Key result
Atriasept II PFO closure shows no adverse or allergic events in 4 nickel-allergic patients.
Why the study?
There are concerns about percutaneous closure of PFO using nitinol-alloy devices in patients with nickel hypersensitivity.
Is the Atriasept II device safe for percutaneous closure of patent foramen ovale in patients with known nickel allergy?
Case Report (n=4)
Is the Atriasept II device safe for percutaneous closure of patent foramen ovale in patients with known nickel allergy?
The Atriasept II device, which has low nickel content, appears to be a safe option for percutaneous PFO closure in patients with known nickel hypersensitivity.
Small series indicates feasibility in nickel-allergic PFO closure; leaves open need for larger studies before wider use.
There are concerns about percutaneous closure of patent foramen ovale (PFO) using nitinol-alloys devices in patients with nickel hypersensitivity. We describe our experience with Atriasept II (Cardia Eagan, Minnesota, USA) used in four patients with known nickel allergy. No intraprocedural or in-hospital adverse events occurred. The follow-up was negative for allergic manifestations, without complications, as assessed by echocardiography. Because of the risk of adverse outcomes in nickel-allergic patients, devices with higher biocompatibility, low-profile, and low nickel content should be preferred in cases of known hypersensitivity. Atriasept II, containing less metallic material, appears to be a safe option in allergic patients undergoing PFO closure.
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Cammalleri et al. (2014) conducted a case report in Patent foramen ovale with nickel allergy (n=4). Atriasept II device was evaluated on Intraprocedural or in-hospital adverse events and allergic manifestations. Percutaneous closure of patent foramen ovale using the Atriasept II device resulted in no intraprocedural or in-hospital adverse events and no allergic manifestations in 4 nickel-allergic patients.
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