Long-Term Follow-Up Post-PFO Closure

Study Questions:

What are long-term (>10 years) clinical outcomes (ischemic, hemorrhagic events) in a cohort of consecutive patients who had a patent foramen ovale (PFO) closure for cryptogenic ischemic stroke, transient ischemic attack (TIA), or peripheral embolism?

Methods:

A total of 201 consecutive patients who had PFO closure for cryptogenic stroke/TIA or peripheral embolism between 2001 and 2008 at a single Canadian center were analyzed retrospectively.

Results:

Mean age was 47 years and cryptogenic stroke (76%) was the most common indication for closure followed by TIA (32%). PFO closure device was successful in all cases, and the majority received an Amplatzer PFO closure device (78%). There were no cases of late device-related complications or cardiovascular mortality. A total of seven patients (3.5%) had ≥1 ischemic (TIA or stroke) neurological event (0.3 per 100 person-years) over a median follow-up of 12 years. History of thrombophilia tended to predict risk of ischemic neurological events at follow-up. Finally, about one-fifth of the patients stopped the antithrombotic therapy at a median time of 6 months post-PFO closure, and this was not associated with any increase in ischemic events at long-term follow-up.

Conclusions:

PFO closure was associated with a low rate of ischemic events and cardiovascular mortality at long-term follow-up in young patients (mean age was 47 years). One-fifth of patients stopped the antithrombotic therapy during the follow-up period, and this was not associated with any increase in ischemic events at long-term follow-up.

Perspective:

This real-world experience from a large expert center provides re-assuring evidence on long-term safety of PFO closure in young patients with cryptogenic stroke. These data combined with previously published results from randomized trials establishes a role for percutaneous PFO closure with currently available devices in young patients with cryptogenic stroke.

Keywords: Brain Ischemia, Embolism, Fibrinolytic Agents, Foramen Ovale, Patent, Heart Defects, Congenital, Hemorrhage, Ischemia, Ischemic Attack, Transient, Secondary Prevention, Stroke, Thrombophilia, Vascular Diseases


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