Objective Tricuspid regurgitation (TR) is a common valvular heart disease with unsatisfactory medical therapeutics and high surgical mortality. The present study aims to evaluate the safety and effectiveness of transcatheter tricuspid valve replacement (TTVR) in high-risk patients with severe TR. Methods This was a compassionate multicentre study. Between September 2018 and November 2019, 46 patients with TR who were not suitable for surgery received compassionate TTVR under general anaesthesia and the guidance of trans-oesophageal echocardiography and fluoroscopy in four institutions. Access to the tricuspid valve was obtained via a minimally invasive thoracotomy and transatrial approach. Patients’ data at baseline, before discharge, 30 days and 6 months after the procedure were collected. Results All patients had severe TR with vena contracta width of 12.6 (11.0, 14.5) mm. Procedural success (97.8%) was achieved in all but one case with right ventricle perforation. The procedural time was 150.0 (118.8, 180.0) min. Intensive care unit time was 2.0 (1.0, 4.0) days. 6-month mortality was 17.4%. Device migration occurred in one patient (2.4%) during follow-up. Transthoracic echocardiography at 6 months after operation showed TR was significantly reduced (none/trivial in 33, mild in 4 and moderate in 1) and the primary safety end point was achieved in 38 cases (82.6%). Patients suffered from peripheral oedema and ascites decreased from 100.0% and 47.8% at baseline to 2.6% and 0.0% at 6 months. Conclusions The present study showed TTVR was feasible, safe and with low complication rates in patients with severe TR. All data relevant to the study are included in the article or uploaded as supplementary information.

中文翻译：

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严重三尖瓣关闭不全患者经导管三尖瓣置换术

目的三尖瓣反流（TR）是一种常见的心脏瓣膜疾病，治疗效果不理想，手术死亡率高。本研究旨在评估经导管三尖瓣置换术 (TTVR) 在重度 TR 高危患者中的安全性和有效性。方法 这是一项富有同情心的多中心研究。2018年9月至2019年11月，46例不适合手术的TR患者在全麻下在4家机构经食管超声心动图和透视指导下接受了体恤TTVR。通过微创开胸术和经心房方法进入三尖瓣。收集患者在基线、出院前、手术后 30 天和 6 个月的数据。结果所有患者均出现严重TR，收缩静脉宽度为12.6（11.0，14.5）mm。除 1 例右心室穿孔外，其他所有病例均获得手术成功 (97.8%)。程序时间为 150.0 (118.8, 180.0) 分钟。重症监护病房时间为 2.0 (1.0, 4.0) 天。6 个月死亡率为 17.4%。在随访期间，一名患者 (2.4%) 发生了设备迁移。术后 6 个月经胸超声心动图显示 TR 显着降低（33 例无/微不足道，4 例轻度，1 例中度），38 例（82.6%）达到主要安全终点。患有外周水肿和腹水的患者从基线时的 100.0% 和 47.8% 下降到 6 个月时的 2.6% 和 0.0%。结论 本研究表明 TTVR 在严重 TR 患者中可行、安全且并发症发生率低。