Investigation of Nickel Sensitization After Percutaneous Implantation of Patent Foramen Ovale Occluder
- Conditions
- Foramen Ovale, PatentMetal AllergyNickel SensitivityDermatitis Contact Irritant
- Interventions
- Device: Percutaneous Patent Foramen Ovale Closure
- Registration Number
- NCT04713683
- Lead Sponsor
- National and Kapodistrian University of Athens
- Brief Summary
Percutaneous PFO closure has been established as a first-line therapy for preventing recurrent strokes in selected patients. The devices used for the specific purpose contain and release nickel, which is considered as the most allergen metal in nature. Skin patch tests are considered as gold-standard for documenting nickel allergy. While the allergic contact dermatitis induced by nickel is well described, literature is inadequate on explaining the effect of nickel release on the clinical manifestations of patients implanted with such devices.
Our prospective, randomized, blinded trial will try to investigate the above by performing nickel skin patch tests to all patients, 14 days before and 90 days after the implantation. During follow-up, clinical manifestations and transthoracic echocardiographic findings will be evaluated and associated with patch skin tests.
- Detailed Description
Percutaneous PFO closure has been established as a first-line therapy for preventing recurrent strokes, after embolic stroke of unknown source (ESUS) and a patent foramen ovale. The PFO closure is achieved by the implantation of suitable devices, which occlude the shunt between the two atria and prevent the creation and detachment of thrombi. Until today, there are two devices approved by FDA for the specific purpose; Amplatzer PFO Occluder and Gore Cardioform Septal Occluder. Despite the architectonic differences between these devices, the main material of both is nitinol, an alloy of nickel and titanium. While titanium is an extremely rare allergen, nickel is considered as one of the most common allergens and the most frequent metal allergen in nature, with a prevalence about 20%. The main clinical expression of nickel hypersensitivity is allergic contact dermatitis, but cases with systemic allergic reaction have been described as well. It has been observed that nickel is released by the implanted devices and circulates through bloodstream, having the potential to cause systemic clinical picture. Device syndrome includes signs and symptoms (i.e. palpitations, dyspnea, chest pain, rash, etc.), which are appeared after the device placement and are associated with hypersensitivity reaction. The existing literature is considered as inadequate for explaining the effect of nickel release in the patients implanted with an occluder.
The aim of our study is to evaluate whether patients with nickel hypersensitivity have an increased risk of adverse events following PFO closure, to assess the potential influence of device selection, and to evaluate potential sensitization or desensitization in patients without or with pre-existing nickel allergy, respectively.
Nickel hypersensitivity was assessed using skin patch testing prior to the procedure. The primary endpoint was device syndrome, a composite of patient-reported symptoms (chest pain, palpitations, migraines, dyspnea, and rash). Secondary endpoints included arrhythmias, bleeding, stroke, and all-cause mortality.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 96
- Age: at least 14 years old
- Well-documented indication for percutaneous PFO closure
- Corticosteroid treatment
- Patient's refusal to participation
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Amplatzer PFO Occluder Percutaneous Patent Foramen Ovale Closure Patients randomized in this arm will be implanted with Amplatzer PFO Occluder. Gore Cardioform Septal Percutaneous Patent Foramen Ovale Closure Patients randomized in this arm will be implanted with Gore Cardioform Septal Occluder.
- Primary Outcome Measures
Name Time Method Device syndrome, a composite endpoint consisting of patient-reported new-onset chest pain, palpitations, new-onset or worsening migraines, dyspnea, and rash The first 90 days after the procedure Clinical signs and symptoms during the first 90 days after the procedure will be evaluated through a questionnaire.
- Secondary Outcome Measures
Name Time Method The nickel patch tests' results change after Amplatzer Device implantation The first 90 days after the procedure Investigating the number of patients received Amplatzer device, who developed nickel sensitization.
The nickel patch tests' results change after Gore Device implantation The first 90 days after the procedure Investigating the number of patients received Gore device, who developed nickel sensitization.
Residual interatrial leakage 90 days after the procedure Evaluation of residual interatrial leakage, by performing transthoracic echocardiography
Rest allergens skin patch test results' change 90 days after the procedure The possible change (either as continuous or dichotomous outcome) of rest allergen skin patch test, after the device implantation
Nickel patch test results' change 90 days after the procedure The possible change (either as continuous or dichotomous outcome) of nickel skin patch test, after the device implantation
patient-reported new-onset chest pain 90 days after the procedure patient-reported new-onset chest pain
palpitations 90 days after the procedure as described by the patients
new-onset or worsening migraines 90 days after the procedure as described by the patients
dyspnea 90 days after the procedure as described by the patients
Atrial arrhythmias 90 days after the procedure as described by the patients
Trial Locations
- Locations (1)
First Department of Cardiology, National and Kapodistrian University of Athens, Hippokration General Hospital of Athens
š¬š·Athens, Attica, Greece