CHOP-led Study Shows Leadless Pacemakers Likely Safe for Children with Irregular Heartbeats

In the largest pediatric study of its kind, an international group of researchers led by Children’s Hospital of Philadelphia (CHOP) has shown that wireless pacemakers appear to be safe for children with irregular heartbeats. However, the research also points to the need for smaller catheters to deliver and place the pacemakers in pediatric patients, which would broaden the population who might benefit from these devices.

The findings were published today in Circulation: Arrhythmia and Electrophysiology, a peer-reviewed journal of the American Heart Association.

Children with bradycardia, a condition in which the heart beats too slowly, require pacemakers to regulate their heartbeat. These devices are surgically implanted under the skin of the chest and transmit electrical impulses to keep the heart beating at a steady rhythm. Standard pacemakers use wires, called leads, that are connected directly to the heart to deliver these electrical signals. However, these wires can break or malfunction in highly active, growing children, putting children at higher risk for wire fractures and pacemaker complications.

Leadless pacemakers are a relatively new alternative to these standard pacemakers, and studies have shown they are safe and effective in adults with heart rhythm disorders. The self-contained devices are approximately the size of a AAA battery and are placed directly inside a patient’s heart non-surgically via a catheter. The lack of wires holds appeal for pediatric patients, but children have not been included in past studies validating the devices, so researchers have had limited data on whether leadless pacemakers are safe and effective in children.

To evaluate the safety, efficacy, and utility of leadless pacemakers in children, the researchers analyzed data from patients less than 21 years of age who were enrolled in the Pediatric and Congenital Electrophysiology Society (PACES) transcatheter leadless pacemaker registry. They found that the device was successfully implanted in 62 of 63 registry patients (98%). During a follow-up period of about 10 months, the pacemaker was effective in its overall performance, in battery longevity, low pacing threshold and ability to detect irregularities. Of the 62 patients who received a leadless pacemaker, 10 (16%) experienced complications, most of which were minor.

The researchers noted that 2 out of 3 major complications occurred in patients weighing less than 66 pounds, underscoring the need for tools that are more suited to the small size of a child’s body.

“Leadless pacemaker technology is the wave of the future,” said lead study author Maully J. Shah, MBBS, director of cardiac electrophysiology in CHOP’s Cardiac Center. “This is an excellent technology that may be offered to a wider pediatric population. However, the techniques and tools to place the device must be adapted to be suitable for use in smaller children, and there needs to be a mechanism to remove this pacemaker without surgery when the battery runs out. Pediatric patients will need pacemaker devices to support their heart rate for several decades of life.”

Learn more about this study in this press release from the American Heart Association.