Noninfectious complications occur in nearly 9% of patients with implantable cardioverter defibrillator (ICD) and pacemaker devices.
Newer devices like the cardiac re-synchronization defibrillators have an even higher incidence of complications like hematomas and dislodgment.
Clinical Trials on Pacemaker Complications and Hematomas
In a study funded by Guidant Corp., “One third of the patients with complications had to undergo intervention procedures,” said Didier Klug, MD, from Cardiologist University of Lille in France. “Patients who underwent re – intervention procedures had 12 times the risk of infection than patients not faced with a second procedure,” he noted.
“This is a good paper that looks at the noninfectious complications of pacing and defibrillators,” commented Harry Mond, MD, session chair and associate professor of medicine at Royal Melbourne Hospital in Parkville, Australia. “It also brought to light the need for adequate procedures to prevent extrusions.”
Dr. Klug said “The study showed that the most common complications in patients undergoing device implantation were hematoma and lead dislodgement”. Other complications included impending extrusion, threshold elevation, and extrusion.
Currently, ICDs have a less than 10% complication rate, while CRT-Ds have about an overall 20% complication rate, he said.