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European position paper on the management of patients with patent foramen ovale. General approach and left circulation thromboembolism

EuroIntervention 2019;14:1389-1402 published online ahead of print August 2018. DOI: 10.4244/EIJ-D-18-00622

1. S. Filippo Neri Hospital - ASL Roma 1, Rome, Italy; 2. CardioVascular Center (CVC) Frankfurt, Frankfurt, Germany; 3. Anglia Ruskin University, Chelmsford, United Kingdom, and University of California San Francisco (UCSF), San Francisco, USA; 4. Città della Salute e della Scienza Hospital, University of Turin, Turin, Italy; 5. Hôpital Sainte-Anne, Université Paris Descartes, Paris, France; 6. University Hospital, Bern, Switzerland; 7. Sussex Cardiac Centre, Brighton and Sussex University Hospitals, Brighton, United Kingdom; 8. Hospital Policlinico Umberto I, Sapienza University, Rome, Italy; 9. Medical University, Vienna, Austria; 10. Leeds General Infirmary, Leeds, United Kingdom; 11. Hôpital Henri Mondor, Faculté de Médecine de Créteil, Créteil, France; 12. Humanitas Gavazzeni, Bergamo, Italy; 13. Campus Großhadern, Ludwig-Maximilians-Universität (LMU), Munich, Germany; 14. Military Hospital, Brussels, Belgium; 15. Heart Hospital, Massa, Italy; 16. Policlinico San Donato, University Hospital, San Donato Milanese, Milan, Italy; 17. University Hospital, Krakow, Poland; 18. University Hospital Ramón y Cajal, Madrid, Spain; 19. Azienda Ospedaliero-Universitaria “Policlinico-Vittorio Emanuele”, University of Catania, Catania, Italy; 20. Deutsches Herzzentrum München, Technische Universität München, Munich, Germany; 21. Okayama University Hospital, Okayama, Japan; 22. University of Colorado Hospital, Denver, CO, USA; 23. Glenmark Cardiac Centre, Mumbai, India; 24. Shanghai Institute of Cardiovascular Disease, Shanghai, China; 25. University of Pennsylvania, Philadelphia, PA, USA; 26. Kinderherzzentrum University of Vienna, Vienna, Austria; 27. Dante Pazzanese Instituto de Cardiologia, Sao Paulo, Brazil; 28. Nicklaus Children’s Hospital, Miami, FL, USA; 29. Rigshospitalet, Copenhagen, Denmark; 30. Haukeland University Hospital, Bergen, Norway; 31. Sapienza University of Rome, Latina, Italy; 32. Department of AngioCardioNeurology, IRCCS Neuromed, Pozzilli, Italy

The presence of a patent foramen ovale (PFO) is implicated in the pathogenesis of a number of medical conditions; however, the subject remains controversial and no official statements have been published. This interdisciplinary paper, prepared with involvement of eight European scientific societies, aims to review the available trial evidence and to define the principles needed to guide decision making in patients with PFO. In order to guarantee a strict process, position statements were developed with the use of a modified grading of recommendations assessment, development, and evaluation (GRADE) methodology. A critical qualitative and quantitative evaluation of diagnostic and therapeutic procedures was performed, including assessment of the risk/benefit ratio. The level of evidence and the strength of the position statements of particular management options were weighed and graded according to predefined scales. Despite being based often on limited and non-randomised data, while waiting for more conclusive evidence, it was possible to conclude on a number of position statements regarding a rational general approach to PFO management and to specific considerations regarding left circulation thromboembolism. For some therapeutic aspects, it was possible to express stricter position statements based on randomised trials. This position paper provides the first largely shared, interdisciplinary approach for a rational PFO management based on the best available evidence.

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