美国阿伯特西北医院Paul Sorajja团队研究了三尖瓣反流患者经导管修复术后的临床预后。相关论文于2023年3月4日发表在《新英格兰医学杂志》上。

严重三尖瓣反流是一种使人衰弱的疾病，与较重发病率和较差生活质量有关。减少三尖瓣反流可减轻患者症状并改善临床结局。

研究组进行了一项经皮三尖瓣导管边缘对缘修复术（TEER）治疗严重三尖瓣反流的前瞻性随机试验。在美国、加拿大和欧洲的65个中心招募有症状的严重三尖瓣反流患者，并按1:1的比例随机分配接受TEER或药物治疗（对照）。主要终点是分层复合，包括全因死亡或三尖瓣手术；心力衰竭住院；以及用堪萨斯城心肌病问卷（KCCQ）测量的生活质量改善，改善定义为在1年随访中KCCQ得分至少增加15分（范围为0至100，得分越高表示生活质量越好）。还评估了三尖瓣反流的严重程度和安全性。

共有350名患者入组；每组175名。患者的平均年龄为78岁，54.9%为女性。主要终点的结果有利于TEER组（优势比为1.48）。两组之间死亡或三尖瓣手术的发生率以及心力衰竭住院率似乎没有差异。TEER组KCCQ生活质量评分的平均值为12.3分，而对照组为0.6分，组间差异显著。在30天时，TEER组87.0%的患者和对照组4.8%的患者三尖瓣反流的严重程度不超过中度。TEER是安全的；98.3%接受手术的患者在30天内没有发生重大不良事件。

研究结果表明，三尖瓣TEER对严重三尖瓣反流患者是安全的，降低了三尖瓣返流的严重程度，并与生活质量的改善相关。

附：英文原文

Title: Transcatheter Repair for Patients with Tricuspid Regurgitation | NEJM

Author: Paul Sorajja, M.D.,, Brian Whisenant, M.D.,, Nadira Hamid, M.D.,, Hursh Naik, M.D.,, Raj Makkar, M.D.,, Peter Tadros, M.D.,, Matthew J. Price, M.D.,, Gagan Singh, M.D.,, Neil Fam, M.D.,, Saibal Kar, M.D.,, Jonathan G. Schwartz, M.D.,, Shamir Mehta, M.D.,, Richard Bae, M.D.,, Nishant Sekaran, M.D.,, Travis Warner, M.D.,, Moody Makar, M.D.,, George Zorn, M.D.,, Erin M. Spinner, Ph.D.,, Phillip M. Trusty, Ph.D.,, Raymond Benza, M.D.,, Ulrich Jorde, M.D.,, Patrick McCarthy, M.D.,, Vinod Thourani, M.D.,, Gilbert H.L. Tang, M.D.,, Rebecca T. Hahn, M.D.,, and David H. Adams, M.D.

Issue&Volume: 2023-03-04

Abstract:

Background

Severe tricuspid regurgitation is a debilitating condition that is associated with substantial morbidity and often with poor quality of life. Decreasing tricuspid regurgitation may reduce symptoms and improve clinical outcomes in patients with this disease.

Methods

We conducted a prospective randomized trial of percutaneous tricuspid transcatheter edge-to-edge repair (TEER) for severe tricuspid regurgitation. Patients with symptomatic severe tricuspid regurgitation were enrolled at 65 centers in the United States, Canada, and Europe and were randomly assigned in a 1:1 ratio to receive either TEER or medical therapy (control). The primary end point was a hierarchical composite that included death from any cause or tricuspid-valve surgery; hospitalization for heart failure; and an improvement in quality of life as measured with the Kansas City Cardiomyopathy Questionnaire (KCCQ), with an improvement defined as an increase of at least 15 points in the KCCQ score (range, 0 to 100, with higher scores indicating better quality of life) at the 1-year follow-up. The severity of tricuspid regurgitation and safety were also assessed.

Results

A total of 350 patients were enrolled; 175 were assigned to each group. The mean age of the patients was 78 years, and 54.9% were women. The results for the primary end point favored the TEER group (win ratio, 1.48; 95% confidence interval, 1.06 to 2.13; P=0.02). The incidence of death or tricuspid-valve surgery and the rate of hospitalization for heart failure did not appear to differ between the groups. The KCCQ quality-of-life score changed by a mean (±SD) of 12.3±1.8 points in the TEER group, as compared with 0.6±1.8 points in the control group (P<0.001). At 30 days, 87.0% of the patients in the TEER group and 4.8% of those in the control group had tricuspid regurgitation of no greater than moderate severity (P<0.001). TEER was found to be safe; 98.3% of the patients who underwent the procedure were free from major adverse events at 30 days.

Conclusions

Tricuspid TEER was safe for patients with severe tricuspid regurgitation, reduced the severity of tricuspid regurgitation, and was associated with an improvement in quality of life.

DOI: 10.1056/NEJMoa2300525

Source: https://www.nejm.org/doi/full/10.1056/NEJMoa2300525