La stimulation vagaleNouveau traitement électrique de
l’insuffisance cardiaque ?
Philippe Mabo, CHU de Rennes
CARDIORUN 2014Boucan Canot, 3 octobre 2014
Mes relations avec l’industrieBourses de recherche:
Boston, Biotronik, Medtronic, St Jude Medical, Sorin Group
Lectures:Bayer, BMS, Boehringer, Boston, Meda-Pharma, Medtronic,St Jude Medical, Servier, Sorin Group
Consultant:Bayer, BMS, Boehringer, Boston, Biotronik, Daiichi-Sankyo,Meda-Pharma, Medtronic, Sorin Group
Le parcours thérapeutique de l’insuffisance cardiaque
TerminaleSévèreSymptomatiqueAsymptomatiquevérité de nsuffisance rdiaque
aitement
3,1 millions
10,2 millions
7,3 millions
1,5 millions
Nombre de personnes atteintes
22 millions de personnes au
Traitement médical
Défibrillateur resynchronisateur **
Revascularisation, chirurgie
Assistance circulatoireTransplantation
Autonomic Activity in Heart FailureSome Basics
mpathetic nerve hyperactivity• Consequently reduced
sympathetic neuronal density and responsiveness
• Abnormal Ca handling
• Apoptosis
duced Parasympathetic activity• Increased HR, Decreased HRV,
etc.
bnormal cardiac reflexes• Suppressed arterial baroreceptor
reflex
BBS?
sympatheticModulators
wer Devicesdostigmine
Sympathetic Tone Modulators
- Beta-blockers- RAAS- Aldosterone - Newer Devices
Sympathovagal Balance and the Heart
agal Nerve Stimulation for Heart FailureIntegrated care between HF, Neurosurgery and EP)
Fit®
atorFit®
ator
•Selective Nerve Cuff Electrode
•Standard Bipolar RV Lead
for Sensing
•Standard Bipolar RV Lead
for Sensing
CardioFit Pilot Protocol
32-patient, multi-center study in Europe
Patient population:– NYHA Class II-IV; LVEF 35%; – Medically stable for 3 months, including -blockers
Primary endpoints: device safety and side effects
Secondary endpoints:• Functional: NYHA, 6 MW, Quality Of Life (MN Living with Heart Failure ) • Structural: EF, EDV, ESV• Heart rate variability
23 patients with 12 month extended follow-up
Randomization and Follow-up
Randomized, parallel controlled (n=650)Intention to treat from randomizationClinic contact with Control group to balance CardioFit titration visitsPrimary endpoint: HF hospitalization and all cause mortality
The Baroreflex Activation System
•Impl nt la abe•Impl nt la abe
•B ror l xa efe
•A t v t on L sci ai ead
•B ror l xa efe
•A t v t on L sci ai ead
Pro r mm nga i g
Syst me
Pro r mm nga i g
Syst me
euromodulation with Spinal Cord Stimulation
Stimulation leads in epidural space; 2 hours TID of stimulationDevice in lumbar region
•T4
•T5
•RV lead
•RA lead •SCS
lead
Renal denervationProcedure:- Low energy RF- Full circumferential- 4-6 lesions- Catheter or balloon based procedure
evolving
Clinical Impact:- Deceased SNS activity- Restores impaired natriuresis- Decreased LV filling pressures- Increased LV function
Physiology Studies: PRESERVE Study (HF Network)
teforme de neurostimulation implantable évoluée
RFommunication
Analog cardiacsensing &
pacing
RAM/ROM
MEMSSensors
High voltageDefibrillation
Titaniumpackage
Hermetic package
MultichannelNeuro sensing
Neurostimulation
Vagal nerve
Low powerCPU