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
Publikation: Bidrag til tidsskrift › Tidsskriftartikel › Forskning › fagfællebedømt
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.
| Originalsprog | Engelsk |
|---|---|
| Tidsskrift | European Heart Journal |
| Vol/bind | 42 |
| Udgave nummer | 16 |
| Sider (fra-til) | 1545-1553 |
| Antal sider | 9 |
| ISSN | 0195-668X |
| DOI | |
| Status | Udgivet - 2021 |
Bibliografisk note
Funding Information:
Conflict of interest: R. Byrne reports personal fees from B. Braun Melsungen AG and from Biotronik, and grants from CeloNova Biosciences, outside the submitted work. B. Dalvi reports other financial activities from Abbott, outside the submitted work. D. Dudek reports grants and personal fees from Abbott, outside the submitted work. D. Hildick-Smith reports personal fees from Abbott, Gore, Occlutech, and Holistick, outside the submitted work. S.E. Kasner reports grants from W.L. Gore, during the conduct of the study, personal fees from Bristol-Myers Squibb and from Boehringer Ingelheim, and grants and personal fees from Medtronic and Bayer, outside the submitted work. J.L. Mas reports personal fees from Abbott, during the conduct of the study. B. Meier reports personal fees from Abbott, outside the submitted work. E.M. Onorato reports personal fees from Occlutech, outside the submitted work. P. Scacciatella reports grants from Abbott Medical and Gore Medical, outside the submitted work. H. Sievert reports reimbursement for clinical trials from 4tech Cardio, Abbott, Ablative Solutions, Ancora Heart, Append Medical, Axon, Bavaria Medizin Technologie GmbH, Bioventrix, Boston Scientific, Carag, Cardiac Dimensions, Cardiac Success, Cardimed, CeloNova, Comed B.V., Contego, CVRx, Dinova, Edwards, Endologix, Endomatic, Hemoteq, Hangzhou Nuomao Medtech, Holistick Medical, K2, Lifetech, Maquet Getinge Group, Medtronic, Mokita, Occlutech, Recor, Renal Guard, Terumo, Trisol, Vascular Dynamics, Vectorious Medtech, Venus, Venock, and Vivasure Medical, outside the submitted work. G. Tarantini reports personal fees from Abbott and Vascular Innovations, during the conduct of the study. J. Thomson reports personal fees from Gore Medical, outside the submitted work. T. Toni reports personal fees from Abbott, Bayer, Boehringer Ingelheim, Daiichi Sankyo, Medtronic, and Pfizer, outside the submitted work. The chairman of the Task Force and all the other authors declare no conflicts of interest for this work. The Guest Editor has no conflicts of interest to declare.
Publisher Copyright:
© The Author(s), 2021.
ID: 302486807