Objectives:To evaluate the feasibility and clinical efficacy of eccentric occluder for the treatment of ventricular septal defect(VSD)without distance from the aortic valve.Methods:This analysis included 16 patients(9 males and 7 females)with VSD without distance from the aortic valve,who were treated at Fuwai Central China Cardiovascular Hospital from February 2022 to June 2024.Ten cases had mild right coronary sinus prolapse,and 2 had mild aortic valve regurgitation.All patients were diagnosed with VSD located zero-distance from aortic valve through transthoracic echocardiography(TTE)and left ventricular angiography.Eccentric occluder was used for interventional closure.TTE and 12-lead electrocardiography(ECG)were performed at 1 month,3 months,and 6 months after surgery to observe the presence of residual shunt,aortic valve regurgitation,and cardiac electrical conduction abnormalities.Results:Transcatheter closure was successful in 15 patients,procedure failed in one patient due to the unstable fixation of the occluder.Average diameter of the defect is(4.37±1.53)mm,and the diameter of the occluder is 6.5(6.0,8.0)mm.Postoperative left ventricular angiography showed minimal residual shunt in 3 cases,and no complications such as pericardial tamponade,hemolysis,thromboembolism,or infection,were observed.At one month after occlusion,TTE results showed that residual shunt disappeared in 3 patients with residual shunt.During 3-month and 6-month follow-up,all the occluders were well-positioned with no new aortic valve regurgitation or worsening of the original regurgitation,and no atrioventricular block or bundle branch block and other electrocardiographic conduction abnormalities.Conclusions:The use of eccentric occluder for intervention of ventricular septal defect patients without distance from the aortic valve is safe and effective.

Objective:To analyze the efficacy and safety of a fully biodegradable occluder for the treatment of ventricular septal defects through percutaneous and transthoracic strategies.Methods:A case series study was conducted.The clinical data of 38 pediatric patients with a ventricular septal defect treated with a fully biodegradable occluder at Central China Fuwai Hospital from January 2023 to July 2024 were retrospectively analyzed.Among these patients, 15 received the percutaneous approach(percutaneous approach group) and the other 23 adopted the transthoracic approach(transthoracic approach group).The diagnosis was confirmed by transthoracic echocardiography before operation in all patients.The percutaneous approach was defined as establishing a venous-arterial track through X-ray and then placing an occluder under the guidance of transthoracic echocardiograph.The transthoracic approach was achieved by establishing a delivery track with a special hollow bougie through a small right subaxillary incision under the real-time guidance of esophageal ultrasound and then delivery and put an occluder.The clinical data of the patients, including general characteristics, electrocardiograms, echocardiograms and the biodegradable occluder system were collected and analyzed.Categorical variables were tested using the chi-square or Fisher′s exact test.Continuous variables were verified using the t-test or Mann-Whitney U test. Results:The patients were aged (5.7±3.9) years on average, with an average weight of 19.5(14.9, 25.9) kg.There were 39.5%(15 cases) of males among the patients included.The average size of the ventricular septal defect was 4.1(4.0, 5.0) mm.A simple perimembrane ventricular septal defect was detected in 29 patients (76.3%), concomitant membranous aneurysm in 4 patients (10.5%), an intracristal ventricular septal defect in 3 patients (7.9%), and a muscular ventricular septal defect in 2 patients (5.3%).Preoperative aortic and tricuspid valve regurgitations accounted for 5.3%(2/38) and 81.6%(31/38), respectively.The average age was (9.0±3.9) years in the percutaneous approach group and (3.6±1.9) years in the transthoracic approach group.In terms of the cardiac structure, the percutaneous approach group had smaller Z values of the left atrial anterior-to-posterior diameter (-0.5±0.6 vs.0.5±1.0, P<0.01) and the left ventricular end-diastolic diameter (-0.5±1.1 vs.0.8±0.8, P<0.01), and a smaller ventricular septal defect [4.0(3.9, 4.2) mm vs.4.5(4.0, 5.5) mm, P=0.01] than the transthoracic approach group.Regarding the operation, the percutaneous approach group had a larger difference between the waist diameter of the selected occluder and the diameter of the ventricular septal defect [2.8(2.0, 3.0) mm vs.2.0(1.5, 2.5) mm, P=0.02], shorter operative time [(61.5±27.3) minutes vs.(91.5±31.4) minutes, P=0.01], and a shorter hospital stay [8(5, 9) days vs.12(9, 15) days, P<0.01] than the transthoracic approach group.Both groups achieved immediate occlusion postoperatively, with no residual shunts and no grade Ⅲ atrioventricular conduction block.Five new cases of bundle branch blocks and 1 case of trivial aortic valve regurgitation occurred in the transthoracic approach group. Conclusions:Both percutaneous and transthoracic approaches are safe and effective in interventional closure of ventricular septal defects, but the former is more applicable to slightly older or heavier patients with a smaller ventricular septal defect, who need a larger occluder.

Objective:To analyze the efficacy and safety of a fully biodegradable occluder for the treatment of ventricular septal defects through percutaneous and transthoracic strategies.Methods:A case series study was conducted.The clinical data of 38 pediatric patients with a ventricular septal defect treated with a fully biodegradable occluder at Central China Fuwai Hospital from January 2023 to July 2024 were retrospectively analyzed.Among these patients, 15 received the percutaneous approach(percutaneous approach group) and the other 23 adopted the transthoracic approach(transthoracic approach group).The diagnosis was confirmed by transthoracic echocardiography before operation in all patients.The percutaneous approach was defined as establishing a venous-arterial track through X-ray and then placing an occluder under the guidance of transthoracic echocardiograph.The transthoracic approach was achieved by establishing a delivery track with a special hollow bougie through a small right subaxillary incision under the real-time guidance of esophageal ultrasound and then delivery and put an occluder.The clinical data of the patients, including general characteristics, electrocardiograms, echocardiograms and the biodegradable occluder system were collected and analyzed.Categorical variables were tested using the chi-square or Fisher′s exact test.Continuous variables were verified using the t-test or Mann-Whitney U test. Results:The patients were aged (5.7±3.9) years on average, with an average weight of 19.5(14.9, 25.9) kg.There were 39.5%(15 cases) of males among the patients included.The average size of the ventricular septal defect was 4.1(4.0, 5.0) mm.A simple perimembrane ventricular septal defect was detected in 29 patients (76.3%), concomitant membranous aneurysm in 4 patients (10.5%), an intracristal ventricular septal defect in 3 patients (7.9%), and a muscular ventricular septal defect in 2 patients (5.3%).Preoperative aortic and tricuspid valve regurgitations accounted for 5.3%(2/38) and 81.6%(31/38), respectively.The average age was (9.0±3.9) years in the percutaneous approach group and (3.6±1.9) years in the transthoracic approach group.In terms of the cardiac structure, the percutaneous approach group had smaller Z values of the left atrial anterior-to-posterior diameter (-0.5±0.6 vs.0.5±1.0, P<0.01) and the left ventricular end-diastolic diameter (-0.5±1.1 vs.0.8±0.8, P<0.01), and a smaller ventricular septal defect [4.0(3.9, 4.2) mm vs.4.5(4.0, 5.5) mm, P=0.01] than the transthoracic approach group.Regarding the operation, the percutaneous approach group had a larger difference between the waist diameter of the selected occluder and the diameter of the ventricular septal defect [2.8(2.0, 3.0) mm vs.2.0(1.5, 2.5) mm, P=0.02], shorter operative time [(61.5±27.3) minutes vs.(91.5±31.4) minutes, P=0.01], and a shorter hospital stay [8(5, 9) days vs.12(9, 15) days, P<0.01] than the transthoracic approach group.Both groups achieved immediate occlusion postoperatively, with no residual shunts and no grade Ⅲ atrioventricular conduction block.Five new cases of bundle branch blocks and 1 case of trivial aortic valve regurgitation occurred in the transthoracic approach group. Conclusions:Both percutaneous and transthoracic approaches are safe and effective in interventional closure of ventricular septal defects, but the former is more applicable to slightly older or heavier patients with a smaller ventricular septal defect, who need a larger occluder.

Objectives:To evaluate the feasibility and clinical efficacy of eccentric occluder for the treatment of ventricular septal defect(VSD)without distance from the aortic valve.Methods:This analysis included 16 patients(9 males and 7 females)with VSD without distance from the aortic valve,who were treated at Fuwai Central China Cardiovascular Hospital from February 2022 to June 2024.Ten cases had mild right coronary sinus prolapse,and 2 had mild aortic valve regurgitation.All patients were diagnosed with VSD located zero-distance from aortic valve through transthoracic echocardiography(TTE)and left ventricular angiography.Eccentric occluder was used for interventional closure.TTE and 12-lead electrocardiography(ECG)were performed at 1 month,3 months,and 6 months after surgery to observe the presence of residual shunt,aortic valve regurgitation,and cardiac electrical conduction abnormalities.Results:Transcatheter closure was successful in 15 patients,procedure failed in one patient due to the unstable fixation of the occluder.Average diameter of the defect is(4.37±1.53)mm,and the diameter of the occluder is 6.5(6.0,8.0)mm.Postoperative left ventricular angiography showed minimal residual shunt in 3 cases,and no complications such as pericardial tamponade,hemolysis,thromboembolism,or infection,were observed.At one month after occlusion,TTE results showed that residual shunt disappeared in 3 patients with residual shunt.During 3-month and 6-month follow-up,all the occluders were well-positioned with no new aortic valve regurgitation or worsening of the original regurgitation,and no atrioventricular block or bundle branch block and other electrocardiographic conduction abnormalities.Conclusions:The use of eccentric occluder for intervention of ventricular septal defect patients without distance from the aortic valve is safe and effective.

Background::Due to the wide variety of morphology, size, and dynamics, selecting an optimal valve size and location poses great difficulty in percutaneous pulmonary valve implantation (PPVI). This study aimed to report our experience with in vitro bench testing using patient-specific three-dimensional (3D)-printed models for planning PPVI with the Venus P-valve. Methods::Patient-specific 3D soft models were generated using PolyJet printing with a compliant synthetic material in 15 patients scheduled to undergo PPVI between July 2018 and July 2020 in Central China Fuwai Hospital of Zhengzhou University.Results::3D model bench testing altered treatment strategy in all patients (100%). One patient was referred for surgery because testing revealed that even the largest Venus P-valve would not anchor properly. In the remaining 14 patients, valve size and/or implantation location was altered to avoid valve migration and/or compression coronary artery. In four patients, it was decided to change the point anchoring because of inverted cone-shaped right ventricular outflow tract (RVOT) ( n = 2) or risk of compression coronary artery ( n = 2). Concerning sizing, we found that an oversize of 2-5 mm suffices. Anchoring of the valve was dictated by the flaring of the in- and outflow portion in the pulmonary artery. PPVI was successful in all 14 patients (absence of valve migration, no coronary compression, and none-to-mild residual pulmonary regurgitation [PR]). The diameter of the Venus P-valve in the 3D simulation group was significantly smaller than that of the conventional planning group (36 [2] vs. 32 [4], Z = -3.77, P <0.001). Conclusions::In vitro testing indicated no need to oversize the Venus P-valve to the degree recommended by the balloon-sizing technique, as 2-5 mm sufficed.

BACKGROUND: The KangDuo-Surgical Robot-01 (KD-SR-01) system is a new surgical robot recently developed in China. The aim of this study was to present our single-center experience and mid-term outcomes of urological procedures using the KD-SR-01 system. METHODS: From August 2020 to April 2023, consecutive urologic procedures were performed at Peking University First Hospital using the KD-SR-01 system. The clinical features, perioperative data, and follow-up outcomes were prospectively collected and analyzed. RESULTS: A total of 110 consecutive patients were recruited. Among these patients, 28 underwent partial nephrectomy (PN), 41 underwent urinary tract reconstruction (26 underwent pyeloplasty, 3 underwent ureteral reconstruction and 12 underwent ureterovesical reimplantation [UR]), and 41 underwent radical prostatectomy (RP). The median operative time for PN was 112.5 min, 157.0 min for pyeloplasty, 151.0 min for ureteral reconstruction, 142.5 min for UR, and 138.0 min for RP. The median intraoperative blood loss was 10 mL for PN, 10 mL for pyeloplasty, 30 mL for ureteral reconstruction, 20 mL for UR, and 50 mL for RP. All procedures were successfully completed without conversion, and there were no major complications in any patient. The median warm ischemia time of PN was 17.3 min, and positive surgical margin was not noted in any patient. The overall positive surgical margin rate of RP was 39% (16/41), and no biochemical recurrence was observed in any RP patient during the median follow-up of 11.0 months. The surgical success rates of pyeloplasty and UR were 96% (25/26) and 92% (11/12) during the median follow-up of 29.5 months and 11.5 months, respectively. CONCLUSION The KD-SR-01 system appears feasible, safe, and effective for most urological procedures, based on our single-center experience.
Male ; Humans ; Robotic Surgical Procedures/methods* ; Robotics ; Treatment Outcome ; Retrospective Studies ; Ureter/surgery* ; Urologic Surgical Procedures/methods* ; Laparoscopy/methods*

Objective:To analyze the short and mid-term efficacy of aortic valvuloplasty with autopericardium on children with aortic valve diseases.Methods:A total of 26 children with aortic valve diseases (stenosis or regurgitation) who underwent aortic valvuloplasty with autopericardium in Fuwai Central China Cardiovascular Hospital from September 2017 to June 2021 were retrospectively analyzed.The short-term and mid-term follow-up data were collected.The maximum aortic valve pressure gradient, subaortic regurgitation area, left ventricular end-diastolic volume (LVEDV) and left ventricular ejection fraction (LVEF) were compared before and after operation.Paired t test was used to analyze the short-term and mid-term efficacy of aortic valvuloplasty with autopericardium on children with aortic valve diseases. Results:All 26 cases were successfully operated, and there were no deaths and serious complications during the follow-up period of (22.96±6.45) months.There was a significant difference between the preoperative and postoperative maximum aortic valve pressure gradient at 1 month ( t=7.85, P<0.05), 6 months ( t=6.43, P<0.05), 1 year ( t=6.16, P<0.05) and 2 years postoperatively ( t=4.22, P<0.05) in children with aortic stenosis or that combined with mild-to-moderate closure.The follow-up data of 9 children with simple aortic stenosis showed that there was a significant difference between the preoperative (8.87±3.57) cm 2 and postoperative aortic regurgitation area at 1 month ( t=6.85, P<0.05), 6 months ( t=5.13, P<0.05), 1 year ( t=6.62, P<0.05) and 2 years postoperatively ( t=5.41, P<0.05). The LVEDV of 26 children was significantly lower at 6 months[(63.54±27.61) mL], 1 year [(53.61±20.20) mL] and 2 years postoperatively [(64.39±17.78) mL] compared with that of preoperative level[(89.42±45.89) mL]( t=3.89, 4.67, 3.58, all P<0.05). The left ventricular pressure and volume decreased, the enlarged heart was narrowed down, and the geometry of the heart was restored.The LVEF of 26 patients also from (61.65±9.67)% before surgery increased to (67.88±4.69)% 6 months after surgery( t=3.68, P<0.05), and increased to (68.62±4.46)% 1 year after surgery( t=4.01, P<0.05), and increased to (67.55±3.09)% 2 years after operation( t=3.01, P<0.05), and the heart function was improved. Conclusions:Aortic valvuloplasty with autopericardium presents an effective short and mid-term efficacy on children with aortic valve diseases, which prevents or delays the aortic valve replacement.

BACKGROUND: LY01005 (Goserelin acetate sustained-release microsphere injection) is a modified gonadotropin-releasing hormone (GnRH) agonist injected monthly. This phase III trial study aimed to evaluated the efficacy and safety of LY01005 in Chinese patients with prostate cancer. METHODS: We conducted a randomized controlled, open-label, non-inferiority trial across 49 sites in China. This study included 290 patients with prostate cancer who received either LY01005 or goserelin implants every 28 days for three injections. The primary efficacy endpoints were the percentage of patients with testosterone suppression ≤50 ng/dL at day 29 and the cumulative probability of testosterone ≤50 ng/dL from day 29 to 85. Non-inferiority was prespecified at a margin of -10%. Secondary endpoints included significant castration (≤20 ng/dL), testosterone surge within 72 h following repeated dosing, and changes in luteinizing hormone, follicle-stimulating hormone, and prostate specific antigen levels. RESULTS: On day 29, in the LY01005 and goserelin implant groups, testosterone concentrations fell below medical-castration levels in 99.3% (142/143) and 100% (140/140) of patients, respectively, with a difference of -0.7% (95% confidence interval [CI], -3.9% to 2.0%) between the two groups. The cumulative probabilities of maintaining castration from days 29 to 85 were 99.3% and 97.8%, respectively, with a between-group difference of 1.5% (95% CI, -1.3% to 4.4%). Both results met the criterion for non-inferiority. Secondary endpoints were similar between groups. Both treatments were well-tolerated. LY01005 was associated with fewer injection-site reactions than the goserelin implant (0% vs . 1.4% [2/145]). CONCLUSION: LY01005 is as effective as goserelin implants in reducing testosterone to castration levels, with a similar safety profile. TRIAL REGISTRATION ClinicalTrials.gov, NCT04563936.
Humans ; Male ; Antineoplastic Agents, Hormonal/therapeutic use* ; East Asian People ; Gonadotropin-Releasing Hormone/agonists* ; Goserelin/therapeutic use* ; Prostate-Specific Antigen ; Prostatic Neoplasms/drug therapy* ; Testosterone

Objective:To evaluate the medium-term clinical and hemodynamic outcomes of percutaneous pulmonary valve implantation (PPVI) using a domestic Venus-P self-expanding valve in the treatment of severe pulmonary regurgitation after Tetralogy of Fallot (TOF).Methods:Retrospective study.From December 2017 to December 2020, 13 TOF patients with (17.8±4.7) years old and (50.2±12.3) kg underwent PPVI using the Venus-P self-expanding valve in the Department of Children′s Heart Center, Zhengzhou University People′s Hospital were recruited.The mean valve size was (31.9±3.1) mm.All patients received the transannular patch surgery and developed severe pulmonary regurgitation.After PPVI, 13 patients were followed up for at least 12 months.The operation-related complications, improvement of valve and heart function and the durability and reintervention of the Venus-P self-expanding valve were analyzed.The right ventricular end-diastolic volume index (RVEDVi) before and after operation was compared by the paired t-test, and the New York Heart Association (NYHA) class was compared by the paired Wilcoxon signed rank sum test. Results:PPVI was successfully performed in all 13 patients without death.At 6 months post-PPVI, cardiac magnetic resonance imaging findings showed that RVEDVi was significantly reduced[(145.7±9.6) mL/m 2vs.(100.2±12.2) mL/m 2, P<0.05], and the NYHA class was significantly improved ( P<0.05). One patient presented moderate pulmonary valve regurgitation at 12 months postoperatively.No vegetation was found on echocardiography, and blood culture was negative in this case.Six patients did not have postoperative pulmonary valve regurgitation, and the remaining presented mild or less pulmonary regurgitation.One patient had sudden ventricular tachycardia on the 6 th day postoperatively, which was converted to sinus rhythm after synchronous electrocardiography.Only one case underwent appendectomy 7 months after operation due to acute appendicitis, and the remaining did not require valve-related reintervention after implantation.During the follow-up for (22.8±8.0) months, no patients had perivalve leakage, stent migration and rupture.Complications like embolization and coronary artery compression were not reported. Conclusions:PPVI using the Venus-P self-expanding valve is safe and effective in patients with severe pulmonary valve regurgitation after TOF surgery, showing an acceptable medium-term follow-up outcome.Studies with a large sample size and long follow-up period are still needed to validate our findings.