Although traditional pacemakers pose minimal risk, patients are still vulnerable to some complications. These can stem from the pulse generator implanted under the skin of the chest, where infections or skin breakdown can occur, and particularly from the leads, or wires, that run from the generator through a vein to the heart. Leads can break, dislodge or contribute to a vein blockage.
To help address these issues, a small, wireless self-contained pacemaker made by Nanostim Inc., appears safe and feasible for use in patients, according to a small study in the American Heart Association journal Circulation. The pacemaker has no leads, its pulse generator lies within the unit in the heart, and is placed without the need for surgery.
At 6 millimeters in diameter and about 42 millimeters long, the wireless device is smaller than a triple-A battery. It's faster and easier to implant than traditional pacemakers, and it's programmed and monitored similarly, according to Vivek Y. Reddy, M.D., lead author of the study and director of the Cardiac Arrhythmia Service at Mount Sinai Hospital in New York City.
"While a much larger study is required to prove this, one may expect the leadless pacemaker to be associated with less chance of infection and lead-related problems such as lead fracture," Reddy said. "Overall, the self-contained pacemaker is a paradigm shift in cardiac pacing."