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New Defibrillators Could Raise Heart Risks, Study Finds

2-Chamber Pacemaker Caused Hospitalization Or Death In Some Cases

Dec 20, 2002 | AP

A new study has linked widely used, sophisticated heart defibrillators with a slightly increased risk of hospitalization and death.

The study questions the value of a costly pacemaking feature in newer defibrillators similar to the device implanted in Vice President Dick Cheney last year.

It doesn't challenge the benefit of implanted defibrillators, which zap rapidly irregular heartbeats back to normal. The devices can prevent cardiac arrest.

Most of the newer models also feature built-in pacemakers, which help maintain a normal heart rhythm.

But most patients who need defibrillators probably need only the less sophisticated devices equipped with a backup pacemaker, the research suggests. The backup pacemaker stimulates the lower heart chamber when the beat becomes too slow.

The researchers found increased risks with newer models featuring pacemakers that supply electrical impulses to the upper and lower heart chambers.

The newer, dual-chamber devices can be programmed to continuously regulate the heartbeat – even though most people who get them don't need that much help, said researcher Dr. Bruce Wilkoff of the Cleveland Clinic.

Many doctors assumed that the extra help would be beneficial for defibrillator patients because previous research showed that stand-alone, dual-chamber pacemakers helped other heart patients, Dr. Wilkoff said Thursday.

But within one year of getting the implants, 26.7 percent of the dual-chamber patients in the study died or were hospitalized with heart failure, compared with 16.1 percent of patients who got only backup pacemaking help.

The researchers halted the study early because of the poor results, which could translate into thousands of hospitalizations or deaths worldwide each year.

"Bigger is not always better; more sophisticated is not always an improvement," Dr. Wilkoff said.

An estimated 80,000 defibrillators have been implanted worldwide this year. While about three-fourths of them are the more sophisticated devices, only about 5 percent of patients need the extra help, Dr. Wilkoff said.

The study appears in the Dec. 25 issue of the Journal of the American Medical Association.

Dr. Wilkoff's research involved 506 people with heart disease or previous heart attacks, though none required continuous pacemaking help. All had defibrillators containing the more sophisticated pacemakers, but the continuous dual-chamber action was activated in only half the patients.

Dr. Wilkoff said dual-chamber devices may be more risky because continuously stimulating the right ventricle, one of the heart's lower chambers, may make the pumping action less efficient.

Defibrillators with pacemaking features are generally small, flat metal devices that come in different shapes and sizes. The devices can cost between $16,000 and $25,000. The more sophisticated ones are at the upper end of that range and can cost about $5,000 extra to implant, Dr. Wilkoff said.

Michael Coyle of St. Jude Medical Inc., which made the devices in the study and funded the research, said the results show "that careful attention must be paid to the programming of pacemaker functions" to minimize effects in defibrillator patients who don't need the extra help.

Dr. Sidney Smith, the American Heart Association's chief science officer, noted that the new study included many patients with mild heart failure and didn't address whether dual-chamber devices would be better than less costly ones for the sickest patients.

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