Armijo Germán, Tang Gilbert H L, Kooistra Nynke, Ferreira-Neto Alfredo Nunes, Toggweiler Stefan, Amat-Santos Ignacio J, Keller Lukas S, Urena Marina, Ahmad Hasan, Tafur Soto Jose, Muñoz-Garcia Erika, Regueiro Ander, Leenders Geert E, Tirado-Conte Gabriela, Sengupta Aditya, McInerney Angela, Couture Thomas, Cuevas Herreros Oscar, Rodriguez-Gabella Tania, Kini Annapoorna, Ahmed Mohammed, Zaid Syed, Gonzalo Nieves, Nuñez-Gil Ivan J, Muñoz-Garcia Antonio J, Jimenez-Quevedo Pilar, Fernández-Ortiz Antonio, Himbert Dominique, Nietlispach Fabian, Stella Pieter, Dangas George D, Escaned Javier, Macaya Carlos, Rodés-Cabau Josep, Nombela-Franco Luis
Department of Cardiology, Cardiovascular Institute, Hospital Clínico San Carlos, Instituto de Investigación Sanitaria San Carlos, Madrid, Spain (G.A., G.T.-C., A.M., N.G., I.J.N.-G., P.J.-Q., A.F.-O., J.E., C.M., L.N.-F.).
Department of Cardiovascular Surgery, Mount Sinai Health System, New York, NY (G.H.L.T., A.S.).
Circ Cardiovasc Interv. 2020 Aug;13(8):e009047. doi: 10.1161/CIRCINTERVENTIONS.120.009047. Epub 2020 Aug 6.
Currently, 2 third-generation transcatheter valves, 29-mm Sapien-3 and 34-mm Evolut-R (ER), are indicated for large sized aortic annuli. We analyzed short and 1-year performance of these valves in patients with large (area ≥575 mm or perimeter ≥85 mm) and extra-large (≥683 mm or ≥94.2 mm) aortic annuli undergoing transcatheter aortic valve replacement.
A total of 833 patients across 12 centers with symptomatic aortic stenosis and large aortic annuli underwent transcatheter aortic valve replacement with 29-mm Sapien-3 (n=640) or 34-mm ER (n=193). Clinical, anatomic, and procedural characteristics were collected, and Valve Academic Research Consortium-2 outcomes were reported.
Median aortic annulus area and perimeter were 617 mm (591-657) and 89.1 mm (87.0-92.1), respectively (704 mm [689-743] and 96.0 mm [94.5-97.9] in the subgroup of 124 patients with extra-large annuli). Overall device success was 94.3% (Sapien-3, 95.8% and ER, 89.3%; =0.001), with a higher rate of significant paravalvular leak (=0.004), second valve implantation (=0.013), and valve embolization (=0.009) in the ER group. Thirty-day and 1-year mortality was 2.4% and 9.2%, respectively, without differences between groups. Valve hemodynamics were excellent (mean gradient, 8.8±3.6 mm Hg; 3.3% rate of moderate-severe paravalvular leak) in the extra-large annulus, without differences compared with the large annulus group.
In patients with large and extra-large aortic annuli, transcatheter aortic valve replacement using 29-mm Sapien-3 and 34-mm ER is safe and feasible. Observed differences in clinical outcomes and hemodynamic performance may guide valve choice in this cohort of patients undergoing transcatheter aortic valve replacement.
目前，两种第三代经导管瓣膜，即29毫米的Sapien-3和34毫米的Evolut-R（ER），适用于大尺寸主动脉瓣环。我们分析了这些瓣膜在接受经导管主动脉瓣置换术的大（面积≥575平方毫米或周长≥85毫米）和超大（≥683平方毫米或≥94.2毫米）主动脉瓣环患者中的短期和1年性能。
12个中心的833例有症状的主动脉瓣狭窄且主动脉瓣环大的患者接受了29毫米Sapien-3（n=640）或34毫米ER（n=193）经导管主动脉瓣置换术。收集临床、解剖和手术特征，并报告瓣膜学术研究联盟-2的结果。
主动脉瓣环面积和周长的中位数分别为617平方毫米（591-657）和89.1毫米（87.0-92.1）（124例超大瓣环患者亚组中为704平方毫米[689-743]和96.0毫米[94.5-97.9]）。总体器械成功率为94.3%（Sapien-3为95.8%，ER为89.3%；P=0.001），ER组中显著瓣周漏（P=0.004）、二次瓣膜植入（P=0.013）和瓣膜栓塞（P=0.009）的发生率更高。30天和1年死亡率分别为2.4%和9.2%，两组间无差异。超大瓣环组的瓣膜血流动力学良好（平均压差，8.8±3.6毫米汞柱；中重度瓣周漏发生率3.3%），与大瓣环组相比无差异。
在大尺寸和超大尺寸主动脉瓣环患者中，使用29毫米Sapien-3和34毫米ER进行经导管主动脉瓣置换术是安全可行的。观察到的临床结果和血流动力学性能差异可能指导该组接受经导管主动脉瓣置换术患者的瓣膜选择。
