Background: Appraisal of the medium-term results of isolated aortic valve replacement with a CarboMedics mechanical prosthesis.
Methods: We assessed the clinical data of 195 consecutive patients (mean age 59.7+/-10.9 years) operated on between January 1992 and June 2000. Valve disease consisted of aortic stenosis regurgitation in 94 patients (48.2%), isolated aortic failure in 57 (29.2%) and isolated stenosis in 44 (22.6%). One hundred and four patients were in NYHA functional class III and 25 in NYHA functional class IV Follow-up was by telephone interview to 100% of the patients (average follow-up 39+/-20 months).
Results: The operative mortality was 3.6% (5% in the period January 1992-December 1995, 1.3% in the period January 1996-June 2000). Sixteen deaths occurred in the long term. Thus, the actuarial survivals at 36 and 72 months were 92+/-7% and 82+/-16% respectively. In the group of survivors, 139 patients (81%) were in NYHA class 1,26 (15%) in NYHA class II, and 7 (4%) in NYHA class III. The freedom from embolic events was 96+/-3.7% and that from hemorrhagic events was 90+/-9.4%. All the events occurred during the first 36 months; none of the patients developed infections or periprosthetic leaks.
Conclusions: At the medium term, the CarboMedics mechanical valve prosthesis appears to be reliable, with an actuarial survival, quality of life and incidence of morbidity comparable to those reported for other types of second-generation mechanical prostheses.