Small, Wireless Pacemaker Is Safe, Effective in Early Testing
Device may reduce risk of complications associated with traditional pacemakers
A small, wireless, self-contained pacemaker appears to be safe and feasible for use in patients, according to a new study in the American Heart Association journal Circulation.
Although traditional pacemakers pose minimal risk, patients are still vulnerable to both short- and long-term complications, according to lead author Vivek Y. Reddy, MD.
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 that run from the generator through a vein to the heart. Leads can break, dislodge, or contribute to a vein blockage.
The new pacemaker has no leads (its pulse generator is located within the device), and it is placed within the heart without the need for surgery.
At 6 mm in diameter and about 42 mm long, the wireless device is smaller than a triple-A battery. It is faster and easier to implant than traditional pacemakers, Reddy said, and it is programmed and monitored similarly.
The LEADLESS trial was conducted in 33 Caucasian patients at hospitals in Prague and Amsterdam. The patients’ average age was 77 years, and two-thirds of the patients were men.
The self-contained pacemaker was successfully implanted in 32 patients (97%). Ninety-four percent of these patients were free of complications through the 3-month study period, the researchers reported. One patient suffered complications during the procedure and underwent emergency surgery, but later died after suffering a stroke.
The new device is a self-modulating pacer that is guided into place using a catheter inserted in the femoral vein. The device is affixed to the heart in the right ventricle, the same place a standard lead would be located. The procedure is intended for patients who require single-chamber pacing, or roughly 20% to 30% of U.S. and European patients who need pacemakers. Patients who require dual-chamber pacing would still need traditional pacemakers, according to Reddy.
After 3 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. sites is under way, Reddy said.
Source: AHA; March 24, 2014.