Electrophysiologists Support Expanded ICD Implantation Guidelines

Cooper electrophysiologists report that recent announcements from the Center for Medicare and Medicaid Services (CMS) have expanded the coverage for implantable cardiovertor defibrillators (ICD’s). The policy decision was based, in part, on the resubmission to CMS of results from the landmark clinical study MADIT II (Multi-Center Automatic Defibrillator Implantation Trial). MADIT II demonstrated a more than 30% reduction in mortality for post myocardial infraction (MI) patients with left ventricular dysfunction who received prophylactic implantation of an ICD.

The expanded coverage refers to two post-MI groups:

  • Patients with CAD who are post-MI, have an ejection fraction of less than or equal to 35% and have inducible, sustained ventricular fibrillation (VF) during an electrophysiology study.
  • Patients with a prior MI, an ejection fraction less than or equal to 30%, and a QRS duration of greater than 120 milliseconds.

“This group is about one-third of the original population of MADIT II, so we are pleased by the increase in patient eligibility for coverage,” says Lawrence Gessman, M.D., director of the Cooper Electrophysiology Laboratory. “However, we are dismayed that the restrictions of requiring an abnormally wide QRS, or inducible episodes of VT or VF remain criteria for implantation. This eliminates many MADIT II patients who would medically benefit from this therapy,” adds Dr. Gessman.

“The eligibility guidelines remain numerous and complex,” says Melvin White, M.D., Cooper electrophysiologist. “However, if the patient would appear to benefit, we recommend referring them for evaluation. We can assist in determining the most effective treatment option for their individual needs.”

Coverage Clarified for Clinical Trials
The policy was also clarified regarding coverage for implantation of ICD’s during clinical trials. This clarification from CMS was eagerly anticipated as the original post MADIT II ICD implantation guidelines were interpreted as excluding coverage for clinical trials. “At Cooper, we are committed to continuing our implantable defibrillator research,” says Dr. Gessman. “We have several automatic external defibrillator (AED) trials in progress.” Dr. Gessman predicts that additional populations, such as the heart failure patients from SCD-HeFT, (Sudden Cardiac Death in Heart Failure Trial) will soon be added to the ICD coverage policy, as studies indicate that the benefits in this population are significant.”

For more information about patient criteria for ICD implantation, clinical trials, or to refer a patient, please call: (856) 342-2034.