This week in the New England Journal of Medicine, such a study was reported. The MADIT II trial enrolled more than a thousand patients who had prior heart attacks and whose left ventricular ejection fractions (a measure of the pumping efficiency of the heart) was less than 30% were randomized to receive either standard medical therapy, or the same standard medical therapy plus the implantable defibrillator. The results were striking: patients who received the defibrillator experienced a 30% reduction in mortality compared to patients without the defibrillator. As a result of MADIT II, the FDA is being petitioned to allow use of the implantable defibrillator in heart attack survivors with reduced ejection fractions. The FDA is expected to grant this new indication relatively soon.
But based on the reaction of doctors and insurers to this new data, a sudden surge in defibrillator implantations may not occur.
Why preventing sudden death is low on everyone's priority list
Three reasons:- 1) Insurance companies and the feds (i.e. Medicare) like sudden death. It is not only the cheapest way to die, but also its victims (most of whom have some form of underlying heart disease) immediately stop consuming precious health care dollars.
- 2) Doctors don't like to think about sudden death because doing something to prevent it is expensive. The implantable defibrillator costs roughly $20,000, and every time a doctor uses one, he/she makes either an insurance company or the feds (the ones who pay the bills) unhappy.
- 3) Unlike AIDS, breast cancer, or the heartbreak of psoriasis, sudden death has no constituency among patient groups. By the time a person realizes it's a problem, he/she may have enough time to utter a gasp, like poor John, but certainly not enough time to found a political action committee. Patients simply aren't demanding that reluctant doctors implant these devices, or that insurance companies pay for them.
What this new information means to you
- 1) If you have had a heart attack, know your ejection fraction. The ejection fraction is routinely measured after a heart attack, either during a heart catheterization, a MUGA scan, or a thallium study. If it is 30% or lower, you are at a relatively high risk for sudden death, and it is now known that an implantable defibrillator will substantially increase your odds of long-term survival. (If the ejection fraction was never measured, go get yourself another doctor.)
- 2) If you do fall into this "high-risk" category, make sure you talk to your doctor about preventing sudden death. If the doctor demurs, assuring you that your beta blockers, ACE inhibitors statins, and aspirin treatment is enough to prevent sudden death, you demur right back. In MADIT II, patients not receiving the implantable defibrillator were getting all those drugs - and still had a 30% higher mortality than patients who received the defibrillator.
- 3) If you think you fit into this high-risk category but feel so well that you just can't believe that sudden death is a possibility, re-read the scenario that began this article. Then stop to think of all the people you know in your life who died suddenly from a "massive heart attack." (Most people over 30 have lived long enough to lose several acquaintances in this way.) And think of what their sudden departure did to their families. That could very easily be you and your family, unless you shame your doctor into taking now-proven and appropriate action.
