Should you repair ASDs without surgery?
Should you repair ASDs without surgery?
Septal occlude saves on open heart, hospitalization
Prior to the debut of two new septal occluders — now in clinical trials — the gold standard for correcting congenital atrial septal defect (ASD) was suturing and patching during open-heart surgery. Another standard was to wait to see if the opening in the wall between the two atria would close on its own. Using a septal occluder eliminates the need for opening the chest, and the procedure’s total cost is a half to two-thirds of the cost of open-heart surgery. The bulk of the savings comes from the dramatically reduced hospital stay and the unused OR.
The Floating Hospital for Children at New England Medical Center in Boston is one of 20 centers around the country participating in a Food and Drug Administration clinical study of the Amplatzer septal occluder manufactured by AGA Medical in Golden Valley, MN. (See photos, below.)
"Avoiding open-heart surgery and all that goes with it — cost, worry, pain, and a long recovery — is this device’s biggest benefit," says Kathleen Hanlon, RN, MA, clinical research coordinator in the pediatric cardiology department at Floating Hospital.
With this device, the patient comes in for one day pre-op. On the day of the procedure, the patient is given general anesthesia. The interventional cardiologist enters the femoral vein in the groin to the area of the heart that requires closure. Half the Amplatzer is released. It remains connected to the guidewire until the specialist is sure of its placement, and released. "Eventually this may be a same-day procedure," says Hanlon. "It depend[s] on the size of the catheter."
Parents are remain in the cath lab during the procedure. Keeping the child and his or her leg straight is the main concern following the catheterization. "The children stay overnight," explains Hanlon. "[They] are looking for fluids and food pretty quickly, and they’re anxious to get out of bed. The next morning, they typically feel so well that we often have to tell them not to run!"
During the 90-minute procedure, an interventional cardiologist compresses a small, umbrella-like device into a catheter for delivery to the heart. The chest is not opened, and the placement is done in the cardiac catheterization laboratory instead of the operating room. Patients can generally go home the next day instead of spending as much as a week in the hospital recovering from major surgery. A stay in intensive care is unnecessary.
The catheter is introduced through the groin and advanced into the heart and positioned across the congenital hole. When the device is released inside the heart, it springs open, returning to its original shape. As it expands outward, the septal occluder’s central "waist" self-centers and fills in the hole to prevent leaks. Two disks squeeze together, gently clamping the septal tissue. The central waist and disks are filled with polyester fabric, the same material used in ASD surgical-patch closure.
The fabric promotes clotting so that the body’s tissues plug the hole. In most cases, the seal is complete after a few hours or the next day, and the body’s tissues completely cover the device after a few months. The only visible reminder of the procedure is a bandage on the groin. Routine follow-up is three months later.
No incision, blood products, pain, narcotics
The occluder can only be used on the most common form of ASD, a secundum defect, which represents about 75% of all ASDs. The Floating Hospital for Children repairs more than 30 ASDs a year and performed six occluder catheter pro-cedures since the study began in May 1997.
Because this is a congenital condition, the hospital follows patients, treating adults as well as children. "The oldest patient we’ve done this procedure on is 86," reports Hanlon.
Children’s Hospital and Regional Medical Center in Seattle is another facility participating in clinical studies of the Amplatzer occluder since September. Collette Tonda, a nurse practitioner, says they have performed seven procedures so far without complications or bad results.
Tonda says that parents receive a special two-page consent form in addition to the routine hospital consent form. The special form explains that this is a new procedure under investigation by the FDA, and there could be some risks the hospital is unaware of.
"This catheterization procedure requires only an overnight stay as opposed to surgical ASD repair which requires three or four days in the hospital," says Tonda. "There’s no incision, no exposure to blood products, and no pain except for local pain at the groin site where the catheter is placed."
Narcotics are not necessary; acetaminophen is sufficient for pain control. Once the children wake up from the general anesthesia, they’re able to eat and play in their bed, she says. Children who have undergone open-heart surgery spend at least one night in the ICU, and it usually takes them a much longer time to feel better. "The families have given us rave reviews," says Tonda.
Other septal occluders now in clinical trials are the CardioSEAL septal occlusion system manufactured by Boston-based Nitinol Medical Technologies and the Angel Wings Transcatheter atrial septal defect occluder manufactured by Microvena Corporation in White Bear Lake, MN.
Suggested reading
1. Masura J, Walsh KP, Thanopoulous B, et al. Catheter closure of moderate-to large-sized patent ductus arteriosus using the new Amplatzer duct occluder: Immediate and short-term results. AJCC 1998; 31(4):878-82.
2. Wilkinson JL, Goh TH. Early clinical experience with use of Amplatzer Septal Occluder device for atrial septal defect. Cardiology in the Young 1998; 8:295-302.
3. Formigari R, Santoro G, Tossetti L et al. Comparison of three different atrial septal defect occlusion devices. Am J Cardiol 1998; 82(5):690-692.
4. Chan KY, et al. Transcatheter occlusion of atrial septal defects: An initial experience with the Amplatzer Septal Occluder. J Paediatr Child Health 1998; 34(4):369-373.
Subscribe Now for Access
You have reached your article limit for the month. We hope you found our articles both enjoyable and insightful. For information on new subscriptions, product trials, alternative billing arrangements or group and site discounts please call 800-688-2421. We look forward to having you as a long-term member of the Relias Media community.