Through a collaborative effort, pediatric cardiologists at Children’s Healthcare of Atlanta’s Heart Center inserted a Medtronic pediatric Implantable Pulse Generator (IPG) into a premature infant, born at 34 weeks and weighing just over two kilograms, who had a congenital complete atrioventricular block. While the device is not FDA approved in these tiny patients, the team was able to secure approval from the Institutional Review Board and then Emergency Use Authorization from the FDA, making this one of only a handful of such implant procedures worldwide.
The baby developed complete heart block prior to birth due to cardiac inflammation related to the mother’s autoimmune disease. Therefore, the Children’s Fetal Cardiology Program in conjunction with the mother’s obstetrician, monitored the baby’s heart in-utero to monitor for changes in the heart rhythm, screen for worsening heart failure, and determine the best delivery plan and cardiology evaluation after delivery.
“Given the very low heart rate in the fetus, the family consulted with members of the Arrhythmia Program, and we determined the baby would need a pacemaker after delivery, and so the plan for implantation was already in place,” said Dr. Erik Michelfelder, Director of the Fetal Cardiology Program at the Children’s Heart Center. “By 34 weeks, the fetal heart rate was not improving, so we worked with the mother’s obstetrician to develop an immediate delivery plan and then to transfer the baby to the Cardiac Intensive Care Unit at Children’s for further evaluation.”
Typically, these small patients in need of pacemakers must wait until they reach 3-3.5 kg so that surgeons can implant an approved, larger device, leading to increased time in the hospital, risk of infection and issues with digestion. This recent procedure, performed by Dr. Joshua Rosenblum, a congenital cardiothoracic surgeon at Children’s Heart Center, represents a breakthrough for…
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