High-Output Mechanical Circulatory Support in Left Main Interventions: The Magenta Elevate High-Risk PCI First-in-Human Study.

Background: The Magenta Elevate is a 9-F, self-expanding, catheter-mounted pump delivered sheathed through a commercially available 10-F femoral introducer over the wire to the left ventricle (LV), providing temporary hemodynamic support up to an equivalent of normal cardiac output.

Objectives: The authors sought to assess the feasibility and outcomes of Elevate-supported high-risk percutaneous coronary intervention (HR-PCI) in a first-in-human study and study the hemodynamic impact of high-output support during prolonged interventional left main coronary artery (LM) occlusions.

Methods: In this study, 14 patients underwent Elevate-supported HR-PCI, with 8 patients undergoing 20 prolonged (39 ± 16 seconds) balloon occlusions of an unprotected LM. Systolic and diastolic aortic pressures, mean arterial pressure (MAP), and diastolic aorto-left ventricular pressure difference (dΔP) were determined before and during inflations.

Results: There were no major device-related adverse events (primary safety endpoint) and no mortality at 30 days. During prolonged LM occlusions, the following changes were observed: There was a significant drop in systolic aortic pressure (-35 mm Hg [-46 to -23 mm Hg]; P < 0.0001) accompanied by a significant increase in diastolic pressure (7 mm Hg [4 to 10 mm Hg]; P < 0.0055). MAP, which showed a small decrease (-7 mm Hg [-13 to -2 mm Hg]; P < 0.001) and dΔP (-2 mm Hg [-5 to 4 mm Hg]; P = 0.51) remained in the normal range. Ventriculo-arterial uncoupling occurred in 13 of 20 LM balloon occlusions.

Conclusions: In this first-in-human study, use of the Magenta Elevate low-profile, high-output catheter during HR-PCI was safe and provided substantial cardiac support. During prolonged interventional LM occlusions, the system unloaded the LV, maintaining a normal MAP and dΔP.