Generator Replacement Outcomes with or Without Capsule Debridement

Background:
The number of cardiovascular implantable electronic devices (CIEDs) replacement is continuously increasing. It has been proposed that removal of capsule at the time of CIED replacement could reduce infection rate.

Objective:
The purpose of this study was to assess the effect of pocket capsule removal on infection rate in patients who underwent CIED replacement.

Methods:
We retrospectively reviewed medical records of patients who underwent CIED replacement from 2006 to 2016 in a single center. Patient data, procedure details, and clinical outcome were reviewed. The relationship between capsule removal and CIED infection was assessed using the Cox Proportional hazard model adjusting for multiple variables.

Results:
During the study period, 773 patients underwent device replacement. Of them 194 patients (25%) underwent capsule removal during the procedure. Mean + age of the patients was 72+ 2 years old, 281 (36.3%) females. The CIEDs that were replaced included DDD pacemakers (32%), VDD pacemakers (15%), VVI/AAI pacemakers (13%), defibrillator (22%) and cardiac resynchronization therapy device (17%) CRT-D/ P. During an average follow up 3.6 years, 42 (5.43%) patients had a CIED infection, and 242 patients died or had a CIED infection.

At 3 years of follow up the cumulative CIED infection rate was 3% and 7% in the capsule removal and no capsule removal groups, respectively (p=0.033)

By multivariate analysis, patients who underwent capsule removal experienced a significantly lower risk for CIED infection (Hazard ratio [HR]0.32, 95% confidence interval [CI] 0.12-0.85, p=0.02)). There was no significant difference in the risk for death or CIED infection between the capsule removal and no capsule removal groups (HR=1.13, p=0.3)

Conclusions

Capsule removal during CIED replacement was associated with a significant reduction in CIED infection risk.

Should further studies confirm our findings, capsule removal during CIED replacement may reduce CIED infection rates.