Nickel is one of the most common contact allergens worldwide; it is used as the main component of the devices used for atrial septal defects (ASDs) and patent foramen ovale (PFO) closure. Developing nickel hypersensitivity after PFO/ASD occlusion is significantly rarer described in medical literature than typical nickel contact sensitization. The exact pathophysiological mechanism of this “device syndrome” remains unknown, and many question the real incidence or even the existence of this clinical entity. Nevertheless, it has been associated with a wide spectrum of symptoms, including chest pain, migraines, palpitation, and dyspnea. Skin patch tests are the first-line approach to diagnose nickel hypersensitivity. However, diagnostic criteria for the device syndrome have not been developed, and diagnosis in reported cases is established by a process of elimination. Management—drug therapy (corticosteroids, clopidogrel, etc.) or even surgical explantation in severe cases—of patients developing such clinical manifestations after percutaneous PFO/ASD occlusion is empirical. Undoubtedly, endocardiac device–related nickel hypersensitivity requires more focused research to discover the underlying mechanism as well as to develop reliable prognostic tests for detecting high-risk patients and preventing severe nickel hypersensitivity reactions.

镍是全球最常见的接触性过敏原之一；它被用作用于房间隔缺损 (ASD) 和卵圆孔未闭 (PFO) 闭合装置的主要部件。与典型的镍接触致敏相比，医学文献中描述的 PFO/ASD 闭塞后发生镍超敏反应要少得多。这种“器械综合征”的确切病理生理机制仍然未知，许多人质疑这种临床实体的真实发病率甚至存在。然而，它与多种症状有关，包括胸痛、偏头痛、心悸和呼吸困难。皮肤斑贴试验是诊断镍超敏反应的一线方法。然而，尚未制定设备综合征的诊断标准，报告病例的诊断是通过消除过程确定的。经皮 PFO/ASD 闭塞后出现此类临床表现的患者的管理——药物治疗（皮质类固醇、氯吡格雷等）甚至在严重病例中进行手术切除——是经验性的。毫无疑问，心内膜装置相关的镍超敏反应需要更集中的研究来发现潜在机制，并开发可靠的预后测试来检测高危患者和预防严重的镍超敏反应。