Retrospective Study
Copyright ©The Author(s) 2022. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Cardiol. Mar 26, 2022; 14(3): 177-186
Published online Mar 26, 2022. doi: 10.4330/wjc.v14.i3.177
Risk profiles and outcomes of patients receiving antibacterial cardiovascular implantable electronic device envelopes: A retrospective analysis
David A Woodard, Grace Kim, Kent R Nilsson
David A Woodard, Kent R Nilsson, Department of Cardiology, Piedmont Heart Institute, Athens, GA 30606, United States
Grace Kim, Kent R Nilsson, Department of Medicine, Augusta University-University of Georgia Medical Partnership, Athens, GA 30606, United States
Author contributions: Woodard D led the conception, design, data collection and analysis, and drafting of the manuscript; Nilsson K and Kim G contributed their expertise to the analysis/interpretation of data and editing of the manuscript; and all authors accept accountability for the accuracy of this work, and drafted, revised, and approved the final version of the manuscript to be published within this journal.
Supported by Aziyo Biologics, Inc.
Institutional review board statement: This study was reviewed and approved by the Ethics Committee of the WIRB-Copernicus Group®.
Informed consent statement: A waiver of informed consent and HIPAA due to the retrospective nature of this study was obtained. This study was conducted in accordance with the ethical principles in the Declaration of Helsinki and conducted according to United States and international standards of Good Clinical Practice in accordance with applicable Federal regulations, International Council for Harmonization guidelines, and institutional research policies and procedures.
Conflict-of-interest statement: Woodard D is a consultant for Aziyo Biologics, Inc. The other authors have no relevant financial relationships to disclose.
Data sharing statement: The dataset supporting the conclusions of this article is available upon reasonable request to the corresponding author.
Open-Access: This article is an open-access article that was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution NonCommercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: https://creativecommons.org/Licenses/by-nc/4.0/
Corresponding author: David A Woodard, MD, Doctor, Department of Cardiology, Piedmont Heart Institute, Piedmont Athens Regional Medical Center 242 King Ave Suite 210, Athens, GA 30606, United States. davidwoodard92464@gmail.com
Received: December 17, 2021
Peer-review started: December 17, 2021
First decision: January 25, 2022
Revised: February 8, 2022
Accepted: March 3, 2022
Article in press: March 3, 2022
Published online: March 26, 2022
Processing time: 94 Days and 10.6 Hours
ARTICLE HIGHLIGHTS
Research background

An increase in cardiac implantable electronic device (CIED) implantation has led to an increase in observed complication rates, including infection. Antibacterial CIED envelopes have been shown to reduce the risk of infection complications, even in high-risk patient groups. There are currently two different CIED envelopes in clinical use which differ in the material from which they are made.

Research motivation

There is a paucity of data describing real-world physician practice patterns when using antibacterial CIED envelopes. Understanding clinical rationale and outcomes from the use of this prophylactic therapy could improve future patient outcomes.

Research objectives

Patient risk profiles and outcomes were compared from patients undergoing CIED procedures receiving either no envelope, or one of two antibacterial envelopes.

Research methods

In this retrospective analysis, the records of consecutive CIED procedure patients were reviewed at one center through a follow-up time of 12 mo.

Research results

Patients who were selected to receive an antibacterial CIED envelope were at significantly higher risk for infection than patients who did not receive an envelope (81.2% vs 49.1%, P < 0.001). Among the infection risks, envelope patients were undergoing more reoperative procedures (47.1% vs 0.0%, P < 0.001) and received more high-powered devices (37.2% vs 5.8%, P = 0.004) than patients who received no envelope. There was a propensity for the physician choosing a biologic envelope in patients who were higher risk than non-biologic patients (84.3% vs 78.4%), and those that were undergoing reoperative procedures (62.9% vs 33.3%). The rate of pocket infection was low (any envelope 0.5% vs no envelope 0.0%), with no significant difference between the two envelope groups.

Research conclusions

There is an apparent benefit for using antibacterial envelopes in patients who are at higher risk of implant site infection. When using antibacterial envelopes, there was no significant difference in infection rate for biologic and non-biologic envelopes.

Research perspectives

Future studies should further explore patient and procedural factors that play a role in antibacterial envelope usage for specific patient types to further improve patient outcomes.