Department of Cardiovascular Surgery, Changhai Hospital, Second Military Medical University, Shanghai, China.
Department of Anesthesiology and Intensive Care, Changhai Hospital, Second Military Medical University, Shanghai, China.
Heart. 2021 Oct;107(20):1664-1670. doi: 10.1136/heartjnl-2020-318199. Epub 2021 Jan 8.
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.
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.
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.
The present study showed TTVR was feasible, safe and with low complication rates in patients with severe TR.
三尖瓣反流(TR)是一种常见的瓣膜性心脏病,其药物治疗效果不佳,手术死亡率高。本研究旨在评估经导管三尖瓣置换术(TTVR)在高危严重 TR 患者中的安全性和有效性。
这是一项同情性多中心研究。2018 年 9 月至 2019 年 11 月,46 例不适合手术的 TR 患者在全身麻醉下,经食管超声心动图和透视引导,在 4 家机构接受了同情性 TTVR。经微创开胸和经心房入路进入三尖瓣。收集患者术前、出院时、术后 30 天和 6 个月的基线数据。
所有患者均有严重的 TR,三尖瓣瓣口收缩期最小宽度为 12.6(11.0,14.5)mm。除 1 例发生右心室穿孔外,所有患者均获得手术成功。手术时间为 150.0(118.8,180.0)min。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%。1 例(2.4%)患者在随访中发生器械移位。术后 6 个月经胸超声心动图显示 TR 明显减轻(无/微量 33 例,轻度 4 例,中度 1 例),38 例(82.6%)达到主要安全性终点。患者外周水肿和腹水分别从基线时的 100.0%和 47.8%减少到 6 个月时的 2.6%和 0.0%。
本研究表明,TTVR 治疗严重 TR 患者是可行的、安全的,并发症发生率低。