Pan Xiangbin, Lu Fanglin, Wang Yiwei, Guo Yingqiang, Chen Mao, Meng Xu, Zhang Haibo, Dong Nianguo, Shang Xiaoke, Yang Jian, Liu Yang, Wang Jianan, Liu Xianbao, Guo Huiming, Liu Jian, Qiao Fan, Ascione Guido, Cheung Anson, Modine Thomas, von Bardeleben Ralph Stephan, Granada Juan F, Xu Zhiyun, Hu Shengshou
Department of Cardiovascular Surgery, Fuwai Hospital, National Center for Cardiovascular Disease, Chinese Academy of Medical Science and Peking Union Medical College, Beijing, China.
Department of Cardiovascular Surgery, Shanghai General Hospital, Shanghai Jiaotong University, Shanghai, China.
JACC Cardiovasc Interv. 2025 May 26;18(10):1276-1285. doi: 10.1016/j.jcin.2024.12.030. Epub 2025 Apr 9.
Transcatheter tricuspid valve replacement (TTVR) is emerging as a promising surgical alternative for high-risk patients with tricuspid regurgitation (TR). Nonetheless, the feasibility of more dedicated devices and the need for additional clinical evidence warrant further exploration.
The purpose of this study was to report the 1-year outcomes of the TRAVEL (Transcatheter Right Atrial-Ventricular Valve Replacement With LuX-Valve) study with the LuX-Valve system for patients with severe TR.
A total of 126 patients with symptomatic severe TR were prospectively enrolled in the single-arm, multicenter TRAVEL study from June 2020 to August 2021. All patients underwent TTVR via the transatrial approach using the LuX-Valve system. The primary endpoint was all-cause mortality and hospitalization for heart failure at 1-year follow-up. Clinical and echocardiographic outcomes were reported.
At baseline, all enrolled patients (mean age 65.8 ± 7.5 years, 79.4% women) were at high surgical risk (mean Society of Thoracic Surgeons score 9.2% ± 4.4%), with severe or greater TR and NYHA functional class ≥ III. In 1-year follow-up, all-cause mortality was 10.3%, and 4.0% of patients were hospitalized for heart failure. TR was reduced to mild or less in 95.2% (P < 0.001), with decreases in right atrial systolic volume (-38.3 ± 21.7 mL; P < 0.001) and mid right ventricular end-systolic diameter (-6.4 ± 2.3 mm; P < 0.001). NYHA functional class I or II was achieved in 79.8% (P < 0.001), and 6-minute walking distance increased by 71.3 ± 42.8 m (P < 0.001).
The 1-year outcomes of the TRAVEL study showed a sustained reduction in TR among patients who underwent LuX-Valve TTVR, accompanied by significant right heart reverse remodeling and improved functional status. Favorable procedural success and survival benefits were also demonstrated. (the TRAVEL Trial: Transcatheter Right Atrial-Ventricular Valve Replacement With LuX-Valve; NCT04436653).
经导管三尖瓣置换术（TTVR）正在成为治疗三尖瓣反流（TR）高危患者的一种有前景的手术替代方案。尽管如此，更多专用器械的可行性以及对更多临床证据的需求仍值得进一步探索。
本研究旨在报告使用LuX瓣膜系统进行TRAVEL（经导管右房室瓣膜置换术-LuX瓣膜）研究中重度TR患者的1年结局。
2020年6月至2021年8月，共有126例有症状的重度TR患者前瞻性纳入单臂、多中心TRAVEL研究。所有患者均通过经心房途径使用LuX瓣膜系统进行TTVR。主要终点是1年随访时的全因死亡率和因心力衰竭住院。报告了临床和超声心动图结局。
基线时，所有入组患者（平均年龄65.8±7.5岁，79.4%为女性）手术风险高（平均胸外科医师协会评分为9.2%±4.4%），伴有重度或更严重的TR且纽约心脏协会功能分级≥III级。在1年随访中，全因死亡率为10.3%，4.0%的患者因心力衰竭住院。TR降至轻度或更低的比例为95.2%（P<0.001），右心房收缩末期容积减少（-38.3±21.7 mL；P<0.001），右心室中间收缩末期直径减少（-6.4±2.3 mm；P<0.001）。79.8%的患者达到纽约心脏协会功能分级I级或II级（P<0.001），6分钟步行距离增加了71.3±42.8 m（P<0.001）。
TRAVEL研究的1年结局显示，接受LuX瓣膜TTVR的患者TR持续降低，同时伴有显著的右心逆向重塑和功能状态改善。还证明了良好的手术成功率和生存获益。（TRAVEL试验：经导管右房室瓣膜置换术-LuX瓣膜；NCT04436653）
