Neurological Research and Practice (Apr 2021)

Closure or medical therapy of patent foramen ovale in cryptogenic stroke: prospective case series

  • Sven Poli,
  • Elisabeth Siebert,
  • Joshua Mbroh,
  • Khouloud Poli,
  • Markus Krumbholz,
  • Annerose Mengel,
  • Simon Greulich,
  • Florian Härtig,
  • Karin A. L. Müller,
  • Wolfgang Bocksch,
  • Meinrad Gawaz,
  • Ulf Ziemann,
  • Christine S. Zuern

DOI
https://doi.org/10.1186/s42466-021-00114-3
Journal volume & issue
Vol. 3, no. 1
pp. 1 – 10

Abstract

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Abstract Background Results of randomized controlled trials (RCT) do not provide definite guidance for secondary prevention after ischemic stroke (IS)/transient ischemic attack (TIA) attributed to patent foramen ovale (PFO). No recommendations can be made for patients > 60 years. We aimed to compare interventional and medical PFO-management in cryptogenic IS/TIA patients, including patients > 60 years. Methods Prospective case series including consecutive cryptogenic IS/TIA patients with PFO at Tuebingen university stroke unit, Germany. ‘PFO-closure’ was recommended in patients ≤70 years when featuring high-risk PFO (i.e., with atrial septal aneurysm, spontaneous, or high-grade right-to-left shunt during Valsalva). Primary (recurrent IS/intracranial hemorrhage) and secondary endpoints (e.g., disability) were assessed during ≥1-year follow-up; planned subgroup analyses of patients ≤60/> 60 years. Results Among 236 patients with median age of 58 (range 18–88) years, 38.6% were females and median presenting National Institutes of Health Stroke Scale score was 1 (IQR 0–4). Mean follow-up was 2.8 ± 1.3 years. No intracranial hemorrhage was observed. Recurrent IS rate after ‘PFO-closure’ was 2.9% (95%CI 0–6.8%) and 7% (4–16.4) in high-risk PFO patients ≤60 (n = 103) and > 60 years (n = 43), respectively, versus 4% (0–11.5) during ‘medical therapy alone’ MTA (n = 28). 42 low-risk PFO patients treated with MTA experienced no recurrent IS/TIA. Conclusions In our real-world study, IS recurrence rate in ‘PFO-closure’ high-risk PFO patients ≤60 years was comparable to that observed in recent RCT. High-risk PFO patients > 60 years who underwent PFO-closure had similar IS recurrence rates than those who received MTA. MTA seems the appropriate treatment for low-risk PFO. Trial registration ClinicalTrials.gov, registration number: NCT04352790 , registered on: April 20, 2020 – retrospectively registered.

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