ABSTRACT

As a rough guideline, mechanical prostheses offer better survival in patients <65 years old undergoing aortic valve replacement and patients <50 years old undergoing mitral valve repair. Older patients and

may be better served with a bioprosthesis (Bonow et al., 1998). An independent need for anticoagulation (e.g. atrial fibrillation) favors the use of a mechanical valve regardless of age. Ultimately, unique features of

prosthetic valves. Food and Drug Administration approved prosthetic heart valves are listed in Table 28. Examples of the more commonly used bioprosthetic valves are shown in 189-194. A variety

Company Device name Date approved Alliance Medical Monostrut cardiac valve prosthesis 1997 Technologies Inc. ATS Medical Centre ATS open pivot bileaflet heart valve 2000 Baxter Healthcare Corp. Starr-Edwards silastic ball heart valve prosthesis 1991 Carbomedics Inc. Carbomedics prosthetic heart valve 1993 Cutter Laboratories Inc. Heart valve prosthetic cooley-cutter 1977 Edwards Lifesciences LLC Carpentier-Edwards Perimount plus pericardial bioprosthesis 2000 Edwards Lifesciences LLC Edwards Prima Plus stentless bioprosthesis model 2500P 2001 Edwards Lifesciences LLC Carpentier-Edwards SAV bioprosthesis model 2650 (aortic) 2002 Edwards Lifesciences LLC Carpentier-Edwards Perimount magna pericardial bioprosthesis

model 3000 aortic 2003 Edwards Lifesciences LLC Carpentier-Edwards Perimount pericardial bioprosthesis 2001 Medical Carbon Research On-X® prosthetic heart valve model ONXA 2001 Instit. LLC Medical Inc. Omniscience prosthetic cardiac valve 1988 Medtronic Inc. Medtronic Hall prosthetic heart valve/Hall easy fit 2003 Medtronic Inc. Medtronic mosaic porcine bioprosthetic heart valve 2000 Medtronic Inc. Hall® easy-fit prosthetic heart valve 2001 Medtronic Inc. Medtronic Hall® prosthetic heart valve 1982 Medtronic Inc. Hancock II porcine bioprosthesis 1999 Medtronic Inc. Medtronic freestyle aortic root bioprosthesis 1997 St. Jude Medical Inc. St. Jude Medical regent mechanical heart valve (aortic) 2002 St. Jude Medical Inc. Toronto SPV valve 1997

FDA: Food and Drug Administration. (Table adapted from FDA website,April 2004.)

Table 28 FDA-approved prosthetic heart valves

192 Carpentier-Edwards SAV bioprosthesis for the mitral position. (Copyright Edwards Lifesciences LLC, printed with permission.)

193 Edwards Prima Plus® stentless bioprosthesis for the aortic position. (Copyright Edwards Lifesciences LLC, printed with permission.)

194 St. Jude Toronto stentless prosthetic valve. (Copyright St. Jude Medical Inc. 2004.This image is provided courtesy of St. Jude Medical Inc.All rights reserved.)

195 Starr-Edwards silastic ball valve for the aortic position. (Copyright Edwards Lifesciences LLC, printed with permission.)

196 Starr-Edwards silastic ball valve for the mitral position. (Copyright Edwards Lifesciences LLC, printed with permission.)

197 Edwards MIRA™ ultra finesse (only available outside the USA). (Copyright Edwards Lifesciences LLC, printed with permission.)

198 Medtronic Hall single tilting disk prosthesis seen from the side. (Copyright Medtronics Inc., printed with permission.)

199 Medtronic Hall single tilting disk prosthesis seen from above. (Copyright Medtronics Inc., printed with permission.)

200 Schematic diagram of Medtronic Hall single tilting disk prosthesis in the aortic root. (Copyright Medtronics Inc., printed with permission.)

201 SJM regent valve, a bileaflet tilting valve. (Copyright St. Jude Medical, Inc. 2004.This image is provided courtesy of St. Jude Medical, Inc.All rights reserved.)

Warfarin Warfarin Aspirin (INR 2.0-3.0) (INR 2.5-3.5) (80-100 mg)

Mechanical prosthetic valves First 3 months after replacement + + After first 3 months

Aortic valve† + + Aortic valve + ‘risk factor’* + + Mitral valve + + Mitral valve + ‘risk factor’* + +

Biological prosthetic valves First 3 months after replacement + + After first 3 months

Aortic valve + Aortic valve + ‘risk factor’* + + Mitral valve + Mitral valve + ‘risk factor’* + +

Note: Depending on patient’s clinical status, antithrombotic therapy must be individualized. * Risk factors: atrial fibrillation, left ventricular dysfunction, previous thromboembolism, and hypercoagulable condition. †INR should be maintained between 2.5 and 3.5 for aortic disk valves and Starr-Edwards valves. INR: international normalized ratio. (Adapted from McAnulty JH and Rahimtoola SH (1998).Antithrombotic therapy in valvular heart disease. In: Hurst’s The Heart,Arteries, and Veins, 9th edn. R Schlant, RW Alexander (eds). McGraw-Hill Publishing Co, New York, pp. 1867-1874.)

Table 29 Antithrombotic therapy with prosthetic heart valves

195-201.