title: Effect of functional electrical stimulation on cardiovascular outcomes in patients with chronic heart failure.
abstract: 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.
authors.affiliation: 1 Department of Cardiology, Catharina Hospital, The Netherlands.
authors.forename: Nikolaos Pe
authors.initials: NP
authors.lastname: Kadoglou
authors.affiliation: 2 Department of Cardiology, Attikon University Hospital, Greece.
authors.forename: Christina
authors.initials: C
authors.lastname: Mandila
authors.affiliation: 3 Department of Cardiology, General Hospital "G. Gennimatas", Greece.
authors.forename: Apostolos
authors.initials: A
authors.lastname: Karavidas
authors.affiliation: 2 Department of Cardiology, Attikon University Hospital, Greece.
authors.forename: Dimitrios
authors.initials: D
authors.lastname: Farmakis
authors.affiliation: 3 Department of Cardiology, General Hospital "G. Gennimatas", Greece.
authors.forename: Vasiliki
authors.initials: V
authors.lastname: Matzaraki
authors.affiliation: 2 Department of Cardiology, Attikon University Hospital, Greece.
authors.forename: Christos
authors.initials: C
authors.lastname: Varounis
authors.affiliation: 3 Department of Cardiology, General Hospital "G. Gennimatas", Greece.
authors.forename: Sofia
authors.initials: S
authors.lastname: Arapi
authors.affiliation: 3 Department of Cardiology, General Hospital "G. Gennimatas", Greece.
authors.forename: Anastasia
authors.initials: A
authors.lastname: Perpinia
authors.affiliation: 2 Department of Cardiology, Attikon University Hospital, Greece.
authors.forename: John
authors.initials: J
authors.lastname: Parissis
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D002908:Chronic Disease; D018450:Disease Progression; D004599:Electric Stimulation Therapy / Q000009:adverse effects / Q000379:methods* / Q000401:mortality; D005081:Exercise Therapy / Q000009:adverse effects / Q000379:methods* / Q000401:mortality; D017079:Exercise Tolerance; D005260:Female; D006333:Heart Failure / Q000175:diagnosis / Q000401:mortality / Q000503:physiopathology / Q000628:therapy*; D006760:Hospitalization; D006801:Humans; D053208:Kaplan-Meier Estimate; D035002:Lower Extremity; D008297:Male; D008875:Middle Aged; D009119:Muscle Contraction; D011446:Prospective Studies; D052097:Quadriceps Muscle / Q000294:innervation*; D013318:Stroke Volume; D013997:Time Factors; D016896:Treatment Outcome; D016277:Ventricular Function, Left
keywords: Chronic heart failure; functional electrical stimulation; heart failure decompensation; hospitalisation; mortality