An Analysis of Driveline Infections with Left Ventricular Assist Devices Utilizing Carbothane versus Pellethane Driveline Sheaths

Purpose Percutaneous driveline infections (DLI) contribute significant morbidity among patients receiving a left ventricular assist device (LVAD). The HeartWare™ HVAD™ System has a thin, flexible, fatigue-resistant driveline, which received FDA approval in mid-2019 to change the outer sheath from a pellethane to a carbothane-based material. Drivelines with carbothane sheaths have a similar outer diameter (4.2 mm) as the pellethane-based drivelines, but have increased flexibility. This enhanced flexibility might allow for improved healing at the skin interface. The DLI infection rate in HVAD Systems with carbothane drivelines in the DT PAS registry will be compared to historical rates from the ENDURANCE Supplemental Trial, which included HVAD Systems with pellethane drivelines. Methods The DT PAS study is the real-world registry of patients receiving the HVAD System as destination therapy in 42 US centers. At the time of presentation, we will have at least 6 months of support data on 184 patients with HVAD implants with a carbothane driveline. Results Descriptive data and rates of driveline infections will be presented, and a comparison with historical data from the HVAD ENDURANCE Supplemental clinical trial will be performed. Baseline parameters of patients currently enrolled in DT PAS includes 71% males with an average age of 58 years, and 16% INTERMACS profile 1. Preliminary data reveals an 8% incidence of driveline infections over a mean time on support of 5 months for all DT PAS patients enrolled (n=212). Data collection and analysis is ongoing. Conclusion This will be the first multicenter clinical evaluation of the driveline infections in HVAD patients receiving the new carbothane drivelines. Final data on driveline infections occurring through 6 months will be available at the time of presentation.