Kadoglou Nikolaos Pe, Mandila Christina, Karavidas Apostolos, Farmakis Dimitrios, Matzaraki Vasiliki, Varounis Christos, Arapi Sofia, Perpinia Anastasia, Parissis John
1 Department of Cardiology, Catharina Hospital, The Netherlands.
2 Department of Cardiology, Attikon University Hospital, Greece.
Eur J Prev Cardiol. 2017 May;24(8):833-839. doi: 10.1177/2047487316687428. Epub 2017 Jan 12.
Background/design Functional electrical stimulation of lower limb muscles is an alternative method of training in patients with chronic heart failure (CHF). Although it improves exercise capacity in CHF, we performed a randomised, placebo-controlled study to investigate its effects on long-term clinical outcomes. Methods We randomly assigned 120 patients, aged 71 ± 8 years, with stable CHF (New York Heart Association (NYHA) class II/III (63%/37%), mean left ventricular ejection fraction 28 ± 5%), to either a 6-week functional electrical stimulation training programme or placebo. Patients were followed for up to 19 months for death and/or hospitalisation due to CHF decompensation. Results At baseline, there were no significant differences in demographic parameters, CHF severity and medications between groups. During a median follow-up of 383 days, 14 patients died (11 cardiac, three non-cardiac deaths), while 40 patients were hospitalised for CHF decompensation. Mortality did not differ between groups (log rank test P = 0.680), while the heart failure-related hospitalisation rate was significantly lower in the functional electrical stimulation group (hazard ratio (HR) 0.40, 95% confidence interval (CI) 0.21-0.78, P = 0.007). The latter difference remained significant after adjustment for prognostic factors: age, gender, baseline NYHA class and left ventricular ejection fraction (HR 0.22, 95% CI 0.10-0.46, P < 0.001). Compared to placebo, functional electrical stimulation training was associated with a lower occurrence of the composite endpoint (death or heart failure-related hospitalisation) after adjustment for the above-mentioned prognostic factors (HR 0.21, 95% CI 0.103-0.435, P < 0.001). However, that effect was mostly driven by the favourable change in hospitalisation rates. Conclusions In CHF patients, 6 weeks functional electrical stimulation training reduced the risk of heart failure-related hospitalisations, without affecting the mortality rate. The beneficial long-term effects of this alternative method of training require further investigation.
背景/设计 下肢肌肉功能性电刺激是慢性心力衰竭（CHF）患者的一种替代性训练方法。尽管它能提高CHF患者的运动能力，但我们进行了一项随机、安慰剂对照研究，以调查其对长期临床结局的影响。方法 我们将120例年龄为71±8岁、CHF病情稳定（纽约心脏协会（NYHA）II/III级（63%/37%），平均左心室射血分数28±5%）的患者随机分为为期6周的功能性电刺激训练组或安慰剂组。对患者进行长达19个月的随访，观察因CHF失代偿导致的死亡和/或住院情况。结果 基线时，两组在人口统计学参数、CHF严重程度和用药方面无显著差异。在中位随访383天期间，14例患者死亡（11例心脏性死亡，3例非心脏性死亡），40例患者因CHF失代偿住院。两组死亡率无差异（对数秩检验P = 0.680），而功能性电刺激组心力衰竭相关住院率显著更低（风险比（HR）0.40，95%置信区间（CI）0.21 - 0.78，P = 0.007）。在对预后因素（年龄、性别、基线NYHA分级和左心室射血分数）进行调整后，后者的差异仍然显著（HR 0.22，95%CI 0.10 - 0.46，P < 0.001）。与安慰剂相比，在对上述预后因素进行调整后，功能性电刺激训练与复合终点（死亡或心力衰竭相关住院）的发生率较低相关（HR 0.21，95%CI 0.103 - 0.435，P < 0.001）。然而，该效应主要由住院率的有利变化驱动。结论 在CHF患者中，6周的功能性电刺激训练降低了心力衰竭相关住院的风险，而不影响死亡率。这种替代性训练方法的有益长期效果需要进一步研究。
