Your cardiac surgeon may have suggested a mechanical heart valve for your heart valve replacement surgery. Mechanical heart valves are made of durable materials proven safe for use in the human body. More durable and longer-lasting than tissue valves, mechanical heart valves do require the recipient to take daily anticoagulation medicine (sometimes called blood thinners) to reduce the possibility of blood clotting on the valve.

Many things must be considered when choosing a mechanical heart valve. We encourage you to gather as much information as possible before participating in this important decision. Remember that in the end, your physician or surgeon is the best judge of what is best for your particular situation.

A Fundamentally Different Mechanical Heart Valve
Implanted in more than 130,000 patients worldwide, the ATS Open Pivot® Heart Valve is different from all other mechanical heart valves. It uses a unique and patented open pivot design and innovative features to improve medical results and quality of life for patients. Specifically, this heart valve is designed to reduce the likelihood of developing blood clots, to provide good performance and to diminish valve noise. Laboratory durability tests indicate that the ATS Open Pivot Heart Valve will last the lifetime of any patient, with a projected life greater than 100 years.^1-10

The Difference is in the Pivots
The ATS Open Pivot Heart Valve is a bileaflet valve, which simply means there are two leaflets that open and close to control the flow of blood through the valve. These leaflets perform the same function as the leaflets in a natural heart valve. All mechanical heart valves have pivots on both ends of each leaflet that act as a hinge on which the leaflet swings. The pivots of mechanical heart valves other than the open pivot design of the ATS Open Pivot Heart Valve create recessed areas or cavities where blood can collect. Stagnant blood can form small clots that may hamper valve function or blood circulation, possibly blocking vital arteries in the brain or other organ systems. The unique design of the ATS Open Pivot Heart Valve eliminates these recessed cavities preventing blood from pooling or clotting reducing the potential for strokes.

Quieter Than Others
Some patients report hearing their mechanical heart valve when it opens or closes. A soft “click” is normal and may be more noticeable when the patient is resting in a quiet room. A “noisy” heart valve may interfere with normal life. Clinical researchers have observed that numerous problems have been caused by loud mechanical heart valves including annoyance, sleep disturbance, interference with concentration and social embarrassment. The ATS Open Pivot Heart Valve is recognized as one of the quietest mechanical heart valves available, and most patients do not find the sound of their ATS Open Pivot Heart Valve disturbing. Clinical studies have shown that the ATS Open Pivot Heart Valve is in fact significantly quieter than other leading mechanical heart valves. One clinical researcher reported that most of the patients in his study did not hear the ATS valve at all and those who did were not disturbed by it.^2,6,9,10  

The Importance of Taking Your Medicine
A mechanical heart valve recipient takes daily anticoagulation medication (blood thinner) to reduce the possibility of clotting on the valve. Anticoagulants alter the clotting mechanism of the blood to prevent or treat thrombus (formation of a blood clot at a specific site such as within a blood vessel or heart valve) and embolus (a clot which drifts unattached in the bloodstream until it becomes lodged in a small vessel and obstructs circulation). To reduce the risk of bleeding or stroke and to provide as normal and happy a life as possible following surgery, it is important that you stay within your prescribed therapeutic range (INR) for anticoagulation medication. In the United States, QAS Home INR Monitoring can provide reliable clinical monitoring in the comfort of your home. For further information, ask your physician.

Care with Your Mechanical Heart Valve
Because mechanical heart valves are not biological, care must be taken to prevent bacteria from entering the blood stream and causing infective or bacterial endocarditis in the tissues around the valve. Avoiding this rare complication is simply to inform your dentist or other health care providers before a procedure that you have an artificial heart valve. Antibiotics can then be prescribed in advance to prevent possible infections or other problems.

Keeping Records
The U.S. Food and Drug Administration (FDA) requires manufacturers to track replacement heart valves and maintain patient records. Before you leave the hospital with your new mechanical heart valve, you will be provided with a temporary patient information card. This will be replaced with a permanent card once you return home. You should keep this card with you to provide healthcare providers with information about your mechanical heart valve. If you move or your contact information changes, contact ATS Medical at 1-763-553-7736 to update your records. All information provided ATS Medical is kept confidential.

References
1. ATS Medical, Inc., Pre-market Approval Application – Summary of Safety and Effectiveness: 2000.  Washington, D.C.; U.S. Food and Drug Administration. 2000. P990046.
2. Emery R, et al. The Initial United States Experience With the ATS Mechanical Cardiac Valve Prosthesis. The Heart Surgery Forum 2001; 4(4):346-353. PMID: 11803148
3. Emery R, et al. Five-Year Follow Up of the ATS Mechanical Heart Valve. J Heart Valve Dis. 2004; 13(2):231-8.  PMID: 15086262
4. Krian A. Clinical results of a large series of ATS valve implants. In: Krian A, Matloff JM, Nicoloff DM, eds. Advancing the Technology of Bileaflet Mechanical Heart Valves: Springer Verlag; 1998:53-71. 
5. Kelly S, et al. A three-dimensional analysis of flow in the pivot regions of an ATS bileaflet valve. Int J Artif Organs. 1999; 22:754-763.  PMID: 10612303
6. Shiono M, et al. Multi-Institutional Experience of the ATS Open Pivot Bileaflet Valve in Japan. Ann Thorac Cardiovasc Surg 1996; 2(1):51-58.
7. Westaby S, et al. Valve Replacement with the ATS Open Pivot Bileaflet Prosthesis. Eur J Cardio-thorac Surg. 1996;10:660-5.
8. Hasegawa M. Clinical evaluation of ATS Prosthetic Valve by Doppler Echocardiography: Comparison with St. Jude Medical (SJM) valve. Ann Thorac Cardiovasc Surg. 2000; 6(4):247-251.  PMID: 11042481
9. Sezai A, et al. Evaluation of valve sound and its effects on ATS prosthetic valves in patient's quality of life. Ann Thorac Surg. 2000; 69:507-512.
10. Hata M, et al. Mid-term results of ATS Open Pivot bileaflet mechanical prosthetic heart valve. Ann Thorac Cardiovasc Surg. 2000; 6(1):34-38.