Brigham and Women's Hospital, Boston, MA.
NorthShore University Health System, Evanston, IL.
Am Heart J. 2020 Aug;226:222-231. doi: 10.1016/j.ahj.2019.10.015. Epub 2019 Nov 11.
A randomized, sham-controlled trial in patients with heart failure (HF) and left ventricular ejection fraction (LVEF) ≥40% demonstrated reductions in pulmonary capillary wedge pressure (PCWP) with a novel transcatheter InterAtrial Shunt Device (IASD). Whether this hemodynamic effect will translate to an improvement in cardiovascular outcomes and symptoms requires additional study.
REDUCE Elevated Left Atrial Pressure in Patients with Heart Failure II (REDUCE LAP HF-II) is a multicenter, prospective, randomized, sham-controlled, blinded trial designed to evaluate the clinical efficacy of the IASD in symptomatic HF and elevated left atrial pressures. Up to 608 HF patients age ≥ 40 years with LVEF ≥40%, PCWP ≥25 mm Hg during supine ergometer exercise, and PCWP ≥5 mm Hg higher than right atrial pressure will be randomized 1:1 to the IASD versus sham control. Key exclusion criteria include hemodynamically significant valvular disease, evidence of pulmonary arterial hypertension, and right heart dysfunction. The primary endpoint is a hierarchical composite, analyzed by the Finkelstein-Schoenfeld methodology, that includes (1) cardiovascular mortality or first nonfatal ischemic stroke through 12 months; (2) total (first plus recurrent) HF hospitalizations or healthcare facility visits for intravenous diuretics up to 24 months, analyzed when the last randomized patient completes 12 months of follow-up; and (3) change in Kansas City Cardiomyopathy Questionnaire overall summary score from baseline to 12 months. Follow-up echocardiography will be performed at 6, 12, and 24 months to evaluate shunt flow and cardiac chamber size/function. Patients will be followed for a total of 5 years after the index procedure.
REDUCE LAP-HF II is designed to evaluate the clinical efficacy of the IASD device in patients with symptomatic HF with elevated left atrial pressure and LVEF ≥40%.
一项针对心力衰竭（HF）且左心室射血分数（LVEF）≥40%患者的随机、假对照试验表明，新型经导管房间隔分流装置（IASD）可降低肺毛细血管楔压（PCWP）。这种血流动力学效应是否会转化为心血管结局和症状的改善，还需要进一步研究。
心力衰竭伴左心房压力升高患者降低压力 II 期（RE- DUCELAPHF-II）是一项多中心、前瞻性、随机、假对照、盲法试验，旨在评估 IASD 对有症状的 HF 和左心房压力升高患者的临床疗效。多达 608 例年龄≥40 岁、LVEF≥40%、仰卧位测力计运动时 PCWP≥25mmHg、PCWP 比右心房压高≥5mmHg 的 HF 患者将按 1:1 随机分为 IASD 组和假对照组。主要排除标准包括血流动力学显著的瓣膜疾病、肺动脉高压证据和右心功能障碍。主要终点是采用芬克尔斯坦-舍恩菲尔德方法分析的分层复合终点，包括（1）12 个月时心血管死亡或首次非致命性缺血性卒中；（2）24 个月内总（首次和再次）HF 住院或因静脉利尿剂就诊的次数，当最后一名随机患者完成 12 个月的随访时进行分析；（3）从基线到 12 个月时堪萨斯城心肌病问卷整体综合评分的变化。将在 6、12 和 24 个月进行随访超声心动图检查，以评估分流流量和心腔大小/功能。在索引手术后，患者将总共随访 5 年。
RE-DUCELAP-HF-II 旨在评估 IASD 装置在有症状的 HF 伴左心房压力升高且 LVEF≥40%的患者中的临床疗效。
