Why the study?
With over 1 million CIEDs implanted annually, rare device hypersensitivity reactions have increased but remain difficult to diagnose given clinical overlap with infection and low patch test sensitivity.
Highlights the potential use of extravascular ICDs or hypoallergenic components for patients with metal allergies requiring cardiac implantable electronic devices.
As global implantation rates for Cardiac Implantable Electronic Devices (CIEDs) exceed 1 million a year (1,2), the number of rare complications including device hypersensitivity has increased. CIED-hypersensitivity reactions (CIED-HSRs) to pacemakers and implantable cardioverter defibrillators (ICDs) are difficult to diagnose as they share a similar presentation as CIED-infection and skin patch testing suffers from low sensitivity (3). Primary and secondary prevention of device reactions involves the utilization of hypoallergenic device components or coatings such as gold, polytetrafluoroethylene (PTFE), and silicone to protect against metal leach.
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Song et al. (2025) studied this question.
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