Initial Public Comments Implantable Cardiac Defibrillators

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Comment Four
May 25-June 25, 2004
Comment #4:
Name: Kousik Krishnan, MD, FACC
Organization: Rush University Medical Center
Date: Fri, June 25, 2004

As a board certified cardiac, I feel that I have a responsibility as a patient advocate to express my thoughts on the matter. I will be brief. I believe that the MADIT II results along with the soon to be published SCD- HEFT Results offer compelling, if not overwhelming evidence that ICD's improve mortality in both ischemic and nonischemic cardiomyopathies. The data does not support arbitrary sub-group analysis to restrict their use. While the date may be even more compelling in patients with a QRS duration greater than 120 ms, this does not negate the fact that all patient groups showed a marked improvement in mortality.

I feel that morally we cannot restrict this technology.

I urge a full reevaluation and approval for the whole MADIT II and SCD-HEFT populations.

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