Notably missing from the analysis of evidence is the data contributed by David Kent, MD and colleagues from the RoPE study,8which used multivariate statistical analyses from over 3000 patients collected from 12 databases to create an index for predicting the propensity of finding a PFO in patients with CS. The RoPE score was developed by using Bayesian mathematics to assign an attributable portion of PFO to patients with CS, and then analyze the characteristics of cases for which PFO had a high attributable portion. This created a circular logic where the presence of traditional risk factors varied inversely with the attributable portion of PFO to CS. The RoPE score has been externally validated by at least one observational study to reliably predict cases where a PFO may be present.9 However, with 25% of the population showing PFO on echocardiogram, the utility of this finding remains uncertain.

Also complicating the PFO closure decision in this cohort was the very low recurrent stroke rate in patients with high attributable portion and RoPE score (2-4% per year), suggesting the risks of closure may outweigh the benefit of reducing an already low recurrence rate.

Despite 3 large randomized trials and updated guidelines, the question of PFO closure remains a complex entity. Stratifying a cohort who may be most likely to benefit from PFO closure remains a work in progress. The Korean Device Closure Versus Medical Therapy for Cryptogenic Stroke Patients with High-Risk Patent Foramen Ovale (DEFENSE-PFO) is estimated to be completed in February 2017 and will attempt to narrow inclusion criteria to patients with postulated high risk features on echocardiogram and randomize to closure with the AMPLATZER PFO Occluder vs antiplatelet therapy. Until then, we wait for more clarity.

References

  1. Gronseth G, Kent DM, Rosterman L. Practice advisory : Recurrent stroke with patent foramen ovale (update of practice parameter) Implementation Subcommittee of the American Academy of Neurology. Neurology. 2016;1-8. doi:10.1212/WNL.0000000000002961.
  2. Carroll JD, Saver JL, Thaler DE, et al. Closure of patent foramen ovale versus medical therapy after cryptogenic stroke. N Engl J Med. 2013;368(12):1092-1100. doi:10.1056/NEJMoa1301440.
  3. Furlan AJ, Reisman M, Massaro J, et al. Closure or medical therapy for cryptogenic stroke with patent foramen ovale. N Engl J Med. 2012;366(11):991-999. doi:10.1056/NEJMoa1009639.
  4. Meier B, Kalesan B, Mattle HP, et al. Percutaneous Closure of Patent Foramen Ovale in Cryptogenic Embolism. N Engl J Med. 2013;368(12):1083-1091. doi:doi:10.1056/NEJMoa1211716.
  5. Furlan AJ, Jauss M. Patent foramen ovale and cryptogenic stroke: The hole story. Stroke. 2013;44(9):2676-2678. doi:10.1161/STROKEAHA.113.001676.
  6. Riaz I, Dhoble A, Mizyed A, Hsu C-H, Husnain M, Lee J. Transcatheter patent foramen ovale closure versus medical therapy for cryptogenic stroke: a meta-analysis of randomized clinical trials. BMC Cardiovasc Disorders. 2013;13(116).
  7. Elmariah S, Furlan AJ, Reisman M, et al. Predictors of recurrent events in patients with cryptogenic stroke and patent foramen ovale within the CLOSURE i (evaluation of the STARFlex septal closure system in patients with a stroke and/or transient ischemic attack due to presumed paradoxical embol. JACC Cardiovasc Interv. 2014;7(8):913-920. doi:10.1016/j.jcin.2014.01.170.
  8. Kent DM, Ruthazer R, Weimar C, et al. An index to identify stroke-related vs incidental patent foramen ovale in cryptogenic stroke. Neurology. 2013;81(7):619-625. doi:10.1212/WNL.0b013e3182a08d59.
  9. Prefasi D, Martinez-Sanchez P, Fuentes B, Diez-Tejedor E. The utility of the RoPE score in cryptogenic stroke patients ≤50 years in predicting a stroke-related patent foramen ovale. Int J Stroke. 2016;11(1):NP7-NP8. doi:10.1177/1747493015607505.