Hypersensitivity to material and environmental burden as a possible cause of late complications of cardiac implantable electronic devices

Abstract

AimsTo evaluate whether patients with late complications of pacemakers or implantable cardioverter-defibrillators have hypersensitivity reactions to some of the materials used in generators or in electrodes, or to environmental metal burden.Methods and resultsThe cohort consisted of 20 men and 4 women (mean age: 62.3 ± 17.2 years) who had a history of late complications of implanted devices. The control group involved 25 men and 8 women (mean age: 64.6 ± 14.0 years) who had comparable devices, but no history of late complications. Lymphocyte transformation test was used to evaluate hypersensitivity to eight metal pollutants (antimony, manganese, mercury, molybdenum, nickel, platinum, tin, and titanium) selected by results of questionnaires on environmental burden, and by material analysis of generators and electrode surfaces. Exposures to metal pollutants were approximately the same in patients and in controls. Titanium alloy used in generators contained at least 99.32% of titanium and trace levels of other metals; higher levels of tin and platinum were detected in electrode surfaces. Hypersensitivity reactions to mercury and tin were significantly more frequent in patients than in controls (patients and controls: mercury: 68.2 and 31.1%, respectively; P = 0.022; tin: 25.0 and 3.2%, respectively; P = 0.035). In contrast, hypersensitivity to manganese was significantly more frequent in controls than in patients (patients and controls: 13.6 and 50.0%, respectively; P = 0.008).ConclusionOur findings suggest a possible relation between hypersensitivity to metals used in implantable devices or to environmental metal burden and the occurrence of their late complications.

Allergy Considerations in Implanted Neuromodulation Devices

“…The IPG, which powers and moderates the voltage or current across the circuit, is composed of the device internals covered by a metal casing, manufactured of essentially pure titanium in most cases (30,31). Maňoušek et al analyzed 38 explanted pacemaker generators with X-ray fluorescence (XRF) spectrometry: each metal casing contained at least 99.32% titanium, with traces of iron, nickel, tin, antimony, molybdenum, and manganese identified across pacemaker manufacturers (32). The seams and connections are covered with a silicone or polymer coating to minimize patient exposure to toxic materials contained within the casing (30).…”

“…Of the materials present in each device, only the titanium housing, polymer coatings, and electrode contacts are in direct contact with human tissue by design, though there is evidence to suggest that metal contaminants populate the polymer coating of electrodes. Maňoušek et al analyzed the polymer surface of unused electrodes from five manufacturers with XRF spectroscopy and found varying concentrations of aluminum, nickel, platinum, and tin present (32). In addition to these potential exposures, hypersensitivities to silicone, polyurethane, and titanium resulting in treatment failure have been reported (37)(38)(39).…”

Titanium and Other Metal Hypersensitivity Diagnosed by MELISA® Test: Follow-Up Study

“…Symptoms of hypersensitivity reaction include pain, joint effusion, swelling or allergic dermatitis (localized or systemic), changes in the oral mucosa and mucosal immune system connected with the presence of dental implants or prosthetic work [59], delayed bone healing, implant instability, and ultimately the aseptic failure of implants [60][61][62]. Due to previously described serious symptoms and the increasing incidence of hypersensitivity reactions to the implant materials in the population in recent years [63][64][65][66][67][68][69][70], this study is aimed at demonstrating the benefits of the MELISA® test for the minimization or complete elimination of health problems in patients with confirmed hypersensitivity to metals. The hypothesis of this study is that compliance with the health recommendations based on the results of MELISA® test will improve patients' symptoms induced by metal hypersensitivity.…”

First-in-man implantation of a gold-coated biventricular defibrillator: Difficult differential diagnosis of metal hypersensitivity reaction vs chronic device infection

“…The prevalence of delayed-type hypersensitivity has been estimated at approximately 1.5% to 2.5% of chronic implantable electronic devices (CIED). 1,3 Pacemaker housings are predominantly made of an alloy usually consisting of over 99% titanium with trace levels of other metals. Although contact hypersensitivity reaction to metals is common in Europe, affecting 27% of the general population, isolated titanium allergy is rare in the field of type IV allergic reactions.…”

“…Nevertheless, in a recent cohort study 11 of 24 patients (46%) developed a hypersensitivity to titanium when examined by lymphocyte transformation test. 3 The scheme of Gell and Coombs 4 for hypersensitivity reactions (1963) classifies type IV to be a cell-mediated immunity with delayed response. This process is mediated by T-cell lymphocytes and is most probably responsible for contact dermatitis to metals.…”