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A prospective case-control validation of procalcitonin as a biomarker diagnosing pacemaker and implantable cardioverter defibrillator pocket infection

Katharina Knoll12, Matthew O’Connor3, Amir Chouchane1, Bernhard Haller4, Claudia Schaarschmidt1, Matthias Bock1, Leonie Förschner1, Rebecca Fröhlich1, Marc Kottmaier1, Felix Bourier1, Tilko Reents1, Gabriele Hessling1, Isabel Deisenhofer1, Christof Kolb1, Carsten Lennerz12
DOI: 10.33963/KP.a2022.0124
·
Pubmed: 35521718
Affiliations
  1. Department of Cardiology and Cardiovascular Diseases, German Heart Center Munich, Technical University of Munich, Munich, Germany
  2. DZHK — German Centre for Cardiovascular Research, partner site Munich Heart Alliance, Munich, Germany
  3. The Royal Brompton and Harefield NHS Trust, Department of Electrophysiology, London, United Kingdom
  4. Institute of Medical Informatics, Statistics and Epidemiology, University Hospital Rechts der Isar, Technical University of Munich, Munich, Germany

open access

Online first
Original article
Published online: 2022-05-06

Abstract

BACKGROUND: The diagnosis of device infections, especially pocket infections, is challenging and relies primarily on the clinical presentation. The prospective DIRT (Device associated infections role of new diagnostic tools) study identified procalcitonin (PCT) among 14 biomarkers as the most promising biomarker to aid the diagnosis of pocket infection and identified an optimized cut-off value of 0.05 ng/ml for a localized generator pocket infection.

AIMS: The present study aims to validate the proposed PCT cut-off value of 0.05 ng/ml for the diagnosis of pocket infection in an independent cohort.

METHODS: We prospectively enrolled 81 patients with pocket infections and 81 age and renal function matched controls presenting for elective device exchange or lead revision. Patients with concomitant infectious or inflammatory diseases, end-stage renal failure, current active malignancy or receiving immunosuppressive therapy were excluded.

RESULTS: An elevated PCT over 0.05 ng/ml was found in 68% (n = 55) of pocket infections and 24% (n = 19) of controls, corresponding to a sensitivity of 68% and a specificity of 77% for diagnosing a pocket infection. In ROC analysis, PCT showed an area under the curve of 0.75 (95% confidence interval, 0.68–0.83; P <0.001). Sensitivity remained high with antibiotic pretreatment (65% c.f. 69% without pretreatment) and in cases with minimal inflammatory signs (67% c.f. 70% with extensive inflammation).

CONCLUSION: Our study validates the cut-off value of 0.05 ng/ml PCT for diagnosis of a pocket infection, even in patients pre-treated with antibiotics or with minimal clinical signs of inflammation.

Abstract

BACKGROUND: The diagnosis of device infections, especially pocket infections, is challenging and relies primarily on the clinical presentation. The prospective DIRT (Device associated infections role of new diagnostic tools) study identified procalcitonin (PCT) among 14 biomarkers as the most promising biomarker to aid the diagnosis of pocket infection and identified an optimized cut-off value of 0.05 ng/ml for a localized generator pocket infection.

AIMS: The present study aims to validate the proposed PCT cut-off value of 0.05 ng/ml for the diagnosis of pocket infection in an independent cohort.

METHODS: We prospectively enrolled 81 patients with pocket infections and 81 age and renal function matched controls presenting for elective device exchange or lead revision. Patients with concomitant infectious or inflammatory diseases, end-stage renal failure, current active malignancy or receiving immunosuppressive therapy were excluded.

RESULTS: An elevated PCT over 0.05 ng/ml was found in 68% (n = 55) of pocket infections and 24% (n = 19) of controls, corresponding to a sensitivity of 68% and a specificity of 77% for diagnosing a pocket infection. In ROC analysis, PCT showed an area under the curve of 0.75 (95% confidence interval, 0.68–0.83; P <0.001). Sensitivity remained high with antibiotic pretreatment (65% c.f. 69% without pretreatment) and in cases with minimal inflammatory signs (67% c.f. 70% with extensive inflammation).

CONCLUSION: Our study validates the cut-off value of 0.05 ng/ml PCT for diagnosis of a pocket infection, even in patients pre-treated with antibiotics or with minimal clinical signs of inflammation.

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Keywords

biomarker, cardiac device infection, pocket infection, procalcitonin

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Title

A prospective case-control validation of procalcitonin as a biomarker diagnosing pacemaker and implantable cardioverter defibrillator pocket infection

Journal

Kardiologia Polska (Polish Heart Journal)

Issue

Online first

Article type

Original article

Published online

2022-05-06

Page views

73

Article views/downloads

26

DOI

10.33963/KP.a2022.0124

Pubmed

35521718

Keywords

biomarker
cardiac device infection
pocket infection
procalcitonin

Authors

Katharina Knoll
Matthew O’Connor
Amir Chouchane
Bernhard Haller
Claudia Schaarschmidt
Matthias Bock
Leonie Förschner
Rebecca Fröhlich
Marc Kottmaier
Felix Bourier
Tilko Reents
Gabriele Hessling
Isabel Deisenhofer
Christof Kolb
Carsten Lennerz

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