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The EP Show: New approaches to heart failure

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The EP Show: New approaches to heart failure. Eric Prystowsky MD ... Cleveland Clinic Foundation. Cleveland, OH. EP Show March 2003. Heart Failure ... – PowerPoint PPT presentation

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Title: The EP Show: New approaches to heart failure


1
The EP Show New approaches to heart failure
  • Eric Prystowsky MD Director, Clinical
    Electrophysiology Laboratory
    St Vincent Hospital Indianapolis, IN
  • Leslie Saxon MD Director of Electrophysiology U
    niversity of Southern California Los Angeles,
    CA
  • Gary Francis MD Director of Coronary Care
    Unit Cleveland Clinic Foundation Cleveland, OH

2
Pharmacologic approach
  • Dramatic changes in the past 15 to 20 years
  • ACE inhibitors and beta blockers are the
    cornerstone of therapy
  • Loop diuretics, spironolactone, and various
    adjunctive therapies remain
  • Francis

3
Dosing
  • Dosing in real practice rarely reflects dosing in
    controlled clinical trials
  • Dosing should be titrated up gradually (over
    several weeks)
  • Using higher doses than those used in trials is
    controversial there is no strong data supporting
    higher doses
  • Francis

4
Diastolic heart failure
  • We currently have no trials to dictate practice
    in these patients
  • In my practice I tend to treat these patients
    with diuretics (careful not to create a
    hypovolemic state)
  • These patients respond to ACE inhibitors and beta
    blockers
  • A regimen of ACE inhibitors, beta blockers, and
    diuretics seems to work
  • Francis

5
Resynchronization therapy
  • Epidemiological outcome studies showed bundle
    branch block had a negative impact on mortality
  • Early 1990s Heart failure patients with RV
    pacemakers didn't do very well
  • Mid-1990s The presence of bundle branch block
    worsens hemodynamics
  • Pacing both ventricles simultaneously seemed to
    improve the hemodynamics
  • Saxon

6
Pilot studies
  • 3 biventricular pacing trials gained approval for
    resynchronization devices in the US
  • MIRACLE
  • InSync ICD
  • CONTAK CD
  • Resynchronization therapy is now indicated for
    NYHA class 3 patients with QRS delay
  • Saxon

7
Functional improvement
  • All resynchronization therapy studies showed
    improvement in functional status
  • Symptom status
  • 6-minute walk
  • Quality of life
  • Peak oxygen consumption
  • Modest reverse remodeling
  • Saxon

8
Class 2 patients
Therapy is labeled for class 3 patients, but the
ICD trials did enroll class 2 patients Class 2
patients showed no significant improvement in
symptoms but did show remodeling benefit Saxon
9
COMPANION Enrollment
  • Enrollment began in 1998, enrolled 1600 patients
    with
  • QRSgt120 ms
  • P-R intervalgt150 ms
  • Class 3 heart failure
  • Hospitalization for heart failure in the past
    year

10
COMPANION End points
  • Patients were randomized to optimal medical
    therapy, cardiac resynchronization, or
    resynchronization with an ICD
  • Trial stopped in November 2002
  • 20 reduction in all-cause mortality and
    all-cause hospitalization in both device groups
  • 40 reduction in all-cause mortality in patients
    who received the combined resynchronization/ICD
    device

11
CARE-HF Enrollment
  • Enrollment began in 2001, enrolled 800 patients
    with
  • NYHA class 3/4
  • 18-month follow-up
  • Randomized to resynchronization or optimal
    medical management

12
Resynchronization therapy
  • It appears to meet the 3 goals of heart failure
    therapy
  • Improves functional status
  • Slows disease progression
  • Improves mortality and hospitalization end
    points
  • Saxon

13
Differing response
  • Patients on cardiac resynchronization fall into 3
    categories
  • Fabulous response, can improve up to 2 heart
    classes
  • "Tweeners" who get some benefit but not as much
    as we would like
  • 20 to 25 who don't respond at all
  • Prystowsky

14
Nonresponders
  • "This is the science that is going to keep the
    next generation of people busy."
  • We don't understand the relationship between QRS
    delay and mechanical dysynchrony
  • Saxon

15
Defining resynchronization
  • We don't understand how to define
    resynchronization
  • QRS delay correlates with ventricular size but
    does not predict clinical response
  • No gold standard of measuring mechanical
    dysynchrony or resynchronization--we simply don't
    know what the best measure is
  • Saxon

16
Lead location
  • Are nonresponders the result of bad lead
    placement?
  • Left bundle-branch block is an incredibly
    heterogeneous condition, and lead placement will
    be very patient specific
  • You should be able to get response in 70 or so
    even without perfect lead placement
  • Saxon

17
Optimal programming
  • We could get better results just from optimal
    programming of AV delay
  • New devices offer new options, but there is no
    established standard way to assess
    resynchronization
  • In my lab we are using echo to follow patients
    and treating the instrument like a drug, altering
    the parameters and finding the best response
  • Saxon

18
Increased expectations
Like all therapies, we found something that
works, and now we demand better and better
results "I'm getting from your thoughts that
we know the therapy works we have a lot of
fine-tuning to do." Prystowsky
19
Advancing the field
Since market approval, gt40 000 have been
implanted in the US These devices and patients
require a lot of attention the science needs to
be resolved "I've had several heart failure
people come up to me and say, 'You know in the
clinical trials our guys were getting results
with implants of 70, 80, 90, 90- plus percent and
now I think our results aren't as good." Saxon
20
Patient selection
  • At what point do you send a patient for
    resynchronization therapy?
  • It's not entirely clear, but the threshold for
    implantation is getting lower and lower
  • We find about one third of patients don't get
    better or have no change
  • We might accept those numbers if this were a
    drug
  • Francis

21
Patient selection
  • Candidates for resynchronization
  • Class 3 patient on full therapy who is still
    clinically struggling
  • Patients with late class 2 and possibly lower if
    we can refine the selection criteria
  • Patients receiving modified Dor procedure who
    don't do well
  • Francis

22
Patient dilemma
  • Patient with class 3 heart failure who isn't
    doing as well as we would like
  • IBCD
  • QRS duration 140 ms
  • EF 25
  • Is there any use for a biventricular pacemaker as
    opposed to a defibrillator in light of what we
    know about COMPANION?

23
Nonischemic cardiomyopathy
"In most instances I would at least bring up
the discussion of the defibrillator." Defibrillat
ors have not yet proved benefit in patients with
nonischemic cardiomyopathy At least 40 of
patients in COMPANION had nonischemic
cardiomyopathy As heart failure progresses, the
etiology may become less relevant Saxon
24
Synchronization device alone
  • There is a role for just synchronization therapy
    in advanced heart failure patients who have very
    poor outlook for 6-month survival
  • Start with a resynchronization device and if
    they respond well put in an ICD
  • It is no good if you put in an ICD, they don't
    get better, you give them lots of shocks and then
    have to take the ICD out
  • Saxon

25
Pacemakers as prevention
  • Could a pacemaker prevent class 2 patients from
    becoming class 3?
  • Does the antiremodeling effect become permanent
    if you pace long enough?
  • If there were permanence you could make an
    argument to use pacemakers in less-ill patients
  • Francis

26
Long-term pacing
  • Follow-up on the chronic trials goes out to 1
    year
  • The remodeling appears to be a direct effect of
    pacing
  • Out to 1 year, volumes improve but mass does not
    change
  • We don't see the same structural changes as with
    drugs, but it may happen in the future
  • Saxon

27
Pacing damage
Pacing just the right ventricle may alter the
heart in a negative way The recognition that we
can create dysynchrony that hurts the ventricle
should make us rethink pacing just the right side
Francis
28
Pacing the left ventricle
  • Patients with significant mitral regurgitation
    can be risky to pace just the right ventricle
  • Especially ones with an AV junction ablation can
    end up in the OR
  • Now that we have other options, we should think
    things through before just putting in an RV lead
    Prystowsky

29
Who follows these patients?
  • Electrophysiologists are putting the devices in,
    but should they follow up?
  • Will heart failure specialists have to learn how
    to implant these devices?
  • How would you develop a program for training for
    the future?
  • Prystowsky

30
Busy EP doctors
  • Electrophysiologists are just too busy to see
    these patients
  • It's unrealistic to expect them to come out of
    the lab 1 or 2 days a week to see these patients
  • We should expect a loose affiliation between
    heart failure specialists and EPs
  • Francis

31
Coordinating care
We scheduled the pacemaker clinic with the heart
failure clinic to allow better coordination of
care We trained heart failure fellows in EP for 3
or 4 months to give them an understanding of the
device area EPs could subspecialize into complex
ablation and device specialists who do
implantation and follow-up Saxon
32
Limited resources
  • Electrophysiologists don't know enough about the
    pharmacologic management of these patients
  • In a small group, you don't have a specialist who
    can focus on the medical management
  • This will have to be a part of training in the
    future because these devices are put in on top of
    medical therapy
  • Prystowsky

33
New pharmacological approaches
  • Additional neurohormonal antagonist agents have
    not proved effective
  • TNF-alpha blockers weren't effective
  • Omapatrilat wasn't effective
  • There is a move to comorbid conditions
  • Francis

34
Comorbid conditions
  • 15 to 20 of heart failure patients are anemic
  • 2 companies launching trials with erythropoeitin
    to address the anemia
  • Also a move to develop drugs to augment renal
    function
  • Arginine vasopressin antagonists
  • Adenosine antagonists
  • Francis

35
Summary
  • Initial approach should be to optimize
    pharmacologic treatment of heart failure patients
  • Patients who remain in class 3 failure with
    significant QRS duration are candidates for a
    resynchronization device, probably with an ICD
  • Once you have a device you need to be managed
    carefully by specialists
  • Prystowsky

36
The EP Show New approaches to heart failure
  • Eric Prystowsky MD Director, Clinical
    Electrophysiology Laboratory
    St Vincent Hospital Indianapolis, IN
  • Leslie Saxon MD Director of Electrophysiology U
    niversity of Southern California Los Angeles,
    CA
  • Gary Francis MD Director of Coronary Care
    Unit Cleveland Clinic Foundation Cleveland, OH
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