Device Therapy in Congestive Heart Failure

1
Device Therapy in Congestive Heart Failure

Teresa Menendez Hood, M.D., F.A.C.C.
2
Congestive Heart Failure
Annual Incidence
Heart Failure Prevalence
Annual Mortality
5.0 million
400,000
250,000
U.S.

• 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
  gt65
• Prevalence is on the rise.

3
NYHA Class-evaluates the disability imposed on
the patient
Class I Asymptomatic heart failureejection
fraction (EF) lt40
Class II Mild symptomatic heart failure with
ordinary exertion
Class IV Symptomatic heart failure at rest
Class III Moderate symptomatic heart
failure with less than ordinary exertion

• The FDA and the ACC/AHA Guidelines have
  approved biventricular pacing for class 3 and 4.

4
Leading Causes of Death in the U.S.
Septicemia
You must combine deaths from all cancers to
outnumber the deaths from SCA each year.
Nephritis
Alzheimers 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,
200149(11). MMWR. State-specific mortality from
sudden cardiac death US 1999. Feb 15,
200251123-126.
5
SCD Rates in CHF Patients with LV Dysfunction
12 months
16 months
41.4 months
27 months
13 months
45 months
6 months
Total Mortality 15-40 SCD accounts for 50
of the total deaths.
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SCD in Heart Failure

• QRS duration is an independent predictor of
  mortality (gt140 ms)
• Other factors are age, creatinine, EF, and HR

QRS
100
Duration
(msec)
lt90
90
90
120
-
-
Cumulative Survival
80
120
170
-
-
170
220
-
-
70
gt220
60
0
60
120
180
240
300
360
Days
.
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SCD in Heart Failure

• Degree of SCD risk by class
• Mortality in NYHA class II is 5 to 15
• 50 to 80 of the deaths are Sudden
• Mortality in NYHA class III is 20 to 50
• Up to 50 of the deaths are Sudden
• Mortality in NYHA class IV is 30 to 70
• 5 to 30 of deaths are Sudden

8
Right Ventricular Pacing

• RV apex pacing is harmful in patients with LV
  dysfunction
• Paced LBBB
• Abnormal LV activation
• Reduced stroke volume

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RV pacing

• 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.

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MADIT II ComplicationsNew or Worsening HF

• RV pacing causes ventricular dysynchrony and may
  lead to worsening HF.
• Intrinsic ventricular activation is better for
  ICD patients with left ventricular dysfunction
  who do not need pacing.
• lt10 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.

11

DAVID Dual Chamber and VVI Implantable
Defibrillator Trial

• ICD indication but no indication for a pacemaker
• Ef lt 40
• DDDR _at_ 70BPM versus VVI 40 BPM

12
The Concept

• In most patients with an IVCD (QRS gt 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.

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The Proof

• 19941997 Mechanistic and both short- and
  longer-term observational studies. Studies
  initially used epicardial leads placed by
  thoracotomy or thorascope.
• The first BiV pacer was implanted in 1994
• 19981999 Randomized, controlled studies to
  assess exercise capacity, functional status, and
  quality of life.
• There was development of transvenous leads via
  the coronary sinus in to get to the LV.

Cohen TJ, Klein J. J Inva20021448-53.
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The Proof

• 20002005 Randomized, controlled trials to
  assess combined mortality and CHF
  hospitalization. Also evaluated the combined
  benefit of ICDs with CRT.
• Future Identify patients who will benefit from
  CRT along with the QRS duration.This will use
  echocardiographic markers of asynchrony.
• 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 lt 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.

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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.

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Cumulative Enrollment in Cardiac
Resynchronization Randomized Trials
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PATH-CHF 1999
Pacing Therapy for Congestive Heart Failure

• 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

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PATH-CHF
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PATH-CHF

• Primary endpoints
• Peak VO2
• Six-minute walk distance
• Secondary endpoints
• 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.
• The best responders were those with QRSgt150 ,
  long PR and dP/dt lt 700 mm Hg/s

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MUSTIC 2001Multicenter Stimulation in CM

• European study with 67 patients
• QRSgt150, CHF, EF lt35
• 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

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MIRACLE2002Multi-center In Sync Randomized
Clinical Evaluation Trial

• Double blinded RCT
• First US trial
• Class 3 or 4, on OPT, QRS gt130 ms, EFlt35
• Enrollment of 453 patients

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MIRACLE
23
MIRACLE
Nonresponders older, ischemic CM, no MR,
QRSlt150 Responders had shorter duration on CHF
and longer QRSgt155
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MIRACLE

• There was a decrease in hospitalizations of 50
  at 6 months and a trend towards a decrease in
  mortality.
• 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)

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FDA Approval

• 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 .

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The primary ICD prevention trials

• MADIT 1 1996 required a positive EP study
• MUSTT 1999 required a positive EP study
• Madit 2 2002 prior MI (ischemic cardiomyopathy)
  and EFlt30 (no EP study required) 60 had CHF
  and 50 had QRS gt 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 gt 120 ms.

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The primary ICD prevention trial

• SCD-Heft 2005 The SCD-Heft trial resulted in FDA
  approval of the ICD January 2005 in patients with
  CHF and EFlt35 that included both ischemic and
  nonischemic cardiomyopathy for primary prevention
  without a positive EP study or ventricular ectopy
  . No QRS cutoff was required.

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ACC/AHA/NASPE 2002 Indications for Cardiac
Resynchronization Therapy

• Class II a ( Level A) Indication for
  Biventricular Pacing in Dilated Cardiomyopathy
• 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

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COMPANION2004
Comparison of Medical Therapy, Pacing and
Defibrillation in Heart Failure
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COMPANION

• Enrolled 1520 patients class 3 and 4, QRS gt120ms
• 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
• OPT had SCD in 36, 23 in CRT and 2.9 in
  CRTICD

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COMPANION

• CRT arm had 20 reduction in mortality and
  hospitalization over OPT arm but it was not
  statistically significant
• Significant reduction in CRT-ICD arm of 40 for
  mortality over OPT arm (19 in OPT and 11 in
  CRT-ICD group)
• Study was halted prematurely due to its positive
  benefit.
• Mean follow up was 16 months

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CARE-HF March 2005

• 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 lt 35, QRS gt120 ms
• There was a 37 reduced mortality or first
  hospitalization for a cardiac cause compared to
  OPT

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CARE-HF

• 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)
• Aortic pre-ejection delay of gt 140 ms ( onset of
  QRS to Aortic ejection)
• Interventricular mechanical delay of gt40 ms (
  RV-LV)
• Delayed activation of the postero-lateral LV wall
  (gt50ms)

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RA Anatomy
35
Anatomical Challenges

• Enlarged right atrium
• Abnormal CS location
• Presence of valves in CS
• Altered CS angulation
• Acute branch take offs
• Tortuous vessel anatomy

36
CRT Procedure and Device Related Risks relative
to CS placement

• CS lead dislogdement 8
• CS dissection or perforation 5
• Failure of lead placement 8
• Phrenic nerve stimulation 2
• ALL other risks associated with pacer or ICD
  implantation and anesthesia in these patients.

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CS Leads they now come in many shapes and sizes
and the the OTW system
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Achieving Cardiac Resynchronization
Goal Atrial synchronous biventricular
pacing Transvenous approach for left ventricular
lead via coronary sinus Back-up epicardial
approach
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RAO is best to distinguish BASE position from
APEX
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ANTERIOR
Anterior
LAO is best to distinguish LATERAL position
from SEPTAL
LATERAL
SEPTAL
Posterior Lateral
INFERIOR
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LAO
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The implant

• 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

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The implant

• 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 gt 4 hours or the patient has been
  unstable in any way. Always use a high energy
  device in these patients.

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The 3 levels of asynchrony

1. 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.
2. Interventricular asynchrony is dealt with by
   adjusting the V-V interval. Get the RV and the LV
   to work together.
3. A-V asynchrony is dealt with by adjusting the A-V
   interval. Get the atria and the ventricles
   working together.

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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
P0.04
-5
9
8
-9.2
-10
6
Improvement
-15
4
-20
2
-25
-28.4
P0.04
2
-30
0
Change in LV End-systolic Volume ml
Change in LVEF
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CRT and Tissue Doppler Imaging -a measure of
intraventricular delay

• Measures dyssynchronous (delayed) contraction
  patterns _at_ 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 gt 50 ms delay this
  indicates intraventricular delay or asynchrony by
  ECHO criteria
• Colors green-yellow-red (the longest delay of
  gt300 ms)

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AV Delay Optimization Methods

• Electrocardiographic
• COMPANION trial method
• Echocardiographic (combined)
• Aortic velocity time integral (VTI) methods
• Mitral velocity Doppler methodsE and A waves
• Ritter formula
• Hemodynamic measurements
• Pulse pressure method
• dP/dtmax method

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COMPANION Method QRS lt 150
Intrinsic QRS duration QRS 140 ms
Intracardiac AV interval AS to VS 300 ms
Sensed AV Delay
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COMPANION Method QRS gt150
Intrinsic QRS duration QRS 180 ms
Intracardiac AV interval AS to VS 240 ms
Sensed AV Delay
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Aortic VTI Method

• Objective
• Identify the AV Delay that yields the maximum
  cardiac output as determined by an aortic VTI
  measurement
• Procedure
• Obtain continuous wave Doppler echo of aortic
  valve outflow to obtain VTI measurement
• Record VTI values over a range of programmed AV
  Delays
• Program the AV Delay value that yields the
  maximum aortic VTI

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Mitral Velocity Doppler Echo Method

• 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

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V-V Timing synchronize the RV and the LV

• The best V-V setting by measuring the RVOT and
  LVOT via PW Doppler
• V-V above gt 40 ms is considered abnormal
• In normals, the RV will contract before the LV
  in the heart by -20 ms
• 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.

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Therapy for Heart Failure

• EF lt40then need to evaluate patient for
  etiology of cardiomyopathy and begin to optimize
  medical therapy.
• If the patient is Class 3 or 4 , has a QRSgt 130
  ms, has had a documented EFlt35 for gt9 months
  then consider for CRT-ICD.

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Stages of Heart Failure
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Summary

• 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.

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Thank you

• Any Questions?