Reduction of INCOR® driveline infection rate with silicone at the driveline exit site

A silicone interface at skin level of left ventricular assist device (LVAD) may reduce the risk of driveline (DL) exit site infections when compared with other materials (e.g. velour). The purpose of this study was to evaluate the rate of DL exit site infection according to the presence of silicone or velour at the exit site with the redesigned INCOR, facilitating the positioning of silicone at the exit site.

The rate of DL exit site infection and overall survival were compared between the two groups (silicone group, n = 16/velour group, n = 24) with 1-year follow-up postimplantation.

Risk factors for infection were more prevalent in the silicone group (obesity P = 0.33, prevalence of renal dysfunction P = 0.007, higher CRP levels P = 0.001). During the observation period, 6 patients developed a DL infection (25%) in the velour group, whereas 1 patient developed a DL infection in (6%) in the silicone group (P = 0.19). The event-per-patient year (EPPY) rates were 0.34 and 0.10 for velour group and silicone group, respectively (P = 0.30). All DL infections could be treated successfully by the antibiotic treatment, surgical debridement and ultimately high urgency heart transplantation, resulting in no direct DL infection-related mortality in this cohort. One-year survival was similar in both the groups (silicone 69 vs 75% in the velour group; P = 0.67).

Fewer infections were observed at the exit site in case of a silicone-covered DL, without reaching statistical significance. More patients and longer observation periods are needed to demonstrate a statistical difference.