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In November 2011, the U.S. Food and Drug Administration (FDA) approved a new treatment for patients with severe aortic valve stenosis, a condition in which the heart's aortic valve does not open fully and blood flow is restricted. Surgery continues to be the most successful way to treat this disease. However, because they are older or have other medical problems, some patients face a greater than 50 percent chance of dying from this complex operation. Now, with the FDA’s approval of the Edwards SAPIEN transcatheter heart valve, many of these patients can have transcatheter aortic valve replacement (TAVR), a procedure to replace the old valve. This new procedure replaces the diseased aortic valve through a tube that is placed in the patient’s leg, or through an incision in the chest that is much smaller than traditional surgery.
Patients in the PARTNER clinical trial who received TAVR were significantly less likely to die within the first year of the procedure, and they experienced more improvement in their symptoms than the group who received other treatments. Unfortunately, however, recipients were at risk of strokes and other vascular complications, such as bleeding. Decisions to treat aortic valve stenosis must weight the benefits and risks of the procedures as compared to other available treatments.
An ideal candidate for transcatheter aortic valve replacement (TAVR) is an elderly person who is high-risk and unable to do conventional surgery. Watch Arvind Kapila, MD, of JFK Medical Center, describe what leads to a need for this procedure.
Aortic valve disease is progressive, and you shouldn't delay transcatheter aortic valve replacement (TAVR) if you're diagnosed, says J. Lancelot Lester, MD, of JFK Medical Center. In this video, he describes who may benefit from TAVR.
Patients who might benefit from transcatheter aortic valve replacement (TAVR) are those with a severely dysfunctional valve (a condition known as aortic stenosis) that is causing them symptoms. Testing is done to see if the person is physically and anatomically appropriate.
The on-label indicated commercially available TAVR valves -- valves in use outside of research trials -- are for “high” or “excessively high risk” people. That’s been the case for a few years now. But, soon that indication is probably going to come down to include intermediate risk people as well. In fact, this valve may very well replace, entirely, the surgical valve. It’s much less invasive. People are out of the hospital in a day or two.
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Many patients who have a narrowing in the opening of the aortic valve might benefit from TAVI (transcatheter aortic valve implantation). Check out this video with Dr. Craig Smith, a cardiothoracic surgeon, to learn why TAVI is recommended for high-risk patients -- and what the current thinking is for patients at lower risk.
Transcatheter aortic valve implantation (TAVI), also known as transcatheter aortic valve reimplantation (TAVR), involves a puncture though the skin into the blood vessels in the groin. It is similar to the approach that is used for a cardiac catheterization of the coronary arteries. The procedure can also be done by making a small incision near the 4th rib.
Candidates for this percutaneous procedure include patients with severe symptomatic aortic stenosis who are deemed inoperable by a surgeon. Inoperability has no single definition but most commonly it is defined as a patient who faces more than a 50% risk of death or severe morbidity following a standard, surgical, aortic valve replacement. Candidates typically have one or more of the following characteristics: advanced age, previous heart surgery, severe COPD, severe diabetes, home oxygen dependence, pulmonary hypertension, previous radiation to the chest, a severely calcified aorta (aka a porcelain aorta), and/or extreme frailty.
The New England Journal of Medicine recently reported that, in patients with severe symptomatic aortic stenosis who are not candidates for surgery, TAVI (aka TAVR) is associated significantly improved survival, improved symptoms, and improved quality of life compared to standard treatment.
Transcatheter aortic valve replacement (TAVR) is a treatment for severe aortic stenosis, which is a condition of scarring, thickening, and narrowing of the aortic valve.
Our population is aging and patients are living longer with chronic diseases. TAVR was developed because it was discovered that many of these patients can either not have surgery or are at very high risk for complications with surgery.
Any patient with severe aortic stenosis could theoretically benefit from TAVR. However, at the present time, the U.S. Food and Drug Administration (FDA) has only approved TAVR for patients who are considered to be at high risk for complications with conventional surgery for aortic valve replacement, or who are not candidates for surgery at all. This FDA decision was made because surgical aortic valve replacement has been performed for many years with good results.
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If a cardiac surgeon determines that you are too sick or high risk for open-heart surgery, TAVR might be an alternative. A heart team will conduct a comprehensive evaluation to determine whether this procedure is an appropriate therapeutic option. In certain cases, TAVR may not be an option because of coexisting medical conditions or disease processes that would prevent you from experiencing the expected treatment benefit or because the risks outweigh the benefits. For those who are candidates for TAVR, this therapy can prolong your life and may also provide relief from the often debilitating symptoms associated with severe symptomatic native aortic valve stenosis.
Current data shows that patients that are high surgical risk or inoperable patients benefit from this life-saving procedure (PARTNER trial and CoreValve trial). Patients at low or intermediate risk do not qualify for this procedure under current FDA indications. More clinical trial data with longer follow up is needed before TAVR can be recommended in lower risk patients.
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