Risk-corrected impact of mechanical versus bioprosthetic valves on long-term mortality after aortic valve replacement.

OBJECTIVE Choice of a mechanical or biologic valve in aortic valve replacement remains controversial and rotates around different complications with different time-related incidence rates. Because serious complications will always "spill over" into mortality, our aim was to perform a meta-analysis on overall mortality after aortic valve replacement from series with a maximum follow-up of at least 10 years to determine the age- and risk factor-corrected impact of currently available mechanical versus stented bioprosthetic valves. METHODS Following a formal study protocol, we performed a dedicated literature search of publications during 1989 to 2004 and included articles on adult aortic valve replacement with a mechanical or stented bioprosthetic valve if age, mortality statistics, and prevalences of well-known risk factors could be extracted. We used standard and robust regression analyses of the case series data with valve type as a fixed variable. RESULTS We could include 32 articles with 15 mechanical and 23 biologic valve series totaling 17,439 patients and 101,819 patient-years. The mechanical and biologic valve series differed in regard to mean age (58 vs 69 years), mean follow-up (6.4 vs 5.3 years), coronary artery bypass grafting (16% vs 34%), endocarditis (7% vs 2%), and overall death rate (3.99 vs 6.33 %/patient-year). Mean age of the valve series was directly related to death rate with no interaction with valve type. Death rate corrected for age, New York Heart Association classes III and IV, aortic regurgitation, and coronary artery bypass grafting left valve type with no effect. Included articles that abided by current guidelines and compared a mechanical and biologic valve found no differences in rates of thromboembolism. CONCLUSION There was no difference in risk factor-corrected overall death rate between mechanical or bioprosthetic aortic valves irrespective of age. Choice of prosthetic valve should therefore not be rigorously based on age alone. Risk of bioprosthetic valve degeneration in young and middle-aged patients and in the elderly and old with a long life expectancy would be an important factor because risk of stroke may primarily be related to patient factors.

[1]  J. Glatz,et al.  Home management of anticoagulation , 2001 .

[2]  F. Dagenais,et al.  Which biologic valve should we select for the 45- to 65-year-old age group requiring aortic valve replacement? , 2005, The Journal of thoracic and cardiovascular surgery.

[3]  M. Knudsen,et al.  Valve replacement for calcified aortic stenosis in septuagenarians infers normal life-length. , 1991, Scandinavian journal of thoracic and cardiovascular surgery.

[4]  G F Tyers,et al.  The Carpentier-Edwards standard porcine bioprosthesis. A first-generation tissue valve with excellent long-term clinical performance. , 1990, The Journal of thoracic and cardiovascular surgery.

[5]  G. Grunkemeier,et al.  Twenty years' experience with the Medtronic Hall valve. , 2001, The Journal of thoracic and cardiovascular surgery.

[6]  C. Mullany,et al.  Risk of thromboembolism with the aortic Carpentier-Edwards bioprosthesis. , 1995, The Annals of thoracic surgery.

[7]  J. Lowe,et al.  Long-term outcome after biologic versus mechanical aortic valve replacement in 841 patients. , 1999, The Journal of thoracic and cardiovascular surgery.

[8]  S. Gutnikov,et al.  Change in stroke incidence, mortality, case-fatality, severity, and risk factors in Oxfordshire, UK from 1981 to 2004 (Oxford Vascular Study) , 2004, The Lancet.

[9]  I. Olkin,et al.  Meta-analysis of observational studies in epidemiology - A proposal for reporting , 2000 .

[10]  D C Naftel,et al.  Long-term performance of heart valve prostheses. , 2000, Current problems in cardiology.

[11]  A. Prat,et al.  Ten-year echocardiographic and clinical follow-up of aortic Carpentier-Edwards pericardial and supraannular prosthesis: a case-match study. , 2002, The Annals of thoracic surgery.

[12]  D J Wheatley,et al.  Twelve-year comparison of a Bjork-Shiley mechanical heart valve with porcine bioprostheses. , 1991, The New England journal of medicine.

[13]  D J Wheatley,et al.  Twenty year comparison of a Bjork-Shiley mechanical heart valve with porcine bioprostheses , 2003, Heart.

[14]  B. Iung,et al.  AREVA: multicenter randomized comparison of low-dose versus standard-dose anticoagulation in patients with mechanical prosthetic heart valves. , 1996, Circulation.

[15]  G. van Melle,et al.  St. Jude Medical valve prosthesis: an analysis of long-term outcome and prognostic factors. , 1997, The Journal of thoracic and cardiovascular surgery.

[16]  S. Armstrong,et al.  Prosthesis-Patient Mismatch Affects Survival After Aortic Valve Replacement , 2000, Circulation.

[17]  Y. Okita,et al.  Elephant trunk procedure for surgical treatment of aortic dissection. , 1998, The Annals of thoracic surgery.

[18]  I. Aleksic,et al.  Mechanical versus biological isolated aortic valvular replacement after the age of 70: equivalent long-term results. , 1998, European journal of cardio-thoracic surgery : official journal of the European Association for Cardio-thoracic Surgery.

[19]  J. Matloff,et al.  The St. Jude Medical valve. Experience with 1,000 cases. , 1994, The Journal of thoracic and cardiovascular surgery.

[20]  J. M. Bernal,et al.  Durability of the Carpentier-Edwards porcine bioprosthesis: role of age and valve position. , 1995, The Annals of thoracic surgery.

[21]  F. Spinale,et al.  3,5,3' Triiodo-L-thyronine pretreatment with cardioplegic arrest and chronic left ventricular dysfunction. , 1995, The Annals of thoracic surgery.

[22]  M. Endo,et al.  Twelve years' experience with the St. Jude Medical valve prosthesis. , 1994, The Annals of thoracic surgery.

[23]  J. Birkmeyer,et al.  Prosthetic valve type for patients undergoing aortic valve replacement: a decision analysis. , 2000, The Annals of thoracic surgery.

[24]  A. Leguerrier,et al.  Aortic Carpentier-Edwards supraannular porcine bioprosthesis: a 12-year experience. , 1999, The Annals of thoracic surgery.

[25]  Julian A. Smith,et al.  Excellent Long‐term Results of Cardiac Valve Replacement With the St Jude Medical Valve Prosthesis , 1993, Circulation.

[26]  W G Henderson,et al.  Outcomes 15 years after valve replacement with a mechanical versus a bioprosthetic valve: final report of the Veterans Affairs randomized trial. , 2000, Journal of the American College of Cardiology.

[27]  A. de la Fuente,et al.  Intact Medtronic and Carpentier Edwards S.A.V.: Clinical and Hemodynamic Outcomes over 13 Years , 2003, Cardiovascular surgery.

[28]  G. Rábago,et al.  Eighteen-year follow up after Hancock II bioprosthesis insertion. , 2000, The Journal of heart valve disease.

[29]  Vittorio Pengo,et al.  Bleeding complications of oral anticoagulant treatment: an inception-cohort, prospective collaborative study (ISCOAT) , 1996, The Lancet.

[30]  L. Cohn,et al.  Twenty-year follow-up of the Hancock modified orifice porcine aortic valve. , 1998, The Annals of thoracic surgery.

[31]  M. De Carlo,et al.  Valve-related complications in elderly patients with biological and mechanical aortic valves. , 1998, The Annals of thoracic surgery.

[32]  D. Loisance,et al.  Lack of durability of the Mitroflow valve does not affect survival. , 1999, The Journal of heart valve disease.

[33]  F. R. Rosendaal,et al.  Thromboembolic and Bleeding Complications in Patients With Mechanical Heart Valve Prostheses , 1994, Circulation.

[34]  S. Aoyagi,et al.  Long-term results of valve replacement with the St. Jude Medical valve. , 1994, The Journal of thoracic and cardiovascular surgery.

[35]  K. Nakashima,et al.  The risk of reoperative heart valve procedures in Octogenarian patients. , 2004, The Journal of heart valve disease.

[36]  N G Smedira,et al.  Long-term results of the Carpentier-Edwards pericardial aortic valve: a 12-year follow-up. , 1998, The Annals of thoracic surgery.

[37]  David Moher,et al.  Meta-analysis of Observational Studies in Epidemiology , 2000 .

[38]  R. Emery,et al.  Ten years' experience with the St. Jude Medical valve prosthesis. , 1989, The Annals of thoracic surgery.

[39]  F. Wuyts,et al.  Risk factors for congestive heart failure after aortic valve replacement with a Carpentier-Edwards pericardial prosthesis in the elderly. , 2005, The Journal of heart valve disease.

[40]  H. Boudoulas,et al.  Left atrial volumes, function and work before and after mitral valve repair in chronic mitral regurgitation. , 2004, The Journal of heart valve disease.

[41]  F. Wuyts,et al.  Risk factors and survival after aortic valve replacement in octogenarians. , 2004, The Journal of heart valve disease.

[42]  G. Grunkemeier,et al.  "Our complication rates are lower than theirs": statistical critique of heart valve comparisons. , 2003, The Journal of thoracic and cardiovascular surgery.

[43]  M. Marchand,et al.  The last generation of pericardial valves in the aortic position: ten-year follow-up in 589 patients. , 1996, The Annals of thoracic surgery.

[44]  M. Cotrufo,et al.  Tilting-disc versus bileaflet mechanical prostheses in the aortic position: a multicenter evaluation. , 2004, The Journal of heart valve disease.

[45]  E W Steyerberg,et al.  Comparison of outcomes after aortic valve replacement with a mechanical valve or a bioprosthesis using microsimulation , 2004, Heart.

[46]  L. Cohn,et al.  Guidelines for reporting morbidity and mortality after cardiac valvular operations. , 1996, European journal of cardio-thoracic surgery : official journal of the European Association for Cardio-thoracic Surgery.

[47]  R. Gibbons,et al.  ACC/AHA Guidelines for the Management of Patients With Valvular Heart Disease. Executive Summary. 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). , 1998, The Journal of heart valve disease.

[48]  F. Crawford,et al.  Twenty-year experience with the St Jude Medical mechanical valve prosthesis. , 2003, The Journal of thoracic and cardiovascular surgery.

[49]  O. Bech-Hanssen,et al.  Influence of aortic valve replacement, prosthesis type, and size on functional outcome and ventricular mass in patients with aortic stenosis. , 1999, The Journal of thoracic and cardiovascular surgery.

[50]  M. Knudsen,et al.  The potential for normal long term survival and morbidity rates after valve replacement for aortic stenosis. , 1996, The Journal of heart valve disease.

[51]  D. Levy,et al.  Survival After the Onset of Congestive Heart Failure in Framingham Heart Study Subjects , 1993, Circulation.

[52]  D. Wheatley The 'threshold age' in choosing biological versus mechanical prostheses in western countries. , 2004, The Journal of heart valve disease.

[53]  O. Lund,et al.  Standard aortic St. Jude valve at 18 years: performance profile and determinants of outcome. , 2000, The Annals of thoracic surgery.

[54]  Anders Odén,et al.  Oral anticoagulation and risk of death: a medical record linkage study , 2002, BMJ : British Medical Journal.

[55]  J. Wada St. Jude Medical valve prosthesis. , 1981, The Journal of thoracic and cardiovascular surgery.

[56]  G. Vlahakes,et al.  Results of bioprosthetic versus mechanical aortic valve replacement performed with concomitant coronary artery bypass grafting. , 2002, The Annals of thoracic surgery.

[57]  A. Carpentier,et al.  Carpentier-Edwards pericardial bioprosthesis in aortic position: long-term follow-up 1980 to 1994. , 1995, The Annals of thoracic surgery.

[58]  F Clerc,et al.  Long-term results of valve replacement with the St. Jude Medical prosthesis. , 1995, The Journal of thoracic and cardiovascular surgery.

[59]  L. Pa,et al.  Arterial risk factors and ischemic cerebrovascular events after aortic valve replacement. , 1995 .

[60]  Susan Armstrong,et al.  Late hemodynamic and clinical outcomes of aortic valve replacement with the Carpentier-Edwards Perimount pericardial bioprosthesis. , 2002, The Journal of thoracic and cardiovascular surgery.

[61]  F. Gueyffier,et al.  Comparison of bioprosthesis and mechanical valves, a meta-analysis of randomised clinical trials. , 2000, Cardiovascular surgery.

[62]  N. Birkmeyer,et al.  Prosthesis size and long-term survival after aortic valve replacement. , 2003, The Journal of thoracic and cardiovascular surgery.

[63]  S. Armstrong,et al.  Late results of heart valve replacement with the Hancock II bioprosthesis. , 2001, The Journal of thoracic and cardiovascular surgery.

[64]  A. Khaghani,et al.  Primary aortic valve replacement with allografts over twenty-five years: valve-related and procedure-related determinants of outcome. , 1999, The Journal of thoracic and cardiovascular surgery.