Background This preclinical study in sheep sought to demonstrate the initial safety and feasibility of a novel transcatheter mitral valve system(Mi-thos valve)composed of a self-expanding frame and a bovine pericardia...Background This preclinical study in sheep sought to demonstrate the initial safety and feasibility of a novel transcatheter mitral valve system(Mi-thos valve)composed of a self-expanding frame and a bovine pericardial tissue bioprosthesis.Methods The valve was implanted in 26 sheep using a transapical approach for short-and long-term evaluation.The technical feasibility,safety,durability,and valve function were evaluated during and 6 months after the procedure using intracardiac and transthoracic echocardiography,multisliced computed tomography,histological analysis,and electron microscopy.Results The success rate of valve implantation was 100%,and the immediate survival rate after surgery was 84%.Five animals died within 90 min after the development of the prosthetic valve due to an acute left ventricular outflow tract obstruction(n=2)and sudden intraoperative ventricular fibrillation(n=3).Twelve animals died within 1 month due to acute left heart dysfunction.Mild(n=5)and moderate(n=2)paravalvular leakage occurred in seven animals,and two moderate PVL animals died of chronic heart failure within three months.Multimodality imaging studies of the remaining seven animals showed excellent function and alignment of the valves,with no coronary artery obstruction,no left ventricular outflow tract obstruction,no severe transvalvular gradients and no paravalvular leakage.Macroscopic evaluation demonstrated stable,secure positioning of the valve,with full endothelialization of the valve leaflets without injury to the ventricular or atrial walls.Histological and electron microscopic examinations at six months showed no obvious macro-or microcalcification in the leaflets.Conclusions Preclinical studies indicate that transcatheter implantation of the Mi-thos valve is technically safe and feasible.The durability,functionality,and lack of leaflet calcification were all verified in animal experiments.The information from these preclinical studies will be applied to patient selection criteria and the first-in-human studies.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
Objective:To evaluate the feasibility,safety,and effectiveness of a novel edge-to-edge mitral valve repair system(the NovoClasp system)in patients with severe mitral regurgitation.Methods:In this prospective,single-ar...Objective:To evaluate the feasibility,safety,and effectiveness of a novel edge-to-edge mitral valve repair system(the NovoClasp system)in patients with severe mitral regurgitation.Methods:In this prospective,single-arm,first-in-human study conducted at Beijing Anzhen Hospital,data were collected from patients undergoing transcatheter edge-to-edge repair using the NovoClasp system.The study candidates were patients exhibiting a mitral regurgitation severity of 3+or more and were at high-risk or contraindicated for surgical intervention.Technical success and device success according to the Mitral Valve Academic Research Consortium definitions were used as primary outcomes.Other safety and efficacy outcomes were prospectively assessed at device implantation,discharge,and 30 d,6 months,and 12 months post-procedure.Results:Between October 1,2021,and January 31,2022,11 patients were treated for moderate-to-severe(grade 3+)or severe(grade 4+)mitral regurgitation using the NovoClasp system.All patients had a baseline New York Heart Association functional class oflll-lIV,with 7/11 exhibiting complex mitral valve disease.All patients achieved the primary endpoints of technical and device success,with a post-operative 30-d mitral regurgitation grade reduction to 2+or lower,which was maintained at 12 months.One patient had minor bleeding and hematoma at the access site before discharge,and 2 patients were readmitted due to fast atrial fibrillation within 12 months post-discharge.No additional cases of death,adverse cerebral or cardiovascular events,or device-related complications was observed during the follow-up.Conclusion:This study suggested the potential feasibility and safety of the NovoClasp system,showing a promising technical and device success rate,along with a decrease in mitral regurgitation severity.A further pivotal study is needed to assess the procedural and long-term outcomes.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
Background Repair of anterior mitral leaflet （AML） prolapse is still a technical challenge for cardiac surgeons. It is an important issue to find a way to repair the AML prolapse with a reliable and reproducible tec...Background Repair of anterior mitral leaflet （AML） prolapse is still a technical challenge for cardiac surgeons. It is an important issue to find a way to repair the AML prolapse with a reliable and reproducible technique.Methods Between January 2002 and June 2009, the operation of chordal transfer based on the ＂edge-to-edge＂technique was performed in 21 patients with serious mitral valve regurgitation because of prolapse of the anterior leaflet.After the operation, echocardiography was performed in each patient before discharge and at the time of follow-up.Results All patients survived the operation. One patient required mitral valve replacement because of anterior leaflet perforation 3 days after the operation. The other patients were free from reoperation. At the time of follow-up, all these patients were in New York Heart Association （NYHA） functional class I. In all these patients, pre-discharge and follow-up echocardiography showed neither stenosis nor significant regurgitation of the mitral valve： the cross-sectional area of the mitral valve was 3.3-4.8 cm2 （mean （3.78：±0.52） cm2）, the mean regurgitation area was （0.45：±0.22） cm2. At the same time, both dimension of left atrium and left ventricle reduced significantly （left atrium diameter： pre-operation （48.26±11.12） mm, post-operation （37.57±9.56） mm, P 〈0.05; the end-diastolic diameter of the left ventricle：pre-operation （61.43±8.24） mm, post-operation （42.35±10.79） mm, P〈0.01）.Conclusion ＂Edge-to-edge＂ chordal transfer technique is a simple, reliable, and reproducible technique that can provide good results for repair of anterior leaflet prolapse of mitral valve.展开更多
基金This paper was supported by the National Key Research and Development Plan(2016YFC1101000)National Natural Science Foundation of China(81600240 and 81470500)The Distinguished Young Scholar Cultivation Project of Xijing Hospital(XJZT14J03,XJZT15ZL01,and 13QNP129)。
文摘Background This preclinical study in sheep sought to demonstrate the initial safety and feasibility of a novel transcatheter mitral valve system(Mi-thos valve)composed of a self-expanding frame and a bovine pericardial tissue bioprosthesis.Methods The valve was implanted in 26 sheep using a transapical approach for short-and long-term evaluation.The technical feasibility,safety,durability,and valve function were evaluated during and 6 months after the procedure using intracardiac and transthoracic echocardiography,multisliced computed tomography,histological analysis,and electron microscopy.Results The success rate of valve implantation was 100%,and the immediate survival rate after surgery was 84%.Five animals died within 90 min after the development of the prosthetic valve due to an acute left ventricular outflow tract obstruction(n=2)and sudden intraoperative ventricular fibrillation(n=3).Twelve animals died within 1 month due to acute left heart dysfunction.Mild(n=5)and moderate(n=2)paravalvular leakage occurred in seven animals,and two moderate PVL animals died of chronic heart failure within three months.Multimodality imaging studies of the remaining seven animals showed excellent function and alignment of the valves,with no coronary artery obstruction,no left ventricular outflow tract obstruction,no severe transvalvular gradients and no paravalvular leakage.Macroscopic evaluation demonstrated stable,secure positioning of the valve,with full endothelialization of the valve leaflets without injury to the ventricular or atrial walls.Histological and electron microscopic examinations at six months showed no obvious macro-or microcalcification in the leaflets.Conclusions Preclinical studies indicate that transcatheter implantation of the Mi-thos valve is technically safe and feasible.The durability,functionality,and lack of leaflet calcification were all verified in animal experiments.The information from these preclinical studies will be applied to patient selection criteria and the first-in-human studies.
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.
基金This study is part of the China Degenerative Valve Disease II Cohort Study(China-DVD2 Study,NCT05044338)which is supported by the National Key R&D Program of China(2020YFC200801100).
文摘Objective:To evaluate the feasibility,safety,and effectiveness of a novel edge-to-edge mitral valve repair system(the NovoClasp system)in patients with severe mitral regurgitation.Methods:In this prospective,single-arm,first-in-human study conducted at Beijing Anzhen Hospital,data were collected from patients undergoing transcatheter edge-to-edge repair using the NovoClasp system.The study candidates were patients exhibiting a mitral regurgitation severity of 3+or more and were at high-risk or contraindicated for surgical intervention.Technical success and device success according to the Mitral Valve Academic Research Consortium definitions were used as primary outcomes.Other safety and efficacy outcomes were prospectively assessed at device implantation,discharge,and 30 d,6 months,and 12 months post-procedure.Results:Between October 1,2021,and January 31,2022,11 patients were treated for moderate-to-severe(grade 3+)or severe(grade 4+)mitral regurgitation using the NovoClasp system.All patients had a baseline New York Heart Association functional class oflll-lIV,with 7/11 exhibiting complex mitral valve disease.All patients achieved the primary endpoints of technical and device success,with a post-operative 30-d mitral regurgitation grade reduction to 2+or lower,which was maintained at 12 months.One patient had minor bleeding and hematoma at the access site before discharge,and 2 patients were readmitted due to fast atrial fibrillation within 12 months post-discharge.No additional cases of death,adverse cerebral or cardiovascular events,or device-related complications was observed during the follow-up.Conclusion:This study suggested the potential feasibility and safety of the NovoClasp system,showing a promising technical and device success rate,along with a decrease in mitral regurgitation severity.A further pivotal study is needed to assess the procedural and long-term outcomes.
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Background Repair of anterior mitral leaflet （AML） prolapse is still a technical challenge for cardiac surgeons. It is an important issue to find a way to repair the AML prolapse with a reliable and reproducible technique.Methods Between January 2002 and June 2009, the operation of chordal transfer based on the ＂edge-to-edge＂technique was performed in 21 patients with serious mitral valve regurgitation because of prolapse of the anterior leaflet.After the operation, echocardiography was performed in each patient before discharge and at the time of follow-up.Results All patients survived the operation. One patient required mitral valve replacement because of anterior leaflet perforation 3 days after the operation. The other patients were free from reoperation. At the time of follow-up, all these patients were in New York Heart Association （NYHA） functional class I. In all these patients, pre-discharge and follow-up echocardiography showed neither stenosis nor significant regurgitation of the mitral valve： the cross-sectional area of the mitral valve was 3.3-4.8 cm2 （mean （3.78：±0.52） cm2）, the mean regurgitation area was （0.45：±0.22） cm2. At the same time, both dimension of left atrium and left ventricle reduced significantly （left atrium diameter： pre-operation （48.26±11.12） mm, post-operation （37.57±9.56） mm, P 〈0.05; the end-diastolic diameter of the left ventricle：pre-operation （61.43±8.24） mm, post-operation （42.35±10.79） mm, P〈0.01）.Conclusion ＂Edge-to-edge＂ chordal transfer technique is a simple, reliable, and reproducible technique that can provide good results for repair of anterior leaflet prolapse of mitral valve.
