This wireless pacemaker is self-contained, lies within the heart and is smaller than a triple-A battery.
Although traditional pacemakers pose minimal risk, patients are still vulnerable to some short- or long-term complications.
Those complications 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,” explained Vivek Y. Reddy, lead author and director of the Cardiac Arrhythmia Service at Mount Sinai Hospital in New York City.
However, 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 six millimetres in diameter and about 42 millimetres long, the wireless device is faster and easier to implant than traditional pacemakers,” Reddy said.
“One may expect the leadless pacemaker to be associated with less chance of infection and lead-related problems such as lead fracture. Overall, the self-contained pacemaker is a paradigm shift in cardiac pacing,” he noted.
The study, called LEADLESS, was conducted in 33 patients, average age 77 at two hospitals in Prague and one in Amsterdam.
The self-contained pacemaker was successfully implanted in 32 patients.
Ninety-four percent of patients were free of complications through the three-month study period, the researchers reported.
The new device is a self-modulating pacer guided into place using a catheter inserted in the femoral vein and 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.
Patients who need dual-chamber pacing would still require traditional pacemakers, according to Reddy.
The report was published in the American Heart Association’s Rapid Access Journal.