近日，美国梅奥诊所医学与科学学院Mayra E Guerrero团队研究了经皮经导管瓣膜置换术治疗不适合手术或经导管边缘修复的二尖瓣反流患者的疗效。相关论文于2025年10月27日发表在《柳叶刀》杂志上。

严重二尖瓣返流的患者通常不适合手术或经导管边缘到边缘修复（TEER）。该研究旨在评估一种新的经皮经间隔经导管二尖瓣置换术（TMVR）系统在不适合手术或TEER患者中的1年预后。

在这项前瞻性、多中心、单臂、关键试验中，研究组在6个国家（美国、加拿大、英国、荷兰、以色列和澳大利亚）的56个中心招募了不适合手术或TEER的有症状的中度至重度或重度二尖瓣反流的成年患者（年龄≥18岁）。符合条件的患者使用SAPIEN M3系统（Edwards Lifesciences, Irvine， CA， USA）进行TMVR治疗。主要终点是治疗人群1年内全因死亡率和心力衰竭再住院率的非分级综合，与预先设定的45%的表现目标相比。

2020年6月9日至2023年10月10日期间，1171名患者接受了筛查，其中299名患者接受了治疗。283例（95%）患者30天随访，243例（81%）患者1年随访（中位随访1.4年[IQR 1·0 - 2.1]）。中位年龄为77.7岁（IQR为70·0 - 82·0），152名（51%）参与者自报为男性，147名（49%）参与者自报为女性，胸外科学会预测二尖瓣置换术30天死亡率的平均风险为6.6%。无术中死亡，无左心室流出道梗阻导致血流动力学损害，无转手术。主要终点率为25.2% (95% CI为20.6 - 30.6)，显著低于预先设定的45%的疗效目标（p< 0.0001）。

研究结果表明，经皮经间隔TMVR与SAPIEN M3系统有效减少二尖瓣反流，并发症和死亡率低。SAPIEN M3系统支持经皮TMVR作为不适合手术或TEER的患者的治疗选择。

附：英文原文

Title: Percutaneous transcatheter valve replacement in individuals with mitral regurgitation unsuitable for surgery or transcatheter edge-to-edge repair: a prospective, multicountry, single-arm trial

Author: Mayra E Guerrero, David V Daniels, Raj R Makkar, Vinod H Thourani, Federico M Asch, Michael Pham, Kamran I Muhammad, Adam B Greenbaum, Alejandro Vasquez, J Bradley Oldemeyer, Thom G Dahle, Charanjit Rihal, M Andrew Morse, Evelio Rodriguez, Brian P ONeill, Mark Russo, Brian Whisenant, Pradeep Yadav, Xiao Yu, Dee Dee Wang, Moody Makar, David A Baran, Paul Mahoney, Gautam Reddy, Philipp Blanke, John Webb, Curtiss Stinis, Matthew Price, Ignacio Inglessis-Azuaje, Nathaniel Langer, Samir Kapadia, Bassem Chehab, Brett Grizell, Jason Foerst, Jorge Castellanos, Matthew Summers, Ricardo Yaryura, George Zorn, Peter Tadros, John Wang, Michael Mullen, Oluseun Alli, Daniel Pu, Santiago Garcia, Biswajit Kar, Dale Murdoch, Frank Zidar, Faraz Kerendi, Hursh Naik, Josep Rodes-Cabau, Marvin Eng, Mohammad Ghani, Neil Fam, Nicolas Van Mieghem, Pranav Loyalka, Robert Cubeddu, Steven Burstein, Ali Gheissari, Charles Klodell, Ilie Bard, Mark Ricciardi, Martin Ng, Michael Young, Noah Jones, Mark Reisman, Somjot Brar, Vijay Iyer, Frank Van Der Kley, Mubashir Mumtaz, Ran Kornowski, Samer Garas, Simon Redwood, Pinak Shah, Paul Sorajja, Neil Gheewala, Thomas Waggoner, David Lasorda

Issue&Volume: 2025-10-27

Abstract:

Background

Patients with severe mitral regurgitation are frequently not candidates for surgery or transcatheter edge-to-edge repair (TEER). We aimed to evaluate 1-year outcomes of a novel percutaneous transseptal transcatheter mitral valve replacement (TMVR) system in patients unsuitable for surgery or TEER.

Methods

In this prospective, multicentre, single-arm, pivotal trial, adult patients (aged ≥18 years) with symptomatic moderate-to-severe or severe mitral regurgitation who were not suitable for surgery or TEER were recruited at 56 centres in six countries (the USA, Canada, the UK, the Netherlands, Israel, and Australia). Eligible patients were treated with TMVR using the SAPIEN M3 system (Edwards Lifesciences, Irvine, CA, USA). The primary endpoint was a non-hierarchical composite of all-cause mortality and heart failure rehospitalisation at 1 year in the as-treated population, compared with a prespecified performance goal of 45%. This trial is registered with ClinicalTrials.gov, NCT04153292, and is ongoing.

Findings

Between June 9, 2020, and Oct 10, 2023, 1171 patients were screened, of whom 299 were treated. Follow-up data were available for 283 (95%) patients at 30 days and 243 (81%) at 1 year (median follow-up 1·4 years [IQR 1·0–2·1]). The median age was 77·0 years (IQR 70·0–82·0), 152 (51%) participants self-reported as male and 147 (49%) as female, and the mean Society of Thoracic Surgeons predicted risk of 30-day mortality for mitral valve replacement was 6·6%. There were no intraprocedural deaths, no instances of left ventricular outflow tract obstruction causing haemodynamic compromise, and no conversions to surgery. The primary endpoint rate of 25·2% (95% CI 20·6–30·6) was significantly lower than the prespecified performance goal of 45% (p<0·0001).

Interpretation

Percutaneous transseptal TMVR with the SAPIEN M3 system effectively reduced mitral regurgitation with low rates of complications and mortality. These findings support percutaneous TMVR with the SAPIEN M3 system as a therapeutic option for patients who are unsuitable for surgery or TEER.

DOI: 10.1016/S0140-6736(25)02073-2

Source: https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(25)02073-2/abstract