spinal cord stimulation for heart failure stuart p. rosenberg, m.s. senior manager, neuromodulation...
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Spinal Cord Stimulation for Heart FailureStuart P. Rosenberg, M.S.
Senior Manager, Neuromodulation Research
Implantable Electronic Systems Division
St. Jude Medical
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Disclosures
I am an employee of St. Jude Medical.
I will be discussing unapproved and/or investigational uses of medical devices.
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Cardiac Dysfunction
Increased Sympathetic
Outflow
RAAS Activation
Fluid Overload
Heart failure is a progressive syndrome
HFSA Guidelines: Lindenfeld, J Card Fail, 2010Schrier, NEJM, 1999
Shortness of breath
Fatigue
Susceptibility to arrhythmias
Myocardial remodeling
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Modern HF treatment paradigm: drugs ± device
AHA/ACC HF Guidelines: Hunt, Circ, 2009
Anti-Sympathetic RxImplantable Cardioverter-Defibrillator (ICD)
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Can we treat patients with heart failure using electrical
neuromodulation?
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SCS for refractory angina pectoris
Promising clinical evidencefrom feasibility studies in man
Decreased frequency of anginal attacks1-3
Decreased nitrate & morphine consumption4-5
Improved functional class6-7 and QoL8,
Increased exercise capacity9-
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Stabilization of intrinsic cardiac nerves during ischemia in canine
Foreman, Cardiovasc Res, 2000
1 Greco, PACE, 19992 Hautvast, Clin Cardiol, 19983 De Jongste H, BHJ, 19944 Murphy, Pain, 19875 Andersen, Pain Clinic, 19956 TenVaarwerk. Heart, 1999
7 Sanderson, BMJ, 19928 Vulink, Intl Neurom, 19999 DeJongste, JACC, 199410 Hautvast, AHJ, 199811 Sanderson, EHJ, 1994
NOTE: SCS is not currently approved in the U.S. for use in treating angina pectoris
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SCS directly affects the heart’s electrical propertiesin healthy canine
Increasing Sympathetic Stimulation
Increasing Vagal Stimulation
Effect of SCS on Sinus Cycle Length
Olgin, J Cardiovasc Electrophysiol, 2002Bernstein, Heart Rhythm, 2012
No SCS
During SCS
Effect of SCS on Atrial Effective Refractory Period
(S1=400 ms)
NOTE: SCS is not currently approved in the U.S. for use in treating cardiac arrhythmia
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SCS improves LV function and reverse remodelingin canine HF
SCSSCS+MEDSMEDSCTRL
Lopshire, Circ, 2009
LVE
DD
(cm
)
BSLN After 2Wk 5Wk 10Wk HF
LVE
SD
(cm
)
BSLN After 2Wk 5Wk 10Wk HF
LVE
DD
(cm
)
BSLN After 2Wk 5Wk 10Wk HF
LVE
SD
(cm
)
BSLN After 2Wk 5Wk 10Wk HF
LV E
ject
ion
Fra
ctio
n (%
)
BSLN After 2Wk 5Wk 10Wk HF
Ser
um B
NP
(pg
/ml)
Systolic function
Reverse remodeling
Neurohormonal biomarkers
BSLN After 2Wk 5Wk 10Wk HF
Ser
um N
orep
inep
herin
e (p
g/m
l)
BSLN After 2Wk 5Wk 10Wk HF
Ser
um B
NP
(pg
/ml)
BSLN After 2Wk 5Wk 10Wk HF
Ser
um N
orep
inep
herin
e (p
g/m
l)
Sp
on
tan
eo
us
arr
hyt
hm
ias
(n)
Sp
on
tan
eo
us
arr
hyt
hm
ias
(n)
Ventricular tachyarrhythmias
NOTE: SCS is not currently approved in the U.S. for use in treating heart failure
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SCS improves LV contractility at reduced O2 demandin porcine HF
HF (No SCS)
During SCS
Liu,J Cardiovasc Electrophysiol, 2012
NOTE: SCS is not currently approved in the U.S. for use in treating heart failure
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SCS is promising at different stimulation durationsin porcine HF
BSLN MI MI+HF 2 Wk 6 Wk 10 Wk
Systolic function Serum Norepinephrine
Tse, ESC Congress (abstract presentation), Aug 2012
LVE
F (
%)
BS
LN
MI
MI+
HF
10 W
k
BS
LN
MI
MI+
HF
10 W
k
BS
LN
MI
MI+
HF
10 W
k
Noe
repi
neph
erin
e (p
g/m
L)
Control SCS 12 hr SCS 24 hr
NOTE: SCS is not currently approved in the U.S. for use in treating heart failure
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Neurostimulation of Spinal Nerves that Affect the Heart
SCS-HEART DEFEAT-HF TAME-HF
Sponsor The Methodist Hospital System(collaboration with SJM)
SJM MDT SJM
Principal Invest-igator
Guillermo Torre-Amione
Hung-Fat Tse Doug Zipes, Heinz Theres
Pierre Bordachar
Sites Houston Methodist, USA
~5 sites: Hong Kong & Australia
~30 sites: USA and EU
Bordeaux, FR
# Patients 10 20 250 20
Clinical Trial ID
NCT01124136 NCT01362725 NCT01112579 not yet registered
Several clinical trials are underway for SCS in HF
Neurostimulation of Spinal Nerves that Affect the Heart
SCS-HEART DEFEAT-HF TAME-HF
Sponsor The Methodist Hospital System(collaboration with SJM)
SJM MDT SJM
Principal Invest-igator
Guillermo Torre-Amione
Hung-Fat Tse Doug Zipes, Heinz Theres
Pierre Bordachar
Sites Houston Methodist, USA
~5 sites: Hong Kong & Australia
~30 sites: USA and EU
Bordeaux, FR
# Patients 10 20 250 20
Clinical Trial ID
NCT01124136 NCT01362725 NCT01112579 not yet registered
ClinicalTrials.gov and internal data
CAUTION Investigational device. Limited by Federal (or United States) law to investigational use.
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Promising early experience with SCS in HF patients
Torre, Heart Failure Society of America (poster presentation), Sep 2012
CAUTION Investigational device. Limited by Federal (or United States) law to investigational use.
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SCS for HF: What else do we need to know?
Mechanism of action
Target patient population and subgroup analyses
Duration, dosage, and other treatment parameters
Possible side effects and interactions with background therapies
NOTE: SCS is not currently approved in the U.S. for use in treating heart failure