Noninvasive tissue adhesive for cardiac implantable electronic device pocket closure: the TAPE pilot study.

PURPOSE: Device infection is a serious complication of cardiac implantable electronic devices (CIED). Ensuring complete pocket closure can be time consuming, but remains vital to prevent infection. The Zip® Surgical Skin Closure (ZIP) is a noninvasive adhesive device applied to the skin as an alternative to subcuticular sutures for skin closure. We hypothesized that using this device would decrease pocket closure times without increasing the risk of pocket infections. This is a single center, retrospective cohort study to compare pocket closure times and infection rates between ZIP and standard suture for CIED pocket closure.

METHODS

Two separate groups of consecutive new intravenous implants, upgrades, and pulse generator replacements from October 2015 to April 2017 were included. A total of 175 patients were included, using either ZIP (n = 80) or suture (n = 95). Total procedure time (local anesthetic to dressing application) and pocket closure time (fascial suture to dressing application) were compared. Pocket infections were defined as infections leading to CIED extraction or wound dehiscence requiring repeat procedure. Statistical analysis was performed using chi square test and Student's t test.

RESULTS

Pocket closure time and procedure time were significantly shorter for the ZIP group (14.9 ± 6.8 vs 20.1 ± 11.09 min, p = 0.0003) and (65.02 ± 30.4 vs 83.83 ± 40.3 min, p = 0.0008), respectively. No pocket infections occurred in the Zip group, while the suture group had 2:1 wound dehiscence and 1 pocket infection.

CONCLUSION

The ZIP device resulted in significantly shorter pocket closure and procedure times without increasing device pocket infections.