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What Heart Patients Should Know Now about Implantable Defibrillators

Even before healthcare reform, there was a lot of talk about whether or not an implantable defibrillator was cost effective. Cost effectiveness in medicine is a very complicated topic, and it basically means that the cost for the therapy is spent wisely and provides value.

An implantable defibrillator, nicknamed ICD, is a like a pacemaker (in fact, it has a built-in pacemaker) but it also has the ability to defibrillate the heart with a big burst of energy if the heart starts to race.

These episodes are sometimes called "sudden cardiac arrest" or SCA but that term is a misnomer. The heart does not actually stop during SCA. Rather, it tries to beat so rapidly that it cannot actually fully open or contract. The result is that the heart muscle just quivers and no blood is pumped. The usual cause of SCA is some kind of heart rhythm disorder or arrhythmia.

ICDs are medical devices which must be implanted inside the body. A typical ICD lasts for about four to six years, depending on how much it is used and the model implanted. When the battery in the ICD wears out, the entire ICD has to be replaced.

The surgery to implant an ICD is considered minimally invasive. It is often done under what is called "conscious sedation" (not general anesthesia) and may be done in a cardiac cath lab rather than an Operating Room. In otherwise strong patients, the procedure can even be done on an outpatient basis.

However, the cost of the ICD is the big factor. Depending on where you live and the type of ICD you need, it will cost in the five figures, sometimes as much as $20,000 or more. Add that to surgery and you come up with a pretty high price tag for therapy.

When ICDs first hit the market in the late 1980s, doctors and the public thought of them as a therapy of last resort. They were extreme treatments for those patients with the most stubborn forms of heart disease.

Then in the late 1990s, a series of clinical trials were conducted which found something amazing. ICDs saved lives.

The initial challenge in ICD therapy was identifying the proper patient. If a person had an episode of SCA and survived it, then he or she could go to the doctor and get an ICD for "next time". But an awful lot of people who get SCA do not survive. So physicians tried to find other ways to identify people at high risk of SCA.

At first, many people in the clinical community doubted such risk factors could really be useful. But study after study found that ICDs save lives.

In 2002, the MADIT II clinical trial was published in The New England Journal of Medicine. In this clinical trial, people who survived a heart attack (a myocardial infarction and not SCA) received an implantable defibrillator. The people in the MADIT II study had no history of arrhythmias and no prior episodes of SCA. They had mainly two things: a heart attack in their past (more than 40 days in their past) and impaired pumping ability of the heart as defined by a low ejection fraction (EF). The EF is a percentage that states how much blood inside the heart gets pumped out in one heart contraction; a healthy EF is around 50% (nobody has 100%). People in MADIT II had an EF of 30% or lower.

Based on the old rules of the game, these people would never have qualified to get an ICD. They had no indication for an ICD. But the MADIT II study found that ICDs significantly reduced the risk of death in these patients.

MADIT II was just the start. More and more studies found out that devices save lives, even in people who have no history of arrhythmias. That brings us back to the old problem of cost effectiveness.

The potential population of patients who could benefit from ICDs - that is, the number of people whose lives may be at risk if they do not get an ICD - is huge. It is much larger than anyone ever thought. What's more, new studies are added all of the time (the last one just came out this year, MADIT-CRT) which continue to expand the number of patients who could use an ICD. This is a lot of new patients. If all of them got an ICD, how could we pay for it?

Let's look at it this way. If we gave every person on earth an ICD, the rate of death from SCA would plummet to almost nothing. But can we really afford that? Of course not. But how do we decide where the line is to be drawn?

Right now, cost-effectiveness models are based on the formula of taking every year the therapy would add to your life and then dividing it by the cost of the therapy to get that added life-year. Some cost-effectiveness analyses ask that you factor in quality of life measures so that life is not simply prolonged but that there is some good functionality.

Right now, ICDs are considered cost effective by most standards. That does not mean they are cheap. But they are on par with other recognized cost-effective therapies like dialysis.

However, that point may be moot in that currently only about 25% of the people who would benefit from an ICD (and who qualify for one and for whom one would be paid by insurance or Medicare, if the patient had those) do not have one. That's right. Three out of the four people who could get life-saving therapy from an ICD do not have one.

Ask device experts about this and they will tell you different theories. There are many factors that make this life-saving therapy so unappealing.

First, many people do not want an implantable device, even if it could save their life.

Second, it is hard to get people to undergo surgery and get a device when they do not feel ill or in any danger of cardiac arrest.

Third, some people do not hear about ICDs from their healthcare providers or, even if they do, do not really understand the issues. And some doctors do not inform their patients about ICDs, even if they might benefit from them.

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