Comparative efficacy and safety of nitinol vs. novel fully biodegradable occluders for transcatheter patent foramen ovale closure in migraine treatment: a retrospective cohort study
Abstract
Background 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. Materials and methods 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 (n = 77) or a biodegradable group (n = 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. Results Both the nitinol group and biodegradable groups showed significant reductions in MIDAS scores post-procedure with no significant difference in migraine relief between groups (P = 0.644,…
How strong is the evidence?
Evidence Hub reads this as a cohort study, done in people. Its evidence level is 3 of 5 (Moderate · trial / cohort / secondary analysis). Trials without a large randomized design, cohorts and secondary analyses give moderate evidence. Reported size: 158 participants or records.
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