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

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.

Advances in the management of cardioembolic stroke associated with patent foramen ovale

“…158 Further observational work suggests that PFO closure is feasible in patients above the age of 60 in real world clinical practice. 159 A trial comparing percutaneous closure with medical treatment is therefore rational in this patient population, 60 especially in those without traditional vascular risk factors. Two observational studies are under way to assess the role of PFOs in older patients with a stroke or transient ischemic attack (NCT00859885) and the interrelation of PFOs and atrial fibrillation in older people (DefenseElderly; NCT04285918).…”

“…High quality observational evidence now links PFO with ESUS in older people,1920 and studies of stroke recurrence in older patients with ESUS and a PFO suggest that PFOs are associated with a meaningfully increased risk of stroke 158. Further observational work suggests that PFO closure is feasible in patients above the age of 60 in real world clinical practice 159. A trial comparing percutaneous closure with medical treatment is therefore rational in this patient population,60 especially in those without traditional vascular risk factors.…”

“…They may thus be compelling targets for further study in patients with cryptogenic stroke and PFO who do not undergo PFO closure, especially in those over the age of 60. Several observational studies suggest that the use of DOACs is feasible in patients with PFO associated stroke 159161…”

Current Challenges and Future Directions in Handling Stroke Patients With Patent Foramen Ovale—A Brief Review

“…They included patients with PFO and TIA or ischemic stroke between 2012 and 2016 (before the large positive randomized trials were published) and treated the patients according to local standards. Poli et al (44) observed fewer recurrent strokes after closure than after drug treatment alone in the subgroup of those under 60 years of age. In contrast, there was no significant difference among those over 60.…”

“…An example of the complexity of drug-and device-based secondary prevention in a real-life setting is a prospective case series published by Poli et al (44). They stratified patients with CS and PFO into groups with PFO closure and drug treatment only.…”