The analysis shows that more than half of the patients who would be good candidates to receive implanted cardioverter-defibrillators (ICDs) according to criteria from the MADIT II clinical trial would not qualify to be reimbursed for them under Medicare's current guidelines.

And some of them will die from sudden cardiac death that could probably have been prevented by an ICD, a pacemaker-like implanted device that monitors heart rhythm and shocks the heart back into a normal pace when an arrhythmia develops.

Today at the Annual Scientific Session of the American College of Cardiology, University of Michigan Cardiovascular Center researcher Richard Otten, M.D., will present the results of the study in an oral presentation and a press conference.

Otten and his colleagues analyzed data on patients who were treated at U-M for acute coronary syndrome in the three years before ICDs received FDA approval for low ejection fraction heart failure patients with a history of myocardial infarction, also called heart attack. That approval was based largely on the results of MADIT-II, a national study published in 2002 in the New England Journal of Medicine.

In June 2003, the Centers for Medicare and Medicaid Services decided to cover ICDs only for Medicare patients who had heart failure, myocardial infarction and a QRS interval greater than 120 milliseconds. The QRS interval is a parameter on electrocardiograms that represents the time it takes for the heart's ventricles to depolarize.

That cutoff was based on a sub-analysis of MADIT-II data, though MADIT-II was not designed to determine how the QRS interval affected patients' likelihood of su
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Contact: Kara Gavin
kegavin@umich.edu
734-764-2220
University of Michigan Health System
9-Mar-2004