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Yesterday, Professor Bruce Wilkoff (Cleveland Clinic, Cleveland, Ohio, USA) presented eagerly awaited findings from the late-breaking trial, WRAP-IT.
“Infection is a significant contributor of morbidity and mortality in those receiving cardiac implantable electronic devices (CIED),” he said. “WRAP-IT was designed as the largest randomised global clinical study in CIED trial history. We wanted to establish the true overall rate of CIED infection and to fill some knowledge gaps in our understanding of the pathophysiology and risk factors for CIED infection. We also wanted to evaluate whether using an absorbable antibiotic-eluting envelope would help to reduce major CIED infections. The TYRX envelope is made from an absorbable multifilament knitted mesh and is coated with a polyarylate polymer that acts as a carrier for two antimicrobial agents, rifampicin and minocycline.1 The antimicrobial agents are released over 7 days or longer, and after around 9 weeks, the envelope is completely absorbed. Low infection rates were seen in observational evaluations of the first- generation TYRX non-absorbable antibacterial envelopes, but we didn’t know the effectiveness of fully absorbable envelopes, especially with randomised therapy.”
Conducted in 181 centres in 25 countries, 6,983 patients who were undergoing CIED generator replacement, upgrade, revision or de novo cardiac resynchronisation therapy-defibrillator (CRT-D) implant were randomised to receive the TYRX envelope or not. The primary endpoint was major CIED infection, efined as CIED infection resulting in system extraction or revision, long-term suppressive antibiotic therapy or death, within 12 months of the procedure. Average follow-up was 20.7 months and around 90% of patients completed 12 months of follow-up.
Prof. Wilkoff described the main results: “Major CIED infections occurred in 1.2% of patients in the control arm at 12 months, but with the TYRX envelope, there was a significant 40% reduction to 0.7% (p=0.041). At the same time, there was a 61% reduction in pocket infections at 12 months, with a rate of 0.4% in the TYRX envelope arm and 1.0% in the control arm. There was no difference in the risk of CIED procedure-related or system- related complications between the TYRX envelope and control groups at 12 months (6.0% and 6.9%, respectively). When we followed the patients for 36 months, there was a 37% reduction in major CIED infections with the TYRX envelope compared with the control group.”
Prof. Wilkoff summarised the findings by saying, “Infections remain a leading CIED procedure-related complication that is associated with high morbidity, mortality and cost. In WRAP-IT, the TYRX envelope achieved the primary objective and we saw a significant reduction in major infections without an increase in the risk of complications over 12 months. These findings provide strong evidence for the use of the TYRX envelope to reduce infections after CIED generator replacement, upgrade, revision or de novo CRT-D implant.”
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