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New Valve For Old Hearts

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DURHAM, N.C. ( Ivanhoe Newswire) - Defective valves are one of the most common causes of heart failure in the elderly. While surgery helps some, for others it's just too risky. Now, there's a new, less invasive solution.

Retired meat cutter Will Neighbors is still plenty sharp. But when he was diagnosed with a failing heart valve, he knew he was in trouble.

"I just couldn't really do anything. I couldn't much more than walk across the floor, and then I just had to labor to do that," Will told Ivanhoe.

Due to his age and medical history, surgery wasn't possible, but at Duke University Will was offered a new less invasive option. A stent valve delivered on a catheter through a groin artery to the heart.

"Rather than removing the valve this catheter-based system is a stent that opens and pushes the old scarred valve out of the way," J. Kevin Harrison, M.D., a professor of medicine and director of the cardiac catheterization laboratories at Duke University, said.

The new valve slides in to immediately replace the old one, restoring normal function.

"Every time a nurse came by I'd snatch ‘em little ol' gizmos off her neck and listen to my heart how smooth it was, and before it was just raggedy as anything you ever seen or heard," Will said.

Now, Will is feeling stronger, and feistier with every step.

"My great-great grandpa lived to be 114. I'm shootin' for that number!" Will said.

With humor and a new heart valve anything's possible. Duke is one of several sites around the U.S. testing a stent valve in patients who are at high risk of complications from open heart surgery. Patients who have the stent valve procedure are typically home within a few days.

RESEARCH SUMMARY

BACKGROUND:  Defective heart valves are one of the most common causes of heart failure in the elderly.  A defective heart valve is one that fails to open and close fully.   A valve also may not be able to close completely, leading to regurgitation (blood leaking back through the valve).  Usually people who have congenital heart valve defects may need treatment with drugs, but some have to undergo surgery.  Surgery is not recommended for patients who are older or have other medical conditions (Source:  www.heart.org).

TRADITIONAL TREATMENT: A median sternotomy is a type of surgical procedure in which a vertical inline incision is made along the sternum, after which the sternum itself is divided, or "cracked". Breaking the sternum provides access to the heart and lungs for surgical procedures such as heart transplants and corrective surgery for defects including heart valve repair and heart valve replacement operations. ( Source: Heartvalvesuregry.com)

A LESS INVASIVE SOLUTION:  Duke cardiologists can replace an old valve with a new pig valve delivered on the end of a catheter through a groin artery to the heart. Doctor J. Kevin Harrison explains how the new valve works. "It's put in through a less traumatic surgery. We still make a small incision but it's in the groin area to expose the artery and then the valve is inserted through a catheter. The catheter is larger than standard heart catheterization catheters, it's about as big as the end of my pinky, and it goes through the blood vessels in the leg or through a blood vessel in the arm. It's positioned across the abnormal valve. Rather than removing the valve, this catheter based valve is a stent that opens and pushes the old scarred valve out of the way. The minute that it pushes the old scarred valve out of the way, it has a valve sewn within the stent, which is really pig valve, similar to those surgeons have been using for years." (Source: Interview with Ivanhoe Broadcast News)

INTERVIEW

J. Kevin Harrison MD, a Professor of Medicine and Director of the Cardiac Catheterization Laboratories at Duke University Medical Center, talks about new hope for failing hearts.

Tell about the clinical trial.

Dr. Kevin Harrison: It's an FDA approved protocol that is sponsored by Medtronic who manufactures this particular device. It has to be used inside the trial guidelines.

Who is a candidate for this trial?

Dr. Kevin Harrison: The device treats aortic valve stenosis and patients with aortic valve stenosis are eligible, but if you have good risk characteristics for standard surgery that's what you really ought to have done. Standard surgery has been around for 40 years and it works extremely well. This trial is different. It's really designed for those patients that don't have reasonable risk with standard surgery.

How does the traditional procedure work?

Dr. Kevin Harrison: With a traditional procedure, most people have median sternotomy, that is when the chest is opened they're put on cardiopulmonary bypass and the dysfunctional valve is physically removed. Then a tissue valve, typically a pig valve is sewn in place and that works great but it involves the trauma of surgery. Patients that are elderly or patients that have co-existing lung disease or renal dysfunction or other medical problems may not be candidates for that kind of surgery.

What's this new valve and how does it work?

Dr. Kevin Harrison: It's put in through a less traumatic surgery. We still make a small incision but it's in the groin area to expose the artery and then the valve is inserted through a catheter. The catheter is larger than standard heart catheterization catheters, it's about as big as the end of my pinky, and it goes through the blood vessels in the leg or through a blood vessel in the arm. It's positioned across the abnormal valve. Rather than removing the valve, this catheter based valve is a stent that opens and pushes the old scarred valve out of the way. The minute that it pushes the old scarred valve out of the way, it has a valve sewn within the stent, which is really pig valve, similar to those surgeons have been using for years.

Will their own tissue grow over it?

Dr. Kevin Harrison: Yes, the tissue grows over the stent portion. It's really a fancy stent of sorts, which is a metal mesh work. This particular device that we use is made out of Nitinol, which is nicknamed "memory metal", they make eyeglasses out of it. You can crush them and they spring back. Nitinol has been used in the medical field for a long time, and it works very well. The advantage of it here, is that it creates a spring loaded system. It is true that over the next few weeks to months that that stent gets covered by the patient's own tissue.

How long does it take for fully recover from this procedure?

Dr. Kevin Harrison: Typically patients do well even by the afternoon of the procedure. The procedure itself takes a few hours and typically they go out to the intensive care unit for an overnight observation, but usually are able to eat supper and visit with their family in the evening. They're typically out into a regular hospital room the next day. The protocol requires them to stay in the hospital for 5 days for monitoring, but if you have a permanent pacemaker already, then you can leave before then. We've had a 93 year old patient leave after 2-1/2 days. There is not a lot of physical recovery.

Has it been used in other countries?

Dr. Kevin Harrison: Yes, in other sites outside the United States where the regulatory issues are not as strict. The valve has been used for the last 4 to 5 years and the track record there has shown good durability over that timeframe.

Has there ever been anything like this in cardiology?

Dr. Kevin Harrison: It's a new concept. There is second valve that's being used in the United States and in fact those trial dates started before CoreValve. That valve is called Sapien and it is a similar concept, but the valve design is different. It is a stainless steel stent frame and it contains cow pericardial tissue, but a similar concept. That valve is balloon expanded into the old valve rather than being spring loaded. But that valve has shown good results and has received conditional approval by the FDA for use in patients that do not have an option for standard open valve surgery.

FOR MORE INFORMATION, PLEASE CONTACT:

J. Kevin Harrison MD
Professor of Medicine
Director of the Cardiac Catheterization Laboratories
Duke University Medical Center
(919) 681-3763 (Suzi Maloney)

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