Results of the Registry To EValuate the HeartWare Left Ventricular Assist System (The REVOLVE Registry)

Purpose The REVOLVE Registry is an investigator-initiated registry established to collect data on the commercial use of the HeartWare® HVAD System in the European Union and Australia. Methods and Materials REVOLVE is a multi-center, prospective, single arm registry. Each patient is followed to device explant, transplantation or death. Data from the first 242 commercial implants performed between February of 2009 and March 2012 from six centers in Europe (4) and Australia (2) is presented. Final data on the total dataset will be available at the time of presentation. Patients receiving the HeartWare System for both labeled and off-label indications were included. Summary statistics are used to describe patient demographics, adverse events, length of support and outcomes. Results When compared to the clinical trial supporting CE Mark of the HVAD Pump, changes in patient selection (older mean age, patients younger than 18 year old and more females), as well as an increase in idiopathic cardiomyopathies are evident in the REVOLVE patients. Implants were performed mostly via sternotomy (96%), and thoracotomy in 4%. Implant was for LVAD support in 91% of cases, biventricular support in 7%, and as right ventricular support in Conclusions Real world use of the HVAD Pump continues to support the excellent outcomes on the device. Complication EPPY (222 years of support) Any INTERMACS Bleeding 0.27 Right Heart Failure 0.16 Stroke 0.09 Driveline Infection 0.08 Sepsis 0.05 Renal Failure 0.03 Pump Thrombus - Overall 0.06 Medically Treated Pump Thrombus 0.02 Pump Thrombus Treated with Exchange 0.04 EPPY=events per patient year.