Brennan Ehrman of Mt. Lebanon sauntered into Children's Hospital of Pittsburgh of UPMC looking relaxed and cool all in black, save for a big red-and-white Boston Red Sox belt buckle. No, he said, he's not Goth. Rather, his role model is Johnny Cash, the original Man in Black, "and I think I look good in black."
The 24-year-old Community College of Allegheny County sophomore certainly looked good on this particular day, the 18th of March -- seemingly too good for someone who just eight days earlier had undergone a cardiac procedure to replace his pulmonary valve.
But this was no conventional valve replacement, for instead of cracking open Mr. Ehrman's chest -- as doctors had done three times before -- pediatric interventional cardiologist Jacqueline Kreutzer moved the valve into place via a catheter inserted into a small opening in his groin.
"I haven't felt better in four years, since my last surgery," Mr. Ehrman said. "I'm walking. I'm breathing. Last time, I was in [the hospital] five or six days." He's had multiple surgeries correcting a birth defect in his heart.
This time, he was walking around his hospital room the evening of his surgery. He went home at 2 p.m. the next day.
It was an historic event for Children's and Dr. Kreutzer, who is director of its Cardiac Catheterization Laboratory.
The Medtronic Melody Trans-catheter Pulmonary Valve and Ensemble Delivery System was just approved for limited use by the Food and Drug Administration in late January. According to the FDA, the OK followed clinical studies of 99 recipients at children's hospitals in Miami, Boston, New York, Seattle and Columbus, Ohio; and 68 more patients in Europe. Both children and adults participated.
With Mr. Ehrman, Children's Hospital of Pittsburgh became the first U.S. site outside of the study to do the procedure.
It went quite well, said James Lock, the chief of cardiology at Children's Hospital Boston who was sent by Medtronic to proctor Dr. Kreutzer during the procedure. Dr. Lock is one of the pediatric interventional cardiologists who has been involved in the trial since its early days. Dr. Kreutzer also had training at Medtronic beforehand.
"She did the whole thing by herself. I just stood on the sidelines and made some tips," said Dr. Lock, who has been part of 67 procedures at Boston, about 55 of them in the trial.
Dr. Kreutzer anticipates doing more. "We do have several candidates that will be evaluated," she said.
Congenital heart disease is the most common birth defect, affecting nine of every 1,000 births, the American Heart Association says. But there are many different types of congenital defects, Many of which require open-heart surgery with placement of valves or tubes as part of the repair. These parts don't last forever and don't grow with the child. Repeated operations are necessary.
Medtronic stresses in its patient literature that the Melody valve system is designed to be used specifically to restore -- not cure -- pulmonary valve conduit function.
The conduit is a tube that connects the right ventricle, or lower right chamber of the heart, to the pulmonary arteries that carry blood to the lungs. In open-heart surgery, a conduit containing a new valve is implanted.
The implant can narrow or develop a valve leak and require still another open-heart replacement. The Melody system, whose lifetime is not yet known, is designed to delay that surgery.
The Melody is on a stent, or wire frame, that expands with the help of a balloon to deliver the new valve. Medtronic says in its literature that the new valve begins to work immediately.
The FDA's approval was under the Humanitarian Device Exemption program, which supports development of devices that would benefit fewer than 4,000 Americans per year. There also must be "reasonable assurance" of safety, and probable benefits must outweigh the risk of injury or illness, the FDA said.
"All of them, when they come in for the procedure, have to pass surgical muster," said Evan Zahn, the pediatric interventional cardiologist who directed a team that did about 30 of the trial procedures at Miami Children's Hospital. "They have to be in need." Most of the patients who have had the procedure so far have been facing at least their second, if not their third or fourth, open-heart procedure, he said.
There are other qualifications:
• The pulmonary valve conduit can not be too big or too small for the device, which comes in limited sizes;
• The veins must be large enough to accommodate the catheter; and
• The patient must be free of infection.
In addition to meeting those qualifications, Dr. Kreutzer said Mr. Ehrman had other factors going for him, including the facts that his old valve had enough tissue left to hook to, and he was not overweight.
The Melody procedure takes from one to two hours, Medtronic said.
In Mr. Ehrman's case, he was put under a general anesthesia with some additional local anesthetic to keep him comfortable, Dr. Kreutzer said. A cardiac catherization was done to inject a dye that allowed the team to take pictures of the heart.
Measurements also were done to assure that the new valve, which was made from a cow's jugular vein valve, would fit the conduit. Balloon sizing was used to stretch the conduit to the right size, and then Dr. Kreutzer moved the valve into position. With the new valve inside its stent, she actually pushed the old valve aside and left the new valve in its place.
After Mr. Ehrman awakened in recovery, Dr. Kreuzer said, he had to lie flat for six hours. After his overnight stay, he went home with instructions not to do any heavy lifting for four weeks.
The procedure sounds as simple to do as Mr. Ehrman's decision to have it done was to make.
"Even before the pre-op appointment, I was expecting to have it," said Mr. Ehrman, who had learned about the Melody from his cardiologist before it became commercially available. "Barring any life-threatening risk, it was a no-brainer to me."
Understandable, considering what he went through over the first 20 years of his life. He was 7 when he underwent his first open-heart procedure, in which surgeons operated on his leaky aortic valve, and 10 when surgeons worked on the valve again.
At 20, he underwent a Ross Procedure, in which the pulmonary valve is moved to replace the aortic valve. A human donor valve then is inserted to replace the pulmonary.
"I'll have one more open-heart surgery down the road," Mr. Ehrman said. "I'll get a mechanical valve, but then I'll have the risk of the blood thinners I'll have to take." (Metal and plastic valves develop blood clots, Dr. Zahn explained.)
Maybe, maybe not. Though it's too soon to tell how long they'll last, early results have been very promising. "We can't prove it yet, but early appearances suggest they might be better than the open-heart surgical valve," he added. He cited studies that show "a large percentage" of the latter leak right away. The catheter-inserted valves don't seem to do that.
"We already have in Europe some going on eight years," Dr. Zahn said. "It hasn't been with everybody, but we're hoping with some of the changes we've made, we'll get between five and 10 years, maybe longer. We just don't know."
In the United States, the earliest patients have had their Melodies for three years.
"There were about 5 percent of the cases that required reintervention, [where we] put another one in, but other than that, the procedures went quite well," said Boston's Dr. Lock.
The benefits obviously include the fact that the chest isn't opened and the heart not stopped, "which are both harmful to some extent to the heart," he said.
"Second, you get a much better idea of the results because it's done in a beating heart. ... If there are problems, you can take care of them.
"Third, they're much cheaper and much less painful."
There also are disadvantages," Dr. Lock acknowledged.
For example, sometimes the area where the valve would be placed is too large or too small, and the patients end up needing surgery. "That's a significant number of patients," Dr. Lock said. "Probably 80 percent will still need [help] in the operating room, rather than in a catheterization lab."
In the patient booklet, Medtronic also warned of the chance of the same complications that accompany any heart catheterization, including death. Others include tearing of or bleeding from the blood vessel at the site where it's inserted; perforation of a heart chamber, allergic reaction to the X-ray dye and infection.
Still, pediatric interventional cardiologists are extremely enthusiastic about the use and future of the Melody.
"I just think they're different [from other valve replacements] -- I won't say they will replace it, but they'll be complementary to it," said Miami's Dr. Zahn, noting that nothing more than a baby aspirin is needed as clot-prevention with the Melody valves.
"I've been doing things like this for 21 years," he said, "and of everything I've been involved with I haven't seen anything this dramatic. Patients feel better and get better. ...
"This is the beginning of a new generation of what we do, valves via catheters," he added. "I can't wait to see what it's going to look like in 10 years. It might be the treatment of choice."
At Cincinnati Children's Hospital Medical Center, pediatric interventional cardiologist Robert Beekman, national chairman of the cardiology section of the American Association of Pediatrics, was anxious to begin doing the procedures. "Like many other pediatric centers, we hope to start doing it in the next six months," he said.
"It's spectacular. I'm telling people it's a game-changer. I mean it's going to allow them to skip one, two, maybe three open-heart surgeries over their lifetime."
Pohla Smith: firstname.lastname@example.org or 412-263-1228. First Published March 31, 2010 4:00 AM