EECP® Newsletter

Updating our clinical knowledge on an evidence-based therapy

VOLUME 2, ISSUE 2

EECP® As An Effective Treatment Of

Heart Failure
John C.K. Hui, Ph.D.
V asomedical , Inc. EECP ®
Epidemiology of Heart Failure
There are 5.7 million heart failure (HF) patients in the United States, 10 million
in Europe and 20 million in Asia. In the US, 670,000 new patients are diagnosed HIGHLIGHTS
with HF, with 12-15 million office visits and 6.5 million hospital days each year.
In the United States, the total inpatient and outpatient costs for HF in 2005 Current Issue
were approximately $37.2 billion with an additional $3 billion spent annually on
HF treatment drugs. (The AHA Heart And Stroke Statistical 2009 Update (2009  Learn about how EECP can treat
Update); European Heart Joural, doi:10.1093/eurhearj/ehi205); heart failure, billing for EECP and
Statistics by Country for Congestive Heart Failure, http://www.wrongdiagnosis. its cost-effectiveness
com/c/congestive_heart_failure/stats-country.htm)
 Vasomedical Unveils New Patient
Definition of Heart Failure Management Products At AHA
Heart failure (HF) is a clinical syndrome resulting from any structural or
functional disorder that impairs the ability of the ventricles to fill or eject blood
to satisfy the metabolic needs of the body. Heart failure patients may have the
symptoms of breathlessness, dyspnea or fatigue, either at rest or during exercise,
Next Issue
or fluid retention that may lead to pulmonary congestion and peripheral edema.  What you should tell your
The most common causes of HF are coronary artery disease, hypertension, dilated patients about EECP®
cardiomyopathy, and valvular heart disease.
Cont’d on page 2

Vasomedical Unveils New Patient

Management Products At AHA NEWS AND EVENTS
Taking care of a patient doesn’t end at the doctor’s office. It is important
 Read what physicians and
for some cardiac patients to monitor their ECG and heart rate at home
real patients have to say
as well. For those patients and today’s health conscious society as
about EECP® on the boards
a whole, Vasomedical offers four new FDA cleared and CE marked
at www.eecpforum.com
EZ ECG™ Monitor patient management products, specially designed to
help monitor fragile cardiac, pulmonary and renal disease patients
 Vasomedical participates
daily at home.
Vasomedical is proud to introduce a portable, easy to use personal
in the AHA Scientific
ECG monitor, the EZ ECG™ monitor. Checking or monitoring a patients
Sessions in Orlando, FL
SpO2, pulse rate ad perfusion index has never been easier or more November 14-18
affordable. Vasomedical also offers lightweight, EZ O ™ Finger Oximeter
2

compact, finger pulse oximeters for quick and

accurate measurements in the EZ O2™ finger oximeter, the
EZ O2™ adult/ pediatric finger oximeter, and a comfortable wrist
oximeter for patients that require long-term monitoring, the EZ O2
EZ O ™ Wrist Oximeter
2
wrist oximeter.
 VOLUME 2, ISSUE 2

Treatment of Heart Failure

The objectives of treatment are to provide symptomatic improvement, prevent transition of asymptomatic cardiac dysfunction
to symptomatic HF, and reduce ER visits, hospitalizations and mortality. Pharmacological therapy is used to treat hypertension,
hyperlipidemia and diabetes. Medical devices such as pacemakers, implantable cardioverter defibrillators, and cardiac resynchronization
therapy are used to correct abnormal conduction and arrhythmia; ultra-filtration for fluid overload, and ventricular assist devices or
artificial heart as a last resource for circulatory assistance.

Pathophysiology of Heart Failure EECP® Treatment

Myocardial Injury
Coronary Artery Disease
Myocardial Structural Damage Coronary Collateral 

Cardiac Output  Cardiac Output 

Endothelial Dysfunction Endothelial Function 

Cascade
Neurohormonal Activation To More
Injury Neurohormonal Activation 
RAAS, Endothelin 

Sympathetic Nervous LV Contractility 

System Activation Exercise Capacity 
Inflammation, Reduces Inflammation,
Hypertrophy, Fibrosis Hypertrophy, Fibrosis

(c) Improved Stop

(a) Heart Failure
Heart Function (The Progession
Of Heart Failure)

Figure 1: (a) the pathophysiology of heart failure starting with some form of injury to the heart muscle
and cascading down to heart failure and leading back to more myocardial injury;
(b) EECP® stops the path back to more myocardial injury; and (c) improved heart function
after EECP® treatment in reducing the negative remodeling effects of heart failure.

Currently there are few effective therapies for heart failure partly because it is not a single organ disease but a systemic disease, as
illustrated in Figure 1, the pathophysiology of heart failure. Heart failure usually starts with some form of injury to the muscle of the
heart due to coronary artery disease or some form of infection, reducing the ability of the heart to perform effectively to eject blood,
decreasing blood flow velocity leading to endothelial dysfunction, activating the neurohormonal renin-angiotensin-aldosterone
system (RAAS) and sympathetic nervous system, promoting further vessel constriction. When the body demands the heart to pump
out more blood to satisfy its metabolic needs, the heart becomes hypertrophied and fibrosis develops. This induces an inflammatory
reaction promoting smooth muscle cell proliferation and migration, building atherosclerotic plaque leading to further injury of the
heart. This condition continues and cascades to worsening of the heart failure.

Enhanced External Counterpulsation (EECP) is the only treatment methodology that deals with every aspect of the deteriorating
effects leading to heart failure. There is ample scientific evidence that EECP therapy promotes coronary collateral circulation providing
more blood supply to ischemic regions of the heart to improve cardiac output. The improved cardiac function increases blood flow
velocity and shear stress on the endothelium, thereby promoting the release of circulating endothelial progenitor cells and improve
endothelial function and vascular tone. This in turn reduces neurohormonal activation, proinflammatory cytokines, arterial wall
stiffness and intimal hyperplasia, thereby lowering vascular resistance and blood pressure, reversing the deteriorating systemic effects
leading to HF.

Page 2
Learn More About Vasomedical And Its Products At www.vasomedical.com
 VOLUME 2, ISSUE 2

The beneficial mechanisms of action of EECP therapy are illustrated in the positive results from a randomized, controlled clinical trial
known as PEECH™ (Prospective Evaluation of EECP® in Congestive Heart Failure). In this trial, 187 mild-to-moderate HF patients with
NYHA II or III classification were randomized into either EECP + pharmacologic therapy (PT) or PT alone. The results of PEECH™ trial
showed a significant increase in the primary end point with 35% of EECP treated patients achieving a 60 seconds or more increase in
exercise duration versus 25% in the PT control group at 6 months (p< 0.016) post treatment. The trial also demonstrated significant
improvements in favor of EECP therapy on several important secondary endpoints, including improvements in exercise duration,
symptom status and quality of life. Measures of change in peak oxygen consumption were not statistically significant in the overall
study population, though a trend favoring EECP therapy was present in the early follow-up period. Patients in the trial who had an
ischemic etiology (i.e. pre-existing coronary artery disease) demonstrated a greater response to EECP therapy than those who had an
idiopathic (non-ischemic) etiology. (J Am Coll Cardiol 2006;48:1198 –205).

A second paper resulting from the PEECH™ trial was published in 2006, focusing on a prespecified subgroup analysis of patients age 65
and over (Congestive Heart Failure. 2006 Nov-Dec;12(6):307-311). This analysis demonstrated a statistically positive response on both
co-primary endpoints of the trial in patients receiving EECP therapy versus those who did not, i.e. a significantly larger % of patients
undergoing EECP® therapy met or exceeded prespecified thresholds of 60 seconds in exercise duration and the % of patients with at
least 1.25 ml/min/kg increase in peak volume of oxygen uptake (VO2) at 6 month follow-up. Moreover, patients age 65 and older who
received EECP therapy demonstrated the greatest improvement in exercise duration, peak oxygen consumption and functional class
(symptom status) compared with those who did not receive EECP® therapy.

Coverage Policy for Heart Failure

In February 1999, the Centers for Medicare and Medicaid Services (CMS) issued a national coverage policy for the use of EECP in
the treatment of patients who have been diagnosed with disabling angina (Class III or Class IV, Canadian Cardiovascular Society
Classification or equivalent classification) who, in the opinion of a cardiologist or cardiothoracic surgeon, are not readily amenable to
surgical intervention, such as PTCA or cardiac bypass because: (1) their condition is inoperable, or at high risk of operative complications
or post-operative failure; (2) their coronary anatomy is not readily amenable to such procedures; or (3) they have co-morbid states
which create excessive risk.

Since 70-80% of heart failure patients suffer from ischemic heart disease, they may be eligible for coverage under the current
guidelines, as long as they meet the angina criteria and their angina is listed as the primary indication for EECP therapy. Patients
suffering from angina often have similar symptoms to those suffering from ischemic HF. Exertional angina pectoris or its equivalents
are often present in patients with ischemic left ventricular dysfunction. Angina or angina equivalent symptoms do not have to be the
only diagnosis, but it must be the reason for which EECP therapy is being prescribed. Ischemic heart failure can be a co-diagnosis.
Data collected and published from the International EECP® Patient Registry™ (IEPR) at the University of Pittsburgh Graduate School
of Public Health on 8,000 patients treated with EECP® shows that approximately one-third of angina patients treated with EECP also
have a history of HF and 70% to 80% have demonstrated positive outcomes from EECP therapy (Cardiology. 2001;96(2):78-84). These
HF patients with refractory angina were covered by CMS and third party insurance.

Cost Effectiveness
As our society ages, and the mortality rate for patients suffering from myocardial infarction decreases, the number of patients with
heart failure will increase at a much faster pace, placing much more stress on the healthcare system. In 2007, Dr. Ozlem Soran
and colleagues published a paper on the “Impact of EECP Treatment on Emergency Department (ED) Visits and Hospitalizations in
Refractory Angina Patients with Left Ventricular Dysfunction” (Congestive Heart Failure. 2007:36-40). The clinical outcomes, number
of all-cause ED visits, and hospitalizations within the 6 months before EECP therapy were compared with those at 6-month follow-up
in 450 patients with LV dysfunction treated with EECP therapy for refractory angina.

The mean number of ED visits per patient decreased from 0.9±2.0 pre-EECP to 0.2±0.7 (p<0.001), a reduction of 78%, and hospitalizations
were reduced from 1.1±1.7 to 0.3±0.7 (p<0.001) at 6 months, a reduction of 73%. There were 1,106,000 hospital discharges for HF
in 2006 (data from U.S. National Hospital Discharge Survey) and 3,390,000 ED visits for HF (U.S. National Center for Health Statistics
Report No.8, 2008). The average cost for an ED visit in 1998 has been estimated to be $12,400 per admission (Heart Lung. 1999 Mar-
Apr;28(2):102-9),. A reduction of 73% or 1 million or more admissions could save the health care budget $10,000,000,000, a welcome
reduction in this era of high health care costs.

Discuss EECP With Patients And Medical Professionals at www.eecpforum.com Page 3

 If you have a story idea or would like to share the results of your experience with other clinicians,
please e-mail your idea/story to: Paul Persaud, Marketing Manager at ppersaud@vasomedical.com.

Recent Publications & Presentations

Predictors of Hospitalization in End Stage Coronary Disease: The Effect of Enhanced External Counterpulsation* FREE
Lawson WE, Kennard ED, Linnemeier G, Hui JC.
Presented at the 2009 AHA Quality of Care and Outcomes Research in Cardiovascular Disease and Stroke Conference in
Washington D.C., April 23-25, 2009.

Peripheral Endothelial Function is a Primary Clinical Target for Enhanced External Counterpulsation in
Patients With Refractory Angina
Braith RW, Casey DP, Beck DT, Nichols WW, Choi CY, Khuddus MA, Conti CR.
Journal of the American College of Cardiology.2009 Mar:53(10 Suppl A); (1054-276).

Promotion of Coronary Collateral Growth by External Counterpulsation in Patients with

Coronary Artery Disease
Gloekler S, de Marchi SF, Rutz T, Meier P, Wustmann K, Rimoldi SF, Togni M, Seiler C.
Journal of the American College of Cardiology.2009 Mar:53(10 Suppl A);(1050-126).

Treatment Options for Refractory Angina Pectoris: Enhanced External Counterpulsation Therapy
Ozlem Soran, MD, MPH, FESC
Practitioner. Current Treatment Options in Cardiovascular Medicine 2009, 11:54–60

Enhanced External Counterpulsation Promotes Growth Cytokines-Mediated Myocardial Angiogenesis In

A Porcine Model Of Hypercholesterolemia
Luo Jing-Yun, Wu Gui-Fu, Xiong Yan, Chen Guo-Wei, Xie Qiang, Yang Da-Ya, He Xiao-Hong, Zhang Yan,
Liu Dong-Hong, Wang Kui-Jian, Ma Hong, Zheng Zhen-Sheng And Du Zhi-Min
Chinese Medical Journal 2009;122(10):1188-1194

Assessment Of The Effect Of External Counterpulsation On Myocardial Adaptive Arteriogenesis By

Invasive Functional Measurements — Design Of The Arteriogenesis Network Trial 2
Nikolaos Pagonas, Wolfgang Utz, Jeanette Schulz-Menger, Andreas Busjahn, Jan Monti, Ludwig Thierfelder,
Rainer Dietz, Volker Klauss, Michael Gross, Ivo R. Buschmann, Eva-Elina Buschmann And On Behalf Of The
Arteriogenesis Network
International Journal of Cardiology (2009), doi:10.1016/j.ijcard.2009.05.050

* Receive a free copy of the complete presentation by email. Email your request to ppersaud@vasomedical.com.

180 Linden Avenue

Vasomedical
Westbury, NY 11590
Phone: 800-455-EECP (3327)
Fax: 516-997-2299
®
, Inc. customerservice@vasomedical.com
www.vasomedical.com
www.EECPforum.com

2009 Vasomedical, Inc. EECP is a registered trademark of Vasomedical, Inc. All rights reserved.
Page 4 V15-0171-003 R.0