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经导管或外科主动脉瓣置换术的5年结局
Five-Year Outcomes of Transcatheter or Surgical Aortic-Valve Replacement


Raj R. Makkar ... 心脑血管疾病 • 2020.02.27
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NEJM 5年随访研究:中危主动脉瓣狭窄TAVR vs. SAVR旗鼓相当还是云泥有别

 

刘洋,杨剑*

空军军医大学西京医院心血管外科

*通讯作者

 

在疗效和安全性相当的前提下,一个主动脉瓣狭窄患者希望做开胸手术更换主动脉瓣,还是愿意选择微创经导管更换?估计绝大多数患者会选择后者。

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摘要


背景

在有中等手术风险的重度主动脉瓣狭窄患者中,目前缺乏比较经导管主动脉瓣置换术(TAVR)和外科主动脉瓣置换术后远期临床结局和生物瓣功能的数据。

 

方法

我们在57个研究中心纳入了2,032例有中等风险的有症状重度主动脉瓣狭窄患者。根据计划的经股动脉或经胸入路对患者进行分层(分别占76.3%和23.7%),并将其随机分配接受TAVR或外科主动脉瓣置换术。我们对临床、超声心动图和健康状况结局随访了5年。主要终点是全因死亡或致残性卒中。

 

结果

5年时,TAVR组和外科手术组的全因死亡或致残性卒中的发生率无显著差异(分别为47.9%和43.4%;风险比,1.09;95%置信区间[CI],0.95~1.25;P=0.21)。经股动脉入路队列的结果与上述结果相似(分别为44.5%和42.0%;风险比,1.02;95% CI,0.87~1.20),但在经胸入路队列中,TAVR组的死亡或致残性卒中的发生率高于外科手术组(59.3% vs. 48.3%;风险比,1.32;95% CI,1.02~1.71)。5年时,TAVR组中至少发生轻度瓣周反流的患者比例超过外科手术组(33.3% vs. 6.3%)。TAVR组中再次住院(33.3% vs. 25.2%)和主动脉瓣再次干预(3.2% vs. 0.8%)的发生率高于外科手术组。5年时,TAVR组和外科手术组患者的健康状况改善程度相似。

 

结论

在有中等手术风险的主动脉瓣狭窄患者中,TAVR后5年时的死亡或致残性卒中发生率与外科主动脉瓣置换术无显著差异(由Edwards Life-sciences资助;PARTNER 2在ClinicalTrials.gov注册号为NCT01314313)。





作者信息

Raj R. Makkar, M.D., Vinod H. Thourani, M.D., Michael J. Mack, M.D., Susheel K. Kodali, M.D., Samir Kapadia, M.D., John G. Webb, M.D., Sung-Han Yoon, M.D., Alfredo Trento, M.D., Lars G. Svensson, M.D., Ph.D., Howard C. Herrmann, M.D., Wilson Y. Szeto, M.D., D. Craig Miller, M.D., Lowell Satler, M.D., David J. Cohen, M.D., Todd M. Dewey, M.D., Vasilis Babaliaros, M.D., Mathew R. Williams, M.D., Dean J. Kereiakes, M.D., Alan Zajarias, M.D., Kevin L. Greason, M.D., Brian K. Whisenant, M.D., Robert W. Hodson, M.D., David L. Brown, M.D., William F. Fearon, M.D., Mark J. Russo, M.D., Philippe Pibarot, D.V.M., Ph.D., Rebecca T. Hahn, M.D., Wael A. Jaber, M.D., Erin Rogers, M.Eng., Ke Xu, Ph.D., Jaime Wheeler, M.B.A., C.Ph.T., Maria C. Alu, M.S., Craig R. Smith, M.D., and Martin B. Leon, M.D. for the PARTNER 2 Investigators*
From Cedars–Sinai Medical Center, Los Angeles (R.R.M., S.-H.Y., A.T.), Stanford University, Stanford (D.C.M., W.F.F.), and Edwards Lifesciences, Irvine (E.R., K.X., J.W.) — all in California; the Department of Cardiovascular Surgery, Piedmont Heart Institute (V.H.T.), and Emory University (V.B.) — both in Atlanta; Baylor Scott and White Healthcare, Plano (M.J.M., D.L.B.), and Medical City Dallas Hospital, Dallas (T.M.D.) — both in Texas; Columbia University Medical Center/New York–Presbyterian Hospital (S.K.K., R.T.H., M.C.A., C.R.S., M.B.L.) and NYU Langone Medical Center (M.R.W.) — both in New York; Cleveland Clinic, Cleveland (S.K., L.G.S., W.A.J.); St. Paul’s Hospital, Vancouver, BC (J.G.W.), and Institut Universitaire de Cardiologie et de Pneumologie de Québec, Université Laval, Quebec, QC (P.P.) — both in Canada; University of Pennsylvania, Philadelphia (H.C.H., W.Y.S.); Medstar Washington Hospital Center, Washington, DC (L.S.); University of Missouri–Kansas City School of Medicine, Kansas City (D.J.C.); Christ Hospital, Cincinnati (D.J.K.); Barnes–Jewish Hospital, Washington University, St. Louis (A.Z.); Mayo Clinic, Rochester, MN (K.L.G.); Intermountain Medical Center, Salt Lake City (B.K.W.); Providence St. Vincent Medical Center, Portland, OR (R.W.H.); and Rutgers–Robert Wood Johnson Medical School, New Brunswick, NJ (M.J.R.). Address reprint requests to Dr. Makkar at Cedars–Sinai Medical Center, 8700 Beverly Blvd., Los Angeles, CA 90048, or at raj.makkar@cshs.org. *A complete list of the PARTNER 2 Investigators is provided in the Supplementary Appendix, available at NEJM.org.

 

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