Percutaneous Mesh Device Treats Congenital Heart Defect

A minimally invasive transcatheter implant the size of a pea closes patent ductus arteriosus (PDA) in premature infants.

The Abbott (Abbott Park, IL, USA) Amplatzer Piccolo Occluder is a self-expanding, nickel-titanium wire mesh device that is inserted through a small incision in the leg and guided into either the aortic or pulmonary artery via an anterograde (venous) or a retrograde (arterial) approach. Because the device can be deployed in a minimally invasive percutaneous procedure, many premature neonatal intensive care unit (NICU) babies can be weaned from artificial respirator support soon after implantation.

“Piccolo is a critical advancement in the standard of care for the most vulnerable of premature babies who may not be able to undergo surgery to repair their hearts,” said Michael Dale, vice president of Abbott's structural heart business. “Our mission is to develop life-changing technology to help people live better lives through improved health. This approval is another important step toward achieving our mission for the patients and physicians we serve.”

“We’ve never had anything like this, a device from a major medical manufacturer that was specifically designed with these tiny, really at risk, very fragile babies in mind,” said Evan Zahn, MD, director of the congenital heart program at Cedars-Sinai Smidt Heart Institute (Los Angeles, CA, USA). “We’re talking about babies the size of the typical water bottle we all drink out of. They are incredibly frail, fragile and at risk for terrible morbidity and mortality.”

PDA is a congenital disorder in the heart wherein a neonate's ductus arteriosus fails to close, remaining patent (open), thus allowing part of the oxygenated blood from the left heart to return to the lungs by flowing from the aorta to the pulmonary artery. Early symptoms are uncommon, but in the first year of life include increased work of breathing and poor weight gain. With age, the PDA may lead to congestive heart failure (CHF) if left uncorrected. Neonates without adverse symptoms may simply be monitored as outpatients, while symptomatic PDA can be treated with both surgical and non-surgical methods.