Primary Children’s Implants First Pulmonary Valve in Region Without Open-Heart Surgery 11/14/2010
Salt Lake City, Nov. 15, 2010 – Signaling a new frontier in the treatment of congenital heart defects and damaged heart valves, Primary Children’s Medical Center announced today that it has successfully performed its first transcatheter pulmonary valve replacement procedure, a non-surgical alternative to open-heart surgery.
Primary Children’s is the first hospital in the region to offer the minimally invasive procedure. The patient – Charli Noyes, 20, from Sunset, Utah – received the Melody Transcatheter Pulmonary Valve on Nov. 11 and was discharged the following day. Three other patients from Idaho, Montana and Arizona also successfully underwent the surgery last week. The Melody valve, from Medtronic, is the first medical device of its kind to be approved by the FDA. It was approved January 2010 under a humanitarian device exemption, a special regulatory approval for treatments intended for fewer than 4,000 U.S. patients per year.
“The Melody valve is an example of our institution’s commitment to the adoption of less invasive cardiac procedures for patients with congenital heart disease,” said Collin Cowley, MD, Director of Cardiac Catheterization and Pediatric Cardiologist, Primary Children’s Medical Center and Associate professor or Pediatrics, University of Utah. “By providing less invasive options that delay open-heart surgery, we hope to improve patients’ quality of life, so we’re excited to be able to offer the Melody valve so that appropriate patients have access to a much less-invasive treatment option.”
Birth defects that involve the heart are referred to as congenital heart defects and affect nearly one percent of all births in the United States each year. These defects range from mild forms to very complex defects that require many high-risk procedures to allow the child to survive and eventually heart transplantation for some individuals.
Robert Gray, MD, Assistant Professor of Pediatrics, University of Utah, further stressed that physician collaboration is key to helping congenital heart disease patients manage their condition. “Effective management of congenital heart defects over a patient’s lifetime requires dedicated cooperation between cardiac surgeons, interventional cardiologists and other clinicians,” said Dr. Gray. “Together, we can draw on a variety of treatment options, and Melody is an important addition to the choices available to us.”
Dr. Cowley and Dr. Gray completed additional education and training from Medtronic earlier this year to become certified in the new procedure.
Congenital heart disease patients often require open-heart surgery to restore effective blood flow to their lungs or their body. Previously, the only way to repair or replace a defective pulmonary valve was through open-heart surgery. With the recent availability of this new transcatheter technology, physicians now have a non-surgical means to address pulmonary valve dysfunction. The procedure allows an interventional cardiologist to deliver a replacement valve through a catheter requiring only a small incision, thus eliminating the immediate need to open the chest and delaying the patient’s next surgical intervention.
About Primary Children’s
Primary Children's Medical Center is the pediatric center serving five states in the Intermountain West - Utah, Idaho, Wyoming, Nevada and Montana. The 271-bed facility is equipped and staffed to treat children with complex illness and injury. Primary Children's is owned by Intermountain Healthcare, a nonprofit health care system. In addition, it is affiliated with the Department of Pediatrics, University of Utah, integrating pediatric programs, research and training for childhood problems. The hospital is located in a beautiful facility designed to meet the special needs of children and their families.