S. Filippo Neri Hospital ASL Roma 1, Rome, Italy.
EuroIntervention. 2021 Aug 6;17(5):e367-e375. doi: 10.4244/EIJ-D-20-00785.
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.
卵圆孔未闭(PFO)与多种医学病症的发病机制有关,但迄今为止,仅发表了一份与左循环血栓栓塞相关的官方立场文件。这份跨学科论文由 8 个欧洲科学协会参与编写,回顾了现有证据,并为其他与 PFO 相关的临床病症提供了决策依据。为了保证严格的循证过程,我们使用了改良的推荐评估、制定与评估分级(GRADE)方法。对诊断和治疗程序进行了严格的定性和定量评估,包括风险/效益比的评估。根据预先设定的标准,权衡和分级了证据水平和立场声明的强度。尽管基于有限的观察性或低确定性随机数据,该论文仍针对不同临床环境下的 PFO 管理提出了一些立场声明,并为新的研究方向提供了建议。这份跨学科立场文件认识到现有证据的低或非常低确定性,首次针对左循环血栓栓塞以外的几个与 PFO 相关的临床情况进行了探讨,并强烈强调了在这些领域获得新的高质量证据的必要性。