Evidence map›Paper›PMID 41394438›Full record

ArticleEuropean heart journal. Case reports2025

Implanting a gold-coated cardioverter-defibrillator as a solution to cardiac implantable device hypersensitivity: a case report.

Grzegorz Ehrenhalt, Paweł Syska, Leszek Blicharz, Michał Lewandowski, Mariusz Pytkowski

Abstract readCase Reports
In one paragraph

Article in European heart journal. Case reports, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Article
  2. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

5 authors.

Grzegorz Ehrenhalt2nd Arrhythmia Department, Narodowy Instytut Kardiologii im. Stefana kardynała Wyszyńskiego, Państwowy Instytut Badawczy w Warszawie, Ul. Alpejska 42, 04-628 Warsaw, Poland.ORCID https://orcid.org/0009-0000-2464-1935
Paweł Syska2nd Arrhythmia Department, Narodowy Instytut Kardiologii im. Stefana kardynała Wyszyńskiego, Państwowy Instytut Badawczy w Warszawie, Ul. Alpejska 42, 04-628 Warsaw, Poland.
Leszek BlicharzKatedra i Klinika Dermatologiczna - Wydział Lekarski, Warszawski Uniwersytet Medyczny, Ul. Nowogrodzka 59, 02-006 Warsaw, Poland.ORCID https://orcid.org/0000-0002-7633-4168
Michał Lewandowski2nd Arrhythmia Department, Narodowy Instytut Kardiologii im. Stefana kardynała Wyszyńskiego, Państwowy Instytut Badawczy w Warszawie, Ul. Alpejska 42, 04-628 Warsaw, Poland.
Mariusz Pytkowski2nd Arrhythmia Department, Narodowy Instytut Kardiologii im. Stefana kardynała Wyszyńskiego, Państwowy Instytut Badawczy w Warszawie, Ul. Alpejska 42, 04-628 Warsaw, Poland.ORCID https://orcid.org/0000-0002-2343-4093

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background: Hypersensitivity to cardiac implantable electronic device (CIED) materials is a rare and underrecognized complication. It often mimics infection, leading to misdiagnosis and inappropriate management. This case report contributes to the literature by demonstrating a structured diagnostic approach and the successful use of a custom-made, gold-coated ICD. Case summary: A 40-year-old male with dilated cardiomyopathy underwent subcutaneous ICD implantation. Seven months later, he presented with symptoms suggesting pocket infection, resulting in device removal. Subsequently, a transvenous ICD was implanted, but within weeks, signs of local inflammation reappeared, progressing to a necrotizing fistula. Blood tests and wound cultures revealed no infection. Given the patient's history of cutaneous allergic reactions to metals, hypersensitivity was suspected. Skin patch testing confirmed allergic responses to multiple device components. The patient underwent complete system extraction. A custom-made, gold-coated single-chamber ICD was provided by the manufacturer and successfully implanted. One-year follow-up revealed no signs of recurrent inflammation or allergic symptoms, confirming the diagnosis and effectiveness of the intervention. Discussion: Hypersensitivity to CIED materials is an important differential diagnosis in cases of recurrent pocket inflammation with negative microbiological findings. Due to overlapping local symptoms, it is frequently mistaken for infection, leading to delayed or inappropriate management. A detailed allergy history and use of skin patch testing are essential in guiding diagnosis. Once confirmed, conservative measures such as corticosteroids have limited value, and definitive treatment requires full system explantation. Reimplantation with a hypoallergenic device-such as a gold-coated generator-represents an effective therapeutic strategy.

Indexed as

Case reportDevice hypersensitivityGold-coated cardioverter-defibrillatorMetal allergy

Identifiers

PMID41394438
PMCPMC12699153

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.