Key result
The TYRX antibacterial-eluting envelope reduced major CIED-related infections compared to control (1.3% vs 1.9%; HR 0.64; 95% CI 0.41-0.99; P=0.046) without increasing complications.
Why the study?
Longer-term (>12 months) effects of an antibacterial-eluting envelope on CIED infection reduction and complications remained to be described following initial 12-month trial findings.
Does an antibacterial-eluting envelope reduce major CIED-related infections in patients undergoing CIED replacement, upgrade, revision, or initial CRT-D implantation?
RCT (n=6,800)
1:1
Yes
Does an antibacterial-eluting envelope reduce major CIED-related infections in patients undergoing CIED replacement, upgrade, revision, or initial CRT-D implantation?
Hazard Ratio: 0.64 (95% CI 0.41–0.99)
Absolute Event Rate: 1.3% vs 1.9%
p-value: p=.046
The use of an antibacterial-eluting envelope during CIED procedures provides a sustained reduction in major infections over long-term follow-up without increasing complications.
Envelope sustains CIED infection reduction beyond 12 months without added complications; extends primary trial efficacy to longer-term follow-up.
BACKGROUND: The World-wide Randomized Antibiotic Envelope Infection Prevention trial reported a 40% reduction in major cardiac implantable electronic device (CIED) infections within 12 months of the procedure with the use of an antibacterial-eluting envelope (TYRX Absorbable Antibacterial Envelope, Medtronic, Mounds View, MN). OBJECTIVE: The purpose of this report was to describe the longer-term (>12 months) envelope effects on infection reduction and complications. METHODS: All trial patients who underwent CIED replacement, upgrade, revision, or initial cardiac resynchronization therapy - defibrillator implantation received standard-of-care infection prophylaxis and were randomized in a 1:1 ratio to receive the envelope or not. CIED infection incidence and procedure and system-related complications were characterized through all follow-up (36 months) by using Cox proportional hazards regression modeling. RESULTS: In total, 6800 patients received their intended randomized treatment (3371 envelope; 3429 control; mean follow-up period 21.0 ± 8.3 months). Major CIED-related infections occurred in 32 envelope patients and 51 control patients (Kaplan-Meier [KM] estimate 1.3% vs 1.9%; hazard ratio [HR] 0.64; 95% confidence interval [CI] 0.41-0.99; P = .046). Any CIED-related infection occurred in 57 envelope patients and 84 control patients (KM estimate 2.1% vs 2.8%; HR 0.69; 95% CI 0.49-0.97; P = .030). System- or procedure-related complications occurred in 235 envelope patients and 252 control patients (KM estimate 8.0% vs 8.2%; HR 0.95; 95% CI 0.79-1.13; P < .001 for noninferiority); the most common were lead dislodgment (1.1%), device lead damage (0.5%), and implant site hematoma (0.4%). Implant site pain occurred less frequently in the envelope group (0.1% vs 0.4%; P = .067). There were no (0.0%) reports of allergic reactions to the components of the envelope (mesh, polymer, or antibiotics). CONCLUSION: The effects of the TYRX envelope on the reduction of the risk of CIED infection are sustained beyond the first year postprocedure, without an increased risk of complications.
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Mittal et al. (2020) conducted an RCT in Cardiac implantable electronic device (CIED) replacement, upgrade, revision, or initial CRT-D implantation (n=6,800). TYRX Absorbable Antibacterial Envelope vs. Standard-of-care infection prophylaxis was evaluated on Major CIED-related infections (HR 0.64, 95% CI 0.41-0.99, p=.046). The TYRX antibacterial-eluting envelope reduced major CIED-related infections compared to control (1.3% vs 1.9%; HR 0.64; 95% CI 0.41-0.99; P=0.046) without increasing complications.
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