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. 2025 Dec;10(4):1392-1401.
doi: 10.1177/23969873251341764. Epub 2025 Jun 3.

Assessment of patent foramen ovale closure in elderly patients with cryptogenic transient ischemic attack or stroke: Efficacy, safety, and potential age-related benefit

Chi-Sheng Wang  1 , Yu-Hsuan Wu  1 , Yun-Ching Fu  2   3 , Sheng-Ling Jan  4   5   6 , Ming-Chih Lin  3   7   8   9 , Chiann-Yi Hsu  10 , Po-Lin Chen  1   7   11
Affiliations

Assessment of patent foramen ovale closure in elderly patients with cryptogenic transient ischemic attack or stroke: Efficacy, safety, and potential age-related benefit

Chi-Sheng Wang et al. Eur Stroke J. 2025 Dec.

Abstract

Introduction: The efficacy and safety of patent foramen ovale closure (PFOC) in cryptogenic stroke (CS) patients aged ⩾ 60 remain controversial. This study evaluates the efficacy and safety of PFOC in elderly (aged ⩾ 60) versus non-elderly (aged < 60) patients and examines potential age-related benefit.

Patients and methods: A hospital-based cohort study (January 2013-June 2023) compared the efficacy and safety between PFOC and non-PFOC groups in patient with CS or cryptogenic TIA. The primary efficacy outcome was recurrent ischemic stroke, and safety outcomes included procedure-related adverse events and periprocedural atrial fibrillation (AF). Subgroup analyses, including various age ranges, were performed for the elderly group.

Results: Among 239 patients (mean age 57.2 years), 120 were elderly. During a mean follow-up of 3.1 years, the PFOC group had significantly fewer recurrent ischemic stroke than the non-PFOC group (adjusted hazard ratio (AHR): 0.10, 95% CI: 0.03-0.29, p = 0.001). The risk reduction was similar in elderly (AHR: 0.11, p = 0.004) and non-elderly (AHR: 0.10, p = 0.005) patients (p for interaction = 0.337). Safety outcomes were comparable across age groups, including younger elderly (60-70) and older elderly (⩾70). No life-threatening complications occurred; one patient required additional intervention. Subgroup analysis indicated significant risk reduction for patients aged ⩾ 65 (AHR: 0.01, p = 0.012) but not for those aged 60-65 (AHR: 0.24, p = 0.071).

Discussion and conclusion: PFO closure is safe and effective in elderly patients with CS. Advanced age should not be a contraindication for PFOC, as older patients may potentially derive more significant benefits from the procedure.

Keywords: Elderly; patent foramen ovale; patent foramen ovale closure.

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Conflict of interest statement

Declaration of conflicting interestsThe author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Figures

Graphical abstract
Graphical abstract
Figure 1.
Figure 1.
Study flow diagram. AIS: acute ischemic stroke; TIA: transient ischemic attack; LAA: large artery atherosclerosis; SVO: small vessel occlusion; CS: cryptogenic stroke; PFOC: patent foramen ovale closure.
Figure 2.
Figure 2.
Subgroup analyses on the elderly group. PFOC: patent foramen ovale closure; AHR: adjusted hazard ratio; na: not applicable; HITS: high-intensity transient signals; RoPE: risk of paradoxical embolism.
See this image and copyright information in PMC

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