Frequently Asked Questions

Frequently Asked
Questions

What causes mitral regurgitation?

Mitral regurgitation occurs when your mitral valveā€™s two leaflets (or flaps) do not close completely, allowing blood to flow backward through the valve into the left atrium. Degenerative mitral regurgitation (also called primary or organic) can be related to age, a birth defect, or underlying heart disease. Watch this video from Dr. Randy Martin to learn more about your mitral valve and mitral regurgitation.

How does my doctor determine if I have mitral regurgitation?

To determine if you have degenerative mitral regurgitation and to assess the function and condition of your heart and mitral valve, your cardiologist may perform diagnostic evaluations including:
  • Listening to your heart with a stethoscope
  • Using an echocardiogram (ultrasound) to get a close look at your heart and mitral valve
  • Taking a chest x-ray to see the size and shape of your heart and evaluate your lungs
  • Evaluating you for symptoms of congestive heart failure (such as shortness of breath or fatigue) or other related heart conditions

What are my treatment options?

Treatment for your degenerative mitral regurgitation depends on how severe it is and how sick you are. Your cardiologist may prescribe medications that reduce symptoms, such as diuretics for fluid buildup in the lungs. However, these medications only treat the symptoms and do not address the underlying problem with your mitral valve that is causing your disease.

Degenerative mitral regurgitation itself can only be treated in two ways: mitral valve surgery or transcatheter mitral valve repair (TMVR). It is important to discuss your treatment options with your cardiologist or TMVR heart team. Learn more about your treatment options.

To learn more about your heart, mitral regurgitation, and valve surgery, visit www.heart-valve-surgery.com.

What is transcatheter mitral valve repair (TMVR) and does it require open-heart surgery?

TMVR is a minimally invasive procedure that may be an option for patients with degenerative mitral regurgitation who are too sick for surgery. Unlike surgery, this procedure does not require opening the chest and temporarily stopping the heart. Instead, doctors access your heart through a vein in your leg to repair your mitral valve. MitraClip therapy is the only TMVR option to treat mitral regurgitation. Your cardiologist or TMVR heart team will determine if you are a candidate for MitraClip therapy.

How will my doctors decide if I am a candidate for the MitraClip procedure?

You will be evaluated by a specially trained heart team at a MitraClip treating center, including a cardiac surgeon and a cardiologist, who will review your medical history and perform a variety of tests. There are several factors they will take into consideration when deciding whether or not you are too sick for open heart surgery, and therefore a possible candidate for MitraClip therapy, such as your age, frailty, and the condition of your heart.

What is the MitraClip device made of and how does it reduce mitral regurgitation?

The MitraClip device is a small metal clip covered with a polyester fabric that is implanted on your mitral valve. The clip is inserted through a catheter, without the need to temporarily stop your heart.

The MitraClip device treats mitral regurgitation by clipping together a small area of the mitral valve. The valve continues to open and close on either side of the clip. This allows blood to flow on both sides of the clip while reducing the flow of blood in the wrong direction. Watch an animation of the procedure to learn more.

How do I find a doctor who performs the MitraClip procedure?

To find the nearest center offering TMVR with MitraClip therapy, go to our TMVR Finder page.

How should I prepare for my MitraClip procedure?

In the days before your procedure, it is important that you:
  • Take all your prescribed medications
  • Tell your doctor if you are taking any other medications
  • Make sure your doctor knows of any allergies you have
  • Follow all instructions given to you by your doctor or nurse

What should I expect after my MitraClip procedure?

The average hospital stay is two to three days. You should experience relief from your symptoms of mitral regurgitation soon after your procedure.

Most patients will not need special assistance at home following discharge from the hospital, outside of ongoing needs for any unrelated health conditions. While in the hospital, you will be closely monitored and your doctor will perform various tests to evaluate your heart function.

Following your procedure, you will receive an Implant Identification Card, which you must carry with you at all times. Show your Implant Identification Card if you report to an emergency room or if you require a magnetic resonance imaging (MRI) scan.

How long before I feel the effects of the MitraClip procedure?

Clinical data from patients who underwent the MitraClip procedure demonstrate an immediate reduction of mitral regurgitation. You should experience significant improvement in your symptoms of mitral regurgitation and quality of life soon after your procedure. It is important to discuss what to expect following the procedure with your TMVR heart team.

Will I be able to feel the MitraClip implant in my heart?

No, you will not be able to feel the implant.

Will I be prescribed any medications following the MitraClip procedure?

You may be prescribed blood-thinning medications to help reduce the risk of developing a blood clot after the procedure. Your doctor or nurse will give you instructions about your medications before you leave the hospital.

Who should not have the MitraClip procedure?

Your doctor may decide that the MitraClip procedure is not appropriate for you if you:
  • Cannot tolerate medications that thin the blood or prevent blood clots from forming
  • Have an active infection or inflammation of the mitral valve
  • Have mitral valve disease as a result of rheumatic fever
  • Have a blood clot in your heart or in the vessels that carry blood from the lower body to the heart
Your doctor should discuss with you if you have any of these issues that would prevent you from having the MitraClip procedure. An evaluation of your heart will also confirm if your heart valve anatomy would allow for successful placement of the device.

Risks, Warnings, and Precautions

What Are the Possible Risks 1 Year After the Procedure?
The most common serious risks observed within 1 year of the MitraClip procedure in patients enrolled in the PR DMR Cohort include:
  • Death from any cause occurred in 30 out of 127 patients (23.6%)
  • Stroke occurred in 3 out of 127 patients (2.4%). Stroke is a condition where lack of blood flow to the brain causes rapid loss of brain function
  • Ventilation longer than 48 hours occurred in 6 out of 127 patients (4.7%). This means that the use of a ventilator was required more than two days to help a patient breathe
  • Major vascular complications occurred in 9 out of 127 patients (7.1%). Examples include a hematoma (large blood clot under the skin) or damage to the artery and surrounding veins where the catheter was inserted that requires surgical repair
  • Bleeding events occurred in 25 out of 127 patients (19.7%). This refers to a loss of blood related to the procedure that required blood transfusion of 2 or more unit
  • Kidney failure occurred in 5 out of 127 patients (3.9%)
  • Gastrointestinal complications occurred in 3 out of 127 patients (2.4%)
  • Septicemia occurred in 6 out of 127 patients (4.7%). Septicemia is a serious infection of the blood often caused by bacteria
Warnings
  • MitraClip therapy should only be used in patients with significant, symptomatic, degenerative mitral regurgitation who are too sick for mitral valve surgery.
  • MitraClip therapy is intended to reduce mitral regurgitation. If mitral regurgitation is not reduced enough, you may not get the full treatment benefits of reduced hospitalizations and improvement in heart failure symptoms and quality of life expected from MitraClip therapy.
Precautions
  • MitraClip therapy should only be used in patients considered to be too sick for surgery. This is determined by the clinical judgment of a heart team, including a cardiac surgeon experienced in mitral valve surgery and a cardiologist experienced in mitral valve disease, based on the presence of one or more surgical risk factors.
  • The major clinical benefits of MitraClip therapy are reduction of mitral regurgitation, resulting in reduced hospitalizations and improvement in heart failure symptoms and quality of life. No benefit on how long a patient survives following MitraClip therapy has been demonstrated. How long the MitraClip device will last is unknown at this time.
  • The first MitraClip device was implanted in 2003 and laboratory testing supports durability of the device over a period of 15 years. Regular medical follow-up is essential to evaluate how the MitraClip device is performing. Notify your doctor immediately if you experience the return of any symptoms related to mitral regurgitation.
  • Patients who have undergone MitraClip therapy should receive prophylactic antibiotic therapy before any medical or dental procedure to minimize the possibility of infection.
  • The safety and effectiveness of MitraClip therapy have not been established in patients who have functional (also called secondary) mitral regurgitation.
  • The safety and effectiveness of MitraClip therapy have not been established in patients who have specific mitral valve anatomy that may interfere with proper placement and positioning of the MitraClip device:
    • A mitral valve opening that is too small
    • Calcified mitral valve leaflets
    • A cleft of the mitral valve leaflet
    • A leaflet flail width or leaflet flail gap that is too large
  • MitraClip therapy has not been tested in pregnant women or children or infants, and the device may not work for these patients.