自扩展或气球扩展的TAVR在患有小动脉环的患者中
Howard C Herrmann1, Roxana Mehran1, Daniel J Blackman1
1From Perelman School of Medicine at the University of Pennsylvania (H.C.H.) and Lankenau Heart Institute (B.R.), Philadelphia, Allegheny General Hospital, Allegheny Health Network, Pittsburgh (S. Bailey), and the University of Pittsburgh Medical Center, Harrisburg (H.G.) - all in Pennsylvania; Icahn School of Medicine at Mount Sinai, New York (R.M.); Leeds Teaching Hospitals, Leeds, United Kingdom (D.J.B.); St. Johannes Hospital Dortmund, Dortmund (H.M.), Heart Center Leipzig at University of Leipzig, Leipzig (M.A.-W.), the Department of Cardiovascular Surgery, Institute Insure, German Heart Center Munich, School of Medicine and Health, Technical University of Munich, Munich (H.R.), and Herz- und Diabeteszentrum Nordrhein-Westfalen, Ruhr-Universität Bochum, Bochum (S. Bleiziffer) - all in Germany; Montreal Heart Institute, Montreal (W.B.A.), and the Centre for Cardiovascular Innovation, University of British Columbia, Vancouver (D.A.W.) - both in Canada; Sentara Heart Hospital, Norfolk (P.D.M.), and Inova Schar Heart and Vascular, Falls Church (W.B.B.) - both in Virginia; the University of Pisa, Azienda Ospedaliero Universitaria Pisana, Pisa, Italy (A.S.P.); Tufts Medical Center, Boston (C.D.R.); Corewell Health, Grand Rapids (W.M.), and the University of Michigan Health Systems-University Hospital, Ann Arbor (G.M.D.) - both in Michigan; Hospital Vall D'Hebron, CIBER CV (Centro de Investigación Biomédica en Red Enfermedades Cardiovasculares), Barcelona (B.G.B.); Harrington Heart and Vascular Institute, University Hospitals Cleveland Medical Center, Cleveland (G.F.A.); Morristown Medical Center, Atlantic Health System, Morristown, NJ (L.D.G.); the Echocardiography Core Laboratory (R.P.), Mayo Clinic (M.G.), Rochester, and Medtronic, Minneapolis (M.T.F., A.D.A.) - both in Minnesota; MedStar Washington Hospital Center, Washington, DC (T.R.); Morton Plant Hospital, Clearwater, FL (J.D.R.); Baylor Scott and White Heart Hospital, Plano, TX (M.S.); Intermountain Medical Center, Murray, UT (B.W.); Emory University, Atlanta (K.J.G.); and Clinique Pasteur, Toulouse, France (D.T.).
对于患有严重的大动脉狭窄和小的大动脉环形的患者,自扩张的上门在经过透气管大动脉置换 (TAVR) 后,与气球扩张门相比,显示出非劣质的临床结果. 自扩展还在减少生物假体功能障碍方面表现出优越性.
科学领域:
- 心血管医学 心血管医学
- 干预心脏病学 干预心脏病学
- 生物材料科学 生物材料科学
背景情况:
- 严重的大动脉狭窄与小的大动脉环带来血动力学表现不佳的风险,以及转管大动脉替换 (TAVR) 后的不良结果.
- 假肢与患者不匹配可以显著影响TAVR的结果,特别是在患有小主动脉环的患者中.
研究的目的:
- 为了比较临床结果和自扩张的门和气球扩展门之间的生物假体门功能障碍,在接受TAVR的重症大动脉狭窄和小大动脉环形患者中进行TAVR.
- 为了评估自扩张与气球扩张的非劣等性,用于死亡,致残性中风或心力衰竭再住院的复合情况.
- 评估自扩展与气球扩展在生物假体功能障碍方面的优势.
主要方法:
- 一项随机对照试验,涉及716名患有严重大动脉狭窄和大动脉环面积≤430mm2.2的患者.
- 患者被分为1:1接受自扩张的门或气球可扩展的门.
- 在12个月评估的共同初级终点包括死亡,致残性中风或心力衰竭再住院 (非劣质) 和生物假肢功能障碍 (优越) 的复合.
主要成果:
- 综合临床终点发生在接受自扩展的9.4%的患者中,而接受气球扩展的10.6% (P<0.001为非劣势).
- 与气球可扩展 (41.6%) 相比,自扩展 (9.4%) 的生物假体功能障碍显着较低 (P<0.001为优越性).
- 自扩张组在12个月后显示出较低的平均大动脉梯度 (7.7比15.7毫米) 和更高的有效孔径面积 (1.99比1.50厘米2).
结论:
- 在患有严重的大动脉狭窄和小的大动脉环形的患者中,自扩张的上门在临床结果方面与气球可扩展门无差.
- 在TAVR后12个月,自扩张的超膜在减少生物假体膜功能障碍方面表现出优越性.
- 这些发现表明,在这种高风险患者群体中,自扩张的上门具有潜在的益处,特别是在门性能方面.
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