本文由小咖机器人翻译整理

期刊来源：Lancet

原文链接：https://doi.org/10.1016/S0140-6736(23)02806-4

摘要内容如下：

背景

对于自体主动脉瓣反流患者，手术仍然是唯一推荐的干预措施。经导管治疗具有高死亡率和并发症风险的外科主动脉瓣置换术患者的需求尚未得到满足。商业经导管心脏瓣膜在单纯主动脉瓣反流中受到不可接受的栓塞率和瓣周反流的阻碍。Trilogy经导管心脏瓣膜（Jenavalve Technology，Irvine，CA，USA）为这些患者提供了一种治疗选择。我们报道了经股动脉经导管主动脉瓣植入术（TAVI）在单纯主动脉瓣反流患者中使用这种专用经导管心脏瓣膜的结果。

方法

ALIGN-AR试验是一项前瞻性、多中心、单组研究。我们在美国20个地点招募了有症状的中度至重度或重度主动脉瓣反流患者（年龄≥18岁），这些患者在外科主动脉瓣置换术后具有很高的死亡率和并发症风险，并接受了Trilogy经导管心脏瓣膜治疗。将30天复合主要安全性终点的非劣效性与预先指定的40.5%的性能目标进行比较。主要疗效终点是1年全因死亡率，与非劣效性相比，性能目标为25%。该试验已在ClinicalTrials.gov（NCT04415047）上注册，目前正在进行中。

调查结果

在2018年6月8日至2022年8月29日期间，我们筛选了346名患者。我们排除了166例（48%）患者，并纳入了180例（52%）心脏团队和独立筛选委员会评估为高风险的症状性主动脉瓣反流患者。研究人群的平均年龄为75.5岁（SD 10.8），其中85人（47%）为女性，95人（53%）为男性，131人（73%）为白人。171例（95%）患者获得了技术成功。30天时，4例（2%）死亡，2例（1%）致残性卒中，2例（1%）非致残性卒中。使用标准瓣膜学术研究联盟-2定义，达到主要安全性终点，48例（27%[97.5%CI 19.2-34.0]）患者发生事件（P非劣效性<0.0001），36例（24%）患者植入新的起搏器。达到主要疗效终点，14例（7.8%[3.3-12.3]）患者在1年时死亡（P非劣效性<0.0001）。

解释

该研究显示了使用专用经导管心脏瓣膜治疗自体主动脉瓣反流的安全性和有效性，以治疗有症状的中度至重度或重度主动脉瓣反流患者，这些患者在外科主动脉瓣置换术后具有高死亡率或并发症风险。观察到的短期临床和血液动力学结果是有希望的，左心室重构的迹象也是有希望的，但长期随访是必要的。

英文原文如下：

Abstracts

BACKGROUND  Surgery remains the only recommended intervention for patients with native aortic regurgitation. A transcatheter therapy to treat patients at high risk for mortality and complications with surgical aortic valve replacement represents an unmet need. Commercial transcatheter heart valves in pure aortic regurgitation are hampered by unacceptable rates of embolisation and paravalvular regurgitation. The Trilogy transcatheter heart valve (JenaValve Technology, Irvine, CA, USA) provides a treatment option for these patients. We report outcomes with transfemoral transcatheter aortic valve implantation (TAVI) in patients with pure aortic regurgitation using this dedicated transcatheter heart valve.

METHODS  The ALIGN-AR trial is a prospective, multicentre, single-arm study. We recruited symptomatic patients (aged ≥18 years) with moderate-to-severe or severe aortic regurgitation at high risk for mortality and complications after surgical aortic valve replacement at 20 US sites for treatment with the Trilogy transcatheter heart valve. The 30-day composite primary safety endpoint was compared for non-inferiority with a prespecified performance goal of 40·5%. The primary efficacy endpoint was 1-year all-cause mortality compared for non-inferiority with a performance goal of 25%. This trial is registered with ClinicalTrials.gov, NCT04415047, and is ongoing.

FINDINGS  Between June 8, 2018, and Aug 29, 2022, we screened 346 patients. We excluded 166 (48%) patients and enrolled 180 (52%) patients with symptomatic aortic regurgitation deemed high risk by the heart team and independent screening committee assessments. The mean age of the study population was 75·5 years (SD 10·8), and 85 (47%) were female, 95 (53%) were male, and 131 (73%) were White. Technical success was achieved in 171 (95%) patients. At 30 days, four (2%) deaths, two (1%) disabling strokes, and two (1%) non-disabling strokes occurred. Using standard Valve Academic Research Consortium-2 definitions, the primary safety endpoint was achieved, with events occurring in 48 (27% [97·5% CI 19·2-34·0]) patients (pnon-inferiority<0·0001), with new pacemaker implantation in 36 (24%) patients. The primary efficacy endpoint was achieved, with mortality in 14 (7·8% [3·3-12·3]) patients at 1 year (pnon-inferiority<0·0001).

INTERPRETATION  This study shows the safety and effectiveness of treating native aortic regurgitation using a dedicated transcatheter heart valve to treat patients with symptomatic moderate-to-severe or severe aortic regurgitation who are at high risk for mortality or complications after surgical aortic valve replacement. The observed short-term clinical and haemodynamic outcomes are promising as are signs of left ventricular remodelling, but long-term follow-up is necessary.

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