Patent foramen ovale closure in the management of cryptogenic stroke: a review of current literature and guideline statements

References

• Adams HP, Jr., Bendixen BH, Kappelle LJ, 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(1):35–41.
   PubMed Web of Science ®Google Scholar
• Petty GW, Brown RD, Jr., Whisnant JP, et al. Ischemic stroke subtypes: a population-based study of incidence and risk factors. Stroke. 1999;30(12):2513–2516.
   PubMed Web of Science ®Google Scholar
• Kolominsky-Rabas PL, Weber M, Gefeller O, et al. Epidemiology of ischemic stroke subtypes according to TOAST criteria: incidence, recurrence, and long-term survival in ischemic stroke subtypes: a population-based study. Stroke. 2001;32(12):2735–2740.
   PubMed Web of Science ®Google Scholar
• Putaala J, Metso AJ, Metso TM, et al. Analysis of 1008 consecutive patients aged 15 to 49 with first-ever ischemic stroke: the Helsinki young stroke registry. Stroke. 2009;40(4):1195–1203.
   PubMed Web of Science ®Google Scholar
• Perera KS, Vanassche T, Bosch J, et al. Embolic strokes of undetermined source: prevalence and patient features in the ESUS Global Registry. Int J Stroke. 2016;11(5):526–533.
   PubMed Web of Science ®Google Scholar
• Healey JS, Connolly SJ, Gold MR, et al. Subclinical atrial fibrillation and the risk of stroke. N Engl J Med. 2012;366(2):120–129.
   PubMed Web of Science ®Google Scholar
• Brambatti M, Connolly SJ, Gold MR, et al. Temporal relationship between subclinical atrial fibrillation and embolic events. Circulation. 2014;129(21):2094–2099.
   PubMed Web of Science ®Google Scholar
• Koutroulou I, Tsivgoulis G, Tsalikakis D, et al. Epidemiology of patent foramen ovale in general population and in stroke patients: a narrative review. Front Neurol. 2020;11:281.
   PubMed Web of Science ®Google Scholar
• Miranda B, Fonseca AC, Ferro JM. Patent foramen ovale and stroke. J Neurol. 2018;265(8):1943–1949.
   PubMed Web of Science ®Google Scholar
• Arboix A, Jiménez C, Massons J, et al. Hematological disorders: a commonly unrecognized cause of acute stroke. Expert Rev Hematol. 2016;9(9):891–901.
   PubMed Web of Science ®Google Scholar
• Hart RG, Diener HC, Coutts SB, et al. Embolic strokes of undetermined source: the case for a new clinical construct. Lancet Neurol. 2014;13(4):429–438.
   PubMed Web of Science ®Google Scholar
• Arsava EM, Ballabio E, Benner T, et al. The causative classification of stroke system: an international reliability and optimization study. Neurology. 2010;75(14):1277–1284.
   PubMed Web of Science ®Google Scholar
• Arboix A, Alió J. Acute cardioembolic stroke: an update. Expert Rev Cardiovasc Ther. 2011;9(3):367–379.
   PubMedGoogle Scholar
• Kernan WN, Ovbiagele B, Black HR, et al. Guidelines for the prevention of stroke in patients with stroke and transient ischemic attack: a guideline for healthcare professionals from the American Heart Association/American Stroke Association. Stroke. 2014;45(7):2160–2236.
   PubMed Web of Science ®Google Scholar
• Masoomi R, Tadros P, Wiley M, et al. National trends and outcomes of percutaneous ASD/PFO closure: a report from the national inpatient sample. J Am Coll Cardiol. 2018;71(11):A1091.
   Web of Science ®Google Scholar
• Kent DM, Dahabreh IJ, Ruthazer R, et al. Device closure of patent foramen ovale after stroke: pooled analysis of completed randomized trials. J Am Coll Cardiol. 2016;67(8):907–917.
   PubMed Web of Science ®Google Scholar
• Mas JL, Derumeaux G, Guillon B, et al. Patent foramen ovale closure or anticoagulation vs antiplatelets after stroke. N Engl J Med. 2017;377(11):1011–1021.
   PubMed Web of Science ®Google Scholar
• Saver JL, Carroll JD, Thaler DE, et al. Long-term outcomes of patent foramen ovale closure or medical therapy after stroke. N Engl J Med. 2017;377(11):1022–1032.
   PubMed Web of Science ®Google Scholar
• Sondergaard L, Kasner SE, Rhodes JF, et al. Patent foramen ovale closure or antiplatelet therapy for cryptogenic stroke. N Engl J Med. 2017;377(11):1033–1042.
   PubMed Web of Science ®Google Scholar
• Lee PH, Song JK, Kim JS, et al. Cryptogenic stroke and high-risk patent foramen ovale: the DEFENSE-PFO trial. J Am Coll Cardiol. 2018;71(20):2335–2342.
   PubMed Web of Science ®Google Scholar
• 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(1):17–20.
   PubMed Web of Science ®Google Scholar
• Meissner I, Whisnant JP, Khandheria BK, et al. Prevalence of potential risk factors for stroke assessed by transesophageal echocardiography and carotid ultrasonography: the SPARC study. Stroke Prevention: assessment of risk in a community. Mayo Clin Proc. 1999;74(9):862–869.
   PubMed Web of Science ®Google Scholar
• Wilmshurst PT, Nightingale S, Walsh KP, et al. Effect on migraine of closure of cardiac right-to-left shunts to prevent recurrence of decompression illness or stroke or for haemodynamic reasons. Lancet. 2000;356(9242):1648–1651.
   PubMed Web of Science ®Google Scholar
• Whisenant B, Reisman M. PFO and migraine: the blind leading the blinded. J Am Coll Cardiol. 2017;70(22):2775–2777.
   PubMed Web of Science ®Google Scholar
• Chen GP, Goldberg SL, Gill EA. Jr. Patent foramen ovale and the platypnea-orthodeoxia syndrome. Cardiol Clin. 2005;23(1):85–89.
   PubMed Web of Science ®Google Scholar
• Sykes O, Clark JE. Patent foramen ovale and scuba diving: a practical guide for physicians on when to refer for screening. Extrem Physiol Med. 2013;2(1):10.
   PubMedGoogle Scholar
• Furlan AJ. Brief history of patent foramen ovale and stroke. Stroke. 2015;46(2):e35–e37.
   PubMed Web of Science ®Google Scholar
• Overell JR, Bone I, Lees KR. Interatrial septal abnormalities and stroke: a meta-analysis of case-control studies. Neurology. 2000;55(8):1172–1179.
   PubMed Web of Science ®Google Scholar
• 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(22):2625–2631.
   PubMed Web of Science ®Google Scholar
• Mas JL, Zuber M. Recurrent cerebrovascular events in patients with patent foramen ovale, atrial septal aneurysm, or both and cryptogenic stroke or transient ischemic attack. French Study Group on Patent Foramen Ovale and Atrial Septal Aneurysm. Am Heart J. 1995;130(5):1083–1088.
   PubMed Web of Science ®Google Scholar
• Meissner I. The management of patients with patent foramen ovale and stroke. Curr Treat Options Neurol. 2005;7(6):483–490.
   PubMedGoogle Scholar
• Homma S, Di Tullio MR, Sciacca RR, et al. Effect of aspirin and warfarin therapy in stroke patients with valvular strands. Stroke. 2004;35(6):1436–1442.
   PubMed Web of Science ®Google Scholar
• 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(7):1042–1050.
   PubMed Web of Science ®Google Scholar
• Kasner SE, Swaminathan B, Lavados P, et al. Rivaroxaban or aspirin for patent foramen ovale and embolic stroke of undetermined source: a prespecified subgroup analysis from the navigate ESUS trial. Lancet Neurol. 2018;17(12):1053–1060.
   PubMed Web of Science ®Google Scholar
• Homma S, Tullio MRD, Sacco RL, et al. Surgical closure of patent foramen Ovale in cryptogenic. Stroke Patients. 1997;28(12):2376–2381.
   PubMed Web of Science ®Google Scholar
• 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.
   PubMed Web of Science ®Google Scholar
• 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.
   PubMed Web of Science ®Google Scholar
• Hornung M, Bertog SC, Franke J, et al. Long-term results of a randomized trial comparing three different devices for percutaneous closure of a patent foramen ovale. Eur Heart J. 2013;34(43):3362–3369.
   PubMed Web of Science ®Google Scholar
• Eeckhout E, Martin S, Delabays A, et al. Very long-term follow-up after percutaneous closure of patent foramen ovale. EuroIntervention: journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the. EuroIntervention. 2015;10(12):1474–1479.
   PubMed Web of Science ®Google Scholar
• Wahl A, Juni P, Mono ML, et al. Long-term propensity score-matched comparison of percutaneous closure of patent foramen ovale with medical treatment after paradoxical embolism. Circulation. 2012;125(6):803–812.
   PubMed Web of Science ®Google Scholar
• Stortecky S, da Costa BR, Mattle HP, et al. Percutaneous closure of patent foramen ovale in patients with cryptogenic embolism: a network meta-analysis. Eur Heart J. 2015;36(2):120–128.
   PubMed Web of Science ®Google Scholar
• Nasir UB, Qureshi WT, Jogu H, et al. Updated meta-analysis of closure of patent foramen ovale versus medical therapy after cryptogenic stroke. Cardiovasc Revasc Med. 2019;20(3):187–193.
   PubMed Web of Science ®Google Scholar
• Garg A, Thawabi M, Rout A, et al. Recurrent stroke reduction with patent foramen ovale closure versus medical therapy based on patent foramen ovale characteristics: a meta-analysis of randomized controlled trials. Cardiology. 2019;144(1–2):40–10.
   PubMed Web of Science ®Google Scholar
• Sa M, Vieira EES, Cavalcanti LRP, et al. Updated meta-analysis on the closure of patent foramen ovale in reduction of stroke rates: the DEFENSE-PFO trial does not change the scenario. Braz J Cardiovasc Surg. 2018;33(5):511–521.
   PubMed Web of Science ®Google Scholar
• Wintzer-Wehekind J, Alperi A, Houde C, et al. Impact of discontinuation of antithrombotic therapy following closure of patent foramen ovale in patients with cryptogenic embolism. Am J Cardiol. 2019;123(9):1538–1545.
   PubMed Web of Science ®Google Scholar
• Mazzucco S, Li L, Rothwell PM. Prognosis of cryptogenic stroke with patent foramen ovale at older ages and implications for trials: a population-based study and systematic review. JAMA Neurol. 2020;77(10):1279–1279.
   PubMed Web of Science ®Google Scholar
• Mas J-L, Derumeaux G, Guillon B, et al. Patent foramen ovale closure or anticoagulation vs antiplatelets after stroke. Antiplatelets after Stroke. 2017;377(11):1011–1021.
   Google Scholar
• Trepels T, Zeplin H, Sievert H, et al. Cardiac perforation following transcatheter PFO closure. Catheter Cardiovasc Interv. 2003;58(1):111–113.
   PubMed Web of Science ®Google Scholar
• Schwerzmann M, Salehian O. Hazards of percutaneous PFO closure. Eur Heart J. 2005;6(6):393–395.
   Google Scholar
• Abdelghani M, Nassif M, de Bruin-Bon R, et al. Aortic root geometric and dynamic changes after device closure of interatrial shunts. J Am Soc Echocardiogra. 2019;32(8):1016–1026.e5.
   PubMed Web of Science ®Google Scholar
• Sanna T, Diener HC, Passman RS, et al. Cryptogenic stroke and underlying atrial fibrillation. N Engl J Med. 2014;370(26):2478–2486.
   PubMed Web of Science ®Google Scholar
• Gladstone DJ, Spring M, Dorian P, et al. Atrial fibrillation in patients with cryptogenic stroke. N Engl J Med. 2014;370(26):2467–2477.
   PubMed Web of Science ®Google Scholar
• Kishore A, Vail A, Majid A, et al. Detection of atrial fibrillation after ischemic stroke or transient ischemic attack: a systematic review and meta-analysis. Stroke. 2014;45(2):520–526.
   PubMed Web of Science ®Google Scholar
• Afzal MR, Gunda S, Waheed S, et al. Role of outpatient cardiac rhythm monitoring in cryptogenic stroke: a systematic review and meta-analysis. Pacing Clin Electrophysiol. 2015;38(10):1236–1245.
   PubMed Web of Science ®Google Scholar
• Wu LA, Malouf JF, Dearani JA, et al. Patent foramen ovale in cryptogenic stroke: current understanding and management options. Arch Intern Med. 2004;164(9):950–956.
   PubMedGoogle Scholar
• Schuchlenz HW, Weihs W, Horner S, et al. The association between the diameter of a patent foramen ovale and the risk of embolic cerebrovascular events. Am J Med. 2000;109(6):456–462.
   PubMed Web of Science ®Google Scholar
• Homma S, Di Tullio MR, Sacco RL, et al. Characteristics of patent foramen ovale associated with cryptogenic stroke. A biplane transesophageal echocardiographic study. Stroke. 1994;25(3):582–586.
   PubMed Web of Science ®Google Scholar
• De Castro S, Cartoni D, Fiorelli M, et al. Morphological and functional characteristics of patent foramen ovale and their embolic implications. Stroke. 2000;31(10):2407–2413.
   PubMed Web of Science ®Google Scholar
• Stone DA, Godard J, Corretti MC, et al. Patent foramen ovale: association between the degree of shunt by contrast transesophageal echocardiography and the risk of future ischemic neurologic events. Am Heart J. 1996;131(1):158–161.
   PubMed Web of Science ®Google Scholar
• Rigatelli G, Dell’avvocata F, Braggion G, et al. Persistent venous valves correlate with increased shunt and multiple preceding cryptogenic embolic events in patients with patent foramen ovale: an intracardiac echocardiographic study. Cathet Cardiovasc Intervent. 2008;72(7):973–976.
   PubMed Web of Science ®Google Scholar
• Meissner I, Khandheria BK, Heit JA, et al. Patent foramen ovale: innocent or guilty? Evidence from a prospective population-based study. J Am Coll Cardiol. 2006;47(2):440–445.
   PubMed Web of Science ®Google Scholar
• Petty GW, Khandheria BK, Meissner I, et al. Population-based study of the relationship between patent foramen ovale and cerebrovascular ischemic events. Mayo Clin Proc. 2006;81(5):602–608.
   PubMed Web of Science ®Google Scholar
• 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.
   PubMed Web of Science ®Google Scholar
• Thaler DE, Ruthazer R, Weimar C, et al. Recurrent stroke predictors differ in medically treated patients with pathogenic vs. other PFOs. Neurology. 2014;83(3):221–226.
   PubMed Web of Science ®Google Scholar
• Morais LA, Sousa L, Fiarresga A, et al. RoPE score as a predictor of recurrent ischemic events after percutaneous patent foramen ovale closure. Int Heart J. 2018;59(6):1327–1332.
   PubMed Web of Science ®Google Scholar
• Volpi JJ, Ridge JR, Nakum M, Rhodes JF, et al. Cost-effectiveness of percutaneous closure of a patent foramen ovale compared with medical management in patients with a cryptogenic stroke: from the US payer perspective. J Med Econ. 2019;22(9):883–890.
   PubMed Web of Science ®Google Scholar
• Hildick-Smith D, Turner M, Shaw L, et al. Evaluating the cost-effectiveness of percutaneous closure of a patent foramen ovale versus medical management in patients with a cryptogenic stroke: from the UK payer perspective. J Med Econ. 2019;22(2):131–139.
   PubMed Web of Science ®Google Scholar
• K F-H, Ning M, Deng W, et al. Effect of Patent Foramen Ovale (PFO) Endovascular Closure on Stroke Quality of Life (P4.229). Neurology. 2014;82(10 Supplement):P4.229.
   Google Scholar
• Mirzada N, Ladenvall P, Hansson PO, et al. Quality of life after percutaneous closure of patent foramen ovale in patients after cryptogenic stroke compared to a normative sample. Int J Cardiol. 2018;257:46–49.
   PubMed Web of Science ®Google Scholar
• Evola S, Kauroo BAW, Trovato RL, et al. The percutaneous closure of patent foramen ovale (PFO): impact on the quality of life. Int J Cardiol. 2013;168(2):1622–1623.
   PubMed Web of Science ®Google Scholar
• Mirzada N, Ladenvall P, Hansson P-O, et al. Multidisciplinary management of patent foramen ovale (PFO) and cryptogenic stroke/TIA. J Multidiscip Healthc. 2013;6:357–363.
   PubMedGoogle Scholar
• Wiktor DM, Carroll JD. The case for selective patent foramen ovale closure after cryptogenic stroke. Circ Cardiovasc Interv. 2018;11(3):e004152.
   PubMed Web of Science ®Google Scholar
• Mazzucco S, Bovi P, Carletti M, et al. A model of multi-disciplinary approach to the diagnosis and treatment of young patients with cryptogenic stroke and patent foramen ovale. Cardiol Young. 2012;22(3):327–334.
   PubMed Web of Science ®Google Scholar
• Percutaneous closure of patent foramen ovale to prevent recurrent cerebral embolic events (Interventional procedures guidance IPG472). NICE, 2013.
   Google Scholar
• (NVVC) NSoC. Guideline for the Closure of Patent Foramen Ovale. 2016.
   Google Scholar
• Kuijpers T, Spencer FA, Siemieniuk RAC, et al. Patent foramen ovale closure, antiplatelet therapy or anticoagulation therapy alone for management of cryptogenic stroke? A clinical practice guideline BMJ. 2018;362:k2515.
   PubMed Web of Science ®Google Scholar
• Pristipino C, Sievert H, D’Ascenzo F, et al. European position paper on the management of patients with patent foramen ovale. General approach and left circulation thromboembolism. EuroIntervention. 2019;14(13):1389–1402.
   PubMed Web of Science ®Google Scholar
• Mas JL, Derex L, Guerin P, et al. Transcatheter closure of patent foramen ovale to prevent stroke recurrence in patients with otherwise unexplained ischaemic stroke: expert consensus of the French Neurovascular Society and the French Society of Cardiology. Arch Cardiovasc Dis. 2019;112(8–9):532–542.
   PubMed Web of Science ®Google Scholar
• Messé SR, Gronseth GS, Kent DM, et al. Practice advisory update summary: patent foramen ovale and secondary stroke prevention. Report of the Guideline Subcommittee of the. Am Acad Neurol. 2020;94(20):876–885. 10.1212/WNL.0000000000009443.
   PubMed Web of Science ®Google Scholar