Enhanced External Counter Pulsation (EECP, also referred to as ECP) is exciting state-of-the-art technology that is a safe, non-invasive method for improving circulation to the important vital organs (heart, brain, kidneys, etc.). Clinical benefits can be maintained for years following a full course therapeutic program.^1-3 Patients report that EECP therapy increases energy, increases vitality for physical therapy, increases circulation to their feet, improves their sleep at night, improves mental performance and helps them be more alert and mentally focused. EECP was initially developed in the United States, but the Chinese quickly followed and have pursued clinical studies for effectiveness much more aggressively than the rest of the world (see Historical Development of EECP below). As a result, the Chinese have become the leading authority in the clinical field of EECP application. In China, External Counter Pulsation has been widely used since 1983 for heart disease and cerebrovascular disease.^4-8 The Germans have also published evidence for EECP improving brain blood flow.⁹ In the United States, the predominant research with EECP has been for ischemic heart disease. EECP is FDA approved for Coronary Artery Disease despite the fact that ECP can be useful and has demonstrated clinical effectiveness in the treatment of many "ischemic" (lack of circulation and/or oxygen) conditions, including glaucoma, angina, coronary artery disease, congestive heart failure, stroke and brain injury.^4-8 External Counter Pulsation increases blood flow 22-26% to the carotid (Neck) arteries to the brain,^3,10 20-42% to the coronary (Heart) arteries³, and 19% to the renal(Kidney) artery.¹⁰ It increases the heart's output (stroke volume) by 12% and increases blood flow to areas not getting enough oxygen in the heart.¹¹

Ischemic heart disease is thought to be due to a lack of adequate blood flow (and oxygen) to the heart which causes the symptoms of angina pectoris (Chest pain), heart attack or stroke. An abnormal lack of oxygen to the heart also causes a decrease in exercise capacity, quality of life, as well as possibly resulting in angina pectoris (Chest pain) heart attack and/or stroke. Until recently, the predominant treatment for ischemic heart disease was symptom suppressing drugs and /or open heart bypass surgery. Unfortunately, drugs are expensive, potentially toxic, associated with unlimited safety unknowns when used chronically (over prolonged periods of time), are scientifically tested for very limited applications ("controlled" research populations and conditions) and for very limited [usually months] test periods before being declared "safe" (usually with potentially heavy influence of FDA "advisory" committee members that are on the payroll of multiple pharmaceutical companies) for general use. In addition, FDA approved drugs are usually never actually tested in "real life" circumstances (i.e. a patient taking 7 different drugs for multiple clinical diagnoses). And coronary bypass surgery is costly, invasive, and associated with serious complications (including blood clots, infection and a 4% mortality rate). In addition, the health benefits of this surgical procedure are often temporary. EECP is an outstanding non-invasive, safe, alternative for the person who may want to reduce or eliminate non-curative pharmaceuticals and/or cannot or will not have a bypass surgery. In addition, EECP also produces numerous benefits to the ischemic brain, kidneys and entire system. Patients with symptoms or signs involving these organs should also consider EECP therapy. Although technically an USFDA "off-label use" when used for any condition other than chronic stage III or IV angina, acute heart attack or congestive heart failure, the procedure of EECP is safe, effective, and generally well tolerated, with few side effects or discomfort to the patients.

The clinical benefits of EECP in patients with chest pain due to blockage of the heart blood vessels (angina pectoris), congestive heart failure and heart attack with or without shock, that have been reported in the scientific literature include:

1) Increase in venous blood flow returning to the heart^11,12

2) Increase in the resting phase of the heart beat cycle, which promotes greater oxygenation to the heart^11,13

3) "Milks" blood flow from lower extremities which increases the filling of the heart and thereby increases cardiac output. In addition, there is increased blood flow to all other vital organs, including the brain and kidneys, without increasing the heart rate.^4,10,11

4) The left ventricle of the heart has less to push against because of decreased peripheral vascular resistance. This reduction in resistance increases the heart's performance and reduces its workload.^11,14

5) Increases perfusion (blood flow) throughout the heart, eliminating or reducing myocardial ischemia (lack of blood flow and oxygen)^12,15

6) Promotes the development of collateral ("natural 'self-bypass") blood vessels. Collateral vessels are blood vessels that develop along side or parallel to blocked or injured blood vessels)^11,16,17

7) Reduces the frequency and intensity of angina symptoms (chest pain)^2,18

8) Reduces ventricular fibrillation (rapid, lethal convulsive movements of the heart muscles)^19,20

9) Improves myocardial lactic acid removal (a build up of lactic acid causes muscle fatigue)¹¹

10) Slows the progression to congestive heart failure in those with cardiac insufficiency^19,20

11) Increases physical endurance and exercise tolerance^12,16,18

12) Improves the sense of well being and overall quality of life^2,21

13) Decreases the risk of heart attack^5,12

14) Reduces the need for anti-anginal medication²

15) The positive effects are sustained between treatments and generally persist for several years after the end of the therapeutic program^1,2,5,16

16) EECP is clinically well tolerated with no significant side effects and few minor side effect^12,18

The beneficial clinical effects on the heart are dependent on there being at least one intact, functional blood vessel to the heart. The greater the number of blocked heart arteries, the less the benefit of EECP. In patients with single vessel obstruction, 95% had no sign of re-obstruction after the treatment program. In those with 2 vessel coronary artery disease, there was 90% improvement, and in those patients with 3-vessel disease, there was a 42% improvement.¹⁷

Brain Disorders Treated By EECP

The Chinese have been using EECP to treat nervous system and ophthalmology disorders as well as cardiovascular disease since the early 1980's. The Germans have also published recent research on the benefits of EECP in improving brain blood circulation. In China, the clinical indications for EECP include:^5-8

1) Brain thrombosis (blood clotting that obstructs blood flow)

2) Lacunar (very tiny or "pin-point") brain infarction (death of small areas of the brain)

3) Transient ischemic attack (short periods of reduced blood flow to the brain)

4) Blood supply shortage of the vertebral-basilar artery (an artery to the brain)

5) Cerebral-vascular dementia (memory loss due to lack of oxygen to the brain)

6) Cerebellar ataxia (irregularity and lack of coordination in cerebellar function)

7) Parkinsonism (condition characterized by muscular rigidity and tremors)

8) Vascular headache and migraine

9) Neuroasthenia - especially with insomnia (lack of strength and energy - low body temperature, loss of muscle tone, low blood sugar, fatigue and muscle pain)

10) Dizziness syndrome

11) Depression

How Does EECP Therapy Work?

Blood pressure readings are actually coordinated with the heart beating. When our blood pressure is taken, we are given a "systolic" and "diastolic" reading, such as 120/70. The systolic phase (systole - Greek for contraction) of the heart muscle is the contraction of the ventricles that pumps the blood into the aorta and pulmonary artery. The diastolic phase (diastole - Greek for dilation) is the relaxation or resting time between the contractions, when the ventricle fills with blood. The EECP "Pump" is also coordinated with the heart beat. The external Counter Pulsation equipment includes large blood pressure cuffs around the legs and lower hips that inflate in synchrony with the person's heart beat based on the electrocardiogram. The cuffs rapidly fill with air during the diastolic phase of the heart beat, compressing or squeezing the legs and pushing the venous blood sequentially from the calves, thighs and buttocks towards the heart. This also increases oxygenated blood flow upwards, supplying greater blood flow to the coronary arteries²², brain, liver and kidneys^4,5,7-9,17.The cuffs then instantly deflate while the heart is contracting, which allows blood to flow easily into the legs. In fact, with the EECP returning more blood to the heart from the lower extremities, the left ventricle is actually pumping against less pressure in the legs. Therefore it takes less effort (and less oxygen demand) for the left ventricle to pump more blood to the system (reduced workload or reduced ventricular after load).^11,22

The increased blood flow to the heart arteries dilates (enlarges) the smaller blood vessels of the heart and this enlargement gradually increases their blood carrying capacity, creating collateral pathways around blocked and injured arteries. This process creates a "natural bypass" and is credited as being a major factor for the benefits of ECP lasting for years after the therapy has ended. In summary, the "pumping action" of ECP increases oxygen supply to the heart and other vital internal organs while reducing heart work load and oxygen demand. The use of EECP in a minimum therapeutic program of 35 one hour sessions revitalizes cardiac and other internal organ functions, reduces angina pectoris symptoms, increases exercise endurance, improves quality of life, and reduces the risk of heart attack and stroke. In addition, there is increased circulation to all the vital organs, including the brain, liver and kidneys - resulting in the potential for improved function throughout the entire system of internal organs. Clinical studies have indicated that 35 hours is the minimum while 72 hours is recommended in the Chinese medical literature to give the best overall results. ^7,8

Historical Development Of EECP

The concept that elevating diastolic pressure in arteries could improve blood flow in the heart and be beneficial in coronary insufficiency was first proposed in 1953 by Kantrowitz.²³ In 1963, Dennis et. al. actually used a pressure sleeve on the hind legs of dogs that was inflated and deflated in synchrony with their electrocardiogram.¹¹ In 1968, Kantrowitz and associates demonstrated the principle of "phase shift", of increasing diastolic blood flow with the intra-aortic balloon pump in 27 patients.¹⁰ Ruiz and associates evaluated the use of external pulsatile pressure to the lower extremities in five normal subjects in 1969. The aortic diastolic pressure was increased by 50 mm Hg with a 20% increase in cardiac output. In two patients with cardiogenic shock, an increase in perfusion pressure was associated with clinical improvement.²⁰ In 1973, Cohen and associates investigated the effects of sequential (inflating the cuffs around the calves area, then thigh area, then buttocks in sequence) and non-sequential (uniform inflation) external counter Pulsation in seven normal subjects. Diastolic augmentation was equivalent in both groups but cardiac output increased 17% with the sequential method. Cardiac output did not rise significantly with the uniform inflation method. The authors also compared sequential external counter Pulsation to the Intra-Aortic Balloon Pump (IABP) in experimental animals before and after inducing cardiac shock. Cardiac output was increased an average of 25% with external counter Pulsation compared to 4% with IABP. The effects were due to an increase in venous return caused by the diastolic augmentation.¹³

Soroff and coworkers reported the results of early models of External Counter Pulsation in 20 patients suffering from cardiac shock following a heart attack in1974. Cardiac shock had a 15% survival rate, but 45% of Soroff's patients survived; a significant increase in survival due to treatment with the ECP. Soroff originally used a device having a fiberglass leg unit with water-filled bladders that enclosed the patient's lower extremities. It was hydraulically operated, triggered by the electrocardiogram signals, filling at diastole and emptying the bladders surrounding the legs at systole.^14,22 In1976, Watson and his associates compared external Counter Pulsation and intra-aortic balloon pumping in anesthetized dogs. Both methods increased the amount of blood returning to the heart; but external Counter Pulsation also significantly increased collateral coronary blood flow to heart tissue. External Counter Pulsation also had the advantage of being non-invasive.²⁴ In 1976, a joint program involving eleven Chinese medical centers and factories developed the first sequential external Counter Pulsation device, followed by clinical investigations.^5,6 Langou and associates published a 1977 review, giving a historical perspective of ECP and explanation of the Tension Time Index (work originally presented by Sarnoff in 1958) and how the ECP increases the rest period of the heart which maximizes oxygen extraction and oxygen delivery to the myocardium while reducing oxygen consumption (cardiac work load).¹¹ In 1980, Amsterdam and coworkers published the clinical results of an early ECP device used for acute myocardial infarction in a prospective, randomized trail of 258 patients in 25 hospitals. Hospital mortality (6.5%; 7 of 108 patients died) was significantly reduced in those receiving 4 or more hours of ECP within the first 24 hours after admission. Mortality in the control group was 14.7 % (17 of 116 patients died). Patients receiving the external Counter Pulsation treatment showed a reduction in chest pain, decreased progression of cardiac failure, reduced ventricular fibrillation, a reduction in heart size and improved clinical cardiac functional status at discharge.¹⁹

Yu-yun Xu and Zhen-sheng Zheng published a review article of research with ECP in China in 1990. At that time, the equipment was used extensively in over 1,800 research, clinic and hospital facilities. In the short term evaluation 52.6% of over 6,000 patients with angina pectoris showed significant improvement in cardiac symptoms, 30.3% showed some improvement, 8% had no change and 2% deteriorated. ECP was effective in promoting improvement in 92% of the cases (5,630 out of 6,116). In another study of 5,067 angina cases, 20.5% showed significant improvement, 47.8% showed some improvement, 30.5% had no change, and 1.2% worsened. The total effective rate in this study was 68.3%. In the evaluation of long term effects 5-7 years after therapy, 102 patients treated with ECP were compared with 111 patients treated with medication. There was significant improvement in clinical symptoms in 67.79% of those treated with ECP compared to 38.74% of those treated with medication. There was also significant improvement in electrocardiogram results for 62.47% of the patients treated with ECP compared to 28.35% of those treated with medication. Mortality rates for cardiovascular disease for the ECP groups were 8.82% compared to 13.51% for the medication group. Acute myocardial infarction rates for the ECP groups were 2.94% compared to 8.11% for the medication group. ECP significantly improved clinical symptoms and electrocardiogram results and significantly reduced the risk of death and heart attack in an 8 year follow up. In 24 patients with cerebral ischemic disease, 54% showed significant improvement with ECP compared to 29% treated with medication. The total effective rate was 95.8% for the ECP group compared to 75% in the medication group. The author cautions that ECP not be used during the acute phase of cerebral ischemia or for hypertensive patients (those with blood pressures exceeding 160/100 mm Hg). external counterpulsation was also effective in treating sudden deafness and eye diseases (thrombus of the retinal artery, traumatic optic atrophy and optic neuritis).⁵

Lawson et. al. studied 18 patients (aged 45-75) in 1992 with chronic angina that persisted despite surgical and medical therapy. After 36 one hour sessions of External Counter Pulsation, all of the 18 patients improved in their chest pain symptoms with 16 reporting complete relief. The treatment was usually well tolerated with less improvement seen in those with blockages in three vessels or with diffuse coronary artery disease.¹² Lawson published a three year follow-up of his 18 patients in 1995. Ten patients consented to being tested again. Of these, 8 continued to demonstrate improved myocardial perfusion (circulation). Two others returned to pre-treatment baseline even though they showed clinical improvement in their symptoms. Lawson concluded that long term improvement in myocardial perfusion and exercise tolerance can occur several years after ECP therapy, probably due to its promotion of collateral circulation.¹⁶ Lawson and his coworkers published an article in 1996 on the effects of ECP on exercise hemodynamics and myocardial perfusion during a stress test in 27 patients with chronic stable angina. 81% (22 out of 27) of the patients improved their exercise tolerance after the ECP treatment and 78% (21 out of 27) demonstrated improvement in their radionuclide stress perfusion images. Because maximal heart rate did not significantly increase despite increased exercise duration, the authors suggested that the increase in exercise tolerance is due to improved mycardial perfusion and altered exercise hemodynamics. ECP therapy therefore appears to exert a "training" effect, decreasing peripheral vascular resistance and cardiac work load in coronary disease patients.¹⁵

In 1997, using a two cuff ECP protocol (leg and thigh), Applebaum and associates measured carotid artery flow in 35 patients (mean age 60) and renal artery flow in 18 patients (mean age 55). An increase in carotid and renal artery flow during diastole was observed in all patients. The mean carotid flow increased by 22%, from 27.7 ccm to 33.1 cm. The mean renal artery flow increased by 19%, from 21 cm to 25 cm. The pressure used was 150-180 mm Hg and all patients tolerated the procedure well without side effects. The authors conclude that ECP significantly increases carotid and renal blood flow and recommend the therapy to support those with decreased cerebral and/or renal circulation.¹⁰ In the November, 1997 issue of the Cardiovascular Reviews and Reports, Dr. Strobeck and Dr. Tartaglia presented case studies of the effects of ECP on coronary artery disease. Stress scintigram images of pre- and post-treatment showed significant improvement in myocardial perfusion and a reduction in ischemia.^25,26 Fricchione also studied the psychological aspects of external Counter Pulsation in 1997 and found that the treatment significantly improved depression scores. Patients often report feeling depressed following invasive procedures. Since depression is associated with poor outcome in those with cardiac disease, external Counter Pulsation offers clinical advantages beyond its circulatory benefits.²¹

In 1999, Arora and his coworkers reported on the results on a multicenter randomized, placebo controlled multi-center trial to evaluate external Counter Pulsation in 139 patients with angina, documented myocardial ischemia and coronary artery disease. The program consisted of 35 hours of treatment, provided in one hour sessions over a 4-7 week period. The authors concluded that the treatment was safe and effective in reducing angina symptoms in patients with coronary artery disease. The treatment was generally well tolerated and free of treatment limiting side effects in most patients. Side effects that were reported included anxiety, dizziness, GI disturbances, arrhythmias, chestpain, edema, and skin abrasions.^18,27 Also in 1999 Werner and associates investigated the changes in flow volume in the carotid, vertebral, hepatic, renal and internal iliac arteries after a one hour session with ECP in 16 healthy volunteers. The greatest increase in the carotid artery flow volume was 26%, seen using three cuffs and a pressure of 300 mm Hg. The two cuff procedure at 200 mm Hg produced a 19% increase in blood flow to the carotid arteries. The three cuff method at 300 mm Hg increased blood flow 42% to the left main coronary stem compared to 18% in the two cuff method at 200 mm Hg. Werner concluded that the increase in blood flow to the coronary arteries leads to a significant increase in blood flow to the brain, liver, kidneys and myocardium. He also reported a 75-80% reduction in the vasocontrictive hormones endothelin and renin in both healthy volunteers and patients with coronary artery disease.³

Ozlem Soran and associates published a paper suggesting that the increase in shear stress by the ECP may result in the release of various growth factors which stimulate angiogenesis (growth of new blood vessels) in the coronary beds. Patients who responded favorably to chronic therapy with EECP showed a significant increase in circulating vascular endothelial growth factor (VEGF) which promotes endothelial cell migration and collateral blood vessel growth.²³ Enhanced External Counter Pulsation therapy is on the forefront of vital organ (i.e. heart, brain, kidney, liver) vascular disease treatment rehabilitation. We have an exciting opportunity at the Bio Health Center to see how much improvement in brain repair can be obtained from the utilization of EECP included in our comprehensive vascular disease treatment, rehabilitation and prevention program.

References

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2) Lawson, William et al. "Enhanced External Counterpulsation: U. S. Clinical Research." CARDIOVASCULAR REVIEWS AND REPORTS. 1997;18:18-22.

3) Werner, Dierk et al. "Pneumatic Exernal Counterpulsation: A New Noninvasive Method to Improve Organ Perfusion." AMERICAN JOURNAL OF CARDIOLOGY. 1999; October 15, 84: 950-952.

4) Wu, Hu Jian. "Probe to the Indications, Contraindications, Course and Therapeutic Effects of ECP-Treatment." CHINESE EXTERNAL COUNTERPULSATION JOURNAL. 1993;5:1-8. (Translated by Z. Huang, M.D., Los Angeles, August, 1995.

5) Xu, Yu-yun and Zhen-sheng Zheng. "External Counterpulsation", CHINESE MEDICAL JOURNAL. 1990;103(9):768-771.

6) Zheng, Zhen-sheng et al. "Sequential External Counterpulsation (SECP) in China." TRANS AM SOC ARTIF INTERN ORGANS. 1983;29:699-603.


7) Effects of External Counter Pulsation on the Event Related Potential P300 of Patients With Vascular Dementia." CHINESE JOURNAL OF CLINICAL REHABILITATION. 2003;7(7):1-5.

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14) Scheidt, Stephen et al. "Mechanical Circulatory Assistance with the Intraaortic Balloon Pump and Other Counterpulsation Devices." PROGRESS IN CARDIOVASCULAR DISEASES. 1982; 25(1):

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16) Lawson, William. "Three Year Sustained Benefit from Enhanced External Counterpulsation in Chronic Angina Pectoris." AMERICAN JOURNAL OF CARDIOLOGY. 1995;75:840-841.

17) Lawson, William et al. "Can Angiographic Findings Predict Which Coronary patients Will Benefit from Enhanced External Counterpulsation?" AMERICAN JOURNAL OF CARDIOLOGY. 1996;77:1107-1109.

18) Arora, Rohit et al. "The Multicenter Study of Enhanced External Counterpulsation (MUST-EECP): Effect of EECP on Exercise-Induced Myocardial Ischemia and Anginal Episodes." JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY. 1999;33(7):1833-1840.

19) Amsterdam, Ezra. "Clinical Assessment of External Pressure Circulatory Assistance in Acute Myocardial Infarction." AMERICAN JOURNAL OF CARDIOLOGY. 1980;45:349-356.

20) Ruiz, U. et al. "Assisted Circulation by External Pressure Variation." JOURNAL OF CARDIOVASCULAR SURGERY. 1969;10:187-197.
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22) Soroff, Harry et al. "External Counterpulsation - Management of Cardiac Shock After Myocardial Infarction." JAMA. 1974;229:1441-1450.

23) Soran, Ozlem et al. "Enhanced External Counterpulsation in the Management of Patients with Cardiovascular Disease." CLINICAL CARDIOLOGY. 1999;22:173-178.

24) Watson, John et al. "Similaries in Coronary Flow Between External Counterpulation and Intra-aortic Balloon Pumping." AMERICAN JOURNAL OF PHYSIOLOGY. 1976; 230(16):1616-1621. 25) Strobeck, John et al. "The Emerging Role of Enhanced External Counterpulsation in Cardiovascular Disease Management." CARDIOVASCULAR REVIEWS AND REPORTS. 1997; 18:6-11.

26) Tartaglia, Joseph. "Case Studies: Enhanced External Counterpulsation." CARDIOVASCULAR REVIEWS AND REPORTS. 197;18:12-17.

27) Conti, R. "EECP-Enhanced External Counterpulsation." JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY. 1999; 33(7):1841-42.

28) Suresh, K. et al. "Maximizing the Hemodynamic Benefit of Enhanced External Counterpulsation." CLINICAL CARDIOLOGY. 1998;21:649-653.

29) Wright, Philip. "External Counterpulsation for Cardiogenic Shock Following Cardiopulmonary Bypass Surgery." AMERICAN HEART JOURNAL. 1975;90(2):231-235.