A pediatric cardiologist here, Dr. Carl Garabedian, has become the first physician in the Inland Northwest to begin using a newly approved alternative to open-heart surgery for treating people, mostly children and young adults, with certain congenital heart defects.
The procedure involves implanting a product called a Melody transcatheter pulmonary valve between the right ventricle of the heart and the main pulmonary artery.
The Melody valve, marketed and sold by Minneapolis-based Medtronic Inc., is a manufactured replacement pulmonary valve, basically made from a cow's jugular vein valve that's enclosed in a metal stent, or wire frame. The pulmonary valve is one of four valves in the human heart that help pump blood throughout the body.
The replacement valve, or implant, is introduced into the heart using a proprietary Medtronic catheter delivery system, with the cathetera thin, hollow tubeinserted through a small incision in the neck or the leg.
The procedure is designed to improve the functioning of the heart and the flow of oxygenated blood to the lungs, thereby enabling patients to resume living more active lives almost immediately.
Garabedian performed his first such implant here on Feb. 28, at Sacred Heart Children's Hospital, and since then has done five more. He says he expects to do 10 to 15 of them annually, and is excited about how they'll benefit patients.
"This procedure can revolutionize care for pulmonary valve-defect patients, saving them from multiple high-risk open-heart surgeries and helping them lead a better quality of life," Garabedian asserts.
The U.S. Food and Drug Administration approved the Melody valve for full commercial use last year, Garabedian says, and he estimates he now is one of 36 physicians nationwide who have been certified by Medtronic to perform the procedure.
Because the valve is intended for a specialized use in a select group of patients, Garabedian says he doesn't expect a large number of physicians to become certified in its use. But for those patients who are good candidates for the procedure, it can lessen recovery time and help buoy their spirits in knowing that they will be able to delay or forego having another open-heart surgery, he contends.
From that perspective, he says, "It's fantastic."
Virtually all of the patients he sees who have congenital heart defects already have endured one or more heart surgeries, Garabedian says. Such surgeries typically must be repeated over time as previously installed valves begin to fail, but each additional surgery creates added risks for the patient, Garabedian says.
Implanting the Melody valve takes two to four hours, he says. The procedure requires an overnight hospital stay, and patients are able to resume a normal activity level within a week or so, which compares with more extended hospital stays and four to six weeks of recovery time after open-heart surgery, Garabedian says.
In the Melody valve implant procedure, the catheter holding the valve and wraparound stent is extended into the heart, using fluoroscopic imaging equipment for guidance. Once the valve and stent are in the right spot, tiny balloons are used to expand them into a fixed position and to push the pulmonary walls open. The catheter then is removed and fluoroscopy is used to ensure the replacement valve is functioning properly.
The new valve begins to work immediately after placement, and patients see rapid improvement after awaking, Garabedian says.
The Melody valve isn't a guaranteed, long-term fix for sufferers of such congenital heart defects. Medtronic says, for example, there's up to a 35 percent chance that the stents will break within a year of placement due to the pressures to which they're subjected. In some cases, a broken stent doesn't require additional treatment, but in other cases it can result in the need for another catheter procedure, an operation to replace that section of vein, or death, the company says.
It also isn't clear yet how long the Melody valves can last, since they're so new, but Garabedian says he believes they might be good for as long as 10 to 15 years, thereby helping patients delay or avoid additional surgeries.
Garabedian is one of five cardiologists in the Providence Center for Congenital Heart Disease, a practice that Providence Health Care acquired around the end of last year and that formerly operated as the Northwest Center for Congenital Heart Disease. The center's main offices are located in the Sacred Heart Children's Hospital, at 101 W. Eighth, but it also operates satellite clinics in a number of other Eastern Washington and North Idaho communities.
Garabedian is a 1987 Ferris High School graduate who received medical training in Wisconsin, Louisiana, and New York. He completed his pediatric cardiology fellowship at Columbia Presbyterian Medical Center in New York City, and received specialized training in interventional catheterizations there under Dr. William Hellenbrand, a renowned pioneer in that field. His patients include many adults as well as children.
Medtronic claims to be the world's leading medical technology company. It employs more than 40,000 people worldwide and had total revenue of $15.8 billion for its fiscal year ended April 30, 2010.