevention |
| A. Documented familial
or inherited conditions with a high risk of life-threatening VT, such as long QT
syndrome or hypertrophic cardiomyopathy |
| B. Coronary artery
disease with a documented prior MI, a measured left ventricular ejection
fraction (LVEF) < 35%, and inducible, sustained VT or VF at EP study. (The EP
test must be performed more than 4 weeks after the qualifying MI.) |
| C. Documented prior MI
and a measured LVEF < 30% |
| D. Patients with
ischemic dilated cardiomyopathy, documented prior MI, New York Heart Association
(NYHA) class II and III heart failure, and measured LVEF < 35% |
| E. Patients with
nonischemic dilated cardiomyopathy > 9 months, NYHA class II and III heart
failure, and measured LVEF < 35% |
| F. Patients who meet
all current Centers for Medicare & Medicaid Services coverage requirements
for a cardiac resynchronization therapy (CRT) device and have NYHA class IV
heart failure |
| G. Patients with
nonischemic dilated cardiomyopathy > 3 months, NYHA class II and III heart
failure, and measured LVEF < 35% |
| III. Exclusions |
| A. NYHA classification
IV without CRT |
| B. Cardiogenic shock or
symptomatic hypotension while in a stable baseline rhythm |
| C. Had a coronary
artery bypass graft or percutaneous transluminal coronary angioplasty within
past 3 months |
| D. Had an enzyme
positive MI within past 40 days |
| E. Clinical symptoms or
findings that would make them a candidate for coronary revascularization
|
| F. Any disease, other
than cardiac disease (eg, cancer, uremia, liver failure), associated with a
likelihood of survival less than 1 year |
| G. Patients must not
have irreversible brain damage from preexisting cerebral disease |
|
Referensi:
Current Diagnosis & Treatment Cardiology 3rd Edition (McGraw-Hill) 2009