New leadless pacemaker safe, reliable
A new small, wireless, self-contained pacemaker appears safe and feasible for use in patients, according to a small study reported in the American Heart Association journal Circulation.
Although traditional pacemakers pose minimal risk, patients are still vulnerable to some short- or long-term complications, said 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.
Complications can result from the pulse generator implanted under the skin of the chest, where infections or skin breakdown can occur. The leads, or wires, that run from the generator through a vein to the heart can also produce complications. Leads can break, dislodge or contribute to a vein blockage.
The new 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, Reddy said, and it’s programmed and monitored similarly.
"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."
The new device is a self-modulating pacer guided into place using a catheter inserted in the femoral vein. It is affixed to the heart in the right ventricle, the same place a standard lead would be located. The device is for patients who require single-chamber pacing, or roughly 20 percent to 30 percent of U.S. and European patients who need pacemakers. Patients who need dual-chamber pacing would still require traditional pacemakers, Reddy said.
After three months, the new pacemakers were functioning well, the researchers found. They are continuing to track the patients and expect to report longer-term outcomes later this year. Meanwhile, a much larger study at multiple U.S. locations that will include longer-term follow-up is under way, Reddy said.