News Release: June 10, 1997

Albuquerque, NM -- Late last month, William Berman, Jr., M.D. and Bradley D. Raisher, M.D. from Pediatric Cardiology Associates of New Mexico and the Presbyterian Children's Program for the first time in New Mexico, inserted a device known as The CardioSEAL™ Septal Occlusion System into the heart of a two-year-old child. The double sided umbrella shaped device was inserted to close a nickel sized hole on the septum, a wall between the two upper heart chambers. This congenital heart defect is known as an atrial septal defect (ASD) or hole in the heart. It is estimated that out of the 30,000 New Mexico children born each year, roughly 30 will have an atrial septal defect (ASD). Ten other centers in the nation, along with Presbyterian Hospital, have been selected to participate in the clinical study.

"I felt as if I made a difference. This is an opportunity to treat and fix an abnormality in the heart and save the child the pain and potential disfigurement of an open heart operation. It's exciting and gave me a real sense of accomplishment. So much of what we do is just diagnostic, finding out what's going on, and then sending the children to the operating room for surgery, said Berman, a pediatric cardiologist.

Nathan, son of Josephine and Johnny Gutierrez of Albuquerque, was the first person in New Mexico to have the device inserted. Although Nathan is only two and a half, he was already having reoccurring heart problems and the right side of his heart was beginning to stretch to accommodate for the increased cardiac flow caused by the defect. Gutierrez was scheduled to have open heart surgery this summer. However, because this option became available, Nathan's parents chose to go ahead with thetherapeutic intervention and avoid the setbacks of open heart surgery. Setbacks like a 3 - 7 day hospitalization, being hooked up to a respirator and undergoing extensive surgery. Gutierrez had the device inserted in the morning and was able to go home that afternoon. After a couple of days of rest, he was back to normal.

"Nathan's doing really well. It's as if he didn't have anything done. I'm glad he didn't have open heart surgery, said Josephine Gutierrez.

The CardioSEAL™ Septal Occlusion System manufactured by Nitinol Medical Technologies, comes in various sizes depending on the size of the hole. It is made out of metal alloy and draped with dacron cloth and resembles a double sided miniature umbrella or clam shell.

For Gutierrez's surgery, the device was closed up and loaded into a catheter delivery system, a thin tube used primarily for diagnosis. The catheter was then inserted into a vein in the leg which wound its way up to the heart, taking less than 2 minutes. Berman continuously watched the catheter through the help of ECHO and fluoroscopic equipment. The catheter then passed through the hole to the left side of the septum. The first umbrella shaped device was pushed out of the tube and it automatically opened up. The catheter backed up and placed the device on the left side of the hole.

The catheter was then retracted passing back through the hole to the right side of the septum. The second umbrella shaped device was pushed out of the tube and placed on the right side of the hole. The intervention is similar to a double patching, acting like a foundation for tissue growth. Within 2 - 6 months, the device becomes a part of the septum wall and the hole is completely closed. The patient is sedated and may feel the catheter going through the skin. The insertion is minimally invasive and requires no overnight hospital stay. Within a couple of days the patient is back to normal.

The device has passed the first few phases of the Food & Drug Administration (FDA) trial and is not commercially for sale in the United States. Participants who meet certain criteria, are participating in the clinical study, which is the next phase of the FDA approval process. The FDA will review the results of the clinical study nationally and determine if there are no adverse consequences such as the device moving around or causing blood clots. Once the device is inserted, patients are monitored for the next 12 -36 months. Expected approval of the device may occur in the year 2000. At that time, patients may have two options available to them, either undergo open heart surgery or have the device inserted. The device and intervention are not for everybody. Some factors in deciding which option is more appropriate include the size of the hole and where the hole is located in the septum.

The heart is a double pump. The right heart receives blood that has just come from the body after delivering nutrients and oxygen to the body tissues. It pumps this blood into the lungs, gets rid of the carbon dioxide and then picks up a fresh supply of oxygen from the lungs. The left heart receives the oxygen enriched blood from the lungs and then pumps it out to the aorta distributing oxygen and nutrients by smaller arteries to all parts of the body. When there is a hole in the atrial septum, blood from the heart's left side passes back into the right side of the heart. This is inefficient because blood that should be going to the body is returning to the right side of the heart and into the lungs where it has just been. This overcirculation causes a stretching of the right side of the heart. If undetected, ASD causes progressive cardiac damage. The heart deteriorates and begins to weaken and causes heart failure and abnormal heart function. Closing the hole at that point may make the patient worse and may not help to prolong life. Repairing an ASD is best done on children whose hearts have not weakened or been damaged irreversibly. The defect is usually detected for the first time when a child undergoes a through preschool or athletic physical. Children with ASD are usually asymptomatic meaning that symptoms are almost never present. Children with ASD continue to grow and breathe normally. During a thorough examination, if an x-ray is taken the heart is bigger than it should be or an EKG will show signs of defect.

Several people were able to observe the new procedure. "There was a huge collective sigh as I finished the intervention," said Berman.

Pediatric Cardiology Associates has been providing cardiac care to children of New Mexico since 1986. Services include diagnostic and treatment services in Albuquerque and around the state through a system of satellite offices and outreach clinics.

Presbyterian Children's Program provides comprehensive primary and tertiary pediatric care. Specialty care includes a heart program, a neonatal unit, pediatric intensive care unit, pediatric surgery and a pediatric medical transport service.