OHSU Studies Nonsurgical Technique for Repairing Congenital Heart Defects

02/24/00    Portland, Ore.

New Device May Offer a Way to Close Holes in Heart With a Quick Recovery

Anne Lingle flew all the way from Alaska to be one of the first two patients to participate in a new study at Oregon Health Sciences University. The 79-year-old grandmother was born with a hole the size of a dime between the upper chambers of her heart. It's a congenital heart defect called atrial septal defect (ASD) and one out of every 1,500 children are born with it, but also is the most common form of congenital heart defects diagnosed in adults. The only procedure currently available to correct the defect is open-heart surgery, a surgery that requires a four- to seven-day hospital stay and weeks of recovery. But a new study at OHSU's School of Medicine and Doernbecher Children's Hospital is looking at the effectiveness of a new device that can close the hole without surgery and only requires a 24-hour hospital stay, allowing patients to resume normal activity soon after discharge.

The device is called the CardioSEAL STARFlex Septal Occlusion System. It looks like two small umbrellas facing each other and is made of polyester fabric attached to metal that can be implanted in the body during cardiac catheterization. A catheter, with the device inside, is gently inserted into a vein in the patient's leg, then routed into the heart. Once in the heart, the device is pushed out of the catheter where it opens on each side of the hole to cover and close it. New tissue grows over the fabric of the device, closing the hole permanently.

"I feel wonderful and so very happy because now I can go home," said Lingle. The hole in her heart was discovered more than a year and a half ago, but she didn't want to have open-heart surgery, so she waited for the opportunity to participate in this study. "I didn't want to spend days in a hospital recuperating from surgery because my family is in Alaska, and without their support it would've been really difficult for me."

ASD is most frequently found in children during early childhood. Then it is diagnosed using an echocardiogram that shows a hole in the wall, or septum, between the two upper chambers, or atria, of the heart. The defect causes blood to recirculate through the lungs unnecessarily. This makes the heart work harder and can eventually lead to the development of abnormal heart rhythms - a condition known as arrhythmia, congestive heart failure, pulmonary hypertension, and, in some cases, death.

"It's really exciting to be able to offer patients this alternative so they can be back on their feet following the procedure quickly and in better health. I expect this new treatment will prove to be extremely effective, based on previous studies of this device at earlier stages of development," said Grant Burch, M.D., principal investigator and assistant professor of pediatrics (pediatric cardiology), School of Medicine and interventional cardiologist, Doernbecher Children's Hospital.

However, this new device is not an appropriate treatment for everyone with ASD. The study criteria stipulates that the patient be at least 2 years old, and the hole in the patient's heart can be no larger than a quarter and must be close to the center of the chamber wall.

OHSU is one of 16 sites around the country and the only center in the Pacific Northwest participating in the study. The study will be completed after 150 patients receive the STARFlex device and complete their 12-month follow up with the principal investigators.

Lingle is one of two OHSU patients who have received the device as part of this study. Seventeen-year-old Melissa Halstead of Portland was the other patient. In addition to her ASD, Halstead has cerebral palsy and scoliosis. She loves school so much that open-heart surgery wasn't an option to her because that meant weeks at home recovering. In addition, Halstead needed to have the hole in her heart closed before she could have further orthopaedic surgeries.

"I had just gone back to school in January following recovery from another surgery," said Halstead. "I hate to miss school because I'm a very determined student." Burch closed the hole in Halstead with the device on Tuesday, and she was back at school on Thursday.