自膨式或球囊扩张式 TAVR 在小主动脉瓣环患者中的应用。
Self-Expanding or Balloon-Expandable TAVR in Patients with a Small Aortic Annulus.
机构信息
From 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.).
出版信息
N Engl J Med. 2024 Jun 6;390(21):1959-1971. doi: 10.1056/NEJMoa2312573. Epub 2024 Apr 7.
BACKGROUND
Patients with severe aortic stenosis and a small aortic annulus are at risk for impaired valvular hemodynamic performance and associated adverse cardiovascular clinical outcomes after transcatheter aortic-valve replacement (TAVR).
METHODS
We randomly assigned patients with symptomatic severe aortic stenosis and an aortic-valve annulus area of 430 mm or less in a 1:1 ratio to undergo TAVR with either a self-expanding supraannular valve or a balloon-expandable valve. The coprimary end points, each assessed through 12 months, were a composite of death, disabling stroke, or rehospitalization for heart failure (tested for noninferiority) and a composite end point measuring bioprosthetic-valve dysfunction (tested for superiority).
RESULTS
A total of 716 patients were treated at 83 sites in 13 countries (mean age, 80 years; 87% women; mean Society of Thoracic Surgeons Predicted Risk of Mortality, 3.3%). The Kaplan-Meier estimate of the percentage of patients who died, had a disabling stroke, or were rehospitalized for heart failure through 12 months was 9.4% with the self-expanding valve and 10.6% with the balloon-expandable valve (difference, -1.2 percentage points; 90% confidence interval [CI], -4.9 to 2.5; P<0.001 for noninferiority). The Kaplan-Meier estimate of the percentage of patients with bioprosthetic-valve dysfunction through 12 months was 9.4% with the self-expanding valve and 41.6% with the balloon-expandable valve (difference, -32.2 percentage points; 95% CI, -38.7 to -25.6; P<0.001 for superiority). The aortic-valve mean gradient at 12 months was 7.7 mm Hg with the self-expanding valve and 15.7 mm Hg with the balloon-expandable valve, and the corresponding values for additional secondary end points through 12 months were as follows: mean effective orifice area, 1.99 cm and 1.50 cm; percentage of patients with hemodynamic structural valve dysfunction, 3.5% and 32.8%; and percentage of women with bioprosthetic-valve dysfunction, 10.2% and 43.3% (all P<0.001). Moderate or severe prosthesis-patient mismatch at 30 days was found in 11.2% of the patients in the self-expanding valve group and 35.3% of those in the balloon-expandable valve group (P<0.001). Major safety end points appeared to be similar in the two groups.
CONCLUSIONS
Among patients with severe aortic stenosis and a small aortic annulus who underwent TAVR, a self-expanding supraannular valve was noninferior to a balloon-expandable valve with respect to clinical outcomes and was superior with respect to bioprosthetic-valve dysfunction through 12 months. (Funded by Medtronic; SMART ClinicalTrials.gov number, NCT04722250.).
背景
经导管主动脉瓣置换术（TAVR）后，严重主动脉瓣狭窄且主动脉瓣环较小的患者存在瓣叶血流动力学性能受损和相关不良心血管临床结局的风险。
方法
我们将 716 名有症状的严重主动脉瓣狭窄且主动脉瓣环面积为 430mm 或更小的患者按 1:1 的比例随机分配，接受自膨式瓣上瓣膜或球囊扩张瓣膜的 TAVR。主要复合终点为 12 个月时死亡、致残性卒中或因心力衰竭再次住院（检测非劣效性）和评估生物瓣功能障碍的复合终点（检测优效性）。
结果
在 13 个国家的 83 个地点治疗了 716 名患者（平均年龄 80 岁；87%为女性；平均胸外科医生协会预测死亡率为 3.3%）。Kaplan-Meier 估计的 12 个月时死亡、致残性卒中或因心力衰竭再次住院的患者百分比，自膨式瓣膜为 9.4%，球囊扩张瓣膜为 10.6%（差值-1.2 个百分点；90%置信区间[CI]，-4.9 至 2.5；P<0.001 用于非劣效性）。Kaplan-Meier 估计的 12 个月时生物瓣功能障碍的患者百分比，自膨式瓣膜为 9.4%，球囊扩张瓣膜为 41.6%（差值-32.2 个百分点；95%CI，-38.7 至-25.6；P<0.001 用于优效性）。12 个月时主动脉瓣平均梯度自膨式瓣膜为 7.7mmHg，球囊扩张瓣膜为 15.7mmHg，12 个月时其他次要终点的相应值如下：平均有效瓣口面积，1.99cm 和 1.50cm；血流动力学结构性瓣功能障碍的患者百分比，3.5%和 32.8%；女性生物瓣功能障碍的患者百分比，10.2%和 43.3%（均 P<0.001）。30 天时自膨式瓣膜组有 11.2%的患者和球囊扩张瓣膜组有 35.3%的患者存在中度或重度假体-患者不匹配（P<0.001）。两组主要安全性终点似乎相似。
结论
在接受 TAVR 的严重主动脉瓣狭窄且主动脉瓣环较小的患者中，自膨式瓣上瓣膜在临床结局方面不劣于球囊扩张瓣膜，在 12 个月时在生物瓣功能障碍方面优于球囊扩张瓣膜。（由美敦力公司资助；SMART 临床试验。gov 编号，NCT04722250。）
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