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Open Access 01-12-2021 | Stroke | Research article

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

Authors: 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

Published in: Neurological Research and Practice | Issue 1/2021

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.

Available only for authorised users

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Title: Closure or medical therapy of patent foramen ovale in cryptogenic stroke: prospective case series
Authors: 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
Publication date: 01-12-2021
Publisher: BioMed Central
Keywords: Stroke
Atrial Fibrillation
Published in: Neurological Research and Practice / Issue 1/2021
Electronic ISSN: 2524-3489
DOI: https://doi.org/10.1186/s42466-021-00114-3

Keynote webinar | Spotlight on medication adherence

Springer Medicine

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

Abstract

Background

Methods

Results

Conclusions

Trial registration

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Abstract

Background

Methods

Results

Conclusions

Trial registration

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