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Europace ; 25(10)2023 10 05.
Artículo en Inglés | MEDLINE | ID: mdl-37831737

RESUMEN

AIMS: TauroPace (Tauropharm, Bavaria Germany), a taurolidine solution for combating cardiac implantable electronic device (CIED) infection, was compared with a historical control of 3% hydrogen peroxide (H2O2) in a prospective observational study. METHODS AND RESULTS: The device pocket was irrigated, and all hardware accessible within (leads, suture sleeves, pulse generator) was wiped with H2O2, TauroPace, or taurolidine in a galenic formulation during any invasive CIED procedure at the study centre. Only CIED procedures covered by TauroPace or H2O2 from 1 January 2017 to 28 February 2022 were included for analysis. Patients who underwent >1 procedure were censored for the last treatment group and reassigned at the next procedure. The primary endpoint was major CIED infection within 3 months. The secondary endpoints were CIED infection beyond 3 months, adverse events potentially related to the antimicrobial solutions, CIED system, procedure, and death, till the end of follow-up. TauroPace covered 654 procedures on 631 patients, and H2O2 covered 551 procedures on 532 patients. The TauroPace group had more patient risk factors for infection than the H2O2 group (P = 0.0058) but similar device and procedure-specific risk factors (P = 0.17). Cardiac implantable electronic device infection occurred in 0/654 (0%) of the TauroPace group and 6/551 (1.1%) of the H2O2 group (P = 0.0075). Death occurred in 23/654 (3.5%) of the TauroPace group and 14/551 (2.5%) of the H2O2 group (P = 0.33). Non-infection related adverse events were rarer in the TauroPace (3.8%) than the H2O2 (6.0%) group (P = 0.0802). CONCLUSION: TauroPace is safe but more effective than H2O2 in reducing CIED infection. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT05576194.


Asunto(s)
Antiinfecciosos , Desfibriladores Implantables , Cardiopatías , Marcapaso Artificial , Infecciones Relacionadas con Prótesis , Humanos , Antiinfecciosos/efectos adversos , Desfibriladores Implantables/efectos adversos , Cardiopatías/etiología , Peróxido de Hidrógeno/efectos adversos , Marcapaso Artificial/efectos adversos , Infecciones Relacionadas con Prótesis/diagnóstico , Infecciones Relacionadas con Prótesis/prevención & control , Infecciones Relacionadas con Prótesis/etiología , Estudios Prospectivos
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