Leadless pacemakers safe for children with congenital heart disease
Click Here to Manage Email Alerts
Key takeaways:
- Wireless pacemakers may be a safe and effective short-term option for children requiring permanent pacing.
- Either femoral or internal jugular venous approaches may be used.
Children who underwent implantation of a transcatheter leadless pacemaker experienced implant success, good electrical performance and a low level of major complications during short-term follow-up, real-world data show.
Transcatheter leadless pacemakers (TLP) are a safe and effective option for adults with pacing indications; however, exemption of children from clinical trials has created uncertainty over pediatric indications for the technology, as well as questions about efficacy and safety, Maully J. Shah, MBBS, director of cardiac electrophysiology in the Cardiac Center at Children’s Hospital of Philadelphia and a professor of pediatrics at the Perelman School of Medicine at the University of Pennsylvania, and colleagues wrote in the study background. However, a new analysis of registry data from the Pediatric & Congenital Electrophysiology Society (PACES) TLP registry demonstrated a high level of implant success in children.
“The leadless pacemaker is an effective option for children, as it eliminates several complications associated with conventional pacemakers such as leads-pocket infections, venous occlusion and lead fractures,” Shah told Healio. “Lead fractures are particularly common in children due to continuing body growth and physical activity. The leadless pacemaker also has cosmetic and psychological appeal to young patients because there is no chest incision or visible pacemaker pocket.”
Registry data show safety
In a retrospective study, Shah and colleagues analyzed data from 63 children enrolled in the clinical nonrandomized multicenter PACES TLP registry, who underwent Micra (Medtronic) TLP implantation between May 2016 and May 2021 and had follow-up of at least 1 week (mean follow-up time, 9.5 months). The implantation technique was left to the discretion of the managing electrophysiologist. Researchers assessed TLP indications and pacemaker programming and electrical parameters at implantation, including threshold, impedance and sensed R-wave. Researchers also reviewed management after implantation, including recovery, hospitalization, imaging, rhythm monitoring and medications.
The findings were published in Circulation: Arrhythmia and Electrophysiology.
The device was successfully implanted in 62 of 63 registry patients (98%) at a mean age of 15 years (eight patients aged 8 years or younger) and 32% of patients had congenital heart disease. The mean body weight of patients at TLP implantation was 55 kg. TLP was implanted by femoral (n = 55; 87%) and internal jugular (n = 8; 12.6%) venous approaches.
During follow-up, 16% of patients experienced complications, including one cardiac perforation/pericardial effusion, one nonocclusive femoral venous thrombus and one retrieval and replacement of TLP due to high thresholds. There were no deaths, TLP infections or device embolizations.
Electrical parameters, including capture thresholds, R-wave sensing and pacing impedances, remained stable, according to the researchers.
The researchers noted that during follow-up, 24% of patients had 100% ventricular pacing, whereas 34% had less than 1% ventricular pacing and 42% had 1% to 50% ventricular pacing.
“This represents a cohort requiring a relatively low burden of ventricular pacing and potentially a longer projected battery life,” the researchers wrote. “However, even with minimal pacing percentage and estimated longevity of 8 to 14.5 years, a Micra TLP will not come close to satisfying a potentially lifelong pacing need in young patients; implanters will have to strategize the next steps in TLP management.”
More pediatric data needed
Shah, who called the technology “the wave of the future,” said TLP may be offered to a wider pediatric population.
“Leadless pacemakers are safe and effective in children and can be implanted successfully from the femoral as well as the internal jugular venous route; however, the current state of leadless technology prevents its use in a wider pediatric population as it is designed for adults,” Shah told Healio. “The marketed leadless pacemakers require a 27F introducer that is too large to be used in small children. In addition, the issues of leadless pacemaker extractability and need for multiple leadless devices over a child’s lifetime have not yet been fully addressed. The study also draws attention to the fact that two of three major complications occurred in small children (< 30 kg) and, therefore, implanters need to be cautious about patient size selection.”
The researchers are currently conducting a prospective study using the same data and plan to follow the registry patients for an additional 5 years, Shah said.
“We hope our data will inform leadless pacemaker manufacturers on how the leadless pacemaker functions in the right ventricle of a small heart and how our industry partners can modify and adapt current technology to suit the needs of pediatric patients, often an overlooked population,” Shah said. “Children with pacemaker indications will need a lifetime of pacing, which is several decades more than an adult patient, and research is needed to make leadless devices last longer and be removed and replaced safely. Research is also needed for further miniaturization of the device, improvement of the atrioventricular synchrony algorithm to be functional at higher atrial rates and more integration with other emerging device technologies.”
For more information:
Maully J. Shah, MBBS, can be reached at solimeon@chop.edu; Twitter: @maullyshah.
Collapse
Read more about
Click Here to Manage Email Alerts