What is TAVR? Transcatheter Aortic Valve Replacement
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1 What is TAVR? Transcatheter Aortic Valve Replacement
2 What Are Your Options for Treating Severe Aortic Stenosis? Treatment for aortic stenosis depends on how far your disease has progressed. If your stenosis is mild, medication may be prescribed to help regulate your heartbeat and prevent blood clots. However, if the severity of your stenosis progresses, your doctor and a specialized Heart Team may recommend replacing your diseased aortic valve. Severe aortic stenosis cannot be treated with medication. The only treatment is to replace your aortic valve. Today, there are two options to replace your diseased aortic valve: transcatheter aortic valve replacement (TAVR) or open heart surgery. For more information on TAVR and open heart surgery, go to NewHeartValve.com.
3 Transcatheter Aortic Valve Replacement (TAVR) TAVR may be a preferred option for people who have been diagnosed with severe aortic stenosis and are at intermediate or greater risk for surgery. TAVR (sometimes called transcatheter aortic valve implantation, or TAVI) is a less-invasive procedure than open heart surgery. This procedure uses a catheter to implant a new valve within your diseased aortic valve. TAVR can be performed through multiple approaches; however, the most common approach is the transfemoral approach (through a small incision in the leg). Only professionals who have received extensive training are qualified to perform the TAVR procedure. A properly trained and dedicated, multidisciplinary Heart Team at a TAVR Center will conduct a thorough evaluation to determine the most appropriate treatment option for you.
4 Open Heart Surgical Aortic Valve Replacement Aortic valve replacement through open heart surgery is another option for treating severe aortic stenosis. Most open heart surgeries are performed through an incision across the full length of the breast bone, or sternum. Open heart surgeries require the use of a heart lung machine which temporarily takes over the function of the heart. During the procedure, the surgeon will completely remove the diseased aortic valve and insert a new valve. There are mechanical (man-made material) or biological (animal or human tissue). Please consult your doctor for more information on surgical aortic valve replacement and its associated risks. Treatment for Failing Surgical Heart Valves Your original heart valve may have been replaced with a surgical heart valve. Treatment for a failing surgical heart valve depends on how far the disease has progressed. Your specialized Heart Team may recommend that your failing surgical tissue valve be replaced through either TAVR with certain valves (sometimes called valve-in-valve) or open heart surgery.
5 Clinical Outcomes with TAVR A recent clinical study of patients who underwent a TAVR procedure with the SAPIEN 3 valve was shown to have a 75% lower incidence of death and stroke compared to open heart surgery.* TAVR may shorten recovery time to allow patients to get back to everyday activities. Patients reported quality of life improvements within 30 days including the ability to take care of themselves. For more information on the clinical benefits of TAVR with the SAPIEN 3 valve, go to TAVRbyEdwards.com. *The PARTNER II trial intermediate-risk cohort 30-day unadjusted clinical event rates for TAVR with the SAPIEN 3 valve, AT population (n=1,077).
6 Questions to Ask Your Doctor: Am I a candidate for transcatheter aortic valve replacement (TAVR)? What tests do I need? How soon will I need treatment? What are the risks associated with not having my aortic valve replaced? How long will I be in the hospital for TAVR vs. open heart surgery? What will the recovery be like for TAVR vs. open heart surgery? What restrictions and/or medications, if any, would I be on after the procedure for TAVR vs. open heart surgery? How frequently will I need to have follow-up visits for TAVR vs. open heart surgery? For a free doctor discussion guide, go to NewHeartValve.com. See accompanying Important Risk Information CAUTION: Federal (United States) law restricts these devices to sale by or on the order of a physician. Edwards, Edwards Lifesciences, the stylized E logo, Edwards SAPIEN, Edwards SAPIEN 3, NewHeartValve.com, SAPIEN, SAPIEN 3, PARTNER, PARTNER II and TAVRbyEdwards.com are trademarks of Edwards Lifesciences Corporation Edwards Lifesciences Corporation. All rights reserved. PP--US-1386 v1.0 Edwards Lifesciences edwards.com One Edwards Way, Irvine CA USA
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