1.One-year outcomes of a novel domestic transcatheter aortic valve system in severe aortic stenosis: a multicenter cohort study
Yuehuan LI ; Jiawei ZHOU ; Lai WEI ; Yingqiang GUO ; Liang MA ; Huiming GUO ; Xiangbin PAN ; Dongjin WANG ; Fanyan LUO ; Jue WANG ; Minxin WEI ; Deguang FENG ; Yingbin XIAO ; Liming LIU ; Jian′an WANG ; Jiangang WANG ; Haibo ZHANG
Chinese Journal of Surgery 2025;63(11):1052-1058
Objective:To examine the safety and effectiveness of a novel domestic transcatheter aortic valve system in addressing severe aortic valve stenosis.Methods:This prospective, multicenter, single-arm target-value clinical trial enrolled patients with severe aortic stenosis meeting inclusion criteria from 13 Chinese centers between July 2021 and April 2022. The primary endpoint was all-cause mortality at 1-year post-procedure. Secondary endpoints included safety outcomes (30-day all-cause mortality, 1-year major adverse cardiovascular events, device success) and efficacy parameters (transvalvular pressure gradient, paravalvular leak severity, New York Heart Association(NYHA)class improvement, and quality of life). Survival analysis was performed using the Kaplan-Meier analysis.Results:The study included 134 patients, 85 males and 49 females, with an age of (73.6±5.6)years (range: 65.1 to 91.8 years). Bicuspid aortic valve morphology was present in 59.7% (80/134). Device success rate was 99.3%, with one case converted to open surgery due to coronary obstruction. All-cause mortality was 0.8% (95% CI: 0.1% to 5.3%) at both 30-day and 1-year follow-up, significantly lower than the 25% target value ( P<0.01). Permanent pacemaker implantation rates remained 2.2% (3/134) at both timepoints. Stroke incidence was 0.7% (1/134) at 30 days and 1.5% (2/134) at 1 year. Myocardial infarction rates were 0.7% (1/134) at both intervals. The postoperative transvalvular pressure gradient of the aortic valve was (6.6±3.1) mmHg(1 mmHg=0.133 kPa) (range: 4 to 8 mmHg). Among the patients, 32 cases (23.9%) had mild paravalvular leakage, 4 cases (3.0%) had moderate paravalvular leakage, and no severe paravalvular leakage was observed. NYHA class Ⅰ and Ⅱ patients increased from 18.7% preoperatively to 99.3% postoperatively. Conclusion:The novel domestic transcatheter aortic valve system demonstrates satisfactory 1-year safety and efficacy outcomes in treating severe aortic stenosis.
2.One-year outcomes of a novel domestic transcatheter aortic valve system in severe aortic stenosis: a multicenter cohort study
Yuehuan LI ; Jiawei ZHOU ; Lai WEI ; Yingqiang GUO ; Liang MA ; Huiming GUO ; Xiangbin PAN ; Dongjin WANG ; Fanyan LUO ; Jue WANG ; Minxin WEI ; Deguang FENG ; Yingbin XIAO ; Liming LIU ; Jian′an WANG ; Jiangang WANG ; Haibo ZHANG
Chinese Journal of Surgery 2025;63(11):1052-1058
Objective:To examine the safety and effectiveness of a novel domestic transcatheter aortic valve system in addressing severe aortic valve stenosis.Methods:This prospective, multicenter, single-arm target-value clinical trial enrolled patients with severe aortic stenosis meeting inclusion criteria from 13 Chinese centers between July 2021 and April 2022. The primary endpoint was all-cause mortality at 1-year post-procedure. Secondary endpoints included safety outcomes (30-day all-cause mortality, 1-year major adverse cardiovascular events, device success) and efficacy parameters (transvalvular pressure gradient, paravalvular leak severity, New York Heart Association(NYHA)class improvement, and quality of life). Survival analysis was performed using the Kaplan-Meier analysis.Results:The study included 134 patients, 85 males and 49 females, with an age of (73.6±5.6)years (range: 65.1 to 91.8 years). Bicuspid aortic valve morphology was present in 59.7% (80/134). Device success rate was 99.3%, with one case converted to open surgery due to coronary obstruction. All-cause mortality was 0.8% (95% CI: 0.1% to 5.3%) at both 30-day and 1-year follow-up, significantly lower than the 25% target value ( P<0.01). Permanent pacemaker implantation rates remained 2.2% (3/134) at both timepoints. Stroke incidence was 0.7% (1/134) at 30 days and 1.5% (2/134) at 1 year. Myocardial infarction rates were 0.7% (1/134) at both intervals. The postoperative transvalvular pressure gradient of the aortic valve was (6.6±3.1) mmHg(1 mmHg=0.133 kPa) (range: 4 to 8 mmHg). Among the patients, 32 cases (23.9%) had mild paravalvular leakage, 4 cases (3.0%) had moderate paravalvular leakage, and no severe paravalvular leakage was observed. NYHA class Ⅰ and Ⅱ patients increased from 18.7% preoperatively to 99.3% postoperatively. Conclusion:The novel domestic transcatheter aortic valve system demonstrates satisfactory 1-year safety and efficacy outcomes in treating severe aortic stenosis.
3.The risk factors of prognosis in the children patients with acute gastrointestinal dysfunction and ;prevention measures
Hong JIANG ; Dongjin FENG ; Feng ZHU ; Junhua CAO ; Qiuli YANG
Chinese Journal of Postgraduates of Medicine 2016;39(5):429-431
Objective To study the risk factors influencing the prognosis in the children patients with acute gastrointestinal dysfunction and to seek their therapeutic measures. Methods The clinical data of 125 cases patients with acute gastrointestinal dysfunction were retrospectively analyzed. The risk factors possibly influencing the prognosis were analyzed by multivariate statistical Logistic analysis. Results Among 125 children patients, 61 cases died, and the mortality rate was 48.8%. Logistic regression analysis indicated that poor circulation, cardiovascular system failure, hepatic failure, brain failure were significant risk factors of death associated with acute gastrointestinal dysfunction. (OR = 4.156, 3.330, 6.903, P<0.05 or<0.01). Conclusions Poor circulation, cardiovascular system failure, hepatic failure and brain failure are significant risk factors of death associated with acute gastrointestinal dysfunction.
4.Effects of bone marrow mesenchymal stem cell transplantation on CD4+CD25+regulatory T cells in rats with primary nephrotic syndrome
Huandan YANG ; Ruifeng ZHANG ; Dongjin FENG ; Bingbing ZHU ; Juan LV
Chinese Journal of Tissue Engineering Research 2014;(1):33-38
BACKGROUND:Decreased function and reduced number of CD4+CD25+regulatory T cells have been considered the major manifestation of immunity dysfunction in children with primary nephrotic syndrome. Bone marrow mesenchymal stem cells have immunoregulation effects, which up-regulate CD4+CD25+regulatory T cells, inhibit proliferation of lymphocytes, and have been widely used in many immune diseases.
OBJECTIVE:To investigate the effects of bone marrow mesenchymal stem celltransplantation on the CD4+CD25+regulatory T cells of peripheral blood in rats with primary nephrotic syndrome.
METHODS:Bone marrow mesenchymal stem cells from six Sprague-Dawley rats were isolated, passaged and utilized for cellsuspension preparation. At the third passage, bone marrow mesenchymal stem cells were used for transplantation. The remaining 30 rats were randomly and equal y divided into three groups:normal group, normal saline infusion group, and bone marrow mesenchymal stem cells group. The rat models of primary nephrotic syndrome were established by single injection of adriamycin intravenously through tail vein in the latter two groups. Rats were then treated with bone marrow mesenchymal stem cells (1×10 7 ) (bone marrow mesenchymal stem cells group) or normal saline (normal saline infusion group) through tail vein at the same time after adriamycin administration. The normal group received no treatment.
RESULTS AND CONCLUSION:Compared with the normal group, rats in the normal saline infusion group developed nephropathy characterized by ascites, proteinuria, hypoalbuminemia, hypercholastero-lnemia, and progressive renal injury. However, the proteinurine and clinical severity in bone marrow mesenchymal stem cells group were significantly ameliorated after treatment with bone marrow mesenchymal stem cells. CD4+CD25+Treg/CD4+Treg in the peripheral blood in the bone marrow mesenchymal stem cells group and normal saline infusion group were significantly higher than that in the normal group at 28 days after model establishment (P<0.05), while there was no significant difference between bone marrow mesenchymal stem cells group and normal saline infusion group (P>0.05). The expression of FoxP3 mRNA in the peripheral blood mononuclear cells of the bone marrow mesenchymal stem cells group was significantly higher than that in the normal saline infusion group and normal group (P<0.05). The bone marrow mesenchymal stem cells play a protective effect in rats with primary nephrotic syndrome, which may be related to the increase of local expression of FoxP3 and generation of CD4+CD25+Treg.
5.The clinical significance of four kinds of microalbuminuria detection in early diagnosis of iodinated contrast agent damage to kidney
Feng LI ; Xuebin XU ; Dongjin XU ; Weijuan ZHANG ; Qihu WANG ; Jiaolong WANG
Chinese Journal of Primary Medicine and Pharmacy 2013;20(21):3258-3260
Objective To analyze the clinical significance of four kinds of microalbuminuria detection in early diagnosis of iodinated contrast agent damage to kidney by studying four elements in the patients' urine:microalbumin (mAlb),immunoglobulin G (IgG),α1-microglobulin (α1-MG) and β2-microglobulin (β2-MG).Methods 106 patients who have received percutaneous coronary interventional therapy were chosen and divided into group A(angiography dose < 100ml,n =51) and group B (angiography dose ≥ 100ml,n =55) according to the amount of contrast agent used.Changes in the amount of mAlb,IgG,α1-MG and β2-MG levels,serum creatinine(Scr),endogenous creatinine clearance rate(eGFR) in the urine of the patients before and after the surgery were observed.Results Postoperative α1-MG and β2-MG levels in the urine of group A higher than before surgery (t =-6.748,-11.173,all P <0.0 5).2 4 hours after the surgery,mA1b,IgG,α1-MG and β2-MG levels in group B were elevated than before surgery,and the differences were significant(t =-6.223,-3.518,-11.532,-10.773,all P < 0.05).Two groups had significant differences in terms of mAlb,IgG,α1-MG and β2-MG levels after the surgery (F =27.306,4.704,5.118,19.011,all P < 0.05).Conclusion Four kinds of microalbuminuria detecting are conducive to early diagnosis of iodinated contrast agent damage to kidney and assessing the damage degree.The contrast agent damage to kidney first occurs as the renal tubular damage.When the contrast agent was used at a dosage of more than 100ml,glomerular damage occurred.
6.Occlusion of atrial septal defect utilizing occluder devise via minimally invasive right chest approach
Feng LI ; Wei LI ; Ning KANG ; Baosheng GONG ; Dongjin WU ; Fangjie XU ; Zhaokun QIU ; Weihua WU
Journal of Shanghai Jiaotong University(Medical Science) 2011;31(3):343-345
Objective To evaluate atrial septal defect (ASD) occlusion employing a small right anterior thoracotomy approach. Methods A total of 21 patients with ASD underwent general anesthesia and 2 -3 cm incision was made in the fourth right intercostal space. Utilizing transesophageal or transthoracic echocardiography, the occluder was released using a monotube unit. Results All patients were occluded successfully. No patient required open surgery utilizing extracorporeal circulation. There were no major complications and no evidence of residual atrial shunt. Conclusion ASD occlusion via a minimal surgical incision is safe, less invasive, and has excellent outcomes.
7.Study on drug-resistance of Mycobacterium tuberculosis isolated from coal workers with silico-tuberculosis.
Ping JIANG ; Hongmin LI ; Dongjin CHEN ; Wei WANG ; Bai FENG ; Zhongyuan WANG ; Guoyang WANG ; Sumei LI ; Huixin HAN
Chinese Journal of Industrial Hygiene and Occupational Diseases 2002;20(2):100-102
OBJECTIVETo study the gene mutation and streptomycin, isoniazid or rifampicin resistance of Mycobacterium isolated from silico-tuberculosis patient's sputum so as to find a more effective therapy for this disease.
METHODSMycobacteria tuberculosis were separated from 96 coal worker with silico-tuberculosis firstly. Then rpsL, KatG and rpoB fragments of genome were copied with PCR and compared their SSCP profiles with standard strains.
RESULTS67 strains of streptomycin, isoniazid or rifampicin resistant Mycobacteria tuberculosis were found in routine drug resistance test, with the percentages of 80.5% (54/67), 58.2% (39/67) respectively. PCR-SSCP showed that out of 67 drug-resistant strains, 66(98.5%) of rpsL, 47(70.1%) of rpoB and 42(62.7%) of KatG appeared abnormal.
CONCLUSIONMost of the resistant strains appeared gene mutation. The mution rates were higher than the results from routine drug resistance test.
Coal ; Drug Resistance, Bacterial ; Humans ; Mutation ; Mycobacterium tuberculosis ; drug effects ; genetics ; Polymerase Chain Reaction ; Polymorphism, Single-Stranded Conformational ; Silicotuberculosis ; microbiology ; Sputum ; microbiology

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