Optimal Use of an FDA-Approved Device for PDA Closure in Infants

In January 2019, the US Food and Drug Administration approved a novel device for patent ductus arteriosus (PDA) closure in infants. The Amplatzer Piccolo Occluder is indicated for catheter-based closure of PDA in infants weighing more than 700 g and aged 3 days and above.

In a new commentary in the Journal of Pediatrics, researchers from Nationwide Children’s and other institutions explore questions around the optimal use of the device. They say that although the Amplatzer Piccolo Occluder provides the health care community with a less invasive alternative to achieve ductal closure, fundamental questions remain regarding its appropriate use.

“There have been some studies showing the device is efficacious at closing the ductus and at least some preliminary safety studies,” says Jonathan Slaughter, MD, MPH, a neonatologist and principal investigator in the Center for Perinatal Research within The Research Institute at Nationwide Children’s and one of the commentary’s authors.

“However, there have not been very many studies of PDA closure outcomes, such as long-term respiratory outcomes and mortality.”

Dr. Slaughter and his co-authors argue that the optimal use of the Amplatzer Piccolo Occluder is unknown due to the lack of randomized, controlled trials with alternative PDA treatments such as surgical ligation and conservative treatment.

“The question for health care providers across the country is, should we use this?” says Carl Backes, Jr., MD, attending neonatologist and attending cardiologist at Nationwide Children’s and a co-author of the commentary.

“We’re trying to figure out the best time to use this device and if its use results in improved outcomes. The only way to answer those questions is with a randomized, controlled clinical trial.”

Dr. Backes points to a proposed 15-site study named PIVOTAL – Percutaneous Intervention Versus Observation and Trial of the Arterial ductus in Low Weight infants. He says this large-scale trial, which will compare the Amplatzer Piccolo Occluder to conservative management, will provide answers to remaining questions about the device.

But at the present, in the absence of these data, there are some potential strategies for the ongoing use of the device in the pediatric community.

“I don’t think every baby with a PDA should be undergoing catheter closure early on,” says Dr. Slaughter, who is also an assistant professor of Pediatrics at The Ohio State University. “We recommend restricting the device to those patients who are high-risk, with evidence of a hemodynamically significant PDA and who are exhibiting symptoms possibly attributed to the ductus.”

Additionally, Dr. Backes recommends restricting where the device is used.

“We should continue to restrict the device to health care providers with the appropriate experience and expertise and to institutions with the infrastructure and multidisciplinary experience necessary for such a procedure,” says Dr. Backes, who is also an assistant professor of Pediatrics at The Ohio State University.

Reference:

Backes CH, Giesinger RE, Rivera BK, Berman DP, Smith CV, Cua CL, Kelleher KJ, McNamara PJ, Slaughter JL. Percutaneous Closure of the Patent Ductus Arteriosus in Very Low Weight Infants: Considerations Following US Food and Drug Administration Approval of a Novel Device. Journal of Pediatrics. 2019 Jun 26. doi: 10.1016/j.jpeds.2019.05.062.