Early studies of the Tendyne transcatheter mitral valve replacement (TMVR) showed promising results in a small selective cohort. The authors present 1-year data from the currently largest commercial, real-world cohort originating from the investigator-initiated TENDER (Tendyne European Experience) registry. All patients from the TENDER registry eligible for 1-year follow-up were included. The primary safety endpoint was 1-year cardiovascular mortality. Primary performance endpoint was reduction of mitral regurgitation (MR) up to 1 year. Among 195 eligible patients undergoing TMVR (median age 77 years [Q1-Q3: 71-81 years], 60% men, median Society of Thoracic Surgeons Predicted Risk of Mortality 5.6% [Q1-Q3: 3.6%-8.9%], 81% in NYHA functional class III or IV, 94% with MR 3+/4+), 31% had “real-world” indications for TMVR (severe mitral annular calcification, prior mitral valve treatment, or others) outside of the instructions for use. The technical success rate was 95%. The cardiovascular mortality rate was 7% at 30 day and 17% at 1 year (all-cause mortality rates were 9% and 29%, respectively). Reintervention or surgery following discharge was 4%, while rates of heart failure hospitalization reduced from 68% in the preceding year to 25% during 1-year follow-up. Durable MR reduction to ≤1+ was achieved in 98% of patients, and at 1 year, 83% were in NYHA functional class I or II. There was no difference in survival and major adverse events between on-label use and “real-world” indications up to 1 year. This large, real-world, observational registry reports high technical success, durable and complete MR elimination, significant clinical benefits, and a 1-year cardiovascular mortality rate of 17% after Tendyne TMVR. Outcomes were comparable between on-label use and “real-world” indications, offering a safe and efficacious treatment option for patients without alternative treatments. (Tendyne European Experience Registry [TENDER]; )

中文翻译：

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经心尖二尖瓣置换术：真实世界 Tendyne 欧洲经验登记的一年结果

Tendyne 经导管二尖瓣置换术 (TMVR) 的早期研究在一小部分选择性队列中显示出有希望的结果。作者提供了来自当前最大的商业现实世界队列的 1 年数据，这些数据源自研究者发起的 TENDER（Tendyne 欧洲经验）注册中心。 TENDER 登记处符合 1 年随访资格的所有患者均被纳入。主要安全终点是一年心血管死亡率。主要性能终点是长达 1 年的二尖瓣反流 (MR) 减少。在 195 名接受 TMVR 的合格患者中（中位年龄 77 岁 [Q1-Q3：71-81 岁]，其中 60% 为男性，胸外科医生协会预测死亡风险中位为 5.6% [Q1-Q3：3.6%-8.9%]，81 % NYHA 功能分级为 III 或 IV，94% 为 MR 3+/4+），31% 具有 TMVR 的“真实世界”适应症（严重二尖瓣环钙化、既往二尖瓣治疗或其他），超出了指导说明使用。技术成功率为95%。 30 天时心血管死亡率为 7%，1 年时心血管死亡率为 17%（全因死亡率分别为 9% 和 29%）。出院后的再干预或手术率为 4%，而心力衰竭住院率从前一年的 68% 降至 1 年随访期间的 25%。 98% 的患者实现了 MR 持久降低至 ≤1+，1 年时，83% 的患者达到 NYHA 功能分级 I 或 II。标签上的使用和“现实世界”适应症之间长达一年的生存率和主要不良事件没有差异。这个大型的、真实的、观察性登记报告显示，Tendyne TMVR 后技术高度成功、持久且完全消除 MR、显着的临床益处以及 17% 的 1 年心血管死亡率。标签使用和“现实世界”适应症之间的结果具有可比性，为没有替代治疗的患者提供了安全有效的治疗选择。 （Tendyne 欧洲经验登记处 [TENDER]；）