Haemodynamic significance of extrinsic outflow graft stenoses during HeartMate 3™ therapy.

Abstract

Aims: The HeartMate 3 (HM3) implantable left ventricular assist device connects the left ventricle apex to the aorta via an outflow graft. Extrinsic obstruction of the graft (eOGO) is associated with serious morbidity and mortality and recently led to a Food and Drug Administration Class 1 device recall of HM3. This study aimed to provide a better understanding of the haemodynamic impact of extrinsic stenoses.

Methods and results: Computed tomography (CT) images of two retrospectively identified patients with eOGO (29 and 36% decrease in cross-sectional area, respectively, by radiological evaluation) were acquired with a novel photon-counting CT system. Numerical evaluations of haemodynamics were conducted using a high-fidelity 3D computational fluid dynamics approach on both the patient-specific graft geometries and in two virtually augmented stenotic severities and three device flows. Visual analysis identified increased velocity, pressure, and turbulent flow in the outer anterior curvature of the outflow graft; however, changes in graft pressure gradients were slight (1-9 mmHg) across the range of stenosis severities and flow rates tested.

Conclusion: Evidence of eOGO during HM3 support and the recent device recall can provoke clinical apprehension and interventions. The haemodynamic impact of a stenosis detected visually or by quantification of cross-sectional area reduction may be difficult to predict and easily overestimated. This numerical study suggests that, for clinically encountered flow rates and stenosis severities below 61% in cross-sectional area decrease, eOGO may have low haemodynamic impact. This suggests that patients without symptoms or signs consistent with haemodynamically significant obstruction might be managed expectantly.