Why the study?
Although thrombophilia increases paradoxical emboli risk through a PFO, such patients were excluded from large randomized trials evaluating transcatheter PFO closure.
Does percutaneous PFO closure prevent recurrent neurological events similarly in cryptogenic stroke patients with and without a hypercoagulable state?
Does percutaneous PFO closure prevent recurrent neurological events similarly in cryptogenic stroke patients with and without a hypercoagulable state?
Percutaneous PFO closure appears safe and effective for secondary stroke prevention in patients with cryptogenic stroke and an underlying hypercoagulable state, a population previously excluded from major randomized trials.
No excess stroke/TIA risk after PFO closure with thrombophilia; leaves open randomized confirmation of equivalent benefit.
BACKGROUND: Transcatheter closure of patent foramen ovale (PFO) in patients with cryptogenic stroke reduces the rate of recurrent events. Although presence of thrombophilia increases the risk for paradoxical emboli through a PFO, such patients were excluded from large randomized trials. OBJECTIVES: We compared the safety and efficacy of percutaneous PFO closure in patients with and without a hypercoagulable state. METHODS: Data from 800 consecutive patients undergoing percutaneous PFO closure in our medical center were analyzed. All patients were independently evaluated by specialists in neurology, cardiology, hematology, and vascular medicine. A post-procedural treatment of at least 3 months of anticoagulation was utilized in patients with thrombophilia. Follow-up events included death, recurrent neurological events, and the need for reintervention for significant residual shunt. RESULTS: A hypercoagulable state was found in 239 patients (29.9%). At median follow-up of 41.9 months, there were no differences in the frequencies of stroke or transient ischemic attack between patients with or without thrombophilia (2.5% in non-hypercoagulable group vs. 3.4% in hypercoagulable group, log-rank test p = 0.35). There were no significant differences in baseline demographics, echocardiographic characteristics, procedural success, or complications between groups. CONCLUSION: Percutaneous PFO closure is a safe and effective therapeutic approach for patients with cryptogenic stroke and an underlying hypercoagulable state.
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Ben–Assa et al. (2021) studied this question.
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