An atrial septal defect is a congenital heart defect that allows blood to flow between the left and right atria by way of a hole. This creates a surplus of blood in the right side of the heart and an increase of blood to the lungs. The more blood that is diverted, the harder the heart and lungs need to work, leading to additional stress and possible weakening or enlargement of the right side of the heart, as well as an abnormal heartbeat.
Joseph A. Paolillo, MD, director of the Pediatric Cardiac Catheterization Program at Carolinas HealthCare System, is the first physician in the country to successfully implant a newly FDA-approved device to treat atrial septal defects. The device, a septal occluder, was approved by the FDA in May. On July 27, the first day it was available for use, Dr. Paolillo performed three procedures to correct atrial septal defects. All procedures were successful.
The first patient to receive the device after FDA clearance was Joshua.
The new device presents a nonsurgical option to correct the abnormality. Dr. Paolillo, who participated in evaluating the prototype 10 years ago, believes it presents a safer, more effective way to treat atrial septal defects.
“By using a catheter-based approach, we can offer our patients a shorter hospital stay, reduced scarring, and an easier, more rapid recovery,” he says. “We felt this was the best option versus surgery,” Joshua's mother, Anna, says. “The device had been in trial for two years by this time, so we decided to wait for it to be approved.”
As soon as the approval came, Dr. Paolillo contacted the Chapmans and scheduled Joshua’s procedure with Levine Children’s Hospital's Pediatric Congenital Heart Center the first day the devices could be shipped. Having the new device in addition to the other devices commercially available increases the likelihood of being able to close an atrial defect with a catheter procedure.
“We couldn’t be happier with our experience at the hospital and with Dr. Paolillo,” Anna says. “Joshua is very proud of the tiny scar on his leg and loves to share with all his friends the story of how his heart got fixed.”
In addition to being the first in the country to utilize the device on a patient, Dr. Paolillo played an integral role in getting the device approved by the FDA. While it was still in the clinical trial phase, Dr. Paolillo enrolled several patients to receive treatment with the device, prompting Carolinas HealthCare System to become one of the highest enrollment sites in the country.
“This is proof that cutting-edge clinical research is not restricted to a university anymore,” Dr. Paolillo says.
