Valvular & structural heart disease
Patent Foramen Ovale Closure in Patients With and Without Nickel Hypersensitivity: A Randomized Trial
Authors' conclusion
Patients with nickel hypersensitivity are at significantly higher risk of developing device syndrome after patent foramen ovale closure. Both the Amplatzer and Gore Cardioform Septal Occluder 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.
Study context
- Population
- Patients with cryptogenic stroke and patent foramen ovale-related ischemic stroke undergoing transcatheter patent foramen ovale closure; nickel hypersensitivity assessed by skin patch testing28 (29.2%) had nickel hypersensitivity
- Participants
- 96 patients
- Comparison
- Patients with nickel hypersensitivity compared with those without; Amplatzer vs Gore Cardioform Septal Occluder device
- Nickel hypersensitivityn = 28
- Primary endpoint
- Incidence of device syndrome, a composite of patient-reported symptoms (chest pain, palpitations, migraines, dyspnea, and rash)
Primary result
As reported in the abstract
nickel hypersensitivity vs without nickel hypersensitivityAdjusted odds ratio (95% CI)P value
Multivariable analysis; 10.5-fold increase in the odds
10.53(3.17–35.00)
P < 0.001- Significantly higher with nickel hypersensitivity
- 71.4% versus 20.6%; P < 0.001
Further findings
New-onset or worsening migraines and palpitations
- More frequent in nickel-hypersensitive patients
Device syndrome by device
- Incidence of device syndrome similar for both devices
Safety
Documented arrhythmias, bleeding, or stroke
- No significant differences
Original publication
Patent Foramen Ovale Closure in Patients With and Without Nickel Hypersensitivity: A Randomized Trial. Circ Cardiovasc Interv. Published 9 March 2025. doi:10.
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