Infections associated with cardiac implantable electronic devices (CIEDs) pose significant clinical challenges due to their life-threatening nature and complex management. Recent advancements in prevention, diagnosis, and treatment have been driven by landmark trials such as PADIT and WRAP-IT, alongside evolving diagnostic tools like [18 F]FDG PET/CT and updated diagnostic criteria (e.g., 2023 Duke-ISCVID). A combination of well-established approaches—such as leadless pacemakers, subcutaneous ICDs, and an antibiotic-eluting envelope—and evolving adjunctive strategies, including a taurolidine-containing antimicrobial agent, incision drapes, fascial plane blocks or double gloving, have broadened the spectrum of options to reduce and potentially mitigate the risk of CIED infection. While devices like leadless pacemakers, subcutaneous ICDs, and antibiotic envelopes are supported by randomized controlled trials, adjunctive measures such as taurolidine rely predominantly on observational data. To address this variation in the strength of available evidence, a modified Delphi consensus process was conducted, bringing together cardiologists and infectious disease experts to define experience-based best practices in areas where current guidelines offer limited or no specific recommendations. The consensus achieved strong agreement (≥ 80%) on key strategies, including mandatory double-gloving to reduce contamination, the use of validated risk models (e.g., PADIT, BLISTER) for tailored infection prevention employing an antibiotic eluting envelope, multidisciplinary decision-making for non-extractable infections and the use of taurolidine solutions as adjuncts to prevent CIED infection. Moderate consensus (60–79%) supported non-delayed reimplantation after lead-related endocarditis and single-session reimplantation in pacing-dependent patients under specific circumstances. However, no consensus was reached on mandating a minimum annual procedural volume (≥ 500 cases) for CIED centers, reflecting concerns about access and operator expertise. The findings emphasize the importance of personalized risk stratification, procedural innovations, and multidisciplinary collaboration in optimizing CIED infection outcomes. Areas requiring further research include the efficacy of iodophor-impregnated drapes, fascial plane blocks, and taurolidine solutions. This consensus provides a pragmatic framework for clinicians, highlighting evidence-informed strategies to mitigate infection risks and improve care for patients undergoing CIED procedures.

Delphi consensus recommendations for preventing and treating cardiac implantable electronic device infections beyond current guidelines

Tascini C.;
2026-01-01

Abstract

Infections associated with cardiac implantable electronic devices (CIEDs) pose significant clinical challenges due to their life-threatening nature and complex management. Recent advancements in prevention, diagnosis, and treatment have been driven by landmark trials such as PADIT and WRAP-IT, alongside evolving diagnostic tools like [18 F]FDG PET/CT and updated diagnostic criteria (e.g., 2023 Duke-ISCVID). A combination of well-established approaches—such as leadless pacemakers, subcutaneous ICDs, and an antibiotic-eluting envelope—and evolving adjunctive strategies, including a taurolidine-containing antimicrobial agent, incision drapes, fascial plane blocks or double gloving, have broadened the spectrum of options to reduce and potentially mitigate the risk of CIED infection. While devices like leadless pacemakers, subcutaneous ICDs, and antibiotic envelopes are supported by randomized controlled trials, adjunctive measures such as taurolidine rely predominantly on observational data. To address this variation in the strength of available evidence, a modified Delphi consensus process was conducted, bringing together cardiologists and infectious disease experts to define experience-based best practices in areas where current guidelines offer limited or no specific recommendations. The consensus achieved strong agreement (≥ 80%) on key strategies, including mandatory double-gloving to reduce contamination, the use of validated risk models (e.g., PADIT, BLISTER) for tailored infection prevention employing an antibiotic eluting envelope, multidisciplinary decision-making for non-extractable infections and the use of taurolidine solutions as adjuncts to prevent CIED infection. Moderate consensus (60–79%) supported non-delayed reimplantation after lead-related endocarditis and single-session reimplantation in pacing-dependent patients under specific circumstances. However, no consensus was reached on mandating a minimum annual procedural volume (≥ 500 cases) for CIED centers, reflecting concerns about access and operator expertise. The findings emphasize the importance of personalized risk stratification, procedural innovations, and multidisciplinary collaboration in optimizing CIED infection outcomes. Areas requiring further research include the efficacy of iodophor-impregnated drapes, fascial plane blocks, and taurolidine solutions. This consensus provides a pragmatic framework for clinicians, highlighting evidence-informed strategies to mitigate infection risks and improve care for patients undergoing CIED procedures.
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Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/11390/1330134
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