Cleveland Clinic pioneers metal-free heart patch

The new device will benefit people who are allergic to metal.
CLEVELAND (AP) -- A 7-year-old with a nickel allergy became the first patient in the United States to receive a new metal-free patch to fix a hole in the heart, a procedure that could reduce complications when the common birth defect is corrected.
"I was very leery of any kind of metals being inside of her," said Nancy Horn of Buffalo, N.Y., whose daughter, Kelly, returned to school last week feeling good. Mom was still concerned enough to volunteer at school to stay close to Kelly.
Horn said by phone from Buffalo that she and her husband, Keith Horn, were wary about letting Kelly become the first patient in the United States to get the metal-free Transcatheter Patch to close an atrial septal defect, which can affect 4 percent or more of children.
Mrs. Horn said the decision came down to the risk of using a metal device that could ignite an allergy that Kelly first experienced with nickel earrings. "We had to go with the nonmetal device," she said.
Procedure
The developer of the patch, E.B. Sideris of Greece's Athenian Institute of Pediatric Cardiology and Custom Medical Devices, attended the Feb. 15 procedure at the Cleveland Clinic in which Drs. Larry Latson and Lourdes Prieto inserted the patch through a catheter.
The tube-like catheter was inserted through a groin vein and threaded to Kelly's heart, where the stretchy, polyurethane foam patch was placed against the hole between the upper heart chambers. Without treatment, Kelly Horn's condition could lead to oxygen-rich blood returning to the lungs, reducing the heart's efficiency.
The patch and catheter were held in place for two days with balloons. The Sideris device is meant to allow the heart tissue to grow into the porous patch, unlike others that rely on a metal connector.
Many people with the defect have few, if any symptoms. Kelly was diagnosed last year when she developed chest pains and felt as if her heart would burst out of her chest, Mrs. Horn said.
In addition to addressing metal allergy questions, the device holds promise because of the rare incidence of metal-related complications, such as erosion, from the current widely used device, according to Dr. William D. Anderson, assistant professor of medicine at the University of Pittsburgh, where he directs a cardiac catheterization laboratory. He is not connected to the Cleveland Clinic-led experiment.
"I think if it works, it's great," said Anderson, who does about 80 procedures a year to correct atrial septal defects. "I think it represents a significant step forward if you can do without metal."
Holding the patch in position with a balloon instead of wires also has the potential to reduce complications, the clinic said.
Experiment expansion
The Food and Drug Administration-approved experiment involving the Sideris device will be expanded to two other research hospitals that haven't been publicly identified and currently are reviewing the proposal to participate, according to clinic spokeswoman Kate Nagel. The trial will involve 45 patients, about 15 at each hospital.
Mrs. Horn said the clinic offered three device options for her daughter, including the Sideris device, but they didn't feel pressured to participate in the experiment.
Kelly experienced dizzy spells just after the procedure, according to Mrs. Horn, who said another hurdle was keeping an active youngster immobilized for 48 hours while the patch became imbedded.
The clinic has about 1,200 doctors and attracts patients from about 90 countries.