‘A new alternative’: Tiny pacemakers for infants show early promise
Small pacemakers built specifically for infants are both safe and effective, according to a new analysis published in Circulation: Arrhythmia and Electrophysiology.[1]
“There are two challenges with placing a pacemaker in a small child,” lead author Charles I. Berul, MD, an electrophysiologist at Children’s National Hospital and professor at George Washington University School of Medicine, said in a statement. “First, the device is large compared to the size of a newborn or preemie. Second, the pacing wire from the device to the heart usually goes through a vein in older children and adults. Infants require an open-chest approach so the surgeon can sew on the wire to the heart.”
Berul et al. hoped to learn if miniature pacemakers about one-quarter the size of a traditional pacemaker could make a difference. The devices included “a Medtronic Micra subassembly in a polymer header connecting to a bipolar epicardial lead.”
The team’s analysis included data from 29 newborn and infant patients at 12 different U.S. pediatric hospitals who received these custom-designed pediatric pacemakers. Many patients were born prematurely and/or with congenital heart defects. The median age was 15 days, and the median weight was five pounds.
A: The Medtronic Pediatric implantable pulse generator (IPG; left), consisting of a Medtronic Micra module in a polyetheretherketone surround with an IS-1 header. The device is 27.6 mm long, has a volume of 2.6 cm3, and a mass of 4.8 g. For comparison, a Medtronic Azure XT single-chamber pacemaker generator (right) measures 50.8 mm in length, 42.6 mm in height, has a volume of 12.3 cm3, and a mass of 22.5 g. B: The Micra module (MC1 VR01) below the Pediatric IPG, showing the connections between the generator and the IS-1 header. Images and captions courtesy of the American Heart Association and Circulation: Arrhythmia and Electrophysiology.
Overall, the group found that the tiny pacemakers were safe and effective. They were safely implanted in all 29 patients and remained stable for an average of 325 days.
In addition, the group is working on making upgrades to the pacemaker that could help these young patients avoid a full surgery.
“We are working on a small port that would deliver this pacemaker through a straw-sized tool instead of requiring open chest surgery,” Berul said in the same statement. “This port has been tested in the lab and in small animals.”
Antonio Cabrera, MD, chair of the American Heart Association’s Young Hearts Council and chief of cardiology at Nationwide Children’s Hospital, was not part of this specific study, but did share encouraging words about the team’s findings.
“Newborns and small infants who need urgent pacemaker placement due to congenital or acquired heart block face challenges with limited insertion locations and potential surgical complications and infections,” Cabrera said. “With this study’s low complication rate and effective pacing, this new device may offer a new alternative for permanent pacemaker placement without the need for temporary leads.”
Three Medtronic representatives are among the study’s co-authors. All other co-authors were physicians from a variety of pediatric hospitals.
Click here to read the full analysis.
Michael has more than 18 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.