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 (dΔPAoLV) 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 dΔPAoLV (-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 dΔPAoLV.