A miniature pacemaker developed for use in infants and those with limited vascular access has passed a proof-of-concept simulation and is entering its second phase of testing, researchers from Children’s National Health System in Washington, D.C., have reported.
The tiny pacemaker, designed by Medtronic, measures around 1 centimeter cubed, Rohan Kumthekar, MD, a lead developer on the project, said in a release. That’s no bigger than the size of an almond.
“As cardiologists and pediatric surgeons, our goal is to put a child’s health and comfort first,” Kumthekar, a cardiology fellow at Children’s National, said. “Advancements in surgical fields are trending toward procedures that are less and less invasive.”
Open surgeries like appendectomies and gallbladder removals have transitioned to become laparoscopic procedures, he said, but pacemaker placement in infants has always required open surgery, and that remains the industry standard.
Kumthekar et al.’s new device would potentially allow physicians to reshape that standard by implanting miniature pacemakers via a 1-centimeter incision just below a child’s rib cage. Using a two-channel, self-anchoring access port to guide a small camera through the chest cavity, doctors could then precisely place and affix the pacemaker to the infant’s heart. The physical result of the procedure is minimal, leaving a small scar but avoiding the large suture marks that typically go hand-in-hand with implantation procedures in kids.
“The advantage is that the entire surgery is contained within a tiny 1-centimeter incision, which is what we find groundbreaking,” Kumthekar said.
Kumthekar and his team tested the novel device in eight piglets under general anesthesia and veterinarian supervision. Implantation was successful in all subjects, and the full procedure took less than an hour on average—a major reduction from the several hours it normally takes to implant a pacemaker in a child’s heart. Time from incision to leadlet fixation in the study was around 25 minutes.
The procedures were successful in reducing surgery and recovery times, pain and hospital costs, Kumthekar said. They were also less invasive and more efficient than today’s standard interventions.
Since there were no complications and the piglets seemed to tolerate implantation well, the researchers said they’re moving into the next phase of testing, which will analyze how well the tiny pacemakers hold up over time.
The team is still far from clinical testing or market availability, but Kumthekar said it's looking into other applications for the small pacemakers, including in adults with limited vascular access and patients who have had prior open-heart surgery or cardiovascular procedures. The research was presented by Kumthekar Nov. 11 at the American Heart Association’s Scientific Sessions in Chicago.