Effect of chronic neuromuscular electrical stimulation on primary cardiopulmonary exercise test variables in heart failure patients: A systematic review and meta-analysis (original) (raw)
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Revista Portuguesa de Cardiologia, 2019
The PARADIGM-HF population may be very different from real-world heart failure patients'' Resposta à Carta ao Editor «A população do PARADIGM-HF pode ser muito diferente do mundo real dos doentes com insuficiência cardíaca» To the Editor: As highlighted by our analysis, 1 the epidemiological study in Lima 2 pertinently quoted by Walter Calderón, and another two large registries, 3,4 patients from randomized trials are frequently different from those found in our daily practice. However, the results of the PARADIGM-HF trial are changing and will continue to change the way we treat patients with heart failure and reduced ejection fraction. Recently, the TRANSITION trial demonstrated the safety of sacubitril/valsartan when initiated prior to discharge from hospitalization for heart failure, achieving similar titration rates (62% vs. 68%), 5 and PIONEER-HF showed that in-hospital initiation of sacubitril/valsartan further reduced NT-proBNP values (ratio of NT-proBNP at week 4 and 8 to baseline value: 0.53 vs. 0.75). 6 Concluding, different pieces of an intricate puzzle are coming together, contributing to the widespread adoption of neuromodulation in patients with heart failure and reduced ejection fraction.
European Journal of Cardiovascular Prevention & Rehabilitation, 2010
Functional electrical stimulation (FES) produces beneficial effects in the treatment of patients with chronic heart failure (CHF), but studies carried out in these patients show small sample sizes and conflicting results. The aim of this metaanalysis was to systematically review the effect of treatment with FES compared with conventional aerobic exercise training (CA) or control group in patients with CHF. The search strategy included MEDLINE, LILACS, Physiotherapy Evidence Database and Cochrane Library. Randomized trials comparing FES versus CA or control group in the treatment of patients with CHF were included. Two reviewers independently extracted the data. Main analysis used a fixed-effects model. The search retrieved 794 articles, from which seven studies were included. Treatment with FES provided a smaller gain in peak VO 2 compared with CA{ -0.74 ml/kg/min [95% confidence interval (CI): -1.38 to -0.10]} . There was no difference in the muscle strength [ -0.33 Nm (95% CI: -4.56 to 3.90)] and in the distance of the 6-min walk test [2.73 m (95% CI: -15.39 to 20.85)] on comparing FES with CA. An increase in peak VO 2 of 2.78 ml/kg/min (95% CI: 1.44-4.13) was observed in FES versus the control group. Treatment with FES provides a similar gain in the distance of the 6-min walk test and in the muscle strength when compared with CA, but a small gain in the peak VO 2 . An increase in the peak VO 2 can be obtained with FES as compared with the control group. Thus, FES may be an alternative in relation with CA for patients with CHF and with those who are unable to perform this kind of exercise. Eur J Cardiovasc Prev
Effects of Nmes in Patients with Refractory Heart Failure
Skeletal muscle strength and mass are severely impaired in patients with chronic heart failure. The aim of the study was to determine the impact of Neuromuscular Electrical Stimulation (NMES) on the thigh muscles of this group of patients. Forty-two subjects with stable disease course were assigned randomly to a stimulation group (SG, mean age: 59y) and a control group (CG, mean age: 57y). A modified version of a space approved eight-channel electrical stimulation device was used to exercise SG for eight weeks. Control parameters were isometric and isokinetic thigh muscle strength and muscle cross sectional area (CSA). An increase in muscle strength of 22.7% for knee extensors and 35.4% for knee flexors could be demonstrated in SG while CG remained unchanged or decreased by 8.4% in extensor strength. CSA increased in SG by 15.5% and in CG by 1.7%. NMES of thigh muscles in patients with refractory heart failure is effective in increasing muscle strength and bulk.
International Journal of Cardiology, 2014
Background: Although cardiac contractility modulation (CCM) has emerged as a promising device treatment for heart failure (HF), the effect of CCM on functional capacity and quality of life has not been the subject of an individual patient data meta-analysis to determine its effect on measures of functional capacity and life quality. This meta-analysis is aimed at systematically reviewing the latest available randomized evidence on the effectiveness of CCM on functional capacity and quality of life indexes in patients with HF. Methods: The Cochrane Central Register of Controlled Trials, MEDLINE, and EMBASE were searched in May 2013 to identify eligible randomized controlled trials comparing CCM with sham treatment or usual care. Primary outcomes of interest were peak oxygen consumption, 6-minute walk test distance and quality of life measured by Minnesota Living With Heart Failure Questionnaire. There was no sufficient information to address safety. Mean difference and 95% confidence intervals (C.I.s) were calculated for continuous data using a fixed-effects model. Results: Three studies enrolling 641 participants were identified and included. Pooled analysis showed that, compared to control, CCM significantly improved peak oxygen consumption (mean difference +0.71, 95% C.I. 0.20 to 1.21 mL/kg/min, p = 0.006), 6-minute walk test distance (mean difference + 13.92, 95% C.I. − 0.08 to 27.91 m, p = 0.05) and quality of life measured by Minnesota Living With Heart Failure Questionnaire (mean difference −7.17, 95% C.I. −10.38 to −3.96, p b 0.0001). Conclusions: Meta-analysis of individual patient data from randomized trials suggests that CCM has significant if somewhat modest benefits in improving measures of functional capacity and quality of life.
Heart failure with reduced ejection fraction (HFrEF) represents a significant public health burden associated with incremental health care costs. Given the limitations associated with pharmacological autonomic regulation therapy (ART), device-based autonomic neuromodulation is on the horizon now for ART in those patients. This systematic review aimed primarily to determine the effect of ART by devices on functional status and quality of life (QOL) in patients with HFrEF. We performed a meta-analysis of five randomized controlled trials (1074 patients) comparing ART by devices versus optimal medical therapy (OMT) in HFrEF. We assessed pooled estimates of odds ratio (OR) for improvement in New York Heart Association (NYHA) class and mean differences (MD) in 6-minute hall walk distance (6-MHWD), Minnesota Living with Heart Failure Questionnaire (MLHFQ) score, N-terminal pro b-type natriuretic peptide (NT-proBNP) levels, and left ventricular end-systolic volume index (LVESVi) with their 95% confidence intervals (CIs) at 6-month follow-up. Compared to OMT alone, ART by devices in HFrEF significantly improves NYHA class (OR 2.26, 95% CI 1.33 to 3.83, P = 0.003), increases 6-MHWD (MD 45.53 m, 95% CI 30.61 to 60.45, P < 0.00001), improves MLHFQ score (MD − 10.59, 95% CI − 20.62 to − 0.57, P = 0.04) with neutral effect on NT-proBNP levels (MD − 236.5 pg/ml, 95% CI − 523.86 to 50.87, P = 0.11) and LVESVi (MD − 1.01 ml/m 2 , 95% CI − 4.49 to 2.47, P = 0.57). We concluded that device-based neuromodulation therapy significantly improves functional status and quality of life in patients with HFrEF.
Journal of Cardiac Failure, 2011
Background: Cardiac contractility modulation (CCM) signals are nonexcitatory electrical signals delivered during the absolute refractory period intended to improve contraction. We previously tested the safety and efficacy of CCM in 428 NYHA functional class III/IV heart failure patients with EF #35% and narrow QRS randomized to optimal medical treatment (OMT) plus CCM (n 5 215) versus OMTalone (n 5 213) and found no significant effect on ventilatory anaerobic threshold (VAT), the study's primary end point. In the present analysis, we sought to identify if there was a subgroup of patients who showed a response to CCM. Methods and Results: The protocol specified that multiregression analysis would be used to determine if baseline EF, NYHA functional class, pVO 2 , or etiology of heart failure influenced the impact of CCM on AT. Etiology and baseline pVO 2 did not affect efficacy. However, baseline NYHA functional class III and EF 2525% were significant predictors of increased efficacy. In this subgroup (comprising 97 OMT and 109 CCM patients, w48% of the entire population) VAT increased by 0.10 6 2.36 in CCM versus À0.54 6 1.83 mL kg À1 min À1 in OMT (P 5 .03) and pVO 2 increased by 0.34 6 3.11 in CCM versus À0.97 6 2.31 (P 5 .001) at 24 weeks compared with baseline; 44% of CCM versus 23% of OMT subjects showed improvement of 251 class in NYHA functional class (P 5 .002), and 59% of CCM versus 42% of OMT subjects showed a $10-point reduction in Minnesota Living with Heart Failure Questionnaire (P 5 .01). All of these findings were similar to those seen at 50 weeks. Conclusions: The results of this retrospective hypothesis-generating analysis indicate that CCM significantly improves objective parameters of exercise tolerance in a subgroup of patients characterized by normal QRS duration, NYHA functional class III symptoms, and EF O25%. (J Cardiac Fail 2011;-:1e8)
2009
Cardiopulmonary exercise testing (CPX) is a well-recognized assessment technique in patients with HF. Ventilatory efficiency, aerobic capacity and heart rate recovery are several parameters obtained from CPX that accurately reflect physiologic function and provide robust prognostic information. Pharmacotherapy is a vital component to the management of patients with HF. Numerous pharmacologic interventions, such as ACE inhibition and beta-blockade have demonstrated significant physiologic and prognostic improvement in this population. Furthermore, a number of investigations demonstrating a positive change in the CPX response resulting from a pharmacologic intervention now exist. Because CPX variables reflect pathophysiologic processes differently, their response to a given pharmacologic is unique. For example, beta-blockade has been shown to significantly improve ventilatory efficiency, one of the most powerful prognostic markers obtained from CPX, while not altering aerobic capacity or heart rate recovery. Conversely, ACE and phosphodiesterase-5 inhibition appears to improve ventilatory efficiency and aerobic capacity. Given the prognostic value of CPX, gauging its improvement from pharmacotherapy may be advantageous in facilitating optimal titration of medications. A comprehensive review describing the physiologic and prognostic importance of CPX in the context of pharmacotherapy does not exist. This mini review will: 1. Identify key CPX variables obtained from CPX including aerobic capacity, ventilatory efficiency and heart rate recovery, 2. Describe the physiologic and prognostic significance of CPX in the heart failure population, and, 3. Summarize the present body of evidence addressing the change in CPX in response to different pharmacologic interventions including beta-blockade, renin-angiotensin-aldosterone axis inhibition and sildenafil.
Journal of Cardiac Failure, 2010
Background: Functional electrical stimulation (FES) improves exercise capacity and quality of life in chronic heart failure (CHF) patients. However, there is no evidence regarding the effectiveness of this treatment modality according to the severity of CHF. This study compares the effectiveness of FES on exercise capacity, endothelial function, neurohormonal status, and emotional stress in New York Heart Association (NYHA) III-IV versus NYHA II patients. Methods and Results: Eighteen NYHA II and 13 age-and sex-matched NYHA III-IV patients with stable CHF (left ventricular ejection fraction !35%) underwent a 6-week FES training program. Questionnaires addressing quality of life (Kansas City Cardiomyopathy Questionnaire, functional and overall), and emotional stress (Zung self-rating depression scale, Beck Depression Inventory), as well as plasma B-type natriuretic peptide (BNP), 6-minute walking distance test (6MWT), and endothelial function (flowmediated dilatation [FMD]) were assessed at baseline and after completion of training protocol. 6MWT and plasma BNP improved significantly in 2 patient groups (both P ! .001) after training program. The improvement of BNP was statistically greater in NYHA III-IV patients posttreatment than in those with NYHA II class (F 5 315.342, P ! .001). Similarly, the improvement of 6MWT was statistically greater in NYHA III-IV group than in NYHA II patients (F 5 79.818, P ! .001). Finally, an FES-induced greater improvement of FMD (F 5 9.517, P 5 .004) and emotional stress scores was observed in NYHA III-IV patients in comparison to NYHA II patients. There was a higher proportion of NYHA III-IV patients adhering to the FES training program for additional 3 months compared with the NYHA II group of patients (76.9% vs. 55.6%, P ! .001). Conclusion: FES might exert a greater beneficial effect on clinical and neurohormonal status of NYHA III-IV patients in comparison to NYHA II patients. This effect may have important clinical relevance leading to increased adherence of severe CHF patients to exercise rehabilitation programs. (J Cardiac Fail 2010;16:244e249)