Cardiovascular News

Defibrillator an Option for More Medicare Patients

Earlier this year Medicare made a major announcement. Medicare will now pay for a broader group of its patients to receive an implantable defibrillator that might extend their lives. Many of the patients who are newly covered are people with heart failure. Medicare made this landmark decision after reviewing several studies. The studies found that certain heart failure patients lived longer when they received defibrillator therapy along with medications.

Offering implantable defibrillators to more people with heart failure "will save thousands of lives each year. And [it] will improve the quality of life for America's seniors," said Mark B. McClellan, MD, PhD. At the time of the announcement, Dr. McClellan was administrator of the US Centers for Medicare and Medicaid Services (CMS). People often refer to CMS as Medicare.

Dr. McClellan's comments refer to people with heart disease who are at risk of sudden cardiac death, which can be caused by rapid heartbeats (arrhythmias). "By increasing the use of defibrillators," he added, "we are striking a blow against the leading cause of death among older Americans."

Medicare's decision means that another type of treatment can be offered to more of its heart failure patients. For more than 10 years implantable cardioverter defibrillators (ICDs) have been an option for people at risk of dangerous arrhythmias. Now Medicare has agreed to pay for a defibrillator for people with heart failure who have not first had a heart attack, arrhythmias, or proven risk of arrhythmias.

About 5 million Americans now have heart failure. And each year doctors diagnose about 550,000 new cases.1 For many of these patients, sudden cardiac death is a major risk:

It occurs six to nine times more often among heart failure patients than in the general population.1
It is the most common cause of death among people with moderate heart failure.2

Because heart failure is a complex disease, no one therapy works for everyone. In fact many people might need several therapies—more than one medication, for instance. Likewise, defibrillator therapy is usually used with medications to relieve as many symptoms as possible.

Heart Conditions: How They Differ

Heart disease—a general term that refers to any heart condition or problem

Heart failure—a condition in which the heart's pumping ability is weakened (and sometimes less coordinated)

Heart attack—an injury to the heart muscle from lack of blood flow, usually caused by a blocked artery

Arrhythmia—an abnormally slow or fast heartbeat caused by problems with the heart's electrical signals

Sudden cardiac death—a sudden stopping of the heart (often caused by fast arrhythmias) that can lead to death unless treated immediately

One type of heart condition can lead to another. For instance, pumping problems in heart failure can interfere with electrical pathways and cause arrhythmias. That's why many heart failure patients are at risk for sudden cardiac death.

Why Medicare Made This Decision

Doctors and scientists test any new medical therapy before it is offered to the general public. This step is to make sure that the new therapy is both safe and effective. Doctors also test existing therapies that they think could be used in more patients. Testing is done through clinical studies, also called clinical trials. Doctors often test the new therapy against the traditional therapy to see which one works better.

Before making its landmark decision, Medicare reviewed several clinical studies, including the Guidant-sponsored COMPANION and MADIT II studies. The studies tested defibrillator therapy in heart failure patients. The findings showed that certain heart failure patients who were given medications plus defibrillator therapy lived longer than people who were given medications only.

The results of these studies—and Medicare's decision—mean that more doctors may consider offering defibrillators to many more of Medicare's heart failure patients. Studies like these are very helpful to doctors and researchers, who are always looking for ways to improve patients' lives.

The Impact of This Decision

While many more Medicare patients may now qualify for device therapy, others will not. Talk to your doctor if you have questions about treatments. If your doctor says you qualify for implantable defibrillator therapy, the two of you will work together on your treatment plan. The decision is based on your medical condition.

Keep in mind that the device doesn't replace medicines that you take for heart failure. The device is another therapy to help prevent sudden cardiac death, a leading cause of death among heart failure patients.

More studies of both devices and medications are being done. But for now, doctors have more treatment choices for their heart failure patients than ever before.

American Heart Association. Heart disease and stroke statistics-2005 update. Available at http://www.americanheart.org/presenter.jhtml?identifier=3000090. Accessed November 6, 2006.
MERIT-HF study group. Effect of metoprolol CR/LX in chronic heart failure: Metoprolol CR/XL Randomised Intervention Trial in Congestive Heart Failure (MERIT-HF). Lancet. 1999;353:2001-2007.

ICDs: Instructions for Use Summary

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