AHA 2019: WRAP-IT shows significant mortality risk with CIED infection and reduced quality of life

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Bruce Wilkoff

Major infection in patients with cardiac implantable electronic devices (CIED) is associated with a threefold risk of mortality at one year, and impaired quality of life through six months, according to data presented by Bruce Wilkoff (Cleveland Clinic, Cleveland, USA) at the American Heart Association Scientific Sessions (AHA 2019; 16–18 November; Philadelphia, USA).

Wilkoff outlined findings from a prespecified, as-treated analysis of WRAP-IT (World-wide randomised antibiotic envelope infection prevention trial), which assessed the clinical and economic impact of the Tyrx (Medtronic) absorbable antibacterial envelope in reducing CIED infections. The present analysis evaluated clinical outcomes related to major CIED infections within 12 months of index procedure.

Previously, a patient’s risk of dying following a CIED infection was recognised to be approximately 50% at three years. Data from WRAP-IT, a multicentre, randomised, prospective, single-blinded trial comparing standard-of-care antibiotic prophylaxis with the adjunctive use of Tyrx, were presented earlier this year at ACC 2019 and EHRA 2019, and published in The New England Journal of Medicine. It found that the Tyrx absorbable antibacterial envelope reduced major infections by 40% in patients at increased risk for infections resulting from CIED implantation.

In the prespecified analysis, major infection was defined as that resulting in CIED system removal, an invasive CIED procedure, treatment with long-term suppressive antibiotic therapy with infection recurrence after discontinuation of antibiotic therapy, or resulting in death. In addition, mortality, quality of life (QOL), disruption in CIED therapy, and healthcare utilisation (HCU) were assessed.

Infections were stratified into two cohorts—a cohort with major infections inclusive of all infections at all sites, and a US cohort with major infections that occurred only at US sites.

Investigators found that, of the 6,903 patients in the as-treated cohort, there were 70 infections among 67 patients in the cohort with major infections, and 43 infections among 41 patients in the US cohort with major infections. Major CIED infection was associated with increased all-cause mortality (12-month risk-adjusted hazard ratio [HR] 3.41, p<0.001). Among patients in the cohort with major infections, Kaplan-Meier estimates of mortality after major infection onset were 16% at 12 months and 23% at 24 months.

In terms of the impact of infections on quality of life, Wilkoff told delegates, linear mixed-effects modelling demonstrated that EQ-5D utilities were significantly reduced at the time that infection was diagnosed in comparison to baseline (adjusted mean difference 0.09, p=0.004), and did not normalise until six months post-diagnosis. In addition, disruptions in CIED therapy were experienced in 36% of infections for a mean duration of 184 days.

The analysis also concluded that the US hospital costs of treating an infection in CIED patients averages about US$56,000, and revealed that patients pay an average of US$2,000 in out-of-pocket costs.

Concluding, Wilkoff said: “This large, prospective analysis corroborates and extends understanding of the impact of CIED infections as seen in real-world datasets. CIED infections severely impact mortality, quality of life, heakthcare utilisation, and cost in the US healthcare system.”

The European Heart Rhythm Association (EHRA) recently published a consensus statement outlining recommendations on preventing, diagnosing and treating CIED infections. The statement recommends use of the TYRX Envelope for patients meeting the WRAP-IT criteria and/or other high-risk factors, and is endorsed by six other prestigious medical societies.


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