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A team from the Heart Institute at UPMC Children’s Hospital of Pittsburgh and the UPMC Heart and Vascular Institute implanted its first leadless pacemaker in a pediatric heart patient in late-October 2023.
Leadless Pacemakers and Their Benefits
Leadless pacemakers were first approved for use in adults in 2012, and since that time have undergone several generations of improvement. Leadless pacemakers are small, self-contained devices implanted directly in the patient’s ventricle and do not require lead wires to a separate implanted pulse generator.
Avoiding the need for lead wires and a separate pulse generator simplifies the implantation process – leadless pacemakers are implanted through a transcatheter approach, which avoids the need for a large incision.
“With a leadless pacemaker, we can avoid many of the most common complications that can arise with a traditional type of pacemaker implant,” says Christopher Follansbee, MD, pediatric cardiologist and electrophysiologist who collaborated on the case. “These include things like infections at the generator pocket site or leads, broken lead wires, venous obstructions, skin erosion, Twiddler syndrome, and others.”
Until recently, leadless pacemakers were predominantly used only in adult patients. However, in April 2023, the multicenter PACES collaborative published findings from a prospective clinical trial1 assessing the safety and efficacy of leadless pacemakers in pediatric patients. That study found a a high success rate and low implantation complication rate of < 2% in kids over 30 kg.
“That study and its findings opened the door to using the current generation of leadless pacemakers in well-selected pediatric patients,” says Dr. Follansbee. “For patients that need pacing and have a condition and structural physiology amenable to their use, there are a lot of benefits.”
About the Case
The first leadless pacemaker implantation at UPMC Children’s was performed in a teenager with a case of paroxysmal atrioventricular heart block (AV block).
In addition to Dr. Follansbee, the clinical team included Gaurav Arora, MD, director of Electrophysiology at the Heart Institute, and Aditya Bhonsale, MD, who is an adult cardiac electrophysiologist from the UPMC Heart and Vascular Institute.
“Our patient is a very active, athletic teenager, who is physically fine 99% of the time, but had been experiencing episodic fainting as a result of the underlying AV block,” says Dr. Follansbee. “With a structurally normal heart and very active lifestyle, the leadless pacemaker gives our patient really no limitations on activity.”
He also explains that right now, with the patient’s minimal need for pacing support, the current device will likely have a lifespan of 10 to 20 years.
“And who knows, perhaps at that time the patient will no longer require pacing, but even if it is still needed, two decades is a long time in between procedures and we won’t have to worry about many of the traditional pacemaker complications that can arise over time,” says Dr. Follansbee.
The Advancing Future of Leadless Pacemakers
As Dr. Follansbee explains, at present the current generation of leadless pacemakers are being used in a somewhat limited fashion depending on the patient’s underlying condition and heart physiology, but new generations of leadless pacemakers will expand options for a larger patient population.
“At some point in the near future, we’ll have synchronous pacing where we can insert two devices that can work in concert with each other,” says Dr. Follansbee. “This will allow for additional patients to take advantage of the devices and the benefits they confer.”
Dr. Follansbee goes on to explain that while the devices have a finite life span based on how much pacing the individual needs and the device’s annual energy consumption, being able to retrieve the device using transcatheter means when it needs replaced, implanting a new one becomes a much less burdensome and invasive approach.
“For young patients who have devices implanted and may need to use them for decades or even their entire life, being able to do so through minimally invasive approaches is huge,” says Dr. Follansbee. “We’re entering a new era for pediatric patients who need pacemakers and that is great news.”