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Wednesday, 24 June 2009 18:36

29% more heart-failure patients live with CRT-D device

A defibrillator-and-cardiac-resynchronization apparatus has been developed by Boston Scientific that reduces deaths from mild heart failure by 29% when compared to a defibrillator alone. It was already shown to greatly cut fatalities in patients with severe heart failure.

The condition, in which the heart beats out of sync (and, thus, needs to be resynchronized) and pumps blood inefficiently (and, thus, needs to be defibrillated), is common after heart attacks and various types of infections.

The implantable cardiac resynchronization therapy defibrillator device (or CRT-D device), manufactured by Boston Scientific Corporation (Natick, Massachusetts), has been approved for implantation in people with severe heart disease.

Heart failure happens when the heart muscles weaken and the heart's ventricles do not coordinate properly; that is, they do not synchronize. This failure reduces the ability of the heart to transport blood throughout the body.

In mild heart failure cases, patients generally have minor symptoms, or no symptoms at all, but are still at great risk for irregular heartbeats (atrial fibrillation) or death.

In severe heart failure cases, patients become so weakened by their medical condition they are unable to have a normal lifestyle, and usually are bedridden. They have major symptoms such as difficulties breathing, buildup of fluids in the lungs and other organs, mental confusion, and general fatigue.

A Boston Scientific study, called MADIT-CRT trial, was performed, with over 1,800 patients, to see if the device could help people with mild heart failure.

Page two continues.

The Los Angeles Times article Combination device reduces heart failure deaths states “The combination device, called a CRT-D, had previously been shown effective in patients with severe heart failure, but this is the first study to investigate its use in those with milder forms of disease, who account for about 70% of the 5.5 million U.S. heart failure patients.”

The CRT-D device, which costs between $25,000 and $30,000, contains:

(1) a cardiac resynchronization component that uses a small implantable device with leads that go to both ventricles for synchroniztion. It delivers a small but regular electric signal to the heart to re-start the beating of the heart.

(2) a defibrillator component that shocks the heart back to a normal rhythm if it begins to beat irregularly.

The Wall Street Journal article Devices Show Promise for Heart Failure discusses the study that was performed by Boston Scientific.

It states, “The Boston Scientific-sponsored study compared cardiac resynchronizers with traditional implanted defibrillators, which wait for the heart to stop and deliver a jolt to restart it. Such defibrillators cost about $25,000 and have been shown to extend lifespan, but at the cost of aggravated heart failure and diminished quality of life from unnecessary shocks.”

And, “In the study, about 24% of the patients with a resynchronizer died or needed treatment for worsening heart failure, such as being hospitalized, within four years. The comparable figure for patients with a defibrillator was about 30%.”

Page three concludes.

In the study, the CRT-D device reduced the risk of death or heart failure interventions by 29% when compared with the use of a defibrillator along.

U.S. cardiologist Arthur J. Moss (University of Rochester School of Medicine), the leader of the study, stated, “We didn’t think there would be any difference in the mortality, and there was not, so all of the effect was in terms of the reduction of the development of heart failure.” [Wall Street Journal]

If eventually approved to be used for mild heart failure cases, then hundreds of thousands of U.S. citizens, all with mild heart failure, could be potential recipients of the device.

In fact, almost 22 million people around the world have some type of heart failure. In the United States, around 5.5 million people have heart failure in one form or the other.

For more information on the Boston Scientific study, go to the company’s website MADIT-CRT Meets its Primary Endpoint.

Part of the article quotes Fred Colen, president of Boston Scientific. He states, "We are very encouraged by these initial positive results, and we are hopeful they will eventually lead to a wider population of heart failure patients being treated with CRT-D therapy."

"I would like to congratulate Dr. Moss, the Executive Committee and all the MADIT-CRT investigators on a well designed and well executed clinical trial. Boston Scientific is proud to continue the tradition of supporting advances in indications in the CRM space through trials like MADIT-CRT. More than 80 percent of U.S. patients who receive an ICD or CRT-D were first indicated for this therapy by a clinical trial sponsored by Boston Scientific or its predecessors(3)."


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