Key result
Nitinol PFO closure in nickel hypersensitivity is linked to more post-procedural symptoms, though severe reactions remain rare.
Why the study?
Most PFO closure devices contain nitinol, raising concerns for systemic reactions in individuals with nickel hypersensitivity, while patch testing value and nickel-free options remain limited.
Management of nickel hypersensitivity in PFO closure relies on empirical symptomatic treatment, as severe reactions are rare and the benefits of closure generally outweigh the risks.
May warrant screening or device alternatives in nickel-allergic patients; leaves open need for prospective trials before changing practice.
Patent foramen ovale (PFO) is implicated in cryptogenic stroke and other clinical syndromes, with transcatheter closure demonstrating superiority over medical therapy in selected patients. Most closure devices are composed of nitinol, a nickel-titanium alloy, raising concerns in individuals with nickel hypersensitivity, one of the most prevalent contact allergies worldwide. Although typically manifesting as localized dermatitis, nickel allergy has been associated with systemic reactions after device implantation, including chest pain, palpitations, migraines, dyspnea, and cutaneous eruptions. Recent evidence indicates that nickel-sensitive patients experience a significantly higher incidence of post-procedural device-related symptoms. Nevertheless, severe reactions remain rare, and the benefits of PFO closure generally outweigh the risks. The predictive value of pre-implantation patch testing remains uncertain, and the lack of nickel-free alternatives constrains device selection. Management strategies are empirical, relying on symptomatic treatment with corticosteroids, antihistamines, or device explantation in refractory cases. Future research should focus on elucidating the pathophysiology of nickel-induced hypersensitivity in cardiovascular implants, improving diagnostic algorithms, and developing biocompatible, nickel-free devices. A multidisciplinary approach involving cardiologists, dermatologists, and allergists is essential to optimize outcomes in this complex subset of patients.
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Apostolos et al. (2025) conducted a review in Patent foramen ovale and nickel hypersensitivity. Patent foramen ovale closure with nitinol devices was evaluated. Patent foramen ovale closure using nitinol devices in patients with nickel hypersensitivity is associated with a higher incidence of post-procedural symptoms, though severe reactions remain rare.
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