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Closure of a Patent Foramen Ovale (PFO): An Intervention Sequence
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Closure of a Patent Foramen Ovale (PFO): An Intervention Sequence

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Patent foramen ovale and migraine: association, causation, and implications of clinical trials

Stewart J Tepper1, Catalina Cleves, Frederick R Taylor

  • 1Center for Headache and Pain, Neurological Institute, Cleveland Clinic, 9500 Euclid Avenue, Cleveland, OH 44195, USA. teppers@ccf.org

Current Pain and Headache Reports
|May 22, 2009
PubMed

Insights

Patent foramen ovale (PFO) closure may not improve migraine with aura (MA) symptoms, despite observational studies suggesting a link. The MIST trial found no benefit, though it confirmed an association between severe PFO shunts and MA.

Area of Science:

  • Cardiology
  • Neurology
  • Medical Devices

Background:

  • Patent foramen ovale (PFO) is frequently observed in patients with cryptogenic stroke and migraine with aura (MA).
  • Previous studies suggested PFO closure could significantly reduce MA frequency, but evidence from rigorous trials is limited.
  • The MIST trial was the first prospective, sham-controlled study investigating PFO closure for MA.

Purpose of the Study:

  • To evaluate the efficacy of PFO closure in reducing migraine with aura symptoms.
  • To investigate the association between PFO characteristics and MA.
  • To assess the safety and effectiveness of PFO closure in a randomized, sham-controlled setting.

Main Methods:

  • The study involved a prospective, randomized, sham-controlled design.
  • Participants with MA and PFO underwent either PFO closure or a sham procedure.
  • Primary and secondary endpoints focused on migraine improvement and reduction in MA frequency.

Main Results:

  • The MIST trial did not meet its primary or secondary endpoints for migraine improvement following PFO closure.
  • However, the study prospectively confirmed a significant association between MA and severe PFO shunts.
  • Recruitment challenges led to the early termination of subsequent trials like MIST II and ESCAPE.

Conclusions:

  • Current evidence from the MIST trial does not support routine PFO closure for the treatment of migraine with aura.
  • A strong association persists between severe PFO shunts and MA, warranting further investigation.
  • Ongoing trials like PREMIUM and PRIMA aim to provide further insights into this complex relationship.

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