Metal Allergy pp 273-283 | Cite as

Hypersensitivity to Cardiovascular Implants: Cardiac Implantable Electronic Devices and Septal Occluders

  • Golara Honari
  • Farshad Raissi


The increasing application of medical devices in the management of various medical and surgical conditions and introduction of various implantable biomedical devices comes with concerns about biocompatibility and putative hypersensitivity. There is an increasing trend of referrals to allergists and dermatologists for pre- and postoperative assessment of patients with suspected allergies to components of medical devices. Hypersensitivity reactions to medical devices can present as localized dermatoses, systemic hypersensitivities, or device malfunction. This chapter provides an overview of the current evidence on hypersensitivity reactions associated with devices used in invasive electrophysiological procedures such as pacemakers. Another category of devices reviewed in this chapter is septal occluders and putative hypersensitivities associated with them.


Medical device allergy Metal hypersensitivity Metal allergy Pacemaker foramen ovale occluder Contact dermatitis 


  1. 1.
    Lyell A, Bain WH. Letter: Nickel allergy and valve replacement. Lancet. 1974;1(7854):408–9.CrossRefGoogle Scholar
  2. 2.
    Lyell A, Bain WH, Thomson RM. Repeated failure of nickel-containing prosthetic heart valves in a patient allergic to nickel. Lancet. 1978;2(8091):657–9.CrossRefGoogle Scholar
  3. 3.
    Elves MW, Wilson JN, Scales JT, Kemp HB. Incidence of metal sensitivity in patients with total joint replacements. Br Med J. 1975;4(5993):376–8.CrossRefGoogle Scholar
  4. 4.
    Evans EM, Freeman MA, Miller AJ, Vernon-Roberts B. Metal sensitivity as a cause of bone necrosis and loosening of the prosthesis in total joint replacement. J Bone Joint Surg Br. 1974;56-B(4):626–42.CrossRefGoogle Scholar
  5. 5.
    Warshaw EM, Raju SI, Fowler JF Jr, et al. Positive patch test reactions in older individuals: retrospective analysis from the north american contact dermatitis group, 1994–2008. J Am Acad Dermatol. 2012;66(2):229–40.CrossRefGoogle Scholar
  6. 6.
    Thyssen JP. Nickel and cobalt allergy before and after nickel regulation--evaluation of a public health intervention. Contact Dermatitis. 2011;65(Suppl 1):1–68.CrossRefGoogle Scholar
  7. 7.
    Caroe C, Andersen KE, Mortz CG. Fluctuations in the prevalence of nickel and cobalt allergy in eczema patients patch tested after implementation of the nickel regulation in denmark. Contact Dermatitis. 2011;64(3):126–31.CrossRefGoogle Scholar
  8. 8.
    Teixeira V, Coutinho I, Goncalo M. Allergic contact dermatitis to metals over a 20-year period in the centre of portugal: evaluation of the effects of the european directives. Acta Medica Port. 2014;27(3):295–303.CrossRefGoogle Scholar
  9. 9.
    Jacob SE, Goldenberg A, Pelletier JL, Fonacier LS, Usatine R, Silverberg N. Nickel allergy and our children's health: a review of indexed cases and a view of future prevention. Pediatr Dermatol. 2015;32(6):779–85.CrossRefGoogle Scholar
  10. 10.
    Senning A. Developments in cardiac surgery in stockholm during the mid and late 1950s. J Thorac Cardiovasc Surg. 1989;98(5 Pt 2):825–32.PubMedGoogle Scholar
  11. 11.
    Mond HG, Proclemer A. The 11th world survey of cardiac pacing and implantable cardioverter-defibrillators: calendar year 2009—a world society of arrhythmia's project. Pacing Clin Electrophysiol. 2011;34(8):1013–27.CrossRefGoogle Scholar
  12. 12.
    Honari G, Ellis SG, Wilkoff BL, Aronica MA, Svensson LG, Taylor JS. Hypersensitivity reactions associated with endovascular devices. Contact Dermatitis. 2008;59(1):7–22.CrossRefGoogle Scholar
  13. 13.
  14. 14.
    DiFilippo FP, Brunken RC. Do implanted pacemaker leads and ICD leads cause metal-related artifact in cardiac PET/CT? J Nucl Med. 2005;46(3):436–43.PubMedGoogle Scholar
  15. 15.
    Dionisio P. Advances in the technology of pacing. Rev Port Cardiol. 1999;18(3):289–98.PubMedGoogle Scholar
  16. 16.
    Mirowski M. The automatic implantable cardioverter-defibrillator: an overview. J Am Coll Cardiol. 1985;6(2):461–6.CrossRefGoogle Scholar
  17. 17.
    Buchet S, Blanc D, Humbert P, et al. Pacemaker dermatitis. Contact Dermatitis. 1992;26(1):46–7.CrossRefGoogle Scholar
  18. 18.
    Weiss R. Pacemaker dermatitis. Contact Dermatitis. 1989;21(5):343–4.CrossRefGoogle Scholar
  19. 19.
    Hayes DL, Loesl K. Pacemaker component allergy: case report and review of the literature. J Interv Card Electrophysiol. 2002;6(3):277–8.CrossRefGoogle Scholar
  20. 20.
    Iguchi N, Kasanuki H, Matsuda N, Shoda M, Ohnishi S, Hosoda S. Contact sensitivity to polychloroparaxylene-coated cardiac pacemaker. Pacing Clin Electrophysiol. 1997;20(2 Pt 1):372–3.CrossRefGoogle Scholar
  21. 21.
    Skoet R, Tollund C, Bloch-Thomsen PE. Epoxy contact dermatitis due to pacemaker compounds. Cardiology. 2003;99(2):112.CrossRefGoogle Scholar
  22. 22.
    Andersen KE. Cutaneous reaction to an epoxy-coated pacemaker. Arch Dermatol. 1979;115(1):97–8.CrossRefGoogle Scholar
  23. 23.
    Abdallah HI, Balsara RK, O'Riordan AC. Pacemaker contact sensitivity: clinical recognition and management. Ann Thorac Surg. 1994;57(4):1017–8.CrossRefGoogle Scholar
  24. 24.
    Dery JP, Gilbert M, O'Hara G, et al. Pacemaker contact sensitivity: case report and review of the literature. Pacing Clin Electrophysiol. 2002;25(5):863–5.CrossRefGoogle Scholar
  25. 25.
    Brun R, Hunziker N. Pacemaker dermatitis. Contact Dermatitis. 1980;6(3):212–3.CrossRefGoogle Scholar
  26. 26.
    Raque C, Goldschmidt H. Dermatitis associated with an implanted cardiac pacemaker. Arch Dermatol. 1970;102(6):646–9.CrossRefGoogle Scholar
  27. 27.
    Wilkerson MG, Jordan WP Jr. Pressure dermatitis from an implanted pacemaker. Dermatol Clin. 1990;8(1):189–92.PubMedGoogle Scholar
  28. 28.
    Beutler BD, Cohen PR. Reticular telangiectatic erythema: case report and literature review. Dermatol Pract Concept. 2015;5(1):71–5.CrossRefGoogle Scholar
  29. 29.
    Aneja S, Taylor JS, Billings SD, Honari G, Sood A. Post-implantation erythema in 3 patients and a review of reticular telangiectatic erythema. Contact Dermatitis. 2011;64(5):280–8.CrossRefGoogle Scholar
  30. 30.
    Chua JD, Wilkoff BL, Lee I, Juratli N, Longworth DL, Gordon SM. Diagnosis and management of infections involving implantable electrophysiologic cardiac devices. Ann Intern Med. 2000;133(8):604–8.CrossRefGoogle Scholar
  31. 31.
    Maushagen E, Reichle B, Simon H. Circumscribed erythema after cardiac pacemaker implantation. Z Kardiol. 1994;83(5):340–2.PubMedGoogle Scholar
  32. 32.
    Kreft B, Thomas P, Steinhauser E, Vass A, Summer B, Wohlrab J. Erythema and swelling after im-plantation of a cardioverter defibrillator (ICD). Dtsch Med Wochenschr. 2015;140(19):1462–4.CrossRefGoogle Scholar
  33. 33.
    Widmark A, Friberg EG. How 'do's' and 'dont's' can be of significant importance in radiation protection: a case report. Radiat Prot Dosim. 2011;147(1–2):99–101.CrossRefGoogle Scholar
  34. 34.
    Rath PC, Purohit BV, Agrawal B, et al. Pacemaker lead endocarditis due to trichosporon species. J Assoc Physicians India. 2015;63(4):66–8.PubMedGoogle Scholar
  35. 35.
    Cutillas E, Ferrando FJ, Marti ME, Mateu A, Rausell N. Reticular variant of mid-dermal elastolysis after insertion of a pacemaker. Clin Exp Dermatol. 2010;35(5):498–500.CrossRefGoogle Scholar
  36. 36.
    Kottler D, Lefevre A, Balme B, Martin-Bourret V, Zaharia D, Skowron F. Mid-dermal elastolysis after insertion of a pacemaker. Ann Dermatol Venereol. 2015;142(11):680–4.CrossRefGoogle Scholar
  37. 37.
    Dy Chua J, Abdul-Karim A, Mawhorter S, et al. The role of swab and tissue culture in the diagnosis of implantable cardiac device infection. Pacing Clin Electrophysiol. 2005;28(12):1276–81.CrossRefGoogle Scholar
  38. 38.
    Taguchi T, Maeba S, Sueda T. Prevention of pacemaker-associated contact dermatitis by polytetrafluoroethylene sheet and conduit coating of the pacemaker system. J Artif Organs. 2014;17(3):285–7.CrossRefGoogle Scholar
  39. 39.
    Ishii K, Kodani E, Miyamoto S, et al. Pacemaker contact dermatitis: the effective use of a polytetrafluoroethylene sheet. Pacing Clin Electrophysiol. 2006;29(11):1299–302.CrossRefGoogle Scholar
  40. 40.
    Hiranaka T, Nomura F, Kurozumi K. Pacemaker contact dermatitis treated by wrapping with a polytetrafluoroethylene (PTFE) sheet. Pacing Clin Electrophysiol. 1992;8:335–8.Google Scholar
  41. 41.
    Kono K, Hara K, Higashi T, et al. Pacemaker contact dermatitis treated with polytetrafluoroethylene sheet. J Arrhythmia. 2000;16:403–7.Google Scholar
  42. 42.
    Tujita J, Nakamura K, Yasumoto S, Ueno Y. Pacemaker dermatitis: report of two cases. Nishinihon J Dermatol. 1996;58:200–2.CrossRefGoogle Scholar
  43. 43.
    Vodiskar J, Schnoring H, Sachweh JS, Muhler E, Vazquez-Jimenez JF. Polytetrafluoroethylene-coated pacemaker leads as surgical management of contact allergy to silicone. Ann Thorac Surg. 2014;97(1):328–9.CrossRefGoogle Scholar
  44. 44.
    Peters MS, Schroeter AL, van Hale HM, Broadbent JC. Pacemaker contact sensitivity. Contact Dermatitis. 1984;11(4):214–8.CrossRefGoogle Scholar
  45. 45.
    Viraben R, Boulinguez S, Alba C. Granulomatous dermatitis after implantation of a titanium-containing pacemaker. Contact Dermatitis. 1995;33(6):437.CrossRefGoogle Scholar
  46. 46.
    Yamauchi R, Morita A, Tsuji T. Pacemaker dermatitis from titanium. Contact Dermatitis. 2000;42(1):52–3.PubMedGoogle Scholar
  47. 47.
    Freeman S. Allergic contact dermatitis to titanium in a pacemaker. Contact Dermatitis. 2006;55(s1):41.Google Scholar
  48. 48.
    Dogan P, Inci S, Kuyumcu MS, Kus O. Contact dermatitis after implantable cardiac defibrillator implantation for ventricular tachycardia. Intractable Rare Dis Res. 2016;5(1):56–7.CrossRefGoogle Scholar
  49. 49.
    Laugier P, Hunziger N, Orusco M, Brun B, Reiffers J, Posternak F. Dermite de contact par pacemaker. Dermatologica. 1975;150:219–26.CrossRefGoogle Scholar
  50. 50.
    Tilsley DA, Rotstein H. Sensitivity caused by internal exposure to nickel, chrome and cobalt. Contact Dermatitis. 1980;6(3):175–8.CrossRefGoogle Scholar
  51. 51.
    Landwehr AJ, van Ketel WG. Pompholyx after implantation of a nickel-containing pacemaker in a nickel-allergic patient. Contact Dermatitis. 1983;9(2):147.CrossRefGoogle Scholar
  52. 52.
    Moini C, d'Alteroche A, Cosnay P, et al. Contact dermatitis following cardiac pacemaker implantation. Arch Mal Coeur Vaiss. 1996;89(2):253–6.PubMedGoogle Scholar
  53. 53.
    Romaguera C, Grimalt F. Pacemaker dermatitis. Contact Dermatitis. 1981;7(6):333.CrossRefGoogle Scholar
  54. 54.
    Verbov J. Pacemaker contact sensitivity. Contact Dermatitis. 1985;12(3):173.CrossRefGoogle Scholar
  55. 55.
    Gimenez CJ. Dermites au pacemaker. Acta Dermatol. 1985;8:117–9.Google Scholar
  56. 56.
    Parker SE, Mai CT, Canfield MA, et al. Updated national birth prevalence estimates for selected birth defects in the united states, 2004–2006. Birth Defects Res A Clin Mol Teratol. 2010;88(12):1008–16.CrossRefGoogle Scholar
  57. 57.
    Snijder RJ, Luermans JG, de Heij AH, et al. Patent foramen ovale with atrial septal aneurysm is strongly associated with migraine with aura: a large observational study. J Am Heart Assoc. 2016;5(12):e003771.CrossRefGoogle Scholar
  58. 58.
    Zier LS, Sievert H, Mahadevan VS. To close or not to close: contemporary indications for patent foramen ovale closure. Expert Rev Cardiovasc Ther. 2016;14:1235–44.CrossRefGoogle Scholar
  59. 59.
    Sun YP, Homma S. Patent foramen ovale and stroke. Circ J. 2016;80(8):1665–73.CrossRefGoogle Scholar
  60. 60.
    Dalen JE, Alpert JS. Cryptogenic strokes and patent foramen ovales: What's the right treatment? Am J Med. 2016;129(11):1159–62.CrossRefGoogle Scholar
  61. 61.
    Mills NL, King TD. Nonoperative closure of left-to-right shunts. J Thorac Cardiovasc Surg. 1976;72(3):371–8.PubMedGoogle Scholar
  62. 62.
    Rashkind WJ. Transcatheter treatment of congenital heart disease. Circulation. 1983;67(4):711–6.CrossRefGoogle Scholar
  63. 63.
    Rome JJ, Keane JF, Perry SB, Spevak PJ, Lock JE. Double-umbrella closure of atrial defects. Initial clinical applications. Circulation. 1990;82(3):751–8.CrossRefGoogle Scholar
  64. 64.
    Babic UU, Grujicic S, Popovic Z, Djurisic Z, Vucinic M, Pejcic P. Double-umbrella device for transvenous closure of patent ductus arteriosus and atrial septal defect: first experience. J Interv Cardiol. 1991;4(4):283–94.CrossRefGoogle Scholar
  65. 65.
    Das GS, Voss G, Jarvis G, Wyche K, Gunther R, Wilson RF. Experimental atrial septal defect closure with a new, transcatheter, self-centering device. Circulation. 1993;88(4 Pt 1):1754–64.CrossRefGoogle Scholar
  66. 66.
    Sharafuddin MJ, Gu X, Titus JL, Urness M, Cervera-Ceballos JJ, Amplatz K. Transvenous closure of secundum atrial septal defects: preliminary results with a new self-expanding nitinol prosthesis in a swine model. Circulation. 1997;95(8):2162–8.CrossRefGoogle Scholar
  67. 67.
    Bridges ND, Hellenbrand W, Latson L, Filiano J, Newburger JW, Lock JE. Transcatheter closure of patent foramen ovale after presumed paradoxical embolism. Circulation. 1992;86(6):1902–8.CrossRefGoogle Scholar
  68. 68.
    Schwetz BA. From the food and drug administration. JAMA. 2002;287(5):578.CrossRefGoogle Scholar
  69. 69.
  70. 70.
  71. 71.
    FDA Document. CardioSEALÒ septal occlusion system; summary of safety and effectiveness data. Updated 2001. Accessed 2 Oct 20016.
  72. 72.
  73. 73.
    Tang B, Su F, Sun X, Wu Q, Xing Q, Li S. Recent development of transcatheter closure of atrial septal defect and patent foramen ovale with occluders. J Biomed Mater Res B Appl Biomater. 2016; doi: 10.1002/jbm.b.33831.
  74. 74.
    Verma SK, Tobis JM. Explantation of patent foramen ovale closure devices: a multicenter survey. JACC Cardiovasc Interv. 2011;4(5):579–85.CrossRefGoogle Scholar
  75. 75.
    Verma DR, Khan MF, Tandar A, et al. Nickel elution properties of contemporary interatrial shunt closure devices. J Invasive Cardiol. 2015;27(2):99–104.PubMedGoogle Scholar
  76. 76.
    Ries MW, Kampmann C, Rupprecht HJ, Hintereder G, Hafner G, Meyer J. Nickel release after implantation of the amplatzer occluder. Am Heart J. 2003;145(4):737–41.CrossRefGoogle Scholar
  77. 77.
    Burian M, Neumann T, Weber M, et al. Nickel release, a possible indicator for the duration of antiplatelet treatment, from a nickel cardiac device in vivo: a study in patients with atrial septal defects implanted with an amplatzer occluder. Int J Clin Pharmacol Ther. 2006;44(3):107–12.CrossRefGoogle Scholar
  78. 78.
    Uguz E, Erdogan K, Sener E. Explantation of an atrial septal occluder device in a patient with nickel hypersensitivity. Anadolu Kardiyol Derg. 2014;14(4):402–3.CrossRefGoogle Scholar
  79. 79.
    Fukahara K, Minami K, Reiss N, Fassbender D, Koerfer R. Systemic allergic reaction to the percutaneous patent foramen ovale occluder. J Thorac Cardiovasc Surg. 2003;125(1):213–4.CrossRefGoogle Scholar
  80. 80.
    Dasika UK, Kanter KR, Vincent R. Nickel allergy to the percutaneous patent foramen ovale occluder and subsequent systemic nickel allergy. J Thorac Cardiovasc Surg. 2003;126(6):2112.CrossRefGoogle Scholar
  81. 81.
    Lai DW, Saver JL, Araujo JA, Reidl M, Tobis J. Pericarditis associated with nickel hypersensitivity to the amplatzer occluder device: a case report. Catheter Cardiovasc Interv. 2005;66(3):424–6.CrossRefGoogle Scholar
  82. 82.
    Prestipino F, Pragliola C, Lusini M, Chello M. Nickel allergy induced systemic reaction to an intracardiac amplatzer device. J Card Surg. 2014;29(3):349–50.CrossRefGoogle Scholar
  83. 83.
    Belohlavek J, Belohlavkova S, Hlubocky J, Mrazek V, Linhart A, Podzimek S. Severe allergic dermatitis after closure of foramen ovale with amplatzer occluder. Ann Thorac Surg. 2013;96(3):e57–9.CrossRefGoogle Scholar
  84. 84.
    Rabkin DG, Whitehead KJ, Michaels AD, Powell DL, Karwande SV. Unusual presentation of nickel allergy requiring explantation of an amplatzer atrial septal occluder device. Clin Cardiol. 2009;32(8):E55–7.CrossRefGoogle Scholar
  85. 85.
    Jain M, Singh S, Cadeiras M. A case of nitinol allergy causing pericardial tamponade. J Invasive Cardiol. 2013;25(9):E180–2.PubMedGoogle Scholar
  86. 86.
    Meier B. Nickel allergy and device closure of the patent foramen ovale, now that we were told should we care? Catheter Cardiovasc Interv. 2009;74(4):652.CrossRefGoogle Scholar
  87. 87.
    Kim HJ, Shin JU, Lee J, et al. Positive reactions to nickel on a patch test do not predict clinical outcome of nickel alloy-based atrial septal defect occluder implantation. Dermatology. 2015;230(2):184–8.CrossRefGoogle Scholar
  88. 88.
    Rigatelli G, Cardaioli P, Giordan M, et al. Nickel allergy in interatrial shunt device-based closure patients. Congenit Heart Dis. 2007;2(6):416–20.CrossRefGoogle Scholar
  89. 89.
    Niki Y, Matsumoto H, Otani T, et al. Screening for symptomatic metal sensitivity: a prospective study of 92 patients undergoing total knee arthroplasty. Biomaterials. 2005;26(9):1019–26.CrossRefGoogle Scholar
  90. 90.
    Carlsson A, Moller H. Implantation of orthopaedic devices in patients with metal allergy. Acta Derm Venereol. 1989;69(1):62–6.PubMedPubMedCentralGoogle Scholar

Copyright information

© Springer International Publishing AG, part of Springer Nature 2018

Authors and Affiliations

  1. 1.Stanford University School of MedicineRedwood CityUSA
  2. 2.Cardiac Electrophysiologist, Sulpizio Cardiovascular Center, Clinical Assistant Professor of MedicineUniversity of California San DiegoLa JollaUSA

Personalised recommendations