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DEFENSE-PFO Model (Cryptogenic Stroke Benefit) Calculator

  • Patient age (years)
  • Atrial Septal Aneurysm (ASA) present?
  • Septal hypermobility (phasic excursion, mm) High-risk threshold in DEFENSE-PFO: ≥10 mm.
  • PFO separation/height (maximum septum primum–secundum separation, mm) High-risk threshold in DEFENSE-PFO: ≥2 mm.
  • DEFENSE-PFO Model (Cryptogenic Stroke Benefit): Explanation and Clinical Context
     The DEFENSE-PFO trial evaluated patients with cryptogenic stroke and high-risk patent foramen ovale (PFO) on transesophageal echocardiography—defined by at least one of the following: atrial septal aneurysm (ASA), marked septal hypermobility (≥10 mm excursion), or a large PFO (≥2 mm separation). In this group, percutaneous closure significantly reduced recurrent events compared to medical therapy alone. At 2 years, ischemic stroke occurred in 10.5% of the medical group versus 0% in the closure group (ARR ≈10%, NNT ≈10). The composite endpoint (stroke, vascular death, or TIMI major bleeding) also favored closure (12.9% vs 0%).

    Because the study exclusively enrolled high-risk PFO, these effect sizes apply only in that subset. Post-hoc analyses suggest that older adults (≥60 years) with high-risk PFO may derive greater absolute benefit, but this requires cautious interpretation. Outside this setting, clinicians should integrate clinical context, imaging findings, and causal probability estimates (e.g., RoPE and PASCAL models) before deciding on closure.

    Reference:
    Lee PH, Song JK, Kim JS, et al. Cryptogenic Stroke and High-Risk Patent Foramen Ovale: The DEFENSE-PFO Trial. J Am Coll Cardiol. 2018;71(20):2335–2342. doi:10.1016/j.jacc.2018.02.046
    Kwon H, Kim BJ, Lee PH, et al. Patent Foramen Ovale Closure in Old Stroke Patients: A Subgroup Analysis of the DEFENSE-PFO Trial. J Stroke. 2021;23(2).
    Kent DM, et al. Heterogeneity of Treatment Effects in PFO Closure Trials and the PASCAL Classification. JAMA. 2021;326(12).
    ESC Council for Cardiology Practice. Patent foramen ovale in patients with cryptogenic stroke: to close or not to close? 2025.