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经导管边缘对合修复减少三尖瓣反流
2019-11-11 21:33

德国伯恩大学医院Georg Nickenig研究团队在研究中取得进展。他们研究了经导管边缘对合修复减少三尖瓣反流的效果。该研究成果2019年11月7日发表于国际一流学术期刊《柳叶刀》上。

三尖瓣反流是一种常见疾病,发病率高,死亡率高,治疗方法少。TriClip系统是一种微创经导管的三尖瓣修复系统。

研究组在欧洲和美国的21个点进行了这项前瞻性、多中心、单臂研究,招募三尖瓣反流中度及以上,纽约心脏协会II级及以上,根据适用标准进行充分治疗的患者,采用TriClip三尖瓣修复系统对患者进行瓣叶边缘对合修复。根据扩展的美国超声心动图学会分级方案将三尖瓣反流的严重程度分为五级:轻度、中度、重度、极重和危重。

2017年8月1日至2018年11月29日,研究组共招募了85名患者,并成功施行TriClip术。83例资料完整的患者中,有71例(86%)在30天内三尖瓣反流的严重程度至少降低一级,显著高于35%的预期目标。

1名患者在6个月随访前退出,未发生重大不良事件。6个月时,84例患者中有3例(4%)发生严重不良事件,显著低于39%的预期目标。72例患者中有5例(7%)出现单叶粘连。所有患者均未发生围手术期死亡、转行手术、器械栓塞、心肌梗死或中风事件。6个月时,84例患者中有4例(5%)发生全因死亡。

总之,TriClip系统可安全有效地降低三尖瓣反流的严重程度,在术后6个月,患者临床改善显著。

附:英文原文

Title: Transcatheter edge-to-edge repair for reduction of tricuspid regurgitation: 6-month outcomes of the TRILUMINATE single-arm study

Author: Georg Nickenig, Marcel Weber, Philipp Lurz, Ralph Stephan von Bardeleben, Marta Sitges, Paul Sorajja, Jrg Hausleiter, Paolo Denti, Jean-Nol Trochu, Michael Nbauer, Abdellaziz Dahou, Rebecca T Hahn

Issue&Volume: November 07, 2019

Abstract: 

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. 

DOI: 10.1016/S0140-6736(19)32600-5

Source: https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(19)32600-5/fulltext

LANCET:《柳叶刀》,创刊于1823年。隶属于爱思唯尔出版社,最新IF:202.731
官方网址:http://www.thelancet.com/
投稿链接:http://ees.elsevier.com/thelancet


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