1.Effectiveness of Transcatheter Closure Treatment of Ventricular Septal Defect Without Distance From the Aortic Valve With Eccentric Occluder
Zirui SUN ; Yu HAN ; Shubo SONG ; Yan HAN ; Lele BEN ; Taibing FAN ; Gejun ZHANG
Chinese Circulation Journal 2025;40(8):795-798
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.
2.The effectiveness and safety of a fully biodegradable occluder for the treatment of ventricular septal defects through percutaneous and transthoracic surgical approaches
Siyang FAN ; Liyun ZHAO ; Bin LI ; Juan CONG ; Chongyang YAN ; Yuhang CAO ; Guangyuan SONG ; Shubo SONG
Chinese Journal of Applied Clinical Pediatrics 2025;40(7):509-514
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.
3.Effectiveness of Transcatheter Closure Treatment of Ventricular Septal Defect Without Distance From the Aortic Valve With Eccentric Occluder
Zirui SUN ; Yu HAN ; Shubo SONG ; Yan HAN ; Lele BEN ; Taibing FAN ; Gejun ZHANG
Chinese Circulation Journal 2025;40(8):795-798
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.
4.The effectiveness and safety of a fully biodegradable occluder for the treatment of ventricular septal defects through percutaneous and transthoracic surgical approaches
Siyang FAN ; Liyun ZHAO ; Bin LI ; Juan CONG ; Chongyang YAN ; Yuhang CAO ; Guangyuan SONG ; Shubo SONG
Chinese Journal of Applied Clinical Pediatrics 2025;40(7):509-514
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.
5.Characteristic changes in blood routine and peripheral blood lymphocyte subpopulations in recipients of different types of rejection
Shuaiyu LUO ; Manhua NIE ; Lei SONG ; Yixin XIE ; Mingda ZHONG ; Shubo TAN ; Rong AN ; Pan LI ; Liang TAN ; Xubiao XIE
Journal of Central South University(Medical Sciences) 2024;49(3):417-425
Objective:Rejection remains the most important factor limiting the survival of transplanted kidneys.Although a pathological biopsy of the transplanted kidney is the gold standard for diagnosing rejection,its limitations prevent it from being used as a routine monitoring method.Recently,peripheral blood lymphocyte subpopulation testing has become an important means of assessing the body's immune system,however,its application value and strategy in the field of kidney transplantation need further exploration.Additionally,the development and utilization of routine test parameters are also important methods for exploring diagnostic strategies and predictive models for kidney transplant diseases.This study aims to explore the correlation between peripheral blood lymphocyte subpopulations and T cell-mediated rejection(TCMR)and antibody-mediated rejection(ABMR),as well as their diagnostic value,in conjunction with routine blood tests. Methods:A total of 154 kidney transplant recipients,who met the inclusion and exclusion criteria and were treated at the Second Xiangya Hospital of Central South University from January to December,2021,were selected as the study subjects.They were assigned into a stable group,a TCMR group,and an ABMR group,based on the occurrence and type of rejection.The basic and clinical data of these recipients were retrospectively analyzed and compared among the 3 groups.The transplant kidney function,routine blood tests,and peripheral blood lymphocyte subpopulation data of the TCMR group and the ABMR group before rejection treatment were compared with those of the stable group. Results:The stable,TCMR group,and ABMR group showed no statistically significant differences in immunosuppressive maintenance regimens or sources of transplanted kidneys(all P>0.05).However,the post-transplant duration was significantly longer in the ABMR group compared with the stable group(P<0.001)and the TCMR group(P<0.05).Regarding kidney function,serum creatinine levels in the ABMR group were higher than in the stable group and the TCMR group(both P<0.01),with the TCMR group also showing higher levels than the stable group(P<0.01).Both TCMR and ABMR groups had significantly higher blood urea nitrogen levels than the stable group(P<0.01),with no statistically significant difference between TCMR and ABMR groups(P>0.05).The estimated glomerular filtration rate(eGFR)was lower in both TCMR and ABMR groups compared with the stable group(both P<0.01).In routine blood tests,the ABMR group had lower hemoglobin,red blood cell count,and platelet count than the stable group(all P<0.05).The TCMR group had higher neutrophil percentage(P<0.05)and count(P<0.05)than the stable group,and the ABMR group had a higher neutrophil percentage than the stable group(P<0.05).The eosinophil percentage and count in the TCMR group were lower than in the stable and ABMR groups(all P<0.05).Both TCMR and ABMR groups had lower basophil percentage and count,as well as lower lymphocyte percentage and count,compared with the stable group(all P<0.05).There were no significant differences in monocyte percentage and count among the 3 groups(all P>0.05).In lymphocyte subpopulations,the TCMR and ABMR groups had lower counts of CD45+cells and T cells compared with the stable group(all P<0.05).The TCMR group also had lower counts of CD4+T cells,NK cells,and B cells than the stable group(all P<0.05).There were no significant differences in the T cell percentage,CD4+T cell percentage,CD8+T cell percentage and their counts,CD4+/CD8+T cell ratio,NK cell percentage,and B cell percentage among the stable,TCMR,and ABMR groups(all P>0.05). Conclusion:The occurrence of rejection leads to impaired transplant kidney function,accompanied by characteristic changes in some parameters of routine blood tests and peripheral blood lymphocyte subpopulations in kidney transplant recipients.The different characteristics of changes in some parameters of routine blood tests and peripheral blood lymphocyte subpopulations during TCMR and ABMR may help predict and diagnose rejection and differentiate between TCMR and ABMR.
6.In vitro bench testing using patient-specific 3D models for percutaneous pulmonary valve implantation with Venus P-valve
Yu HAN ; Zehua SHAO ; Zirui SUN ; Yan HAN ; Hongdang XU ; Shubo SONG ; Xiangbin PAN ; De Jaegere Peter P. T. ; Taibing FAN ; Gejun ZHANG
Chinese Medical Journal 2024;137(8):990-996
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.
7.Early and mid-term outcomes of aortic valvuloplasty in children
Weijie LIANG ; Maozheng XUAN ; Jiangzhen LI ; Dong LIANG ; Liyun ZHAO ; Sijie ZHOU ; Shubo SONG ; Bin LI ; Manman HU ; Taibing FAN
Chinese Journal of Applied Clinical Pediatrics 2023;38(9):681-685
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.
8.Medium-term follow-up of percutaneous pulmonary valve implantation using the Venus-P self-expanding valve
Shubo SONG ; Taibing FAN ; Yu HAN ; Weijie LIANG ; Bin LI ; Kaiyuan WU ; Lin LIU ; Dong LIANG ; Gejun ZHANG ; Xiangbin PAN
Chinese Journal of Applied Clinical Pediatrics 2022;37(2):98-102
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.
9.Recent clinical development of minimally invasive closure for atrial septal defect
Qi ZHOU ; Yu HAN ; Shubo SONG ; Taibing FAN ; Xiangbin PAN
Chinese Journal of Clinical Thoracic and Cardiovascular Surgery 2021;28(12):1508-1512
Atrial septal defect (ASD) is a congenital heart disease that causes blood communication between the left and right ventricles due to partial atrial septal tissue defects, accounting for about 13% of all heart malformations. Secondary ASD is the most common type of ASD and can generally be treated with minimally invasive closure. At present, the commonly used minimally invasive methods in clinical practice mainly include X-ray-guided percutaneous occlusion, transesophageal ultrasound-guided transthoracic occlusion and ultrasound-guided percutaneous occlusion. This review focuses on the basic research process of occluder materials, and advantages and disadvantages of three different surgical methods.
10.Effect of stage 1 repair of coarctation of aorta combined with cardiac anomalies and analysis of median follow-up finding
Weijie LIANG ; Taibing FAN ; Liyun ZHAO ; Bin LI ; Shubo SONG ; Haoju DONG ; Sijie ZHOU
Chinese Journal of Applied Clinical Pediatrics 2018;33(23):1785-1787
Objective To summarize the outcomes and the median follow -up finding of stage 1 surgical approaches of coarctation of aorta(CoA)combined with cardiac anomalies.Methods A retrospective study was per-formed for summarizing the operative and follow-up finding of 82 patients(40 males and 42 females)of CoA combined with cardiac anomalies,who underwent stage 1 repair from February 2013 to December 2016 at the Department of Cardio-vascular Surgery,Henan Provincial People's Hospital.The operative age was ranged from 1 month to 8 years old[mean (11.92 ± 22. 51)months]and the weight was (7.31 ± 6.79)kg. Forty -five cases had ventricular septal defect (VSD)or atrial septal defect (ASD).Septal defect and patent ductus arteriosus were found in 31 patients.CoA was associated with aortic arch hypoplasia in 5 patients.Complex cardiovascular deformity was found in 7 cases.The surgical methods included end-to-end anastomosis,end-to-side anastomosis and patch augmentation of the coarctation seg-ment.Results Seven patients died after operation,3 cases of them died of low cardiac output syndrome amd circulatory failure,1 case died of circulatory failure and respiratory failure,1 patient died of malignant arrhythmia,and 2 cases died of respiratory failure.Postoperative echocardiogram suggested that anastomosis maintained patency in all the patients. The follow-up time was 8 months to 4 years,63 patients were followed up,and follow-up rate was 77%.No death or aneurysm occurred during follow-up period.Recoarctation was found in 5 cases.Conclusions Stage 1 repair for CoA combined with cardiac anomalies is effective,and has low complications during postoperative and median follow-up period.Long-term results need further study.

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