Chlorhexidine gluconate pocket lavage to prevent cardiac implantable electronic device infection in high-risk procedures.

BACKGROUND

Infection is the most dreaded complication of cardiac implantable electronic devices (CIEDs), particularly in patients undergoing high-risk procedures (eg, generator change, device upgrade, lead/pocket revision).

OBJECTIVE

The purpose of this study was to describe the impact of chlorhexidine gluconate (CHG) pocket lavage in high-risk procedures.

METHODS

Patients from a prospective multicenter registry undergoing high-risk procedures were included. CHG lavage was performed by irrigating the generator pocket with 20 cc of 2% CHG without alcohol followed by and normal saline (NS) irrigation. Only NS irrigation was performed in the comparison group. The primary efficacy outcome was CIED-related infection at 12 months. The primary safety outcome was any CHG-associated adverse event. The secondary outcome was CIED infection during long-term follow-up. Propensity score matching (PSM) analysis was performed for the primary efficacy outcome.

RESULTS

A total of 1504 patients were included. At 12-month follow-up, the primary efficacy outcome occurred in 4 of 904 CHG (0.4%) and 14 of 600 NS (2.3%) subjects (log-rank P = .005). On multivariate analysis, the use of CHG irrigation was associated with a lower risk of infection at 1-year follow-up (Cox proportional hazard ratio [HR] 0.138; 95% confidence interval [CI] 0.04-0.45; P = .001). This effect persisted during long-term follow-up. PSM demonstrated a significant reduction in CIED-related infection for the CHG group (0.2% vs 2.5%; Cox proportional HR 0.08; 95% CI 0.01-0.59; P = .014). No adverse events were associated with the use of CHG.

CONCLUSION

CHG lavage during high-risk procedures was associated with a reduction in CIED-related infections without any adverse events reported. The benefits of CHG lavage were observed even during long-term follow up and in PSM analysis.