Li Rui-Lin, Huang Jing-Juan, Ming Jie, Hao Ying, Wen Wei, Shen Yun-Li, Lin Li, Lu Lin-Xiang
Department of Cardiology, Shanghai East Hospital, Tongji University School of Medicine, Shanghai, China.
Department of Cardiology, Shanghai Chest Hospital, Shanghai Jiao Tong University, Shanghai, China.
Front Med (Lausanne). 2025 Jul 2;12:1613687. doi: 10.3389/fmed.2025.1613687. eCollection 2025.
Transcatheter closure of patent foramen ovale (PFO) has shown potential therapeutic benefits for clinical symptoms in selected patients with migraine. Nevertheless, the comparative effectiveness and safety of traditional nitinol vs. fully biodegradable occluders remain to be fully elucidated and warrant further investigation.
This retrospective cohort study included 158 migraine patients with a confirmed patent foramen ovale (PFO) and a grade II-III right-to-left shunt (RLS) as determined by contrast-enhanced transthoracic echocardiography (cTTE), who underwent transcatheter PFO closure at Shanghai East Hospital, Tongji University, between October 2023 and January 2024. Based on the occluder type, patients were categorized into a nitinol group ( = 77) or a biodegradable group ( = 81). Clinical baseline characteristics, echocardiographic parameters, procedural data, safety outcomes, residual right-to-left shunt (RLS) grades, and migraine severity assessed using the Migraine Disability Assessment Scale (MIDAS) were compared between groups. The primary outcome was migraine relief (≥50% reduction in MIDAS score) following the procedure. Secondary outcomes included the incidence of safety-related events and the rate of residual right-to-left shunt.
Both the nitinol group and biodegradable groups showed significant reductions in MIDAS scores post-procedure with no significant difference in migraine relief between groups ( = 0.644, Kaplan-Meier analysis). Both occluders showed a high procedural success rate (100%) and similar safety profiles, with low rates of perioperative complications. The biodegradable occluder exhibited progressive degradation, with a significant reduction in size by 12 months, while maintaining closure efficacy. Residual right-to-left shunting was minimal in both groups, with RLS grades 0 and 1 observed in 82.35% of patients in the nitinol group and 78.87% in the bioabsorbable group at the 12-month follow-up.
Both biodegradable and nitinol PFO occluders were equally effective in alleviating migraine symptoms, with excellent procedural success and safety profiles. The biodegradable occluder demonstrated effective closure and gradual degradation, offering a promising alternative to nitinol occluders, especially for patients concerned about long-term foreign body implantation. These findings support the clinical utility of both occluder types in PFO-related migraine treatment, with individualized device selection based on patient preferences and clinical factors.
经导管封堵卵圆孔未闭（PFO）已显示出对部分偏头痛患者的临床症状具有潜在治疗益处。然而，传统镍钛合金封堵器与完全可生物降解封堵器的相对有效性和安全性仍有待充分阐明，值得进一步研究。
这项回顾性队列研究纳入了158例偏头痛患者，这些患者经对比增强经胸超声心动图（cTTE）确诊为卵圆孔未闭（PFO）且存在II - III级右向左分流（RLS），于2023年10月至2024年1月在同济大学附属上海东方医院接受了经导管PFO封堵术。根据封堵器类型，患者被分为镍钛合金组（n = 77）或生物可降解组（n = 81）。比较两组患者的临床基线特征、超声心动图参数、手术数据、安全结局、残余右向左分流（RLS）分级以及使用偏头痛残疾评估量表（MIDAS）评估的偏头痛严重程度。主要结局是术后偏头痛缓解（MIDAS评分降低≥50%）。次要结局包括安全相关事件的发生率和残余右向左分流率。
镍钛合金组和生物可降解组术后MIDAS评分均显著降低，两组在偏头痛缓解方面无显著差异（P = 0.644，Kaplan - Meier分析）。两种封堵器均显示出高手术成功率（100%）和相似的安全性，围手术期并发症发生率低。生物可降解封堵器呈现出渐进性降解，到12个月时尺寸显著减小，同时保持封堵效果。两组残余右向左分流均极少，在12个月随访时，镍钛合金组82.35%的患者RLS分级为0和1级，生物可吸收组为78.87%。
生物可降解和镍钛合金PFO封堵器在缓解偏头痛症状方面同样有效，手术成功率高且安全性良好。生物可降解封堵器显示出有效的封堵和逐渐降解，为镍钛合金封堵器提供了一个有前景的替代方案，特别是对于担心长期异物植入的患者。这些发现支持了两种封堵器类型在PFO相关偏头痛治疗中的临床应用，可根据患者偏好和临床因素进行个体化器械选择。
