2026 Southeastern Residency Conference

Nguyen Minh Anh Ngo, Amanda Sowder
AdventHealth Orlando
Background: Cardiac implantable electronic devices (CIED) are essential for managing arrythmias and preventing sudden cardiac death thereby improving survival. However, transvenous CIED-related infections are a serious complication, occurring in 2% to 4% of high-risk patients yearly. Device-related infections are associated with increased healthcare costs, morbidity, and mortality. The 2023 American Heart Association Update on CIED Infections recommends cefazolin as a standard preprocedural systemic antibiotic, with vancomycin reserved for select patients, and suggest consideration of an antimicrobial envelope in high-risk patients. The use of a novel absorbable antibiotic envelope, coated with rifampin and minocycline eluted to local tissues over nine weeks, has been shown to reduce infection rates in CIED patients compared to standard care; however, data in high-risk populations remain limited. While the BLISTER study validated the use of a risk stratification tool to identify patients most likely to benefit from the antibiotic envelope with a qualifying score threshold over five, the comparison group used in this study received antibiotics that do not align with current recommendations. Currently, practical use of prophylactic antibiotic regimens varies at physicians’ discretion despite existing guidance. This study aims to describe outcomes of antibiotic envelope use compared to real-world antibiotic prophylaxis regimens in high-risk patients undergoing CIED placement.


Methods: Adult patients undergoing transvenous CIED placement, including first placement, generator exchange, or upgrade, at AdventHealth Orlando between October 1, 2024 and September 30, 2025 were identified using electronic health records report generation. Key exclusion criteria included epicardial pacing lead placement, leadless pacemaker, subcutaneous implantable cardioverter-defibrillators, or temporary pacing systems. High-risk patients were identified using the BLISTER score. The primary outcome was incidence of CIED-related infections at 12 months. Secondary outcomes included incidence of pocket hematoma, infection-related hospitalization, and all-cause mortality at 12 months.


Results: During the interim timeframe (October 1, 2024 – December 26, 2024), 265 patients were screened; 50 high-risk patients were identified based on BLISTER score of 6 or greater. Of these, 24 received the antibiotic envelope and 26 received other antibiotic prophylaxis. Baseline characteristics were well-balanced between groups, with a mean age of 70 years, 70% male, and 60% with history of severe left ventricle dysfunction. The majority of patients underwent cardiac resynchronization therapy-related procedure (86% new implant or generator exchange), followed by pacemakers (8%) and implantable cardioverter-defibrillators (6%). Regarding procedure type, 44% had generator exchanges and median procedure duration was 74 minutes (IQR 42 – 112 minutes). Antibiotic appropriateness, based on institutional standards, was 92% in the envelope group and 85% in the other antibiotics group. CIED-related infection at 12 months for the antibiotic envelope versus other antibiotics group was comparable between groups (4.1% vs 3.8%). Secondary outcomes resulted as follows: pocket hematoma (8.3% vs 3.8%), infection-related hospitalization (8.3% vs 15.3%), and all-cause mortality (20.8% vs 15.3%).


Conclusion: In this interim analysis, CIED-related infection rates were similar between patients receiving antibiotic envelope and those receiving other antibiotic prophylaxis regimens. While infection-related hospitalization showed higher rates in the other antibiotics group, these cases were driven by infectious sources outside of CIED. Additionally, the high all-cause mortality across both groups reflects the baseline risk of this patient population. These preliminary findings highlight the potential for cost savings  supporting  a default strategy of prophylactic antibiotics over antibiotic envelope. Moreover, standardized use of pre-procedural risk stratification tool prior to CIED procedures may allow for individualized approaches. Larger prospective studies are warranted to further define the role of antibiotic envelope use compared to real-world antibiotic strategies in high-risk patients.