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Yale-New Haven Hospital, New Haven, Connecticut, USA HealthLINK: Women's Health

August 20, 2002

News this month
Results of new pacemaker heartening

A half century of breakthroughs has driven down the percentage of deaths attributable to cardiovascular disease. Though heart problems still kill more Americans than any other condition, age-adjusted rates of death from cardiovascular disease fell about 20 percent from the mid-1980s to the mid-1990s.

The death rate from heart failure has more than doubled in the last two decades.

This victory has a peculiar twist, however. While the death rate from heart attacks fell 44 percent over the last two decades, the death rate from heart failure has more than doubled. Annual deaths now number about 50,000, and about a million hospitalizations each year are linked to heart failure.

Heart failure tends to be a disease of the elderly, so the graying of America is sending the numbers even higher. As the ranks of the elderly swell, the numbers with the condition are certain to increase. “If you do a good job of keeping people alive, this is where they end up,” said Dr. Ann Bolger, a cardiologist who serves as a national spokeswoman for the American Heart Association.

New kind of pacemaker resyncs hearts
New research, published in The New England Journal of Medicine (NEJM) suggests a new kind of pacemaker may be able to relieve symptoms in some people with heart failure, keeping them out of the hospital.

Biventricular pacemakers synchronize the left and right sides of the heart.

Biventricular pacemakers have recently been approved for sale by the federal Food and Drug Administration. Unlike typical pacemakers, which connect to the upper and lower chambers on the right side of the heart, this new kind of pacemaker carries a third lead for the left ventricle, synchronizing the left and right sides of the heart.

In about one-third of heart failure patients, the walls of the left ventricle—the heart's main pumping chamber—are no longer synchronized, or pumping together as they normally would. People with this complication often have worsening of the symptoms that typically occur with heart failure, which include fatigue, shortness of breath and swelling of the feet and ankles. A biventricular pacemaker is designed to resynchronize the pumping action of the left ventricle and relieve the symptoms of people with this condition.

Patients who received pacemakers along with drug treatment reported a better quality of life…

Symptoms significantly improved
The NEJM study followed 453 people diagnosed with moderate to severe heart failure who also had this pumping chamber abnormality. All were implanted with the pacemakers, but they were turned on in only 228 patients. Both groups were treated with conventional drug therapy. After six months, the patients who received pacemakers along with drug treatment reported a better quality of life; and they were able to walk farther than those treated with drugs alone. Also, only 8 percent of people in the pacemaker group ended up in the hospital with worsening heart failure, compared with 15 percent of those treated with drugs alone.

Getting the heart's chambers to work together results in significant improvement in symptoms, says the study's lead author William T. Abraham, MD, of the University of Kentucky College of Medicine.

Cautions
While the results of the study are “exciting,” doctors need to be careful when choosing patients for this type of therapy, wrote Dr. Joshua M. Hare of Johns Hopkins Medical Institutions in Baltimore, MD, in an editorial accompanying the article. “Right now, what we know about this therapy is that it makes patients feel better. But they may not need it if symptoms can be controlled with medication,” Hare wrote. “We don't yet know if this therapy helps patients live longer. If future studies show that it does, then it would be an appropriate first-line treatment for all patients in this category.”

The treatment does have some potential complications, including a high rate of implantation and maintenance problems. The pacemakers could not be implanted successfully in 8 percent of people in the study, and other patients experienced problems after implantation. The devices are harder to implant than conventional pacemakers because they have an extra wire that must be fed into a small vein in the heart. As with any new treatment approach, it's important to weigh the benefits against potential risks.



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Stuart Katz, MD portrait

More effective treatment options for heart failure patients

It's possible the number of heart failure patients in the country may double to 10 million in less than a decade. The disease is approaching epidemic proportions. People who in the past would have died from heart attacks are now often being treated with drugs and surgery and continue to live for many years. But damage from the heart attack and the underlying conditions that contribute to heart disease, such as high blood pressure and atherosclerosis, persist, weakening the heart's function and compromising an individual's quality of life.

“The number of heart failure patients. . .may double to 10 million in less than a decade.”

Fortunately, better treatments are appearing across the spectrum of the condition, from those at risk of developing the disease to those for whom a heart transplant appears the best choice. For decades, we had few effective options for dealing with heart failure, other than to make people as comfortable as possible during their inevitable decline.

There is still no known cure, but we have an ever-increasing number of treatment options to minimize symptoms and slow the progression of the disease. The combination of lifestyle changes and drug therapy—the foundation of almost all heart failure treatment regimens—can markedly improve both survival rates and quality of life.

Treatment options
Treatment varies according to the stage of heart failure and each individual's specific medical history. We counsel most patients to make adjustments in their lifestyle, including stopping smoking, reducing consumption of salt and saturated fat and increasing exercise. We also prescribe a variety of medications depending on the stage of the disease.

Old standbys for high blood pressure treatment, such as beta blockers and ACE inhibitors, have found new roles for heart failure patients. These have joined traditional treatments including diuretics and digoxin, an age-old drug that helps the heart beat more forcefully.

“Biventricular pacemakers…are designed to induce a failing heart into beating more effectively.”

If medications do not adequately enhance heart function, however, certain patients with advanced heart failure may become candidates for other interventions, including surgery and implantable devices.

Resychronization pacemakers
Last year, the FDA approved a special kind of device, known as resynchronization or biventricular pacemakers, which are designed to induce a failing heart into beating more effectively. The pacemakers work by delivering an electrical pulse to prod the heart's ventricles into beating simultaneously, as they do in undamaged hearts. These devices are designed to work in patients with a specific electrocardiogram abnormality called “intraventricular conduction delay” (IVCD). Approximately one third of patients with heart failure have IVCD.

Though expensive, about $10,000, those devices have quickly found a place in the arsenal of heart failure experts looking for effective ways to treat the third of patients whose heart chambers fail to pump together. As the recent study published in The New England Journal of Medicine shows, these implanted devices have an immediate impact on the quality of life of some patients who have not been responsive to drug therapy—improved energy, less shortness of breath, fewer hospitalizations.

“Those with pacemakers were able to exercise harder and walk farther than those treated with medication alone.”

By the end of the study, it was clear that patients with the pacemaker did better than those treated with medication alone. Among those whose pacemaker was not turned on, 34 required hospitalization for worsening heart failure, compared to 18 in the pacemaker group. Those with pacemakers were able to exercise harder and walk farther than those treated with medication alone. And those in the pacemaker group reported a much higher quality of life than those who received medication alone.

The devices, like drug therapy, appear to reduce costs long-term by keeping patients out of the hospital. We do not yet know if these devices will result in prolonging a patient's life. Currently, only about 50 percent of patients with heart failure live for another five years after their diagnosis.

In addition, the patients implanted with the new devices run the risk of implantation and maintenance problems. In about 8 percent of the patients in the study, the pacemakers could not be implanted successfully; other patients experienced problems after implantation. The benefits are significant however, and I would suggest any heart failure patients discuss this option with their physicians to determine if they are appropriate candidates.


Dr. Katz is the director of the Yale Cardiomyopathy Program. He is a cardiologist at Yale-New Haven Heart Center and Yale-New Haven Hospital, as well as an associate professor of internal medicine in the cardiovascular medicine section at the Yale School of Medicine.


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