1.Experimental study on the ultrasound visibility of a novel interventional catheter and delivery system: In vitro and animal experiments
Ziping LI ; Wenbin OUYANG ; Zizheng LIU ; Ning ZHOU ; Jie DONG ; Shouzheng WANG ; Xiangbin PAN
Chinese Journal of Clinical Thoracic and Cardiovascular Surgery 2026;33(05):784-790
Objective To assess the echogenicity of the ultrasound-guided catheter and its associated delivery system. Methods The study consisted of in vitro characterization experiments and animal studies. In the in vitro phase, the acoustic and mechanical properties of the ultrasound-guided catheter were compared with those of the traditional MPA2 catheter, including parameters such as echo intensity, recognizability, and angle dependence. In the animal experiments, a ventricular septal defect (VSD) model was established in miniature pigs to compare the procedural performance of the ultrasound-guided delivery system versus the conventional system. Evaluation indicators included the time required for the system to cross the VSD, the detection rate of the system within the right ventricle, and the occurrence of intraoperative complications. Results The ultrasound-guided catheter demonstrated a significantly higher mean echo intensity than the MPA2 catheter [(237.3±1.8) dB vs. (190.9±13.1) dB, P<0.001] and a markedly improved recognizability rate (82.3%±5.6% vs. 26.7%±3.2%, P<0.001), along with better angle independence and image quality. In animal experiments, the ultrasound-guided delivery system significantly reduced the time required to cross the VSD [(18.5±5.7) min vs. (30.3±4.5) min, P<0.001] and substantially increased the detection rate within the right ventricle (100.0% vs. 30.0%). No severe complications occurred in any experimental animal. Conclusion The ultrasound-guided catheter and its corresponding delivery system exhibite superior ultrasound visibility and operational performance in both in vitro and animal experiments, indicating strong potential for clinical application.
2.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+).
3.Comparison of Embolization Coils and Patent Ductus Arteriosus Occluders for Coronary Artery Fistula Transcatheter Closure: A Single Centre Experience
Peijian WEI ; Yihang LI ; Liang XU ; Junyi WAN ; Fengwen ZHANG ; Gary TSE ; Jeffrey Shi Kai CHAN ; Shouzheng WANG ; Wenbin OUYANG ; Gejun ZHANG ; Fang FANG ; Xiangbin PAN
Korean Circulation Journal 2025;55(3):199-212
Background and Objectives:
There is no dedicated occlusive device for closing coronary artery fistulas (CAFs), and specific efficacy and safety data of various off-label occlusive devices for CAFs closure are scarce.
Methods:
Patients undergoing transcatheter closure of CAFs from January 2011 to December 2022 were included in the single-center retrospective study. The study population was divided into 2 groups: coils group (n=35) and patent ductus arteriosus (PDA) occluders group (n=66).
Results:
No significant intergroup differences were observed in demographic characteristics except age. The presence of multiple CAF origins (54.3% vs. 4.5%, p<0.001) and multiple draining sites (51.4% vs. 3.0%, p<0.001) were more common in the coils group. In contrast, the presence of aneurysm (72.7% vs. 14.3%, p<0.001), and large fistula (75.8% vs. 37.1%, p<0.001) were more prevalent in the PDA occluders group. The acute procedural success rate of the PDA occluders group was higher compared to that of the coils group (87.9% vs.62.9%, adjusted odds ratio [OR], 7.20; 95% confidence interval, 1.59–32.64; p=0.01).In addition, no significant intergroup differences were noted in both the recanalization rate (7.8% vs. 20%, p=0.107) and the reintervention rate (3.1% vs. 8.6%, p=0.342).
Conclusions
Transcatheter closure of CAFs using PDA occluders was associated with significantly higher acute procedural success rates compared to coil embolization with comparable late outcomes.
4.Comparison of Embolization Coils and Patent Ductus Arteriosus Occluders for Coronary Artery Fistula Transcatheter Closure: A Single Centre Experience
Peijian WEI ; Yihang LI ; Liang XU ; Junyi WAN ; Fengwen ZHANG ; Gary TSE ; Jeffrey Shi Kai CHAN ; Shouzheng WANG ; Wenbin OUYANG ; Gejun ZHANG ; Fang FANG ; Xiangbin PAN
Korean Circulation Journal 2025;55(3):199-212
Background and Objectives:
There is no dedicated occlusive device for closing coronary artery fistulas (CAFs), and specific efficacy and safety data of various off-label occlusive devices for CAFs closure are scarce.
Methods:
Patients undergoing transcatheter closure of CAFs from January 2011 to December 2022 were included in the single-center retrospective study. The study population was divided into 2 groups: coils group (n=35) and patent ductus arteriosus (PDA) occluders group (n=66).
Results:
No significant intergroup differences were observed in demographic characteristics except age. The presence of multiple CAF origins (54.3% vs. 4.5%, p<0.001) and multiple draining sites (51.4% vs. 3.0%, p<0.001) were more common in the coils group. In contrast, the presence of aneurysm (72.7% vs. 14.3%, p<0.001), and large fistula (75.8% vs. 37.1%, p<0.001) were more prevalent in the PDA occluders group. The acute procedural success rate of the PDA occluders group was higher compared to that of the coils group (87.9% vs.62.9%, adjusted odds ratio [OR], 7.20; 95% confidence interval, 1.59–32.64; p=0.01).In addition, no significant intergroup differences were noted in both the recanalization rate (7.8% vs. 20%, p=0.107) and the reintervention rate (3.1% vs. 8.6%, p=0.342).
Conclusions
Transcatheter closure of CAFs using PDA occluders was associated with significantly higher acute procedural success rates compared to coil embolization with comparable late outcomes.
5.Anesthesia management experience in transcatheter ultrasound-guided percutaneous interventional treatment of congenital heart disease at a mobile operating platform
Chunmei XIE ; Da ZHU ; Shouzheng WANG ; Yaling FENG ; Jiang LU ; Jianbin GAO ; Ke YANG ; Xinghuan LI ; Deyuan ZHANG ; Xiangbin PAN
Chinese Journal of Clinical Thoracic and Cardiovascular Surgery 2025;32(10):1467-1472
Objective To explore the anesthesia management experience in the interventional treatment of pediatric congenital heart diseases (CHD) percutaneously guided by transthoracic echocardiography (TTE) on a mobile operating platform. Methods From March to July 2023, a total of 13 patients from remote areas underwent interventional treatment for CHD on the mobile operating platform of Fuwai Yunnan Cardiovascular Hospital. Patients who received non-tracheal intubation general anesthesia were retrospectively included. Results Eight children who had difficulty cooperating with the surgery (due to young age, emotional tension, crying) received monitored anesthesia care with local anesthesia supplemented by sedative and analgesic drugs while maintaining spontaneous breathing under the monitoring and management of an anesthesiologist (i.e., non-tracheal intubation general anesthesia). Among them, there were 5 males and 3 females, with an age of (6.95±3.29) years and a body weight of (19.50±6.04) kg. Through transthoracic echocardiography, they were diagnosed with atrial septal defect (6 patients), residual shunt after patent ductus arteriosus ligation (1 patient), and severe pulmonary valve stenosis (1 patient). The surgery proceeded smoothly, with satisfactory anesthesia and surgical effects, complete analgesia, and satisfactory postoperative recovery. There was 1 patient of body movement and 1 patient of respiratory depression during the operation, and both patients completed the surgery successfully after treatment. All children had no serious surgery- and anesthesia-related complications. The anesthesia time was 40.5 (34.5, 47.5) min, the surgery time was 39.0 (33.0, 45.5) min, and the recovery time was 43.0 (28.0, 52.5) min Conclusion Interventional surgery for CHD guided by TTE at a mobile platform is a minimally invasive approach without radiation damage. Non-tracheal intubation general anesthesia with spontaneous breathing can be safely and effectively implemented in children who cannot cooperate.
6.Multivue reconstruction technique during mitral valve transcatheter edge-to-edge repair: A case report
Qiuzhe GUO ; Yunfei ZHOU ; Da ZHU ; Shouzheng WANG ; Zhiling LUO
Chinese Journal of Clinical Thoracic and Cardiovascular Surgery 2025;32(10):1517-1520
Echocardiography is an important imaging technique in mithal valve transcatheter edge-to-edge repair (TEER). During the operation, mitral leaflets capture and clamping have the highest requirements for ultrasound image quality and should be performed under the guidance of high-quality commissural view. However, standard commissural view cannot be obtained in some patients due to cardiac enlargement, transposition or limited esophageal acoustic window. In this condition, the optimal view can be obtained by Multivue technology. This paper reports a male patient aged 67 years with successful mitral valve TEER under the real-time guidance of Multivue technology, and summarizes the key points of this technology.
7.Comparison of Embolization Coils and Patent Ductus Arteriosus Occluders for Coronary Artery Fistula Transcatheter Closure: A Single Centre Experience
Peijian WEI ; Yihang LI ; Liang XU ; Junyi WAN ; Fengwen ZHANG ; Gary TSE ; Jeffrey Shi Kai CHAN ; Shouzheng WANG ; Wenbin OUYANG ; Gejun ZHANG ; Fang FANG ; Xiangbin PAN
Korean Circulation Journal 2025;55(3):199-212
Background and Objectives:
There is no dedicated occlusive device for closing coronary artery fistulas (CAFs), and specific efficacy and safety data of various off-label occlusive devices for CAFs closure are scarce.
Methods:
Patients undergoing transcatheter closure of CAFs from January 2011 to December 2022 were included in the single-center retrospective study. The study population was divided into 2 groups: coils group (n=35) and patent ductus arteriosus (PDA) occluders group (n=66).
Results:
No significant intergroup differences were observed in demographic characteristics except age. The presence of multiple CAF origins (54.3% vs. 4.5%, p<0.001) and multiple draining sites (51.4% vs. 3.0%, p<0.001) were more common in the coils group. In contrast, the presence of aneurysm (72.7% vs. 14.3%, p<0.001), and large fistula (75.8% vs. 37.1%, p<0.001) were more prevalent in the PDA occluders group. The acute procedural success rate of the PDA occluders group was higher compared to that of the coils group (87.9% vs.62.9%, adjusted odds ratio [OR], 7.20; 95% confidence interval, 1.59–32.64; p=0.01).In addition, no significant intergroup differences were noted in both the recanalization rate (7.8% vs. 20%, p=0.107) and the reintervention rate (3.1% vs. 8.6%, p=0.342).
Conclusions
Transcatheter closure of CAFs using PDA occluders was associated with significantly higher acute procedural success rates compared to coil embolization with comparable late outcomes.
8.Comparison of Embolization Coils and Patent Ductus Arteriosus Occluders for Coronary Artery Fistula Transcatheter Closure: A Single Centre Experience
Peijian WEI ; Yihang LI ; Liang XU ; Junyi WAN ; Fengwen ZHANG ; Gary TSE ; Jeffrey Shi Kai CHAN ; Shouzheng WANG ; Wenbin OUYANG ; Gejun ZHANG ; Fang FANG ; Xiangbin PAN
Korean Circulation Journal 2025;55(3):199-212
Background and Objectives:
There is no dedicated occlusive device for closing coronary artery fistulas (CAFs), and specific efficacy and safety data of various off-label occlusive devices for CAFs closure are scarce.
Methods:
Patients undergoing transcatheter closure of CAFs from January 2011 to December 2022 were included in the single-center retrospective study. The study population was divided into 2 groups: coils group (n=35) and patent ductus arteriosus (PDA) occluders group (n=66).
Results:
No significant intergroup differences were observed in demographic characteristics except age. The presence of multiple CAF origins (54.3% vs. 4.5%, p<0.001) and multiple draining sites (51.4% vs. 3.0%, p<0.001) were more common in the coils group. In contrast, the presence of aneurysm (72.7% vs. 14.3%, p<0.001), and large fistula (75.8% vs. 37.1%, p<0.001) were more prevalent in the PDA occluders group. The acute procedural success rate of the PDA occluders group was higher compared to that of the coils group (87.9% vs.62.9%, adjusted odds ratio [OR], 7.20; 95% confidence interval, 1.59–32.64; p=0.01).In addition, no significant intergroup differences were noted in both the recanalization rate (7.8% vs. 20%, p=0.107) and the reintervention rate (3.1% vs. 8.6%, p=0.342).
Conclusions
Transcatheter closure of CAFs using PDA occluders was associated with significantly higher acute procedural success rates compared to coil embolization with comparable late outcomes.
9.Animal study results of a novel designed transcatheter mitral valve replacement system
Da ZHU ; Shouzheng WANG ; Jianbin GAO ; Zhiling LUO ; Ke YANG ; Chunmei XIE ; Pengxu KONG ; Shuyi FENG ; Hong JIANG ; Xiangbin PAN
Chinese Journal of Cardiology 2025;53(3):287-292
Objective:To preliminarily assess the biocompatibility and durability of the TruDelta TM transcatheter mitral valve replacement (TMVR) system. Method:Six adult sheep were divided into 3 groups based on the duration of follow-up: 30 days ( n=1), 90 days ( n=3) and 180 days ( n=2). The TruDelta TM TMVR system was implanted through a transapical approach under transesophageal echocardiographic guidance. The operability of the TMVR system was evaluated using an instrument performance evaluation scale (consisting of 39 items), with scores ranging from 1 (worst) to 10 (best) assigned by the operator. Echocardiography was conducted preoperatively, immediately after surgery, and at 30, 90, and 180 days post-implantation. At the last follow-up time point, the intervention mitral valve membrane and major organs were dissected for observation. The artificial valves were taken for hematoxylin eosin (HE) staining and observed under a scanning electron microscope. Result:All six procedures were successfully completed using 29S size TruDelta TM TMVR device. At the final follow-up, echocardiogram demonstrated good valve function without obvious paravalvular leakage, with a transvalvular gradient of (7.8±3.2) mmHg (1 mmHg=0.133 kPa) and a mitral valve orifice area of (1.8±0.2) cm 2. Autopsy findings revealed no structural valve failure and almost complete endothelialization (>75%) with 90 to 180 days. Both HE staining and scanning electron microscopy confirmed optimal endothelialization of the valve stent. Conclusion:The preclinical animal study indicates that the TruDelta TM device exhibits favorable biocompatibility and durability.
10.Clinical efficacy of transcatheter edge-to-edge repair in patients with non-central degenerative mitral regurgitation
Peijian WEI ; Junke CHANG ; Jianrui MA ; Guangzhi ZHAO ; Jing DONG ; Cheng WANG ; Fengwen ZHANG ; Shiguo LI ; Fujian DUAN ; Wenbin OUYANG ; Shouzheng WANG ; Fang FANG ; Xiangbin PAN
Chinese Journal of Cardiology 2025;53(4):373-381
Objective:To evaluate the clinical efficacy of mitral valve transcatheter edge-to-edge repair (TEER) in patients with non-central degenerative mitral regurgitation (DMR).Methods:This retrospective study included patients with non-central DMR who underwent TEER at Fuwai Hospital between January 2021 and February 2024. Patients were categorized into two groups: the commissure-involved group and the non-commissure group, based on whether the mitral valve commissures were involved. Clinical data, surgical outcomes, and echocardiographic findings at 3 months postoperatively were collected and compared, and patients were followed up. The primary endpoint was the procedural success rate at discharge.Results:A total of 59 patients were included, aged (68.6±9.3) years, including 23 females (39%). In the overall study population, 78% (46/59) of patients had severe mitral regurgitation. Forty-two cases were in the non-commissure group, and 17 cases were in the commissure-involved group. Patients in the non-commissure group mainly had lesions in the A1/P1 region, while patients in the commissure-involved group mainly had lesions in the A3/P3 region. There was no significant difference in the procedural success rate at discharge (93% vs. 88%, P=0.95) and the incidence of postoperative complications (5% vs. 6%, P=1.00) between the two groups. Two patients in the commissure-involved group experienced single leaflet device attachment, with one of them requiring conversion to surgical mitral valve surgery; In the non-commissure group, two patients experienced single-valve clamping, and one of them was converted to surgical mitral valve surgery. The follow-up time of the entire cohort was (15.5±10.3) months. In the non-commissure group, 2 patients died and 2 were readmitted. While in the commissure-involved group, no patients died and only 1 patient was readmitted. Conclusion:TEER is an effective treatment for patients with non-central DMR involving the commissures, without increasing the incidence of postoperative complications.

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