Transcatheter tricuspid valve interventions (TTVIs) have arisen in recent years as an alternative treatment of tricuspid regurgitation (TR) in high risk patients. TTVIs can be classified as annuloplasty devices, caval valve implantation (CAVI), tricuspid valve replacement and coaptation devices. The FORMA repair system (Edwards Lifesciences, Irvine, CA, USA) aims to improve the coaptation of tricuspid leaflets by occupying the regurgitant orifice with a balloon spacer, which reduces the regurgitant orifice area. After the first-in-human reported case back in 2015, data from 18 patients treated under compassionate clinical use conditions and from 29 patients under the US early feasibility (EFS) trial have been published. The two studies included very high-risk surgical patients (Euroscore II >8 in both cohorts). Implantation success was achieved in 16 (89%) and 27 (93%) of patients, respectively. In the US EFS trial, results at 30 days showed improvements in New York Heart Association (NYHA) functional class (NYHA class ≥ III in 28% vs 84% at baseline, p =0.0002), 6-minute walking test (increase by 21 m, p =0.012) and in the Kansas City Cardiomyopathy Questionnaire (increase by 29 points, p < 0001). In addition, the Core Lab evaluation at 30 days showed statistically significant reductions in TR severity grading in the 25 available patients. Regarding the compassionate cohort, 15 patients had available data at long-term follow-up (≥ 2 years). NYHA functional class ≥ III was reduced from 93% to 34% (p <0.001). However, two-thirds of the patients remained with significant TR at last available follow-up, and there were no significant changes in EROA (0.92 vs. 0.77 cm2; p = 0.516). In conclusion, this first experience with the FORMA device showed the feasibility of the procedure. Despite the magnitude of TR reduction was moderate at long-term, significant improvements in heart failure symptoms and quality of life were achieved.

中文翻译：

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三尖瓣反流的经导管创新：FORMA设备。

近年来，经导管三尖瓣介入治疗（TTVIs）成为高危患者三尖瓣关闭不全（TR）的替代疗法。TTVIs可以分为瓣环成形术设备，瓣膜植入术（CAVI），三尖瓣置换术和接合术。FORMA修复系统（Edwards Lifesciences，美国加利福尼亚州尔湾市）旨在通过用气球间隔物占据反流孔口来改善三尖瓣小叶的适应性，从而减少反流孔口面积。在2015年首次报道人类以来，该病例已发表了来自18例在同情临床使用条件下治疗的患者和29例在美国早期可行性（EFS）试验中的患者的数据。两项研究包括极高风险的外科手术患者（两个队列中的Euroscore II> 8）。分别有16位（89％）和27位（93％）的患者获得了成功的植入。在美国EFS试验中，第30天的结果显示，纽约心脏协会（NYHA）功能等级（NYHA≥III级，分别为28％和基线时的84％，p = 0.0002），步行6分钟（增加21分） m，p = 0.012）和堪萨斯城心肌病问卷（增加29分，p <0001）。此外，核心实验室在30天时的评估显示，在25位可用患者中，TR严重程度分级具有统计学上的显着降低。关于富有同情心的队列，有15名患者在长期随访（≥2年）时有可用数据。NYHA功能类别≥III从93％降低到34％（p <0.001）。但是，三分之二的患者在最近的随访中仍具有明显的TR，而且EROA没有显着变化（0.92对0.77 cm2； p = 0.516）。总之，FORMA设备的首次使用经验证明了该程序的可行性。尽管长期以来TR的降低幅度是中等的，但心力衰竭症状和生活质量仍得到了显着改善。