BACKGROUND Mid-term comparative data for the self-expanding ACURATE neo2 transcatheter heart valve and the balloon-expandable SAPIEN 3 Ultra are lacking. OBJECTIVES The aim of this study was to compare 1-year outcomes after transcatheter aortic valve replacement of these 2 valves. METHODS A total of 2,106 patients from 3 centers (neo2, n = 1,166; Ultra, n = 940) undergoing transfemoral transcatheter aortic valve replacement were analyzed retrospectively. The primary endpoint was the composite of all-cause mortality, stroke, and rehospitalization at 1 year. Secondary endpoints were the individual components of the primary endpoint at 1 year. To adjust for baseline differences, nearest neighbor propensity score matching was used. RESULTS After matching (702 pairs), baseline characteristics were similar between groups. Device success was more common in the neo2 group (87.5% vs 82.3%; P = 0.007), irrespective of matching. DP mean after the procedure was higher for Ultra (13 mm Hg [Q1-Q3: 10-15 mm Hg] vs 8 mm Hg [Q1-Q3: 6-11] mm Hg; P < 0.001). Rates of paravalvular leakage, device embolization, and multiple valve implantations were more common in the neo2 arm, whereas major cardiac structural complications and major vascular complications occurred more frequently in the Ultra group. All other in-hospital complication rates were similar between the 2 groups. At 1 year, the cumulative incidence of the primary endpoint (14.1% for neo2 vs 14.5% for Ultra; P = 0.819) was similar between the groups. Likewise, the individual components showed no difference between the groups. CONCLUSIONS Despite differing immediate results, the outcomes at 1 year, including the composite of all-cause mortality, stroke, or hospitalization, were similar for neo2 and Ultra transcatheter heart valves.

中文翻译：

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使用自扩张与球囊扩张经导管主动脉瓣置换术的 1 年结果。


背景 缺乏自膨式 ACURATE neo2 经导管心脏瓣膜和球囊扩张型 SAPIEN 3 Ultra 的中期比较数据。目的 本研究的目的是比较经导管主动脉瓣置换这 2 个瓣膜后 1 年的结果。方法 来自 3 个中心的共 2,106 例患者 （neo2，n = 1,166;Ultra，n = 940）接受经股动脉经导管主动脉瓣置换术。主要终点是 1 年时全因死亡率、卒中和再住院的复合值。次要终点是 1 年时主要终点的各个组成部分。为了调整基线差异，使用了最近邻倾向得分匹配。结果 匹配后 （702 对），组间基线特征相似。设备成功在 neo2 组中更为常见 （87.5% 对 82.3%;P = 0.007），无论匹配如何。Ultra（13 毫米汞柱 [Q1-Q3：10-15 毫米汞柱] 与 8 毫米汞柱 [Q1-Q3：6-11] 毫米汞柱;P < 0.001）。瓣周渗漏、装置栓塞和多瓣膜植入的发生率在 neo2 组中更常见，而 Ultra 组的主要心脏结构并发症和主要血管并发症更常见。两组之间的所有其他院内并发症发生率相似。1 年时，主要终点的累积发生率（neo2 为 14.1%，Ultra 为 14.5%;P = 0.819）在各组之间相似。同样，各组分之间没有差异。 结论 尽管即时结果不同，但 neo2 和 Ultra 经导管心脏瓣膜的 1 年结局，包括全因死亡率、中风或住院的复合结果相似。