Premature Twins are First in NE Ohio to Receive Newly-approved Medical Device at University Hospitals

Specialists from UH Rainbow utilize Abbott’s Piccolo™ Occluder to repair congenital heart defect 

Innovations in Congenital Heart | Summer 2019 Special Issue

The pediatric heart team at University Hospitals Rainbow Babies & Children’s Hospital has successfully treated its first patient with a congenital heart defect using Abbott’s Amplatzer Piccolo™ Occluder, a device smaller than a pea.

The Piccolo is the first and only minimally invasive, transcatheter device specifically approved for premature infants. Additionally, it’s the world's first medical device that can be implanted in the tiniest babies (weighing as little as 700 grams or 1 ½ pounds) and offers hope to premature babies and newborns with a life-threatening condition in their hearts called patent ductus arteriosus (PDA).

The procedure was performed by Martin Bocks, MD, Director of Pediatric Interventional Cardiology at UH Rainbow Babies & Children’s Hospital; and Associate Professor of Pediatrics, Case Western Reserve University School of Medicine, who now looks forward to using the Abbott Piccolo device to meet the needs of premature infants who need PDA closure, and in whom medical therapy fails.

Martin Bocks, MD

“We have spent the last couple of years developing a comprehensive program for transcatheter PDA closure in premature infants,” said Dr. Bocks. “Before Piccolo was approved, we were using other devices that worked, but were not specifically designed for neonates this size. This prior expertise and programmatic development is what allowed us to be the first center in NE Ohio to have access to the device and to use them to treat Everly and Maverick.”

One of the most common congenital heart defects occurring in premature babies, a PDA is an opening between two blood vessels leading from the heart. This pathway is present in normally developing infants, and for most, typically seals itself shortly after birth.  In some cases, primarily in babies born prematurely, the PDA fails to spontaneously close, which can make it difficult for babies to breathe normally due to increased blood flow to the lungs.

Approximately 60,000 premature babies in the U.S. are born each year with a very low birth weight, and nearly 12,000 (one out of five) of these have a hemodynamically significant PDA that is large enough to cause symptoms and which requires urgent treatment for the baby to survive.

Contact Dr. Bocks or The Congenital Heart Collaborative physician leadership team at Peds.Innovations@UHhospitals.org or call 216-714-8358.

¹ National Vital Statistics Reports: Births: Final Data for 2016. Final Vol 67; Number 1; January 31, 2018. 
² Tashiro, Jun, Bo Wang, Juan E. Sola, Anthony R. Hogan, Holly L. Neville, and Eduardo A. Perez. "Patent ductus arteriosus ligation in premature infants in the United States." journal of surgical research 190, no. 2 (2014): 613-622.
³ Bonamy, Anna-Karin Edstedt, Anna Gudmundsdottir, Rolf F. Maier, Liis Toome, Jennifer Zeitlin, Mercedes Bonet, Alan Fenton et al. "Patent ductus arteriosus treatment in very preterm infants: a European population-based cohort study (EPICE) on variation and outcomes." Neonatology 111, no. 4 (2017): 367-375.