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全磁悬浮左心室辅助装置——最终报告
A Fully Magnetically Levitated Left Ventricular Assist Device — Final Report


Mandeep R. Mehra ... 心脑血管疾病 • 2019.04.25

摘要


背景

在本试验的两项期中分析中,与接受机械轴承轴流式左心室辅助装置治疗的晚期心力衰竭患者相比,接受全磁悬浮离心式左心室辅助装置治疗的患者发生泵血栓或非致残性卒中的可能性较低。

 

方法

我们将晚期心力衰竭患者随机分配接受离心泵或轴流泵治疗,不考虑治疗目的(移植前过渡治疗或永久替代治疗)。复合主要终点是在无致残性卒中也未因更换或移除故障装置而再次手术的情况下,患者在2年时存活。关键次要终点是2年时更换泵的情况。

 

结果

此项最终分析包括本试验纳入的1,028例患者:离心泵组516例,轴流泵组512例。在主要终点分析中,离心泵组397例患者(76.9%)与轴流泵组332例患者(64.8%)在2年时仍存活,并且无致残性卒中,也未因更换或移除故障装置而再次手术(相对危险度,0.84;95%置信区间[CI],0.78~0.91;优效性P<0.001)。离心泵组更换泵的情况比轴流泵组少(12例患者[2.3%] vs. 57例患者[11.3%];相对危险度,0.21;95% CI,0.11~0.38;P<0.001)。离心泵组每患者-年的任何严重程度的卒中、大出血和胃肠道出血事件数量均低于轴流泵组。

 

结论

在晚期心力衰竭患者中,与轴流式装置相比,全磁悬浮离心式左心室辅助装置与较低的泵更换率相关,并且在无致残性卒中也未因更换或移除故障装置而再次手术情况下,患者的生存率较优(由雅培公司资助;MOMENTUM 3在ClinicalTrials.gov注册号为NCT02224755)。





作者信息

Mandeep R. Mehra, M.D., Nir Uriel, M.D., Yoshifumi Naka, M.D., Joseph C. Cleveland, Jr., M.D., Melana Yuzefpolskaya, M.D., Christopher T. Salerno, M.D., Mary N. Walsh, M.D., Carmelo A. Milano, M.D., Chetan B. Patel, M.D., Steven W. Hutchins, M.D., John Ransom, M.D., Gregory A. Ewald, M.D., Akinobu Itoh, M.D., Nirav Y. Raval, M.D., Scott C. Silvestry, M.D., Rebecca Cogswell, M.D., Ranjit John, M.D., Arvind Bhimaraj, M.D., Brian A. Bruckner, M.D., Brian D. Lowes, M.D., Ph.D., John Y. Um, M.D., Valluvan Jeevanandam, M.D., Gabriel Sayer, M.D., Abeel A. Mangi, M.D., Ezequiel J. Molina, M.D., Farooq Sheikh, M.D., Keith Aaronson, M.D., Francis D. Pagani, M.D., Ph.D., William G. Cotts, M.D., Antone J. Tatooles, M.D., Ashok Babu, M.D., Don Chomsky, M.D., Jason N. Katz, M.D., Paul B. Tessmann, M.D., Pharm.D., David Dean, M.D., Arun Krishnamoorthy, M.D., Joyce Chuang, Ph.D., Ia Topuria, M.P.H., Poornima Sood, M.D., and Daniel J. Goldstein, M.D. for the MOMENTUM 3 Investigators*
From Brigham and Women’s Hospital Heart and Vascular Center and Harvard Medical School, Boston (M.R.M.); University of Chicago School of Medicine and Medical Center, Chicago (N.U., V.J., G.S.), Advocate Christ Medical Center, Oak Lawn (W.G.C., A.J.T.), and Abbott, Abbott Park (J.C., I.T., P.S.) — all in Illinois; Columbia University College of Physicians and Surgeons and New York–Presbyterian Hospital (Y.N., M.Y.) and Montefiore Einstein Center for Heart and Vascular Care (D.J.G.), New York; University of Colorado School of Medicine, Aurora (J.C.C.); St. Vincent Heart Center, Indianapolis (C.T.S., M.N.W.); Duke University Medical Center, Durham (C.A.M., C.B.P.), and the University of North Carolina, Chapel Hill (J.N.K., P.B.T.) — both in North Carolina; Baptist Health Medical Center, Little Rock, AR (S.W.H., J.R.); Washington University School of Medicine, St. Louis (G.A.E., A.I.); Advent Health Transplant Institute, Orlando, FL (N.Y.R., S.C.S.); University of Minnesota, Minneapolis (R.C., R.J.); Houston Methodist Hospital, Houston (A. Bhimaraj, B.A.B.); University of Nebraska Medical Center, Omaha (B.D.L., J.Y.U.); Yale Medical School, New Haven, CT (A.A.M.); MedStar Washington Hospital Center, Washington, DC (E.J.M., F.S.); University of Michigan, Ann Arbor (K.A., F.D.P.); St. Thomas Hospital, Nashville (A. Babu, D.C.); and Piedmont Hospital, Atlanta (D.D., A.K.). Address reprint requests to Dr. Mehra at the Brigham and Women’s Hospital Heart and Vascular Center, Center for Advanced Heart Disease, 75 Francis St., Boston, MA 02115 or at mmehra@bwh.harvard.edu. *A complete list of the investigators in the MOMENTUM 3 trial is provided in the Supplementary Appendix, available at NEJM.org.

 

参考文献

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