Pre-Op Renal Failure Is Not Associated With Increased Mortality Following LVAD Implantation

pulsation (C-Pulse®) system also has a DL exit site. C-Pulse was involved in a United States (US) Feasibility IDE and ongoing Outside US (OUS) post market studies. To determine if exit site management changes used in the OUS reduced the infection rate as compared to the US study. Secondly, to compare the US and OUS exit site infection rates (ESI) to known LVAD published historical data where inadequate exit site management may have contributed to higher infection rates. Methods: C-Pulse was implanted in the US feasibility IDE study (n= 20, 12 male, age 56.7±7 years) and OUS post market study (n= 12, 9 male, age 59.7±8.8 years). Infection events were collected from implant through 12 months and adjudicated by an independent clinical events committee. Results: ESI for the US and OUS studies were 40% (8/20) and 8.3% (1/12) respectively with MRSA/staph aureus as the most common organism. Reduced ESI in the OUS C-Pulse study are attributed to an improved exit site wound care regimen, stabilization of the DL to promote exit site healing, and strict patient compliance to maintain DL connections. Conclusion: Early results from the C-Pulse OUS study demonstrate that proper exit site DL stabilization and monitoring can effectively reduce the rate of C-Pulse ESI to acceptable levels as compared to the US study experience and known LVAD published historical data. Best practices for C-Pulse DL management have been incorporated into the ongoing US pivotal trial.