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Long-term results of a cardiovascular implantable electronic device wrapped with an expanded polytetrafluoroethylene sheet

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Abstract

The use of an expanded polytetrafluoroethylene (ePTFE) sheet wrapping device for patients with pacemaker contact dermatitis is still controversial. This study aimed to retrospectively investigate the occurrence rate of allergies and other complications after implantation of a cardiovascular implantable electronic device (CIED) wrapped with an ePTFE sheet. A total of 4,497 procedures of CIED implantation were performed at our institution between January 1993 and April 2010. Among 19 patients who underwent implantation of an electronic cardiac device wrapped with an ePTFE sheet, device implantation was performed in 11 patients for secondary prevention of device contact sensitivity, in 7 patients for primary prevention of device contact sensitivity, and in 1 patient for avoiding over-sensing of myopotentials. During follow-up periods (mean 46 ± 34 months), there were no allergic or inflammatory reactions to components of the device or ePTFE itself. Among 11 patients with a device wrapped with an ePTFE sheet for secondary prevention, 5 patients completed device replacement due to battery depletion and 3 patients had infections from the device. Wrapping implantable devices with an ePTFE sheet is an effective way of preventing device sensitivity in patients who require CIED therapy. However, the risk of infection from the device should be taken into consideration.

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References

  1. Moss AJ, Zareba W, Hall J, Klein H, Wilber DJ, Cannom DS, Daubert JP, Higgins S, Brown M, Andrews ML, For the Multicenter Automatic Defibrillator Implantation Trial II Investigators. Prophylactic implantation of a defibrillator in patients with myocardial infarction and reduced ejection fraction. N Engl J Med. 2002;346:877–83.

    Article  PubMed  Google Scholar 

  2. Brady GH, Mark DB, Poole JE, Packer DL, Boineau R, Domanski M, Troutman C, Anderson J, Johnson G, McNulty SE, Clapp-Channing N, Davidson LD, Fraulo ES, Fishbein DP, Luceri RM, John H, For the Sudden Cardiac Death in Heart Failure Trail (SCD-HeFT) investigators. Amiodarone or an implantable cardioverter-defibrillator for congestive heart failure. N Engl J Med. 2005;352:225–37.

    Article  Google Scholar 

  3. Bristow MR, Saxon LA, Boehmer J, Krueger S, Kass DA, Marco TD, Carson P, DiCarlo L, DeMets D, White BG, DeVries DW, Feldman AM, For the Comparison of Medical Therapy, Pacing, and Defibrillation in Heart Failure (COMPANION) Investigators. Cardiac-resynchronization therapy with or without an implantable defibrillator in advanced chronic heart failure. N Engl J Med. 2004;305:2140–50.

    Article  Google Scholar 

  4. Stevenson WG, Chaitman BR, Ellenbogen KA, Epstein AE, Gross WL, Hayes DL, Strickberger SA, Sweeney MO, For the Subcommittee in Electrocardiography and Arrhythmias of the American Heart Association Council on Clinical Cardiology, in Collaboration With the Heart Rhythm Society. Clinical assessment and management of patients with implanted cardioverter-defibrillators presenting to nonelectrophysiologists. Circulation. 2004;110:3866–9.

    Article  PubMed  Google Scholar 

  5. Sawa Y, Tatsumi E, Funakubo A, Horiuchi T, Iwasaki K, Kishida A, Masuzawa T, Matsuda K, Myoui A, Nishimura M, Nishimura T, Tokunaga S, Tomizawa Y, Tomo T, Tsukiya T, Yamaoka T. Journal of artificial organs 2010: the year in review. J Artif Organs. 2011;14:1–8.

    Article  Google Scholar 

  6. Iguchi N, Kasanuki H, Matsuda N, Shoda M, Ohnishi S, Hosoda S. Contact sensitivity to polychloroparaxylene-coated cardiac pacemaker. PACE. 1997;20:372–3.

    Article  PubMed  CAS  Google Scholar 

  7. Ishii K, Kodani E, Miyamoto S, Otsuka T, Hosone M, Ogata K, Sato W, Matsumoto S, Tadera T, Ibuki C, Kusama Y, Atarashi H. Pacemaker contact dermatitis: the effective use of a polytetrafluoroethylene sheet. PACE. 2006;29:1299–302.

    Article  PubMed  Google Scholar 

  8. Yamamoto M, Uchiyama M, Nakajima S, Hanyaku H, Suda Y, Niinami H, Kono K, Tabata M, Sasaki A, Asano R, Ikeda M, Kataoka G, Harada T, Takeuchi Y. Two cases of pacemaker allergic dermatitis treated with polytetrafluoroethylene sheet. Ther Res. 2004;25:991–8. (in Japanese).

    Google Scholar 

  9. Kono K, HaraK, Higashi T, Watanabe S, Asakawa H, Ono H, Horinaka S, Matsuoka H, Mochizuki Y, Yamada Y, Mori H, Okamura Y. Pacemaker contact dermatitis treated with polytetrafluoroethylene sheet. J Arrhythmia 2000;16:403–7 (in Japanese).

  10. Fujimori M, Akagi T, Tanabe M, Matsumoto N. Patients with metal allergy after implantation of a pacemaker. J Arrhythmia. 2003;19:79–83. (in Japanese).

    Google Scholar 

  11. Tamenishi A, Usui A, Oshima H, Ueda Y. Entirely polytetrafluoroethylene coating for pacemaker system contact dermatitis. Interact Cardiovasc Thorac Surg. 2008;7:275–6.

    Article  PubMed  Google Scholar 

  12. Marks JG Jr, Belsito DV, DeLeo VA, Fowler JF Jr, Fransway AF, Maibach HI, Mathias CG, Pratt MD, Rietschel RL, Sherertz EF, Storrs FJ, Taylor JS. North American Contact Dermatitis Group patch-test results, 1998 to 2000. Am J Contact Dermat. 2003;14:59–62.

    PubMed  Google Scholar 

  13. Peters MS, Schroeter AL, van Hale HM, Broadbent JC. Pacemaker contact sensitivity. Contact Dermat. 1984;11:214–8.

    Article  CAS  Google Scholar 

  14. Viraben R, Boulinguez S, Alba C. Granulomatous dermatitis after implantation of a titanium containing pacemaker. Contact Dermat. 1995;33:437.

    Article  CAS  Google Scholar 

  15. Tomizawa Y, Hanawa T. Corrosion of pure titanium sternal wire. Ann Thorac Surg. 2007;84:1012–4.

    Article  PubMed  Google Scholar 

  16. Dery JP, Gilbert M, O’Hara G, Champagne J, Desaulniers D, Cartier P, Philippon F. Pacemaker contact sensitivity: case report and review of the literature. PACE. 2002;25:863–5.

    Article  PubMed  Google Scholar 

  17. Oprea ML, Schnoring H, Sachweh JS, Ott H, Biertz J, Vazquez-Jimenez JF. Allergy to pacemaker silicone compounds: recognition and surgical management. Ann Thorac Surg. 2009;87:1275–7.

    Article  PubMed  Google Scholar 

  18. Raque C, Goldschmidt H. Dermatitis associated with an implanted cardiac pacemaker. Arch Dermatol. 1970;102:646–9.

    Article  PubMed  CAS  Google Scholar 

  19. Thyssen JP, Menne T. Metal allergy: a review on exposures, penetration, genetics, prevalence, and clinical implication. Chem Res Toxicol. 2010;23:309–18.

    Article  PubMed  CAS  Google Scholar 

  20. Yamauchi R, Morita A, Tsuji T. Pacemaker dermatitis from titanium. Contact Dermat. 2000;42:52–3.

    CAS  Google Scholar 

  21. Brun R, Hunziker N. Pacemaker dermatitis. Contact Dermat. 1980;6:212–3.

    Article  CAS  Google Scholar 

  22. Baddour LM, Epstein AE, Erickson CC, Knight BP, Levison ME, Lackhart PB, Masoudi FA, Okum EJ, Wilson WR, Beerman LB, Bolger AF, Estes NAM 3rd, Gewitz M, Newburger JW, Schron EB, Taubert KA; on behalf of the American Heart Association Rheumatic Fever, Endocarditis, and Kawasaki Disease Committee of the Council on Cardiovascular Disease in the Young; Council on Cardiovascular Surgery and Anesthesia; Council on Cardiovascular Nursing; Council on Clinical on Cardiology; and the Interdisciplinary Council on Quality of Care and Outcomes Research. Update on cardiovascular implantable electronic device infections and their management: a scientific statement from the American Heart Association. Circulation. 2010;121:458–77.

  23. Dy Chua J, Abdul-Karim A, Mawhorter S, Procop GW, Tchou P, Niebauer M, Saliba W, et al. The role of swab and tissue culture in the diagnosis of implantable cardiac device infection. Pacing Clin Electrophysiol 2005;28:1276–81.

    Google Scholar 

  24. Wilkerson MG, Jordan WP. Pressure dermatitis from an implanted pacemaker. Dermatol Clin. 1990;8:189–92.

    PubMed  CAS  Google Scholar 

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Correspondence to Bun Yashiro or Yasuko Tomizawa.

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Yashiro, B., Shoda, M., Tomizawa, Y. et al. Long-term results of a cardiovascular implantable electronic device wrapped with an expanded polytetrafluoroethylene sheet. J Artif Organs 15, 244–249 (2012). https://doi.org/10.1007/s10047-012-0634-8

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  • DOI: https://doi.org/10.1007/s10047-012-0634-8

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