Abstract
OBJECTIVE: From January 1, 1985 through December 31, 1994, one surgeon implanted cryopreserved valved homografts into 149 patients--65 since December 1988. This latter series (II) was accomplished in a single hospital, facilitating patient follow-up with biannual echocardiograms. Analysis of these 65 patients is the primary focus of this report; the indications and early surgical results for the two parts of the series (I and II) are compared to assess the evolution of a single surgeon's use of homografts in a mixed pediatric and adult practice. METHODS: Fifty-one variables for each patient (series II) were entered into a computerized database and analyzed (multivariate and univariate) using SPSS 6.1 software (Statistical Products and Service Solutions, Chicago, IL). Cox proportional hazard model was used to identify the independent contribution of each variable for patient mortality and homograft failure. Cumulative survival estimates were made using Kaplan-Meier analysis. Homograft failure was defined as requirement for replacement or death. In series I, there were 41 left ventricular outflow tract (LVOT) reconstructions (31 adult) and 43 right ventricular outflow tract (RVOT) reconstructions (42 pediatric). In series II, there were 55 RVOT reconstructions (52 pediatric) and 10 LVOT reconstructions (7 adult). RESULTS: There were no technical surgical failures. Total surgical mortality rate was 6% (5/84) in series I (3 LVOT, 2 RVOT) and 15% (10/65) in series II (2 LVOT, 8 RVOT) (I vs. II NS; p = 0.11, two-tailed Fisher exact test). By the Cox analysis, only age < 2 years (p < 0.03) and cross-clamp time > 120 minutes (p < 0.05) were significant predictors for death. Age-based survival curves were compared in a sequential bivariate analyses (log rank test) and age < 2 years again was a significant predictor of decreased patient survival (p < 0.006). Actuarial freedom from patient death or reoperation for homograft failure was 82% +/- 7% at 1000 days and 77% +/- 10% at 2000 days. Three patients required re-replacement for homograft failure (5.4%); one of these patients died. The only significant predictor of homograft failure was postoperative endocarditis (p < 0.05). Homograft performance was evaluated by an extensive echocardiography protocol: in surviving patients and homografts, three valved conduits were judged to have severely impaired performance (stenosis or regurgitation), awaiting surgical replacement for a putative total homograft-related structural failures rate of 11% at 5 1/2 years. CONCLUSIONS: Comparisons of series I and II shows, in one surgeon's practice, an evolution away from use of cryopreserved homografts for LVOT reconstructions except when needed for destructive bacterial endocarditis or complex congenital anatomy. Homograft efficacy and durability were similar in RVOT and LVOT positions, with 78.5% of patients surviving at 5 1/2 years; in surviving patients, 89% of homografts have continued to function well. Homografts are not immune to prosthetic bacterial endocarditis, and its occurrence is associated with accelerated deterioration. Cryopreserved homograft valves are an imperfect but satisfactory biological material for specific ventricular outflow reconstructions.