Patent Foramen Ovale Closure in Patients With and Without Nickel Hypersensitivity: A Randomized Trial.

Abstract

Background: Nickel-containing devices, such as the Amplatzer PFO Occluder and Gore® Cardioform Septal Occluder (GSO), are used for transcatheter patent foramen ovale (PFO) closure. However, the impact of nickel hypersensitivity on post-procedural outcomes remains poorly understood. This study aimed to evaluate the risk of adverse events, in patients with nickel hypersensitivity undergoing PFO closure. Methods: Our study was a prospective, double-blinded, randomized study enrolling patients with cryptogenic stroke and PFO-related ischemic stroke to receive either the Amplatzer or GSO device. Nickel hypersensitivity was assessed using skin patch testing. The primary endpoint was the incidence of device syndrome, a composite of patient-reported symptoms (chest pain, palpitations, migraines, dyspnea, and rash). Results: Of the 96 patients, 28 (29.2%) had nickel hypersensitivity. The incidence of device syndrome was significantly higher in patients with nickel hypersensitivity compared to those without (71.4% vs. 20.6%, p < 0.001). Specifically, new-onset or worsening migraines and palpitations were more frequent in nickel-hypersensitive patients. No significant differences were observed in documented arrhythmias, bleeding, or stroke. Multivariable analysis showed that nickel hypersensitivity was associated with a 10.5-fold increase in the odds of device syndrome (aOR = 10.53, 95% CI: 3.17-35.00, p < 0.001). The incidence of device syndrome was similar for both devices. Conclusions: Patients with nickel hypersensitivity are at significantly higher risk for developing device syndrome after PFO closure. Both the Amplatzer and GSO devices demonstrated comparable safety and efficacy in this population. These findings highlight the need for further research to optimize device selection and improve outcomes in nickel-hypersensitive patients.