February 2008
Medtronic heart implants
"10,000 kisses ... 532 candlelight dinners ... 687 walks in the rain ... 996 bedtime stories ... and one more thing ... peace
of mind," claims an ad for Medtronic implantable cardioverter defibrillators, or ICDs.
The $20,000 to $30,000 device detects abnormal heart rhythms that can cause sudden cardiac arrest and shocks the heart back to normal rhythm. But it won't necessarily ensure peace of mind, said heart experts we consulted. Patients with ICDs may experience stress as a result of their concern about their underlying illness as well as the possibility of getting shocked, research shows. And a global recall by Medtronic in October 2007 poses challenges for some 235,000 ICD patients.
At press time, a portion of the ad appeared on the company's Web site, although TV and print ads stopped appearing in June 2007. The company voluntarily recalled certain defibrillator leads, the thin wires that connect the ICD to the heart, because they can fracture and send inappropriate shocks, or fail. Such fractures may have contributed to five patient deaths, a spokesman said. Replacing the implanted leads is usually too risky, Medtronic advises. It recommends that physicians make adjustments in the device to reduce potential problems and set off an audible alarm if a lead breaks.
Experts we consulted said that despite the massive recall, research supports the belief that ICD therapy saves lives. But there is uncertainty in the medical literature about who should and should not get an ICD at all. Researchers say that finding valid tests to identify patients who would benefit most is a priority.
CR's take. People at high or moderately high risk of ventricular fibrillation (a dangerous heart arrhythmia) or cardiac arrest should still consider getting an implantable cardiac device as long as it does not use recalled leads. Whether the benefits of ICDs outweigh the risks is a question the patient and a cardiologist should answer together, without letting advertising claims influence that decision.
The $20,000 to $30,000 device detects abnormal heart rhythms that can cause sudden cardiac arrest and shocks the heart back to normal rhythm. But it won't necessarily ensure peace of mind, said heart experts we consulted. Patients with ICDs may experience stress as a result of their concern about their underlying illness as well as the possibility of getting shocked, research shows. And a global recall by Medtronic in October 2007 poses challenges for some 235,000 ICD patients.
At press time, a portion of the ad appeared on the company's Web site, although TV and print ads stopped appearing in June 2007. The company voluntarily recalled certain defibrillator leads, the thin wires that connect the ICD to the heart, because they can fracture and send inappropriate shocks, or fail. Such fractures may have contributed to five patient deaths, a spokesman said. Replacing the implanted leads is usually too risky, Medtronic advises. It recommends that physicians make adjustments in the device to reduce potential problems and set off an audible alarm if a lead breaks.
Experts we consulted said that despite the massive recall, research supports the belief that ICD therapy saves lives. But there is uncertainty in the medical literature about who should and should not get an ICD at all. Researchers say that finding valid tests to identify patients who would benefit most is a priority.
CR's take. People at high or moderately high risk of ventricular fibrillation (a dangerous heart arrhythmia) or cardiac arrest should still consider getting an implantable cardiac device as long as it does not use recalled leads. Whether the benefits of ICDs outweigh the risks is a question the patient and a cardiologist should answer together, without letting advertising claims influence that decision.
