Transcatheter Aortic Valve Replacement (TAVR) - Coming Soon

Introduction

Aortic stenosis is a progressive disease that occurs with a narrowing of the patient’s aortic valve opening. Aortic stenosis can be caused by a birth defect, rheumatic fever, radiation therapy, or it can be related to age. In fact, the prevalence of aortic stenosis increases with age. It is estimated that approximately 2.5 million people, or 12.4% of the population, in the United States over the age of 75 suffer from aortic stenosis.

Overview of the Disease

Human heart valves are remarkable structures. These tissue-paper thin membranes attached to the heart wall constantly open and close to regulate blood flow (causing the sound of a heartbeat). When there is a narrowing of your heart's aortic valve opening, this is known as aortic stenosis. This narrowing does not allow normal blood flow. It is most often caused by age-related calcification, but can be caused by a birth defect, rheumatic fever, or radiation therapy

In elderly patients, aortic stenosis is sometimes caused by the build-up of calcium (mineral deposits) on the aortic valve's leaflets. Over time, the leaflets become stiff, reducing their ability to fully open and close. When the leaflets don't fully open, a person's heart must work harder to push blood through the aortic valve to the rest of the body. Eventually, the heart gets weaker, increasing the risk of heart failure (heart cannot supply enough blood to the body).

If you have severe aortic stenosis and are experiencing symptoms, it can be life-threatening and can progress rapidly.
Because the heart needs to work so much harder pumping blood through the body, it may cause symptoms like severe shortness of breath and extreme fatigue.

However, it's important to know that heart valve disease may occur with no outward symptoms.
While symptoms of aortic valve disease are more associated with severe aortic stenosis, the symptoms are commonly misunderstood by patients as ‘normal’ signs of aging. Many patients initially appear asymptomatic, but on closer examination up to 32% exhibit symptoms.

What are the signs of aortic stenosis?

You may notice symptoms like:

• Chest pain
• Fatigue
• Shortness of breath
• Lightheadedness, feeling dizzy, and/or fainting
• Difficulty when exercising

Major risk factors

Factors associated with aortic valve disease include the following:

• Increasing age
• High blood pressure
• High cholesterol
• Smoking

Severe aortic stenosis is life threatening, and treatment for this condition is critical. Without aortic valve replacement, patients with severe aortic stenosis have a survival rate as low as 50% at 2 years after the onset of symptoms, and 20% at 5 years after the onset of symptoms.

Diagnosis

In addition to a physical exam, severe aortic stenosis is diagnosed in several ways, the most common being: echocardiogram, electrocardiogram (EKG), chest X-ray of the patient’s heart, and cardiac catheterization (angiography).

Aortic Valve Replacement Options

Transcatheter Aortic Valve Replacement (TAVR)

TAVR (sometimes called transcatheter aortic valve implantation, or TAVI), is a less invasive procedure which allows a new valve to be inserted within the native, diseased aortic valve.

The TAVR procedure can be performed using one of many approaches, the most common being the transfemoral approach (through a small incision in the leg). Only a Heart Team can decide which approach is best, based on the patient’s medical condition and other factors.

In preparation for the patient’s procedure, the patient may be placed under anesthesia. The doctor will make an incision in the leg, and will insert a short hollow tube called a sheath. This will allow the doctor to put various devices through the sheath to access the patient’s heart. The heart valve is placed on the delivery system, and compressed onto a balloon to make it small enough to fit through the sheath. Once the delivery system reaches the patient’s diseased valve, the balloon will be inflated with fluid, expanding the new valve into place. The new valve pushes the leaflets of the patient’s diseased valve aside, and the frame of the new valve uses the diseased valve’s leaflets to secure itself in place. The balloon is then deflated and removed. The patient’s doctor will ensure the new valve is working properly before closing up the incision.

The TAVR procedure may involve general anesthesia and is associated with specific contraindications as well as adverse effects, including risks of death, stroke, major vascular complications and major bleeding, and other life-threatening and serious events. To see a full list of warnings and precautions, please visit SAPIEN3.com.

Open-Heart Surgery

During open-heart surgery, the surgeon removes the diseased aortic valve and replaces it with either a mechanical valve (made from man-made materials) or a biological valve (made from animal or human tissue).
Additional Information

To review all important risks for the SAPIEN 3 valve, please visit www.SAPIEN3.com.

More information about the TAVR procedure can be found at www.NewHeartValve.com.