近日，中国医学科学院阜外医院、北京协和医学院潘湘斌团队比较了生物可吸收封堵器与金属封堵器封堵经导管心房间隔缺损对患者预后的影响。这一研究成果发表在2025年10月23日出版的《美国医学会杂志》上。

用于房间隔缺损（ASD）闭合的永久性金属闭塞器与晚期并发症的风险相关，并可能阻碍左心房的通道。生物可吸收封堵器有潜力解决这些局限性，但尚未在随机临床试验中得到验证。

为了评估生物可吸收封堵器在经导管ASD封闭中的有效性和安全性是否优于金属封堵器，研究组进行了一项多中心、非劣效性、开放标签随机临床试验，纳入了继发性ASD患者。研究于2021年5月8日至2022年8月3日在中国的10家医院进行。为期两年的随访期于2024年9月结束。将参与者按1:1的比例随机分配，接受生物可吸收闭塞器（n=116)或金属闭塞器（n=114）。主要结局是6个月时ASD关闭的成功率（关闭成功定义为手术成功，残余分流直径≤2mm，通过经胸超声心动图评估）。在2年的随访中，比较了封堵器组在ASD关闭成功率和设备相关不良事件方面的差异。在2年时评估生物可吸收封堵剂的降解情况。

在随机分配的230名参与者中，生物可吸收封堵器组中有1名参与者因股静脉狭窄而未尝试植入，其余229名参与者（中位年龄14.1岁[IQR， 7.0至37.3岁]；68%为女性）参与试验。6个月时，生物可吸收封堵器组ASD闭合成功率为96.5%（111 / 115例），金属封堵器组为97.4%（111 / 114例）(组间差异为0.8个百分点；P<001表示非劣效性)。2年时，两组间ASD闭合成功率差异无统计学意义(生物可吸收封堵器组为94.8%[109/115]，金属封堵器组为96.5% [110/114];P =75)，或器械相关不良事件（分别为2.6%[3/115]和3.5% [4/114];P = 0.72）。生物可吸收封堵剂2年的降解率约为99.8%。

研究结果表明，在ASD闭合方面，生物可吸收封堵器不逊于金属封堵器，在2年内几乎完全降解。这些发现表明，生物可吸收封堵器可能是经导管ASD封闭选择的一个有价值的补充。

附：英文原文

Title: Bioresorbable vs Metallic Occluders for Transcatheter Atrial Septal Defect Closure: A Randomized Clinical Trial

Author: Wenbin Ouyang, Hong Jiang, Xinxin Yan, Yimin Hua, Zhiling Luo, Shiwei Yang, Wei Duan, Tao You, Jun Jin, Xianxian Zhao, Lang Hong, Xiaofei Jiang, Shenglin Ge, Qiuzhe Guo, Jiahua Pan, Chuangshi Wang, Fengwen Zhang, Shouzheng Wang, Yunbing Wang, Xiangbin Pan

Issue&Volume: 2025-10-23

Abstract:

Importance  The permanent metallic occluders used for atrial septal defect (ASD) closure are associated with risks of late complications and may impede access to the left atrium. Bioresorbable occluders have the potential to address these limitations but have yet to be validated in randomized clinical trials.

Objective  To evaluate whether a bioresorbable occluder is noninferior to a metallic occluder based on its efficacy and safety for transcatheter ASD closure.

Design, Setting, and Participants  This multicenter, noninferiority, open-label randomized clinical trial included participants with secundum ASD. Enrollment occurred from May 8, 2021, to August 3, 2022, at 10 hospital sites in China. The 2-year follow-up period ended in September 2024.

Interventions  Participants were randomized in a 1:1 ratio to receive a bioresorbable occluder (n=116) or a metallic occluder (n=114).

Main Outcomes and Measures  The primary outcome was the success rate of ASD closure at 6 months (closure success was defined as procedural success with a residual shunt diameter of ≤2 mm, which was assessed using transthoracic echocardiography). At the 2-year follow-up, the occluder groups were compared regarding the success of ASD closure and the device-related adverse events. The degradation profile of the bioresorbable occluder was assessed at 2 years.

Results  Of the 230 participants randomized, implantation was not attempted in 1 participant in the bioresorbable occluder group due to a small femoral vein, leaving 229 (median age, 14.1 years [IQR, 7.0 to 37.3 years]; 68% were female). At 6 months, the success rate of ASD closure was 96.5% (111 of 115 patients) for the bioresorbable occluder group vs 97.4% (111 of 114 patients) for the metallic occluder group (between-group difference, 0.8 percentage points [95% CI, 5.0 to 3.7]; P<.001 for noninferiority). At 2 years, there were no statistically significant between-group differences in ASD closure success (94.8% [109/115] in the bioresorbable occluder group vs 96.5% [110/114] in the metallic occluder group; P=.75), or in device-related adverse events (2.6% [3/115] vs 3.5% [4/114], respectively; P=.72). The rate of degradation at 2 years was approximately 99.8% for the bioresorbable occluder.

Conclusions and Relevance  A bioresorbable occluder is noninferior to a metallic occluder for ASD closure, with near-complete degradation by 2 years. These findings suggest that a bioresorbable occluder could be a valuable addition to the options for transcatheter ASD closure.

DOI: 10.1001/jama.2025.17639

Source: https://jamanetwork.com/journals/jama/fullarticle/2840484