ATLANTA (February 1, 2023) – 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 these vulnerable patients, allowing their heart rate to increase substantially so that they be discharged from the hospital sooner and into their homes with less morbidity and fewer risks.
“Not only was this an innovative procedure, but it also was a remarkable display of teamwork,” said Dr. Robert Whitehill, a pediatric cardiologist at Children’s Heart Center. “Through combined efforts of the cardiac intensive care unit, the cardiothoracic surgery program and the electrophysiology department, we were able to quickly help a patient in need so that he could go home safely with his family only two weeks after being born.”
In addition to the efforts of Children’s Cardiology, the Children’s research team that shepherds institutional approvals, as well as Medtronic, both were instrumental in the efforts to support this young patient.
“Obtaining expanded access approval to implant either a device or to administer a medication is crucial for patient care especially when there are no other alternatives for the patient,” according to Melissa Burnett, senior research coordinator at Children’s. “This process contained many moving parts that had to be completed simultaneously by key personnel at both Children’s and Medtronic. We all worked together seamlessly to guarantee the patient could receive their new device in a timely manner.”
Now that the patient is home, the smaller device can not only monitor his heart safely, but it also can send updates about his heart rate and the device’s battery life to the clinicians remotely so he and his family can avoid more clinic visits.
“This entire process has been so much easier than we expected,” said Amanda Brinker, the patient’s mother. “A pacemaker was inevitable, but we anticipated having to stay in the hospital a lot longer after Connor was born, and we expected to have more frequent doctor visits once we got home. We are so grateful to the team at Children’s that not only helped Connor’s heart but did so in a way with the least impact on our new life as a family.”
The Children’s Heart Center is one of the largest cardiac programs in the Southeast, one of the top five largest pediatric heart centers in the nation for Cardiac Intensive Care Unit (CICU) and Cardiac Acute Care Unit (CACU) volumes, and one of the top ten largest pediatric heart centers for heart surgery, catheterization procedure and transplant volumes.
About Children's Healthcare of Atlanta
As the only freestanding pediatric healthcare system in Georgia, Children’s Healthcare of Atlanta is the trusted leader in caring for kids. The not-for-profit organization’s mission is to make kids better today and healthier tomorrow through more than 60 pediatric specialties and programs, top healthcare professionals, and leading research and technology. Children’s is one of the largest pediatric clinical care providers in the country, managing more than one million patient visits annually at three hospitals, Marcus Autism Center, the Center for Advanced Pediatrics, urgent care centers and neighborhood locations. Consistently ranked among the top children’s hospitals by U.S. News & World Report, Children’s Healthcare of Atlanta has impacted the lives of kids in Georgia, across the United States and around the world for more than 100 years thanks to generous support from the community.