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Patent Foramen Ovale and Atrial Septal Aneurysm: Current Perspectives
Jesse Jorgensen, MD Carolina Cardiology Consultants
November 19, 2011
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Objectives
1. Identification of Patent Foramen Ovale (PFO)/Atrial Septal Aneurysm (ASA) and its role in acute ischmeic stroke
2. Treatment of PFO/ASA for stroke prevention
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Basic Atrial Septal Anatomy
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PFO Devices
• Amplatzer (FDA approval Dec 2001) • HELEX (FDA approval Aug 2006)
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Amplatzer Septal Occluder
Kurt Amplatz, MD, May 2006, Twin Cities Business Magazine
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Amplatzer Septal Occluder
• 72 braided nitinol wires • Self-Expandable • Polyester material for occlusion • Nickel allergy contraindication
(8% women, 2% men)
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Amplatzer Septal Occluder
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GORE HELEX Septal Occluder
• ePTFE patch material (Gore-Tex) supported by a single nitinol wire frame
• ASD size up to 18 mm
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PFO: Guilty or Innocent Bystander?
• Incidence ~25% in the general population • Associated with paradoxical embolism (esp stroke),
migraine headache, decompression sickness, platypnea orthodeoxia, left-sided valvular involvement with carcinoid
• Associations largely based on retrospective case-control studies
• The management of PFO following stroke among the most controverstial areas in cardiology
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PFO Case: A.F.
53 yo woman with symptoms since 1991 of fatigue, diagnosed with fibromyalgia and chronic fatigue syndrome. Now legs are weak, vertigo, progressive left arm weakness and paresthesias. Chronic, severe right frontal migraines. MRI: right sided lesions, multiple sclerosis vs emboli. Lumbar puncture nondiagnostic.
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TEE: PFO with Atrial Septal Aneurysm
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TEE: positive bubble study
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PFO prevalence in young stroke patients
Neurology 2000;55:1172-1179
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PFO prevalence in stroke patients
A. Age <55
A. Age >55
Neurology 2000;55:1172-1179
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PFO and Cryptogenic Stroke
• While more than 50% of stroke pts younger than 45 have a PFO, observational studies have not found an increased risk of CVA from an incidentally detected PFO over time
• Surgical closure of incidental PFOs has no long term benefit and increases risk of perioperative stroke
J Am Coll Cardiol 2006;47:440-445 JAMA 2009;302(3):290-297
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PFO and Cryptogenic Stroke
• Frequency of DVT ranges from 10-57% (5 of 53 patients in one series, 24 of 42 patients in another)
• Hypercoagulable state rare in this population • High Risk Anatomic Features: Atrial Septal Aneurysm Wide (≥4mm) separation between septum primum &
secundum Greater degree of right-to-left shunting Shunting at rest
Am J Cardiol 1997;80:1066-1069 N Engl J Med 2005;353:2361-72 Ann Intern Med 1993;119:461-465
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Thrombus-in-Transit: the smoking gun?
J Am Soc Echocardiogr 2007;20:1219.e6-e8
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PFO and Migraine
• Migraine is present in 10-12% of the population • Association between PFO with right to left shunt
and migraine (esp with aura) • Migraine resolution following PFO closure for
other indication
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PFO prevalence in migraine pts
CCI 2007 69:9-14
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Effect of PFO closure on migraine
CCI 2007 69:9-14
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PFO: Options for Therapy
• ASA • Plavix • ASA + Plavix • Coumadin • PFO closure: surgical vs. percutaneous
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PFO Medical Therapy
• Warfarin-Aspirin Recurrent Stroke Study (WARSS): 2,206 pts with prior CVA randomized to ASA 325 QD or Warfarin (target INR 1.4-2.8). 2y recurrent CVA or death similar
• Patent Foramen Ovale in Cryptogenic Stroke Study (PICCS, substudy of WARRS), 250 pts had TEE revealing 98 PFOs (39%). PFO did not increase risk of subsequent CVA or death
• In PFO pts, 2y risk of CVA or death was 17.9% vs 9.5% with ASA vs. Coumadin (p=NS), minor hemorrhage 8.7% vs. 22.9% (P=NS)
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PFO Medical Therapy
• Meta-analysis (including PICCS): annual CVA or death 4.7% on Coumadin vs 8.9% on ASA (RR .53, .18-1.58)
• Warfarin is not clearly superior but is often recommended in practice as first-line therapy
• ASA ± thienopyridine reasonable alternative • American Academy of Neurology 2004: “clinicians who
encounter patients with cryptogenic stroke and PFO (and/or ASA) should encourage them to consider participating in research protocols”
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Long Term Efficacy of Anticoagulation vs Antiplatelet Therapy
Recurrent ischemic events long term in patients arbitrarily assigned to coumadin or aspirin SUBOPTIMAL
Circ 2009;120:1837-1841
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PFO: Transcatheter Therapy
• First reported in 1992 • Variety (>12) of device designs • In general, safe, effective, high procedural
success, low risk of periprocedural complications, favorable results long term
• >200,000 percutaneous PFO closures worldwide
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(No controlled trials have compared PFO closure with medical therapy)
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Data Summary: PFO closure vs. medical therapy
Ann Intern Med. 2003;139:753-760
Incidence of recurrent stroke by age
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PFO: Transcatheter Therapy
• THERE IS NO FDA-APPROVED PFO DEVICE • FDA HDE for 2 devices (Amplatzer PFO
Occluder and CardioSeal) withdrawn August 2006; target population was recurrent embolic CVA with anticoagulation failure (exceeded limit of 4,000 pts annually)
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PFO Closure Device Trials
Circ 2009;120:1837-1841
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Off Label Use of Devices for PFO
• Amplatzer Cribriform Septal Occluder (labeled for treating multiple ASDs): really the PFO Occluder by a different name
• HELEX occluder (labeled for ASD) • CardioSeal (labeled for VSD)
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PFO: Guidelines Summary
,AHA/ASA (IIb)
**AHA/ASA: “Insufficient data exist to make a recommendation about PFO closure in patients with a first stroke and a PFO”
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Summary of Nonrandomized Trials on the Effects of PFO Closure on Migraine
Clev Clin J Med 2007;74 suppl 1:S114-S117
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MIST I results
Dowson A. i2 Summit at the American College of Cardiology 2006 Scientific Sessions; March 13, 2006; Atlanta, GA.
End point PFO closure
Sham p
Headache cessation (n) 3 3 NS
50% reduction in headache days (%)
42 23 0.038
Reduced headache burden (%) 37 17 0.033
•Prospective RCT of PFO closure in treating severe therapy-resistant migraine with aura •147 English patients, 1:1 PFO closure:sham •6 month follow up •Controversial trial
Circ 2008;177:1397-1404
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Randomized PFO Migraine Trials
Circ 2009;120:1837-1841
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PFO Case: A.F.
53 yo woman with symptoms since 1991 of fatigue, diagnosed with fibromyalgia and chronic fatigue syndrome. Now legs are weak, vertigo, progressive left arm weakness and paresthesias. Chronic, severe right frontal migraines. MRI: right sided lesions, multiple sclerosis vs emboli. Lumbar puncture nondiagnostic.
TEE: PFO, right to left shunt, atrial septal aneurysm
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PFO in the real world: Tedy Bruschi
• Feb 2005: left sided weakness, visual field cut, & headache 4 days after playing in Super Bowl
• Diagnosed with Stroke by CT, found to have PFO
• PFO closed March 2005 • Returned to work Oct 2005,
played through 2008 season
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• Dec 18, 2005: small ischemic stroke at age 77
• PFO discovered, placed on Lovenox, scheduled for PFO closure Jan 5
• Jan 4, 2006: massive cerebral hemorrhage, ? related to cerebral amyloid angiopathy
PFO in the real world: Ariel Sharon
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PFO Closure with ICE
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PFO Closure with ICE
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PFO closure: follow up
• ASA long term • Plavix + Abx proph x 6 months is the convention • TTE at 3, 6, and 12 months
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PFO Case Follow Up
6 months post procedure, doing well with stable neurologic symptoms, no procedural complications, migraines resolved (bonus!)
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PFO Summary
• Randomized trials need to be completed—both for stroke and migraine indications
• Currently, PFO closure offered as alternative to medical therapy following first cryptogenic stroke (ignores the guidelines)
• PFO closure for migraine not recommended outside of clinical trial
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THANK YOU!