經導管邊緣對合修復減少三尖瓣反流
作者：
小柯機器人發布時間：2019/11/11 21:33:47
德國伯恩大學醫院Georg Nickenig研究團隊在研究中取得進展。他們研究了經導管邊緣對合修復減少三尖瓣反流的效果。該研究成果2019年11月7日發表於國際一流學術期刊《柳葉刀》上。
三尖瓣反流是一種常見疾病，發病率高，死亡率高，治療方法少。TriClip系統是一種微創經導管的三尖瓣修復系統。
研究組在歐洲和美國的21個點進行了這項前瞻性、多中心、單臂研究，招募三尖瓣反流中度及以上，紐約心臟協會II級及以上，根據適用標準進行充分治療的患者，採用TriClip三尖瓣修復系統對患者進行瓣葉邊緣對合修復。根據擴展的美國超聲心動圖學會分級方案將三尖瓣反流的嚴重程度分為五級：輕度、中度、重度、極重和危重。
2017年8月1日至2018年11月29日，研究組共招募了85名患者，並成功施行TriClip術。83例資料完整的患者中，有71例（86%）在30天內三尖瓣反流的嚴重程度至少降低一級，顯著高於35%的預期目標。
1名患者在6個月隨訪前退出，未發生重大不良事件。6個月時，84例患者中有3例（4%）發生嚴重不良事件，顯著低於39%的預期目標。72例患者中有5例（7%）出現單葉粘連。所有患者均未發生圍手術期死亡、轉行手術、器械栓塞、心肌梗死或中風事件。6個月時，84例患者中有4例（5%）發生全因死亡。
總之，TriClip系統可安全有效地降低三尖瓣反流的嚴重程度，在術後6個月，患者臨床改善顯著。
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