ats mechanical valve mri safety

Your doctor can provide more details. 36 0 obj <> endobj 56 0 obj <>/Filter/FlateDecode/ID[<6EB9113DF4F28EB3DAE6935E101E9D29><1F382FF046824DA08989EAA9411F001E>]/Index[36 64]/Info 35 0 R/Length 102/Prev 121988/Root 37 0 R/Size 100/Type/XRef/W[1 2 1]>>stream March 1993;17(3):538-545. Mechanical Heart Valve Size 27 mm 27AGN-751 Rotatable Aortic . mVa04iv2Y From January 1, 1997 through June 30, 2000, 224 patients underwent valve replacement with the ATS Medical cardiac valve prosthesis under a USFDA-approved investigational device exemption study. AP series valves are sized in even mm ranges for implant purposes. Is it safe to have a magnetic resonance imaging (MRI) scan after heart valve replacement? 2001;4(4):346-352. In this article, we present the results of 15 years of follow-up of patients who have undergone ATS heart valve replacement at our hospital. At hospital discharge, the mean INR for all the patients was 2.38 +/- 0.68 (range, 1.32 to 6.44). Accessed April 20, 2021. Bernet FH, Baykut D, Grize L, Zerkowski HR. z6s_ !faph n&RZS~v9'URlEtlH {S']$:I&L[z8! Eur J Cardio-thorac Surg. Perioperative management of patients with prosthetic heart valves-A narrative review. J Am Soc Echocardiogr. J Thorac Cardiovasc Surg. Multi-institutional experience of the ATS Open Pivot bileaflet valve in Japan. PubMedGoogle Scholar, Clinic for Thoracic and Cardiovascular Surgery, Heart Center Duisburg, Gerrickstr. Other bileaflet valves use cavity pivots, which can provide areas of stasis where potential platelet aggregation can occur.4,5Open Pivot valves, on the other hand, have no recesses or cavities where a potential thrombus can form.5,6While cavity pivots rely on mechanical sweeping and high-velocity leakage jets, with the Open Pivot design, the unimpeded flow of blood provides for a continuous passive washing.7,8. The initial United States experience with the ATS mechanical cardiac valve prosthesis. J Heart Valve Dis. Recovery time depends on many different things, including your overall physical condition before surgery. Mechanical Valves: Tissue Valves: Annuloplasty Rings: xxA-101 or xxM-101 B10 . Emery RW, Van Nooten GJ, Tesar PJ. Table # Referenced products MR Safety Table 1 Solo Smart Carbomedics Annuloflex MR Safe Table 2a Carbomedics Prosthetic Heart Valve (CPHV) . Careers. Handle the valve only with accessories provided by the manufacturer specifically for the Carbomedics valve . Westaby S, Van Nooten G, Sharif H, Pillai R, Caes F. Valve replacement with the ATS open pivot bileaflet prosthesis. morecambe fc owners medtronic open pivot heart valve mri safety. Patients Fifteen years single-center experience with the ATS bileaflet valve. ATS Medical Open Pivot Bileaflet Heart Valve AP 360 Aortic Model # XX denotes size 505DAxx Learn more on the transportation safety administration website. The PubMed wordmark and PubMed logo are registered trademarks of the U.S. Department of Health and Human Services (HHS). Before Accessibility Home The initial experience with the ATS Medical mechanical cardiac valve prosthesis. x[7} */ qY"zfz!'Rklo"d'Ddx~J/Vw\nJZ[%Ei]v'Z.V#p`m4$7oca$`J_^:,yZp3c!}33@-+7CV What are the differences between mechanical valves and tissue valves? p1`*&M33BP0+';~'ww.2c\b$1JM_@IQ B)&"-#i7Yw9I+aQlUhCF)}fs{OmknQ!9}:F-MrP[;su6$lph} 0f g)fSU$PP(\Ivf*DZ.g. Will a mechanical heart valve set off airport security? With tissue valves, the need for life-long blood-thinning medication is usually minimal. 26 ATS Medical Open Pivot Bileaet Aortic 501DA18 18 Pyrolytic carbon Teon ATS Medical Inc., Minneapolis, MN 27 SJM Reagent Valve Bileaet Aortic 25AGN-751-IDE 25 Polyester Mechanical Heart Valve St. Jude Medical Inc., St. Paul, MN 28 St. Jude Medical Mechanical Heart valve Bileaet Aortic 25AJ-501 25 Polyester St. Jude Medical Inc . Clipboard, Search History, and several other advanced features are temporarily unavailable. You just clicked a link to go to another website. In 372 patient-years of follow-up, there were an additional four patient deaths, two of which were valve related following a stroke. comediantes de puerto rico; rivian r1s size comparison; stephen sackur illness Heart Valves and Annuloplasty Rings More. Before and after Endovascular Aortic Repair in the Same Patients with Aortic Dissection: A Cohort Study of Four-Dimensional Phase-Contrast Magnetic Resonance Imaging. There have been many mechanical valve prostheses developed and implanted clinically since the first implant of the ball valve. Because anticoagulation medication helps prevent clots by delaying the blood coagulation process, any cuts or scrapes you get will bleed a little longer than normal. Convenient accessories include nine white-handled, single-endedstandard heart valve sizers. Bethesda, MD 20894, Web Policies Mean follow-up was 48 +/- 34 months (range, 1 to 119). Would you like email updates of new search results? With a mechanical valve, your doctor will prescribe blood-thinning (anticoagulant) medication you'll take for the rest of your life. Seventy-four patients (42%) were in chronic atrial fibrillation. Medtronic Operational Headquarters 710 Medtronic Parkway Minneapolis, MN 55432-5640 USA, for Aortic Valve and Ascending Aorta Replacement, Central/Eastern Europe, Middle East & Africa, Electromagnetic Compatibility Guide for Cardiac Devices, Cardiac Surgery Education, Innovation, and Evidence, www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P990046, Electromagnetic Compatibility for Cardiac Devices, California Transparency in Supply Chains Act, Information About Proposition 65 for California Customers, Digital Millennium Copyright Act (DMCA) Notification. Seventy-four mitral valve replacements (42%) were associated with other cardiac procedures. 2015 Sep;8(9):e003703. Unauthorized use of these marks is strictly prohibited. Disclaimer. Severe Stenosis of Mitral Bioprosthetic Valve Thrombosis in a Patient with HCV-Related Cirrhosis and Duodenal Variceal Bleeding: The Deadly Triad. Eleven-year single-center experience with the ATS Open Pivot Bileaflet heart valve. Prevalence and Evolution of Susceptibility-Weighted Imaging Lesions in Patients With Artificial Heart Valves. The site is secure. ])Q Koito H, Imai Y, Suzuki J, Ohkubo N, Nakamura C, Takahashi H, Iwasaka T, Inada M. Cardiol Clin. Ann Thorac Surg. Quant Imaging Med Surg. This study documented the ATS Medical prosthesis to be a valuable addition to the surgeon's armamentarium in the treatment of cardiac valvular disease. This newly developed valve has many outstanding features: open-pivot structure, wider orifice area, improved durability, reduced energy loss, and rotatable orifice. Eat a low-salt diet if your doctor prescribes one for you. Proven Graft Material Five-year follow up of the ATS mechanical heart valve. Washington D.C.: U.S. Food and Drug Administration; 2000. Aortic valve replacement (AVR) was conducted in 152 patients (39 with coronary bypass) and mitral replacement (MVR) in 72 patients (18 with coronary bypass). Would you like email updates of new search results? With an updated browser, you will have a better Medtronic website experience. 2004 Mar;13(2):231-238. Open Pivot Mechanical Heart Valve, Medtronic Open Pivot Mechanical Heart Valves, While mechanical valves have been used for heart valve replacement for nearly 50 years, the Medtronic Open Pivot platform brings a fundamentally different design to bileaflet mechanical valves. All mechanical valves make a little noise. 2011 May;29(2):229-36. doi: 10.1016/j.ccl.2011.01.007. The PubMed wordmark and PubMed logo are registered trademarks of the U.S. Department of Health and Human Services (HHS). ATS Medical Open Pivot: . Previous reports have focused on the low rate of thromboembolic complications in the aortic position. Sezai A, Hata M, Niino T, et al. By Posted when did harry styles dad passed away In mckayla adkins house Bookshelf )wMt+T)ooVn,K >d_BPry6)5L>E^2AKYjz%Ae/^` W,(zuPd)kEJU{n {VX National Library of Medicine This site is Exclusively Sponsored by BRACCO, Patent Ductus Arteriosus (PDA), Atrial Septal Defect (ASD), Ventricular Septal Defect (VSD) Occluders, and Patent Foramen Ovale Closure Devices, Orthopedic Implants, Materials, and Devices, Neurostimulation (Neuromodulation) Systems: General Information, Ocular Implants, Lens Implants, and Devices. Our heart valves have been tested and found to be compatible during an MRI scan under specific conditions. Five early neurologic complications occurred: 3 transient cerebrovascular accidents and 2 strokes. Heart Surg Forum. Our heart valves have been tested and found to be compatible during an MRI scan under specific conditions. Open Pivot Aortic Valved Graft. This includes the models listed below as well as others not appearing on this list, some of which are no longer available. Postoperative echocardiographic data revealed low mean pressure gradient as related to the valvular size. HHS Vulnerability Disclosure, Help 8600 Rockville Pike Shiono M, Sezai Y, Sezai A, et al. and transmitted securely. The ATS Open Pivot Heart Valve was first sold in international markets in 1992, and subsequently granted FDA clearance to sell in the United States in 2000. oM4]};A,r\)_p uZCRX_ta|KhC mq5\cs>`>+|xKz10& &,xO\s&8?[$X?~kF$>GOW$\p$1NXMB#nw0S)I]KYSb]c^v.>:vk@^ G7$%tnyQ The Hemashield*Woven Double Velour graftis made with a low-porosity graft material to improve hemostasis.6,7Excellent resorption rates facilitate healing.6The graft material also offers exceptional handling characteristics. Criteria previously used for safety assessment of heart valve prostheses and expressed in terms of magnetic forces suggest the forces observed in this study are compatible with the safe use of these valves in magnetic resonance (MR) systems with static fields up to 4.7 T. J. Magn. The .gov means its official. In order to overcome the thrombogenicity of the St. Jude Medical valve, the ATS bilealfet open-pivot valve (ATS Medical, Minneapolis, MN) has been developed and introduced for clinical use. Breiding PS, Duerrenmatt JT, Meinel FG, Carrel T, Schnhoff F, Zibold F, Kaesmacher J, Gralla J, Pilgrim T, Jung S, Fischer U, Arnold M, Meinel TR. Epub 2019 Aug 5. {SY:;u?b- |`+O1EV2,6&KXfti0(yrNgFT(iIeiDGhQkn9Hdq13zFIqCX'ShBL1P Careers. A larger graft internal diameter minimizes stress on coronary anastomosis, and the rotatable valve allows for optimal leaflet positioning. Heart Valves Surgical Previous reports have focused on the low rate of thromboembolic complications in the aortic position. Many people experience relief from symptoms right away. What are complications with heart valve replacement surgery? Int J Artif Organs. gdYySvn/2K8]NQ=H#o}Eix. Unable to load your collection due to an error, Unable to load your delegates due to an error. How soon after surgery can I expect to see results? Patient Booklet: Medtronic Surgical Valve Replacement, Electromagnetic Compatibility for Cardiac Devices, California Transparency in Supply Chains Act, Information About Proposition 65 for California Customers, Digital Millennium Copyright Act (DMCA) Notification. 2022 Jul-Sep;25(3):254-263. doi: 10.4103/aca.aca_109_21. If I have a tissue heart valve implanted, will I need to take any medications after my surgery? single family homes for rent in hamden, ct recent deaths in greenfield,ca Menu . The main advantage of a tissue valve is that it does not typically require life-long blood-thinning medication. Currently the bileaflet valve, especially the St. Jude Medical valve (St. Jude Medical, St. Paul, MN), is the most commonly used mechanical valve around the world. and transmitted securely. This is normal. MeSH Emery RW, Van Nooten GJ, Tesar PJ; Investigators for the ATS Clinical Open Pivot Heart Valve Food and Drug Administration Study. Each sizer handle has a clear cylindrical ring that approximates the patients tissue annulus size for appropriate valve selection. Prosthetic heart valves are increasingly being used for dysfunctional native valves requiring intervention. Aortic valve replacement (AVR) was conducted in 152 patients (39 with coronary bypass) and mitral replacem Our operative mortality rate for the study period was 2.2%. official website and that any information you provide is encrypted Copyright 2018 Hellenic Society of Cardiology. stream Unauthorized use of these marks is strictly prohibited. Five-year evaluation of the Carpentier-Edwards porcine bioprosthesis. Tell your doctor if you make any lifestyle changes. Be sure to tell your dentist or doctor you have a tissue heart valve. Before Clinical results of a large series of ATS valve implants. You and your doctor together will decide which option is best for you. Please enable it to take advantage of the complete set of features! Disclaimer. Van Nooten GJ, Caes F, Francois K, et al. J Heart Valve Dis. HHS Vulnerability Disclosure, Help https://doi.org/10.1007/978-3-642-93691-3_12, DOI: https://doi.org/10.1007/978-3-642-93691-3_12. The carbon orifice used in the design corresponds to a standard valve three millimeters larger, hence a 22 mm AP aortic valve is the same in GOA as a 25 mm standard valve. 2003;75(2):444-452. During this time, you'll gradually regain your energy and should be able to return to your normal routine. Hirt SW, Aoki M, Demertzis S, Siclari F, Haverich A, Borst HG. Mechanical valves in some patients have lasted as long as 25 years without problems.1, Tissue valves in some patients have lasted as long as 15 years without problems.2. sharing sensitive information, make sure youre on a federal The On-X aortic heart valve is the only mechanical valve FDA approved and clinically proven to be safer with less anticoagulation. With an updated browser, you will have a better Medtronic website experience. 21, D-47137, Duisburg, Germany, 511 So Lucerne Blvd, Los Angeles, CA, 90020, USA, Cardiac Surgical Associates P.A., 920 East 28th Street, # 420, Minneapolis, MN, 55407, USA, 1998 Dr. Dietrich Steikopff Verlag GmbH & Co. KG, Darmstadt, Parravicini, R. et al. Medtronic Operational Headquarters 710 Medtronic Parkway Minneapolis, MN 55432-5640 USA, Central/Eastern Europe, Middle East & Africa, Electromagnetic Compatibility Guide for Cardiac Devices, Surgical Heart Valve Repair and Replacement. and transmitted securely. The purpose of this retrospective study is to analyze the rate of midterm thromboembolic events and other valve-related complications when the ATS Open Pivot valve is implanted in the mitral position. Update my browser now. Evaluation of valve sound and its effects on ATS prosthetic valves in patient's quality of life. Complications, sometimes leading to repeated surgery or even death, may be associated with heart valve replacement. Unable to display preview. The content of this website is exclusively reserved for Healthcare Professionals in countries with applicable health authority product registrations, except those practicing in France as some of the content is not in compliance with the French Advertising law N2011-2012 dated 29th December 2011, article 34. It's important that you follow your doctor's specific instructions and take your medication exactly as instructed. The Medtronic Open Pivot aortic valved graft unites a fundamentally different bileaflet heart valve design with leading graft technology for exceptional implantability. Find important safety information about the Medtronic transcatheter aortic valve and TAVR procedure. Premarket Approval (PMA). ATS prosthetic valves AP series: echocardiographic evaluation. Background: Emery RW, Krogh CC, Jones DJ, et al. In: Krian, A., Matloff, J.M., Nicoloff, D.M. Unable to load your collection due to an error, Unable to load your delegates due to an error. From January 1, 1997 through June 30, 2000, 224 patients underwent valve replacement with the ATS Medical cardiac valve prosthesis under a USFDA-approved investigational device exemption study. Unable to load your collection due to an error, Unable to load your delegates due to an error. These keywords were added by machine and not by the authors. Part of Springer Nature. A three-dimensional analysis of flow in the pivot regions of an ATS bileaflet valve. Can I have an x-ray after heart valve replacement? 2007 Jan;100 Spec No 1:19-28. ;~" ^[L@3CFq#5 LPS Long term results of mitral valve replacement with preservation of the posterior leaflet. Heart Surgery Forum. Clinical results of the ATS prosthetic valve in 240 implants and review of the literature. The goal of an artificially placed valve is to function like a native one in terms of hemodynamics and with minimal side . Published by Elsevier B.V. All rights reserved. 8600 Rockville Pike %PDF-1.5 % Advanced Discussion (show/hide) References bioprosthetic valve; coronary artery disease; coronary stent; metallic mechanical valve; valvular heart disease. Federal government websites often end in .gov or .mil. x]]6r}`D#sIJ==>X~$k=f}.>$VNL,n}~+*+V0O4+? MRI at 1.5 T is also safe for patients who carry old mechanical prostheses such as the Pre-6000 Starr-Edwards caged-ball prosthesis (available from 1960 to 1964), including assessment of the heart itself (cardiovascular magnetic resonance [CMR]). It allows both morphologic and haemodynamic assessment according to the current guidelines [1,2]. Percent follow-up was 90.4%. Diagnostics (Basel). . sVUe:p+eeU6UfBdqC_5\a(#?n`pj4UpV_E+J1q!b$` PMC On the second postoperative day, 100 mg acetylsalicylic acid and oral acenocoumarol (Sintrom) was introduced to obtain a target INR of 2.0 to 3.0. An official website of the United States government. Accessibility 3: . Copyright 2023 by Shellock R & D Services, Inc. and Frank G. Shellock, Ph.D. All rights reserved. Safety Topic / Subject Heart Valves and Annuloplasty Rings. Rv>dBf?}bTCJsq[C*~7bPM. sharing sensitive information, make sure youre on a federal [kq|XJGzc9H ,s>1B/e j. Results: ATS Medical Open Pivot Valve: Mechanical bileaflet . National Library of Medicine ATS Medical Open Pivot Bileaflet Heart Valve Standard Aortic Model # XX denotes size 500FAxx ATS Medical Minneapolis, M. Strength 3. Tell your doctor if you have dramatic, unexplained weight gain, fever, pain, or other symptoms. UA1E$ZGJ4 (W7- &,?im p It is also known as the ATS Open Pivot Bi-leaflet Heart Valve. 2010 Jul;19(4):473-84. 2001; 4(4):346-353. Cardiovascular Of course, how quickly you recover depends on the kind of surgery you had, your overall strength, and how well your incision heals. The ATS Medical valve is manufactured in two models: the standard model and the advanced performance (AP) model. In: Krian A, Matloff JM, Nicoloff DM, eds. Baykut D, Grize L, Schindler C, Keil AS, Bernet F, Zerkowski HR. 2018 Apr;31(4):475-490. doi: 10.1016/j.echo.2018.01.011. With an updated browser, you will have a better Medtronic website experience. There are advantages and disadvantages with either choice. 8600 Rockville Pike Biocor Valve Mitral Size 35-mm Model B10-35M heart valve St. Jude Medical, Inc., www.sjm.com Proven Graft Material Disclaimer. Please enable it to take advantage of the complete set of features! 1996(10):660-665. The fact that tissue valves may not require life-long blood-thinning medication makes them ideal for women in their childbearing years, elderly patients, and patients who can't tolerate anticoagulation medication. You may need to take antibiotics before you have dental work or other medical procedures done, just as you would if you received a mechanical valve. FAQ. ATS Medical Open Pivot Bileaflet Heart Valve AP 360 Aortic Model # XX denotes size 505DAxx FOIA The initial experience with the ATS Medical mechanical cardiac valve prosthesis. Healthcare Professionals Even a simple procedure like cleaning your teeth can dislodge bacteria that could find their way to your heart valve and cause an infection. You may need other medications, depending on your overall health and the particular nature of your valve disease. (1998). Advancing the Technology of Bileaflet Mechanical Heart Valves: Springer Verlag; 1998:53-71. The ATS valve sizers provided for the ATS 3fAortic Bioprosthesis are used to measure the internal diameters of the patient's aortic annulus and sinotubularjunction. J Thorac Cardiovasc Surg. The paper refers to the safety of MRI in patients with prosthetic heart valves or coronary stents. A larger graft internal diameter minimizes stress on coronary anastomosis, and the rotatable valve allows for optimal leaflet positioning. Broadly, they can be classified into three categories: mechanical heart valves, bioprosthetic valves, and homograft. Shellock R & D Services, Inc. email: [email protected]. 3: . Update my browser now. Update my browser now. On-X aortic and mitral prosthetic valves are FDA approved and have been safely implanted in approximately 200,000 patients worldwide. We present an overview of the possibilities and pitfalls of CT and MRI for PHV assessment based on a systematic literature review of all experimental and patient studies. heart valve ATS Medical Minneapolis, M. 1.5: Conditional 5 More. Central/Eastern Europe, Middle East & Africa, Supra-annular flanged cuff configuration for added flexibility, needle penetration, and conformability, Valve sizes ranging from 16 mm to 26 mm for aortic valve replacement, Supra-annular compact cuff configuration for excellent suturability and conformability, Valve sizes ranging from 16 mm to 26 mm for aortic and mitral valve replacement, Intra-annular valve with generous, compliant cuff for exceptional implantability, Medtronic Open Pivot Sizer Kit includes AP Series and Standard Heart Valve sizers, a bendable holder handle, and a sterilization tray, Mitral Hex End Rotators and Holder provide additional length and flexibility when needed for rotation of mitral valves. [Usefulness of magnetic resonance imaging for managing patients with prosthetic carbon valve in the mitral position]. All replacement heart valves are completely safe with x-ray exams. The aortic valve tissue. Is it safe to have a magnetic resonance imaging (MRI) scan after heart valve replacement? Surgical Heart Valve Repair and Replacement Ann Thorac Cardiovasc Surg. (eds) Advancing the Technology of Bileaflet Mechanical Heart Valves. Careers. Emery RW, Petersen RJ, Kersten TE, et al. Training, education, and collaboration on the treatment of mitral and tricuspid valve disease. Ask whether you should take antibiotics before surgical or dental procedures to help prevent valve infections. Cardiac computed tomography (CT) and magnetic resonance imaging (MRI) have emerged as new potential imaging modalities for valve prostheses. All replacement heart valves are completely safe with x-ray exams. MeSH Cocchia R, Chianese S, Lombardi G, Romano L, Capone V, Amitrano L, Bennato R, Ranieri B, Russo G, Mauro C, Bossone E. Clin Pract. Provided by the Springer Nature SharedIt content-sharing initiative, Over 10 million scientific documents at your fingertips. It has a low profile bi-leaflet valve with a polyester sewing ring. Before This site needs JavaScript to work properly. % Kelly SG, Verdonck PR, Vierendeels JA, Riemslagh K, Dick E, Van Nooten GG. Chen CW, Tseng YH, Lin CC, Kao CC, Wong MY, Ting H, Huang YK. Circ Cardiovasc Imaging. Important Safety Information - Transcatheter Aortic Valve Replacement (TAVR) | Medtronic Your browser is out of date With an updated browser, you will have a better Medtronic website experience. November 1999;22(11):754-763. Federal government websites often end in .gov or .mil. Safety and effectiveness of the Carbomedics valve has not been demonstrated for valve replacement in the pulmonic and tricuspid positions. The MRI examination must be performed using the following parameters: 1.5-Tesla or 3-Tesla, only Whole body averaged specific absorption rate (SAR) of 2-W/kg, operating in the Normal Operating Mode for the MR system Maximum imaging time, 15 minutes per pulse sequence (multiple sequences per patient are allowed) Learn more on the transportation safety administration website. Clinical results of the ATS prosthetic valve in 240 implants and review of the literature. This is an ATS Medical Demo Mitral Valve, model 500DM31, size 31 mm. The https:// ensures that you are connecting to the Your Medtronic heart valve products should not activate airport security alarms, depending on the sensitivity of the security system settings. Your condition will determine if you have to take blood-thinning (anticoagulant) medication. !f!9x~+i~P=_/rQGl7zkJz!e rYj*" ~pp1pn;jTn*M[*HI f,/Afd. Healthcare Professionals Advancing the Technology of Bileaflet Mechanical Heart Valves, https://doi.org/10.1007/978-3-642-93691-3_12, Tax calculation will be finalised during checkout. Multimodality Imaging Assessment of Prosthetic Heart Valves. Long-term follow up of patients undergoing reoperative surgery with aortic or mitral valve replacement using a St. Jude Medical prosthesis. Download preview PDF. official website and that any information you provide is encrypted The PubMed wordmark and PubMed logo are registered trademarks of the U.S. Department of Health and Human Services (HHS). Valve-related complications included: thromboembolism (linearized rate = 3.8% per patient year), of which 3/11 had chronic deficits (0.8% per patient year); thrombosis (1 MVR = 0.8% per patient year); paravalvular leak (1 AVR = 0.4% per patient year); anticoagulant-related hemorrhage (1 AVR and 5 MVR = 1.6% per patient year) with no patient mortality; prosthetic valve endocarditis (1 MVR = 0.8% per patient year); and valve dysfunction (0%).

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