Preemies With Most Common Heart Defect Benefit From New Procedure
FDA Approves New Device to Treat Infants With Minimally Invasive Procedure Tested at Smidt Heart Institute, Allowing Smallest Babies to Forgo Invasive Surgeries and Medication Risks
Maxwell and Mason Bradford were born at 27 weeks gestation – about 13 weeks early. Each weighed just 2 pounds, 10 ounces. Like many extremely premature babies, both Maxwell and Mason were born with patent ductus arteriosus (PDA), the most common heart-related birth defect, which is commonly called “a hole in the heart.”
The brothers were just 2 weeks old when they arrived at Cedars-Sinai to undergo a minimally invasive procedure to fix their hearts.
The device used to treat the boys in a clinical trial, the Amplatzer Piccolo™ Occluder developed by Abbott, was recently approved by the Food and Drug Administration (FDA). During the nonsurgical procedure first tested at Cedars-Sinai, a physician guides a catheter through a vein in the leg to the heart and closes the hole. The procedure can be performed at the bedside and takes only a few minutes.
“This is a huge win for countless preemies and their families,” said Evan Zahn, MD, director of the Guerin Family Congenital Heart Program in the Smidt Heart Institute, who performed the initial United States implants and led the clinical trial for the transcather procedure. “Our goal in all we do is to see children grow up healthy and happy, despite the gestational age they were born. We always want to see more children prosper like Maxwell and Mason have, and this FDA approval will allow us to do just that for so many babies to come.”
The PDA condition can be traced to the developing heart in utero. Before birth, a fetus' blood does not need to go to its lungs to get oxygenated because the mother's own blood circulation supplies oxygen. Key to this process is the ductus arteriosus, a connection between the heart's two major arteries that allows the fetus' blood to bypass its lungs. After birth, however, the baby needs to breathe on its own, so this connection naturally closes. When the hole does not close, patent ductus arteriosus ensues and can lead to difficulty with breathing and feeding, brain hemorrhages, heart failure and even death.
Medication therapy is successful in less than 60 percent of newborns with PDA and can cause side effects such as kidney failure and bleeding, Zahn said. Open-heart surgery has its own short-term risks, and recent evidence suggests that long-term outcomes after surgery for preemies with PDA may be worse than previously thought.
The new procedure and the device have changed those prospects, giving physcians new options in their nonsurgical tool kits.
“As an institution, we are driven to do all we can for every patient who comes under our care,” said Eduardo Marbán, MD, PhD, director of the Smidt Heart Institute. “Nothing is truer than for our tiniest babies who rely solely on their parents and medical team to survive. This is a tremendous achievement for a deserving, in-need community.”
Today, Maxwell and Mason are energetic and healthy 1-year-olds with no signs of premature birth or congentital PDA condition. Their mother, Jocelyn Collins, is forever grateful to Cedars-Sinai.
“There are truly no words to describe how thankful we are for the timing of this procedure and the gift of life it gave to my sons,” said Jocelyn, a mother of seven who lives in Lancaster, California. “Our family is able to enjoy each day together because of this exceptional care and innovation.”