of nonheadache indications (3–5). “Blind” cardiologists, lacking specialist understanding of migraine, began to investigate PFO closure for migraine headache relief with modest insight into likely responsive populations. Neurologists joined the effort, but similarly with modest insight into mechanisms and responsive populations. As transcatheter PFO closure is an invasive procedure, presumably with risks beyond those of medications, a conservative approach was selected for this early trial, limiting enrollment to those with few options. The PREMIUM trial thus restricted inclusion to those who continued to experience 6 to 14 migraine days/month despite failing at least 3 migraine preventative medications. The PREMIUM trial represents a tremendous collaborative effort of cardiologists and neurologists to test a hypothesis of PFO closure for the prevention of episodic migraine, refractory to medications.

中文翻译：

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PFO 和偏头痛

非头痛适应症 (3-5)。“盲人”心脏病专家对偏头痛缺乏专业了解，开始研究 PFO 闭合以缓解偏头痛，并对可能有反应的人群有适度的了解。神经学家加入了这项工作，但同样对机制和响应人群的洞察力有限。由于经导管 PFO 封堵是一种侵入性手术，其风险可能超出药物的风险，因此该早期试验选择了一种保守的方法，将招募仅限于那些几乎没有选择的人。因此，PREMIUM 试验仅限于那些尽管至少 3 种偏头痛预防药物失败但仍继续经历 6 至 14 天/月偏头痛的患者。