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Efficacy of a Bio‐Absorbable Antibacterial Envelope to Prevent Cardiac Implantable Electronic Device Infections in High‐Risk Subjects
Author(s) -
KOLEK MATTHEW J.,
PATEL NEEL J.,
CLAIR WALTER K.,
WHALEN S. PATRICK,
ROTTMAN JEFFREY N.,
KANAGASUNDRAM ARVINDH,
SHEN SHARON T.,
SAAVEDRA PABLO J.,
ESTRADA JUAN C.,
ABRAHAM ROBERT L.,
ELLIS CHRISTOPHER R.
Publication year - 2015
Publication title -
journal of cardiovascular electrophysiology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.193
H-Index - 138
eISSN - 1540-8167
pISSN - 1045-3873
DOI - 10.1111/jce.12768
Subject(s) - medicine , confidence interval , retrospective cohort study , cohort , propensity score matching , relative risk , cohort study , surgery
Efficacy of Bio‐Absorbable Antibacterial Envelope Introduction Cardiac implantable electronic device (CIED) infections are potentially preventable complications associated with high morbidity, mortality, and cost. A recently developed bio‐absorbable antibacterial envelope (TYRX™‐A) might prevent CIED infections in high‐risk subjects. However, data regarding safety and efficacy have not been published. Methods and Results In a single‐center retrospective cohort study, we compared the prevalence of CIED infections among subjects with ≥2 risk factors treated with the TYRX™‐A envelope (N = 135), the nonabsorbable TYRX™ envelope (N = 353), and controls who did not receive an envelope (N = 636). Infection was ascertained by individual chart review. The mean (95% confidence interval) number of risk factors was 3.08 (2.84–3.32) for TYRX™‐A, 3.20 (3.07–3.34) for TYRX™, and 3.09 (2.99–3.20) for controls, P = 0.3. After a minimum 300 days follow‐up, the prevalence of CIED infection was 0 (0%) for TYRX™‐A, 1 (0.3%) for TYRX™, and 20 (3.1%) for controls (P = 1 for TYRX™‐A vs. TYRX™, P = 0.03 for TYRX™‐A vs. controls, and P = 0.002 for TYRX™ vs. controls). In a propensity score‐matched cohort of 316 recipients of either envelope and 316 controls, the prevalence of infection was 0 (0%) and 9 (2.8%), respectively, P = 0.004. When limited to 122 TYRX™‐A recipients and 122 propensity‐matched controls, the prevalence of CIED infections was 0 (0%) and 5 (4.1%), respectively, P = 0.024. Conclusions Among high‐risk subjects, the TYRX™‐A bio‐absorbable envelope was associated with a very low prevalence of CIED related infections that was comparable to that seen with the nonabsorbable envelope.