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Transcatheter edge-to-edge repair for reduction of tricuspid regurgitation: 6-month outcomes of the TRILUMINATE single-arm study.
The Lancet ( IF 168.9 ) Pub Date : 2019-11-07 , DOI: 10.1016/s0140-6736(19)32600-5
Georg Nickenig 1 , Marcel Weber 1 , Philipp Lurz 2 , Ralph Stephan von Bardeleben 3 , Marta Sitges 4 , Paul Sorajja 5 , Jörg Hausleiter 6 , Paolo Denti 7 , Jean-Noël Trochu 8 , Michael Näbauer 6 , Abdellaziz Dahou 9 , Rebecca T Hahn 10
Affiliation  

BACKGROUND Tricuspid regurgitation is a prevalent disease associated with high morbidity and mortality, with few treatment options. The aim of the TRILUMINATE trial is to evaluate the safety and effectiveness of TriClip, a minimally invasive transcatheter tricuspid valve repair system, for reducing tricuspid regurgitation. METHODS The TRILUMINATE trial is a prospective, multicentre, single-arm study in 21 sites in Europe and the USA. Patients with moderate or greater triscuspid regurgitation, New York Heart Association class II or higher, and who were adequately treated per applicable standards were eligible for enrolment. Patients were excluded if they had systolic pulmonary artery pressure of more than 60 mm Hg, a previous tricuspid valve procedure, or a cardiovascular implantable electronic device that would inhibit TriClip placement. Participants were treated using a clip-based edge-to-edge repair technique with the TriClip tricuspid valve repair system. Tricuspid regurgitation was graded using a five-class grading scheme (mild, moderate, severe, massive, and torrential) that expanded on the standard American Society of Echocardiography grading scheme. The primary efficacy endpoint was a reduction in tricuspid regurgitation severity by at least one grade at 30 days post procedure, with a performance goal of 35%, analysed in all patients who had an attempted tricuspid valve repair procedure upon femoral vein puncture. The primary safety endpoint was a composite of major adverse events at 6 months, with a performance goal of 39%. Patients were excluded from the primary safety analysis if they did not reach 6-month follow-up and did not have a major adverse event during previous follow-ups. The trial has completed enrolment and follow-up is ongoing; it is registered with ClinicalTrials.gov, number NCT03227757. FINDINGS Between Aug 1, 2017, and Nov 29, 2018, 85 patients (mean age 77·8 years [SD 7·9]; 56 [66%] women) were enrolled and underwent successful TriClip implantation. Tricuspid regurgitation severity was reduced by at least one grade at 30 days in 71 (86%) of 83 patients who had available echocardiogram data and imaging. The one-sided lower 97·5% confidence limit was 76%, which was greater than the prespecified performance goal of 35% (p<0·0001). One patient withdrew before 6-month follow-up without having had a major adverse event and was excluded from analysis of the primary safety endpoint. At 6 months, three (4%) of 84 patients experienced a major adverse event, which was less than the prespecified performance goal of 39% (p<0·0001). Single leaflet attachment occurred in five (7%) of 72 patients. No periprocedural deaths, conversions to surgery, device embolisations, myocardial infarctions, or strokes occurred. At 6 months, all-cause mortality had occurred in four (5%) of 84 patients. INTERPRETATION The TriClip system appears to be safe and effective at reducing tricuspid regurgitation by at least one grade. This reduction could translate to significant clinical improvement at 6 months post procedure. FUNDING Abbott.

中文翻译:

经导管边缘到边缘修复可减少三尖瓣关闭不全:TRILUMINATE单臂研究的6个月结果。

背景技术三尖瓣关闭不全是与高发病率和死亡率相关的普遍疾病,几乎没有治疗选择。TRILUMINATE试验的目的是评估TriClip(一种微创经导管三尖瓣修复系统)减少三尖瓣关闭不全的安全性和有效性。方法TRILUMINATE试验是一项前瞻性,多中心,单臂研究,在欧洲和美国的21个地点进行。患有中度或更高三尖瓣关闭不全,纽约心脏协会II级或更高水平且已按照适用标准得到充分治疗的患者符合入组条件。如果患者的收缩期肺动脉压超过60毫米汞柱,以前的三尖瓣手术或可抑制TriClip放置的可植入心血管的电子设备,则将其排除在外。使用TriClip三尖瓣修复系统,采用基于夹子的边缘到边缘修复技术对参与者进行治疗。三尖瓣关闭不全的分级采用五级分级方案(轻度,中度,重度,重度和洪流),该方案在标准的美国超声心动图学会分级方案上进行了扩展。主要功效终点是在手术后30天将三尖瓣关闭不全的严重程度降低至少一个等级,其性能目标为35%,对所有在股静脉穿刺时尝试进行三尖瓣修复手术的患者进行了分析。主要安全终点是6个月时主要不良事件的综合表现,目标是39%。如果患者未进行6个月的随访且在先前的随访中未发生重大不良事件,则将他们排除在主要安全性分析之外。该试验已完成招募,正在进行随访;它已在ClinicalTrials.gov上注册,编号为NCT03227757。结果在2017年8月1日至2018年11月29日之间,纳入了85例患者(平均年龄77·8岁[SD 7·9]; 56名[66%]女性),并成功进行了TriClip植入。有超声心动图数据和影像学检查的83例患者中,有71例(86%)在30天时三尖瓣关闭不全的严重程度降低了至少一个等级。较低的97·5%可信度下限为76%,大于预先指定的35%的性能目标(p <0·0001)。一名患者在6个月的随访前退出,没有发生重大不良事件,因此被排除在主要安全性终点分析之外。在6个月时,84名患者中有3名(4%)经历了严重的不良事件,这低于预先设定的39%的绩效目标(p <0·0001)。72名患者中有五名(7%)发生了单瓣附着。没有发生围手术期死亡,转为手术,器械栓塞,心肌梗塞或中风。在6个月时,84例患者中有4例(5%)发生了全因死亡率。解释TriClip系统似乎可以安全有效地将三尖瓣关闭不全降低至少一级。减少可能会在术后6个月转化为明显的临床改善。资助雅培。84例患者中有3例(4%)发生了严重不良事件,这低于预定的39%的绩效目标(p <0·0001)。72名患者中有五名(7%)发生了单瓣附着。没有发生围手术期死亡,转为手术,器械栓塞,心肌梗塞或中风。在6个月时,84例患者中有4例(5%)发生了全因死亡率。解释TriClip系统似乎可以安全有效地将三尖瓣关闭不全降低至少一级。减少可能会在术后6个月转化为明显的临床改善。资助雅培。84例患者中有3例(4%)发生了严重不良事件,这低于预定的39%的绩效目标(p <0·0001)。72名患者中有五名(7%)发生了单瓣附着。没有发生围手术期死亡,转为手术,器械栓塞,心肌梗塞或中风。在6个月时,84例患者中有4例(5%)发生了全因死亡率。解释TriClip系统似乎可以安全有效地将三尖瓣关闭不全降低至少一级。减少可能会在术后6个月转化为明显的临床改善。资助雅培。发生了向手术,器械栓塞,心肌梗塞或中风的转换。在6个月时,84例患者中有4例(5%)发生了全因死亡率。解释TriClip系统似乎可以安全有效地将三尖瓣关闭不全降低至少一级。减少可能会在术后6个月转化为明显的临床改善。资助雅培。发生了向手术,器械栓塞,心肌梗塞或中风的转换。在6个月时,84例患者中有4例(5%)发生了全因死亡率。解释TriClip系统似乎可以安全有效地将三尖瓣关闭不全降低至少一级。减少可能会在术后6个月转化为明显的临床改善。资助雅培。
更新日期:2019-11-29
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