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Device Therapy in Congestive Heart Failure

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Device Therapy in Congestive Heart Failure Teresa Menendez Hood, M.D., F.A.C.C. Up to 30 % of CHF patients have an IVCD (80% with a LBBB) which has been linked to ... – PowerPoint PPT presentation

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Title: 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.
6
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
.
7
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

9
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.

10
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.

13
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.
14
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.

15
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.

16
Cumulative Enrollment in Cardiac
Resynchronization Randomized Trials
17
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

18
PATH-CHF
19
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

20
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

21
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

22
MIRACLE
23
MIRACLE
Nonresponders older, ischemic CM, no MR,
QRSlt150 Responders had shorter duration on CHF
and longer QRSgt155
24
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)

25
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 .

26
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.

27
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.

28
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

29
COMPANION2004
Comparison of Medical Therapy, Pacing and
Defibrillation in Heart Failure
30
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

31
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

32
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

33
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)

34
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.

37
CS Leads they now come in many shapes and sizes
and the the OTW system
38
Achieving Cardiac Resynchronization
Goal Atrial synchronous biventricular
pacing Transvenous approach for left ventricular
lead via coronary sinus Back-up epicardial
approach
39
RAO is best to distinguish BASE position from
APEX
40
ANTERIOR
Anterior
LAO is best to distinguish LATERAL position
from SEPTAL
LATERAL
SEPTAL
Posterior Lateral
INFERIOR
41
LAO
42
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

43
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.

44
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.

45
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
46
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)

47
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

48
COMPANION Method QRS lt 150
Intrinsic QRS duration QRS 140 ms
Intracardiac AV interval AS to VS 300 ms
Sensed AV Delay
49
COMPANION Method QRS gt150
Intrinsic QRS duration QRS 180 ms
Intracardiac AV interval AS to VS 240 ms
Sensed AV Delay
50
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

51
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

52
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.

53
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.

54
Stages of Heart Failure
55
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.

56
Thank you
  • Any Questions?
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