Wireless pacemakers could be a safe and effective short-term option for children with slow heartbeats, a new study suggests.
Children with a heartbeat that's too slow -- a condition called bradycardia -- need a pacemaker to keep their hearts beating normally.
Researchers successfully implanted wireless pacemakers into 62 kids to see if the cutting-edge devices could be safely used in children, according to a new report in the journal Circulation: Arrhythmia and Electrophysiology.
"Leadless pacemaker technology is the wave of the future,"said lead researcher Dr. Maully Shah, director of cardiac electrophysiology in the Cardiac Center at Children's Hospital of Philadelphia.
"This is an excellent technology that may be offered to a wider pediatric population," Shah said in a journal news release. "However, techniques and tools to place the device must be designed for smaller patients, specifically children, and there needs to be a mechanism to remove and replace this pacemaker without surgery when the battery runs out since pediatric patients will likely require pacing for the rest of their lives."
Traditional pacemaker devices are implanted outside the heart, with electrical leads running through the veins into the heart. These wires deliver electrical pulses that help the heart maintain a normal pulse.
Wireless pacemakers are a newer innovation.
They're the size of a AAA battery -- about 90% smaller than traditional pacemakers. Doctors implant these tiny capsule-like devices directly inside one of the heart's chambers through a catheter. Because it's inside the heart, the device needs no wires to deliver electrical pulses.
These wireless devices have some clear advantages for kids. The lack of wires means they don't have to limit their upper body activity for fear of jostling a lead loose or causing a wire to break.
But implanting a wireless pacemaker requires a catheter that's too large for use in smaller children, the study authors noted.
For this study, the researchers evaluated the implantation of wireless pacemakers in 63 children aged 4 to 21 at 15 medical centers across the United States, United Kingdom and Italy between 2016 and 2021. This was the first pacemaker for 77% of the kids.
In 62 out of 63 children, the implant was successful and the patient's heartbeat stabilized within 24 hours, even though doctors had to use adult-sized catheters to deliver the implant.
During an average follow-up of 10 months, the pacemakers remained effective. Pacemaker batteries typically last between five and 10 years, depending on how often the device has to deliver pulses to maintain a steady heart rhythm, the researchers said.
Ten of the children experienced complications after receiving the pacemaker, according to the report.
Many of the side effects involved easily treated minor bleeding, but there were three major complications -- one blood clot in the femoral vein of a patient, one patient whose heart was torn in the procedure , and one pacemaker that had to be removed after a month due to suboptimal performance.
"Using adult catheter-guided delivery systems in children is challenging and may increase the risk of major complications. Since these are big catheters, selection of patients by size is very important. Two out of the three complications occurred in patients weighing less than 60 pounds,"Shah said.
"The femoral vein in the groin is the conventional route to place the leadless pacemaker,"Shah continued. "For some patients, especially the younger and smaller children, the jugular vein (in the neck) was a better option because it provides a more direct route to implant the tiny pacemaker in a smaller heart."
The investigators plan to track the children for another five years to make sure the pacemakers continue to safely and effectively treat their slow heartbeat.
More information
The U.S. National Heart, Lung, and Blood Institute has more on how pacemakers work.
SOURCE: American Heart Association, news release, April 11, 2023