Patent Ductus Arteriosus Closure: Which Patients and When?Patent Ductus Arteriosus Closure: Which Patients and When? https://pediatricsnationwide.org/wp-content/themes/corpus/images/empty/thumbnail.jpg 150 150 Mary Bates, PhD Mary Bates, PhD https://secure.gravatar.com/avatar/c6233ca2b7754ab7c4c820e14eb518c8?s=96&d=mm&r=g
- July 23, 2019
- Mary Bates, PhD
New review cites need for randomized clinical trials comparing conservative management, surgery, and catheter-based closure.
Patent ductus arteriosus (PDA) is a common condition among preterm infants. It increases mortality risk and is linked to harmful long-term outcomes including chronic lung disease, heart failure, and brain injury. Yet the optimal treatment for infants with a PDA is one of the most controversial topics in neonatal medicine.
Many health care providers first try drug therapies to induce PDA closure and, if that fails to work, turn to surgical or catheter-based closure options.
“The problem is no trials have shown that treating preterm infants with a PDA actually improves outcomes,” says Carl Backes, Jr., MD, attending neonatologist and attending cardiologist at Nationwide Children’s Hospital.
Risks associated with surgical PDA closure have led to the increased consideration of conservative (nonintervention) management, as PDAs spontaneously close on their own in some patients. However, uncertainty remains as to what providers should do when PDAs fail to close following a period of conservative management.
Over the past decade, Nationwide Children’s has moved away from surgical solutions and currently emphasizes conservative management followed by catheter-based closure for infants needing definitive ductal closure.
Dr. Backes and his team has spent the past 5 years investigating the feasibility and safety profile of catheter-based PDA closure, with evidence showing that this is a reasonable option for infants necessitating ductal closure. “However, questions regarding whom to treat, when to treat, and how to treat remain unanswered” says Dr. Backes, who is also an assistant professor of Pediatrics at The Ohio State University of Medicine and a member of the Center for Perinatal Research at the Abigail Wexner Research Institute at Nationwide Children’s. “With that in mind, we’ve used catheter-based PDA closure on infants who have not spontaneously closed their PDA beyond the first thirty days of life and who continue to have evidence of potential complications related to an open ductus.”
Dr. Backes and his colleagues recently reviewed the available evidence addressing PDA treatment strategies and, overall, they found the existing data insufficient. He and his colleagues suggest that new clinical trials are warranted. They emphasize the importance of identifying subgroups of infants most likely to benefit from PDA closure or most likely to undergo spontaneous closure to help minimize unnecessary PDA treatments. Dr. Backes and his colleagues say that in designing clinical trials, researchers should focus on characterizing high-risk subgroups of infants with PDA and defining what constitutes clinical success following PDA treatment.
The U.S. Food and Drug Administration recently approved a catheter-based closure device for infants called the amplatzer piccolo occluder. It’s the first FDA-approved device for catheter-based PDA closure in infants available to the U.S. market.
The new device provides the neonatal community with a nonsurgical alternative to achieve definitive ductal closure, but fundamental questions remain about its optimal use.
Dr. Backes believes use of the device should be restricted to health care providers experienced with the device and at institutions with the infrastructure and interdisciplinary collaborations to make sure the procedure is done safely.
“I don’t think we should use the device in all patients with a PDA,” he says. “We need to be more selective in the subgroup of infants that we use the device in, those in which spontaneous closure has not occurred and still have evidence of adverse consequences potentially attributable to the ductus.
“We need to be aware of the potential problems or unexpected benefits of the device and, in the absence of comparative prospective trials, that data is not available to us. It will take the health care community working together with families and regulators to begin to design trials that will answer some of these questions.”
Mitchell, CC, Rivera, BK, Cooper, JN, Smith, CV, Berman, DP, Slaughter, JL, Backes, CH. Percutaneous closure of the patent ductus arteriosus: Opportunities moving forward. Congenital Heart Disease. 2019; 14(1):95-99. Doi: 10.1111/chd.12704.
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