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Background: A bioprosthetic valve is recommended for women of childbearing age who require cardiac valve replacement in order to minimize the risk of blood clot formation. However, it should be noted that compared to mechanical valves, bioprosthetic valves have a shorter lifespan and a higher likelihood of requiring reoperation during follow-up. To assess the long-term postoperative results, including the incidence of structural valve deterioration (SVD) and other clinical outcomes, in female patients aged 50 years and younger who underwent BalMedic bovine pericardial bioprosthetic valve replacement, a multicenter retrospective study was implemented in China. Methods: Between 2004 and 2015, a cohort of 86 female patients across three medical centers underwent the implantation of 97 bioprosthetic valves. The primary outcome measure was overall survival (OS), while the secondary outcome measures were preliminary evidence of reoperation, SVD incidence, and bioprosthetic valve-related complications. Results: In this cohort study, 21 patients (24.4%, 21/86) died, while 37 patients (43.0%, 37/86) underwent a second valve replacement. The OS rates at 5 and 10 years were 97.56% and 71.93%, respectively. Additionally, the reoperation-free rates at 5 and 10 years were 92.83% and 80.68%, respectively. Similarly, the rates of freedom from SVD at 5 and 10 years were 95.65% and 51.82%, respectively, and the average duration of bioprosthetic valve replacement in our study was 9.34±3.31 years. Conclusions: Despite the recruitment of younger female patients of child-bearing age in our cohort, the OS, reoperation-free survival, and SVD-free rates of the BalMedic bovine pericardial bioprosthetic valve were not inferior to those of the other age groups in the study or those reported in the literature.
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BACKGROUND: In China, where Rheumatic heart disease is still prevalent, two thirds of valve replacements are in mitral position. Before a valve replacement operation is conducted, most patients have reached Class III/IV heart function under the New York Heart Association (NYHA) classification system. As the background to this disease is quite different to that of degenerated cases, which are more prevalent in Western countries, the development of an artificial heart valve that is suitable for local patients is very significant for China. In this medium long-term clinical follow-up study, a data analysis was conducted of domestic heart valve production for mitral replacement. METHODS: A total of 288 patients who underwent mitral valve replacements from 2005 to 2015 at 2 cardiac surgery centres (i.e., The Affiliated Hospital of Qingdao University, and The First People's Hospital of Yulin) were evaluated. All implanted bioprostheses were BalMedic® bovine pericardial bioprosthetic valves, which had been granted marketing approval by the China Food and Drug Administration (CFDA) in 2003. Double valve cases that involved both aortic and mitral replacements were not included in the study. On average, patients were aged 54.5±10.8 (range, 11 to 77 years) before the procedure. The mean follow-up period was 7.2±2.6 years. The study examined the overall survival (OS) curve, and different age group results. To gain further insights into the functions of the valves, the OS curve and the age group results for the reoperation-free and structural valve deterioration (SVD)-free rates are also presented. RESULTS: The 10-year OS rate was 65.6%, the 10-year reoperation-free rate was 76.3%, and the 10-year SVD-free rate was 58.0%. In relation to the age group results, younger patients had higher survival rates, while older patients had higher reoperation-free rates and SVD-free rates. CONCLUSIONS: In relation to the medium long-term clinical follow-up results, the durability performance of the BalMedic® bovine pericardial valve in the mitral position was satisfactory, especially among patients whose heart function was worse than that of Western sufferers. Survival rate, reoperation-free rate and SVD-free rate were used for the comprehensive analysis.
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BACKGROUND: The causes of valvular disease in China are complex, with a broad age distribution. For patients with early mechanical valve replacement, the quality of life is affected by postoperative anticoagulation-related complications. Since 2005, we have used bioprosthetic valves to provide more options for patients. In this study, we retrospectively analyzed the 14-year follow-up data of patients undergoing BalMedic bovine pericardial bioprosthetic valve replacement (manufacturer: Beijing Balance Medical Tech Co., Ltd.) to evaluate its intermediate- to long-term clinical effectiveness. METHODS: From 2005 to 2014, 336 BalMedic pericardial bioprosthesis valves were implanted in 299 patients (mean age 53.5 years, 59.86% female) at The First People's Hospital of Yulin. Among followed up 290 discharged patients, 284 underwent aortic valve replacement and mitral valve replacement (AVR group, MVR group) for further grouping analysis, 6 underwent tricuspid valve replacement (TVR). The mean follow-up was 7.7±2.5 years (5 to 14), for a total of 2,196 valve-years, 98.28% of the patients completed follow-up. RESULTS: The perioperative mortality was 3% (9/299). After discharge, 68 patients (23.4%, 68/290) died, and 36 (12.4% 36/290) underwent the second valve replacement. The overall 5- and 10-year survival rates were 89.95% and 72.53%, respectively. For patients undergoing AVR alone, the overall 10-year survival rates were 80.64%, the reoperation-free rates were 92.94%, and the SVD-free rates were 90.95%. For patients undergoing MVR and double valve replacement (DVR group), the 10-year survival rates were 67.21% and 82.90%, the reoperation-free rates were 72.26% and 73.33%, the SVD-free rates were 58.90% and 53.80%, respectively. Subgroup analysis by age showed no significant intergroup difference in overall survival but a significant intergroup difference in reoperation-free and SVD-free rates (P<0.05). CONCLUSIONS: With a similar 10-year overall survival rate as its foreign counterparts, BalMedic bovine pericardial bioprosthesis is reliable choice for both aortic valve and mitral valve. In patients undergoing AVR, the BalMedic valve is superior to the similar foreign counterparts in overall survival, reoperation-free survival, and SVD-free rates. While in MVR or DVR, Chinese patients are younger because of different etiology, postoperative outcomes show non-inferior to those from the foreign counterparts.
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BACKGROUND: To maximize the preservation of functional pulmonary parenchyma and improve the quality of life of patients with centrally located lung cancer, trachea-bronchoplasty has been used in clinical application with good efficacy. The aim of this study is to explore the appropriate admission and management of trachea-bronchoplasty and prevent complications of trachea-bronchial sleeve resection in the treatment of centrally located lung cancer. METHODS: Seventy-six patients with central lung cancer, who were treated with trachea-bronchoplasty from June, 1988 to October, 2004, were analyzed. There were 49 cases of squamous cell carcinoma, 16 adenocarcinoma, 7 adenosquamous carcinoma, 3 small cell lung cancer and 1 adenoid cystic adenocarcinoma. Seventeen patients were in stage I, 39 in stage II, 17 in stage IIIA and 3 in stage IIIB. There were 55 cases of sleeve lobectomy, 12 lobectomy with wedge resection of the main bronchus, 8 big arc resection of superior lobar bronchus-main trachea-lateral wall of trachea, 1 resection of right upper lobe-right main bronchus-carina-lateral trachea and carinal reconstruction. RESULTS: Postoperative complications happened in 7 patients. Pneumonia and atelectasis occurred in 6 cases, in which 1 died of heart and respiratory failure. Another one died of haemorrhage of upside alimentary canal. Seventy-one patients were followed up (93.4%). The 1-, 3-, 5-year survival rate was 82.4% (56/68), 57.8% (26/45) and 41.7% (15/36) respectively. CONCLUSIONS: The trachea-bronchoplasty can not only preserve functional pulmonary parenchyma as much as possible and improve the quality of life of patients, but also provide an operative opportunity to those patients with poor pulmonary function in the treatment of centrally located lung cancer.