Evaluation of clinically relevant operating conditions for left ventricular assist device investigations

Abstract

Standardized boundary conditions for flow rate and pressure difference are currently not available for the development and certification process of ventricular assist devices. Thus, interdisciplinary studies lack comparability and quantitative assessment. Universally valid boundary conditions could be used for the application of numerical and experimental investigations and the approval procedure of ventricular assist devices. In order to define such boundaries, physiological data from INCOR® patients were evaluated. A total of 599 out of possible 627 ventricular assist device patients were analyzed regarding their cardiac demands of flow rate and pressure head. An analysis of long-term data was performed, in order to provide respective, static mean values for benchmark testing. Furthermore, the short-term data of 188 patients delivered field data-based dynamic flow and pressure curves. The results of the study revealed physiologically reasonable boundary conditions, which can be applied in numerical or experimental investigations of ventricular assist devices. For steady flow analysis, single values for flow rate (4.46 L/min) and pressure head (62 mmHg) are suggested. For the support of pulsatile and unsteady flow studies, seven typical patients and one representative dynamic curve for flow rate and pressure head are proposed. The standardized results provided in this article, can be used in favor of interdisciplinary comparability of future numerical computations or in vitro ventricular assist device tests in research, development, and approval.