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Enhanced External Counterpulsation

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Coronary artery disease patients with angina pectoris refractory to ... Radionuclide Defects in Fifty Consecutive Patients at SUNY ... stress test, plus... – PowerPoint PPT presentation

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Title: Enhanced External Counterpulsation


1
Enhanced External Counterpulsation
2
Symptomatic Coronary Artery DiseasePatient
Distribution by Amenability to Treatments
7.2 Million
Medication
Surgical and/or percutaneous intervention
Not readily amenable to intervention
3
The Weight of Clinical Evidence
  • In most patients, EECP treatment...
  • Reduces anginal pain
  • Increases functional ability
  • Improves quality of life
  • both short-term and long-term

4
Target Population for EECP Therapy
  • Coronary artery disease patients with angina
    pectoris refractory to medical therapy.

5
EECP Therapy Covered by Medicare
  • For patients with a diagnosis of disabling angina
    pectoris who, in the opinion of their
    cardiologists or cardiac surgeons, are not
    readily amenable to invasive procedures because
  • They are inoperable or at high risk of operative
    complications or failure
  • Their coronary anatomy is not readily accessible
    to such procedures
  • Co-morbid states create excessive risk

6
The EECP Procedure
  • Series of 3 cuffs wrapped around calves, lower
    thighs,
  • upper thighs and buttocks
  • Sequential distal to proximal compression upon
    diastole, and
  • Simultaneous release of pressure at end-diastole
  • Increased diastolic pressure and retrograde
    aortic flow
  • Increased venous return and...
  • Systolic unloading, resulting in increased
    cardiac output
  • Noninvasive procedure
  • Produces

7
Enhanced External Counterpulsation
8
Cuffs Inflation/Compression Sequence
9
Required Treatment Regimens
  • A total of 35 hours is required
  • Regimen1 or 2 hours daily
  • At least 5 days per week for 4 to 7 weeks

It is recommended that 2 hours daily treatment
sessions are separated by a 30 minutes rest
interval.
10

Early external counterpulsationdevices had
hydraulic pulsator chambers.
11
History of External Counterpulsation
  • 1950s - Kantrowitz Brothers - diastolic
    augmentation
  • - Sarnoff - LV unloading
  • - Birtwell - combined concepts
  • - Gorlin - defined counterpulsation
  • 1960s - Birtwell Soroff - Dennis- Osborne -
    hydraulic external counterpulsation
  • 1970s - Soroff - cardiogenic shock
  • - Banas - stable angina
  • - Amsterdam - acute MI
  • 1980s - Failure to gain acceptance
  • - China redeveloped technology- pneumatic
    system
  • - Soroff, Hui, Zheng collaboration at Stony Brook

12
SUNY Stony Brook The first publication - 1992
  • Background Of 18 patients with chronic angina
    refractory to medical therapy - 8 had 19
    prior revascularization attempts
    - 7 had 14 prior mycardial infarcts
  • Methods 36 one-hour treatment sessions
  • Pre- and post-treatment thallium treadmill
    stress tests to
  • identical exercise times
  • Separate post-treatment maximal routine
    treadmill stress test
  • Results All patients reported improvement in
    anginal symptoms
  • - 16 patients (89) reported no angina during
    usual activities
  • - 12 patients (67) with resolution of
    reversible perfusion defects
  • - 2 patients (11) with improvement of
    reversible perfusion defects - 4 patients
    (22) with no change
  • Lawson WE, Hui JCK, Soroff HS, et al. Efficacy
    of enhanced external counterpulsation in the
    treatment
  • of angina pectoris. Am J Cardiol.
    199270859-862.

13
SUNY Stony Brook 3-year follow-up of the
first 18 patients
  • Background Clinical follow-up of 18 initially
    treated patients was conducted after 3 years
  • Methods Repeat stress thallium test performed
    to same exercise duration as initial study
  • Results Of 14 patients who showed
    resolution/improvement in initial study
  • - 11 patients remained free of limiting
    angina
  • - 1 patient was lost to follow-up and 1
    refused another stress test
  • - 1 patient had surgical revascularization, 1
    patient had an MI
  • Of the remaining 10 patients, 8 retained
    benefits and 2 reverted to pre- treatment
    baseline perfusion defects despite symptomatic
    benefit
  • Lawson WE, Hui JCK, Zheng ZS, et al. Three year
    sustained benefit from enhanced external
    counterpulsation in chronic angina pectoris. Am
    J Cardiol. 199575840-841.

14
SUNY Stony Brook Patient Response Studies
  • Results In sixty patients with CAD, after EECP
    treatment, improvement or resolution of
    reversible radionuclide perfusion defects were
    seen in
  • 86 (18/21) of patients with residual 1-vessel
    disease
  • 85 (17/20) of patients with residual 2-vessel
    disease
  • 53 (10/19) of patients with residual 3-vessel
    disease
  • 75 (45/60) of patients overall
  • Conclusion A proximally patent conduit may be
    necessary to allow transmission of augmented
    diastolic pressure and flow to distal coronary
    circulation.
  • Lawson WE, Hui JCK, Tong G et al. Prior
    Revascularization Increases the Effectiveness of
    enhanced external counterpulsation? Clin.
    Cardiol. 1998 21841-844.

15
SUNY Stony Brook 5-year Follow-up
  • Background A five-year follow-up was conducted
    on 33 angina
  • patients treated between 1989 and 1992 with
    EECP,
  • to assess morbidity and mortality.
  • Methods Review of patient records at 5 years
    post-EECP (range 4-7 years).
  • Results 29 of 33 patients remained alive. Of
    these, 9 patients
  • were hospitalized (4 acute MI, 6 CABG/PTCA,
  • 1 unstable angina and 1 other cardiac surgery).
  • Conclusions Five-year survival without an
    interim event of 60 of patients treated with
    EECP appears similar to that seen
  • with comparable populations treated with
    CABG/PTCA.
  • Lawson WE, Hui JCK, Burger L, et al. Five-year
    follow-up of morbidity and mortality in 33 angina
    patient treated with enhanced external
    counterpulsation. J Invest Med. 199745212A.

16
Effect of EECP Treatment on Exercise-Induced
Radionuclide Defects in Fifty Consecutive
Patients at SUNY Stony Brook
Lawson WE, Hui JCK, Zheng SZ et al. Can
Angiographic Findings Predict Which Coronary
Patients Will Benefit from Enhanced External
Counterpulsation? Am J Cardiol 1996771107-09
17
Results of The Multicenter Study of Enhanced
External Counterpulsation (MUST-EECP) EECP
Reduces Time to ST-Segment Depression and
Episodes of Angina with Improved Long-term
Quality of Life
  • Rohit R. Arora, MD Tony Chou, MD Diwakar Jain,
    MD
  • Richard Nesto, MD Bruce Fleishman, MD
  • Lawrence Crawford, MD and Thomas McKiernan, MD
  • for the MUST-EECP Investigators

18
MUST-EECP Study Sites
Columbia Presbyterian Medical Center Rohit Arora,
MD University of California San Francisco Tony
Chou, MD Yale University School of
Medicine Diwakar Jain, MD Beth Israel Deaconess
Medical Center Richard Nesto, MD Grant/Riverside
Methodist Hospitals Bruce Fleishman,
MD University of Pittsburgh Medical Center
Lawrence Crawford, MD Loyola University Medical
Center Thomas McKiernan, MD
19
MUST-EECP Study Goals
  • To confirm efficacy and safety of EECP using
    rigorous scientific method, i.e. a randomized,
    sham-controlled, double-blinded protocol
    generally reserved for drug trials
  • To broaden study experience beyond initial
    trial site
  • To determine effect vs. placebo

20
MUST-EECP Method
  • Design Multicenter, randomized,
    sham- controlled, double-blinded trial
  • Randomization Even assignment to EECP group
    or sham group in blocks of 10
  • allocated to each center
  • Subjects 139 patients with chronic stable
    angina pectoris (137 evaluable )
  • Duration May 1995 - July 1997

21
MUST-EECP Pre-specified Parameters
  • Evaluate effect
  • of EECP on... Measured by
  • Exercise ability Exercise duration Time to
    ST-segment depression
  • Clinical status Frequency of anginal
    episodes Intake of nitroglycerin
  • Adverse experiences Physical exams Lab
    tests Daily questions
  • Statistical analysis P-values calculated for
    between-group differences using
    Cochran-Mantel-Haenszel Chi-Squared tests for
    ordered categories stratified by investigator

22
MUST-EECP Inclusion Criteria
  • Written informed consent
  • 21-81 years of age
  • Canadian Cardiovascular Society Class I, II, or
    III
  • Evidence of CAD by one of following criteria
  • Angiographic
  • (1 or more major arteries with gt70 stenosis)
    or
  • Documented evidence of MI or
  • Positive nuclear stress test, plus...
  • A positive exercise stress test within 4-week
    baseline period

23
MUST-EECP Exclusion Criteria
  • Pregnant or childbearing potential without
    contraception
  • Unstable angina
  • MI and/or CABG in prior 3 months
  • Cardiac catheterization in prior 2 weeks
  • Arrhythmias (AF or VPBs) interfering with
    triggering of EECP
  • Marked baseline ECG abnormalities limiting
    interpretation (digoxin use, LVH with strain,
    LBBB)
  • Permanent pacemaker or defibrillator
  • CHF (LVEF lt30)
  • Significant valvular heart disease

Severe symptomatic peripheral vascular
disease History of varicosities, deep vein
thrombosis, phlebitis and/or stasis ulcer ABP gt
180/100 mm Hg Bleeding diathesis Coumadin use
with INR gt2.0 Inability to undergo treadmill
tests Non-bypassed left main with gt50 Inability
to consent and/or cooperate throughout study
duration Enrollment in cardiac rehab.
program Participation in other research study
24
MUST-EECP Demographic Characteristics
Active Sham (n 71)
(n 66)
Age (yr. SD) 64.3 9.4 62.2
9.1 Sex Male 85.9 87.9 Race/Ethnicity W
hite 77.5 74.2 Black 4.2 3.0
Hispanic 7.0 15.2 Asian 7.0 4.5
Other 4.2 3.0
25
MUST-EECP CV Morbidity Profiles
CV history
CCS class I 26.8 25.8
II 49.3 51.5 III 23.9 22.7 Years of
angina (SD) 8.6 7.9 4.1 4.5 p
lt0.01Previous MI 56.3 40.9 p lt0.05Previous
CABG 46.5 37.9 Previous PTCA 38.0 33.3
Active Sham (n 71) (n 66)
26
MUST-EECP Exercise Results
Sham Active
Between- Change (sec)
Change (sec) group
Parameter N Mean SE N Mean SE
p-value Exercise 58 26 12 57 42 11 gt0.3duratio
n Time to ST- 56 -4 12 56 37 11 0.01depressi
on
Follow-up exercise data not available in 25
patients (Sham-10, Active-15)
27
MUST-EECPExercise Results

p ns

p 0.01
Seconds
Adjusted mean of change from baseline
28
MUST-EECP Angina Change Results
Improvement Worsening
Between- N Median 50 25-49 0-24 1-25 26-50 5
1-100 100 group
Change p-value Intent-to-treat Sham 66 0
21 3 28 2 2 4 6 Active 71 -20 32 1 33 0 0 2 3 lt0.
05 Per protocol Sham 59 0 19 2 24 0 2 5 7 Acti
ve 57 -50 29 1 23 0 0 0 4 gt0.01
(Patient numbers by category of
percentage change from baseline) 7
patients in Sham and 14 patients in Active did
not complete a minimum of 34 sessions.
29
MUST-EECP Percentage Change in Angina Counts
Active (N57) Sham (N59) Active (N71) Sham
(N66)

Per Protocol
P lt 0.02

P lt 0.05
Intent-to-treat
Change
30
MUST-EECP On-demand Nitro. Results
Improvement Worsening Between-
group N Median 50 25-49 0-24 1-25 26-
50 51-100 100 p-value Change Intent-to-treat
Sham 66 0 18 1 40 0 3 2 2 Active 71 0 16 2 50 1 0
0 2 gt0.7 Per protocol Sham 59 0 17 2 34 0 1 1
4 Active 57 0 12 2 40 0 1 1 1 gt0.9
(Patient numbers by category of percentage change
from baseline)
7 patients in Sham and 14 patients in Active did
not complete a minimum of 34 sessions.
31
MUST-EECP Percentage Change in On-demand
Nitroglycerin
Active (N57) Sham (N59) Active (N71) Sham
(N66)

P gt 0.9
Per Protocol

P gt 0.7
Intent-to-treat
Change
32
MUST-EECP Adverse ExperiencesConsidered by
investigators not to be device related
Sham (N 66)
Active (N 71)
Viral syndrome 0 1 Anxiety 0 2 Dizziness
1 3 Tinnitus 0 1 GI disturbances 1 1 H
eadache 0 1 Blood pressure change 1 1 Epistax
is 0 2 Angina 1 1 Chest pain 3 7 A/V
arrhythmia 3 9 Heart Rate change 3 0 Respirat
ory 2 4 Total
15 33 p lt 0.005
33
MUST-EECP Adverse ExperiencesConsidered by
investigators to be probably, possibly or
definitely device related
Sham Active
(n66) (n71) Paresthesia 1
2 Edema, swelling 0 2 Skin abrasion, bruise,
blister 2 13 Pain in legs or back
7 20 Total 10 37 No. of patients reporting AE
17 (25.8) 39 (54.9) Withdrew
because of AEs 1 7
P 0.005
P 0.01
P lt 0.001
P lt 0.001
34
Summary of Clinical Results
  • Compared to sham, EECP
  • Increased time to exercise-induced ST segment
    depression (p 0.01)
  • Decreased the frequency of angina episodes (plt
    0.04)
  • Compared to baseline
  • Exercise duration increased significantly in both
    groups(Sham- plt0.03, Active- plt 0.001)
  • Time to ST segment depression increased
    significantly in Active Group only (plt 0.002)
  • EECP was generally well tolerated but with
    significantly fewer adverse experiences reported
    in the sham group.

35
International EECP Patient Registry (Department
of Epidemiology, University of Pittsburgh School
of Public Health)
  • Before treatment, the first 445 consecutive
    patients
  • 75 had Functional Class III or IV disease
  • (With a mean of 9 angina episodes per week
    before treatment)
  • 78 have multi-vessel disease
  • 81 had prior CABG or PTCA
  • 66 were not eligible for CABG or PTCA
  • 66 had a prior MI
  • 38 have diabetes

36
International EECP Patient Registry CCS Classes
Pre- Post- Treatment (N268)

CCS Classes
37
International EECP Patient Registry CCS Classes
Pre- Post- Treatment (N268)

CCS Classes
38
Discussion and Conclusions
  • Despite study size limitations, overall, patients
    who received EECP reported that they
  • experienced less activity-limiting physical pain
  • were in better general health one year
    post-treatment
  • were more satisfied with their energy level, and
    the degree of stress, chest pain and shortness of
    breath that they were experiencing.
  • SHAM-treated patients reported no statistically
    significant improvement.
  • Results of the outcomes study are consistent with
    previous clinical study results and demonstrate
    that the short-term benefits reported in
    MUST-EECP may extend over the longer term.

39
The Weight of Clinical Evidence Summary
  • EECP is a safe and effective treatment for angina
    pectoris refractory to medical therapy
  • Benefits of EECP include an improvement of
    functional status in more than 70 of patients
  • Benefits accrue both short-term and long-term

40
EECPEnhanced External Counterpulsation
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