The CarboMedics prosthetic heart valve: experience with 1,084 implants.
OBJECTIVE
The study aim was to evaluate our clinical experience with the CarboMedics heart valve prosthesis.


METHODS
Between October 1991 and December 2000, 942 consecutive patients (514 males, 428 females; mean age 58+/-11 years; range: 6-78 years) underwent mechanical valve implantation with the CarboMedics prosthesis. Preoperatively, 47% of patients were in NYHA class III and 22% in class IV; in addition, 134 patients (14.2%) had undergone a previous cardiac operation. Aortic valve replacement (AVR) was performed in 469 patients (49.8%), mitral valve replacement (MVR) in 330 (35.0%), double valve replacement (DVR) in 142 (15.1%), and isolated tricuspid valve replacement (TVR) in one patient. Eighty-eight patients (9.3%) underwent associated myocardial revascularization. Mean cardiopulmonary bypass and aortic cross-clamp times for the entire group were 107+/-39 min and 74+/-24 min, respectively.


RESULTS
Overall early mortality was 2.3% (6/469 AVR, 1.2%; 12/330 MVR, 3.6%; 4/142 DVR, 2.8%). Late mortality was 3.1% (n = 29; including 17 cardiac deaths (10 were valve-related). Mean follow up was 66+/-31 months (range: 1-109 months), and was 98% complete yielding a total follow up of 4959 years. Actuarial survival at five years for the entire group was 89.3+/-1.6% (AVR 91.1%, MVR 86.4%, DVR 90.5%). Thromboembolism occurred in 26 patients (2.8%, 0.52%/pt-year) and major hemorrhagic events in 20 (2.1%, 0.4%/pt-year). Nine patients (0.9%) required a reoperation, in three cases (0.3%) after Staphylococcus epidermidis-mediated endocarditis. No structural deterioration occurred. Among 891 survivors, 94% of the patients are currently in NYHA classes I or II (p <0.05).


CONCLUSIONS
This study confirmed the safety and reliability of the CarboMedics mechanical valve prosthesis, even in old age groups. This bileaflet prosthesis showed no structural deterioration, and a low incidence of overall complications.
Santini
Francesco
F
Divisions of Cardiac Surgery, University of Verona Medical School, Italy.
Casali
Gianluca
G
Viscardi
Francesca
F
Favaro
Alessandro
A
Luciani
Giovanni Battista
GB
Pentiricci
Samuele
S
Lusini
Mario
M
Rossi
Andrea
A
Mazzucco
Alessandro
A
D000293:Adolescent; D000328:Adult; D017677:Age Distribution; D000368:Aged; D002315:Cardiopulmonary Bypass; D002648:Child; D001026:Coronary Artery Bypass; D003327:Coronary Disease / Q000150:complications / Q000601:surgery; D005260:Female; D006349:Heart Valve Diseases / Q000150:complications / Q000601:surgery; D006350:Heart Valve Prosthesis; D006801:Humans; D008297:Male; D008875:Middle Aged; D011474:Prosthesis Design; D015203:Reproducibility of Results; D012189:Retrospective Studies; D016896:Treatment Outcome