Antibacterial Envelope Prevents Cardiac Implantable Electronic Device Infections: The Largest Asia Real World Data.

Background: , Medtronic, Minneapolis, US) has been reported to reduce the risk of CIED infection without increasing the risk of additional complications. To investigate the real-world efficacy in Taiwanese patients, we retrospectively reviewed the outcomes of CIED patients with and without the use of an envelope. Methods: A total 456 patients underwent CIED procedure from January 2022 to June 2023, including initial implantation, generator replacement, upgrade, or revision. There were 154 patients in the envelope group and 302 patients in the control group, all of whom received our standard infection prophylaxis care. Patient demographics and CIED complications during serial clinical follow-ups were analyzed. Results: Both groups demonstrated comparable characteristics including age, sex, body mass index, CIED type, and left ventricular ejection fraction. More of the envelope group were receiving dialysis (Envelope vs. Control: 13.6% vs. 7.0%, p = 0.015), anticoagulant therapy (Envelope vs. Control: 35.7% vs. 27.5%, p = 0.048), and had a longer procedure time (Envelope vs. Control: 83.4 ± 40.3 vs. 70.4 ± 31.7 minutes, p = 0.0002). CIED-related infections occurred in none of the envelope patients and 4 of the control patients (0% vs. 1.3%, p = 0.19; Kaplan-Meier estimate 0% vs. 2.02%, hazard ratio: 0.24, 95% confidence interval: 0.03-2.03, p = 0.19). Two patients reported allergic reactions to the envelope. Conclusions: The envelope group had a higher risk of CIED infections but similar infection rate , compared with the control group. However, the envelope group had a slightly longer procedure time and possibly an increased risk of allergic reaction.