Long-term results of a cardiovascular implantable electronic device wrapped with an expanded polytetrafluoroethylene sheet.

The use of an expanded polytetrafluoroethylene (ePTFE) sheet wrapping device for patients with pacemaker contact dermatitis is still controversial. This study aimed to retrospectively investigate the occurrence rate of allergies and other complications after implantation of a cardiovascular implantable electronic device (CIED) wrapped with an ePTFE sheet. A total of 4,497 procedures of CIED implantation were performed at our institution between January 1993 and April 2010. Among 19 patients who underwent implantation of an electronic cardiac device wrapped with an ePTFE sheet, device implantation was performed in 11 patients for secondary prevention of device contact sensitivity, in 7 patients for primary prevention of device contact sensitivity, and in 1 patient for avoiding over-sensing of myopotentials. During follow-up periods (mean 46 ± 34 months), there were no allergic or inflammatory reactions to components of the device or ePTFE itself. Among 11 patients with a device wrapped with an ePTFE sheet for secondary prevention, 5 patients completed device replacement due to battery depletion and 3 patients had infections from the device. Wrapping implantable devices with an ePTFE sheet is an effective way of preventing device sensitivity in patients who require CIED therapy. However, the risk of infection from the device should be taken into consideration.