Patent Foramen Ovale and Stroke

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Patent Foramen Ovale and Stroke

2006 ASA/AHA Guidelines (1)

  • For patients with an ischemic stroke or TIA and a PFO, antiplatelet therapy is reasonable to prevent a recurrent event (Class IIa, Level of Evidence B).
  • Warfarin is reasonable for high-risk patients who have other indications for oral anticoagulation such as those with an underlying hypercoagulable state or evidence of venous thrombosis (Class IIa, Level of Evidence C).
  • Insufficient data exist to make a recommendation about PFO closure in patients with a first stroke and a PFO. PFO closure may be considered for patients with recurrent cryptogenic stroke despite optimal medical therapy (Class IIb, Level of Evidence C).

American Academy of Neurology 2004 (2)

  • Only 4 studies up to that time met their inclusion and exclusion criteria, particularly the inclusion criterion of either an RCT or prospective cohort study.
  • No increased risk of subsequent stroke or death in patients with PFO compared to those without when both treated medically.
  • No significant difference in stroke or death rate in warfarin-treated patients relative to ASA-treated patients, though minor bleeding rates were significantly higher in the warfarin group.
  • Insufficient evidence to evaluate the efficacy of surgical or percutaneous closure compared with medical therapy

Patent Foramen Ovale in Cryptogenic Stroke Study (PICSS) - Circulation 2002 (3)

  • 33.8% of 630 patients having a stroke had PFO
  • Only RCT of warfarin (Target INR 1.4-2.8) vs ASA 325 in patients with PFO
  • 2 year event rates (stroke/death):
  1. In the entire PICCS Cohort with PFOs, 16.5% event rate for warfarin, 13.2% event rate for ASA 325 (P = 0.49)
  2. In the entire PICCS Cohort without PFOs, 13.4% event rate for warfarin, 17.4% event rate for ASA 325 (P = 0.40)
  3. In the cryptogenic cohort with PFO, 9.5% event rate for warfarin, 17.9% event rate for ASA 325 (P = 0.28)
  4. In the cryptogenic cohort without PFO, 8.3% event rate for warfarin, 16.3% event rate for ASA 325 (P=0.16)

French PFO-ASA study – NEJM 2001(4)

  • 216 patients with cryptogenic stroke with PFO
  • Stroke recurrence rate after 4 years 2.3% on ASA 300mg vs 4.2% for those with cryptogenic stroke and no PFO on ASA 300mg.
  • Significant differences in average age (44.5 without PFO vs 40.3), migraine, HTN, HL - all favoring PFO group

Transcatheter Closure – J Am Coll Cardiol 2002 (5)

  • Meta analysis of 10 studies (1355 patients) of transcatheter closure and 6 studies of medical therapy (895 patients) for stroke or TIA + PFO.
  • 1 year recurrence rate was 0 to 4.9% with transcatheter closure
  • Incidence of major (death, hemorrhage needing transfusion, tamponade, need for surgery, fatal PE) and minor complications of closure 1.5% and 7.9% respectively
  • 1-year recurrence rate of 3.8% to 12% on medical therapy (ASA (avg 233mg), a couple with warfarin)
  • Flaws:
  1. More diabetics and smokers in medically treated arms
  2. More thromboembolic events in those undergoing closure

Surgical Closure – Circulation 1999 (6)

  • 91 patients (avg age 44) with 1 or more TIAs/strokes with subsequently closed PFO
  • No subsequent stroke or TIA in 93% at 1 year, 83% at four years.
  • All recurrence events that did occur were TIAs.
  • NOTE: After PFO closure, residual shunt may persist or thrombus may form on left atrial wall from stagnant flow.

(1) Sacco, RL, Adams, R, Albers, G, et al. Guidelines for prevention of stroke in patients with ischemic stroke or transient ischemic attack: a statement for healthcare professionals from the American Heart Association/American Stroke Association Council on Stroke: co-sponsored by the Council on Cardiovascular Radiology and Intervention. Stroke 2006; 37:577.

(2) Messe, SR, Silverman, IE, Kizer, JR, et al. Practice parameter: recurrent stroke with patent foramen ovale and atrial septal aneurysm: report of the Quality Standards Subcommittee of the American Academy of Neurology. Neurology 2004; 62:1042.

(3) Homma, S, Sacco, RL, Di Tullio, MR, et al. Effect of medical treatment in stroke patients with patent foramen ovale: Patent Foramen Ovale in Cryptogenic Stroke Study. Circulation 2002; 105:2625.

(4) Mas, JL, Arquizan, C, Lamy, C, et al. Recurrent cerebrovascular events associated with patent foramen ovale, atrial septal aneurysm, or both. N Engl J Med 2001; 345:1740.

(5) Braun, MU, Fassbender, D, Schoen, SP, et al. Transcatheter closure of patent foramen ovale in patients with cerebral ischemia. J Am Coll Cardiol 2002; 39:2019.

(6) Dearani, JA, Ugurlu, BS, Danielson, GK, et al. Surgical patent foramen ovale closure for prevention of paradoxical embolism-related cerebrovascular ischemic events. Circulation 1999; 100:II171.

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