Taurolidine Containing Antimicrobial CIED Wash to Prevent Infection

Study Overview
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Brief Summary
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From January 1st 2020, any CIED procedure conducted with adjunct TauroPace™ CIED and pocket irrigation is enrolled in a consecutive manner and followed up in one centre. Follow-up is prospectively. Before that date any CIED procedure conducted with adjunct antispetic pocket and CIED irrigation is evaluated retrospectively to form a comparable group.

Detailed Description
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All the hardware (leads, suture sleeves, pulse generator) is washed and the device pocket irrigated with an adjunct antimicrobial solution, which could be 3% hydrogen peroxide (H2O2), taurolidine in a galenic formulation or TauroPace™ (TP, Tauropharm, Bavaria, Germany), during any invasive procedure (new implantation, pulse generator replacement, lead repositioning or insertion, system upgrade or downgrade, revision) involving a CIED system at the authors' institute. Before 01/01/2020, the choice of antimicrobial solution was at the operator's discretion. These procedures were evaluated retrospectively. With change of policy on the first of January 2020, in every consecutive patient and procedure only TP is used. Patients were enrolled and followed consecutively in order of appearance. All CIED procedures performed at the author's institute between 01/01/2017 and 28/02/2022 are included for analysis. Patients who receive the galenic taurolidine formulation were excluded from analysis.

Official Title
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Effect of Intraoperative Topical Application of a Taurolidine Solution on CIED Related Infections in the Clinical Setting - a Prospective Observational Study With a Restrospective Historical Control

Conditions
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Cardiac Implantable Electronic Device Infection

Intervention / Treatment
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* Device: TauroPace
* Device: Hydrogen Peroxide
* Drug: Taurolidine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: CIED procedure, signs PIC Exclusion Criteria: PIC not signed, minor

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| TauroPace irrigation group<br>every consecutive CIED placement, revision, extraction conducted with TauroPace | Device: TauroPace<br>* All the hardware (leads, suture sleeves, pulse generator) is washed and the device pocket irrigated with an adjunct antimicrobial solution containing Taurolidine (TauroPace™, Tauropharm, Bavaria, Germany), during any invasive procedure (new implantation, pulse generator replacement, lead repositioning or insertion, system upgrade or downgrade, revision) involving a CIED system since January 2019<br>|
| antiseptic irrigation group<br>every procedure conducted with adjunct antiseptic irrigation, which could be Taurolidine, TauroPace or Hydrogen Peroxide 3% | Device: TauroPace<br>* All the hardware (leads, suture sleeves, pulse generator) is washed and the device pocket irrigated with an adjunct antimicrobial solution containing Taurolidine (TauroPace™, Tauropharm, Bavaria, Germany), during any invasive procedure (new implantation, pulse generator replacement, lead repositioning or insertion, system upgrade or downgrade, revision) involving a CIED system since January 2019<br>Device: Hydrogen Peroxide<br>* All the hardware (leads, suture sleeves, pulse generator) was washed and the device pocket irrigated with an adjunct antimicrobial solution containing 3% hydrogen peroxide (H2O2) during any invasive procedure (new implantation, pulse generator replacement, lead repositioning or insertion, system upgrade or downgrade, revision) involving a CIED system at the authors' institute before 01/01/2020<br>Drug: Taurolidine<br>* All the hardware (leads, suture sleeves, pulse generator) was washed and the device pocket irrigated with an adjunct antimicrobial solution containing taurolidine in a galenic formulation during any invasive procedure (new implantation, pulse generator replacement, lead repositioning or insertion, system upgrade or downgrade, revision) involving a CIED system at the authors' institute before 01/01/2019<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CIED infection | cardiac implantable electronic device infection | three months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| all cause mortality | death of any cause during the observation | three months | 
| adverse events grade 3-5 | adverse events related to CIED, procedure or the atiseptic used | three months | 
| all cause mortality | death of any cause during all of the follow up period | 36 months | 
| adverse events grade 3-5 | adverse events related to CIED, procedure or the atiseptic used during all of the follow-up period | 36 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cardiac implantable electronic device infection, taurolidine