美国西北大学范伯格医学院Sanjiv J Shah团队研究了心房分流装置治疗射血分数保留并轻度降低的心力衰竭患者的疗效。这一研究成果发表在2022年2月2日出版的《柳叶刀》杂志上。

在心力衰竭和射血分数保留或轻度降低的患者中，放置心房分流器可降低运动期间的肺毛细血管楔压。该研究旨在调查心房分流装置是否可减少心力衰竭事件或改善这些患者的健康状况。

研究组在89家医疗中心进行了一项随机、国际、双盲、假对照试验，纳入年龄≥40岁、有症状性心力衰竭、射血分数至少为40%、运动期间肺毛细血管楔压至少为25mmHg，同时超过右心房压至少5mmHg的患者。患者被随机分配（1:1）接受心房分流手术或假手术。

患者和结果评估者双盲。主要终点是12个月时的心血管死亡或非致命性缺血性卒中发生率、24个月时的总心衰事件发生率以及12个月时堪萨斯城心肌病问卷总体得分的变化。对心力衰竭事件终点进行预先指定的亚组分析。主要终点、所有其他疗效终点和安全终点的分析均在改良意向治疗人群中进行，该人群定义为随机分配接受治疗的所有患者，不包括随机化后发现不合格未接受治疗的患者。

2017年5月25日至2020年7月24日，研究组共招募了1072名参与者，其中626人被随机分配，314人接受心房分流术，312人接受假手术。两组在主要综合终点或主要终点的各个组成部分上没有差异。预先指定的亚组显示心房分流术治疗对心力衰竭事件有不同的效果，运动20W时的肺动脉收缩压>70mmHg时预后较差，右心房容积指数≥29.7ml/m²时预后较差，男性预后较差。两组之间的复合安全终点没有差异，分别为38%与31%。

研究结果表明，放置心房分流器并没有降低心衰事件的总发生率，也没有改善心衰患者和射血分数≥40%患者的健康状况。

附：英文原文

Title: Atrial shunt device for heart failure with preserved and mildly reduced ejection fraction (REDUCE LAP-HF II): a randomised, multicentre, blinded, sham-controlled trial

Author: Sanjiv J Shah, Barry A Borlaug, Eugene S Chung, Donald E Cutlip, Philippe Debonnaire, Peter S Fail, Qi Gao, Gerd Hasenfu, Rami Kahwash, David M Kaye, Sheldon E Litwin, Philipp Lurz, Joseph M Massaro, Rajeev C Mohan, Mark J Ricciardi, Scott D Solomon, Aaron L Sverdlov, Vijendra Swarup, Dirk J van Veldhuisen, Sebastian Winkler, Martin B Leon, Joseph Akar, Jiro Ando, Toshihisa Anzai, Masanori Asakura, Steven Bailey, Anupam Basuray, Fabrice Bauer, Martin Bergmann, John Blair, Jeffrey Cavendish, Eugene Chung, Maja Cikes, Ira Dauber, Erwan Donal, Jean-Christophe Eicher, Peter Fail, James Flaherty, Xavier Freixa, Sameer Gafoor, Zachary Gertz, Robert Gordon, Marco Guazzi, Cesar Guerrero-Miranda, Deepak Gupta, Finn Gustafsson, Cyrus Hadadi, Emad Hakemi, Louis Handoko, Moritz Hass, Jorg Hausleiter, Christopher Hayward, Gavin Hickey, Scott Hummel, Imad Hussain, Richard Isnard, Chisato Izumi, Guillaume Jondeau, Elizabeth Juneman, Koichiro Kinugawa, Robert Kipperman, Bartek Krakowiak, Selim Krim, Joshua Larned, Gregory Lewis, Erik Lipsic, Anthony Magalski, Sula Mazimba, Jeremy Mazurek, Michele McGrady, Scott Mckenzie, Shamir Mehta, John Mignone, Hakim Morsli, Ajith Nair, Thomas Noel, James Orford, Kishan Parikh, Tiffany Patterson, Martin Penicka, Mark Petrie, Burkert Pieske, Martijn Post, Philip Raake, Alicia Romero, John Ryan, Yoshihiko Saito, Takafumi Sakamoto, Yasushi Sakata, Michael Samara, Kumar Satya, Andrew Sindone, Randall Starling, Jean-Nol Trochu, Bharathi Upadhya, Jan van der Heyden, Vanessa van Empel, Amit Varma, Amanda Vest, Tobias Wengenmayer, Ralf Westenfeld, Dirk Westermann, Kazuhiro Yamamoto, Andreas Zirlik

Issue&Volume: 2022-02-02

Abstract:

Background

Placement of an interatrial shunt device reduces pulmonary capillary wedge pressure during exercise in patients with heart failure and preserved or mildly reduced ejection fraction. We aimed to investigate whether an interatrial shunt can reduce heart failure events or improve health status in these patients.

Methods

In this randomised, international, blinded, sham-controlled trial performed at 89 health-care centres, we included patients (aged ≥40 years) with symptomatic heart failure, an ejection fraction of at least 40%, and pulmonary capillary wedge pressure during exercise of at least 25 mm Hg while exceeding right atrial pressure by at least 5 mm Hg. Patients were randomly assigned (1:1) to receive either a shunt device or sham procedure. Patients and outcome assessors were masked to randomisation. The primary endpoint was a hierarchical composite of cardiovascular death or non-fatal ischemic stroke at 12 months, rate of total heart failure events up to 24 months, and change in Kansas City Cardiomyopathy Questionnaire overall summary score at 12 months. Pre-specified subgroup analyses were conducted for the heart failure event endpoint. Analysis of the primary endpoint, all other efficacy endpoints, and safety endpoints was conducted in the modified intention-to-treat population, defined as all patients randomly allocated to receive treatment, excluding those found to be ineligible after randomisation and therefore not treated. This study is registered with ClinicalTrials.gov, NCT03088033.

Findings

Between May 25, 2017, and July 24, 2020, 1072 participants were enrolled, of whom 626 were randomly assigned to either the atrial shunt device (n=314) or sham procedure (n=312). There were no differences between groups in the primary composite endpoint (win ratio 1·0 [95% CI 0·8–1·2]; p=0·85) or in the individual components of the primary endpoint. The prespecified subgroups demonstrating a differential effect of atrial shunt device treatment on heart failure events were pulmonary artery systolic pressure at 20W of exercise (pinteraction=0·002 [>70 mm Hg associated with worse outcomes]), right atrial volume index (pinteraction=0·012 [≥29·7 mL/m2, worse outcomes]), and sex (pinteraction=0·02 [men, worse outcomes]). There were no differences in the composite safety endpoint between the two groups (n=116 [38%] for shunt device vs n=97 [31%] for sham procedure; p=0·11).

Interpretation

Placement of an atrial shunt device did not reduce the total rate of heart failure events or improve health status in the overall population of patients with heart failure and ejection fraction of greater than or equal to 40%.

DOI: 10.1016/S0140-6736(22)00016-2

Source: https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(22)00016-2/fulltext