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| Name | Class |
|---|---|
| University of Luebeck | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TauroPace irrigation group | every consecutive CIED placement, revision, extraction conducted with TauroPace |
| |
| antiseptic irrigation group | every procedure conducted with adjunct antiseptic irrigation, which could be Taurolidine, TauroPace or Hydrogen Peroxide 3% |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TauroPace | Device | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| CIED infection | cardiac implantable electronic device infection | three months |
| 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 |
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Inclusion Criteria:
CIED procedure, signs PIC
Exclusion Criteria:
PIC not signed, minor
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The intervention group consists of every consecutive patient eligible for any CIED related surgical procedure in the centre of the investigation from January 2020 through February 2022 onwards.
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| Name | Affiliation | Role |
|---|---|---|
| Stefan Borov, MD | Lakumed Landshut, CAU Kiel | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lakumed | Landshut | Bavaria | 84036 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | Borov, S., Baldauf, B., Lau, E.W. et al. Salvage of infected cardiac implantable electronic device with taurolidine-a case report. Cardiothorac Surg 30, 7 (2022). https://doi.org/10.1186/s43057-022-00068-5 | ||
| 35323629 | Background | Giaccardi M, Baldauf B, Lau EW, Borov S, Bonnemeier H. Salvage of Cardiac Implantable Electronic Device Pocket Infection with Skin Erosion in Frail 92-Year-Old. J Cardiovasc Dev Dis. 2022 Mar 10;9(3):81. doi: 10.3390/jcdd9030081. | |
| 35050228 |
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| ID | Term |
|---|---|
| C012566 | taurolidine |
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|
| Hydrogen Peroxide | Device | 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 |
|
| Taurolidine | Drug | 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 |
|
| 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 |
| Background |
| Weichsel J, Baldauf B, Bonnemeier H, Lau EW, Dittrich S, Cesnjevar R. Eradication of Ventricular Assist Device Driveline Infection in Paediatric Patients with Taurolidine. J Cardiovasc Dev Dis. 2022 Jan 10;9(1):18. doi: 10.3390/jcdd9010018. |
| 37831737 | Derived | Borov S, Baldauf B, Henke J, Pavaci H, Perani A, Zrenner B, Dietl J, Mehilli J, Lau EW, Vonthein R, Bonnemeier H. Use of a taurolidine containing antimicrobial wash to reduce cardiac implantable electronic device infection. Europace. 2023 Oct 5;25(10):euad306. doi: 10.1093/europace/euad306. |