Guideline sources The following summarized guidelines for the evaluation and management of patent foramen ovale (PFO) are prepared by our editorial team based on guidelines from the Society for Cardiovascular Angiography and Interventions (SCAI 2022), the American Heart Association (AHA/ASA 2021), the European Society of Cardiology (ESC 2021; 2019), the American Academy of Neurology (AAN 2020), the British Medical Journal (BMJ 2018), and the American College of Chest Physicians (ACCP 2012). 1 2 3 4 5 6 7 8 Guidelines 1. Screening and diagnosis Indications for screening: do not obtain primary screening for PFO on a routine basis in divers and/or aircrews. D Show 4 more https://web.pathway.md/diseases/recKxWVPDfIM08rQ6 1/6 6/29/23, 10:55 PM Patent foramen ovale Pathway 2. Diagnostic investigations Diagnostic imaging: combine different diagnostic techniques to achieve maximal accuracy in PFO diagnosis. A Show 2 more Evaluation of hypoxemia: recognize that PFO has the potential to generate clinically significant right-to-left shunts, often only aggravating preexisting arterial oxygen desaturation. B Show 5 more Evaluation of left circulation thromboembolism: recognize that PFO plays a pathogenic role in cryptogenic left circulation thromboembolism. Evaluate the role of PFO in any given left circulation thromboembolism. A Show 13 more Evaluation of decompression sickness: obtain secondary prevention workup only if a decompression sickness diagnosis is probable or if uncertainty regarding decompression sickness is unacceptable for the individual risk profile or patient's preference. B Show 6 more Pre-closure evaluation: As per AAN 2020 guidelines, obtain a thorough evaluation to rule out alternative mechanisms of stroke in patients considered for PFO closure. B Show 9 more As per ESC 2019 guidelines, obtain a routine 12-lead ECG and either in-patient cardiac telemetry or 24-hour Holter monitoring in all patients with PFO. B Show 7 more 3. Medical management General principles: Ensure interdisciplinary assessment and decision-making in patients with PFO, taking into account an estimation of the individual probability of a causal role of the PFO in the clinical picture and the risk of recurrence. Take into account clinical, anatomical and imaging characteristics during individual risk stratification. Document shared decision-making in an open, individualized, informed consent. B Use decision aids and narrative tools to enhance patient involvement. B Antithrombotic therapy: As per AAN 2020 guidelines, consider initiating either antiplatelet therapy (such as aspirin) or anticoagulation (using a vitamin K antagonist, a direct thrombin inhibitor, or a factor Xa inhibitor) in patients with cryptogenic ischemic stroke and a PFO opting to receive medical therapy alone without PFO closure. C As per ESC 2019 guidelines, consider obtaining PFO assessment for possible closure in patients on temporary OACs, OACs for PE, or at high risk of recurrences despite OACs. C Show 3 more https://web.pathway.md/diseases/recKxWVPDfIM08rQ6 2/6 6/29/23, 10:55 PM Patent foramen ovale Pathway As per BMJ 2018 guidelines, prefer anticoagulants over antiplatelets in patients with cryptogenic stroke and a PFO, if PFO closure is contraindicated, unacceptable, or unavailable. B As per ACCP 2012 guidelines, avoid initiating antithrombotic therapy in patients with asymptomatic PFO or atrial septal aneurysm. D Show 3 more 4. Surgical interventions Indications for closure, patients with prior stroke: As per SCAI 2022 guidelines, perform PFO closure over antiplatelet therapy alone in 18-60 years old patients with a prior PFO-associated stroke. B Show 12 more As per ASA/AHA 2021 guidelines, decide on PFO closure versus medical management jointly with the patient, a cardiologist, and a neurologist, taking into account the probability of a causal role for the PFO in patients with a non-lacunar ischemic stroke of undetermined cause. B Show 3 more As per AAN 2020 guidelines, consider performing PFO closure following a discussion of potential benefits (reduction of stroke recurrence) and risks (procedural complication and AF) in < 60 years old patients with a PFO and an embolic-appearing infarct and no other mechanism of stroke identified. C Show 3 more As per BMJ 2018 guidelines: Perform PFO closure followed by antiplatelet therapy over antiplatelet therapy alone in patients with cryptogenic stroke and a PFO. A Consider performing PFO closure followed by antiplatelet therapy rather than anticoagulation therapy in patients with cryptogenic stroke and a PFO. C Indications for closure (patients with no history of stroke): consider performing PFO closure rather than offering medical therapy alone in patients with systemic embolism and without a prior PFO-associated stroke if other embolic etiologies have been excluded. C Show 5 more 5. Specific circumstances Pregnant patients: do not screen for PFO in unselected healthy, asymptomatic females planning a pregnancy or during a normal pregnancy. D Show 2 more Patients with Ebstein anomaly: perform atrial septal defect/PFO closure at the time of tricuspid valve repair in patients with Ebstein anomaly, when tricuspid valve repair is indicated, if it is expected to be hemodynamically tolerated. B Show 2 more https://web.pathway.md/diseases/recKxWVPDfIM08rQ6 3/6 6/29/23, 10:55 PM Patent foramen ovale Pathway Patients undergoing non-cardiac surgery: do not screen for PFO during preoperative evaluations for non-cardiac surgery in unselected healthy, asymptomatic patients. D Show 5 more 6. Patient education General counseling: As per ESC 2021 guidelines: Do not advise any restrictions on conventional altitude flights for any patient when the PFO is an incidental finding. D Provide counseling by an experienced diving physician in recreational divers, according to the context, size of shunt and the individual's compliance/preferences, when the PFO is an incidental finding. B As per AAN 2020 guidelines, counsel patients with a PFO detected after stroke and no other etiology identified after a thorough evaluation about the following: having a PFO is common it occurs in about 1 in 4 adults in the general population it is difficult to determine with certainty whether their PFO caused their stroke PFO closure probably reduces recurrent stroke risk in select patients. B Show 3 more 7. Preventative measures Secondary prevention of decompression sickness: provide secondary prevention primarily aiming at suppressing venous gaseous emboli production up to possible permanent cessation of the activity, regardless of the presence of a PFO. B Show 4 more 8. Follow-up and surveillance Serial imaging assessment: Consider obtaining the following to acquire comparable data: TTE before hospital discharge contrast-enhanced transcranial Doppler at least once beyond 6 months to assess effective PFO closure and thereafter, if residual shunt persists, annually until closure contrast-enhanced TEE or TTE in case of severe residual shunt at contrast-enhanced transcranial Doppler or recurrent events or symptoms during follow-up. C Insufficient evidence regarding the value of residual shunt after percutaneous closure. I Post-closure antiplatelet therapy: consider initiating dual antiplatelet therapy for 1-6 months after PFO closure. B Show 2 more https://web.pathway.md/diseases/recKxWVPDfIM08rQ6 4/6 6/29/23, 10:55 PM Patent foramen ovale Pathway Post-closure antibiotic prophylaxis: administer antibiotic prophylaxis for any invasive procedure performed in the first 6 months from PFO closure. B Clinical findings Symptoms Past medical history Dyspnea Congenital heart disease Exertional dyspnea Decompression sickness Platypnea Ebstein anomaly Migraine Vital signs Obstructive sleep apnea Stroke O2 saturation TIA Diagnostic procedures Tetralogy of Fallot Orthodeoxia Integument exam Cyanosis Studies 2013 RESPECT In patients who have had a cryptogenic stroke, and a patent foramen ovale identified by means of transesophageal echocardiography, patent foramen ovale closure was not superior to medical therapy with respect to recurrent stroke. Carroll JD et al. N Engl J Med. 2013 Mar 21. 2012 CLOSURE I In patients with cryptogenic stroke or TIA who had a patent foramen ovale, closure with a device did not offer a greater benefit than medical therapy alone for the prevention of recurrent stroke or TIA. A cause other than paradoxical embolism was usually apparent in patients with recurrent neurologic events. Furlan AJ et al. N Engl J Med. 2012 Mar 15. References 1. Christian Pristipino, Horst Sievert, Fabrizio D'Ascenzo et al. European position paper on the management of patients with patent foramen ovale. General approach and left circulation thromboembolism. Eur Heart J. 2019 Oct 7;40 38 3182 3195. Open 2. Steven R Mess , Gary S Gronseth, David M Kent et al. Practice advisory update summary: Patent foramen ovale and secondary stroke prevention: Report of the Guideline Subcommittee of the American Academy of Neurology. Neurology. 2020 May 19;94 20 876 885. Open https://web.pathway.md/diseases/recKxWVPDfIM08rQ6 5/6 6/29/23, 10:55 PM Patent foramen ovale Pathway 3. Dawn O Kleindorfer, Amytis Towfighi, Seemant Chaturvedi et al. 2021 Guideline for the Prevention of Stroke in Patients With Stroke and Transient Ischemic Attack: A Guideline From the American Heart Association/American Stroke Association. Stroke. 2021 Jul;52 7):e364-e467. Open 4. Clifford J. Kavinsky, Molly Szerlip, Andrew M. Goldsweig et al. SCAI Guidelines for the Management of Patent Foramen Ovale. JSCAI. 2022 May 19. Open 5. Christian Pristipino, Peter Germonpr , Danilo Toni et al. European position paper on the management of patients with patent foramen ovale. Part II Decompression sickness, migraine, arterial deoxygenation syndromes and select high-risk clinical conditions. EuroIntervention. 2021 Aug 6;17 5):e367-e375. Open 6. Richard P Whitlock, Jack C Sun, Stephen E Fremes et al. Antithrombotic and thrombolytic therapy for valvular disease: Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines. Chest. 2012 Feb;141 2 Suppl):e576S- e600S. Open 7. Helmut Baumgartner, Julie De Backer, Sonya V Babu-Narayan et al. 2020 ESC Guidelines for the management of adult congenital heart disease. Eur Heart J. 2021 Feb 11;42 6 563 645. Open 8. Ton Kuijpers, Frederick A Spencer, Reed A C Siemieniuk et al. Patent foramen ovale closure, antiplatelet therapy or anticoagulation therapy alone for management of cryptogenic stroke? A clinical practice guideline. BMJ. 2018 Jul 25;362:k2515. Open 9. Steven R Mess , Gary Gronseth, David M Kent et al. Practice advisory: Recurrent stroke with patent foramen ovale (update of practice parameter): Report of the Guideline Development, Dissemination, and Implementation Subcommittee of the American Academy of Neurology. Neurology. 2016 Aug 23;87 8 815 21. Open https://web.pathway.md/diseases/recKxWVPDfIM08rQ6 6/6