1.Novel X-Clip transcatheter edge-to-edge repair system for treating severe functional mitral regurgitation: The first case report
Jiaqi DAI ; Da ZHU ; Shouzheng WANG ; Xiangbin PAN
Chinese Journal of Clinical Thoracic and Cardiovascular Surgery 2025;32(04):567-570
For patients with moderate-to-severe functional mitral regurgitation (FMR) who continue to experience heart failure symptoms despite optimized medical and device therapy, transcatheter mitral valve edge-to-edge repair (TEER) is increasingly becoming a reliable treatment option. With the continuous research and development and improvement of TEER-related devices, there are currently dozens of domestically developed TEER devices undergoing clinical trials in China. In this study, we report the first case of a patient with severe FMR treated with the X-Clip® TEER system. The patient, a 60-year-old male, suffered FMR attributed to dilated cardiomyopathy. Preoperative transthoracic echocardiography showed severe mitral regurgitation (4+). He underwent percutaneous repair using the X-Clip® system, and immediate postoperative ultrasound showed mild mitral regurgitation. At the 1-month follow-up, the patient’s symptoms and New York Heart Association (NYHA) functional class improved, and a follow-up transthoracic echocardiogram showed mild mitral regurgitation (1+).
2.Outcome analysis of functional mitral regurgitation after transcatheter aortic valve replacement in patients with severe bicuspid aortic stenosis
Da-Wei LIN ; Zi-Long WENG ; Feng ZHANG ; Wen-Zhi PAN ; Da-Xin ZHOU
Fudan University Journal of Medical Sciences 2024;51(1):34-40
Objective To explore the relationship between the types of bicuspid aortic valves(BAV)and the outcome of functional mitral regurgitation(FMR)and the affecting factors of FMR.Methods From Jun 2018 to Sep 2022,patients with severe BAV aortic valve stenosis(AS)complicated with FMR underwent post transcatheter aortic valve replacement(TAVR)in Zhongshan Hospital,Fudan University were retrospectively analyzed.The baseline information and imaging data of different BAV patients were collected.Logistic regression was used to analyze the factors affecting the outcome of FMR(improvement and non-improvement).Result A total of 100 patients with TAVR were included,including 49 patients with type 0 of BAV and 51 patients with type 1 of BAV.Compared with patients of type 1,patients of type 0 had younger age[(72.78±6.09)y vs.(77.00±8.35)y,P=0.050],lower male ratio(47%vs.73%,P= 0.009)higher BMI[(23.19±2.62)kg/m2 vs.(21.99±3.13)kg/m2,P=0.041],and lower incidence of aortic regurgitation(69%vs.92%,P=0.040).Compared with the non-improvement group,the improvement group had a lower incidence of coronary heart disease(5%vs.18%,P=0.042),higher incidence of pulmonary hypertension(20%vs.2%,P=0.007),larger left ventricular diastolic diameter[(51.98±6.74)mm vs.(48.04±7.72)mm,P=0.009]and higher maximum flow velocity[(4.86±0.95)cm/s vs.(4.47±0.75)cm/s,P= 0.023]of the aortic valve.The results of Logistic regression analysis showed that preoperative pulmonary hypertension,left ventricular end-diastolic diameter and maximum valvular flow velocity of BAV patients were the potential affecting factors of FMR improvement after TAVR.Conclusion No significant difference was found in FMR improvement between BAV patients of type 0 and type 1 after TAVR.For BAV patients with AS,preoperative pulmonary hypertension,larger left ventricular end-diastolic diameter,and faster aortic valve flow velocity were associated with higher FMR improvement rate.
3.Research advances in animal models of tricuspid regurgitation
Da-Wei LIN ; Xiao-Chun ZHANG ; Feng ZHANG ; Wen-Zhi PAN ; Da-Xin ZHOU
Fudan University Journal of Medical Sciences 2024;51(2):257-261
Tricuspid regurgitation(TR)cases are widely distributed in China.Poor clinical drug efficacy,high surgical risk,and poor prognosis for right heart failure are found in patients with moderate or severe TR.In recent years,with the innovation of valve instruments and the development of technology,transcatheter tricuspid valve treatment could be a new choice for high-risk TR patients in surgery.Many TR animal models have emerged these years for the research of the mechanism of TR and for the clinical verification of instruments.Therefore,this review focuses on how to develop an animal model of TR and discusses the advantages and disadvantages of these techniques.
4.Efficacy and safety of recombinant human anti-SARS-CoV-2 monoclonal antibody injection(F61 injection)in the treatment of patients with COVID-19 combined with renal damage:a randomized controlled exploratory clinical study
Ding-Hua CHEN ; Chao-Fan LI ; Yue NIU ; Li ZHANG ; Yong WANG ; Zhe FENG ; Han-Yu ZHU ; Jian-Hui ZHOU ; Zhe-Yi DONG ; Shu-Wei DUAN ; Hong WANG ; Meng-Jie HUANG ; Yuan-Da WANG ; Shuo-Yuan CONG ; Sai PAN ; Jing ZHOU ; Xue-Feng SUN ; Guang-Yan CAI ; Ping LI ; Xiang-Mei CHEN
Chinese Journal of Infection Control 2024;23(3):257-264
Objective To explore the efficacy and safety of recombinant human anti-severe acute respiratory syn-drome coronavirus 2(anti-SARS-CoV-2)monoclonal antibody injection(F61 injection)in the treatment of patients with coronavirus disease 2019(COVID-19)combined with renal damage.Methods Patients with COVID-19 and renal damage who visited the PLA General Hospital from January to February 2023 were selected.Subjects were randomly divided into two groups.Control group was treated with conventional anti-COVID-19 therapy,while trial group was treated with conventional anti-COVID-19 therapy combined with F61 injection.A 15-day follow-up was conducted after drug administration.Clinical symptoms,laboratory tests,electrocardiogram,and chest CT of pa-tients were performed to analyze the efficacy and safety of F61 injection.Results Twelve subjects(7 in trial group and 5 in control group)were included in study.Neither group had any clinical progression or death cases.The ave-rage time for negative conversion of nucleic acid of SARS-CoV-2 in control group and trial group were 3.2 days and 1.57 days(P=0.046),respectively.The scores of COVID-19 related target symptom in the trial group on the 3rd and 5th day after medication were both lower than those of the control group(both P<0.05).According to the clinical staging and World Health Organization 10-point graded disease progression scale,both groups of subjects improved but didn't show statistical differences(P>0.05).For safety,trial group didn't present any infusion-re-lated adverse event.Subjects in both groups demonstrated varying degrees of elevated blood glucose,elevated urine glucose,elevated urobilinogen,positive urine casts,and cardiac arrhythmia,but the differences were not statistica-lly significant(all P>0.05).Conclusion F61 injection has initially demonstrated safety and clinical benefit in trea-ting patients with COVID-19 combined with renal damage.As the domestically produced drug,it has good clinical accessibility and may provide more options for clinical practice.
5.Current applications of transcatheter edge-to-edge tricuspid valve repair
Chun-Mei XIE ; Meng-Qi SHEN ; Da ZHU ; Shou-Zheng WANG ; Zhi-Ling LUO ; Xiang-Bin PAN
Chinese Journal of Interventional Cardiology 2024;32(1):45-50
Tricuspid regurgitation(TR)is a common heart valve disease.According to the pathogenesis,TR can be divided into primary(organic)and secondary(functional)regurgitation,of which functional TR accounts for more than 90%.Patients with severe TR have poor prognosis and poor drug treatment,and surgery(valvuloplasty)is the main treatment.At present,transcatheter edge-to-edge tricuspid valve repair(T-TEER)has become an essential program of transcatheter treatment for TR,providing minimally invasive treatment for TR patients who cannot undergo surgery or are at high risk of surgery.T-TEER reduces the degree of regurgitation by clamping leaflets,and is currently in the early stage of research and development exploration and clinical validation,mainly for functional TR.T-TEER devices have also made significant progress(TriClip,PASCAL),and Chinese-made novel-designed T-TEER devices are also undergoing clinical trials(DragonFly-TTM,SQ-Kyrin-TTM,NeoBlazarTM).This paper reviews the current applications and research progress of T-TEER.
6.An in vitro evaluation of the hydromechanical properties on transcatheter edge-to-edge repair
Hao WANG ; Da ZHU ; Zhi-Qian LU ; Zhao-Ming HE ; Li LIU ; Xiang-Bin PAN
Chinese Journal of Interventional Cardiology 2024;32(2):89-95
Objective To establish a method for testing isolated mitral valve in vitro and quantitatively evaluate the effect of transcatheter edge-to-edge repair technology(TEER)on functional mitral regurgitation(FMR)(non-A2-P2 regurgitation).Methods In this study,an FMR(non-A2-P2 regurgitation)model was developed by dilating the annulus orifice and displacing the papillary muscle in isolated porcine mitral valve.The hydrodynamics characteristics of 6 valves were tested by a pulsatile flow testing system under different physiological and pathological conditions before and after TEER.Results The results show that the valve regurgitation improved from moderate-severe[regurgitant fraction(60.2±17.5)%]to mild-moderate[regurgitant fraction(34.7±12.0)%]by repair(P<0.001).The EOA[(3.8±1.6)cm2 vs.(2.2±0.5)cm2,P<0.001]and the forward cross valve pressure difference[(1.8±1.3)mmHg vs.(3.8± 1.8)mmHg,P<0.001],which characterize the forward flow performance of the valve,were compared before and after repair,and the differences were statistically significant.At the same time,the repair caused valve stenosis(the effective orifice area decreased by 40%and the positive differential pressure increased by 110%),but the valves was still within the normal physiological range,and no iatrogenic stenosis was caused.Conclusions It can be seen that TEER has an effect on FMR.This study provides validation and evaluation methods in vitro for expanding indications and improving TEER,and reference for developing standards of transcatheter valve repair testing in vitro.
7.Application of 3D printing in the preoperative evaluation of transcatheter aortic valve replacement for patients at risk of coronary artery obstruction:two case reports
Jia-Qi DAI ; Shou-Zheng WANG ; Da ZHU ; Xiang-Bin PAN
Chinese Journal of Interventional Cardiology 2024;32(2):116-120
Transcatheter aortic valve replacement(TAVR)is currently one of the main therapeutic strategies for aortic valve disease.Preoperative imaging assessment is crucial for operation project planning and prevention of procedure-associated complications.Different from planar image reconstruction,3D printing technology can accurately depict the anatomical structure of the aortic root.It enables further assessment of operative risk and therapeutic strategy through in vitro simulation,especially for assessing the risk of coronary artery obstruction and planning interventional procedures.Here,we report on two patients who underwent a 3D printing aortic root anatomical simulation model,followed an by in vitro balloon dilatation/valve implantation test,to evaluate the risk of coronary artery obstruction suggested by CT angiography planar image reconstruction before TAVR.
8.Analysis of Cardiac Reverse Remodeling After Transcatheter Edge-to-edge Repair of Mitral Regurgitation due to Various Etiologies and Experience of Echocardiography Application
Zhiling LUO ; Xiaoli DONG ; Qiuzhe GUO ; Yuanzheng WANG ; Jin LI ; Yunfei ZHOU ; Shuanglan YU ; Da ZHU ; Shouzheng WANG ; Xiangbin PAN
Chinese Circulation Journal 2024;39(3):234-241
Objectives:To evaluate the valvular and cardiac function,cardiac reverse remodeling at 6-month after transcatheter edge-to-edge repair(TEER)for patients with functional and degenerative mitral valve regurgitation,and summarize the experience of echocardiography application. Methods:The clinical data of 93 patients with moderate to severe mitral regurgitation(MR)treated with TEER and completed 6-month follow-up in Yunnan Fuwai Cardiovascular Hospital from July 2022 to February 2023 were retrospectively analyzed.Patients were divided into functional mitral regurgitation(FMR)and degenerative mitral regurgitation(DMR)groups according to MR etiology.The valve characteristic parameters,as well as valvular function,chamber volume and cardiac functional parameters before and at 6 months after operation were compared.The key points of echocardiography application were summarized. Results:Among all patients,71 were FMR and 22 were DMR.There were differences in valve structure between the two groups.Mitral TEER were successfully accomplished and all patients completed 6-month follow-up.The key points of echocardiography application included:valve structure analysis,atrial septal puncture location,device delivery process monitoring and image optimization during clamping process.The mitral regurgitation grade and NYHA grade were significantly improved in all patients at 6 months after TEER(P<0.05),and the mean mitral valve pressure gradient was higher than that before operation(P<0.05).Left ventricular end-diastolic volume(LVEDV),left ventricular end-systolic volume(LVESV)and left atrial volume index in FMR group were significantly decreased(P<0.05),while left ventricular and left atrial volume in DMR group remained unchanged(P>0.05).There were no significant changes in left ventricular ejection fraction and left ventricular global strain in both groups during the observation period(P>0.05).The changes of LVEDV and LVESV before and after operation were more significant in FMR group than those in DMR group(P<0.05). Conclusions:Mitral TEER can reduce the degree of regurgitation and improve cardiac function in the early postoperative period for moderate and severe MR patients with different etiologies.There are differences in preoperative valve structure and postoperative cardiac reverse remodeling between FMR and DMR patients.Echocardiography is an important imaging technique for the evaluation and monitoring process before,during and post mitral TEER.
9.Robotic Assisted Transcatheter Edge-to-edge Repair for Functional Mitral Regurgitation With Pure Trans-esophageal Echocardiography-guidance
Da ZHU ; Wenbin OUYANG ; Shouzheng WANG ; Zhiling LUO ; Xiangbin PAN
Chinese Circulation Journal 2024;39(6):606-609
We report the first in man experience of robotic assisted transcatheter edge-to-edge repair(TEER)with pure Trans-esophageal echocardiography-guidance.A 55y female was diagnosed with heart failure with 4+functional MR despite optimal medical treatment.TEER procedure was planned with robotic assistance.After guiding catheter,the robotic system was incorporated into the TEER device to replace manual operation.Under pure echo-guidance one clip was successfully placed in A2/P2 region with marked reduction of MR to 1+.Patient was discharged without complication.
10.A Case Report of Remote Robotic Transcatheter Edge-to-Edge Repair Under Pure Transesophageal Echocardiographic Guidance
Shouzheng WANG ; Da ZHU ; Shiguo LI ; Yaoxing LU ; Wenbin OUYANG ; Xiangbin PAN
Chinese Circulation Journal 2024;39(8):816-818
We report the successful treatment of mitral regurgitation by remote robotic transcatheter edge-to-edge repair(TEER)under pure transesophageal echocardiographic guidance in a 70-year-old male patient with severe mitral regurgitation due to ischemic cardiomyopathy.The patient showed no significant improvement after coronary interventional treatment and guideline-directed medical therapy before TEER.Following a multidisciplinary discussion,a TEER procedure was indicated and performed.The procedure utilized robotic assistance guided by echocardiography,combined with 5G communication technology,to remotely operate the surgical robot in Shenzhen from Beijing.Postoperatively,the patient's mitral regurgitation was reduced to trace,symptoms were markedly improved,there were no severe complications,and the patient was discharged five days after the operation.The integration of pure echo-guided interventional technology with remote robotic operation holds significant importance for enhancing the capabilities in treating cardiovascular diseases at the primary hospitals.

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