Clinical event rates with the On-X bileaflet mechanical heart valve: a multicenter experience with follow-up to 12 years.

OBJECTIVE The aim of the study was to establish clinical event rates for the On-X bileaflet mechanical heart valve (On-X Life Technologies Inc, Austin, Tex) using an audit of data from the 3 centers within Europe with the longest history of implanting. METHODS All patients receiving the On-X valve between March 1, 1998, and June 30, 2009, at 3 European centers were studied. Data were collected using questionnaire and telephone surveys augmented by outpatient visits and examination of clinical records. RESULTS There were 691 patients, with a mean age of 60.3 years, who received 761 valves in total: 407 mitral valve replacements, 214 aortic valve replacements, and 70 aortic + mitral valve replacements (dual valve replacement). Total follow-up was 3595 patient-years, with a mean of 5.2 years (range, 0-12.6 years). Early (≤ 30 days) mortality was 5.4% (mitral valve replacement), 0.9% (aortic valve replacement), and 4.3% (dual valve replacement). Linearized late (>30 days) mortality expressed per patient-year was 3.6% (mitral valve replacement), 2.2% (aortic valve replacement), and 4.1% (dual valve replacement), of which valve-related mortality was 0.5% (mitral valve replacement), 0.2% (aortic valve replacement), and 1.8% (dual valve replacement). Late linearized thromboembolism rates were 1.0% (mitral valve replacement), 0.6% (aortic valve replacement), 1.8% (dual valve replacement). Bleeding rates were 1.0% (mitral valve replacement), 0.4% (aortic valve replacement), and 0.9% (dual valve replacement). Thrombosis rates were 0.1% (mitral valve replacement), 0% (aortic valve replacement), and 0.3% (dual valve replacement). Reoperation rates were 0.6% (mitral valve replacement), 0.2% (aortic valve replacement), and 1.2% (dual valve replacement). CONCLUSIONS The On-X valve has low adverse clinical event rates in longer-term follow-up (mean 5.2 years and maximum 12.6 years).

[1]  A. Haverich,et al.  Multicentered European study on safety and effectiveness of the On-X prosthetic heart valve: intermediate follow-up. , 2007, The Annals of thoracic surgery.

[2]  J. Chambers,et al.  Early postoperative echocardiographic hemodynamic performance of the On-X prosthetic heart valve: a multicenter study. , 1998, The Journal of heart valve disease.

[3]  M. Ozkan,et al.  Early clinical experience with the On-X prosthetic heart valve. , 2005, Interactive cardiovascular and thoracic surgery.

[4]  Thierry Bové,et al.  Fifteen years' single-center experience with the ATS bileaflet valve. , 2009, The Journal of heart valve disease.

[5]  T. Holland-Letz,et al.  Single-center experience with the On-X prosthetic heart valve between 1996 and 2005. , 2007, The Journal of heart valve disease.

[6]  Y. Ochiai,et al.  A 10-year experience with the Carbomedics cardiac prosthesis. , 2005, The Annals of thoracic surgery.

[7]  R. Emery,et al.  The St. Jude Medical cardiac valve prosthesis: a 25-year experience with single valve replacement. , 2005, The Annals of thoracic surgery.

[8]  J. Ely,et al.  Pure pyrolytic carbon: preparation and properties of a new material, On-X carbon for mechanical heart valve prostheses. , 1998, The Journal of heart valve disease.

[9]  M. Ruel,et al.  Influence of the On-X mechanical prosthesis on intermediate-term major thromboembolism and hemorrhage: a prospective multicenter study. , 2010, The Journal of thoracic and cardiovascular surgery.

[10]  J. Chambers,et al.  Doppler echocardiography in normally functioning replacement aortic valves: a review of 129 studies. , 2007, The Journal of heart valve disease.

[11]  E. Wolner,et al.  The On-X prosthetic heart valve at five years. , 2002, The Annals of thoracic surgery.

[12]  D Horstkotte,et al.  Results with mechanical cardiac valvular prostheses. , 1996, The Annals of thoracic surgery.

[13]  J. Toole,et al.  Twenty-five year experience with the St. Jude medical mechanical valve prosthesis. , 2010, The Annals of thoracic surgery.

[14]  Philippe Ravaud,et al.  A prospective survey of patients with valvular heart disease in Europe: The Euro Heart Survey on Valvular Heart Disease. , 2003, European heart journal.

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

[16]  M. Mack,et al.  North American multicenter experience with the On-X prosthetic heart valve. , 2006, The Journal of heart valve disease.

[17]  M. Williams,et al.  The On-X heart valve: mid-term results in a poorly anticoagulated population. , 2006, The Journal of heart valve disease.

[18]  C. Akins,et al.  Results with mechanical cardiac valvular prostheses. , 1995, The Annals of thoracic surgery.

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

[20]  C. Kang,et al.  Long-term result of 1144 CarboMedics mechanical valve implantations. , 2005, The Annals of thoracic surgery.

[21]  Guidelines for reporting mortality and morbidity after cardiac valve interventions. , 2008, The Journal of thoracic and cardiovascular surgery.