新系统经导管三尖瓣置换术：TRAVEL研究的1年结果

IF 11.7 1区医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS

JACC. Cardiovascular interventions Pub Date : 2025-05-26 DOI:10.1016/j.jcin.2024.12.030

Xiangbin Pan MD, PhD , Fanglin Lu MD, PhD , Yiwei Wang MD, PhD , Yingqiang Guo MD, PhD , Mao Chen MD, PhD , Xu Meng MD, PhD , Haibo Zhang MD, PhD , Nianguo Dong MD, PhD , Xiaoke Shang MD, PhD , Jian Yang MD, PhD , Yang Liu MD, PhD , Jianan Wang MD, PhD , Xianbao Liu MD, PhD , Huiming Guo MD, PhD , Jian Liu MD, PhD , Fan Qiao MD, PhD , Guido Ascione MD, PhD , Anson Cheung MD, PhD , Thomas Modine MD, PhD , Ralph Stephan von Bardeleben MD, PhD , Shengshou Hu MD, PhD

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引用次数: 0

摘要

背景：经导管三尖瓣置换术（TTVR）正在成为高风险三尖瓣反流（TR）患者的一种有前景的手术选择。尽管如此，更多专用设备的可行性和对额外临床证据的需求值得进一步探索。目的：本研究的目的是报告使用LuX-Valve系统治疗严重TR患者的TRAVEL（经导管右房室瓣膜置换术）研究的1年结果。方法：从2020年6月至2021年8月，共有126例有症状的严重TR患者前瞻性地纳入了单组、多中心TRAVEL研究。所有患者均采用LuX-Valve系统经心房入路行TTVR。主要终点是随访1年的全因死亡率和心力衰竭住院率。报告了临床和超声心动图结果。结果：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（胸外科学会平均评分9.2%±4.4%），严重或更严重的TR和NYHA功能分级≥III。在1年的随访中，全因死亡率为10.3%，4.0%的患者因心力衰竭住院。95.2%的患者TR降至轻度或以下（P < 0.001），右心房收缩容积降低(-38.3±21.7 mL；P < 0.001)和右心室收缩末期内径(-6.4±2.3 mm；P < 0.001)。NYHA功能I级或II级达到79.8% (P < 0.001)， 6分钟步行距离增加71.3±42.8 m （P < 0.001）。结论：TRAVEL研究的1年结果显示，在接受LuX-Valve TTVR的患者中，TR持续降低，并伴有显著的右心反向重构和功能状态改善。良好的手术成功和生存效益也被证明。TRAVEL试验：经导管右房室瓣膜置换术；NCT04436653)。

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Transcatheter Tricuspid Valve Replacement With the Novel System

Background

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.

Objectives

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.

Methods

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.

Results

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).

Conclusions

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)

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来源期刊

JACC. Cardiovascular interventions CARDIAC & CARDIOVASCULAR SYSTEMS-

CiteScore

11.60

自引率

8.80%

发文量

756

审稿时长

4-8 weeks

期刊介绍： JACC: Cardiovascular Interventions is a specialist journal launched by the Journal of the American College of Cardiology (JACC). It covers the entire field of interventional cardiovascular medicine, including cardiac, peripheral, and cerebrovascular interventions. The journal publishes studies that will impact the practice of interventional cardiovascular medicine, including clinical trials, experimental studies, and in-depth discussions by respected experts. To enhance visual understanding, the journal is published both in print and electronically, utilizing the latest technologies.