Advancing the knowledge and practice of TAVR.

PATIENT RESOURCES

Transcatheter Aortic Valve Replacement (TAVR) is a therapy for patients with severe, aortic stenosis. Unlike open heart surgery to replace a diseased heart valve, TAVR is a less-invasive, non-surgical approach.

How does the heart work?

The main function of the heart is to pump blood and oxygen to the body. Your heart beats between 60 to 90 times a minute and over 100,000 times a day.

The heart has four chambers.  The right side of the heart has an upper chamber, called the right atrium, and a lower chamber, called the right ventricle.  The left side of the heart also has an upper chamber, the left atrium, and a lower chamber, the left ventricle.

The right side of the heart receives blood from the body and pumps it through the pulmonary artery to the lungs, where it is supplied with oxygen. This oxygen-rich blood from the lungs is in turn pumped through the aorta to the rest of the body by the left side of the heart.

Separating the chambers and major blood vessels are valves, which act like one-way doors allowing blood to flow in one direction only.

×

What is aortic stenosis?

Aortic stenosis is one of the most common and serious valve disease issues.  Aortic stenosis is a narrowing of the aortic valve opening . The native aortic leaflets of the valve become stiff and do not completely open.  Because the aortic valve does not fully open, the heart has to work harder to pump blood to the rest of the body.

People with severe aortic stenosis may complain they have chest pain, feel tired or short of breath, have heart beat irregularities, or even faint.  Many patients say they are unable to do activities that require mild exertion. If left untreated, aortic stenosis may lead to heart failure.

Normal Aortic Valve
Aortic Valve Stenosis

What causes aortic stenosis?

Aortic stenosis may be caused by several different conditions:

  • Degenerative Changes

    In some elderly people, the aging process may cause calcium build up on the valve leaflets. Calcium can make the leaflets stiff and narrow the aortic valve

  • Rheumatic Fever

    This infection can cause scar tissue to develop on the valve leaflets. Scar tissue may stiffen and narrow the valve so it does not fully open

  • Congenital Heart Defect

    The aortic valve typically consists of three leaflets. In some cases, there are only two leaflets, which can lead to stenosis

There are several treatment options for aortic stenosis. Each patient has unique medical issues, so the most appropriate treatment may vary from patient to patient. Talk to your physician to determine the best treatment path for you.

 

How is aortic stenosis typically treated?

Medical Therapy

Physicians may prescribe medicine to treat the symptoms of aortic stenosis. The medications may be used to control heart rhythm or regulate blood pressure to prevent blood clots.

Even with medical therapy, aortic stenosis may progress and, if left untreated, and could lead to more serious health problems.

 

Open Heart Surgery

A common treatment for severe aortic stenosis is open-heart surgery to replace the aortic valve.  Open-heart surgery has been the standard of care to replace a diseased heart valve. During open-heart surgery, the chest is opened, the patient is placed on a heart-lung machine and the heart is temporarily stopped. This allows the doctor to work on the heart and remove the diseased valve. The doctor then implants a new surgical valve.  

Watch the full animation

Transcatheter Aortic Valve Replacement (TAVR)

To achieve the effectiveness of surgical aortic valve replacement without the risks associated with open-heart surgery, an alternative treatment has been developed. This type of aortic valve replacement procedure is called Transcatheter Aortic Valve Replacement (TAVR).  Since 2011 in the United States , TAVR has been an alternative to open-heart surgery for aortic valve replacement. Unlike open-heart surgery, a TAVR procedure is a less-invasive approach to replace the diseased aortic valve.

In this procedure, a doctor will guide a new valve through a long, thin flexible tube, or catheter, that is inserted through a skin incision in the groin area.  The catheter is then threaded up through the bloodstream to the heart. The valve, which is inside the catheter, can then be implanted, replacing the function of the diseased valve.  All this is done while the heart is beating and you are awake. Generally, patients who undergo a TAVR procedure may have shorter recovery times versus those that have a surgical valve replacement.

Positioned to Perform.

Frequently Asked Questions

What is a clinical trial?

A clinical trial is a research study involving patients, that is intended to add to medical knowledge. Clinical studies help the medical community gain important insights into the mechanism of disease and the potential benefits of therapy.

Patients may volunteer to participate in a clinical trial after learning about the study and any probable risks. The decision on whether a clinical trial is right for you will be made in conjunction with your physician and your care team. Every patient enrolled in the study is required to provide their informed consent prior to participation. No information is collected without your written consent.

Patients in clinical trials can be more involved in their health care and have access to new treatments before those treatments are widely available. Data from a clinical trial can provide new medical information that helps doctors treat patients with similar health problems. Future patients with the disease or condition, in this case, severe aortic stenosis, may benefit from the information obtained during the study. It is unknown if you will have any additional health benefits to this treatment over conventional treatment, however you will be contributing to the body of knowledge.

The RADIANT clinical trial will collect information on the safety and performance of the new Meridian® II Valve.

To find out more about this clinical trial or to find out if you qualify, go to www.clinicaltrials.gov.

How long does a TAVR procedure take?

A transcatheter valve replacement procedure usually takes 2 to 3 hours.

What happens to the original valve in a TAVR procedure?

The original diseased valve remains in the heart. During the procedure, the diseased valve is pushed aside, which allows the new transcatheter valve to be secured in position.

How long will a TAVR valve last?

TAVR valves are tested in a laboratory setting to meet standards for valve durability.However, currently there is no standard known durability length for TAVR valves andthere are ongoing clinical trials to better determine how long the valve will maintain optimal function.

What is the Meridian® II Valve made of?

The HLT valve is made from treated porcine (pig) tissue that is supported on a braided wire frame. The Meridian® II Valve will stay in the heart permanently, replacing the original aortic heart valve

Who manufactures the valve?

HLT, Inc. a medical device company based in Minnesota, USA, manufactures the Meridian® II Valve.

If I participate in HLT’s clinical trial, how often will I have to see my doctor?

If you and your physician determine you are a good candidate for the HLT Clinical trial and if you sign the informed consent form, you will then be seen for clinical study appointments. These appointments will also include clinical data collection. The schedule of clinical appointments is as follows:

  • Before the TAVR procedure
  • Immediately after the TAVR procedure and before you go home from the hospital
  • Thirty days after your procedure
  • Six months after your implant
  • Once per year up to five years+
  • Additional visits as indicated by your physician