Patent foramen ovale closure for patients with cryptogenic stroke: A systematic review and comprehensive...

Area of Science:

• Cardiology
• Neurology
• Medical Interventions

Background:

• Previous reviews on randomized controlled trials (RCTs) suggested potential benefits of patent foramen ovale (PFO) closure for cryptogenic stroke patients.
• Systematic reviews including observational studies yielded unclear findings regarding PFO closure efficacy in stroke prevention.

Purpose of the Study:

• To systematically evaluate the efficacy and safety of patent foramen ovale (PFO) closure versus medical therapy for cryptogenic stroke prevention.
• To identify patient subgroups who may benefit most from PFO closure.

Main Methods:

• A systematic literature search was conducted across MEDLINE, Embase, and Cochrane databases.
• Included studies comprised five randomized trials and fourteen observational studies, totaling 6301 participants.
• Primary endpoints were recurrent stroke or transient ischemic attack (TIA); secondary outcomes included all-cause death, atrial fibrillation (AF), and hemorrhagic events.

Main Results:

• PFO closure demonstrated superiority over medical therapy in preventing recurrent stroke (RR, 0.38; 95% CI, 0.24-0.60).
• A significantly increased risk of atrial fibrillation (AF) was observed with PFO closure (RR, 4.96; 95% CI, 2.31-10.7).
• No significant differences were found in TIA recurrence, all-cause death, or hemorrhagic events.
• Subgroup analyses indicated that patients with substantial residual shunt, atrial septal aneurysm (ASA), males, and those younger than 45 years experienced a lower risk of recurrent stroke with PFO closure.

Conclusions:

• Patent foramen ovale (PFO) closure appears superior to medical therapy for stroke prevention in cryptogenic stroke patients, albeit with an increased incidence of atrial fibrillation.
• Predictive factors for successful PFO closure include male sex, age under 45 years, substantial residual shunt, and a history of atrial septal aneurysm (ASA).