Background and aim of the study: The CarboMedics bileaflet prosthetic heart
valve was introduced in 1986, and first implanted by the authors in March
1991. The aim of this study was to analyze the authors' clinical experience
with this valve. Methods: Between March 1991 and October 1998, 1,503 valve
s were implanted in 1,350 patients (758 males, 592 female; mean age 62 +/-
13 years). Follow up was 99% complete and totaled 4,342 patient-years (pt-y
r).
Results: The hospital mortality rate was 4.3% (59/1,350). Preoperative NYHA
class (p = 0.012), emergency surgery (p = 0.03) and cardiopulmonary bypass
time (p = 0.01) were significantly associated with increased risk of opera
tive death (multiple logistic regression). Mean (It SEM) survival rates at
one and five years were 92.0 +/- 0.7% (n = 1,109) and 80.0 +/- 1.3% (n = 33
5). Freedom from valve-related complications (linearized rate 5.6%/pt-yr) a
t one and five years was 89.5 +/- 0.8% (n = 1,031) and 76.3 +/- 1.4% (n = 2
84). Linearized rates for bleeding events were 2.19%/pt-yr, thromboembolic
events 2%/pt-yr, operated valvular endocarditis 0.18%/pt-yr, valve thrombos
is 0.14%/ptyr and non-structural dysfunction 1.22%/pt-yr. Freedom from reop
eration at one and five years was 98.5 +/- 0.3% (n = 1,107) and 97.3 +/- 0.
5% (n = 334).
Conclusion: Mid-term results demonstrate that the CarboMedics prosthetic he
art valve exhibits a low incidence of valve-related complications.