For Patients With a Failing Surgical Bioprosthetic Heart Valve Transcatheter Heart Valve Replacement With the Edwards SAPIEN 3 Transcatheter Heart Valve for Patients & Caregivers This patient booklet is for those who are suffering from a failing surgical bioprosthetic heart valve in the aortic or mitral position and are at high or greater risk for surgical valve replacement. This information will help you learn more about your heart and your treatment options, including a less invasive procedure called transcatheter valve replacement. Be sure to ask your specialized Heart Team to explain all of your treatment options and the possible risks and benefits of each. 2 Table of Contents This booklet is not intended Your Heart Valves ....................................................................................................................................................................................................................................... 3 to explain everything you need Why Could Your Surgical Bioprosthetic Heart Valve Be Failing? ................................................................ 4 to know about your treatment options or about the Understanding Your Treatment Options ............................................................................................................................................. 5-6 transcatheter procedure. Please discuss any questions Transcatheter Valve Replacement ................................................................................................................................................................. 5 you have with your doctor. Surgical Valve Replacement...................................................................................................................................................................................... 6 Only a specialized Heart Team Edwards SAPIEN 3 Transcatheter Heart Valve....................................................................................................................... 8-12 can decide which treatment option is right for you. What Do You Need to Do Before the Procedure? ........................................................................................................... 9 Delivery Approaches: Aortic ................................................................................................................................................................................ 11 Delivery Approaches: Mitral ................................................................................................................................................................................ 12 What Happens After the Procedure? .................................................................................................................................................. 13 What Are the Benefits? .................................................................................................................................................................................................. 14 How Long Will My Valve Last?............................................................................................................................................................................14 Transcatheter Valve Replacement Clinical Outcomes .....................................................................................16-17 Replacement of Failing Surgical Bioprosthetic Aortic Valve ................................................................... 16 Replacement of Failing Surgical Bioprosthetic Mitral Valve ......................................................................... 17 What Are the Risks? ........................................................................................................................................................................................................................ 20 Precautions ....................................................................................................................................................................................................................................................... 21 Warnings ................................................................................................................................................................................................................................................................. 21 Who Should Not Have the Procedure? ..................................................................................................................................................... 21 Contact Information ....................................................................................................................................................................................................................... 23 Your Heart Valves The heart is a muscular organ in your chest that is about the size of your fist. The heart’s main function is to pump blood to the rest of your body. Each valve usually has two or three leaflets (flaps of tissue) that open and close like gates to regulate the one-way flow of blood through the heart. It is important that your valves are always working properly: Left Atrium • Be properly formed and flexible Right • Open all the way so that the right amount Atrium of blood can pass through Mitral valve • Close tightly so that no blood leaks Pulmonary Aortic valve back into the chamber valve There are two problems that can Tricuspid valve occur in heart valves: Stenosis: when your valve narrows and does not open completely Right Left Ventricle Ventricle Regurgitation: when your valve does not close completely and blood leaks backwards 3 Why Could Your Surgical time, the leaflets become stiff, reducing Bioprosthetic Heart Valve their ability to fully open and close. be Failing? When the leaflets don’t fully open and close, your heart must work harder to Your original heart valve may have been push blood through the valve to your replaced with a surgical bioprosthetic body. heart valve. Over time, there are two Eventually, your heart gets weaker. This common problems that can develop increases the risk of heart failure (when with a surgical bioprosthetic heart valve: your heart cannot keep up with its • Stenosis: when your valve narrows workload). Stenosis or regurgitation of and does not open completely your surgical bioprosthetic heart valve • Regurgitation: when your valve does can be a very serious problem. not close completely and blood leaks backwards With either problem, your heart needs to work harder and may not pump enough blood to your body. In elderly patients, failing surgical bioprosthetic heart valves are sometimes caused by the build up of calcium (mineral deposits) on the valve’s leaflets. Over If you suspect any change in your ability to perform routine daily activities, consult your cardiologist right away. 3 4 Understanding Your Transcatheter Valve Treatment Options Replacement If you have a failing aortic or Transcatheter valve replacement is a mitral surgical bioprosthetic less invasive, catheter-based technique heart valve, and your doctor has for replacing the failing valve. An evaluated you to be at high or interventional cardiologist, along with greater risk for surgery, a cardiothoracic surgeon, will work transcatheter valve replacement together during the procedure. They may be an option for you. will guide a new valve into the heart while the heart is still beating, using However, only a specialized guidance from X-ray and Heart Team can determine echocardiography. which treatment option is best for you. They may use one of the following delivery approaches: transfemoral (through an incision in your leg), transapical (through an incision in the bottom of your heart), transaortic (through an incision in the top of your heart), or transseptal (through an incision in your leg). Your doctor will determine the best delivery approach for you. Transfemoral Approach 5 Surgical Valve Replacement Most open heart surgeries are performed For more information through an incision across the full on treatment options, length of the breast bone, or sternum. please visit This incision is called a median sternotomy. Occasionally, open heart surgeries can be performed through smaller incisions. Open heart surgeries, including those performed through smaller incisions, 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 or mitral valve and insert a new valve. There are two different types of surgical valves: • Mechanical (man-made material) • Biological (animal or human tissue) 6 7 Edwards SAPIEN 3 Transcatheter Heart Valve The Edwards SAPIEN 3 transcatheter heart valve is a biological tissue valve that will replace your failing valve. It is available in four sizes: 20, 23, 26, and 29 mm in diameter. Your specialized Heart Team will determine which size is right for you. Edwards Lifesciences’ first transcatheter heart valve was approved commercially in Europe in 2007 and in the United States in 2011. Metal frame An illustration of the SAPIEN 3 valve is pictured to the right. Image is larger than actual valve size. Three tissue leaflets (made from cow heart tissue) Fabric skirt 8 Transcatheter Procedure What Do You Need to Do Transcatheter valve replacement 4. The balloon of the delivery system Before the Procedure? allows a new valve to be inserted carrying the valve will be inflated, through