Efficacy and safety of percutaneous patent foramen ovale closure in patients with a hypercoagulable disorder

Abstract

Abstract Background Transcatheter closure of patent foramen ovale (PFO) in patients with cryptogenic stroke reduce the rate of recurrent events. Although presence of thrombophilia increases the risk for paradoxical emboli through a PFO, such patients were excluded from the large randomized studies. Purpose To examine the effect of hypercoagulable state on clinical outcomes after PFO closure. Methods We retrospectively analyzed data of 800 consecutive patients undergoing percutaneous PFO closure at the Massachusetts general hospital. We compared the safety and efficacy of the procedure in patients with and without a hypercoagulable state. Periprocedural treatment included 3 months of anticoagulation followed by low dose aspirin. Results A hypercoagulable disorder was found in 239 patients (29.9%). There were no significant differences in baseline demographics, echocardiographic characteristics, procedural success rate, or complication rate between both groups. At median follow-up of 41.9 months there were no differences in the rate of stroke/transient ischemic attack (2.5% in non-hypercoagulable group vs. 3.4% in hypercoagulable group, log-rank test p=0.349). Survival analysis of composite outcome that included: ischemic neurologic event, reintervention and procedural or neurologic death did not show significant difference between groups (Log-rank p=0.122). Conclusion Percutaneous PFO closure is a safe and effective therapeutic approach for patients with cryptogenic stroke and an underlying hypercoagulable state Funding Acknowledgement Type of funding source: Public hospital(s). Main funding source(s): Research funds of the Massachusetts general hospital