CMS Grants Approval for MADIT II Indications for Implantable Cardioverter-Defibrillators

Recently, CMS (Medicare) granted approval for MADIT II indications with one provision. This is the addition of QRS duration greater than 120 ms. Previously, Arthur Moss, MD, the principal investigator of MADIT II (Multicenter Automatic Defibrillator Implantation Trial II), released the results of this multicenter trial. In this study, patients who have had a myocardial infarction and an ejection fraction equal to 30% or less were randomized to an implantable cardioverter-defibrillator (with optimal drug therapy) versus optimal drug therapy. There was a 31% reduction in mortality in patients who were randomized to the implantable cardioverter-defibrillator. The United States Food and Drug Administration, as well as the American College of Cardiology, American Heart Association, and the North American Society of Pacing and Electrophysiology, have all amended the MADIT II indications to the guidelines for implantation of the implantable cardioverter-defibrillators. However, despite the unanimous approval of the scientific board from Medicare and CMS had been delaying approval of MADIT II indications until these recent actions. CMS decided to embrace a substudy, which evaluated patients who had a QRS duration greater than 120 ms, and found that this patient population had a significantly higher risk of sudden death in comparison to MADIT II patients. Although the MADIT II criteria along with the QRS duration greater than 120 ms significantly expands the indication for implantable cardioverter-defibrillators, most electrophysiologists, including myself, feel that this approval by CMS comes up short on what is truly required. First, MADIT II was a randomized, multicenter trial, whose primary endpoint was survival. Secondly, there was no provision for QRS duration with respect to the entry criteria in this study. This was merely a substudy performed after the fact. Based on evidence-based medicine, the MADIT II criteria, mainly an ejection fraction less than or equal to 30% and a prior myocardial infarction would warrant an implantable defibrillator. I believe that all electrophysiologists and cardiologists should lobby to amend the MADIT II indications to that approved by the Food and Drug Administration, as well as other cardiology societies. I will be happy to receive letters. Please send any thoughts on this issue.