Catheter valves are provided to prevent people with multiple heart operations

The children were born with certain heart defects, impaired blood circulation of right ventricle to the pulmonary artery to the lungs that keep the implanted devices (called ducts right ventricular ejection channels) with the flow. But not these lines over time, and children often face a number of open heart surgery during their life re open in its place.

It is now a prospective multicenter study to the 27th October issue of the Journal of the American College of Cardiology, under the direction of the Children's Hospital Boston cardiologist Doff McElhinney, MD, good preliminary results can be provided with a valve which nonsurgical - over a leg vein to the heart - potentially avoiding the need for repeat open heart surgery.

The device, to the knowledge of the Melody Transcatheter Pulmonary Valve (Medtronic Inc.) has received support from an advisory panel to the FDA in July, what would happen to the FDA approval soon for some patients. The device is currently approved in Europe and Canada, if approved by the FDA, it could be the first catheter used heart valve approved in U.S.

"With a percutaneous valve, you should not open his chest and place the patient on a heart-lung machine, lung, with all that that implies," said McElhinney. "Patients can come to have a catheterization procedure for the book, then go home the next day."

The study was the first prospective, multicenter unit involved 34 children and young adults at Boston Children's Hospital, Miami Children's Hospital and the Hospital Morgan Stanley Children's Fund (New York, NY), the existing law does pipe exits, the blood flow back to the pulmonary artery (in the right ventricle and pulmonary insufficiency) or obstruction of blood from the right ventricle to the lungs. They had different forms of congenital heart defects, including tetralogy of Fallot, truncus arteriosus, aortic valve disease and transposition of the great vessels.

All patients underwent cardiac catheterization with the intent to implant the artificial valve, and 30 of the 34 underwent implantation of actual experiences, of which 29 were successful. Three patients (9 percent) had complications during implantation, but all survived.

At follow-up six months later, no patients had more moderate pulmonary insufficiency. Of the 24 patients who had Class II or III heart failure (mild to moderate physical activity) before surgery have improved 19 by at least one functional class after six months, and no patient refused the operation. Eight of the 29 units are partially developed fractures during follow-up, and 3 patients required a second melody valve (included in the first) for recurring blockage. In July, called on members of council for the long-term monitoring of patients, but indicated that the potential benefits outweigh the concerns fractures. Medtronic is currently working on an improved version.

"This study demonstrates that the valve can be used safely and effectively in the hands of many different skilled cardiologists," said McElhinney. "It is early and short-term data, but if the longer-term data are encouraging, because this technology could have a major impact on the long-term health of our patients and their hearts."


"At a time when patients become dysfunctional, which are lines, we tolerate with the choice of this dysfunction, or refer to the operation," said McElhinney faced. "Because the pipes belching or disability can develop rapidly, almost inevitably we end up adopting some failures, often for many years because the patient can continue to surgery a few years."
Conduit dysfunction can cause chronic symptoms and may lead to ventricular dysfunction. Since the percutaneous valve can be implanted without the risks and morbidity of the procedure, the threshold can be reduced, giving patients the prospect of a better quality of life preserved heart function and fewer transactions, "explains McElhinney.

"Obviously, we need to learn before knowing if the promise is realized by this technology," he says.