Ten-year outcome with the sorin bicarbon and Baxter Mira bileaflet prostheses in the aortic position.
OBJECTIVE
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%); nonstructural 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.


CONCLUSIONS
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.
Vitale
Nicola
N
Department of Cardiac Surgery, Policlinico Hospital, University of Bari, Italy. Nicola_Vitale@lycos.co.uk
de Feo
Marisa
M
Renzulli
Attilio
A
Gregorio
Rosario
R
Cappabianca
Giangiuseppe
G
Onorati
Francesco
F
de Luca
Luigi
L
Schinosa
Tupputi
T
Cotrufo
Maurizio
M
D000368:Aged; D001021:Aortic Valve / Q000503:physiopathology / Q000601:surgery*; D015415:Biomarkers / Q000097:blood; D002423:Cause of Death; D018572:Disease-Free Survival; D004696:Endocarditis / Q000209:etiology / Q000401:mortality; D005260:Female; D005500:Follow-Up Studies; D006349:Heart Valve Diseases / Q000503:physiopathology / Q000601:surgery*; D006350:Heart Valve Prosthesis; D017052:Hospital Mortality; D006801:Humans; D019934:International Normalized Ratio; D007558:Italy; D008297:Male; D008875:Middle Aged; D011183:Postoperative Complications / Q000209:etiology / Q000401:mortality / Q000601:surgery; D019106:Postoperative Hemorrhage / Q000209:etiology / Q000401:mortality; D011474:Prosthesis Design; D016459:Prosthesis-Related Infections / Q000209:etiology / Q000401:mortality; D012086:Reoperation; D013923:Thromboembolism / Q000209:etiology / Q000401:mortality; D016896:Treatment Outcome
D015415:Biomarkers