Cardiac Rehabilitation and Electromyostimulation

Transcription

1 CREMS-HF Cardiac Rehabilitation and Electromyostimulation Dr Marie Christine Iliou Dr Bénédicte Vergès CREMS-HF study GERS SFC

2 Déclaration de Relations Professionnelles Disclosure Statement of Financial Interest J'ai actuellement, ou j'ai eu au cours des deux dernières années, une affiliation ou des intérêts financiers ou intérêts de tout ordre avec une société commerciale ou je reçois une rémunération ou des redevances ou des octrois de recherche d'une société commerciale : I currently have, or have had over the last two years, an affiliation or financial interests or interests of any order with a company or I receive compensation or fees or research grants with a commercial company : Affiliation/Financial Relationship Grant/Research Support Consulting Fees/Honoraria Major Stock Shareholder/Equity Royalty Income Ownership/Founder Intellectual Property Rights Other Financial Benefit Company ResMed Servier, Astra Zeneca Novartis, Boerhingher, Sanofi, Bayer, Actelion, MSD, Pfizer

3 Background EMS : High (strength) and low (endurance) frequencies In CHF = Low frequency (10-50 Hz) Previous studies : EMS as alternative to Ex T n = 38 n = Ex T EMS Harris S, Eur Heart J 2003;24:871 Deley G, EJCPR 2005;12:226

4 EMS meta-analysis Peak VO2 6 min W T Sbruzzi G, Eur J Cardiovasc Prev Rehab 2010;17:254-60

5 ExT combined with EMS 71 patients : 23 EMS (home), vs 26 ExT (endurance + resistance) vs 22 ExtT + EMS (%) QOL gain VO2 gain Soska V. Biomed Pap Med Fac Univ Palacky 2012;156

6 Design Ex T + EMS 1 h:10 Hz, 200 µsec, on/off:20/40 CHF Evaluation Randomization Evaluation Exercise Training Evaluation: CPx validation by 3 blinded reviewers, 6 walk test, muscular strength, biology, QOL

7 CREMS-study The primary outcome is the improvement of peak VO2 estimated by relative changes between before and at the end of the cardiac rehabilitation program Secondary end points include changes on muscular strength changes on sub maximal parameters (ventilatory threshold, 6 min walk test) Modifications of quality of life (Minnesota questionnaire) Identification of sub-groups of maximal benefits

8 Methods Inclusion criteria Exclusion criteria - age from 18 to 80 years - stable CHF under optimal treatment since at least 1 week - NYHA functional class II to IIIb - LVEF < 40% - Cardiopulmonary exercise test feasible with QR > 1 - whatever etiology of heart failure - previous treatment by EMS - recent acute heart failure, surgical or coronary episodes - valvular disease requiring surgical treatment - uncontrolled hypertension - severe respiratory insufficiency - pregnancy - Automatic implantable defibrillator - Pace-makers : cardiac stimulation dependence or not known - absolute contra-indication to exercise test and/or exercise training - Obesity (BMI > 35) - known peripheral myopathy - participation to another study protocol - refusal protocol

9 CREMS-HF flow chart )

10 Population I TRAINING (n=41) TRAINING + EMS (n=50) ALL (n=91) Age (years) 59,2 ± 7,2 57,6 ± 9,8 58,3 ± 8,7 Male sex (n, %) 32 (78) 38 (76) 70 (77 %) BMI 26,1 ± 3,8 26,1 ± 4,3 26,1 ± 4,1 HF Etiology (n, %) Ischemic DCM Others Sinus rythm (n, %) Atrial Fibrillation (n, %) NYHA class (n, %) II III 21 (52,5) 11 (27,5) 8 (20) 38 (92,7) 3 (7,3) 23 (56) 18 (44) 20 (40) 18 (36) 12 (24) 42 (84) 8 (16) 31 (62) 19 (36) 41 (45,6 %) 29 (32,2 %) 20 (22,2 %) 80 (88 %) 11 (12 %) 54 (59 %) 37 (41 %) LVEF (%) 30,4 ± 6,7 31,9 ± 4,4 30,7 ± 5,9 Treatment (n, %) Betablockers 41 (100) 50 (100) 91 (100 %) ACEi-ARB 41 (100) 50 (100) 91(100 %) Diuretics 33 (80) 47 (88) 80 (87 %) Antialdosterone 26 (63) 24 (48) 50 (55 %)

11 Population II Baseline TRAINING (n=41) TRAINING + EMS (n=50) Workload (watts) 79.1 ± ± 25 Peak VO2 (ml/kg/min) 16.8 ± ± 5 Max HR (b/min) 113 ± ± 25 VT (ml/kg/min) 12.2 ± ± 3 6 walk test (m) 448 ± ± 89 QOL (Minnesota) 37.5 ± ± 20 Program Sessions Sessions ET (n) (min) Sessions EMS (n) (min) 19.4 ± 4 35 ± ± 3 39 ± ± 4 59 ± 4

12 Compliance Training sessions EMS sessions N sessions performed/ n sessions scheduled 94,2 % 95,3 % Prescribed HR 98,7 ± 15,7 HR reached 91,6 ± 15,0 Borg scale 12,1 ± 2,2 Visible contraction 91 % EVA (/10) 3,8 ± 2,7 Tolerated amplitude (ma) 48,2 ± 19,2

13 * Results : main outcome ns * ns * *

14 Secondary Outcomes

15 Safety and tolerability Skin pb (electrodes allergy) Paresthesia Varicula 1000 / 1049 EMS sessions 16 sessions 3 sessions 3 sessions Withdrawn 0

16 Summary Low frequency EMS is safe in CHF patients Exercise training significantly improve exercise tolerance EMS + Ex Training does not demonstrate any significant additional improvement in exercise capacity

17 Conclusions Improvement in exercise tolerance, enhancement of peak VO2 and favorable modification of the quality of life in patients with CHF are obtained by a personalized exercise training program. EMS of skeletal lower limbs may constitutes an alternative suitable effective training for patients who cannot perform conventional exercise training programs.

18 Acknowledgements J P Mabire - CH de la Cote Fleurie- Criqueboeuf B Pavy CH Loire Vendée Océan Machecoul C Bosse Pillon Clinique St Yves Rennes Y Morvan - CH Joigny - Joigny E Kessler - CH Saint Luc - Abreschwiller M Ghannem Fondation L Bellan - Tracy le Mont J C Eicher CHU Dijon Dijon P Meurin Les Grands Prés Villeneuve St Denis CPx Reviewers : R Richard, JC Verdier, C Monpère