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What makes the ATS Open Pivot® Heart Valve different than other mechanical heart valves?
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The ATS Open Pivot Heart Valve is a fundamentally different design. Unlike all other bileaflet valves, ATS Open Pivot Valves have no cavities and do not rely on mechanical sweeping and high velocity leakage jets to completely wash the valve. Instead of cavities in the hinge area, the patented open pivot design has open pivots enabling the leaflets to pivot on smooth convex spheres that project gently into the bloodstream and provides continuous passive washing for gentle treatment of red blood cells. This difference has been shown to facilitate reductions in thromboembolism, hemolysis, pressure gradients and sound.1-9
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What is the difference between the ATS Open Pivot® Standard and ATS Open Pivot® AP™ Series Heart Valves?
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Both valves utilize the same open pivot design and solid carbon orifice. The ATS Open Pivot Standard Heart Valve is intended for intra-annular placement. The ATS Open Pivot AP Series Heart Valves are indicated for supra-annular placement. The ATS AP Series Heart Valves have reduced cuff size and higher efficiency index than cavity pivot/reduced cuff designs and provide a greater geometric orifice area for a given annulus and are ideal for small aortic root or pediatric applications. Both provide excellent hemodynamic performance, thromboresistance, easy implantability, enhanced visualization post-implant and improved quality of life for the patient. |
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What suture techniques are recommended for use with the ATS Open Pivot Heart Valve?
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There are no specific suturing techniques required for implantation of the ATS Open Pivot Heart Valve. Surgeons frequently use interrupted everting mattress sutures when implanting the ATS Open Pivot Heart Valve. Pledgets may be used at the discretion of the surgeon for support of the annulus.
The ATS Open Pivot AP Series Heart Valves have a supra-annular configuration with a modified cuff, so different suture techniques such as horizontal mattress or simple stitch may be more effective. The sutures should be placed in the outer half of the cuff to facilitate appropriate supra-annular positioning and avoid interference with the strengthening band.
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How is the ATS Open Pivot Heart Valve sized?
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To size for the ATS Open Pivot Standard Heart Valve, gently pass the end of the sizer ring through the patient’s annulus. The sizer should pass through without resistance yet still provide a snug fit between the sizer ring and tissue annulus. Care should be taken to not “oversize” the valve.
To size for the ATS Open Pivot AP Series Heart Valves, first use the cylindrical ring to approximate the size of the patient’s annulus by gently passing the sizer through the annulus. The sizer should pass through without resistance yet still provide a snug fit between the sizer ring and tissue annulus. Next, use the flanged end of the sizer to simulate the position of the supra-annular cuff and ensure appropriate supra-annular placement and valve seating. Care should be taken not to “oversize” the valve.
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What valve orientation is recommended for use with the ATS Open Pivot Heart Valve?
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There is no hemodynamic data to support a specific orientation of the ATS Open Pivot Heart Valve in either the aortic or mitral position. However, surgeons frequently report using an anti-anatomical orientation in the mitral position and an orientation perpendicular to the septum in the aortic position. |
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What are the resterilization parameters for the ATS Open Pivot Heart Valve sizers and accessories?
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Based upon current studies, the validated sterilization parameters are listed below:
121˚C (250˚F) for a minumum exposure time of 15 minutes.
132˚C (270˚F) for a minimum exposure time of 4 minutes.
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Can the ATS Open Pivot Heart Valve be resterilized?
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No. ATS Medical strongly advises the return of expired product in its original packaging to the company for resterilization and repackaging. Contact a local ATS Medical sales representative for more details.
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What are the recommended levels of anticoagulation for the ATS Open Pivot Heart Valve?
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ATS Medical cannot make recommendations regarding anticoagulation.
Anticoagulation during the US clinical study for FDA approval followed American Heart Association and American College of Cardiology guidelines for the anticoagulation of bileaflet mechanical heart valves. Low intensity anticoagulation regimes using the ATS Open Pivot Heart Valve have been utilized and reported in several publications.10,11
For further information you may reference:
The American College of Cardiology/American Heart Association Task Force Report entitled “ACC/AHA Guideline for the Management of Patients With Valvular Heart Disease” which was published in 1998.
Bonow RO, Carabello B, de Leon AC, JR, Edmunds LH Jr, Fedderly BJ, Freed MD, Gaasch WH, McKay CR, Nishimura RA, O’Gara PT, O’Rourke RA, Rahimtoola SH, ACC/AHA guidelines for the management of patients with valvular heart disease; a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Committee on Management of Patients with Valvular Heart Disease). J Am Coll Cardiol. 1998;32:1486-588.
These guidelines can also be accessed through the AHA web site at:
www.americanheart.org
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How is the patient’s anticoagulation altered prior to surgery or dental procedures?
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ATS Medical cannot make recommendations regarding anticoagulation.
For further information you may reference:
The American College of Cardiology/American Heart Association Task Force Report entitled “ACC/AHA Guideline for the Management of Patients With Valvular Heart Disease” which was published in 1998.
Bonow RO, Carabello B, de Leon AC, JR, Edmunds LH Jr, Fedderly BJ, Freed MD, Gaasch WH, McKay CR, Nishimura RA, O’Gara PT, O’Rourke RA, Rahimtoola SH, ACC/AHA guidelines for the management of patients with valvular heart disease; a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Committee on Management of Patients with Valvular Heart Disease). J Am Coll Cardiol. 1998;32:1486-588.
These guidelines can also be accessed through the AHA web site at:
americanheart.org
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The ATS Open Pivot Heart Valve is composed of what materials?
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The orifice is made of solid pyrolytic carbon with a metal strengthening band. The leaflets are composed of graphite coated with pyrolytic carbon. The sewing cuff is made of double velour polyester. In sizes 27-33, the mitral valve cuff contains a polytetrafluoroethylene (PTFE) liner inside the polyester fabric. This enhances needle passage and coaptation of the ring to the annulus. |
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How long is an ATS Open Pivot Heart Valve expected to last without wearing out?
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ATS Medical has completed extensive durability testing utilizing accelerated component-on-component wear studies. The ATS Open Pivot Heart Valve has exhibited acceptable wear after 15 years of accelerated aging. This type of accelerated testing is known to be far more rigorous than actual in vivo experience. As a result, the ATS Open Pivot Valves have a projected life of greater than 100 years. There have been more than 130,000 implants of ATS Open Pivot Heart Valves with no post-operative failures. |
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Is it safe to have an MRI examination with the ATS Open Pivot mechanical valve?
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The ATS Open Pivot mechanical valve has been found safe under predetermined conditions while undergoing an MRI scan.
MRI and ATS Open Pivot Heart Valve
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Does the ATS Open Pivot Heart Valve contain any latex?
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The ATS Open Pivot Heart Valve and its packaging contain no latex material. |
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How do I place an urgent request for an ATS Open Pivot Heart Valve?
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In the United States, contact ATS Medical customer service at 866-287-6331. Outside the U.S., contact a local ATS Medical sales representative. |
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What should I do if I need to explant an ATS Open Pivot Heart Valve?
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The explanted valve should be completely submersed in a 2-5% formalin solution immediately after excision unless otherwise directed by an ATS Medical representative. Upon return of the explanted valve to ATS Medical, studies of it may be performed and a written report summarizing the findings will be returned to the sender. Please contact ATS Medical to obtain a Returned Material Authorization (RMA) and instructions on proper handling. |
References
1. 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.
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.
3. Emery R, et al. Five-Year Follow Up of the ATS Mechanical Heart Valve. J Heart Valve Dis. 2004; 13(2):231-8.
4. ATS Medical Inc., Pre-market Approval Application – Summary of Safety and Effectiveness: 2000. Washington, D.C.; U.S. Food and Drug Administration. 2000. P990046.
5. Echevarria J, et al. Clinical and Hemodynamic Performance of the ATS Heart Vavle Prosthesis (AP Series) in the Small Aortic Root. Abstract presented at: 15th World Congress of the World Society of Cardiothoracic Surgeons, 1999.
6. Jazayeri S, et al. Clinical Experience and Doppler Echocardiographic Assessment of the First One Hundred ATS AP (Advanced Perfomance) Prosthetic Valve in the Aortic Position. J Heart Valve Disease. 2003; 12(2):628-634.
7. Karpuz H, et al. Doppler Echocardiographic Assessment of the New ATS Medical Prosthetic Valve in the Aortic Position. Am J Card Imaging. 1996; 10(4):254-60.
8. 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.
9. 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.
10. Stefanidis C, et al. 10-Year Experience with the ATS Mechanical Valve in the Mitral Position. Ann Thorac Surg. 2005; 79:1934-8.
11. Van Nooten, G, et al. Lower-Intensity Anticoagulation for Mechanical Heart Vavles: A New Concept with the ATS Bileaflet AorticValve. J Heart Valve Disease. 2003; 12:495-502.
Federal Law restricts this device to sale by or on the order of a physician or properly licensed practitioner. Refer to the Instructions For Use packaged with each valve for a complete listing of warnings and precautions. The ATS Open Pivot Heart Valve is indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic aortic or mitral valves. The ATS Open Pivot Heart Valve is contraindicated in patients unable to tolerate anticoagulation therapy. Adverse events potentially associated with the use of prosthetic heart valves include: cardiac arrhythmias, death, leaflet entrapment (impingement), endocarditis, hemolysis, anticoagulant-related hemorrhage, transvalvular or perivalvular leak, prosthesis thrombosis, structural deterioration, valve thromboembolism.
Manufactured under licensed U.S. Patent 4,692,165. United States Patent Number No. 5,354,330, European Patent Number 0541215 and German Patent No. P69214597.4. ATS Medical and ATS Open Pivot are registered trademarks of ATS Medical, Inc. All rights reserved
. ©2006 ATS Medical
, Inc
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