Patent foramen ovale (PFO) is implicated in the pathogenesis of a number of medical conditions but to date only one official position paper related to left circulation thromboembolism has been published. This interdisciplinary paper, prepared with the involvement of eight European scientific societies, reviews the available evidence and proposes a rationale for decision making for other PFO-related clinical conditions. In order to guarantee a strict evidence-based process, we used 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 were weighed and graded according to predefined scales. Despite being based on limited and observational or low-certainty randomised data, a number of position statements were made to frame PFO management in different clinical settings, along with suggestions for new research avenues. This interdisciplinary position paper, recognising the low or very low certainty of existing evidence, provides the first approach to several PFO-related clinical scenarios beyond left circulation thromboembolism and strongly stresses the need for fresh high-quality evidence on these topics.
Pristipino C, Germonpré P, Toni D, Sievert H, Meier B, D'Ascenzo F, Berti S, Onorato EM, Bedogni F, Mas JL, Scacciatella P, Hildick-Smith D, Gaita F, Kyrle PA, Thomson J, Derumeaux G, Sibbing D, Chessa M, Hornung M, Zamorano J, Dudek D; EVIDENCE SYNTHESIS TEAM:, D'Ascenzo F, Omedè P, Ballocca F, Barbero U, Giordana F, Gili S, Iannaccone M; INTERNATIONAL EXPERTS:, Akagi T, Anzola G, Carroll J, Dalvi B, De Angelis C, Junbo G, Kasner SE, Michel-Behnke I, Musumeci G, Søndergaard L, Tarantini G, Biondi-Zoccai GGL; joint task force of European Association of Percutaneous Cardiovascular Interventions (EAPCI), European Stroke Organisation (ESO), European Heart Rhythm Association (EHRA), European Association for Cardiovascular Imaging (EACVI), European Paediatric and Congenital Cardiology (AEPC), ESC Working Group on Adult Congenital Heart Disease, ESC Working Group on Thrombosis, European Haematological Society (EHA), European Underwater and Baromedical Society (EUBS); EAPCI SCIENTIFIC DOCUMENTS AND INITIATIVES COMMITTEE:, Capodannno D, Valgimigli M, Byrne R, Kunadian V. 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. Eur Heart J 2021 Jan 28;ehaa1070. doi: 10.1093/eurheartj/ehaa1070