Clin Res Cardiol (2022). https://doi.org/10.1007/s00392-022-02002-5

A prospective case-control validation of procalcitonin as a biomarker diagnosing pacemaker and implantable cardioverter defibrillator pocket infection
K. Knoll1, M. O`Connor2, A. Chouchane1, B. Haller3, C. Schaarschmidt1, M. Bock1, L. V. Förschner1, R. Fröhlich1, M. Kottmaier1, F. Bourier1, T. Reents1, G. Heßling1, I. Deisenhofer1, C. Kolb1, C. Lennerz1
1Klinik für Herz- und Kreislauferkrankungen, Deutsches Herzzentrum München, München; 2Department of Electrophysiology, The Royal Brompton and Harefield NHS Trust, Department of Electrophysiology, London; 3Institut für KI und Informatik in der Medizin, Klinikum rechts der Isar der TU München, München;

IntroductionDevice infections are a one of the main complications of cardiac implantable electronic device implantation. While lead related infective endocarditis and CIED systemic infections are associated with bacteraemia and systemic inflammatory response, pocket infections are limited to the generator pocket. Thus their diagnosis relies mainly on clinical judgement based on local inflammation signs and can be easily missed. Identification of relevant biomarkers to aid diagnosis of such pocket infection is thus of vital importance.

Aim: We previously identified procalcitonin (PCT) as promising biomarker for diagnosing localised pocket infections and identified an optimised cut-off value of 0.05 ng/ml. This study aimed to validate the proposed PCT cut-off value in an independent cohort. 

MethodsIn this prospective case-control validation study 81 patients with confirmed pocket infections were compared to 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.

ResultsAn elevated PCT over 0.05 ng/ml was found in 68 % (n= 55) of pocket infections and 24 % (n= 19) of controls. Using the pre-defined cut-off value of 0.05 ng/ml PCT had a sensitivity of 68 % and a specificity of 77 % for diagnosing pocket infections. ROC analysis revealed area under the curve of 0.752 (standard error 0.039, p <0.001) for PCT. Sensitivity remained high in subgroup analyses of patients presenting with minimal local inflammation signs (67 % vs. 70 % with extensive inflammation) or receiving antibiotic pretreatment (65 % vs. 69 % without pretreatment).

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

 

 

 

 


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