Allergic reaction to pacemaker compounds: Case reports

Hypersensitivity Reactions to Components of Cardiac Implantable Electronic Devices and Their Treatment: A Systematic Review

“…8 Other groups have identified only three HSR cases out of more than 5,500 implanted devices (incidence <0.5/100 procedures). 26 Thus, even if the true incidence of HSR is unknown and the cases are likely under-reported, it is reasonable to conclude that CIED infections have an approximate 5-to 10-fold increased incidence compared with CIED HSR. 8 Even though the estimated of risk of HSR to CIED is low, it is advisable to inform the patient regarding this potential complication during the informed consent process, because of the significant associated morbidity.…”

“…Indeed, even some cases of CIED HSR attributed to nickel may have been, in fact, titanium HSR, as is case number 3 in Robledo-Nolasco et al, where isolating the titanium pacemaker pulse generator in PTFE coating resulted in excellent outcomes at 9-year follow-up. 26 Whether exposure of the metallic conductor through lead insulation breaches increases the risk of nickel HSR is not known, but the risk appears very low.…”

“…In cases of allergy to metals or when allergens have not been identified, options may include gold coating, paralyne C (a highly inert, biocompatible polymer) or PTFE sheaths. 8,26,42 Indeed, in a cohort of nearly 4,500 patients with implants over 17 years, PTFE was used in 19 patients for both primary and secondary prevention of allergy with no reports of reactions to PTFE. 8…”

“…Systemic reactions included a generalised dermatitis in 5 patients, chest pain and shortness of breath, a pompholyx reaction on the hands, eosinophilic myocarditis, widespread nummular eczema, anaphylactoid reaction, widespread erythroderma, fever, and deterioration of the patient's asthma. [18][19][20][21][22][23][24][25][26][27] Interestingly, one case reported pacemaker malfunction, resulting from the development of a serous fluid pocket that seeped into the connector site causing excessive current drainage and early battery depletion; the patient presented with recurrent syncope because of no output. 28 In addition, one patient was known to have a titanium allergy and was implanted with a gold coated pacemaker at the index procedure.…”

“…Explantation and reimplantation of a device coated with a non-allergenic material was usually successful (gold in 6/6 cases, polytetrafluoroethylene [PTFE] in 8/8 cases and titanium in 1/1 case), but the numbers of reported cases is small and the reported followup duration was below 2 years in a majority of cases, except one report with a 9 year follow-up. 26 In patients with silicone allergy, implantation of a silicone-free device had limited efficiency (3/5 cases, 60%). In one case, anti-histamine drugs were used to treat local reactions, but the efficiency was not clearly reported.…”