American Heart Association
American Heart Association
December 11, 2019
2 min read

Implantable cardiac device infections affect cost, quality of life, mortality

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Bruce L. Wilkoff
Bruce L. Wilkoff

PHILADELPHIA — In a new analysis from the WRAP-IT trial, patients with cardiac implantable electronic devices, or CIEDs, who had major infections from their devices had higher rates of mortality, higher costs and worse quality of life compared with those who did not.

As Healio previously reported, in the main results of the WRAP-IT trial, patients whose cardiac implantable device was wrapped in a bioabsorbable antibacterial envelope (Tyrx, Medtronic) had lower rates of major infections than those who received standard infection-prevention strategies.

The present prespecified, as-treated analysis, presented at the American Heart Association Scientific Sessions by Cardiology Today Editorial Board Member Bruce L. Wilkoff, MD, FACC, FHRS, FAHA, director of Cardiac Pacing and Tachyarrhythmia Devices and a staff cardiologist in the Robert and Suzanne Tomsich Department of Cardiovascular Medicine, Section of Cardiac Pacemakers and Electrophysiology at Cleveland Clinic and professor of medicine at Cleveland Clinic Lerner College of Medicine at Case Western Reserve University, determined the effect of major infections, regardless of whether they occurred in the interventional or control group, on mortality, cost and quality of life.

“The WRAP-IT trial offers a unique opportunity to evaluate the clinical and economic impact of CIED infection from prospectively collected, longitudinal data,” Wilkoff said during the presentation.

Of 6,903 patients in the as-treated cohort, at 1 year, 67 patients in the overall cohort had 70 major infections and 41 patients in the U.S. cohort had 43 major infections, Wilkoff said, noting that major infection was associated with elevated risk for all-cause mortality at 1 year (adjusted HR = 3.41; 95% CI, 1.81-6.41).

Among those with major infection, the Kaplan-Meier estimates of mortality were 16% at 1 year and 23% at 2 years, he said.

The EuroQOL-5D score, an assessment of quality of life, was reduced at the time of infection diagnosis compared with baseline (adjusted mean difference, 0.09; P = .004) and remained reduced at 1 month (P = .001) and 3 months (P = .02), not normalizing until 6 months (P = .423), he said.

Among those with major infection, disruption in device therapy occurred in 36% of infections, lasting for a mean of 184 days, according to the researchers.

Mean hospital costs were $55,547 per infection (median, $45,206) and mean hospital margins per infection were negative (Medicare, mean –$30,828 and median –$18,664; Medicare Advantage, mean –$6,055 and median $6,392), Wilkoff said.


He said mean payer costs per infection were $26,867 for Medicare fee-for-service (median, $30,562) and $57,928 for Medicare Advantage (median, $54,082).

Mean patient costs per infection were $2,156 for Medicare fee-for-service (median, $1,374) and $1,658 for Medicare Advantage (median, $1,435), Wilkoff said.

“This large, prospective analysis corroborates and extends understanding of the impact of CIED infections as seen in real-world data sets,” Wilkoff said during the presentation. “CIED infections severely impact mortality, quality of life, health care utilization and cost in the U.S. health care system.” – by Erik Swain


Wilkoff BL, et al. Abstract Su3088. Presented at: American Heart Association Scientific Sessions; Nov. 16-18, 2019; Philadelphia.

Disclosures: WRAP-IT was funded by Medtronic. Wilkoff reports he received consultant fees and/or honoraria from Abbott, Medtronic and Philips.