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You are here: Contents > 2004 > Volume 13 Number 4 July 2004 > MECHANICAL PROSTHESES > Ten-Year Outcome with the Sorin Bicarbon and Baxter Mira Bileaflet Prostheses in the Aortic Position

Ten-Year Outcome with the Sorin Bicarbon and Baxter Mira Bileaflet Prostheses in the Aortic Position

Nicola Vitale, Marisa de Feo, Attilio Renzulli, Rosario Gregorio, Giangiuseppe Cappabianca, Francesco Onorati, Luigi de Luca, Tupputi Schinosa, Maurizio Cotrufo
Department of Cardiac Surgery, Policlinico Hospital, University of Bari, Department of Cardio-thoracic and Respiratory Sciences, Monaldi Hospital, Second University of Naples, Italy

Background and aim of the study: Sorin Bicarbon (SB) and Baxter Mira (BM) are almost identical bileaflet prostheses that share the same mechanical design, the only difference being in the sewing cuff. Hence, the long-term clinical performance of the two prostheses, when implanted in the aortic position, was evaluated in a combined population of patients.
Methods: Between January 1992 and December 2002, 714 patients (454 males, 260 females; mean age 60 ± 13 years) underwent single aortic valve replacement with SB (n = 392) or BM (n = 322) valves. Concomitant non-valve procedures were performed in 64 patients (9.5%). Follow up was 95.7% complete, with a mean of 3.1 ± 2.4 years.
Results: Operative mortality was 5.4% (39/714). Overall patient survival at five and 10 years was 89.3 ± 1.4% and 77.7 ± 4.3%, respectively; the linearized rate was 3.37% per pt-yr. Overall freedoms from complications at 10 years and valve group

freedoms at four years were: thromboembolism 92.9 ± 3.6% (SB 96.8 ± 1.2% versus BM 98.4 ± 0.8%); bleeding 94.5 ± 3.5% (SB 97.5 ± 1.1% versus BM 98.5 ± 0.5%); non-structural dysfunction 85.8 ± 7.5% (SB 97.1 ± 1.2% versus BM 99.3 ± 0.07%); endocarditis 98.0 ± 1.2% (SB 98.6 ± 0.9% versus BM 100%); reoperation 95.1 ± 3% (SB 98.6 ± 0.9% versus BM 100%). Neither structural dysfunction nor valve thrombosis were observed. At the end of follow up, 78.3% of survivors were in NYHA class I, 17.3% in class II, 3.6% in class III, and 0.8% in class IV.
Conclusion: Experience with Sorin Bicarbon and Baxter Mira valve prostheses shows that these valves, when implanted in the aortic position, provide a satisfactory clinical performance, with low complication rates.


The Journal of Heart Valve Disease 2004;13:632-637
Ten-Year Outcome with the Sorin Bicarbon and Baxter Mira Bileaflet Prostheses in the Aortic Position

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