European Stroke Organisation (ESO) Guidelines on the diagnosis and management of patent foramen ovale (PFO) after stroke

Abstract

Patent foramen ovale (PFO) is frequently identified in young patients with cryptogenic ischaemic stroke. Potential stroke mechanisms include paradoxical embolism from a venous clot which traverses the PFO, in situ clot formation within the PFO, and atrial arrhythmias due to electrical signalling disruption. The purpose of this guideline is to provide recommendations for diagnosing, treating, and long-term managing patients with ischaemic stroke and PFO. Conversely, Transient Ischaemic Attack (TIA) was not considered an index event in this context because only one RCT involved TIA patients. However, this subgroup analysis showed no significant differences between TIA and stroke outcomes. The working group identified questions and outcomes, graded evidence, and developed recommendations following the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) approach and the European Stroke Organisation (ESO) standard operating procedure for guideline development. This document underwent peer-review by independent experts and members of the ESO Guideline Board and Executive Committee. The working group acknowledges the current evidentiary gap in delineating an unequivocal diagnostic algorithm for the detection of PFO. Although transoesophageal echocardiography is conventionally held as the most accurate diagnostic tool for PFO identification, its status as the ‘gold standard’ remains unsubstantiated by rigorously validated evidence. We found high-quality evidence to recommend PFO closure plus antiplatelet therapy in selected patients aged 18–60 years in whom no other evident cause of stroke is found but a PFO (i.e. PFO-associated stroke). The PASCAL classification system can be used to select such candidates for PFO closure. Patients with both a large right-to-left shunt and an atrial septal aneurysm benefit most from PFO closure. There is insufficient evidence to make an evidence-based recommendation on PFO closure in patients older than 60 and younger than 18 years. We found low quality evidence to suggest against PFO closure in patients with unlikely PFO-related stroke according to the PASCAL classification, except in specific scenarios (Expert Consensus). We suggest against long-term anticoagulation in patients with PFO-associated stroke unless anticoagulation is indicated for other medical reasons. Regarding the long-term AF monitoring after PFO closure, the working group concluded that there remains significant uncertainty regarding the risks and benefits associated with the use of long-term cardiac monitoring, such as implantable loop recorders. This document provides additional guidance, in the form of evidence-based recommendations or expert consensus statements, on diagnostic methods for PFO detection, and medical management after PFO closure.

Patent Foramen Ovale Occlusion in Elderly Patients: Is It Worth It? A Large, Single-Center Retrospective Analysis

“…Handke and colleagues [ 13 ] showed in a large prospective cohort that the prevalence of PFO was higher in older patients with cryptogenic stroke compared to patients with stroke of known origin. A subsequent meta-analysis similarly reported a PFO prevalence ranging from 16% to 38% among older patients with cryptogenic stroke compared to 8–23% among control patients, confirming the existence of a significant association between PFO and cryptogenic stroke also in this category of patients [ 14 , 15 , 16 , 17 , 18 ]. In the same study, it was estimated that the probability of PFO being an incidental finding was 20% among younger cryptogenic stroke patients and 48% in older patients, while high-risk anatomical characteristics (i.e., atrial septal aneurysm) reduced the PFO incidental finding down to 9% and 26%, respectively.…”

“…All examinations performed during the diagnostic workup leading to PFO closure were assessed, including carotid ultrasound, thrombophilic screening and ambulatory ECG monitoring (or loop recorder implantation), transcranial Doppler, transthoracic or transesophageal echocardiography. The RoPE scores were calculated in any patient [ 16 ]. In the case of the detection of atrial fibrillation, significant carotid atherosclerotic disease (stenosis ≥ 50%) or uncontrolled hypertension during diagnostic workup, patients were not referred for PFO closure.…”

“…The European position paper on the management of patients with PFO emits a possible indication in patients over 65 years, despite the lack of evidence, taking into account the age-related confounder and the risks of interventional procedures, on a case-by-case basis. Finally, the expert panel recently releasing the European Stroke Organization (ESO) guidelines on the diagnosis and management of patent foramen ovale encourages the inclusion of patients older than 60 years old with stroke and PFO in randomized trials whenever possible, or at least in a registry, given the impossibility to provide any evidence-based recommendation [ 16 ]. The accurate patient selection needs, especially in older patients, include atrial fibrillation risk factor assessments as well as non-invasive imaging to detect subclinical atherosclerotic disease [ 17 ].…”