| Objective: To retrospectively analyze the clinical data of patients after using BalMedic bovine pericardial artificial bioprosthesis and follow-up to obtain the mid-and long-term survival status,secondary valve replacement surgery,and valve-related complications after the use of BalMedic bovine pericardial artificial bioprosthesis.Prognostic factors,in which long-term clinical efficacy is evaluated,are intended to provide further guidance for patients after valve replacement.Methods: A retrospective analysis was performed on patients who had undergone valve replacement using BalMedic bovine pericardial artificial bioprostheses in cardiac surgery at the Affiliated Hospital of Qingdao University.Basic information such as gender,age,heart function,ejection fraction,and surgical methods were obtained from clinical data.Through the follow-up of patients discharged from the hospital,their survival status,secondary valve replacement surgery,and valve-related complications were obtained.According to the surgical approach,age,and ejection fraction,group comparisons were performed and the inter-group measurement data were compared using the t test.The count data were compared using the chi-square test and the Kaplan-Meier method was used for univariate survival analysis.According to the analysis results,the mid-term and long-term clinical efficacy of BalMedic bovine pericardial artificial bioprosthesis replacement was evaluated.Result: From June 2007 to March 2015,a total of 347 BalMedic bovine pericardial artificial bioprostheses were implanted in 264 patients in our hospital.According to the inclusion and exclusion criteria,a total of 260 patients were included in this clinical study.Of the 260 patients,152 were male(58.5%)and 108 were female(41.5%).The average age was 60.1±8.7(18-76),126(48.5%)were older than 60,and the ejection fraction was<50 % of the patients were 46(17.7%).There were 113 patients(43.5%)with mitral valve replacement and 66 patients(25.4%)with aortic valve replacement(including the diagnosis of "A type aortic dissection" with Bentall + total arch replacement + descending aortic stent implantation.Among the 4 patients who underwent surgery,81 patients(31.2%)had mitral valve and aortic valve replacement.Perioperative mortality was 17 and the perioperative mortality was 6.5%(17/260).243 patients were discharged from the hospital successfully and were lost to 9 patients.The outcomes of 234 patients were successfully followed up.The follow-up rate was 96.3%(234/243).The average follow-up time was 5.9±2.5 years,and the median follow-up time was 5.6 years,a total of1383.6 person-years.After follow-up,40 patients died in later stages(16.5%,40/243).Eight patients underwent secondary valve replacement.According to the univariate survival analysis results,patients with ejection fraction≥50% had higher overall survival rate than those with ejection fraction <50%(P<0.05).In the mitral valve replacement group,the 5-year and 10-year survival rates were 90.7% and 69.2%,respectively,and the rate of secondary valve replacement was 96.6% and 89.0%.Patients in the aortic valve replacement group were postoperative.The 5-year and 9-year survival rates were 93.8%and 53.5%.No valve replacement was performed in the patients.The survival rate of the patients in the double valve replacement group was 88.8% and 68.7% at 5 and 9 years after operation.The rate of secondary valve replacement surgery was 100.0% and 89.1%.After grouping the above three groups according to age,there was no significant difference between the young and elderly patients in the secondary valve replacement(P>0.05).In the mitral valve replacement group,no bleeding occurred;in the aortic valve replacement group,there was no valve leakage and structural valve damage.Conclusion: Preoperative ejection fraction <50% was significantly associated with death in the mid-and long-term.The clinical efficacy of the BalMedic bovine pericardial artificial bioprosthesis is generally satisfactory in the mid-to long-term.Good long-term clinical results of the BalMedic aotic valve have been demonstrated. |
