Prospective Multicenter Study of Myocardial Recovery Using Left Ventricular Assist Devices (RESTAGE-HF [Remission from Stage D Heart Failure]) Medium-Term and Primary End Point Results
Prospective Multicenter Study of Myocardial Recovery Using Left Ventricular Assist Devices (RESTAGE-HF [Remission from Stage D Heart Failure]) Medium-Term and Primary End Point Results
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DOI：
10.1161/circulationaha.120.046415
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发表时间：
2020-11-24
期刊：
影响因子：
37.8
通讯作者：
Rame, Jesus E.
中科院分区：
文献类型：
--
作者：
Birks, Emma J.;Drakos, Stavros G.;Rame, Jesus E.
背景技术背景：晚期慢性心力衰竭患者的左心室辅助装置（LVAD）卸载和血流动力学支持可显著改善心功能，允许LVAD移除;然而，通常认为其发生率较低。这项前瞻性多中心非随机研究（RESTAGE-HF [D期心力衰竭缓解]）研究了优化LVAD机械卸载方案，结合标准化特异性药物治疗以诱导逆转重塑和定期检测潜在心肌功能，是否可以产生较高的LVAD逆转发生率。从6个中心招募了40名接受Heartmate II LVAD的非缺血性心肌病慢性晚期心力衰竭患者。采用积极的药理学方案优化LVAD速度，并在降低的LVAD速度（6000 rpm，无净流量）下进行常规超声心动图检查，以检测潜在的心肌功能。主要终点是在18个月内心肌功能充分改善以达到心力衰竭持续缓解标准的患者比例（无移植/心室辅助装置/死亡）。LVAD前，年龄为35.1 ± 10.8岁，67.5%为男性，心力衰竭平均持续时间为20.8 ± 20.6个月，95%需要正性肌力药物，20%需要临时机械支持，左心室射血分数为14.5 ± 5.3%，舒张末期直径为7.33 ± 0.89 cm，收缩末期直径为6.74 ± 0.88 cm，肺动脉饱和度为46.7 ± 9.2%，肺毛细血管楔压为26.2 ± 7.6 mm Hg。4例入组患者因与研究程序无关的医学并发症而未接受方案。总体而言，40%（16/40）的入组患者达到了主要终点，P
BACKGROUND: Left ventricular assist device (LVAD) unloading and hemodynamic support in patients with advanced chronic heart failure can result in significant improvement in cardiac function allowing LVAD removal; however, the rate of this is generally considered to be low. This prospective multicenter nonrandomized study (RESTAGE-HF [Remission from Stage D Heart Failure]) investigated whether a protocol of optimized LVAD mechanical unloading, combined with standardized specific pharmacological therapy to induce reverse remodeling and regular testing of underlying myocardial function, could produce a higher incidence of LVAD explantation.METHODS: Forty patients with chronic advanced heart failure from nonischemic cardiomyopathy receiving the Heartmate II LVAD were enrolled from 6 centers. LVAD speed was optimized with an aggressive pharmacological regimen, and regular echocardiograms were performed at reduced LVAD speed (6000 rpm, no net flow) to test underlying myocardial function. The primary end point was the proportion of patients with sufficient improvement of myocardial function to reach criteria for explantation within 18 months with sustained remission from heart failure (freedom from transplant/ventricular assist device/death) at 12 months.RESULTS: Before LVAD, age was 35.1 +/- 10.8 years, 67.5% were men, heart failure mean duration was 20.8 +/- 20.6 months, 95% required inotropic and 20% temporary mechanical support, left ventricular ejection fraction was 14.5 +/- 5.3%, end-diastolic diameter was 7.33 +/- 0.89 cm, end-systolic diameter was 6.74 +/- 0.88 cm, pulmonary artery saturations were 46.7 +/- 9.2%, and pulmonary capillary wedge pressure was 26.2 +/- 7.6 mm Hg. Four enrolled patients did not undergo the protocol because of medical complications unrelated to the study procedures. Overall, 40% of all enrolled (16/40) patients achieved the primary end point, P