机械循环辅助支持的医疗臂（MedaMACS）注册研究中的门诊晚期心力衰竭的结果。
Outcomes with ambulatory advanced heart failure from the Medical Arm of Mechanically Assisted Circulatory Support (MedaMACS) Registry.
机构信息
Department of Medicine, Division of Cardiology, University of Colorado, Aurora, Colorado, USA.
Smidt Heart Institute, Cedars-Sinai Medical Center, Los Angeles, California, USA.
出版信息
J Heart Lung Transplant. 2019 Apr;38(4):408-417. doi: 10.1016/j.healun.2018.09.021. Epub 2018 Oct 1.
BACKGROUND
The outlook for ambulatory patients with advanced heart failure (HF) and the appropriate timing for left ventricular assist device (LVAD) or transplant remain uncertain. The aim of this study was to better understand disease trajectory and rates of progression to subsequent LVAD therapy and transplant in ambulatory advanced HF.
METHODS
Patients with advanced HF who were New York Heart Association (NYHA) Class III or IV and Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) Profiles 4 to 7, despite optimal medical therapy (without inotropic therapy), were enrolled across 11 centers and followed for the end-points of survival, transplantation, LVAD placement, and health-related quality of life. A secondary intention-to-treat survival analysis compared outcomes for MedaMACS patients with a matched group of Profile 4 to 7 patients with LVADs from the INTERMACS registry.
RESULTS
Between May 2013 and October 2015, 161 patients were enrolled with INTERMACS Profiles 4 (12%), 5 (32%), 6 (49%), and 7 (7%). By 2 years after enrollment, 75 (47%) patients had reached a primary end-point with 39 (24%) deaths, 17 (11%) undergoing LVAD implantation, and 19 (12%) receiving a transplant. Compared with 1,753 patients with Profiles 4 to 7 receiving LVAD therapy, there was no overall difference in intention-to-treat survival between medical and LVAD therapy, but survival with LVAD therapy was superior to medical therapy among Profile 4 and 5 patients (p = 0.0092). Baseline health-related quality of life was lower among patients receiving a LVAD than those enrolled on continuing oral medical therapy, but increased after 1 year for survivors in both cohorts.
CONCLUSIONS
Ambulatory patients with advanced HF are at high risk for poor outcomes, with only 53% alive on medical therapy after 2 years of follow-up. Survival was similar for medical and LVAD therapy in the overall cohort, which included the lower severity Profiles 6 and 7, but survival was better with LVAD therapy among patients in Profiles 4 and 5. Given the poor outcomes in this group of advanced HF patients, timely consideration of transplant and LVAD is of critical importance.
背景
对于门诊患有晚期心力衰竭（HF）的患者，以及左心室辅助装置（LVAD）或移植的适当时机仍然不确定。本研究的目的是更好地了解疾病轨迹以及进展为随后的 LVAD 治疗和移植的门诊高级 HF 的进展率。
方法
在 11 个中心招募了 NYHA 心功能分级 III 或 IV 级且 INTERMACS 机械循环支持登记册（INTERMACS）分级 4 至 7 级的晚期 HF 患者，尽管接受了最佳药物治疗（无正性肌力药物治疗），并随访至生存、移植、LVAD 植入和健康相关生活质量的终点。次要意向治疗生存分析比较了 MedaMACS 患者与 INTERMACS 登记册中具有 LVAD 的 Profile 4 至 7 患者匹配组的结局。
结果
在 2013 年 5 月至 2015 年 10 月期间，共招募了 161 名患者，其 INTERMACS 分级为 4 级（12%）、5 级（32%）、6 级（49%）和 7 级（7%）。在登记后 2 年内，75 名（47%）患者达到了主要终点，其中 39 名（24%）死亡，17 名（11%）植入 LVAD，19 名（12%）接受了移植。与接受 LVAD 治疗的 Profile 4 至 7 级 1753 名患者相比，药物和 LVAD 治疗的意向治疗生存无总体差异，但在 Profile 4 和 5 患者中，LVAD 治疗的生存优于药物治疗（p=0.0092）。与接受 LVAD 治疗的患者相比，接受 LVAD 治疗的患者的基线健康相关生活质量较低，但两组幸存者的生活质量在 1 年后均有所提高。
结论
门诊患有晚期 HF 的患者预后较差，在 2 年的随访后，仅 53%的患者接受药物治疗后存活。在整个队列中，药物和 LVAD 治疗的生存率相似，其中包括严重性较低的 Profile 6 和 7，但在 Profile 4 和 5 患者中，LVAD 治疗的生存率更高。鉴于这组晚期 HF 患者的预后较差，及时考虑移植和 LVAD 至关重要。
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