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New Life-Saving Clip for the Heart

A new option for patients with severe mitral regurgitation who are too sick for open heart surgery.

When a person’s heart valves don’t close tightly enough, blood can leak into the heart and lungs. The condition is known as mitral regurgitation and affects about 4 million people in the United States.

For those with severe MR, open heart surgery used to be the only option. But, now a new FDA approved device is helping the sickest patients.

Alice Comer is thankful to show off pictures of her grandkids. After her second open heart surgery two years ago, her heart valve started leaking, filling her lungs with fluid.

“I was in and out of the hospital about every 2 weeks, sometimes every week. They would take a very long needle and go in your back and draw the fluid out. It was awful,” Comer told Ivanhoe.

But, Comer was too sick for another open heart surgery.

“They said it would kill me,” Comer said.

Instead, Mark Stankewicz, MD, Interventional Cardiologist, Saint Thomas Heart, offered her a new treatment known as, Mitraclip.

A catheter is guided through the leg vein to the heart valve where the Mitraclip is sent, clipping it together.

“There is no incision, the heart is not stopped, it’s beating the whole time,” Dr. Stankewicz said.

It worked for Comer. No shortness of breath. No other symptoms.

“I don’t feel tied down and I do about everything I want to,” Comer said.

Like spending quality time with her daughter.

Unlike traditional surgery, where patients will spend at least a week in the hospital recovering, patients with Mitraclip are generally up the same day and often go home the day after.


BACKGROUND:  Congestive heart failure or CHF affects about 5 million Americans every year, according to the National Institute of Health. It can happen at any age but it is more common in older people. The heart is not able to pump blood to the rest of the body at a normal rate. A healthy heart pumps 50 percent of the blood in the ventricle in one beat. An abnormal heart pumps 40 percent or less of the blood in the ventricle in one beat. When this happens excess blood and fluid can back up into the lungs. This causes the congestion. The lack of blood being supplied to the body causes symptoms of heart failure. Another common heart problem that affects about 4 million people in the United States is mitral regurgitation. This is a condition in which the heart valve that separates the upper and lower chambers on the left side of the heart don't close properly. It may begin suddenly with a heart attack. If the regurgitation does not go away it becomes chronic. (Source:
http://www.nlm.nih.gov/medlineplus/tutorials/congestiveheartfailure/ct129106.pdf)

SIGNS/SYMPTOMS:  According to the Mayo Clinic, congestive heart failure needs lifelong treatments. Doctors can sometimes correct the condition by repairing a heart valve or controlling a fast rhythm could reverse the heart failure. But, typically, the treatment involves the right medication and devices that help the heart beat and contract properly. Some of the medications are angiotensin-converting enzyme inhibitors, digoxin, diuretics, and beta blockers. Congestive heart failure is caused by a weakened or damaged heart because the blood vessels that supply blood and oxygen to the heart narrow. High blood pressure and infections that weaken the heart muscle can also lead to congestive heart failure. Mitral valve regurgitation can be caused by valve collapse, damaged tissue cords, rheumatic fever and untreated high blood pressure. (Source:http://www.mayoclinic.org/diseases-conditions/mitral-valve-regurgitation/basics/causes/con-20022644)

NEW TECHNOLOGY:  A new treatment is now being tested on patients with congestive heart failure and MR. It's called the MitraClip. It's another option for patients who are not candidates for invasive open heart surgery. The doctors use a catheter-based technology to repair the mitral valve with a groin puncture. The MitraClip is positioned by grasping both leaflets of the mitral valve. The MitraClip device is left in place and the delivery catheter is removed. This does not require the patient to undergo cardiopulmonary bypass or the need for chest incisions. Doctors at Saint Thomas Heart say the procedure shortens recovery time and improves problems with fatigue and shortness of breath. According to the FDA this treatment should not be used in patients with endocarditis, rheumatic mitral valve disease, blood clots at the intended site of the implant and patients who can't tolerate blood thinners. (Source:
http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/Recently-ApprovedDevices/ucm375149.htm)

FOR MORE INFORMATION, PLEASE CONTACT:

 Joe Hagan
 Marketing Director
 Saint Thomas Heart
 Office: (615) 284-5641
 Email: joe.hagan@sth.org



Mark Stankewicz, MD, Interventional Cardiologist at Saint Thomas Heart, talks about a new FDA approved device that is helping patients with mitral regurgitation.

Could you explain what mitral regurgitation is?
Dr. Stankewicz: Mitral regurgitation, or MR, is a leaky valve. Basically, the main valve that connects the lungs to the main pumping chamber of the heart is separated by a valve and it keeps the blood from leaking back to the lungs.
Is MR relatively common?
Dr. Stankewicz:  Mitral regurgitation is very common. Most people have a trace or very tiny amounts of MR with a normal valve. But if the valve leaks a lot, then blood flow goes back towards the lungs and can fill up the lungs with fluid making people short of breath.
 In the past, what has been the only option for this?
Dr. Stankewicz: The treatment for a leaky valve is mitral valve surgery. The old valve is cut out and replaced with a new valve that’s sewn in with a standard surgical procedure.
So, is it like open-heart surgery?
Dr. Stankewicz: It’s open-heart surgery. It requires opening the chest and going in the heart/lung machine. It’s a pretty big surgery.
For some patients though, it’s not an option right?
Dr. Stankewicz: Some people are just too sick to have valve surgery. Their heart is not strong enough or they have other medical problems that won’t allow them to have surgery. So for these people, there’s a new treatment called the mitral clip.
How does this new treatment work?
Dr. Stankewicz: The mitral clip is nice because it can be performed on a beating heart. The heart doesn’t have to be stopped. The patient is sedated, brought to a hybrid operating room, a small tube is put in the vein down near the leg and then a catheter or a tube travels through the circulation. It goes up to the heart and crosses the mitral valve and clips the two leaflets together.
It sounds like the Taber procedure, but that’s for stenosis.
Dr. Stankewicz: Sure. It’s similar in that both procedures require a catheter, but different in that the valve is not replaced with a new valve on a stent. Instead, you take the two leaflets which are not functioning well and connect them in the middle so the valve doesn’t leak as much.
 Is this only for patients who cannot withstand open-heart surgery?
Dr. Stankewicz: Correct. So far, all the trials and all the studies on this have been done on people who are much too sick for standard surgical operations. We still think that mitral surgery is really good. It’s a durable, long lasting procedure. For people who can tolerate the standard surgery, these people should have regular mitral valve replacement. But for a lot of people, that’s not an option. Those who are really sick and can’t tolerate a standard surgery; this is giving them new life.
Do you foresee this procedure taking over as the gold standard?
Dr. Stankewicz: For right now, it’s approved for people who are too sick for standard surgery.
In the past, if you were too sick for standard surgery, what the prognosis?
Dr. Stankewicz: People were suffering because the blood would leak through the valve and backup to the lungs. They would have severe heart failure symptoms, swelling in their legs and not be able to breathe. Medicines can make things better but the only cure is to fix the valve.
How big of a breakthrough would you say this is?
Dr. Stankewicz: This is a huge breakthrough! We’ve seen people who were readmitted to the hospital week in and week out and extraordinarily sick and very short of breath, who were basically cured of their symptoms. It’s really remarkable. And, it’s a real privilege to be able to offer this brand-new technology that’s not available in a lot of places to patients. This gives them an option that they didn’t have before. It’s a new lease on life for people.
What’s the recovery time?
Dr. Stankewicz: Recovery time for the procedure is really remarkable. Instead of a week in the hospital, people are generally out of bed later the same day or are up walking around the next day and often home the day after. This is a big difference between the clip and standard surgery.
How does the recovery for the standard surgery compare?
Dr. Stankewicz:  Recovery for standard valve surgery is generally about a week in the hospital, several days in the intensive care unit with drains and tubes recovering from a chest that had to be cut open to get at the valve. Whereas now, there’s no incision, the heart is not stopped, the heart is beating the whole time and as long as the groin incision heals up, which is less than a 1-inch incision, people do great.




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