doi: 10.1161/CIRCULATIONAHA.109.903427
(Circulation. 2009;120:1837-1841.)
© 2009 American Heart Association, Inc.
Clinician Update |
Catheter-Based Closure of the Patent Foramen Ovale
From Cardiology, Cardiovascular Department, University Hospital, Bern, Switzerland.
Correspondence to Bernhard Meier, MD, Professor and Chairman of Cardiology, Cardiovascular Department, University Hospital, 3010 Bern, Switzerland. E-mail bernhard.meier{at}insel.ch
 |
Introduction |
|---|
 Top Introduction Qualification of PFO as...Percutaneous Closure of the...PFO Closure TechniquesThe Migraine SagaConclusionsReferences |
|---|
Case presentation: A 34-year-old woman was admitted for chest pain lasting 5 hours. She had been in excellent health except for migraine attacks with rare aura that kept her away from work about twice a month. She took no medication except for birth control pills. The ECG was unrevealing, but cardiac biomarkers were elevated. Emergency cardiac catheterization showed an occluded small left circumflex coronary artery (Figure 1) and a corresponding small akinetic area in the left ventriculogram. No attempt at coronary recanalization was made because the symptoms had abated, the injured myocardium was akinetic, and there were no collaterals. However, a catheter was introduced into the right atrium, and contrast medium injection proved the suspected patent foramen ovale (PFO; Figure 2 and Movies I and II in the online-only Data Supplement). An Amplatzer PFO occluder was implanted in <10 minutes. The patient was discharged 36 hours later after her cardiac biomarkers had normalized.
|
|
Several lessons are to be gleaned from this case: (1) paradoxical embolism does not necessarily require clinically apparent deep vein thrombosis; (2) paradoxical embolism is not confined to the brain; (3) if coronary artery disease had been present, the connection to paradoxical embolism would probably have been missed; (4) attention was correctly directed primarily at the PFO with a potential to obviate subsequent infarctions of brain, heart, or other sensitive organs; (5) echocardiography is not mandatory to prove a PFO or to close it; (6) migraine symptoms may be linked to the PFO and influenced by PFO closure; and (7) someday, workup for migraine may include screening for a PFO, and treatment for migraine may include closure of a PFO, which, in this case, would have prevented the myocardial infarction.
|
Qualification of PFO as a Disease |
|---|
|
TopIntroductionQualification of PFO as...Percutaneous Closure of the...PFO Closure TechniquesThe Migraine SagaConclusionsReferences |
|---|
Figure 3 and Movie III in the online-only Data Supplement show a large clot caught in the act of slipping through the PFO, proving the potential of a PFO to cause harm. However, the formation of such a large thrombus that will find its way to and through the PFO is an exquisite rarity. Such a problem can also be demonstrated with magnetic resonance (which is not true for the PFO itself) or computed tomography.1
|
The PFO accounts for 
95% of right-to-left shunts.2 The remainder are mainly pulmonary arteriovenous fistulas (4%) or atrial septal defects (1%). The prevalence of a PFO ranges from 15% to 25% in autopsy studies,3,4 7% to 24% with transthoracic echocardiography,5,6 and 20% to 40% with transesophageal echocardiography in patients with a history of cerebral events.7,8 Tiny emboli (a few millimeters in size) that can form anywhere in the venous system are the culprits. Such emboli are absent in children and young adults with few exceptions but tend to occur with increasing frequency with age, particularly after 50 years of age.9 Most thrombi will emerge from the inferior vena cava. Both an atrial septal aneurysm (ASA), which is a flagellate central part of the septum primum forming the lower rim of the foramen ovale, and a Eustachian valve, which is a ledge extending the vena cava onto the foramen ovale, increase the chance for such clots to hit the foramen ovale and pass through it should it be open. Incessant motion in the case of the ASA and the continuous blood pounding the foramen in the case of the Eustachian valve render the fusion of the septum primum and septum secundum after birth all but impossible. The ASA and Eustachian valve increase the duration of time the flap-like PFO is actually gaping. In the case of the ASA, this may occur with every heartbeat.
It is assumed that one or both of these features are present in 2% to 4% of the population. These individuals may account for most of the mishaps attributable to the PFO, a feature present in 20% to 30% of the general population. Screening for such ominous PFO combinations (with ASA and/or Eustachian valve) may therefore make sense.10 Yet, current guidelines of regulatory bodies concentrate on conservative therapeutic options (Table 1).11–14
|
The ASA has been a regularly cited cause for cerebral ischemic stroke. Really at fault, however, is the PFO that typically went undetected in the early transthoracic echocardiograms showing only the ASA in patients with cryptogenic stroke.
Most analyses corroborate the PFO as a stroke risk, at least for cryptogenic stroke. A number of studies appeared to prove the ominous role of a PFO without acknowledging it. In a 20-year population-based cohort study in Denmark15 of almost 200 000 people, an increase in risk of myocardial infarction or stroke was recorded immediately after a clinically apparent venous thromboembolic event. The risk decreased over the subsequent year but never quite normalized.
The true peril of the PFO emerges from a study already a decade old.16 In patients with clinically apparent pulmonary embolism, the mere presence of a PFO increased mortality from 14% to 33% and systemic embolism from 2% to 28% (P<0.02).
|
Percutaneous Closure of the PFO and the Alternatives |
|---|
|
TopIntroductionQualification of PFO as...Percutaneous Closure of the...PFO Closure TechniquesThe Migraine SagaConclusionsReferences |
|---|
The first percutaneous atrial shunt closures17 happened in the seventies, a couple of years before the first percutaneous coronary angioplasty.18 Interest in the topic ignited, however, with a series of percutaneous PFO closures published in 1992.19 It is estimated that >200 000 PFOs have been closed percutaneously since, with more than a dozen device designs. Success rates, defined as no significant residual shunt at the latest follow-up echocardiography, vary between 50% and 100%.20 Randomized controlled trials comparing devices are scarce.
Complications include cardiac perforation or air embolization during implantation, induced atrial fibrillation, nonspecific malaise attributed to nickel allergy, and puncture site problems. Puncture site problems were the only significant complications in the past 1000 cases at our center and occurred in <1%.
Thrombosis on the device during follow-up varies significantly between device families. A German registry found no thrombus with transesophageal echocardiography at 4 weeks on 292 Amplatzer occluders (AGA Medical, Plymouth, Minn), 1 (1%) on 161 Helex occluders (WL Gore and Associates, Newark, Del), 3 (7%) on 127 PFO Star occluders (Cardia Inc., Burnsville, Minn), and 7 (7%) on 100 CardioSEAL/STARFlex occluders (NMT Medical, Boston, Mass).21
|
PFO Closure Techniques |
|---|
|
TopIntroductionQualification of PFO as...Percutaneous Closure of the...PFO Closure TechniquesThe Migraine SagaConclusionsReferences |
|---|
Percutaneous Closure
The simplest technique described so far includes the Amplatzer PFO occluder. It takes <15 minutes in the catheterization laboratory, with the option of the patient pressing a finger on the venous puncture at the groin, walking out of the catheterization laboratory, leaving the hospital within a couple of hours, and participating in whatever physical activity is desired (including sports) the same day. This technique has been validated in a large consecutive patients series22 and may prevent the problems listed in Table 2.
|
So far, no noninvasive technique has been able to induce PFO closure. Local radiofrequency application (deviceless but still invasive) may someday offer an attractive option. Percutaneous intracardiac suture techniques are also in clinical evaluation. However, the PFO typically is a slit of about 20 mm requiring several well-placed stitches, an intricate task for a percutaneous approach.
Guidance with transesophageal or intracardiac echocardiography is still preferred by a majority of operators, but it has disadvantages (Table 3). Randomized trials of PFO device closure to prevent paradoxical embolism are listed in Table 4.23 None has been published yet.
|
|
Surgical Closure
Although surgical closure is still mentioned as an alternative, it has all but lost its indication as an isolated procedure. None of our 1500 patients admitted for PFO closure over the past 12 years has required a surgical intervention for the PFO. However, during cardiac surgery for another reason, surgical PFO closure remains the technique of choice.
Medical Treatment
Warfarin is a better anticoagulant in the venous circulation than acetylsalicylic acid (Figure 4).24,25 Because the absolute risk for paradoxical embolism increases with age and spontaneous closure of the PFO is unlikely, medical treatment should be lifelong. In light of the superiority of oral anticoagulation, device closure of the PFO has to be compared with lifelong warfarin rather than antiplatelet treatment.
|
|
The Migraine Saga |
|---|
|
TopIntroductionQualification of PFO as...Percutaneous Closure of the...PFO Closure TechniquesThe Migraine SagaConclusionsReferences |
|---|
No randomized trial has yet unequivocally shown the benefit of PFO closure for reducing the frequency of migraine headache (Table 5), but the accumulated clinical evidence is hard to ignore (Figure 5).
|
|
|
Conclusions |
|---|
|
TopIntroductionQualification of PFO as...Percutaneous Closure of the...PFO Closure TechniquesThe Migraine SagaConclusionsReferences |
|---|
Seeking a PFO should be part of the workup for stroke, and the term cryptogenic should be pushed beyond the exclusion of a PFO. This would result in the new stroke classification drafted in Table 6.
|
Follow-Up of Case Vignette
The patient was placed on aspirin for 6 months, at which time a transesophageal echocardiography showed complete closure of the PFO. Therefore, aspirin was discontinued. She switched from birth control pills to an intrauterine device. In the 7 years since, she had noted a marked reduction in headache days and complete abolition of aura.
|
Acknowledgments |
|---|
Disclosures
Dr Meier has received research support and honoraria from, served on the speakers’ bureau for, and been a consultant to or on the advisory board for AGA Medical.
|
Footnotes |
|---|
The online-only Data Supplement is available with this article at http://circ.ahajournals.org/cgi/content/full/120/18/1837/DC1.
|
References |
|---|
|
TopIntroductionQualification of PFO as...Percutaneous Closure of the...PFO Closure TechniquesThe Migraine SagaConclusionsReferences |
|---|
1. Fukumoto A, Yaku H, Doi K, Ito H, Numata S, Hayashida K, Inoue T, Akabame S, Oda Y, Matsubara H, Nishimura T. Images in cardiovascular medicine: continuous thrombus in the right and left atria penetrating the patent foramen ovalles. Circulation. 2005; 112: e143–e144.
2. Weber F, Goriup A. Prevalence of right-to-left shunts in active fighter pilots. Aviat Space Environ Med. 2007; 78: 135–136.[Medline] [Order article via Infotrieve]
3. Parsons FG, Keith A. Seventh report of the Committee of Collective Investigation of the Anatomical Society of Great Britain and Ireland, 1896–97. J Anat Physiol. 1897; 32: 164–186.[Medline] [Order article via Infotrieve]
4. Hagen PT, Scholz DG, Edwards WD. Incidence and size of patent foramen ovale during the first 10 decades of life: an autopsy study of 965 normal hearts. Mayo Clin Proc. 1984; 59: 17–20.[Medline] [Order article via Infotrieve]
5. Lechat P, Mas JL, Lascault G, Loron P, Theard M, Klimczac M, Drobinski G, Thomas D, Grosgogeat Y. Prevalence of patent foramen ovale in patients with stroke. N Engl J Med. 1988; 318: 1148–1152.[Abstract]
6. Webster MW, Chancellor AM, Smith HJ, Swift DL, Sharpe DN, Bass NM, Glasgow GL. Patent foramen ovale in young stroke patients. Lancet. 1988; 2: 11–12.[Medline] [Order article via Infotrieve]
7. Hausmann D, Mugge A, Becht I, Daniel WG. Diagnosis of patent foramen ovale by transesophageal echocardiography and association with cerebral and peripheral embolic events. Am J Cardiol. 1992; 70: 668–672.[CrossRef][Medline] [Order article via Infotrieve]
8. Van Camp G, Schulze D, Cosyns B, Vandenbossche JL. Relation between patent foramen ovale and unexplained stroke. Am J Cardiol. 1993; 71: 596–598.[CrossRef][Medline] [Order article via Infotrieve]
9. Anderson FA Jr, Wheeler HB, Goldberg RJ, Hosmer DW, Patwardhan NA, Jovanovic B, Forcier A, Dalen JE. A population-based perspective of the hospital incidence and case-fatality rates of deep vein thrombosis and pulmonary embolism: the Worcester DVT Study. Arch Intern Med. 1991; 151: 933–938.
10. Meier B, Lock JE. Contemporary management of patent foramen ovale. Circulation. 2003; 107: 5–9.
11. Albers GW, Amarenco P, Easton JD, Sacco RL, Teal P. Antithrombotic and thrombolytic therapy for ischemic stroke: the Seventh ACCP Conference on Antithrombotic and Thrombolytic Therapy. Chest. 2004; 126: 483S–512S.
12. Messe SR, Silverman IE, Kizer JR, Homma S, Zahn C, Gronseth G, Kasner SE. 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: 1042–1050.
13. Sacco RL, Adams R, Albers G, Alberts MJ, Benavente O, Furie K, Goldstein LB, Gorelick P, Halperin J, Harbaugh R, Johnston SC, Katzan I, Kelly-Hayes M, Kenton EJ, Marks M, Schwamm LH, Tomsick T. 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: the American Academy of Neurology affirms the value of this guideline. Stroke. 2006; 37: 577–617.
14. Guidelines for management of ischaemic stroke and transient ischaemic attack 2008. Cerebrovasc Dis. 2008; 25: 457–507.[CrossRef][Medline] [Order article via Infotrieve]
15. Soerensen H, Horvath-Puho E, Pedersen L, Baron JA, Prandoni P. Venous thromboembolism and subsequent hospitalisation due to acute arterial cardiovascular events: a 20-year cohort study. Lancet. 2007; 370: 1773–1779.[CrossRef][Medline] [Order article via Infotrieve]
16. Konstantinides S, Geibel A, Kasper W, Olschewski M, Blumel L, Just H. Patent foramen ovale is an important predictor of adverse outcome in patients with major pulmonary embolism. Circulation. 1998; 97: 1946–1951.
17. King TD, Thompson SL, Steiner C, Mills NL. Secundum atrial septal defect: nonoperative closure during cardiac catheterization. JAMA. 1976; 235: 2506–2509.
18. Gruentzig AR. Transluminal dilatation of coronary-artery stenosis. Lancet. 1978; 1: 263.[CrossRef][Medline] [Order article via Infotrieve]
19. Bridges ND, Hellenbrand W, Latson L, Filiano J, Newburger JW, Lock JE. Transcatheter closure of patent foramen ovale after presumed paradoxical embolism. Circulation. 1992; 86: 1902–1908.
20. Wahl A, Meier B. Patent foramen ovale and ventricular septal defect closure. Heart. 2009; 95: 70–82.
21. Krumsdorf U, Ostermayer S, Billinger K, Trepels T, Zadan E, Horvath K, Sievert H. Incidence and clinical course of thrombus formation on atrial septal defect and patent foramen ovale closure devices in 1,000 consecutive patients. J Am Coll Cardiol. 2004; 43: 302–309.
22. Wahl A, Praz F, Stirnimann J, Windecker S, Seiler C, Nedeltchev K, Mattle HP, Meier B. Safety and feasibility of percutaneous closure of patent foramen ovale without intra-procedural echocardiography in 825 patients. Swiss Med Wkly. 2008; 138: 567–572.[Medline] [Order article via Infotrieve]
23. O'Gara PT, Messe SR, Tuzcu EM, Catha G, Ring JC. Percutaneous device closure of patent foramen ovale for secondary stroke prevention: a call for completion of randomized clinical trials: a science advisory from the American Heart Association/American Stroke Association and the American College of Cardiology Foundation. J Am Coll Cardiol. 2009; 53: 2014–2018.
24. Windecker S, Wahl A, Nedeltchev K, Arnold M, Schwerzmann M, Seiler C, Mattle HP, Meier B. Comparison of medical treatment with percutaneous closure of patent foramen ovale in patients with cryptogenic stroke. J Am Coll Cardiol. 2004; 44: 750–758.
25. Schuchlenz HW, Weihs W, Berghold A, Lechner A, Schmidt R. Secondary prevention after cryptogenic cerebrovascular events in patients with patent foramen ovale. Int J Cardiol. 2005; 101: 77–82.[CrossRef][Medline] [Order article via Infotrieve]
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||