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Device Therapy in Congestive
Heart Failure
Teresa Menendez Hood, M.D., F.A.C.C.
Congestive Heart Failure
U.S.
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Annual
Incidence
Heart Failure
Prevalence
Annual
Mortality
400,000
5.0 million
250,000
Up to 30 % of CHF patients have an IVCD (80% with a LBBB) which
has been linked to increases in mortality and morbidity.
CHF is the leading cause hospitalizations in the US and uses up 5% of
the health care costs (1999 stats)
1-2% of the population and 6% of the population >65
Prevalence is on the rise.
NYHA Class-evaluates the disability
imposed on the patient
Class I
Class II
Class III
Asymptomatic
heart failure
ejection fraction
(EF) <40%
Mild symptomatic
heart failure
with ordinary
exertion
Moderate
symptomatic
heart failure
with less than
ordinary exertion
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The FDA and the ACC/AHA Guidelines have
approved biventricular pacing for class 3 and 4.
Class IV
Symptomatic
heart failure
at rest
Leading Causes of Death in the
U.S. You must combine
Septicemia
deaths from all cancers
to outnumber the deaths
from SCA each year.
Nephritis
Alzheimer’s Disease
Influenza/pneumonia
Diabetes
Accidents/injuries
Chronic lower respiratory diseases
Cerebrovascular disease
Other cardiac causes
Sudden cardiac arrest (SCA)
All other causes
All cancers
0%
5%
10%
15%
20%
25%
National Vital Statistics Report. Oct. 12, 2001;49(11).
MMWR. State-specific mortality from sudden cardiac death – US 1999. Feb 15, 2002;51:123-126.
SCD Rates in CHF Patients with LV
Dysfunction
Total Mortality
Sudden Death
Control Group Mortality
30
20
20
19
17
15
11
9
10
7
8
6
4
0
CHF-STAT
45 months
GESICA
13 months
SOLVD
V-HeFT I
41.4 months
27 months
MERIT-HF
12 months
CIBIS-II
16 months
CARVEDILOL-US
6 months
Total Mortality ~15-40%; SCD accounts for ~50% of the total deaths.
SCD in Heart Failure
QRS
Duration
(msec)
Cumulative Survival
100%
<90
90%
90-120
80%
120-170
170-220
70%
>220
60%
0
60 120 180 240 300 360
Days
.
• QRS duration is an
independent predictor
of mortality (>140 ms)
• Other factors are:
age, creatinine, EF,
and HR
SCD in Heart Failure
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Degree of SCD risk by class
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Mortality in NYHA class II is 5 to 15%
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Mortality in NYHA class III is 20 to 50%
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50 to 80% of the deaths are Sudden
Up to 50% of the deaths are Sudden
Mortality in NYHA class IV is 30 to 70%
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5 to 30% of deaths are Sudden
Right Ventricular Pacing
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RV apex pacing is harmful in patients with
LV dysfunction
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“Paced” LBBB
Abnormal LV activation
Reduced stroke volume
RV pacing
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MADIT II (2002) had a survival benefit
with the ICD but in a subgroup analysis,
there was an increase in heart failure
morbidity (more hospitalizations) felt due to
forced RV pacing compared to controls in
which no pacing was present.
MADIT II: Complications
New or Worsening HF
19.9%
20.00%
14.9%
10.00%
0.00%
• Intrinsic ventricular activation is
better for ICD patients with left
ventricular dysfunction who do not
“need” pacing.
(p= 0.09)
Conventional Therapy
N= 490
•RV pacing causes ventricular
dysynchrony and may lead to
worsening HF.
ICD Therapy
N= 742
•<10% of ICD patients have a Class
I pacing indication at the time of
implant.
•Physicians, when appropriate,
should consider programming of
ICDs to avoid frequent RV pacing.
DAVID — Dual Chamber and VVI
Implantable Defibrillator Trial
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ICD indication but no
indication for a
pacemaker
Ef < 40%
DDDR @ 70BPM
versus VVI 40 BPM
The Concept
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In most patients with an IVCD (QRS > 130 ms) ,
the presence of atrial-biventricular (RV + LV)
pacing will provide early stimulation to an
otherwise late segment of electrical activation in
the LV.
This should translate into an increase in the EF,
decrease of the LV dimension, improvement in the
QOL and NYHA class.
This may translate into an decrease in CHF
exacerbations , hospitalizations and a decrease in
mortality.
The Proof
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1994–1997: Mechanistic and both short- and
longer-term observational studies. Studies initially
used epicardial leads placed by thoracotomy or
thorascope.
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The first BiV pacer was implanted in 1994
1998–1999: Randomized, controlled studies to
assess exercise capacity, functional status, and
quality of life.
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There was development of transvenous leads via the
coronary sinus in to get to the LV.
Cohen TJ, Klein J. J Inva2002;14:48-53.
The Proof
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2000–2005: Randomized, controlled trials to assess
combined mortality and CHF hospitalization. Also
evaluated the combined benefit of ICD’s with CRT.
Future: Identify patients who will benefit from CRT along
with the QRS duration.This will use echocardiographic
markers of asynchrony.
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20% of patients do not respond to therapy in clinical trials with a
wide QRS and 50% patients with a narrow QRS/CHF have
asynchrony on echo and may benefit from this therapy.
If the QRS is < 150 then the chances of responding to BiVP is
~5%. It will be in this patient group of QRS of 120-150 ms where
preselection of responders will be most valuable.
The Cardiac
Resynchronization
Clinical Trials
PATH-CHF, MUSTIC, MIRACLE,
COMPANION, and CARE-HF*
*This is not a complete list of all the CRT trials and the dates given are
when the trial results were published.
Cumulative Patients
Cumulative Enrollment in Cardiac
Resynchronization Randomized
Trials
4000
CARE HF
MIRACLE ICD
3000
2000
1000
MIRACLE
MUSTIC AF
MIRACLE ICD II
MUSTIC SR
COMPANION
PATH CHF
PATH CHF II
CONTAK CD
0
1999
2000
2001
2002
2003
Results Presented
2004
2005
PATH-CHF: 1999
Pacing Therapy for Congestive Heart Failure
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This was the first multicenter trial and used the
standard endocardial RV lead and an epicardial
LV lead via thoracotomy or thorascope
Single blinded RCT
53 centers in Europe
41 patients
PATH-CHF
NYHA class III-IV
DCM
QRS > 120 ms
PR>150
Implant
Acute hemodynamic testing
Randomization 1:1
4 weeks
Best single chamber
CRT
8 weeks
No CRT
No CRT
CRT
Best single chamber
12 weeks
One year
Best mode
PATH-CHF
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Primary endpoints
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Secondary endpoints
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Peak VO2
Six-minute walk distance
Minnesota Living with Heart Failure score (QOL)
NYHA class
EF
Trend towards decrease in Hospitalizations
Acute hemodynamic testing revealed that the lateral and
posterolateral walls were the best target sites.
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The best responders were those with QRS>150 , long PR and
dP/dt < 700 mm Hg/s
MUSTIC: 2001
Multicenter Stimulation in CM
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European study with 67 patients
QRS>150, CHF, EF <35%
BiVP versus backup VVI pacing at 40 BPM
Increase in 6 minute walk time , QOL and Peak VO2
with BiVP and persisted for up to 12 months
60% decrease in CHF hospitalizations
First to use endocardial LV leads via the CS
No significant change in mortality, but a trend
towards an improvement.
Acute hemodynamic studies showed the mid lateral
wall to be the best site
MIRACLE:2002
Multi-center In Sync Randomized Clinical
Evaluation Trial
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Double blinded RCT
First US trial
Class 3 or 4, on OPT, QRS >130 ms, EF<35%
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Enrollment of 453 patients
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MIRACLE
NYHA class III-IV
LVEDD > 60 mm
QRS > 130 ms
Stable 3 month regimen of beta-blocker/ACE inhibitor
EF < 35%
Randomization
CRT on
CRT off
1- and 3-month follow-up
1- and 3-month follow-up
6-month follow-up
6-month follow-up
CRT on
Long-term follow-up
MIRACLE
P < 0.001
67%
Proportion
60%
40%
39%
34%
27%
20%
17%
16%
0%
Improved
Control N=225
No Change
Worsened
CRT N=228
Nonresponders: older, ischemic CM, no MR, QRS<150
Responders: had shorter duration on CHF and longer QRS>155
MIRACLE
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There was a decrease in hospitalizations of 50% at 6 months
and a trend towards a decrease in mortality.
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All other primary and secondary endpoints were met: 6 minute
walk time, peak Vo2, QOL, EF , NYHA class, LVEDD
Magnitude of improvement not influenced by degree of QRS
shortening with BiVP (average in all was –20msec)
FDA Approval
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The first CRT device was
approved by the FDA in
September 2001 .
The first CRT with an ICD was
approved by the FDA in May
2002 .
The primary ICD prevention trials
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MADIT 1 1996 required a positive EP study
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MUSTT 1999 required a positive EP study
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Madit 2 2002 prior MI (ischemic cardiomyopathy) and
EF<30% (no EP study required) ;60% had CHF and 50%
had QRS > 120 ms; resulted in a 31% decrease risk of
death and halted prematurely due to the positive effect of
the ICD: resulted in the FDA approving the ICD for
primary prevention this patient population, but only those
with a QRS > 120 ms.
The primary ICD prevention trial
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SCD-Heft 2005 The SCD-Heft trial
resulted in FDA approval of the ICD
January 2005 in patients with CHF and
EF<35 % that included both ischemic and
nonischemic cardiomyopathy for primary
prevention without a positive EP study or
ventricular ectopy . No QRS cutoff was
required.
ACC/AHA/NASPE 2002 Indications for
Cardiac Resynchronization Therapy
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Class II a ( Level A) Indication for Biventricular Pacing in
Dilated Cardiomyopathy
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Biventricular pacing in medically refractory,
symptomatic NYHA Class III/IV patients with
idiopathic dilated or ischemic cardiomyopathy,
prolonged QRS interval (130 msec), LV end diastolic
diameter 55mm, and LVEF 35%
COMPANION:2004
Comparison of Medical Therapy, Pacing
and
Defibrillation in Heart Failure
• OPT
Randomization
• OPT
• CRT
• OPT
• CRT-D
1
2
+
2
+
COMPANION
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Enrolled 1520 patients class 3 and 4, QRS >120ms
Primary endpoint: death or hospitalization for any cause
CRT met the primary endpoints and the CRT +/- ICD
significantly reduces mortality
This was the first to show mortality benefit from CRT
alone
Showed that patients with CRT also benefit from ICD therapy
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OPT had SCD in 36%, 23% in CRT and 2.9% in CRT+ICD
COMPANION
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CRT arm had 20% reduction in mortality and
hospitalization over OPT arm but it was not statistically
significant
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Significant reduction in CRT-ICD arm of 40% for
mortality over OPT arm (19% in OPT and 11% in CRTICD group)
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Study was halted prematurely due to its positive benefit.
•
Mean follow up was 16 months
CARE-HF : March 2005
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The effect of cardiac resynchronization on morbidity and
mortality in heart failure in 813 patients in Europe (
prospective multicenter RCT) with completed enrollment
by 2002
Large patient size and length of trial (average follow up of
29 months) allowed ability to asses effects of CRT
Looked at CRT alone (no ICD)
Patients with class 3 or 4, EF < 35%, QRS >120 ms
There was a 37% reduced mortality or first hospitalization
for a cardiac cause compared to OPT
CARE-HF
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All endpoints were met : EF, NYHA, QOL, BNP, Echo and
hemodynamic parameters
33% of the deaths in the CRT group were due to SCD
For every 9 devices, one death and 3 hospitalizations were
prevented
Echo criteria in patients with QRS 120-149ms to look for
asynchrony (had to have 2 of 3)
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Aortic pre-ejection delay of > 140 ms ( onset of QRS to Aortic
ejection)
Interventricular mechanical delay of >40 ms ( RV-LV)
Delayed activation of the postero-lateral LV wall (>50ms)
RA Anatomy
Anatomical Challenges
Enlarged right atrium
 Abnormal CS location
 Presence of valves in CS
 Altered CS angulation
 Acute branch take offs
 Tortuous vessel anatomy
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CRT Procedure and Device Related
Risks relative to CS placement
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CS lead dislogdement 8%
CS dissection or perforation 5%
Failure of lead placement 8%
Phrenic nerve stimulation 2%
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ALL other risks associated with pacer or ICD implantation
and anesthesia in these patients.
CS Leads they now come in many shapes and sizes and the the
OTW system
Achieving Cardiac
Resynchronization
Goal: Atrial synchronous
biventricular pacing
Right Atrial
Lead
Transvenous approach for left ventricular lead via
coronary sinus
Back-up epicardial approach
Left Ventricular
Lead
Right Ventricular
Lead
BASE
Anterior
Posterior
APEX
RAO is best
to
distinguish
BASE
position
from
APEX
ANTERIOR
Anterior
LAO is best
to
distinguish
LATERAL
position
from
SEPTAL
S
E
P
T
A
L
Posterior
Lateral
INFERIOR
L
A
T
E
R
A
L
LAO
The implant
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3 separate sticks via Seldinger technique in the subclavian
vein -can be done from the right but it is more difficult.
Use standard peel back sheaths for the RA and RV leads
The RV lead is positioned first - could develop CHB or VT so
it is good to have this in (screw-in or tined)
Advance the long guide sheath into the RA ( not to the CS)
Advance a Coronary Sinus EP catheter via the long guide
sheath into the CS – the LAO is the best: point towards the
spine.
Advance the sheath while pulling back on the CS catheter to
get the sheath into the CS
Some would use dye at this point to look at the anatomy of the
CS and its branches
The implant
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Advance the CS lead with or without the OTW system and
make sure you place it in a mid/lateral or posterolateral
position. Never go where the LAD would be but where the
obtuse marginals would be.
Test the CS lead including at 10 volts for phrenic nerve
stimulation
Pull back on the sheath until it is out of the OS, then peel it
out with a retention guide wire in the CS-be careful about
dislodgement
Position the atrial lead in the RAA (screw-in or tined)
Test the ICD with induction of VF twice separated by 3-5
minutes: can do at a later time if the time is > 4 hours or the
patient has been unstable in any way. Always use a high
energy device in these patients.
The 3 levels of asynchrony
1.
2.
3.
Intraventricular asynchrony is best treated by
placing the LV lead in the best anatomic
location-usually the lateral or posterolateral
(proven my multiple studies). Get the LV working.
Interventricular asynchrony is dealt with by
adjusting the V-V interval. Get the RV and the LV
to work together.
A-V asynchrony is dealt with by adjusting the A-V
interval. Get the atria and the ventricles working
together.
Posterolateral or Lateral walls are the best with LBBB where
the septum contracts first and then the lateral wall last.
Paced at most
mechanically
delayed LV site
Paced at any
other LV site
0
10%
P=0.04
9%
-5
-9.2
Improvement
8%
-10
6%
-15
4%
-20
2%
2%
0%
Change in LVEF [%]
-25
-30
P=0.04
-28.4
Change in LV
End-systolic Volume [ml]
CRT and Tissue Doppler Imaging -a measure of
intraventricular delay
• Measures
dyssynchronous (delayed)
contraction patterns @
different areas of the
ventricle
•Measure from the onset
of the QRS to the peak
systolic shortening of that
segment
•Defined as a segment
with > 50 ms delay: this
indicates intraventricular
delay or asynchrony by
ECHO criteria
•Colors: greenyellow-red (the
longest delay of >300
ms)
AV Delay Optimization Methods
1.
Electrocardiographic
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2.
COMPANION trial method
Echocardiographic (combined)
Aortic velocity time integral (VTI) methods
 Mitral velocity Doppler methods:E and A waves
 Ritter formula
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3.
Hemodynamic measurements
Pulse pressure method
 dP/dtmax method
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COMPANION Method:
QRS < 150
Intrinsic QRS duration:
QRS = 140 ms
Sensed AV Delay:
Intracardiac AV interval:
AS to VS = 300 ms
COMPANION Method:
QRS >150
Intrinsic QRS duration:
QRS = 180 ms
Sensed AV Delay:
Intracardiac AV interval:
AS to VS = 240 ms
Aortic VTI Method
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Objective:
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Identify the AV Delay that yields the maximum cardiac output
as determined by an aortic VTI measurement
Procedure:
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Obtain continuous wave Doppler echo of aortic valve outflow
to obtain VTI measurement
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Record VTI values over a range of programmed AV Delays
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Program the AV Delay value that yields the maximum aortic
VTI
Mitral Velocity Doppler Echo
Method
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Objective:
 Identify the AV Delay that maximizes LV filling using mitral velocity
echocardiographic measurements1
Procedure #1: “A-wave cutoff”
 Obtain transmitral Doppler echo at a “long” programmed AV Delay
during ventricular pacing
 Shorten the programmed AV Delay by 10-20 ms until the echo Doppler
A-wave becomes truncated (A wave is atrial contraction)
 Lengthen the programmed AV Delay back to the value where there is no
A-wave cutoff. This timing should enable ventricular contraction to occur
just at the end of atrial systole
V-V Timing: synchronize the RV
and the LV
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The best V-V setting by measuring the RVOT and LVOT via
PW Doppler
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V-V above > 40 ms is considered abnormal
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In normals, the RV will contract before the LV in the heart by
-20 ms
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LV and RV have different outputs in the newer devices that
allow sequential instead of simultaneous delivery of output
and thus allow for this to be programmable.
Therapy for Heart Failure
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EF <40%…then need to evaluate patient for etiology
of cardiomyopathy and begin to optimize medical
therapy.
If the patient is Class 3 or 4 , has a QRS> 130 ms, has
had a documented EF<35% for >9 months… then
consider for CRT-ICD.
Stages of Heart Failure
Summary
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Large number of patients studied in multiple RCTs.
CRT improves quality of life, exercise capacity,
functional capacity, EF, peak VO2.
CRT reduces the risk of mortality, worsening HF, and
hospitalizations for CHF.
CRT + ICD significantly reduces risk of mortality.
Thank you
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Any Questions?