Neurological Complications in Patients Requiring Durable VAD Systems after ECLS Support. On Behalf of ECLS- Durable MCS Study Group

Purpose Neurological complications are considered as most frequent complications following left ventricular device device (VAD) implantation. The aim of this multicenter study is to investigate neurological complications in patients requiring durable VADs following extra-corporeal life support (ECLS) implantation. Methods Data of eleven high volume ECLS/VAD centers are collected and evaluated to identify patients who underwent durable mechanical circulatory support system implantation after ECLS systems between January 2010 and July 2018. Preoperative parameters and postoperative outcome are analysed. Data of patients who developed postoperative neurological complication will be analysed and compared. A total of 531 patients meets the inclusion criteria. Patients who were supported with pulsatile pumps, CardioWest TAH and DeBakey VADs will be excluded. The outcome of the remaining 501 patients (mean age 53 ±2 yo, 82% male, average ECLS support duration of 7 ± 7 days and average MELD score of 19 ± 8), who were supported with either HeartWare HVAD, HeartMate II or HeartMate III pumps will be analysed. Endpoints The primary endpoint will be freedom from stroke at 30, 180, and 360 days post implant. Association of stroke events with operative strategies (using heart lung machine vs. ECLS for VAD implantation) will be evaluated. Further, factors predicting stroke events in this patient population are analyzed. We hypothesize that postoperative (after VAD Implantation) stroke complications may be higher in this sick patient population on ECLS compared to traditional VAD candidates.