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:10.1186/s42466-021-00114-3

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

Neurol Res Pract. 2021 Apr 1;3(1):16. doi: 10.1186/s42466-021-00114-3.

Authors

Sven Poli^{1

2}, Elisabeth Siebert³, Joshua Mbroh^{4

5}, Khouloud Poli^{4

5}, Markus Krumbholz^{4

5}, Annerose Mengel^{4

5}, Simon Greulich³, Florian Härtig^{4

5}, Karin A L Müller³, Wolfgang Bocksch³, Meinrad Gawaz³, Ulf Ziemann^{4

5}, Christine S Zuern^{4

3

6}

Affiliations

¹ Department of Neurology & Stroke, Eberhard-Karls University, Hoppe-Seyler-Str. 3, 72076, Tübingen, Germany. sven.poli@uni-tuebingen.de.
² Hertie Institute for Clinical Brain Research, Eberhard-Karls University, Tuebingen, Germany. sven.poli@uni-tuebingen.de.
³ Department of Cardiology, Eberhard-Karls University, Tuebingen, Germany.
⁴ Department of Neurology & Stroke, Eberhard-Karls University, Hoppe-Seyler-Str. 3, 72076, Tübingen, Germany.
⁵ Hertie Institute for Clinical Brain Research, Eberhard-Karls University, Tuebingen, Germany.
⁶ Cardiology Division, Department of Medicine, University Hospital, and Cardiovascular Research Institute, Basel, Switzerland.

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.

Keywords: Cryptogenic stroke; ESUS; Embolic stroke of undetermined source; PFO-closure; Patent foramen ovale; Secondary stroke prevention.

Associated data

ClinicalTrials.gov/NCT04352790