Background: Infections resulting from cardiac implantable electronic device (CIED) implantation are severely impacting on patients' and on health care systems. The use of TYRXTM absorbable antibiotic-eluting envelope has proven to decrease major CIED infections within 12 months of CIED surgery. Aims: to evaluate the impact of the envelope use on infection-related clinical events in a real-world contemporary patient population. Methods: Data on patients undergoing CIED surgery were collected prospectively by participating centers of the One Hospital ClinicalService project. Patients were divided into two groups according to whether TYRXTM absorbable antibiotic-eluting envelope was used or not. Results: Out of 1819 patients, 872 (47.9%) were implanted with an absorbable antibiotic-eluting envelope and included in the Envelope group and 947 (52.1%) patients who did not receive an envelope were included in the Control group. Compared to control, patients in the Envelope group had higher thrombo-embolic or hemorrhagic risk, higher BMI, lower LVEF and more comorbidities. During a mean follow-up of 1.4 years, the incidence of infection-related events was significantly higher in the control compared to the Envelope group (2.4% vs 0.8%, p = 0.007). The 5-year cumulative incidence of infection-related events was 8.1% in the control and 2.1% in the Envelope group (HR: 0.34, 95%CI: 0.14-0.80, p = 0.010). Conclusions: In our analysis, the use of an absorbable antibiotic-eluting envelope in the general CIED population was associated with a lower risk of systemic and pocket infection.

REducing INFectiOns thRough Cardiac device Envelope: insight from real world data. The REINFORCE Project / Ziacchi, Matteo; Biffi, Mauro; Iacopino, Saverio; di Silvestro, Michele; Marchese, Procolo; Miscio, Francesca; Caccavo, Vincenzo Paolo; Zanotto, Gabriele; Tomasi, Luca; Dello Russo, Antonio; Donazzan, Luca; Boriani, Giuseppe. - In: EUROPACE. - ISSN 1099-5129. - 25:11(2023), pp. N/A-N/A. [10.1093/europace/euad224]

REducing INFectiOns thRough Cardiac device Envelope: insight from real world data. The REINFORCE Project

Marchese, Procolo;Zanotto, Gabriele;Boriani, Giuseppe
2023

Abstract

Background: Infections resulting from cardiac implantable electronic device (CIED) implantation are severely impacting on patients' and on health care systems. The use of TYRXTM absorbable antibiotic-eluting envelope has proven to decrease major CIED infections within 12 months of CIED surgery. Aims: to evaluate the impact of the envelope use on infection-related clinical events in a real-world contemporary patient population. Methods: Data on patients undergoing CIED surgery were collected prospectively by participating centers of the One Hospital ClinicalService project. Patients were divided into two groups according to whether TYRXTM absorbable antibiotic-eluting envelope was used or not. Results: Out of 1819 patients, 872 (47.9%) were implanted with an absorbable antibiotic-eluting envelope and included in the Envelope group and 947 (52.1%) patients who did not receive an envelope were included in the Control group. Compared to control, patients in the Envelope group had higher thrombo-embolic or hemorrhagic risk, higher BMI, lower LVEF and more comorbidities. During a mean follow-up of 1.4 years, the incidence of infection-related events was significantly higher in the control compared to the Envelope group (2.4% vs 0.8%, p = 0.007). The 5-year cumulative incidence of infection-related events was 8.1% in the control and 2.1% in the Envelope group (HR: 0.34, 95%CI: 0.14-0.80, p = 0.010). Conclusions: In our analysis, the use of an absorbable antibiotic-eluting envelope in the general CIED population was associated with a lower risk of systemic and pocket infection.
2023
25
11
N/A
N/A
REducing INFectiOns thRough Cardiac device Envelope: insight from real world data. The REINFORCE Project / Ziacchi, Matteo; Biffi, Mauro; Iacopino, Saverio; di Silvestro, Michele; Marchese, Procolo; Miscio, Francesca; Caccavo, Vincenzo Paolo; Zanotto, Gabriele; Tomasi, Luca; Dello Russo, Antonio; Donazzan, Luca; Boriani, Giuseppe. - In: EUROPACE. - ISSN 1099-5129. - 25:11(2023), pp. N/A-N/A. [10.1093/europace/euad224]
Ziacchi, Matteo; Biffi, Mauro; Iacopino, Saverio; di Silvestro, Michele; Marchese, Procolo; Miscio, Francesca; Caccavo, Vincenzo Paolo; Zanotto, Gabri...espandi
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Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/11380/1322508
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