Study Finds Major Problems From Surgeries to Replace or Add Pacemaker Wires
A new study finds patients risk serious and potentially fatal complications when they undergo surgery to replace or add wiring to implanted pacemakers or other devices designed to stabilize heart rhythms.
Researchers from the University of Washington, Seattle took data from patients who had surgeries to replace or add wires to a pacemaker, implantable cardioverter defibrillator (ICD), or cardiac resynchronization (CRT) generator and compared the findings to patients who did not require such surgeries, according to a HealthDay news report.
They found more than 15 percent of the 713 patients who had surgery to add wires suffered major complications. Patients who had surgery to implant a wire lead to connect a device directly to the heart had the highest rate of complications, the study found. About 7.6 percent of patients who had wiring surgery suffered minor complications, according to the study.
On average, the patients required surgery to change or add wiring at age 69.5. Three out of four of the patients were men, about 40 percent had suffered a previous heart attack, 30 percent had diabetes, and more than 55 percent also had a form of congestive heart failure.
Heart Device Recalls are Common
Faulty defibrillators and similar cardiac devices have been associated with patient deaths and injuries for years. Medtronic Inc., a leading manufacturer of the medical devices, has issued recalls and warnings for its products for various reasons.
Medtronic’s Sprint Fidelis heart defibrillator leads were recalled in 2007 after patients complained that the wires did not work properly. At least five patients died as a result of defective Sprint Fidelis leads. Also, Medtronic recently recalled about 21,000 pacemakers because wires inside the devices that connect the electronic circuit to the battery and other components might break.
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