European Position Paper on Management of PFO

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. Eur Heart J 2018;Oct 25:[Epub ahead of print].

The following are key perspectives from the European position paper on the management of patients with patent foramen ovale (PFO):

  1. PFO is present in about 25% of the general population. PFO can play a pathogenic role in cryptogenic left circulation thromboembolism.
  2. There is no gold standard for diagnosing PFO. A combination of transthoracic echocardiography (TTE), transesophageal echocardiography (TEE), and transcranial Dopplers (TCDs) may be required. The authors set forth the following algorithm for PFO detection: If TTE is positive, pursue TEE for corroboration. If TCD is positive, pursue TEE for corroboration. If TTE is negative or equivocal, pursue TCD, and if TCD is negative, stop investigation.
  3. Patients with PFO and left circulation arterial embolism of unknown cause despite a comprehensive workup should be classified as having PFO-related embolism instead of cryptogenic embolism.
  4. To rule out causes other than PFO, patients with left circulation embolism and PFO should undergo a 12-lead electrocardiogram (ECG) and either inpatient telemetry or 24-hour Holter monitoring to evaluate for atrial fibrillation (AF). Patients ≥65 years or patients 55-64 years with AF risk factors should undergo 6 months of AF monitoring with an implantable cardiac monitor.
  5. An atrial septal aneurysm, a moderate-to-severe shunt, and atrial septal hypermobility have been strongly associated with a causal role of PFO in cryptogenic stroke in some studies.
  6. The risk of paradoxical embolism (RoPE) score attempts to predict how likely a PFO is causal in the setting of a cryptogenic stroke. The RoPE score can be used to guide management decisions, but should be used in conjunction with other parameters, such as the presence of atrial septal aneurysm or deep venous thrombosis/pulmonary embolism.
  7. The risk of recurrence in a PFO-associated stroke is likely quite low based on observational/randomized studies. An atrial septal aneurysm may convey a higher risk of recurrence. The authors’ meta-analysis of randomized clinical trials suggests a recurrent stroke risk on medical therapy of 4.6% over 3.8 years of follow-up.
  8. There are no definitive data to guide the selection of an antiplatelet versus oral anticoagulation (OAC) with vitamin K antagonists for secondary stroke prevention after PFO-related stroke. While OAC may be superior to antiplatelets in preventing PFO-related stroke, OAC also increases the risk of both intracranial and major extracranial hemorrhage. OAC may be preferred if the patient has a low hemorrhagic risk, high compliance is expected, and proper anticoagulant monitoring can be guaranteed.
  9. The role of direct oral anticoagulants (DOACs) is not clear and is an important area for future research. Future research should include a randomized controlled trial of secondary prevention with a DOAC compared to PFO closure in patients with PFO-related left circulation embolism.
  10. Percutaneous PFO closure results in complete closure at 1 year in 93-96%.
  11. After PFO closure, it is reasonable to continue dual antiplatelet therapy for 1-6 months and then continue single antiplatelet therapy for ≥5 years.
  12. In the authors’ meta-analysis with 3.8 mean years of follow-up, the number needed to treat with PFO closure to prevent 1 stroke in all patients was 37 (95% confidence interval [CI], 26-68) and in patients with high-risk features (e.g., atrial septal aneurysm), it was 21 (95% CI, 16-61).
  13. It is the position of the authors that patients ages 18-65 years with a confirmed cryptogenic stroke, transient ischemic attack, or systemic embolism with a high probability of a causal role of their PFO should undergo percutaneous PFO closure.
  14. Interdisciplinary collaboration with an interventional cardiologist and a relevant specialist (e.g., neurologist) and active collaboration with the patient are key in decision-making regarding PFO management.
  15. Antibiotic prophylaxis against endocarditis before an invasive procedure or surgical intervention should be pursued for all patients within the first 6 months after closure.

Clinical Topics: Anticoagulation Management, Arrhythmias and Clinical EP, Congenital Heart Disease and Pediatric Cardiology, Noninvasive Imaging, Prevention, Anticoagulation Management and Atrial Fibrillation, SCD/Ventricular Arrhythmias, Atrial Fibrillation/Supraventricular Arrhythmias, Congenital Heart Disease, CHD and Pediatrics and Arrhythmias, CHD and Pediatrics and Imaging, CHD and Pediatrics and Quality Improvement, Echocardiography/Ultrasound

Keywords: Aneurysm, Antibiotic Prophylaxis, Anticoagulants, Atrial Fibrillation, Atrial Septum, Diagnostic Imaging, Echocardiography, Transesophageal, Electrocardiography, Electrocardiography, Ambulatory, Embolism, Embolism, Paradoxical, Endocarditis, Foramen Ovale, Patent, Hemorrhage, Heart Defects, Congenital, Heart Septal Defects, Atrial, Ischemic Attack, Transient, Platelet Aggregation Inhibitors, Pulmonary Embolism, Risk Factors, Secondary Prevention, Stroke, Telemetry, Venous Thrombosis, Vitamin K, Vascular Diseases

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