II, the survival benefit was entirely due to a reduction in SCD and it was similar in subgroup analyses stratified by age, sex, LVEF, NYHA functional class, and QRS width.
Analysis of the first MADIT
, which included patients at extremely high risk for SCD, showed that ICD therapy costs about $27,000 per life-year saved, while a cost analysis of the MADIT
-II trial with a lower risk population showed a cost for one patient of $43,200.
Arthur Moss, principal investigator of the MADIT
II trial, told the Post.
Takanori Ikeda of Toho University in Tokyo presented the results of the prospective study of 82 consecutive MADIT
II type patients with mean follow-up of 2 years.
At the same time, implantable defibrillator systems, led by the VENTAK(R) PRIZM(TM) family, continue to benefit from the wide acceptance of the results from the MADIT
II trial," said Dollens.
Although the decision regarding EF was backed by the evidence from the MADIT
II trial, there was no evidence for the QRS duration except for a subanalysis from the MADIT
A few private insurers have begun accepting and paying for ICDs for MADIT
II-type patients, but it is not a widespread practice.
II trial was a prospective, randomized, multi-center study that enrolled more than 1,200 patients in 71 centers in the United States and five European centers.
II trial of patients with disease-weakened hearts found that individuals with implanted defibrillators lived longer than the group on medical therapy alone.
Findings from the MADIT
II trial were so convincing that an independent review panel decided that the device's effectiveness no longer needed to be proven because it had clearly demonstrated the lifesaving benefits of ICDs.
Basically, we found that only one-third of Americans who met existing ICD indications--prior to MADIT
II--were actually receiving an ICD.
The researchers were able to identify about 20% of the subjects in the MADIT
II conventional therapy group who had none of the six identifiable high-risk factors; these patients were younger in age, had sinus rhythm, had no kidney dysfunction, and were in New York Heart Association (NYHA) class II.