Baroreflex activation therapy for the treatment of heart failure with a reduced ejection fraction: safety and efficacy in patients with and without cardiac resynchronization therapy
Baroreflex activation therapy for the treatment of heart failure with a reduced ejection fraction: safety and efficacy in patients with and without cardiac resynchronization therapy
复制标题
DOI：
10.1002/ejhf.299
复制
发表时间：
2015-10-01
影响因子：
18.2
通讯作者：
Little, William C.
中科院分区：
文献类型：
--
作者：
Zile, Michael R.;Abraham, William T.;Little, William C.
目的交感神经活性增加和副交感神经活性降低导致心力衰竭(HF)症状和疾病进展。颈动脉压力感受器刺激(压力感受性反射激活疗法，BAT)导致中枢调节的交感神经减少和副交感神经活动增加。由于接受心脏再同步治疗(CRT)的患者可能出现较少的交感/副交感神经失衡，我们假设CRT患者与未接受CRT治疗的患者对BAT的反应可能存在差异。方法和结果纽约心脏协会(NYHA)III级射血分数(EF)为35%的患者被随机(1：1)分为正在进行的指南指导的医疗和装置治疗(GDMT，对照组)或正在进行的GDMT加BAT。安全终点为系统/程序相关的主要不良神经和心血管事件(MANCE)。治疗终点为明尼苏达州心力衰竭生活质量(QOL)、6分钟步行距离(6MHWD)、N末端脑利钠肽原(NT-proBNP)、左心室射血分数(LVEF)和心力衰竭住院率。在该样本中，146名患者被随机分配(70名对照组；76名BAT)，140名患者被激活(45名接受CRT治疗，95名不接受CRT治疗)。术后6个月无瘤生存率CRT组为100%，非CRT组为96%。在6个月时，无CRT组患者的QOL评分、6MHWD、LVEF、NT-proBNP和心衰住院时间较对照组明显改善。CRT组疗效终点的改变有利于BAT；但改善程度小于非CRT组，且与对照组相比无统计学差异。结论BAT是安全的，显著改善了接受GDMT治疗的NYHA III级心衰患者的生活质量、运动能力、NTproBNP、EF和心衰住院率。这些影响在未接受CRT治疗的患者中最为明显。
AimsIncreased sympathetic and decreased parasympathetic activity contribute to heart failure (HF) symptoms and disease progression. Carotid baroreceptor stimulation (baroreflex activation therapy, BAT) results in centrally mediated reduction of sympathetic and increase in parasympathetic activity. Because patients treated with cardiac resynchronization therapy (CRT) may have less sympathetic/parasympathetic imbalance, we hypothesized that there would be differences in the response to BAT in patients with CRT vs. those without CRT.Methods and resultsNew York Heart Association (NYHA) Class III patients with an ejection fraction (EF) 35% were randomized (1 : 1) to ongoing guideline-directed medical and device therapy (GDMT, control) or ongoing GDMT plus BAT. Safety endpoint was system-/procedure-related major adverse neurological and cardiovascular events (MANCE). Efficacy endpoints were Minnesota Living with Heart Failure Quality of Life (QoL), 6-min hall walk distance (6MHWD), N-terminal pro-brain natriuretic peptide (NT-proBNP), left ventricular ejection fraction (LVEF), and HF hospitalization rate. In this sample, 146 patients were randomized (70 control; 76 BAT) and were 140 activated (45 with CRT and 95 without CRT). MANCE-free rate at 6 months was 100% in CRT and 96% in no-CRT group. At 6 months, in the no-CRT group, QoL score, 6MHWD, LVEF, NT-proBNP and HF hospitalizations were significantly improved in BAT patients compared with controls. Changes in efficacy endpoints in the CRT group favoured BAT; however, the improvements were less than in the no-CRT group and were not statistically different from control.ConclusionsBAT is safe and significantly improved QoL, exercise capacity, NTpro-BNP, EF, and rate of HF hospitalizations in GDMT-treated NYHA Class III HF patients. These effects were most pronounced in patients not treated with CRT.