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, are used for transcatheter patent foramen ovale closure. However, the impact of nickel hypersensitivity on postprocedural outcomes remains poorly understood. This study aimed to evaluate the risk of adverse events in patients with nickel hypersensitivity undergoing patent foramen ovale closure.
METHODS: This was a prospective, double-blinded, randomized study enrolling patients with cryptogenic stroke and patent foramen ovale-related ischemic stroke to receive either the Amplatzer or Gore Cardioform Septal Occluder device. Nickel hypersensitivity was assessed using skin patch testing. The primary end point 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 with those without (71.4% versus 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 (adjusted odds ratio, 10.53 [95% CI, 3.17-35.00]; P<0.001). The…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 96 participants or records.
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