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Maintenance of valvular integrity with I mpella left heart support: Results from the multicenter PROTECT II randomized study
Author(s) -
Goldstein James A.,
Dixon Simon R.,
Douglas Pamela S.,
Ohman E. Magnus,
Moses Jeffrey,
Popma Jeffrey J.,
O'Neill William W.
Publication year - 2018
Publication title -
catheterization and cardiovascular interventions
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.988
H-Index - 116
eISSN - 1522-726X
pISSN - 1522-1946
DOI - 10.1002/ccd.27242
Subject(s) - impella , medicine , ejection fraction , cardiology , aortic valve , hemodynamics , mitral valve , ventricular assist device , heart failure
Background The Impella 2.5 axial flow pump, which is positioned across the aortic valve, is widely employed for hemodynamic support. The present study compared structural and functional integrity of the left heart valves in patients undergoing Impella vs intra‐aortic balloon pump in the randomized PROTECT II trial. Methods and Results Transthoracic echocardiograms were performed at baseline, 1 and 3 months in 445 patients in the PROTECT II trial. Serial studies were analyzed by an independent echocardiography core laboratory for aortic and mitral valve structure and function, and left ventricular ejection fraction (LVEF). During Impella support there was no appreciable change in the degree of baseline valvular regurgitation. There were no cases of structural derangement of the mitral or aortic valve after use of the Impella device. At 90‐day follow‐up, there was an average 22% relative increase in LVEF from baseline (27% ± 9 vs. 33% ± 11, P < 0.001). Conclusions The present echocardiographic analysis of the PROTECT II study confirms prior observations regarding the safety of the Impella 2.5 device with respect to mitral and aortic valve function.