759 Safety Evaluation of the HeartWare MVAD Pump in the Pericardial Position in an Ovine Model

Abstract

Purpose: Clinical studies have shown that renal function is either maintained or significantly improved while supported with a continuous flow left ventricular assist device (CF-LVAD). Due to the lack of strict criteria and risk of acute renal injury after cardiac surgery some centers have been reluctant to offer this option to patients with advanced chronic kidney disease (CKD). We examined the clinical outcomes in patients with stage 3 or 4 CKD implanted with a CF-LVAD. Methods and Materials: All patients (n 138) who were supported 365 days with a CF-LVAD between March 2005 and November 2010 at our institution were retrospectively analyzed. Renal function was assessed using the Modification of Diet in Renal Disease (MDRD) derived glomerular filtration rate (GFR) ml/min/1.73 m. Patients with an average GFR 35 ml/mt on three consecutive days with the last GFR collected on the day of implant were included. Preoperative urinalysis and renal ultrasound were performed. Results: Patients (n 11) were 72% male, 55% white, average age 63 with an average baseline GFR 29.8 ml/mt ( 5.8 ml/mt) while on inotropes medically optimized in a critical care unit. All patients had a history of hypertension; seven (64%) patients were diabetic, 18% had documented protienuria of at least one plus on dipstick and one patient required renal replacement therapy within 6 months prior to LVAD placement for volume overload and metabolic derangements. There was a significant improvement (p .05) in renal function 30 days post-implant with an increase in average GFR (29.8 5.8 ml/mt to 41.3 11.7 ml/mt) and Cr (2.4 .53 to 1.8 .60) which was maintained out to one year. Survival at 365 days was 91% with no patients requiring dialysis. Conclusions: Patients with a GFR 35 supported with a LVAD had significant improvement in their renal function 30 days post implant which was sustained out to one year. In addition the one year survival rate for patients with advanced CKD is superior to recent multicenter results with the HeartMate II for destination therapy.