Department of Cardiovascular Surgery, University Hospital of Zürich, University of Zürich, Zürich Switzerland.
New York-Presbyterian/Columbia University Medical Center, New York, New York.
JACC Cardiovasc Interv. 2017 Oct 9;10(19):1982-1990. doi: 10.1016/j.jcin.2017.08.011.
This study sought to develop a large, international registry to evaluate the diffusion of these approaches and investigate patient characteristics and initial clinical results.
Several transcatheter tricuspid valve therapies are emerging as therapeutic options for patients with severe symptomatic tricuspid regurgitation (TR), generally a high-risk surgical population.
The TriValve (Transcatheter Tricuspid Valve Therapies) registry included 106 high-risk patients (76 ± 9 years of age; 60.4% women; European System for Cardiac Operative Risk Evaluation II 7.6 ± 5.7%) from 11 cardiac centers, with severe TR.
A total of 35% of the patients had prior left heart valve intervention (surgical in 29 of 106 and transcatheter in 8 of 106 patients). Right ventricular (RV) dysfunction (tricuspid annular plane systolic excursion <17 mm) was present in 56.3% of the patients; 95% of the patients were in New York Heart Association functional class III to IV. The etiology of TR was functional in 95.2%, and the mean tricuspid annulus was 45.4 ± 11 mm. In 76.9% of the patients, the main location of the regurgitant jet was central; pre-procedural systolic pulmonary artery pressure was 39.7 ± 13.8 mm Hg; and the inferior vena cava was severely dilated in most of the patients (27.4 ± 6.8 mm). Implanted devices included MitraClip (n = 58), Trialign (n = 17), TriCinch (n = 15), FORMA (n = 7), Cardioband (n = 5), and caval valve implantation (n = 3). One case had combined Trialign + MitraClip. Patients treated with the different techniques were similar in terms of European System for Cardiac Operative Risk Evaluation II and degree of RV dysfunction. In 68% of the cases the tricuspid intervention was performed as an isolated procedure. Procedural success was achieved in 62% of cases. At 30-day follow-up, all-cause mortality was 3.7%, with an overall incidence of major adverse cardiac and cerebrovascular events of 26%; 58% of the patients were New York Heart Association functional class I or II at 30 days.
Patients currently undergoing transcatheter tricuspid valve therapy are mostly high risk, with a functional etiology and very severe central regurgitation, and do not have severely impaired RV function. Initial results suggest that transcatheter tricuspid valve therapy is feasible with different techniques, but clinical efficacy requires further investigation.
本研究旨在建立一个大型的国际注册中心，以评估这些方法的应用情况，并研究患者特征和初步临床结果。
几种经导管三尖瓣治疗方法正在成为严重症状性三尖瓣反流（TR）患者的治疗选择，这些患者通常是高危手术人群。
TriValve（经导管三尖瓣治疗）注册研究纳入了 106 名高危患者（76 ± 9 岁；60.4%为女性；欧洲心脏手术风险评估系统 II 评分为 7.6 ± 5.7%），这些患者来自 11 个心脏中心，均患有严重的 TR。
共有 35%的患者有左心瓣膜介入治疗史（106 例患者中手术治疗 29 例，经导管治疗 8 例）。56.3%的患者存在右心室（RV）功能障碍（三尖瓣环平面收缩期位移<17 mm）；95%的患者纽约心脏协会心功能分级为 III 级或 IV 级。TR 的病因主要为功能性，平均三尖瓣环为 45.4 ± 11 mm。76.9%的患者反流射流的主要部位为中心型；术前收缩期肺动脉压为 39.7 ± 13.8 mmHg；大多数患者下腔静脉严重扩张（27.4 ± 6.8 mm）。植入的器械包括 MitraClip（n=58）、Trialign（n=17）、TriCinch（n=15）、FORMA（n=7）、Cardioband（n=5）和腔静脉瓣膜植入（n=3）。1 例患者同时接受了 Trialign+MitraClip 治疗。采用不同技术治疗的患者在欧洲心脏手术风险评估系统 II 评分和 RV 功能障碍程度方面相似。68%的患者为单纯三尖瓣介入治疗。62%的病例达到了手术成功。30 天随访时，全因死亡率为 3.7%，主要不良心脑血管事件总发生率为 26%；58%的患者在 30 天时纽约心脏协会心功能分级为 I 级或 II 级。
目前接受经导管三尖瓣瓣膜治疗的患者大多为高危患者，病因主要为功能性，且存在严重的中心型反流，RV 功能并未严重受损。初步结果表明，不同技术的经导管三尖瓣瓣膜治疗是可行的，但临床疗效仍需进一步研究。
