CLOSURE OF PATENT FORAMEN OVALE

Faruk Kara

Health Sciences University, Faculty of Medicine, Ahi Evren Thoracic Cardiovascular Surgery Training and Research Hospital, Department of Cardiology, Trabzon, Türkiye

Kara F. Closure of Patent Foramen Ovale. In: Tanık VO, Özlek B editors. Invasive Interventions in Structural Heart Diseases: Comprehensive Techniques. 1st ed. Ankara: Türkiye Klinikleri; 2025. p.405-420.

ABSTRACT

Patent foramen ovale (PFO) is a common cardiac anomaly affecting approximately 25% of the adult population. It is usually benign and diagnosed incidentally. However, it can also cause different clinical conditions due to paradoxical embolism in some individuals. It has been shown to play a role in the pathogenesis of clinical conditions such as cryptogenic stroke, systemic embolisation, migraine with aura, platypnoea-orthodeoxia syndrome and decompression illness. Studies have shown that PFO closure reduces recurrence and sometimes even prevents the disease in selected patients. In this article, we will explain the detection of PFO, the clinical conditions it is associated with and the indications for closure, closure procedures and devices.

Keywords: Patent foramen ovale; Paradoxical embolism; Cryptogenic stroke; Closure devices

Referanslar

  1. Ntaios G, Papavasileiou V, Sagris D, Makaritsis K, Vemmos K, Steiner T, et al. Closure of Patent Foramen Ovale Versus Medical Therapy in Patients With Cryptogenic Stroke or Transient Ischemic Attack: Updated Systematic Review and Meta-Analysis. Stroke. 2018;49(2):412-418. [Crossref]  [PubMed]
  2. Kim MS, Klein AJ, Carroll JD: Transcatheter closure of intracardiac defects in adults. J Interv Cardiol 20:524,2007. [Crossref]  [PubMed]
  3. Kedia G, Tobis J, Lee MS: Patent foramen ovale: Clinical manifestations and treatment. Rev Cardiovasc Med 9:168,2008. [PubMed]
  4. Gibblet JP, Samad OA, Shapiro LM, Rana BS, Calvert PA. Patent Foramen Ovale Closure in 2019. Intervent Cardiol Rev 2019;14:34-41. [Crossref]  [PubMed]  [PMC]
  5. Anderson RH, Brown NA, Webb S. Development and structure of the atrial septum. Heart. 2002;88(1):104-10. [Crossref]  [PubMed]  [PMC]
  6. Calvert PA, Rana BS, Kydd AC, Shapiro LM. Patent foramen ovale: anatomy, outcomes, and closure. Nat Rev Cardiol 2011;8:148-60. [Crossref]  [PubMed]
  7. Yang H, Nassif M, Khairy P, de Groot JR, Roos YBWEM, de Winter RJ, et al. Cardiac diagnostic work-up of ischaemic stroke. Eur Heart J 2018;39:1851-1860. [Crossref]  [PubMed]
  8. Bhatia N, Abushora MY, Donneyong MM, Stoddard MF. Determination of the optimum number of cardiac cycles to differentiate intra-pulmonary shunt and patent foramen ovale by saline contrast two and three dimensional echocardiography. Echocardiography. 2014;31:293-301. [Crossref]  [PubMed]
  9. Pizzino F, Khandheria B, Carerj S, Oreto G, Piccione MC, Todaro MC, et al. PFO: button me up, but wait comprehensive evaluation of the patient. J Cardiol 2016;67:485-92. [Crossref]  [PubMed]
  10. Zoghbi WA. Patent foramen ovale: going beyond the bubbles. J Am Coll Cardiol Img 2014;7:251-253. [Crossref]  [PubMed]
  11. Mahmoud AN, Elgendy IY, Agarwal N, Tobis JM, Mojadidi MK. Identification and quantification of patent foramen ovale- mediated shunts: echocardiography and transcranial doppler. Interv Cardiol Clin 2017;6:495-504. [Crossref]  [PubMed]
  12. Pristipino C, Sievert H, D'Ascenzo F, Louis Mas J, Meier B, Scacciatella P, et al. European position paper on the management of patients with patent foramen ovale. General approach and left circulation thromboembolism. European Heart Journal. 2019;1-14. [Crossref]  [PubMed]
  13. Kim YJ, Hur J, Shim CY, Lee HJ, Ha JW, Choe KO, et al. Patent foramen ovale: diagnosis with multidetector CT-comparison with transesophageal echocardiography. Radiology. 2009;250(1):61-7. [Crossref]  [PubMed]
  14. Nusser T, Höher M, Merkle N, Grebe OC, Spiess J, Kestler HA, et al. Cardiac magnetic resonance imaging and transesophageal echocardiography in patients with transcatheter closure of patent foramen ovale. J Am CollCardiol. 2006;48(2):322-9. [Crossref]  [PubMed]
  15. Handke M, Harloff A, Olschewski M, Hetzel A, Geibel A. Patent foramen ovale and cryptogenic stroke in olderpatients. N Engl J Med 2007;357:2262-8. [Crossref]  [PubMed]
  16. Adams HPJ, Bendixen BH, Kappelle LJ, Biller J, Love BB, Gordon DL, et al. Classification of subtype of acute ischemic stroke. Definitions for use in a multicenter clinical trial. TOAST. Trial of Org 10172 in Acute Stroke Treatment. Stroke 1993;24:35-41. [Crossref]  [PubMed]
  17. Fonseca AC, Ferro JM. Cryptogenic stroke. Eur J Neurol 2015;22:618-623. [Crossref]  [PubMed]
  18. Alsheikh-Ali AA, Thaler DE, Kent DM. Patent foramen ovale in cryptogenic stroke: incidental or pathogenic? Stroke 2009;40:2349-2355. [Crossref]  [PubMed]  [PMC]
  19. Furlan AJ, Reisman M, Massaro J, Mauri L, Adams H, Albers GW, et al. Closure or medical therapy for cryptogenic stroke with patent foramen ovale. N Engl J Med 2012;366:991-999. [Crossref]  [PubMed]
  20. Carroll JD, Saver JL, Thaler DE, Smalling RW, Berry S, Mac-Donald LA, et al. Closure of patent foramen ovale versus medical therapy after cryptogenic stroke. N Engl J Med 2013;368:1092-1100. [Crossref]  [PubMed]
  21. Meier B, Kalesan B, Mattle HP, Khattab AA, Hildick-Smith D, Dudek D, et al. Percutaneous closure of patent foramen ovale in cryptogenic embolism. N Engl J Med 2013;368:1083-1091. [Crossref]  [PubMed]
  22. Kent DM, Dahabreh IJ, Ruthazer R, Furlan AJ, Reisman M, Carroll JD, et al. Device closure of patent foramen ovale after stroke: pooled analysis of completed randomized trials. J Am Coll Cardiol 2016;67:907-917. [Crossref]  [PubMed]  [PMC]
  23. Saver JL, Carroll JD, Thaler DE, Smalling RW, MacDonald LA, Marks DS, et al. Long-term outcomes of patent foramen ovale closure or medical therapy after stroke. N Engl J Med 2017;377:1022-1032. [Crossref]  [PubMed]
  24. Mas JL, Derumeaux G, Guillon B, Massardier E, Hosseini H, Mechtouff L, et al. Patent foramen ovale closure or anticoagulation vs. antiplatelets after stroke. N Engl J Med 2017;377:1011-1021. [Crossref]  [PubMed]
  25. Sondergaard L, Kasner SE, Rhodes JF, Andersen G, Iversen HK, Nielsen-Kudsk JE, et al. Patent foramen ovale closure or antiplatelet therapy for cryptogenic stroke. N Engl J Med 2017;377:1033-1042. [Crossref]  [PubMed]
  26. Lee PH, Song JK, Kim JS, Heo R, Lee S, Kim DH, et al. Cryptogenic stroke and high-risk patent foramen ovale: the DEFENSE- PF0 trial. J Am Coll Cardiol 2018;71:2335-42. [Crossref]  [PubMed]
  27. Rana BS, Shapiro LM, McCarthy KP, Ho SY. Three-dimensional imaging of the atrial septum and patent foramen ovale anatomy: defining the morphological phenotypes of patent foramen ovale. Eur J Echocardiogr. 2010;11(10):19-25. [Crossref]  [PubMed]
  28. Mas JL, Saver JL, Kasner SE, Nelson J, Carroll JD, Chatellier G, et al. Association of atrial septal aneurysm and shunt size with stroke recurrence and benefit from patent foramen ovale closure. JAMA Neurol. 2022;79:1175- 1179. [Crossref]  [PubMed]  [PMC]
  29. Kent DM, Ruthazer R, Weimar C, Mas JL, Serena J, Homma S, et al. An index to identify stroke-related vs incidental patent foramen ovale in cryptogenic stroke. Neurology. 2013;81:619-25. [Crossref]  [PubMed]  [PMC]
  30. 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:NP7-NP8. [Crossref]  [PubMed]
  31. Kent DM, Saver JL, Kasner SE, Nelson J, Carroll JD, Chatellier G, et al. Heterogeneity of treatment effects in an analysis of pooled individual patient data from randomized trials of device closure of patent foramen ovale after stroke. JAMA 2021;326:2277-2286. [Crossref]  [PubMed]  [PMC]
  32. Sposato LA , Albin CSW, Elkind MSV, Kamel H, Saver JL. Patent Foramen Ovale Management for Secondary Stroke Prevention: State-of-the-Art Appraisal of Current Evidence. Stroke 2024;55(1):236-247. [Crossref]  [PubMed]
  33. Kim RJ, Girardi LN. "Lots of clots": multiple thromboemboli including a huge paradoxical embolus in a 29-year old man. Int J Cardiol 2008;129:e50-2. [Crossref]  [PubMed]
  34. Ahmed S, Sadiq A, Siddiqui AK, Borgen E, Mattana J. Paradoxical arterial emboli causing acute limb ischemia in a patient with essential thrombocytosis. Am J Med Sci 2003;326:156-8. [Crossref]  [PubMed]
  35. Pavoni D, Zanuttini D, Spedicato L, Mazzaro E, Ugolino L. Large interatrial thrombus-in-transit resulting in acute myocardial infarction complicated by atrioventricular block and cardiogenic shock. J Am Coll Cardiol 2012;59:1329. [Crossref]  [PubMed]
  36. Burch RC, Loder S, Loder E, Smitherman TA. The prevalence and burden of migraine and severe headache in the United States: updated statistics from government health surveillance studies. Headache 2015;55:21-34. [Crossref]  [PubMed]
  37. Lipton RB, Liberman JN, Kolodner KB, Bigal ME, Dowson A, Stewart WF. Migraine headache disability and health-related quality-of-life: a population-based case-control study from England. Cephalalgia 2003;23:441-50. [Crossref]  [PubMed]
  38. Finocchi C, Del Sette M. Migraine with aura and patent foramen ovale: myth or reality? Neurol sci. 2015;36:61-6. [Crossref]  [PubMed]
  39. Schwerzmann M, Nedeltchev K, Lagger F, Mattle HP, Windecker S, Meier B,et al. Prevalence and size of directly detected patent foramen ovale in migraine with aura. Neurology. 2005;65:1415-8. [Crossref]  [PubMed]
  40. Dowson A, Mullen MJ, Peatfield R, Muir K, Khan AA, Wells C, et al. Migraine Intervention with STARFlex Technology (MIST) trial: a prospective, multicenter, double-blind, sham-controlled trial to evaluate the effectiveness of patent foramen ovale closure with STARFlex septal repair implant to resolve refractory migraine headache. Circulation 2008;117;1397-404. [Crossref]  [PubMed]
  41. Mattle HP, Evers S, Hildick-Smith D, Becker WJ, Baumgartner H, Chataway J, et al. Percutaneous closure of patent foramen ovale in migraine with aura, a randomized controlled trial. Eur Hear J 2016;37:2029-36. [Crossref]  [PubMed]
  42. Tobis JM, Charles A, Silberstein SD, Sorensen S, Maini B, Horwitz PA, et al. Percutaneous closure of patent foramen ovale in patients with migraine: the PREMIUM trial. J Am Coll Cardiol 2017;70:2766-74. [Crossref]  [PubMed]
  43. Butler BD, Hills BA. The lung as a filter for microbubbles. J Appl Physiol Respir Environ Exerc Physiol. 1979;47:537-43. [Crossref]  [PubMed]
  44. Vanden Eede M, Van Berendoncks A, De Wolfe D, De Maeyer C, Vanden Eede H, Germonpre P. Percutaneous closure of patent foramen ovale for the secondary prevention of decompression illness in sports divers: mind the gap. Undersea Hyperb Med 2019;46:625-32. [Crossref]  [PubMed]
  45. Godart F, Rey C, Prat A, Vincentelli A, Chmait A, Francart C, et al. Atrial right-to-left shunting causing severe hypoxaemia despite normal right-sided pressures. Report of 11 consecutive cases corrected by percutaneous closure. Eur Hear J 2000;21:483-9. [Crossref]  [PubMed]
  46. Shah AH, Osten M, Leventhal A, Bach Y, Yoo D, Mansour D, et al. Percutaneous intervention to treat platypnea-orthodeoxia syndrome: the Toronto experience. JACC Cardiovasc Interv 2016;9:1928-38. [Crossref]  [PubMed]
  47. Blackshear JL, Odell JA. Appendage obliteration to reduce stroke in cardiac surgical patients with atrial fibrillation. Ann Thorac Surg 1996;61:755-9. [Crossref]  [PubMed]
  48. Cotter PE, Martin PJ, Ring L, Warburton EA, Belham M, Pugh PJ. Incidence of atrial fibrillation detected by implantable loop recorders in unexplained stroke. Neurology. 2013;80:1546-50. [Crossref]  [PubMed]  [PMC]
  49. Sanna T, Diener HC, Passman RS, Lazzaro VD, Bernstein RA, Morillo CA, et al. Cryptogenic stroke and underlying atrial fibrillation. N Engl J Med. 2014;370:2478-86. [Crossref]  [PubMed]
  50. Podd SJ, Sugihara C, Furniss SS, Sulke N. Are implantablecardiac monitors the 'gold standard ' for atrial fibrillation detection? A prospective randomized trial comparing atrial fibrillation monitoring using implantable cardiac monitors and DDDRP permanent pacemakers in post atrial fibrillation ablation patients. Europace. 2016;18:1000-5. [Crossref]  [PubMed]
  51. Davison P, Clift PF, Steeds RP. The Role of Echocardiography in Diagnosis, Monitoring Closure and Post-Procedural Assessment of Patent Foramen Ovale. Eur J Echocardiogr. 2010;11(10):i27-34. [Crossref]  [PubMed]
  52. Pristipino C, Sievert H, D'Ascenzo F, Mas JL, Meier B, Scacciatella P, et al. European position paper on the management of patients with patent foramen ovale. General approach and left circulation thromboembolism. Eur Heart J 2019;40:3182-95. [Crossref]  [PubMed]
  53. Giblett JP, Williams LK, Kyranis S, Shapiro LM, Calvert PA. Patent Foramen Ovale Closure: State of the Art. Interv Cardiol. 2020;15:e15. [Crossref]  [PubMed]  [PMC]
  54. Kumar P, Rusheen J, Tobis JM. A Comparison of Methods to Determine Patent Foramen Ovale Size. Catheter Cardiovasc Interv. 2020;96(6):E621-9. [Crossref]  [PubMed]
  55. Collado FMS, Poulin MF, Murphy JJ, Jneid H, Kavinsky CJ. Patent Foramen Ovale Closure for Stroke Prevention and Other Disorders. J Am Heart Assoc. 2018;7(12):e007146. [Crossref]  [PubMed]  [PMC]
  56. Abbott Laboratories. Amplatzer Talisman PFO Occluder Instructions for Use [Internet]. Chicago: Abbott Laboratories; 2023 [cited 2023 Nov 11]. Available from: [Link]
  57. Tanaka J, Izumo M, Fukuoka Y, Saitoh T, Harada K, Harada K, et al. Comparison of Two- Dimensional Versus Real-Time Three-Dimensional Transesophageal Echocardiography for Evaluation of Patent Foramen Ovale Morphology. Am J Cardiol. 2013;111(7):1052-6. [Crossref]  [PubMed]
  58. Datta T, Ruggiero N, Peters A, Pender A, Vishnevsky A, Mehrotra P. Three-dimensional Transesophageal Echocardiography for Transcatheter Patent Foramen Ovale Closure: Standardizing Anatomic Nomenclature and Novel Sizing Concepts. CASE (Phila). 2022;7(1):14-20. [Crossref]  [PubMed]  [PMC]
  59. Demulier L, Paelinck BP, Coomans I, Hemelsoet D, De Backer J, Campens L, et al. A New Dimension in Patent Foramen Ovale Size Estimation. Echocardiography. 2020;37(7):1049-55. [Crossref]  [PubMed]
  60. Sperlongano S, Giordano M, Ciccarelli G, Bassi G, D'Aquino MMC, Del Giudice C, et al. Advances in Percutaneous Patent Foramen Ovale Closure: from the Procedure to the Echocardiographic Guidance. J Clin Med. 2022;11(14):4001. [Crossref]  [PubMed]  [PMC]
  61. Awad SM, Garay FF, Cao QL, Hijazi ZM. Multiple Amplatzer Septal Occluder Devices for Multiple Atrial Communications: Immediate and Long-Term Follow-Up Results. Catheter Cardiovasc Interv. 2007;70(2):265-73. [Crossref]  [PubMed]
  62. Thompson AJ, Hagler DJ, Taggart NW. Transseptal Puncture to Facilitate Device Closure of "Long-Tunnel" Patent Foramen Ovale. Catheter Cardiovasc Interv. 2015;85(6):1053-7. [Crossref]  [PubMed]
  63. Lin CH, Balzer DT, Lasala JM. Defect Closure in the Lipomatous Hypertrophied Atrial Septum with the Amplatzer Muscular Ventricular Septal Defect Closure Device: a Case Series. Catheter Cardiovasc Interv. 2011;78(1):102-7. [Crossref]  [PubMed]
  64. MacDonald ST, Daniels MJ, Ormerod OJ. Initial use of the new GORE® septal occluder in patent foramen ovale closure: implantation and preliminary results. Catheter Cardiovasc Interv 2013;81:660-5. [Crossref]  [PubMed]  [PMC]
  65. Hardt SE, Eicken A, Berger F, Schubert S, Carminati M, Butera G, et al. Closure of patent foramen ovale defects using GORE® CARDIOFORM septal occluder: results from a prospective European multicenter study. Catheter Cardiovasc Interv 2017;90:824-9. [Crossref]  [PubMed]