Impact of Device Insertion Technique on Impella CP Position and Orientation Within the Left Ventricle

BACKGROUND: Impella CP malrotation diminishes the unloading effect of the device. There is a paucity of data informing on the insertion procedural factors associated with malrotation. OBJECTIVES: The aim of the study was to analyze the impact of each device insertion step on the final orientation of the Impella CP within the left ventricle using an ex vivo simulator. METHODS: Two expert operators ran a prespecified set of Impella CP insertion procedures (n = 96) across different anatomical silicon models printed from electrocardiogram-gated computed tomography scans obtained during Impella support (n = 6). One operator ran Impella CP insertion blinded to the simulator, while the other assessed the position and orientation of the device in real time under direct visualization and was considered the gold standard. The operators then swapped their roles. RESULTS: All 96 preplanned insertions were successfully carried out. Impella malrotation rate was 45.8%. The lowest rate of malrotation was found when the device was inserted in the femoral sheath with its convex elbow at 9 o'clock (16.7%; P = 0.008). At the end of insertion procedure, a "deep" position was observed more frequently in optimally oriented cases (98.1% vs 70.5%; P < 0.001). Finally, a pull-back maneuver to bring the radiopaque marker at the level of the aortic valve, as recommended, led to malrotation in 99.0%. CONCLUSIONS: In this preclinical study malrotation occurred in 45.8%, with no interaction with operator or anatomical model. Pump orientation in the introducer sheath and insertion depth in the left ventricle were associated with malrotation outcome. This experiment identified actionable targets to prevent Impella CP malrotation that warrant validation in clinical studies.