Background: Compared to the Western countries, Chinese patients present a special primary disease spectrum, diverse valvular pathogenesis, and different postoperational anticoagulation strategy. This research aimed to evaluate the mid- to long-term clinical performance of Hancock II bioprosthesis in the Chinese population.
Methods: This study retrospectively reviewed all patients who received surgical treatments with at least one Hancock II bioprosthesis implantation from January 2004 to December 2013 at a single center in China. Totally 647 patients were included in the clinical evaluation, and 629 patients were successfully discharge, among whom 605 patients were completely followed-up. The follow-up rate was 96.2%. The mean and median follow-up time was 62.0 ± 59.0 and 56.0 months, respectively. Postoperative outcomes of survival rates, reoperations and valve related morbidities were assessed. Continuous and categorical variables were compared using the t -test and Chi-square test, respectively. Survival and freedom from adverse events were calculated by using a Kaplan-Meier method.
Results: The overall in-hospital mortality was 2.8% (18/647) while there were 34 deaths (5.6%, 34/605) in the follow-up stage after discharge. The overall survival rate was 94.6% and 82.7% at 5 years and 10 years, respectively. The cumulative survival rate of 10 years was 82.8% in AVR group, 84.4% in MVR group, and 78.4% in DVR group. The overall rate of freedom from reoperations was 95.5% at 5 years and 86.8% at 10 years. The freedom from reoperation at 10 years was 87.0%, 88.1%, and 84.0% in AVR, MVR, and DVR group, respectively. The freedom from morbidities at 10 years was: 90.3% for thromboembolism, 95.2% for hemorrhage, 97.5% for prosthesis endocarditis, 95.9% for paravalvular leak, and 94.6% for structural valve deterioration, respectively.
Conclusions: Hancock II bioprosthesis exhibited a satisfactory mid- to long-term durability and promising clinical performance in the Chinese population. The occurrence rates of death and other adverse events in this single-center study were overall coincident and quite acceptable when compared with existing data.