The analysis found:

62 of the 63 children had the leadless pacemaker successfully implanted, and the heart’s electrical parameters were stable within the first 24 hours.
During an average follow-up period of about 10 months, the pacemaker was effective in its overall performance, including battery longevity, low pacing threshold (signals if pacemaker is performing well) and ability to detect the heart’s native electrical beats. Pacemaker batteries typically last 5-10 years, depending on how often the device is needed to maintain regular pacing, added Shah.

Overall, 16% (10) of the children experienced complications after receiving the leadless pacemaker. Most of these were due to minor bleeding, which was treated promptly and easily. There were 3 major complications — one blood clot in the femoral vein of one patient; one cardiac perforation; and one patient had sub optimal pacemaker function requiring removal of the pacemaker after one month.
“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. 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.”

During the follow-up period after implantation, the leadless pacemakers continued to have stable performance, and there were no reported complications. The researchers have now converted this retrospective study to a prospective study and plan to follow these patients for an additional 5 years.

“Leadless pacemaker technology is the wave of the future,” Shah said. “This is an excellent technology that may be offered to a wider pediatric population. 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, which is several decades after implantation.”

The major limitations of this study are the small study size and short term follow up.

“This initial report looking at implanting leadless pacemakers in children and adolescents may provide information to guide clinicians on how to select children who might benefit from a leadless pacemaker,” said Kenneth A. Ellenbogen, M.D., FAHA, co-author of the 2018 ACC/AHA/HRS Guideline on the Evaluation and Management of Patients With Bradycardia and Cardiac Conduction Delay, and Kimmerling Professor of Cardiology at the VCU School of Medicine in Richmond, Virginia. “This new information may also allow more access to leadless pacing for children.”

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