Long-Term Follow-Up After Closure of Patent Foramen Ovale in Patients With Cryptogenic Embolism.

BACKGROUND

Patent foramen ovale (PFO) closure is the gold standard for treating patients with cryptogenic stroke and PFO. However, scarce data exist on the long-term outcomes following PFO closure.

OBJECTIVES

The purpose of this study was to determine the long-term (>10 years) clinical outcomes (death, ischemic, hemorrhagic events) following transcatheter PFO closure.

METHODS

We included 201 consecutive patients (mean age: 47 ± 12 years, 51% women) who underwent PFO closure due to a cryptogenic embolism (stroke: 76%, transient ischemic attack [TIA]: 32%, systemic embolism: 1%). Echocardiographic examinations were performed at 1- to 6-month follow-up. Ischemic and bleeding events and antithrombotic medication were collected at a median follow-up of 12 years (range 10 to 17 years), and follow-up was complete in 96% of the patients.

RESULTS

The PFO closure device was successfully implanted in all cases, and residual shunt was observed in 3.3% of patients at follow-up echocardiography. A total of 13 patients died at follow-up (all from noncardiovascular causes), and nondisabling stroke and TIA occurred in 2 and 6 patients, respectively (0.08 strokes per 100 patient-years; 0.26 TIAs per 100 patient-years). A history of thrombophilia (present in 15% of patients) tended to associate with a higher rate of ischemic events at follow-up (p = 0.067). Bleeding events occurred in 13 patients and were major (intracranial bleeding) in 4 patients (all of them under aspirin therapy at the time of the event). A total of 42 patients stopped the antithrombotic treatment at a median of 6 months (interquartile range 6 to 14 months) post-PFO closure, and none of them had any ischemic or bleeding episode after a mean of 10 ± 4 years following treatment cessation.

CONCLUSIONS

PFO closure was associated with a low rate of ischemic events (stroke, 1%) at >10 years of follow-up. Major bleeding events occurred in 2% of the patients (all of them in patients on antiplatelet therapy). One-fifth of patients stopped the antithrombotic therapy during the follow-up period (the majority within the first-year post-PFO closure), and this was not associated with any increase in ischemic events at long-term follow-up.