新型完全生物可吸收封堵器经导管封堵膜周部室间隔缺损:一项多中心前瞻性随机对照研究

生物可吸收封堵器的应用有望降低传统金属封堵器并发症的风险.之前研制的生物可吸收封堵器存在不完全降解的局限性并导致新的并发症,因此目前尚未有相关产品获批上市.本研究使用了一种新型完全可吸收封堵器,旨在探索完全可吸收封堵器治疗室间隔缺损的疗效和安全性.从2019年4月到2020年1月,本研究在七个医学中心入组125名膜周部室间隔缺损患者,经筛查后108名患者被纳入研究并随机分为植入生物可吸收封堵器实验组和金属封堵器组.所有受试者均成功植入封堵器并完成24个月的随访.生物可吸收封堵器组患者经胸超声心动图显示高亮回声在24个月内逐渐消失,说明可吸收封堵器在体内实现完全降解.对比金属封堵器,实验组器械相关心律失常发生率(5.56%vs.14.81%,P=0.112)和持续传导阻滞发生率(0/54 vs.6/54,P=0.036)显著降低.本研究提示新型完全可吸收封堵器可以在单纯超声引导下实现成功植入,同时降低术后永久性心律失常的发生率.

经导管缘对缘二尖瓣修复:历史、现状与未来

Mitral valve regurgitation(MR)is a common heart valve disease that affects>10%of the elderly population.Epidemiological data estimate that the number of MR patients has reached more than2.5 million in the USA,with an extremely low surgical intervention rate(<5%)[1].

Thirty-day Outcomes of First-in-man Implantation of a Novel Transcatheter Edge-to-edge Mitral Repair System in Patients With Severe Mitral Regurgitation

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.

First-in-man Experience of a New Transcatheter Edge-to-edge Repair System Neoblazar in Patients With Severe Tricuspid Regurgitation

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.