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Efficacy of the antibacterial envelope to prevent cardiac implantable electronic device infection in a high-risk population

Chaudhry, Uzma LU ; Borgquist, Rasmus LU orcid ; Smith, J Gustav LU and Mörtsell, David LU orcid (2022) In Europace 24(12). p.1973-1980
Abstract
Aims

Infection is a serious complication of cardiac implantable electronic device (CIED) therapy. An antibiotic-eluting absorbable envelope has been developed to reduce the infection rate, but studies investigating the efficacy and a reasonable number needed to treat in high-risk populations for infections are limited.
Methods and results

One hundred and forty-four patients undergoing CIED implantation who received the antibacterial envelope were compared with a matched cohort of 382 CIED patients from our institution. The primary outcome was the occurrence of local infection, and secondary outcomes were any CIED-related local or systemic infections, including endocarditis, and all-cause mortality. The results were... (More)
Aims

Infection is a serious complication of cardiac implantable electronic device (CIED) therapy. An antibiotic-eluting absorbable envelope has been developed to reduce the infection rate, but studies investigating the efficacy and a reasonable number needed to treat in high-risk populations for infections are limited.
Methods and results

One hundred and forty-four patients undergoing CIED implantation who received the antibacterial envelope were compared with a matched cohort of 382 CIED patients from our institution. The primary outcome was the occurrence of local infection, and secondary outcomes were any CIED-related local or systemic infections, including endocarditis, and all-cause mortality. The results were stratified by a risk score for CIED infection, PADIT. The envelope group had a higher PADIT score, 5.9 ± 3.1 vs. 3.9 ± 3.0 (P < 0.0001). For the primary endpoint, no local infections occurred in the envelope group, compared with 2.6% in the control group (P = 0.04), with a more pronounced difference in the stratum with a high (>7 points) PADIT score, 0 vs. 9.9% (P = 0.01). The total CIED-related infections were similar between groups, 6.3% compared with 5.0% (P = 0.567). Mortality after 1600 days of follow-up did not differ between groups, 22.9 vs. 26.4%, P = 0.475.
Conclusion

Our study confirms the clinical efficacy of an antibacterial envelope in the prevention of local CIED infection in patients with a higher risk according to the PADIT score. In an effort to improve cost–benefit ratios, ration of use guided by the PADIT score is advocated. Further prospective randomized studies in high-risk populations are called for. (Less)
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author
; ; and
organization
publishing date
type
Contribution to journal
publication status
published
subject
keywords
Cardiac implantable electronic device, Infection, An antibiotic-eluting absorbable envelope, TYRX, Health economy
in
Europace
volume
24
issue
12
pages
1973 - 1980
publisher
Oxford University Press
external identifiers
  • pmid:35989511
  • scopus:85143916911
ISSN
1532-2092
DOI
10.1093/europace/euac119
project
TYRX i en högrisk population
language
English
LU publication?
yes
id
2bde0441-5b85-40bd-b73d-9354e3cdf9ed
date added to LUP
2022-08-23 08:01:53
date last changed
2023-03-30 04:11:45
@article{2bde0441-5b85-40bd-b73d-9354e3cdf9ed,
  abstract     = {{Aims<br/><br/>Infection is a serious complication of cardiac implantable electronic device (CIED) therapy. An antibiotic-eluting absorbable envelope has been developed to reduce the infection rate, but studies investigating the efficacy and a reasonable number needed to treat in high-risk populations for infections are limited.<br/>Methods and results<br/><br/>One hundred and forty-four patients undergoing CIED implantation who received the antibacterial envelope were compared with a matched cohort of 382 CIED patients from our institution. The primary outcome was the occurrence of local infection, and secondary outcomes were any CIED-related local or systemic infections, including endocarditis, and all-cause mortality. The results were stratified by a risk score for CIED infection, PADIT. The envelope group had a higher PADIT score, 5.9 ± 3.1 vs. 3.9 ± 3.0 (P &lt; 0.0001). For the primary endpoint, no local infections occurred in the envelope group, compared with 2.6% in the control group (P = 0.04), with a more pronounced difference in the stratum with a high (&gt;7 points) PADIT score, 0 vs. 9.9% (P = 0.01). The total CIED-related infections were similar between groups, 6.3% compared with 5.0% (P = 0.567). Mortality after 1600 days of follow-up did not differ between groups, 22.9 vs. 26.4%, P = 0.475.<br/>Conclusion<br/><br/>Our study confirms the clinical efficacy of an antibacterial envelope in the prevention of local CIED infection in patients with a higher risk according to the PADIT score. In an effort to improve cost–benefit ratios, ration of use guided by the PADIT score is advocated. Further prospective randomized studies in high-risk populations are called for.}},
  author       = {{Chaudhry, Uzma and Borgquist, Rasmus and Smith, J Gustav and Mörtsell, David}},
  issn         = {{1532-2092}},
  keywords     = {{Cardiac implantable electronic device; Infection; An antibiotic-eluting absorbable envelope; TYRX; Health economy}},
  language     = {{eng}},
  month        = {{08}},
  number       = {{12}},
  pages        = {{1973--1980}},
  publisher    = {{Oxford University Press}},
  series       = {{Europace}},
  title        = {{Efficacy of the antibacterial envelope to prevent cardiac implantable electronic device infection in a high-risk population}},
  url          = {{http://dx.doi.org/10.1093/europace/euac119}},
  doi          = {{10.1093/europace/euac119}},
  volume       = {{24}},
  year         = {{2022}},
}