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.Analysis of the characteristics of platelet changes and influencing factors after transcatheter aortic valve implantation
Xiangyu LI ; Haibo ZHANG ; Fangyu YANG ; Shuai ZHENG ; Fei MENG ; Shengxun WANG ; Yuqing JIAO ; Yuehuan LI ; Kaisheng WU ; Jinglun SHEN
Chinese Journal of Clinical Thoracic and Cardiovascular Surgery 2024;31(06):832-837
Objective To analyze the characteristics of platelet changes and their influencing factors during postoperative hospitalization in patients who underwent transcatheter aortic valve implantation (TAVI). Methods The patients who underwent TAVI at Beijing Anzhen Hospital Valve Surgery Center between March 2017 and October 2021 were retrospectively selected. The patients were divided into a self-limiting group and a non-self-limiting group according to the characteristics of postoperative platelet decline. In addition, the general preoperative data, preoperative and postoperative ultrasound data, intraoperative data, and the use of anticoagulant drugs during the postoperative stay in the hospital were compared between the two groups. Results A total of 249 patients were enrolled in this study. There were 175 (70.3%) patients in the self-limiting group, including 100 males and 75 females, and there were 74 (29.7%) patients in the non-self-limiting group, including 43 males and 31 females, with no statistical difference between the two groups (P=0.863). The mean age of patients was 73.11±8.88 years in the self-limiting group and 71.54±10.39 years in the non-self-limiting group (P=0.231). The decline of platelets in the self-limiting group generally occurred on the postoperative day 2 and reached the lowest count on the postoperative day 4, and returned to the baseline level on the postoperative day 5-7, while the platelets in the non-self-limiting group changed by simple rise, fall or irregular fluctuation. Patients in the self-limiting group had severer preoperative aortic stenosis (P<0.001) and used more extracorporeal circulation assistance during surgery (P<0.001). Postoperatively, patients in the self-limiting group were more likely to have periaortic valve leakage than those in the non-self-limiting group (P=0.013). Conclusion Platelet changes in most patients after TAVI show a self-limiting decline, which may be related to the severity of patients’ preoperative aortic stenosis, intraoperative extracorporeal circulation device use, and postoperative perivalvular leakage.
4.Protective effect of J-Valve transapical aortic Valve replacement in patients with aortic stenosis with low coronary ostium
Quanhui XU ; Haibo ZHANG ; Zhenzong DU ; Yuehuan LI ; Jinglun SHEN ; Kaisheng WU
Chinese Journal of Thoracic and Cardiovascular Surgery 2023;39(10):594-598
Objective:To investigate the safety and efficacy of J-valve transapical catheter aortic Valve replacement(TA-TAVI) in the early treatment of aortic stenosis with low coronary ostium.Methods:From January 2020 to April 2022, 20 patients with aortic stenosis with coronary opening height ≤10 mm who underwent TA-TAVI treatment in the Valve Surgery Center of Beijing Anzhen Hospital Affiliated to Capital Medical University were enrolled retrospectively. All patients underwent preoperative imaging screening, and 5 patients underwent preoperative coronary artery protection: The height of coronary artery opening was less than 5 mm in 3 cases. 2 cases had stent stenosis & LT after coronary artery stenting 50%, and the position of the coronary artery opening was less than 8mm. The postoperative complications, mortality and cardiac function prognosis of TA-TAVI were analyzed.Results:There were 5 males and 15 females. The average age of the whole group was(73.00±6.20) years. Transthoracic echocardiography showed that all patients had severe aortic valve stenosis, and 85% of the patients had NYHA grade Ⅲ-Ⅳ, and 80% of the patients had aortic valve stenosis with insufficiency. The mean height of left coronary artery opening was(9.07±3.70) mm. RCA(11.39±3.00) mm; The opening height of coronary artery was ≤5 mm in 3 cases(left 7.5%), 5-8 mm in 5 cases(12.5%), and 8-10mm in 16 cases(40.0%). Mean aortic sinus(valsalva) diameter: Left(30.06±5.90) mm; Right(28.50±5.68) mm; Non(29.96±6.15) mm. J-valve Valve was successfully implanted through apical catheter in all patients, most of whom were size 23. CPB was performed in 2 patients at the same time, permanent pacemaker was inserted in 2 patients, and moderate or above perivalvular leakage was found in 0 patients. All patients had TNI( P=0.12) and MYO( P=0.03) before and 24 hours after operation. None of the 5 patients underwent coronary artery stenting. None of the 5 patients died within 30 days after the operation. Ta-tavi is effective 30 days after operation, with low complication rate and good prognosis of cardiac function. Conclusion:J-valve transapical catheter aortic Valve replacement is safe and effective in the treatment of aortic stenosis with low coronary ostium.
5.Adaptive Bird-like Genome Miniaturization During the Evolution of Scallop Swimming Lifestyle
Li YULI ; Liu YARAN ; Yu HONGWEI ; Liu FUYUN ; Han WENTAO ; Zeng QIFAN ; Zhang YUEHUAN ; Zhang LINGLING ; Hu JINGJIE ; Bao ZHENMIN ; Wang SHI
Genomics, Proteomics & Bioinformatics 2022;(6):1066-1077
Genome miniaturization drives key evolutionary innovations of adaptive traits in verte-brates,such as the flight evolution of birds.However,whether similar evolutionary processes exist in invertebrates remains poorly understood.Derived from the second-largest animal phylum,scallops are a special group of bivalve molluscs and acquire the evolutionary novelty of the swimming lifestyle,providing excellent models for investigating the coordinated genome and lifestyle evolution.Here,we show for the first time that genome sizes of scallops exhibit a generally negative correlation with loco-motion activity.To elucidate the co-evolution of genome size and swimming lifestyle,we focus on the Asian moon scallop(Amusium pleuronectes)that possesses the smallest known scallop genome while being among scallops with the highest swimming activity.Whole-genome sequencing of A.pleuronectes reveals highly conserved chromosomal macrosynteny and microsynteny,suggestive of a highly con-tracted but not degenerated genome.Genome reduction of A.pleuronectes is facilitated by significant inactivation of transposable elements,leading to reduced gene length,elevated expression of genes involved in energy-producing pathways,and decreased copy numbers and expression levels of biomineralization-related genes.Similar evolutionary changes of relevant pathways are also observed for bird genome reduction with flight evolution.The striking mimicry of genome miniaturization underlying the evolution of bird flight and scallop swimming unveils the potentially common,pivotal role of genome size fluctuation in the evolution of novel lifestyles in the animal kingdom.
6.Comparative Genomics Reveals Evolutionary Drivers of Sessile Life and Left-right Shell Asymmetry in Bivalves
Zhang YANG ; Mao FAN ; Xiao SHU ; Yu HAIYAN ; Xiang ZHIMING ; Xu FEI ; Li JUN ; Wang LILI ; Xiong YUANYAN ; Chen MENGQIU ; Bao YONGBO ; Deng YUEWEN ; Huo QUAN ; Zhang LVPING ; Liu WENGUANG ; Li XUMING ; Ma HAITAO ; Zhang YUEHUAN ; Mu XIYU ; Liu MIN ; Zheng HONGKUN ; Wong NAI-KEI ; Yu ZINIU
Genomics, Proteomics & Bioinformatics 2022;(6):1078-1091
Bivalves are species-rich mollusks with prominent protective roles in coastal ecosystems.Across these ancient lineages,colony-founding larvae anchor themselves either by byssus produc-tion or by cemented attachment.The latter mode of sessile life is strongly molded by left-right shell asymmetry during larval development of Ostreoida oysters such as Crassostrea hongkongensis.Here,we sequenced the genome of C.hongkongensis in high resolution and compared it to reference bivalve genomes to unveil genomic determinants driving cemented attachment and shell asymmetry.Importantly,loss of the homeobox gene Antennapedia(Antp)and broad expansion of lineage-specific extracellular gene families are implicated in a shift from byssal to cemented attachment in bivalves.Comparative transcriptomic analysis shows a conspicuous divergence between left-right asymmetrical C.hongkongensis and symmetrical Pinctada fucata in their expression profiles.Especially,a couple of orthologous transcription factor genes and lineage-specific shell-related gene families including that encoding tyrosinases are elevated,and may cooperatively govern asymmet-rical shell formation in Ostreoida oysters.
7.Protective effects of levosimendan combined with lyophilized recombinant human brain natriuretic peptide on myocardium in patients with acute myocardial infarction complicated by heart failure
Chinese Journal of Primary Medicine and Pharmacy 2021;28(9):1303-1307
Objective:To investigate the protective effects of levosimendan combined with lyophilized recombinant human brain natriuretic peptide (rhBNP) on myocardium in patients with acute myocardial infarction complicated by heart failure.Methods:140 patients with acute myocardial infarction complicated by heart failure who received treatment in Changxing People's Hospital from June 2018 to June 2020 were included in this study. They were randomly assigned to receive either routine treatment (control group, n = 70) or routine treatment, levosimendan combined with rhBNP (study group, n = 70). Serum levels of creatine kinase (CK)-MB, cardiac troponin I (cTnI), lactate dehydrogenase (LDH), high-sensitivity C-reactive protein (hs-CRP), which were associated with myocardial injury, were measured in each group. In addition, the changes in cardiac ultrasound indexes left ventricular end diastolic diameter (LVEDD), left ventricular end systolic diameter (LVESD) and left ventricular ejection fraction (LVEF) were observed. Clinical effects on heart failure were evaluated. Adverse drug reactions were monitored during the treatment. Results:After treatment, CK-MB, cTnI, LDH and hs-CRP levels in the study group were (56.73 ± 12.15) U/L, (0.41 ± 0.19) μg/L, (126.83 ± 15.26) U/L and (1.59 ± 0.27) mg/L, respectively, which were significantly lower than those in the control group [(78.52 ± 14.07) U/L, (0.68 ± 0.21) μg/L, (187.25 ± 23.04) U/L, (2.84 ± 0.41) mg/L, t = 5.569-12.418, all P < 0.05]. LVEDD and LVESD in the study group were significantly lower than those in the control group, while LVEF in the study group was significantly higher than that in the control group ( t = 4.435-6.426, all P < 0.05). Total effective rate in the study group was significantly higher than that in the control group [88.57% (62/70) vs. 72.86% (51/70), χ2 = 5.552, P < 0.05]. There was no significant difference in total incidence of adverse drug reactions between study and control groups [11.43% (8/70) vs. 8.57% (6/70), χ2 = 0.317, P > 0.05]. Conclusion:Levosimendan combined with rhBNP can effectively alleviate myocardial injury in patients with acute myocardial infarction complicated by heart failure, improve myocardial function, is highly safe, and thereby deserves clinical application.
8.Risk factors and management experiences of stent valves detachment in transcatheter aortic valve implantation (TAVI)
Yuehuan LI ; Xu MENG ; Yujie ZHOU ; Wei LIU ; Zhihui ZHU ; Kun LIU ; Han ZHANG ; Shengxun WANG ; Haibo ZHANG
Chinese Journal of Clinical Thoracic and Cardiovascular Surgery 2020;27(07):807-812
Objective To summarize and analyze the risk factors and management of artificial valve slippage in transcatheter aortic valve implantation (TAVI). Methods We retrospectively analyzed the clinical data of 131 patients undergoing TAVI surgery in our center from September 2017 to May 2019, including 62 patients through transapical approach and 69 patients through transfemoral artery approach. Results A total of 131 patients received TAVI surgery, among whom 4 patients had slipped during the operation, 2 patients via transfemoral artery approach, and another 2 patients via transapical. The average age was 77±9 years with one female (25%). Preoperative evaluation, higher position and poor coaxial were main risk factors for valve slip in TAVI. Conclusion Valve slippage is also a serious complication in TAVI surgery. Reasonable and effective treatment can avoid thoracotomy.
9.Transcatheter valve in valve implantation treatment for the mitral bioprothesis deterioration
Haibo ZHANG ; Xu MENG ; Shengxun WANG ; Yuehuan LI ; Wei LIU ; Yujie ZHOU
Chinese Journal of Thoracic and Cardiovascular Surgery 2019;35(6):331-333
Objective To explore the clinic results of our new designed transcatheter valve in valve for the mitral biopro-thesis deterioration.Methods Mitral bioprothesis deterioration patients with high risk for the routine bypass surgery got con-sent.After general anesthesia in the hybrid operation the left ventricle apical puncture was performed with guidance of 3D echo and X-ray.The retro-preset J Valve system was guided into the left atrium and the mitral bioprothesis with the beating heart . Results There were total 9 cases between Jan 2019 to Mar 2019 which had STS score above 6-8.The mitral bioprothesis in-cluded Hancock valve 3 cases, Perimount valve 3 cases, Epic valve 2 cases, Baxiter valve 1 case.The mitral bioprosthesis size included 27 for 6 cases and 25 for 3 cases.The successful implant rate was 100%, mortality rate 0, and all the patients recov-ered well without any main complications.The mean tran-valular pressure was only(8 ±2) mmHg (1 mmHg=0.133 kPa). Conclusion This innovative mitral valve in valve technique with retro-preset J Valve system got very good clinic results and worthy of deep research.
10.Quantitative analysis of mitral valve morphology in rheumatic and degenerative mitral valve disease with real-time 3-dimensional echocardiography
Yuehuan LI ; Haibo ZHANG ; Xv MENG ; Jie HAN ; Yan LI ; Han ZHANG
Chinese Journal of Thoracic and Cardiovascular Surgery 2017;33(8):462-465,471
Objective To analyze abnormal characteristics of mitral valve (MV) caused by rheumatic and degenerative mitral valvedisease in virtue of the real-time three-dimensional transesophageal echocardiography(RT3DTEE) and quantitative analysis software.Methods Sixty patients underwent RT3DTEE study:21 patients with rheumatic valvular disease(RHD) studied intraoperatively(9 severe mitral stenosis,6 severe mitral regurgitation,6 severe mitral stenosis couple with regurgitation ) and 20 patients with normal MV who were used as controlsubjects(NS).TomTec-Arena 1.0-4D MV-Assessment 2.3 software was used to measure parameters of annular dimensions and geometry,[eafletsurface area and so on.Results Compared with NS,the diameter between anterior and posterior(AP) of RIID increased,however,the commissural width (CW)didn't change.Parameters of AP,CW,annulus circumference(AC) and annulus area(AA) of degenerative mitral valve disease(DMVD) increased obviously,the spherical index instead didn't change,the original "saddle" shapebecame flat.The impact on mitral valve leaflets is difference between RHD and DMVD.The anterior instead of posterior leaflet arena and length became larger of the group MS and MS&MI.However,the group of DMVD has increased leaflet area of anterior as well as posterior.Posterior leaflet angle is significantly increased in the group of MS&MI.The angle,between the DAP and plane of aortic valve annular (Angle AAo-AP),were magnified in both RHD and DMVD.From the automatic dynamic analysis,the parameters of annular displacement(max),annulus area fraction(2D)decreased considerably in RHD group.Conclusion RHD has relatively mild impact on annular of MV,but the lesions of mitral valve leaflet and chordae tendineae limit the movement of bicuspid valve an nular.The dilated and flattened annular of DMVD still has the "saddle" shape.

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