Abstract 14453: Patent Foramen Ovale Closure in Patients With and Without Nickel Hypersensitivity Using Two Different Devices

Background: Transcatheter PFO closure has been established as a safe and effective approach for secondary prevention in patients with ESUS. The Amplatzer® PFO occluder and Gore Helex® septal occluder are two FDA-approved devices, which consist of a nickel-titanium alloy frame. While nickel is the first cause of hypersensitivity reaction worldwide, the potential occurrence of nickel hypersensitivity following PFO closure is still under investigation.

Aim: Our aim is to investigate whether patients with nickel allergy are more susceptible to experiencing adverse events after device implantation and to explore the potential role of device selection.

Methods: We prospectively enrolled patients undergoing PFO closure. Before the procedure, nickel skin patch tests were performed in all the patients. The patients were randomized to receive either Amplatzer® or Gore® device. During a three-month follow-up period, we evaluated the primary endpoint, which was a composite outcome including patient-reported chest pain, palpitations, headaches, and rash. We used the chi-squared test to evaluate the primary endpoint and performed multivariate binary logistic regression analysis to assess the effect of device selection on the primary endpoint.

Results: A total of 50 patients (50% female, 45.4±10.3 years old) completed the follow-up and were included in the present analysis. Among them, 29 patients received the Gore device, while the remaining 21 patients received the Amplatzer device. Fourteen patients were diagnosed with nickel hypersensitivity. The primary endpoint was reached in 40% of the analyzed patients. The occurrence of the primary endpoint was significantly higher in patients with nickel hypersensitivity compared to those without (50% vs. 13.3%, p=0.005). Additionally, multivariate binary logistic regression analysis demonstrated no association between device selection and the composite outcome (p=0.892).

Conclusions: Our preliminary results indicate that patients with nickel hypersensitivity are more likely to develop symptoms such as chest pain, palpitations, headaches, and rash following the procedure. However, the completion of our study is necessary to obtain more reliable and conclusive results.