A widely anticipated heart disease study released Tuesday could boost the use of an advanced type of heart defibrillator made by companies with strong roots in Minnesota.
The 1,820-patient study -- large by medical technology standards -- found that patients treated with a type of device called cardiac resynchronization therapy defibrillators (CRT-D) were 41 percent less likely to be hospitalized or need outpatient therapy.
But while the higher-priced CRT-D device spared many patients from going to the hospital, it made no difference in saving lives, and some doctors say they won't rush to implant more patients with them.
The study was funded by Boston Scientific Corp., which employs about 2,500 people at its Cardiac Rhythm Management division in Arden Hills, but it will also benefit Fridley-based Medtronic Inc. and St. Jude Medical Inc., of Little Canada, which make versions of the device.
The study compared patients who were treated with an implantable cardioverter defibrillator (ICD) to correct abnormal heart rhythms with patients who got a cardiac resynchronization device, which helps the lower chambers of the heart pump at the same time.
The results were announced Tuesday at the European Society for Cardiology meeting in Barcelona, Spain, and published online in the New England Journal of Medicine.
"This will likely broaden the number of patients who will be treated with [CRT-D] devices," said Dr. William Katsiyiannis, a cardiologist at Minneapolis Heart Institute. "Now, only the sickest patients get these devices."
The combined defibrillator and resynchronization device is commonly used in patients with serious heart failure, and doctors wondered if patients with a mild version of the illness might benefit, as well.
"The answer is a clear, unequivocal yes," said Arthur Moss, of the University of Rochester Medical Center in New York, and the study's lead author.
Not everyone agreed. Douglas Zipes of the Indiana School of Medicine said too many patients already are treated with the devices and that doctors need to rethink who should get them.
Moss' study tracked patients with mild heart disease in North America and Europe for more than four years, including patients enrolled at the Mayo Clinic in Rochester and Minneapolis Heart Institute at Abbott Northwestern Hospital. About half of the patients were treated with a defibrillator, while the other half got a resynchronization device with a defibrillator.
In the United States, about 60,000 patients with more-severe heart disease get the devices every year, out of more than 5.5 million people who have heart failure. Boston Scientific said it will seek approval from the Food and Drug Administration to treat an expanded group of patients with cardiac resynchronization devices.
CRT devices sell for about $30,000, about $7,000 more than a traditional heart defibrillator. The worldwide market for heart defibrillators, estimated to be $6 billion, has stabilized following a series of safety recalls in recent years, and companies that make the devices are always looking for new ways to use them in patients.
"Medtronic welcomes the added evidence of CRT effectiveness in this mildly symptomatic heart-failure patient population," said Dr. David Steinhaus, medical director of Medtronic's Cardiac Rhythm Disease Management business.
The Associated Press, Bloomberg News and Star Tribune staff writer Janet Moore contributed to this report. jmmoore@startribune.com • 612-673-7752
