Transcatheter Mitral Valve Repair (TMVR)

What is Transcatheter Mitral Valve Repair (TMVR)?

Transcatheter mitral valve repair (TMVR) is used in the treatment of mitral regurgitation.

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How does Transcatheter Mitral Valve Repair (TMVR) work?

A TMVR device involves clipping together a portion of the mitral valve leaflets as treatment for reducing mitral regurgitation (MR).

Which company has the FDA approval for TMVR device?

• Abbott Vascular's MitraClip® is the only one with Food and Drug Administration (FDA) approval.

Who is a candidate for Transcatheter Mitral Valve Repair (TMVR)?

• Transcatheter Mitral Valve Repair (TMVR) is a treatment option for those with significant symptomatic degenerative mitral regurgitation

MitraClip Clip Delivery System (MitraClip) was indicated to reduce mitral regurgitation in certain patients whose significant mitral regurgitation and heart failure symptoms result from abnormalities of the mitral valve (commonly known as primary or degenerative mitral regurgitation) and whose risks for mitral valve surgery are prohibitive. It is also approved for patients with normal mitral valves who develop heart failure symptoms and moderate-to-severe or severe mitral regurgitation because of diminished left heart function (commonly known as secondary or functional mitral regurgitation) despite being treated with optimal medical therapy.

What is ptimal medical therapy for medical regurgitation?

Optimal medical therapy includes combinations of different heart failure medications along with, in certain patients, cardiac resynchronization therapy and implantation of cardioverter defibrillators.

How is MitraClip inserted?

The MitraClip is inserted in a minimally invasive procedure through the femoral vein in the leg and guided into the heart’s left ventricle where it grasps the two leaflets of the mitral valve, clipping them together to reduce the backflow of blood.

What studies are done to support the use of MitraClip?

• The approval of the new indication is based on a study of 614 patientsExternal Link Disclaimer with heart failure who had moderate-to-severe or severe secondary mitral regurgitation and were randomly assigned to get either continuation of their optimized medication treatment plus the MitraClip (MitraClip group) or continuation of their optimized medication treatment only (control group).
• The risk of being re-hospitalized for heart failure symptoms was reduced by approximately 47 percent in the MitraClip group compared to the control group. In addition, the risk of death within two years was decreased by approximately 37 percent in the MitraClip group compared to the control group.

What are some potential adverse events with the MitraClip?

Potential adverse events from the device and implant procedure include death, stroke, major bleeding, and erratic heart beat (atrial fibrillation).

Who should not use MitraClip?

The MitraClip is contraindicated in patients who cannot tolerate blood thinners during or after the procedure, who have active inflammation (endocarditis) of the mitral valve, rheumatic mitral valve disease or evidence of blood clots in the heart or veins leading to the heart.

Who manufactures MitraClip?

The MitraClip Clip Delivery System is manufactured by Abbott Vascular Inc.

Observed survival for MitraClip patients was 83.8%, 61.5%, and 39.8% at 1-year, 3-year, and 5-year follow-up, respectively.

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

How long does it take to recover from mitral valve clip surgery?== You will probably go home 5-7 days after surgery but recovery can take longer

Is MitraClip a major surgery?

The MitraClip procedure is a minimally invasive, catheter-based therapy

What is the success rate of MitraClip?

The MitraClip was safe and significantly reduced mitral regurgitation, with a procedural success rate of 95.8%.

How long does the MitraClip procedure take?

• On average, this minimally invasive procedure takes only 1-3 hours.
• Most patients go home within 1-3 days

How is MitraClip performed?

• During the MitraClip™ procedure, your CT surgeon or cardiologist Inserts a catheter (small tube) through a vein in your groin. Uses advanced imaging to guide the catheter to your heart.

Is MitraClip procedure painful?

You will receive general anesthetic during the procedure and pain medications after the procedure as appropriate.

What is MitraClip made of?

The implantable MitraClip Device is manufactured with metal alloys and polyester fabric (Clip cover) that are commonly used in cardiovascular implants.

When do you use MitraClip?

The MitraClip is indicated in patients with severe, symptomatic primary mitral regurgitation (NYHA class III or IV) who are deemed to have a 'prohibitive risk' for mitral valve surgery by a heart team (Table 1).

How big is a MitraClip?

The Delivery Catheter: coated with a hydrophilic coating for a length of approximately 131 cm.

How safe is MitraClip procedure?

The chance of procedural success is >90%, and the chance of surviving the procedure is >99% although there are some risks

When was MitraClip invented?

In the year 1999 Evalve (inventor of MitraClip) founded.

Can a MitraClip be removed?

MitraClip can be removed

Is the heart stopped during mitral valve surgery?

Your heart is stopped while you are connected to this machine.

How long is hospital stay after mitral valve repair?

It varies but most will be in the hospital for 3 to 10 days, depending on how quickly you recover.

What is MitraClip G4?

The MitraClip G4 delivery system is designed for the mitral valve to allow precise and controlled steering and facilitates Left Atrial Pressure

How successful is mitral valve repair?

With proper patient selection and timely intervention, the estimated success rate of mitral valve repair surgery is around 95%.

How much does a MitraClip cost?

The acquisition cost for the MitraClip device is currently $30 000 per procedure and does not vary with the number of MitraClips used or implanted as per the following article.

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