Medical University of South Carolina, Charleston, South Carolina, USA; Ralph H. Johnson Veterans Affairs Medical Center, Charleston, South Carolina, USA.
Corvia Medical Inc, Tewksbury, Massachusetts, USA.
JACC Heart Fail. 2023 Aug;11(8 Pt 2):1103-1117. doi: 10.1016/j.jchf.2023.01.030. Epub 2023 Mar 20.
Many patients with heart failure and preserved ejection fraction have no overt volume overload and normal resting left atrial (LA) pressure.
This study sought to characterize patients with normal resting LA pressure (pulmonary capillary wedge pressure [PCWP] <15 mm Hg) but exercise-induced left atrial hypertension (EILAH).
The REDUCE LAP-HF II (A Study to Evaluate the Corvia Medical, Inc. IASD System II to Reduce Elevated Left Atrial Pressure in Patients With Heart Failure) trial randomized 626 patients with ejection fraction ≥40% and exercise PCWP ≥25 mm Hg to atrial shunt or sham procedure. The primary trial outcome, a hierarchical composite of death, heart failure hospitalization, intensification of diuretics, and change in health status was compared between patients with EILAH and those with heart failure and resting left atrial hypertension (RELAH).
Patients with EILAH (29%) had similar symptom severity, but lower natriuretic peptide levels, higher 6-minute walk distance, less atrial fibrillation, lower left ventricular mass, smaller LA volumes, lower E/e', and better LA strain. PCWP was lower at rest, but had a larger increase with exercise in EILAH. Neither group as a whole had a significant effect from shunt therapy vs sham. Patients with EILAH were more likely to have characteristics associated with atrial shunt responsiveness (peak exercise pulmonary vascular resistance <1.74 WU) and no pacemaker (63% vs 46%; P < 0.001). The win ratio for the primary outcome was 1.56 (P = 0.08) in patients with EILAH and 1.51 (P = 0.04) in those with RELAH when responder characteristics were present.
Patients with EILAH had similar symptom severity but less advanced myocardial and pulmonary vascular disease. This important subgroup may be difficult to diagnose without invasive exercise hemodynamics, but it has characteristics associated with favorable response to atrial shunt therapy. (A Study to Evaluate the Corvia Medical, Inc. IASD System II to Reduce Elevated Left Atrial Pressure in Patients With Heart Failure [REDUCE LAP-HF TRIAL II]; NCT03088033).
许多射血分数保留的心力衰竭患者没有明显的容量超负荷和正常静息左心房(LA)压。
本研究旨在描述静息左心房压正常(肺毛细血管楔压[PCWP]<15mmHg)但运动诱导左心房高压(EILAH)的患者特征。
REDUCE LAP-HF II 试验(一项评估 Corvia Medical, Inc. IASD 系统 II 降低射血分数≥40%和运动 PCWP≥25mmHg 的心力衰竭患者左心房压力升高的研究)将 626 例患者随机分为房缺分流或假手术组。主要试验终点为死亡、心力衰竭住院、利尿剂强化和健康状况改变的分层复合终点,比较 EILAH 患者与心力衰竭和静息左心房高压(RELAH)患者的差异。
EILAH 患者(29%)的症状严重程度相似,但利钠肽水平较低,6 分钟步行距离较长,心房颤动较少,左心室质量较低,左心房容积较小,E/e'较低,左心房应变较好。EILAH 患者静息时 PCWP 较低,但运动时增加更多。两组患者整体均未从分流治疗中获益。EILAH 患者更有可能具有与房缺分流反应性相关的特征(运动时肺动脉阻力峰值<1.74 WU)和无起搏器(63%比 46%;P<0.001)。当存在反应特征时,EILAH 患者的主要终点赢率为 1.56(P=0.08),RELAH 患者的赢率为 1.51(P=0.04)。
EILAH 患者的症状严重程度相似,但心肌和肺血管疾病程度较轻。如果没有侵入性运动血流动力学检查,这个重要的亚组可能难以诊断,但它具有与房缺分流治疗反应良好相关的特征。(评估 Corvia Medical, Inc. IASD 系统 II 降低心力衰竭患者左心房压力升高的研究[RE- DUCE LAP-HF 试验 II];NCT03088033)。