Key result
Antibiotic-eluting envelope linked to ~66% lower 5-year infection risk in CIED surgery.
Why the study?
The study aimed to evaluate the impact of an absorbable antibiotic-eluting envelope on infection-related clinical events in a real-world contemporary patient population undergoing CIED surgery.
Does the use of a TYRX absorbable antibiotic-eluting envelope reduce infection-related events in patients undergoing CIED surgery?
Observational (n=1,819)
Yes
Does the use of a TYRX absorbable antibiotic-eluting envelope reduce infection-related events in patients undergoing CIED surgery?
Hazard Ratio: 0.34 (95% CI 0.14–0.8)
Absolute Event Rate: 2.1% vs 8.1%
Absolute Risk Reduction: 6%
Number Needed to Treat: 17
p-value: p=0.010
In a real-world setting, using an absorbable antibiotic-eluting envelope during CIED surgery significantly reduced long-term risk of systemic and pocket infections, further validating findings from previous randomized trials.
Envelope use was associated with fewer CIED infections; leaves open whether routine adoption is warranted pending further randomized data.
AIMS: 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. The aim is to evaluate the impact of the envelope use on infection-related clinical events in a real-world contemporary patient population. METHODS AND RESULTS: 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. 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 five-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). CONCLUSION: 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.
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Ziacchi et al. (2023) conducted an observational in Patients undergoing cardiac implantable electronic device (CIED) surgery (n=1,819). TYRX absorbable antibiotic-eluting envelope vs. No envelope (Standard CIED surgery) was evaluated on Five-year cumulative incidence of infection-related events (systemic or pocket infections) (HR 0.34, 95% CI 0.14-0.80, p=0.010). The use of an absorbable antibiotic-eluting envelope reduced the five-year cumulative incidence of infection-related events by 66% (HR 0.34) compared to no envelope in patients undergoing CIED surgery.
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