Frequency of Contact Allergy to Implanted Cardiac Devices | Allergy and Clinical Immunology | JAMA Dermatology | JAMA Network
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Table 1.  Clinical Characteristics
Clinical Characteristics
Table 2.  Device Data and Patch Test Results
Device Data and Patch Test Results
1.
Harris  PA, Taylor  R, Thielke  R, Payne  J, Gonzalez  N, Conde  JG.  Research electronic data capture (REDCap)—a metadata-driven methodology and workflow process for providing translational research informatics support.  J Biomed Inform. 2009;42(2):377-381. doi:10.1016/j.jbi.2008.08.010PubMedGoogle ScholarCrossref
2.
Wilkinson  DS, Fregert  S, Magnusson  B,  et al.  Terminology of contact dermatitis.  Acta Derm Venereol. 1970;50(4):287-292.PubMedGoogle Scholar
3.
Pratt  MD, Belsito  DV, DeLeo  VA,  et al.  North American Contact Dermatitis Group patch-test results, 2001-2002 study period.  Dermatitis. 2004;15(4):176-183.PubMedGoogle Scholar
4.
Schalock  PC, Dunnick  CA, Nedorost  S, Brod  B, Warshaw  E, Mowad  C.  American Contact Dermatitis Society Core Allergen Series: 2017 update.  Dermatitis. 2017;28(2):141-143. doi:10.1097/DER.0000000000000261PubMedGoogle ScholarCrossref
5.
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. doi:10.1111/j.1600-0536.2008.01351.xPubMedGoogle ScholarCrossref
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Research Letter
April 3, 2019

Frequency of Contact Allergy to Implanted Cardiac Devices

Author Affiliations
  • 1Duke University School of Medicine, Durham, North Carolina
  • 2Aurora St Luke’s Medical Center, Milwaukee, Wisconsin
  • 3Department of Biostatistics and Bioinformatics, Duke University School of Medicine, Durham, North Carolina
  • 4Department of Dermatology, Duke University School of Medicine, Durham, North Carolina
JAMA Dermatol. 2019;155(6):749-752. doi:10.1001/jamadermatol.2019.0036

Allergic contact dermatitis associated with implanted cardiac devices is rare. This study evaluates patients who underwent cardiac implant patch testing.

Methods

This retrospective study used data from a preexisiting database repository and was approved by the Duke University Health System Institutional Review Board, which also provided waiver for individual consent. Adult patients who underwent cardiac implant patch testing from March 1, 2012, to September 15, 2017, at Duke University School of Medicine’s Department of Dermatology were included. Data from patch test results were recorded in REDCap.1

Allergens were obtained from Chemotechnique (Sweden), Allergeaze (SmartPractice Canada), and cardiac device companies. Allergens were applied on Finn Chambers (SmartPractice USA) with Scanpor Tape (Norgesplaster; Norway). Readings were completed on D2 and D4/D5 in accordance with International Contact Dermatitis Research Group criteria.2 Relevance was designated as definite, probable, possible, past, or unknown.3

Results

Of the 11 patients who completed 15 patch test sessions, the mean (SD) age was 58.4 (15.6) years, and 3 (27%) were women. Six patients had pacemakers implanted, and 5 patients had implantable cardioverter defibrillators implanted. Clinical characteristics are summarized in Table 1. Common indications for patch testing were concern for allergy, skin eruption, skin symptoms, and concern for infection. Common symptoms included pruritus and pain. Erythema was noted at the implant scar in 8 patients (72.7%).

Table 2 summarizes device data and patch test results.4 Eight patients (72.7%) underwent device extraction. Duration of device implantation prior to extraction was 1 to 77 months if extracted before patch testing and 1 to 11 months if extracted after patch testing. Six patients (55%) had relevant positive patch test reactions, and 4 (36%) of these included reactions to metals. Other positive patch test results included reactions to rubber accelerators, lidocaine, silicone, and a device-related dexamethasone plug. Six patients underwent device extraction prior to patch testing, and 1 patient underwent extraction 4 months after patch testing. Patient 2 underwent extraction prior to the first negative patch test result; a new device was placed, and symptoms recurred. Additional testing revealed relevant allergens, but an alternative device could not be identified. Treatment with maintenance prednisone was required to avoid recurrent reaction.

Culture data were available for 7 patients who underwent extraction (Table 1). Five cultures had negative results. Based on clinical impression, patient 7 had a true infection, and patient 11 had a secondary infection. With one exception, electrophysiologists avoided relevant allergens during reimplantation. The duration of success after reimplantation ranged from 11 to 36 months. As of September 15, 2017, one patient had died, and the remainder of the patients’ devices were functioning as expected. In comparison, of the 5 patients with negative patch test results, 3 patients kept their devices, which demonstrated that the negative patch test result had important diagnostic value. The remaining patients had their devices extracted prior to testing, and reimplantation was not indicated.

Discussion

This study included 11 patients who underwent cardiac implant patch testing. The majority of patients had history of erythema at the implant site. Concern for infection was common, and more than half of patients had devices extracted prior to presentation. Culture results, with 2 exceptions, were negative.

More than half of the patients had relevant positive patch test results, and the most common allergens were metals, rubber accelerators, and silicone. Cardiac device allergy to metals, silicone-based components, and thiuram rubber accelerators has been published previously.5 To our knowledge, there are previous reports of allergy to carbamate rubber accelerators, diphenylguanidine rubber accelerators, and lidocaine, though not in the setting of cardiac devices. The majority of patients with relevant positive patch test reactions underwent device extraction and successful reimplantation. In a majority of cases, electrophysiologists were able to avoid allergens. For those patients in which we have follow-up data, new cardiac devices were functioning well.

One limitation of this study is the lack follow-up data for 2 subjects. In addition, the duration of follow-up was limited to a maximum of 36 months. Cardiac device allergy should be considered when there is clinical concern for infection, history of device extraction, history of erythema at the implant site, or negative culture results. When cases are identified, positive outcomes may be obtained when allergen-guided reimplantation is performed. Contact allergy to cardiac devices is an uncommon but important phenomenon.

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Article Information

Accepted for Publication: January 1, 2019.

Corresponding Author: Amber Reck Atwater, MD, Department of Dermatology, Duke University Medical Center, 5324 McFarland Dr, Suite 210, Durham, NC 27707 (amber.atwater@duke.edu).

Published Online: April 3, 2019. doi:10.1001/jamadermatol.2019.0036

Author Contributions: Dr Atwater had full access to all of the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis.

Study concept and design: Gold, Atwater.

Acquisition, analysis, or interpretation of data: All authors.

Drafting of the manuscript: Gold, Atwater.

Critical revision of the manuscript for important intellectual content: All authors.

Statistical analysis: Gold, Green.

Administrative, technical, or material support: Gold, Nath.

Study supervision: Atwater.

Conflict of Interest Disclosures: None reported.

Funding/Support: This study was supported in part by Duke Dermatology, which provided statistical funding.

Role of the Funder/Sponsor: The funder had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication.

References
1.
Harris  PA, Taylor  R, Thielke  R, Payne  J, Gonzalez  N, Conde  JG.  Research electronic data capture (REDCap)—a metadata-driven methodology and workflow process for providing translational research informatics support.  J Biomed Inform. 2009;42(2):377-381. doi:10.1016/j.jbi.2008.08.010PubMedGoogle ScholarCrossref
2.
Wilkinson  DS, Fregert  S, Magnusson  B,  et al.  Terminology of contact dermatitis.  Acta Derm Venereol. 1970;50(4):287-292.PubMedGoogle Scholar
3.
Pratt  MD, Belsito  DV, DeLeo  VA,  et al.  North American Contact Dermatitis Group patch-test results, 2001-2002 study period.  Dermatitis. 2004;15(4):176-183.PubMedGoogle Scholar
4.
Schalock  PC, Dunnick  CA, Nedorost  S, Brod  B, Warshaw  E, Mowad  C.  American Contact Dermatitis Society Core Allergen Series: 2017 update.  Dermatitis. 2017;28(2):141-143. doi:10.1097/DER.0000000000000261PubMedGoogle ScholarCrossref
5.
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. doi:10.1111/j.1600-0536.2008.01351.xPubMedGoogle ScholarCrossref
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