Objective To study and test novel hybrid valves in vitro and in vivo, and provide basis for clinical use in future. Methods The hybrid valves were fabricated from decellularized porcine aortic valves coated with poly (3-hydroxybutyrate-co-3hydroxyhexanoate, PHBHHx).（1）In the mechanical test in vitro, the uniaxial tensile biomechanics test of the fresh (n=12), uncoated (n=12) and hybrid valve leaflets (n=12) were investigated. (2）In study in vivo, hybrid valves(n=5) implanted in pulmonary position in sheep without cardiopulmonary bypass. Uncoated grafts (n=5) used as control. The specimens of the hybrid or uncoated valve in sheep were explanted and examined by scanning electron microscopy, histology, calcium content and immunofluorescence staining 18 weeks after surgery. Results The mechanical test in vitro revealed that coating with PHBHHx increased maximal tensile strength of hybrid valves compared with the fresh and uncoated state (P＜0.05). The results in vivo indicated the hybrid valves maintained original shape and softness. Immunofluorescence staining for CD31 confirmed that the surface of hybrid valve was covered by confluent CD31+ cells.The interstitium of hybrid valve indicated that smooth muscle actin (SMA)+ cells population were similar to native valvular tissue. The calcium content of hybrid valve was significantly lower than that of uncoated valve leaflets (P＜0.05). Conclusion Decellularized porcine aortic valves coated with PHBHHx have good biological and biomechanical characteristics. The hybrid valve may provide superior valve replacement with current techniques.
Objective To summarize clinical characteristics and treatment results of adult patients with coronary heart disease and ventricular aneurysm，and evaluate surgical outcomes. Methods Clinical data of 86 adult patients with coronary heart disease and ventricular aneurysm who underwent surgical treatment in Fu Wai Hospital from January 2011 to November 2012 were retrospectively analyzed. There were 70 male and 16 female patients with their average age of 57.7±10.6 years and average body weight of 71.7±10.5 kg. Preoperative echocardiography or left ventriculography showed left ventricular thrombus in 22 patients. Coronary angiography showed 47 patients with 3 vessel disease，29 patientswith 2 vessel disease，and 10 patients with single vessel disease. Sixteen patients underwent direct linear suturing of theaneurysm off pump，39 patients underwent simple linear suturing under cardiopulmonary bypass，15 patients received endoventricular purse-string reconstruction，and 16 patients received endoventricular purse-string reconstruction and patch plasty. Three patients underwent reexploration for bleeding. Sixty-four patients received concomitant coronary artery bypass grafting（CABG）. Results Postoperatively 2 patients（2.3%） died of refractory ventricular fibrillation and multiple organ dysfunction syndrome respectively. Patients undergoing concomitant CABG received 2.3±1.2 grafts on the average. Seventy-eightpatients （92.9%） were followed up for 2-24 months after discharge. During follow-up，patients’ angina symptoms significantlyresolved，heart function improved in varying degrees，and no new sign of myocardial ischemia was found on electrocardiogram.Left ventricular ejection fraction （LVEF） was significantly higher than preoperative LVEF（51%±7% vs. 41%±9% ，t=6.20，P=0.00），and left ventricular end-diastolic diameter （LVEDD） was significantly smaller than preoperative LVEDD （54.2±6.2 mm vs. 56.0±6.8 mm，t=4.60，P=0.00） . Conclusion Ventricular aneurysm repair and concomitant CABG （or ventricular septal perforation repair，mitral valvuloplasty et al） are positive and effective treatment strategies for postinfarction ventricular aneurysm. Satisfactory clinical outcomes can be achieved by individualized treatment based on appropriate surgical strategies according to the size of ventricular aneurysm.
ObjectiveTo analyze the characteristics and reporting quality of the registered health Qigong-related clinical trials, and to analyze the progress and shortcomings of health Qigong-related clinical trials.MethodsChinese Clinical Trial Registry (ChiCTR) and ClinicalTrials.gov were electronically searched to collect the health Qigong-related clinical trials from inception to October 15st, 2020. Characteristics of trials were analyzed in the aspects of basic information, funding source, study content and more. The quality of registration was evaluated by WHO Trial Registration Data Set (TRDS).ResultsA total of 121 registered clinical trials were included. The annual registration quantity has been increasing with a peak (33.06%) reached in 2020. Among the registered trials, Baduanjin exercise- related studies accounted for the highest proportion (65.29%). The quantity of studies registered in Shanghai accounted for the most (29.75%). The largest contribution of registered trials was from Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine (5.79%). 50.83% funds in trials were originated from universities and hospitals. Type 2 diabetes, and chronic obstructive pulmonary disease were the most studied diseases in the registered trials. 90.08% trials were designed as randomised parallel control studies, and the sample sizes of trials were concentrated between 30 and 100 (71.07%), and the age of the subjects was distributed over 40 years old (46.15%). The average quality of registration completion of the two registries was 87.44%.ConclusionsAt present, the general trend of health Qigong clinical research is positive. However, these trials contain unbalanced attributes such as the research type of health Qigong, distribution of registration area and organization, allocation of funds, and age composition of subjects. The design of clinical trials and registration details are needed to be improved.