Background:Transcatheter closure(TCC)has emerged as the preferred treatment for selected congenital heart disease(CHD).While TCC offers benefits for patients with postoperative residual shunts,understanding its mid-and...Background:Transcatheter closure(TCC)has emerged as the preferred treatment for selected congenital heart disease(CHD).While TCC offers benefits for patients with postoperative residual shunts,understanding its mid-and long-term efficacy and safety remains crucial.Objective:This study aims to assess the mid-and long-term safety and efficacy of TCC for patients with residual atrial or ventricular septal shunts following CHD correction.Methods:In this consecutive retrospective study,we enrolled 35 patients with residual shunt who underwent TCC or surgical repair of CHD between June 2011 to October 2022.TCC candidacy was determined based on established criteria.Echocardiography and electrocardiogram were conducted during the perioperative period and continued as part of long-term follow-up.Results:Among the patients,5(14.3%)exhibited interatrial shunt-ing,while 30(85.7%)had interventricular shunting.TCC was successfully implemented in 33 of 35 patients,with exceptions in two cases of post-ventricular septal defect repair due to anatomical challenges involving the shape and aortic angulation.This resulted in a TCC success rate of 94.3%.Trace residual shunt was detected in two interventricular shunting cases and a mild residual shunt in one interventricular shunting case;all resolved by the three-month follow-up after TCC.Minor complications included one hematoma at the puncture site and one transient junctional rhythm during the perioperative period.During a median follow-up of 73 months,there were no instances of residual shunt,device embolization,occluder displacement,valve insufficiency,malignant arrhythmia,infective endocarditis,death,or other serious complications.Conclusion:TCC is an effective and safe therapy for patients with residual atrial or ventricular septal shunts following CHD correction.Thesefindings support the consideration of TCC as the preferred treatment option for appropriate patient populations.展开更多
objective:Severe tricuspid regurgitation frequently leads to increased mortality and a poor prognosis.Transcatheter edge-to-edge repair(TEER)for tricuspid valve regurgitation has been reported as a safe alternative to...objective:Severe tricuspid regurgitation frequently leads to increased mortality and a poor prognosis.Transcatheter edge-to-edge repair(TEER)for tricuspid valve regurgitation has been reported as a safe alternative to traditional open-heart surgery.This study endeavors to assess the efficacy and safety of a newly designed Neoblazar TEER system in this high-risk population.Methods:This investigation was structured as a prospective,single-arm,first-in-man trial in China(ClinicalTrials.gov number:NCT05497141).From August 2022 to October 2022,patients with severe tricuspid regurgitation were enrolled from 3 centers(Xiamen Cardiovascular Hospital,Fuwai Yunnan Cardiovascular Hospital,and Wuhan Union Hospital).The primary endpoint was achieving a minimum 1-grade reduction in tricuspid regurgitation at the 6-month post-TEER intervention,in addition to the pertinent New York Heart Association class.Scheduled echocardiographic evaluations were conducted at the following distinct intervals:baseline,discharge,1 month,and 6 months post-TEER intervention.Results:A total of 10 patients were enrolled in the study.Immediately after the TEER procedure with the Neoblazar system,massive tricuspid regurgitation(grade 5+)at baseline decreased to moderate-severe tricuspid regurgitation(grade 3+)in 2 patients and the optimal tricuspid regurgitation reduction(severe tricuspid regurgitation(grade 4+)to mild tricuspid regurgitation(grade 1+)were achieved in 6 patients.After 6 months of follow-up,tricuspid regurgitation reduction was found to be durable in all enrolled patients,among whom at least 1 grade of tricuspid regurgitation reduction was sustained,even without reintervention.Consistently,the New York Heart Association class among these subjects significantly improved,with the percentage of patients categorized as class I-ll increasing from 0/10 at baseline to 5/10 after 1 month(P=0.015)and 8/10 after 6 months(P<0.001).Conclusion:Tricuspid TEER with the newly designed Neoblazar system appears to be a feasible and safe alternative in treating patients with severe tricuspid regurgitation.However,the implementation of larger and more robust randomized trials is still necessary for further verification of the potential benefits.展开更多
Objective To analyze whether association of edge to edge valve repair with artificial ring annuloplasty would result in better results in patients with severe tricuspid regurgitation (TR) . Methods From April,2001 to ...Objective To analyze whether association of edge to edge valve repair with artificial ring annuloplasty would result in better results in patients with severe tricuspid regurgitation (TR) . Methods From April,2001 to May, 2010,41 patients underwent tricuspid valve repair to treat severe TR were studied. Twenty-one patients were done artificial ring annuloplasty alone (group R) and twenty patients were done artificial ring annuloplasty associated with edge to edge valve repair (group E) . All the展开更多
Objectives:The aim of this multicenter,prospective,single-arm pilot study(ClinicalTrials.gov number:NCT05040074)was to observe the procedural and 30-day results of the novel transcatheter mitral valve repair system,SQ...Objectives:The aim of this multicenter,prospective,single-arm pilot study(ClinicalTrials.gov number:NCT05040074)was to observe the procedural and 30-day results of the novel transcatheter mitral valve repair system,SQ-Kyrin■-M Clip(Shenqi Medical,Shanghai,China),in patients with severe mitral regurgitation(MR).Methods:The heart team considered patients from 5 centers in China with clinically significant functional mitral regurgitation≥3+despite optimal medical therapy or degenerative mitral regurgitation≥3+with high surgical risk as candidates for transcatheter repair.All patients received transcatheter edge-to-edge mitral valve repair under general anesthesia.The primary outcome was technical success,which included all of the following measured at the exit from the catheterization laboratory:(1)absence of procedural mortality;(2)successful access,delivery,and retrieval of the device delivery system;(3)successful deployment and correct positioning of the frst intended device;and(4)no emergency surgery or reintervention related to the device or access procedure.The secondary outcomes included all-cause mortality,serious adverse events,device success,and procedural success 30 d after the intervention.Results:From June 2021 to December 2021,18 patients were enrolled in this study with age(75.7±7.4)years.Fifteen patients had MR 4+,while 3 had MR 3+.Technical success was achieved in all patients,including 6 degenerative mitral regurgitation and 12 functional mitral regurgitation patients.There was no all-cause mortality at 30 d.One patient had single leaflet device attachment within 30 d,which was regarded as a serious adverse event,and the patient was successfully treated with reintervention by implanting another clip.Another patient's transmitral gradient was 6 mmHg(>5 mmHg),with an effective orifice area of 2.57 cm^(2) after the procedure.Sixteen patients had device success and procedural success at 30 d postoperation.Fourteen patients had MR 1+,3 had MR 2+,and only 1 patient had MR 3+30 d after the procedure.Conclusions:The results of this feasibility study showed the efficacy and safety of the SQ-Kyrin■-M device in the Chinese population with severe MR,laying a solid foundation for a subsequent large-scale confirmatory study.展开更多
文摘Background:Transcatheter closure(TCC)has emerged as the preferred treatment for selected congenital heart disease(CHD).While TCC offers benefits for patients with postoperative residual shunts,understanding its mid-and long-term efficacy and safety remains crucial.Objective:This study aims to assess the mid-and long-term safety and efficacy of TCC for patients with residual atrial or ventricular septal shunts following CHD correction.Methods:In this consecutive retrospective study,we enrolled 35 patients with residual shunt who underwent TCC or surgical repair of CHD between June 2011 to October 2022.TCC candidacy was determined based on established criteria.Echocardiography and electrocardiogram were conducted during the perioperative period and continued as part of long-term follow-up.Results:Among the patients,5(14.3%)exhibited interatrial shunt-ing,while 30(85.7%)had interventricular shunting.TCC was successfully implemented in 33 of 35 patients,with exceptions in two cases of post-ventricular septal defect repair due to anatomical challenges involving the shape and aortic angulation.This resulted in a TCC success rate of 94.3%.Trace residual shunt was detected in two interventricular shunting cases and a mild residual shunt in one interventricular shunting case;all resolved by the three-month follow-up after TCC.Minor complications included one hematoma at the puncture site and one transient junctional rhythm during the perioperative period.During a median follow-up of 73 months,there were no instances of residual shunt,device embolization,occluder displacement,valve insufficiency,malignant arrhythmia,infective endocarditis,death,or other serious complications.Conclusion:TCC is an effective and safe therapy for patients with residual atrial or ventricular septal shunts following CHD correction.Thesefindings support the consideration of TCC as the preferred treatment option for appropriate patient populations.
基金National Key Researchand Development Program(2022YFC2503400)Yunnan Provincial Clinical Research Center for Cardiovascular Diseases(202302AA310045).
文摘objective:Severe tricuspid regurgitation frequently leads to increased mortality and a poor prognosis.Transcatheter edge-to-edge repair(TEER)for tricuspid valve regurgitation has been reported as a safe alternative to traditional open-heart surgery.This study endeavors to assess the efficacy and safety of a newly designed Neoblazar TEER system in this high-risk population.Methods:This investigation was structured as a prospective,single-arm,first-in-man trial in China(ClinicalTrials.gov number:NCT05497141).From August 2022 to October 2022,patients with severe tricuspid regurgitation were enrolled from 3 centers(Xiamen Cardiovascular Hospital,Fuwai Yunnan Cardiovascular Hospital,and Wuhan Union Hospital).The primary endpoint was achieving a minimum 1-grade reduction in tricuspid regurgitation at the 6-month post-TEER intervention,in addition to the pertinent New York Heart Association class.Scheduled echocardiographic evaluations were conducted at the following distinct intervals:baseline,discharge,1 month,and 6 months post-TEER intervention.Results:A total of 10 patients were enrolled in the study.Immediately after the TEER procedure with the Neoblazar system,massive tricuspid regurgitation(grade 5+)at baseline decreased to moderate-severe tricuspid regurgitation(grade 3+)in 2 patients and the optimal tricuspid regurgitation reduction(severe tricuspid regurgitation(grade 4+)to mild tricuspid regurgitation(grade 1+)were achieved in 6 patients.After 6 months of follow-up,tricuspid regurgitation reduction was found to be durable in all enrolled patients,among whom at least 1 grade of tricuspid regurgitation reduction was sustained,even without reintervention.Consistently,the New York Heart Association class among these subjects significantly improved,with the percentage of patients categorized as class I-ll increasing from 0/10 at baseline to 5/10 after 1 month(P=0.015)and 8/10 after 6 months(P<0.001).Conclusion:Tricuspid TEER with the newly designed Neoblazar system appears to be a feasible and safe alternative in treating patients with severe tricuspid regurgitation.However,the implementation of larger and more robust randomized trials is still necessary for further verification of the potential benefits.
文摘Objective To analyze whether association of edge to edge valve repair with artificial ring annuloplasty would result in better results in patients with severe tricuspid regurgitation (TR) . Methods From April,2001 to May, 2010,41 patients underwent tricuspid valve repair to treat severe TR were studied. Twenty-one patients were done artificial ring annuloplasty alone (group R) and twenty patients were done artificial ring annuloplasty associated with edge to edge valve repair (group E) . All the
基金supported by the National Key Project of Research and Development Plan during the fourteenth Five-year Plan Period(2022YFC2503400).
文摘Objectives:The aim of this multicenter,prospective,single-arm pilot study(ClinicalTrials.gov number:NCT05040074)was to observe the procedural and 30-day results of the novel transcatheter mitral valve repair system,SQ-Kyrin■-M Clip(Shenqi Medical,Shanghai,China),in patients with severe mitral regurgitation(MR).Methods:The heart team considered patients from 5 centers in China with clinically significant functional mitral regurgitation≥3+despite optimal medical therapy or degenerative mitral regurgitation≥3+with high surgical risk as candidates for transcatheter repair.All patients received transcatheter edge-to-edge mitral valve repair under general anesthesia.The primary outcome was technical success,which included all of the following measured at the exit from the catheterization laboratory:(1)absence of procedural mortality;(2)successful access,delivery,and retrieval of the device delivery system;(3)successful deployment and correct positioning of the frst intended device;and(4)no emergency surgery or reintervention related to the device or access procedure.The secondary outcomes included all-cause mortality,serious adverse events,device success,and procedural success 30 d after the intervention.Results:From June 2021 to December 2021,18 patients were enrolled in this study with age(75.7±7.4)years.Fifteen patients had MR 4+,while 3 had MR 3+.Technical success was achieved in all patients,including 6 degenerative mitral regurgitation and 12 functional mitral regurgitation patients.There was no all-cause mortality at 30 d.One patient had single leaflet device attachment within 30 d,which was regarded as a serious adverse event,and the patient was successfully treated with reintervention by implanting another clip.Another patient's transmitral gradient was 6 mmHg(>5 mmHg),with an effective orifice area of 2.57 cm^(2) after the procedure.Sixteen patients had device success and procedural success at 30 d postoperation.Fourteen patients had MR 1+,3 had MR 2+,and only 1 patient had MR 3+30 d after the procedure.Conclusions:The results of this feasibility study showed the efficacy and safety of the SQ-Kyrin■-M device in the Chinese population with severe MR,laying a solid foundation for a subsequent large-scale confirmatory study.
