Beaumont Hospital Royal Oak, Royal Oak, Michigan.
Duke Clinical Research Institute, Durham, North Carolina.
Catheter Cardiovasc Interv. 2018 Oct 1;92(4):813-817. doi: 10.1002/ccd.27242. Epub 2017 Oct 8.
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.
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).
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.
Impella 2.5 轴流泵经主动脉瓣定位，广泛用于血液动力学支持。本研究比较了 PROTECT II 试验中随机接受 Impella 与主动脉内球囊泵治疗的患者左心瓣膜的结构和功能完整性。
PROTECT II 试验中的 445 例患者在基线、1 个月和 3 个月时进行经胸超声心动图检查。由独立的超声心动图核心实验室对主动脉瓣和二尖瓣的结构和功能以及左心室射血分数（LVEF）进行了系列研究分析。在 Impella 支持期间，基线瓣膜反流程度没有明显变化。使用 Impella 装置后，二尖瓣或主动脉瓣无结构紊乱。90 天随访时，LVEF 从基线平均增加了 22%（27%±9 比 33%±11，P<0.001）。
PROTECT II 研究的本次超声心动图分析证实了先前关于 Impella 2.5 装置在二尖瓣和主动脉瓣功能方面安全性的观察结果。
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