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外科或经导管主动脉瓣置换术治疗中危患者
Surgical or Transcatheter Aortic-Valve Replacement in Intermediate-Risk Patients


Michael J. Reardon ... 心脑血管疾病 • 2017.04.06
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中危患者行经导管主动脉瓣置换术(TAVR)的中期评估及思考

 

何国伟

中国医学科学院,北京协和医学院,泰达国际心血管病医院(天津)心血管外科

 

经导管主动脉瓣置换术(TAVR)的主要指征是严重主动脉瓣狭窄而不适合外科手术者(即高危患者),其效果优于保守治疗1,2。由于TAVR在高危患者中的成功,心血管界也逐渐开始了在非高危患者中的探索。但对于这些外科手术危险较低的患者,关于TAVR是否可与成熟的外科手术相比的研究至今仍然较少。以往的随机研究报告在这些非高危患者中,术后2年的效果不低于外科换瓣手术3;然而,TAVR的主动脉瓣残余瘘及起搏器的使用率高于外科手术2。相反,外科手术的卒中率、房颤发生率、急性肾功能衰竭以及输血量均高于TAVR2。因此,对TAVR及外科手术在非高危(主要是中危)患者中进行前瞻性随机研究是非常必要的。本文的研究目的即在于此。

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摘要


背景

尽管对于患重度主动脉瓣狭窄的外科手术高危患者而言,经导管主动脉瓣置换术(TAVR)可以作为外科手术的替代疗法,但是在外科手术中危的主动脉瓣狭窄患者中,对于结局的比较情况了解较少。

 

方法

在比较TAVR(使用一种自膨胀式假体)与外科主动脉瓣膜置换术的随机试验中,我们评价了重度、有症状的主动脉瓣狭窄的外科手术中危患者临床结局。主要终点是主动脉瓣置换后24个月时,任何原因死亡或致残性卒中构成的复合终点。我们使用贝叶斯分析方法(边际0.07)评价TAVR与外科瓣膜置换术相比的非劣效性。

 

结果

我们对87个中心共1,746例患者进行了随机化。在这些患者中,1,660例患者经历了TAVR或外科手术。患者平均年龄(±SD)79.8岁±6.2岁,并且所有患者处于外科手术中危(美国胸外科医师学会[Society of Thoracic Surgeons]预测的死亡风险[predicted risk of mortality],4.5%±1.6%)。24个月时,估计的主要终点发生率在TAVR组是12.6%,外科手术组是14.0%(差异的95%可信区间[贝叶斯分析],-5.2%~2.3%;非劣效性的后验概率,>0.999)。外科手术伴有较高的急性肾脏损伤、心房颤动发生率和输血需求,而TAVR伴有较高的残留主动脉瓣反流发生率和起搏器置入需求。TAVR比手术产生更低的平均压力阶差和更大的主动脉瓣口面积。各组在24个月时都没有发生结构性瓣膜毁损。

 

结论

对于外科手术中危的重度主动脉瓣狭窄患者,TAVR是外科手术的非劣效性替代操作,但每种操作都有不同的不良事件模式(美敦力公司[Medtronic]资助;SURTAVI在ClinicalTrials.gov注册号为NCT01586910)。





作者信息

Michael J. Reardon, M.D., Nicolas M. Van Mieghem, M.D., Ph.D., Jeffrey J. Popma, M.D., Neal S. Kleiman, M.D., Lars Søndergaard, M.D., Mubashir Mumtaz, M.D., David H. Adams, M.D., G. Michael Deeb, M.D., Brijeshwar Maini, M.D., Hemal Gada, M.D., Stanley Chetcuti, M.D., Thomas Gleason, M.D., John Heiser, M.D., Rüdiger Lange, M.D., Ph.D., William Merhi, D.O., Jae K. Oh, M.D., Peter S. Olsen, M.D., Nicolo Piazza, M.D., Ph.D., Mathew Williams, M.D., Stephan Windecker, M.D., Ph.D., Steven J. Yakubov, M.D., Eberhard Grube, M.D., Ph.D., Raj Makkar, M.D., Joon S. Lee, M.D., John Conte, M.D., Eric Vang, Ph.D., M.P.H., Hang Nguyen, B.S., Yanping Chang, M.S., Andrew S. Mugglin, Ph.D., Patrick W.J.C. Serruys, M.D., Ph.D., and Arie P. Kappetein, M.D., Ph.D., for the SURTAVI Investigators*
From Methodist DeBakey Heart and Vascular Center, Houston (M.J.R., N.S.K.); Erasmus University Medical Center, Rotterdam, the Netherlands (N.M.V.M., P.W.J.C.S., A.P.K.); Beth Israel Deaconess Medical Center, Boston (J.J.P.); the Heart Center, Rigshospitalet, Copenhagen (L.S., P.S.O.); PinnacleHealth Hospitals, Harrisburg (M.M., H.G.), and University of Pittsburgh Medical Center, Pittsburgh (T.G., J.S.L.) — both in Pennsylvania; Mount Sinai Health System (D.H.A.) and New York University Langone Medical Center (M.W.) — both in New York; University of Michigan, Ann Arbor (G.M.D., S.C.), and Spectrum Health Hospitals, Grand Rapids (J.H., W.M.) — both in Michigan; Tenet Healthcare, Delray Beach, FL (B.M.); German Heart Center Munich, Munich (R.L.), and Siegburg Heart Center, Siegburg (E.G.) — both in Germany; Mayo Clinic, Rochester (J.K.O.), Medtronic, Minneapolis (E.V., H.N., Y.C.), and Paradigm Biostatistics, Anoka (A.S.M.) — all in Minnesota; McGill University Medical Centre, Montreal (N.P.); University Hospital Bern, Bern, Switzerland (S.W.); Riverside Methodist Hospital, Columbus, OH (S.J.Y.); Cedars–Sinai Medical Center, Los Angeles (R.M.); and Johns Hopkins University, Baltimore (J.C.). Address reprint requests to Dr. Reardon at the Methodist DeBakey Heart and Vascular Center, 6550 Fannin St., Houston, TX 77030, or at mreardon@houstonmethodist.org. *A complete list of investigators in the Surgical Replacement and Transcatheter Aortic Valve Implantation (SURTAVI) trial is provided in the Supplementary Appendix, available at NEJM.org.

 

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