Skip to main content
Edwards Lifesciences Logo

Severe
tricuspid valve regurgitation and treatment

Elderly couple

What is tricuspid valve regurgitation? 

Tricuspid Regurgitation (TR) happens when the tricuspid valve on the right side of the heart does not close properly. When the valve does not fully close, blood flows backward from the lower chamber (ventricle)  into the upper chamber (atrium) making your heart work harder to move blood through the valve.



TR worsens with time. It often does not show signs or symptoms until the disease is severe. With TR, you may have shortness of breath or feel weak. It may also cause abnormal heart beats or swelling in your abdomen, ankles, veins in your neck or feet. These symptoms can seriously affect your quality of life.

Tricuspid regurgitation image
healthy heart image

Tricuspid regurgitation vs a healthy heart

The tricuspid valve does not close properly due to an issue with the valve’s leaflets or an enlarged heart chamber. As a result, blood leaks backward into the right atrium (upper chamber) instead of moving forward into the right ventricle (lower chamber).

EVOQUE system image
healthy heart image

EVOQUE system vs a healthy heart

Clinical trial data showed patients who received an EVOQUE valve could experience health improvements within 30 days, including the ability to take care of themselves and participate in everyday activities.

By treating  severe tricuspid regurgitation, you can potentially:

Improve your quality of life image

Improve your quality of life

with improved ability to do physical activities

Reduce TR image

Reduce TR

with a procedure that involves implanting a device through a small cut in your leg

Relief of symptoms image

Relieve symptoms

with TR, you may have shortness of breath or feel weak.

A less invasive
treatment option

img

If you have severe TR and continue to have heart failure symptoms on medical therapy, transcatheter tricuspid valve replacement may be an option for you. Only a specialized Heart Team can determine which treatment option is best for you.

There are a few different ways to treat TR:

img

Medication

Your doctor may prescribe certain medications to help some symptoms of the failure of your heart valve. However, it will not cure or fix the valve.  

img

Open heart surgery

Open heart surgical valve repair or replacement* is where the doctor will open your chest and repair or replace the damaged valve. It is often in conjunction with another heart valve procedure.

*There are no surgical valve replacement devices approved by FDA for use in the tricuspid valve.

img

Transcatheter tricuspid valve repair or replacement

During a transcatheter tricuspid valve replacement procedure, the doctor replaces your old leaky tricuspid valve without open heart surgery, using a delivery catheter (a tube-like device) with an artificial valve attached to its tip.

Deciding on the appropriate treatment option for you

What is the best treatment  
option for you? 

Seeing a specialized doctor on a Heart Team will ensure you are evaluated for all treatment options. They will consider factors about your health to decide the most appropriate treatment option for you. Your doctor will consider these factors: 

  • Your medical history 
  • Your age 
  • Your current health status 
  • Your ability to undergo the procedure and recover from it
  • The overall condition of your heart

What are the benefits of transcatheter
valve replacement? 

If you have severe TR and continue to have symptoms on medical therapy, transcatheter valve replacement may help your heart work better. Other potential benefits may include:

  • Reduced tricuspid regurgitation
  • Improved quality of life 
  • Relief of symptoms
  • Improved exercise capacity

Talk to your doctor for a full explanation of the benefits and risks associated with this procedure

The EVOQUE valve

The Edwards EVOQUE tricuspid valve replacement system is a device designed to replace your tricuspid valve and help reduce or eliminate tricuspid regurgitation. The valve is put into place using a minimally invasive delivery system through a small puncture in your groin. On average, a TTVR procedure with the EVOQUE system lasts about 2 hours.

Evoque valve

EVOQUE valve

What are the risks?

As with any medical procedure, there is a possibility of risks. The Edwards TTVR procedure’s most
serious risks are:

Doctor with patients
  • Death
  • Stroke
  • Serious bleeding (with the potential to be given blood)
  • Problems with the electrical pathway of your heart that requires a pacemaker
  • Unplanned repeat procedure, hospitalization, or surgery
  • Major vascular complications
  • Permanent disability

Watch the EVOQUE valve procedural animation

What to expect from the procedure

Transcatheter tricuspid valve replacement involves implanting a device through a small cut in your leg. The device is used to replace your leaky heart valve.

During the procedure

img
  1. Your doctor will make a small incision to access your femoral vein in your leg to insert a delivery system to reach your heart.
  2. The EVOQUE delivery system will be advanced through the access site across the tricuspid valve and positioned to the appropriate location within your heart.
  3. The EVOQUE valve will be deployed and replace your original tricuspid valve to restore proper function. 

On average, a transcatheter tricuspid valve replacement procedure with the EVOQUE system lasts about 2 hours.

What to ask your doctor 

Patient with patients
  • How long does the EVOQUE valve last?
  • How will I feel after the procedure?
  • Will I get an implant card?
  • Is it safe to have an X-ray with an EVOQUE valve?
  • Can I go through airport security with my EVOQUE valve?
  • Could other medical devices interfere with my EVOQUE valve?
  • Will I need to take a blood thinner medication?

Download a helpful guide

Read an overview of severe TR and the treatment process. 

img
Important Risk Information

Important Risk Information

Edwards EVOQUE Tricuspid Valve Replacement System

Who can be treated:

The EVOQUE tricuspid valve replacement system (the EVOQUE system) is approved for treating patients with symptomatic severe tricuspid regurgitation (TR) for the improvement of health status. TR is a condition in which the tricuspid valve on the right side of the heart doesn't close properly. When the valve does not fully close, blood flows backward from the lower chamber (ventricle) into the upper chamber (atrium) making the patient's heart work harder to move blood through the valve. Patients should work with their doctor and a specialized Heart Team to determine if the patient is a suitable candidate for the EVOQUE valve.

Who should not use:

The EVOQUE system should not be used in patients who:

  • Cannot take blood thinning medications
  • Have an active infection in the heart or elsewhere
  • Have an untreatable allergy to nickel or titanium

If used in the patients mentioned above, it will not work properly and could make you feel sick or even cause death.

Warnings:

How long your tissue valve will last depend on many patient factors and medical conditions. Follow all care instructions to ensure the best possible results. The Edwards EVOQUE valves have been tested in a laboratory to mimic 5 years of use without failure. Regular follow-ups will help your doctor know how your EVOQUE valve is working.

  • Follow all care instructions to ensure the best possible results. Regular follow-up is advised to evaluate the performance of your device
  • Blood thinning medication may be necessary after valve replacement with the EVOQUE system. Your doctor should prescribe this and other medical therapy per standard guideline.

The safety and effectiveness of the transcatheter heart valve is not known for patients:

  • Who are dependent on their pacemaker without other pacing options
  • Who had a pacemaker implanted within the last 3 months before the valve implantation procedure
  • Who have severe pulmonary hypertension not managed by medication
  • Who have severe right ventricular dysfunction
Precautions:

Precautions Prior to Use

Seeing a specialized doctor on a Heart Team will ensure you are evaluated for all treatment options. They will consider factors about your health to decide the most appropriate treatment option for you.

Your doctor will consider these factors:

  • Your medical history
  •  Your age
  • Your current health status
  •  Your ability to undergo the procedure and recover from it
  •  The overall condition of your heart



General Precautions
  • Problems with the electrical pathway of your heart that require a pacemaker may occur before, during, or following implantation of the    EVOQUE valve
  • Talk to your doctor about risk of infection and needing antibiotics if you require a dental procedure after your heart valve replacement
  • Long-term durability has not been established for the EVOQUE valve. Clinical data is reflective of short-term follow-up, and regular medical follow-up is advised



Potential Risks

As with any medical procedure, there is a possibility of risks.

The most serious risks associated with the procedure are:

  • Death
  • Stroke
  • Serious bleeding (with the potential to be given blood)
  • Problems with the electrical pathway of your heart that requires a pacemaker
  • Unplanned repeat procedure, hospitalization, or surgery
  •  Major vascular complications
  • Permanent disability

Additional potential risks include:

  • Abnormal lab values
  • Abnormal low or high blood pressure
  • Additional cardiac surgery, vascular surgery, or intervention, including removal of the transcatheter heart valve
  • Allergic reaction
  • Anemia
  • Blood leak around the valve
  • Chest pain
  • Collection of fluid or blood around your heart
  • Damage to blood cells
  • Damage to the swallowing passage (esophagus), with possible puncture or narrowing
  • Damage to the valve or deterioration (wear, tear, fracture, leaflet thickening, stenosis), malposition, clotting, movement or embolization of the valve, which might require removal of the valve
  • Failure to retrieve any EVOQUE system components
  • Fluid buildup in your lungs
  • Having an abnormal particle (air or blood clots) floating in the bloodstream or attached to an object, including the valve
  • Heart attack or heart failure/decreased heart pumping
  • Incorrect position of valve or valve movement
  • Infection in your heart, blood, or other areas
  • Interference/damage with an existing permanent pacemaker or defibrillator
  • Irregular heart rate
  • Kidney failure
  • Nausea and/or vomiting
  • Nerve injury, paralysis or neurological symptoms, including problems with movement or walking
  • Organ failure, including heart failure
  • Pain, inflammation, or fever
  • Right ventricular outflow tract (RVOT) obstruction
  • Severe bleeding or fluid in or around the heart or in the body that could require a transfusion or surgery
  • Skin burn, injury or tissue changes due to exposure to X-rays
  • Sudden or unexpected loss of heart function
  • Swelling
  • Trouble or inability to breathe
  • Valve regurgitation (new or worsening tricuspid, aortic, mitral, or pulmonary)



CAUTION: Federal (United States) law restricts these devices to sale by or on the order of a physician.