Clinical results with an ePTFE inflow conduit for mechanical circulatory support.

ABSTRACT

BACKGROUND: Neurologic complication is an adverse event associated with mechanical circulatory support. To decrease the incidence of embolic cerebrovascular accidents (CVA) during support with the Novacor left ventricular assist system (LVAS), an expanded polytetrafluoroethylene (ePTFE) inflow conduit has been developed and introduced clinically. METHODS: Using clinical data from Europe and Canada, we conducted a retrospective analysis of the incidence of embolic CVA with the ePTFE inflow conduit (n=88) in comparison with the previously used polyester inflow conduits (n=310, including Vascutek n=155 and Cooley n=155). We calculated freedom from embolic CVA, risk reduction for embolic CVA, and linearized rates of embolic CVA. RESULTS: A significant decrease in the incidence of embolic CVA was demonstrated with the ePTFE conduit (ePTFE 10% vs polyester 23%, p=0.002). Kaplan-Meier analysis of freedom from embolic CVA at 180 days after implantation was 86% for the ePTFE group vs 72% for the polyester group (log-rank test, 0.0185). We also found an associated risk reduction of 55% in CVA occurrence in the ePTFE group when compared with the Polyester group (hazard ratio, 0.445; 95% confidence limit, 0.222-0.890; p=0.0221). Linearized CVA rates also were decreased at all time intervals after implantation in the ePTFE group. CONCLUSIONS: Preliminary clinical results with the newly introduced ePTFE inflow conduit provide compelling evidence that the ePTFE conduit material significantly decreases thromboembolic complications during mechanical circulatory support with the Novacor LVAS.