Clinical Advance

Children born with congenital heart defects of the pulmonary valve require surgery to place a conduit or valve from the right ventricle to the pulmonary artery. But these devices have limited life spans, so patients must undergo multiple open heart surgeries throughout childhood and over the course of their lives to replace them.

Yale Medical Group physicians are the only ones in Connecticut offering a nonsurgical option for these patients: the first heart valve to be implanted through a catheter. The Medtronic Melody Transcatheter Pulmonary Valve was approved by the FDA in early 2010, following approval in Canada and Europe in 2006.

The implantation technique, available to children and adults, is much less invasive than open-heart surgery and is intended to reduce the number of invasive surgeries and their associated risks. "Every day I witness the effects that multiple open-heart surgeries have on patients' health, and the anxiety that their families suffer,” said Jeremy Asnes, MD, pediatric interventional cardiologist, who has performed three of the procedures since May. “This allows us to defer or skip a couple of those operations along the way.”

Pulmonary conduits and valves must be replaced over time either because they narrow from calcium buildup or begin to leak as patients outgrow them. With the new replacement technique, a catheter with an artificial heart valve is inserted into a vein in the leg and guided up to the heart. A stent attached to the catheter is used to open the blocked conduit so that the valve can be placed in the correct position.

The procedure is technically demanding and requires training in pediatric interventional cardiology. Dr. Asnes leads a team that includes cardiologist John Fahey, MD; anesthesiologist Dorothy Gaal, MD; registered nurses Donna Bressler and Shelly Folsom;, and registered radiography technologists Nina Purslow, Mary Reilly and Heather Meyerjack. Drs. Asnes and Fahey were advised on the procedure by William Hellenbrand, MD, who joined the practice in September as section chief of pediatric cardiology.

“We’ve only done a few of these procedures so far, but they’ve all gone very well,” said Dr. Fahey. “It’s meant avoiding major surgery for these patients, hopefully for several years.”

The youngest patient to undergo the procedure at Yale-New Haven Children’s Hospital—and one of the youngest to have the procedure in the United States—was a 5-year-old boy with pulmonary atresia. He had already had three prior heart surgeries, including placement of a conduit that had been replaced once due to narrowing. Because he had a complicated medical history and required additional unrelated surgeries, his medical team was anxious to avoid another invasive open-heart procedure. “He’s back to all of his usual activities, running around.” said Dr. Asnes. “We’ve allowed him to avoid the setback of coming in for surgery and he can move on with the progress he’s been making.”

So far, patients with the implant have gone for up to eight years without a subsequent surgery. Dr. Asnes hopes that his young patient won’t require further surgery for five or more years, although he’s still growing, which complicates the situation. “Our hope would be that in two years, if he’s showing evidence that he’s outgrowing the valve, we can dilate it and bring it up to the next level without having to go to the operating room or implant a new valve,” he explained.

The other two patients who received the implant at Yale were both adult women who were born with tetralogy of Fallot, a defect in the heart’s structure that causes low oxygen levels in the blood. In one case, the procedure allowed the 33-year-old patient to get right back to caring for her toddler without a long recuperative period. The other patient, age 20, had a valve that was narrowed and leaking. Dr. Asnes and his team were able to put in a new valve, seal up the leak and resolve the narrowing in the catheter lab, without resorting to open-heart surgery.

It’s likely that the Yale team will perform anywhere from six to 10 procedures a year, according to Dr. Asnes. “There is a crop of growing kids and it’s just a matter of when they need it,” he said. “There aren’t a lot of people in the state who follow these patients, so we’re happy to provide the service.”