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4CPS-209 Retrospective monocentric study evaluating the proper use and effectiveness of TYRX absorbable antibacterial envelope in a rhythmology department

ejhpharm · 2026-03-18 · canonical JSON source

19 visible annotations · policy: published · automated confidence ≥ 75.00%

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Background and Importance The TYRX antibacterial envelope is a class III active implantable medical device (IMD). Since September 2020, the National Authority for Health (HAS) has recommended its use to reduce infection risks from cardiac implantable electronic devices in high-risk subjects.Aim and Objectives This study aimed to assess the proper use and efficacy of the envelope in a rhythmology department in current practice.Material and Methods Implantation data and associated medical procedures were extracted from the Medical Information Department’s traceability data between June 2021 and April 2024. The concordance between the indications recorded in the traceability data (CCAM procedures) and those in the electronic patient‘s medical record (ORBIS ) was verified individually. The indications reported in the medical records were classified according to those recommended by the HAS. The efficacy (rate of infection requiring rehospitalisation at one year) of TYRX was assessed using a patient’s subgroup eligible for TYRX over a three-year period by comparing data from two cohorts: those not implanted with TYRX (Cohort A) and those implanted with TYRX (Cohort B).Results A total of 587 patients (=606 TYRX implants) was analysed, after excluding two failed implantations and thirteen devices reported twice. The mean age was 69±16 years, and 64% (n=377) of the patients were male. In 12% (n=72) of cases, the CCAM procedure codes were discordant with the procedure truly performed. The indications were in line with the HAS recommendations in 96.8% (587/606) of cases. When devices were implanted off recommendations use, it corresponded to primary pacemaker implantations. Regarding efficacy, of the subgroup of patients eligible for TYRX (n = 568), one patient among 273 (0.37%) in ‘cohort A’ had an mycosis infection (C. albicans) requiring rehospitalisation at one year. Among the 295 patients in ‘cohort B’, one material-related infection (E. dermatitidis) requiring rehospitalisation at one year was observed (0.34%).Conclusion and Relevance Although there are coding inaccuracies that require staff awareness, the rythmology department’s traceability rate remains high. Most implant indications comply with HAS guidelines. According to the WRAP-IT study, the 1 year infection rate among implanted patients is lower than expected (0.34% vs. 0.70%).Conflict of Interest No conflict of interest