Endovascular closure of patent foramen ovale: A critical appraisal of published trials

Abstract

The treatment of cryptogenic stroke patients with a patent foramen ovale (PFO) is controversial. A critical review of these studies is presented. Methods: A description of all trials comparing medical and endovascular treatment with closing devices is given. Additional pertinent studies are discussed to help construct a rational basis for treatment decisions. Results: Initial negative trials evaluating PFO closure were followed by positive studies published in 2017 and 2018. All trials evaluated young patients (up to 60 years). Methodological problems are present in all trials including their open label construction. Most positive trials developed strategies to increase the percentage of patients with interatrial septal aneurysms or hypermobility and large right-to-left shunts. Even in these positive trials, large numbers of patients need to be treated to avoid one stroke. Atrial fibrillation occurred in 2-6% and other adverse effects related to the procedure and to the devices occurred in a substantial number of patients. Incomplete occlusion of the PFO is also frequent. Anticoagulant treatment has not been adequately studied as a therapeutic option. Conclusion: Young patients with cryptogenic strokes seem to benefit from endovascular closure of a PFO in the presence of a large right-to-left shunt or an associated atrial septum aneurysm. For most other patients, a highly-individualized decision must be made, taking into account the low risk of recurrence in patients with a cryptogenic stroke attributable to a PFO, the high numbers needed to treat and the risks related to the procedure.