Improving cardiovascular disease one heartbeat at a time.

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Improving cardiovascular disease one heartbeat at a time. Global Cardio Care Centers EECP treatment is for patients suffering from angina pectoris and other cardiovascularrelated diseases.

1 Improving cardiovascular disease one heartbeat at a time. Global Cardio Care Centers EECP treatment is for patients suffering from angina pectoris and other cardiovascularrelated diseases. Global Cardio Care Centers is the leader in providing EECP (Enhanced External Counterpulsation) therapy. It is the largest out-patient stand alone center that delivers EECP treatment. GlobalCardioCare.com

2 EECP therapy is non-surgical, requires no medication and is an FDA-cleared treatment for cardiovascular disease. Global Cardio Care Centers Global Cardio Care Centers provides patients the opportunity to experience a non-invasive and medication-free therapy combined with the Sara Soulati Health For Life Program. A course of EECP therapy is 35 hours or more. Sara Soulati and Her Management Team In 1996, Sara Soulati launched her career in the field of EECP, and she is one of the earliest pioneers in the delivery of the treatment. She has been managing physician practices since She is founder and CEO of Global Cardio Care, the team that manages the out-patient stand alone center that delivers EECP therapy. EECP World-Wide There are more than 900 academic institutions and independent physician practices throughout the U.S and the world that use EECP therapy for cardiovascular disease. They include: Mayo Clinic St. Francis Heart Hospital Beth Israel Medical Center University of New York at Stony Brook The Cleveland Clinic NYU Langone Medical Center University of California Los Angeles University of California San Diego Duke University Medical Center University of Pittsburgh Medical Center She has developed the Sara Soulati Health For Life Program which is completed over 35 days and longer. It is a vegan/plant-based, nutrition and exercise program that correlates to lifestyle modification featuring the power of EECP at its core. When patients follow this daily program, they will completely transform physically and mentally. Patients are coached one-on-one daily every step of the way to help them achieve their goals.

How EECP Works The History of EECP The device used for EECP was invented in the late 1950s at Harvard University.

Food and Drug Administration cleared EECP in: 3 4 5 1995 for chronic stable and unstable angina pectoris, cardiogenic shock,

Three large blood-pressure-like cuffs wrap around the (2) calves, (3) thighs, and (4) buttocks.

To optimize therapeutic benefit, the cuffs are timed to a patient s ECG squeezing calves, thighs and buttocks in rapid

When the heart is at rest, in early diastole the cuffs inflate sequentially from distal to proximal, and then deflate in late

How EECP Works EECP works by pumping blood from the legs upward to the heart while the heart is at rest.

3 How EECP Works The History of EECP The device used for EECP was invented in the late 1950s at Harvard University. 1 2 In the 1970s EECP was in use for acute myocardial infarction and cardiogenic shock. The U.S. Food and Drug Administration cleared EECP in: for chronic stable and unstable angina pectoris, cardiogenic shock, and acute myocardial infarction for congestive heart failure. (1) You lie on a comfortable EECP bed. Three large blood-pressure-like cuffs wrap around the (2) calves, (3) thighs, and (4) buttocks. (5) You are hooked to a heart monitor. To optimize therapeutic benefit, the cuffs are timed to a patient s ECG squeezing calves, thighs and buttocks in rapid sequence. When the heart is at rest, in early diastole the cuffs inflate sequentially from distal to proximal, and then deflate in late diastole prior to onset of systole. Early counterpulsation therapy was done with hydraulics at Harvard University. How EECP Works EECP works by pumping blood from the legs upward to the heart while the heart is at rest. This mechanism improves circulation throughout the body, promotes angiogenesis, and has long-term, positive effects. Sequential cuff inflation creates a retrograde pressure wave that augments diastolic pressure, increasing pressure of coronary perfusion and venous return to the right side of the heart. This increases preload and cardiac output. Rapid, simultaneous cuff deflation decreases systemic vascular resistance, after load, and cardiac workload.

Mechanism of EECP Mechanism of EECP The squeezing mechanism of EECP improves the hemodynamics of blood flow and shear stress to help generate progenitor and hematopoietic stem cells in the bone

EECP, Angina Pectoris & Disease The Centers for Medicare and Medicaid Services (CMS) and other third-party insurance payers have been providing reimbursement for the treatment of angina symptoms

4 Mechanism of EECP Mechanism of EECP The squeezing mechanism of EECP improves the hemodynamics of blood flow and shear stress to help generate progenitor and hematopoietic stem cells in the bone marrow improving endothelial function and reprofusing organ tissue. EECP, Angina Pectoris & Disease The Centers for Medicare and Medicaid Services (CMS) and other third-party insurance payers have been providing reimbursement for the treatment of angina symptoms since In addition, elevated levels of nitric oxide and vascular endothelial growth factor are evident during EECP that helps improve circulation as well as stimulates angiogenesis, resulting in improved endothelial function and a reduction of both circulating inflammatory markers and arterial stiffness. EECP promotes angiogenesis to help grow new collaterals for blood to flow, like a NaturalBypass around blocked arteries. Mechanism of Action Increased venous return Increased preload/stretch Increased cardiac output Retrograde arterial flow Increased diastolic pressure Increased intracoronary perfusion Increased vascular recoil and systolic unloading Decreased systemic vascular resistance Decreased afterload EECP is proven to help patients with the following angina symptoms: Ischemic heart disease with associated symptoms of fatigue Dyspnea Angina pectoris and unspecified angina pectoris Heart failure occurring with less than ordinary exertion and chronic stable angina pectoris.

EECP promotes angiogenesis, growth of new collaterals to improve circulation. EECP treatment increases nitric oxide, vascular endothelial growth factor, and other endothelial growth factors.

5 EECP promotes angiogenesis, growth of new collaterals to improve circulation. EECP treatment increases nitric oxide, vascular endothelial growth factor, and other endothelial growth factors. Documented minimal cardiovascular disease (Objective Assessment) Angiography Stress Test Nuclear Scan Cardiac Ultrasound ECG Holter Symptoms with Physical Exertion Patients who are comfortable at rest with less than ordinary physical activity experience: Chest or atypical pain Shortness of breath Fatigue Palpitation Symptoms of ischemic heart failure More Patient Groups to Consider Patients that are in-operable Patients with excessive risk or co-morbid conditions that create unnecessary risk for invasive procedures Patients who refuse or are unwilling to risk another invasive procedure due to age Inadequate relief from medication or complication from excessive medication Post-Invasive Patients. These are patients who have had Bypass Surgery (CABG) or Percutaneous Coronary Intervention (PCI) within the last five years or more. Statistics show that these patients will be symptomatic as early as one year post procedure. EECP is a safe, non-invasive treatment option. Diabetic patients with underlying ischemic heart disease. These are patients who suffer from neuropathy and often have symptoms of shortness of breath on physical exertion. Many of these patients are NOT good candidates for surgery as many have excessive risk factors and postoperative complications. Inactive or Sedentary Lifestyle. These patients avoid any activity that brings them discomfort. Many experts say that EECP therapy provides as much as six times the amount of exercise benefit per hour of treatment than any other form of tolerated physical exercise. Many of these patients are obese or elderly with many health complications that pose significant risk factors for other traditional invasive procedures.

EECP Guidelines Candidates to Consider: Small vessel or diffuse disease resulting in symptoms CAD patients who live sedentary lifestyles Patients looking to restore exercise tolerance / functional

Clinical studies have shown that there is a definite trend demonstrating EECP therapy, when done post PCI, may reduce restenosis rates. PCI and CABG target the lesion.

6 EECP Guidelines Candidates to Consider: Small vessel or diffuse disease resulting in symptoms CAD patients who live sedentary lifestyles Patients looking to restore exercise tolerance / functional capacity Patients who take excessive medication (Nitroglycerin, Ranexa) or do not get ample relief Patients looking to restore and improve overall quality of life Post PCI and EECP. Clinical studies have shown that there is a definite trend demonstrating EECP therapy, when done post PCI, may reduce restenosis rates. PCI and CABG target the lesion. EECP with its mechanisms of action targets the disease. Ozlem Soran, MD, MPH, FACC, FESC. Director of EECP Research Lab, Associate Professor of Medicine, Epidemiology and Research, University of Pittsburgh, Heart and Vascular Institute Cardiac Syndrome X (microvascular angina) Left main disease Mild refractory angina (CCS Class II) Diabetes mellitus Patients looking to improve exercise capacity and oxygen consumption in heart failure patients with New York Heart Association Class II/III A course of EECP therapy is 35 hours and more. Systolic or diastolic heart failure Severe, diffuse coronary atherosclerosis Significant silent ischemia Unsuccessful or incomplete coronary revascularization High risk of adverse events related to invasive revascularization Challenging coronary anatomy, heart failure, renal failure, or pulmonary disease As early as 1996, Sara Soulati pioneered EECP. She is one of the most experienced practitioners in its practice.

7 Clinical Benefits Clinical Benefits of EECP Sustainable increase in coronary perfusion Retrograde arterial flow (shear stress) increases endothelial function Peripheral training effects (similar to exercise) Cardiac remodeling (stunned and hibernated myocardium) Improvement in oxygen consumption (VO 2 ) Regression of atherosclerosis Improvement in ventricular function Increase in cardiac output Decrease in cardiac workload of the heart Release of growth factors Increased coronary pressure Increased levels of nitric oxide and decreased levels of ANP and BNP. Acute improvement in peripheral endothelial function (increase in RH-PAT index) Increased time to the onset of ischemia Decrease in number and severity of angina episodes Reduction in angina and heart failure classifications Decreased medication (including Nitroglycerin and Ranexa) Decrease in arterial stiffness Although the patient benefits of EECP therapy have been proven to last for more than 5 years, it is not uncommon for Medicare or other thirdparty payers to reimburse for repeat treatment session (35 days) twice each year. Patient Benefits of EECP Therapy Proven in Clinical Studies: Increase in energy and exercise tolerance Increased alertness (brain function) Reduced or eliminated symptoms of chest pain Reduced symptoms of shortness of breath Reduced symptoms of fatigue Reduced heart palpitation Reduced leg pain from peripheral vascular disease Strengthened heart muscle by reviving parts of the heart that have hibernated from lack of blood flow Increased perfusion and collateralization by creating a NaturalBypass around narrowed arteries in heart as well as other organs Sustainable relief of symptoms related to ischemic heart disease Sustainable increase in coronary perfusion Improvement in sexual function for men Reduced symptoms of Parkinson s Disease Reduced symptoms of dementia (Alzheimers Disease) Reduced blood pressure

Clinical Proof Points Clinical Trials Throughout the years, randomized, controlled clinical trials have been conducted to prove the efficacy of EECP for angina pectoris.

The long-term care of patients with chronic coronary artery disease requires the cardiologist to use aggressive preventive methods and more cost-effective treatment to improve clinical and financial

8 Clinical Proof Points Clinical Trials Throughout the years, randomized, controlled clinical trials have been conducted to prove the efficacy of EECP for angina pectoris. There have been more than 200 published papers in peer-reviewed medical journals demonstrating safety and efficacy of EECP in the treatment of angina pectoris and chronic heart failure. The long-term care of patients with chronic coronary artery disease requires the cardiologist to use aggressive preventive methods and more cost-effective treatment to improve clinical and financial outcomes. EECP treatment is a safe, cost-effective, non-invasive method of restoring myocardial perfusion and reducing symptoms of angina. EECP treatment is the perfect disease management tool for chronic coronary artery disease. John E. Strobeck, MD, PhD, Interventional Cardiologist, Co-founder of the Heart Failure Society of America, Medical Director, The Heart & Lung Center, Hawthorne, NJ Arterial Stiffness Arterial Stiffness Arterial Stiffness Augmentation Index 27±10% Pre-EECP p= ±10% Post-EECP Enhanced External Counterpulsation Treatment Improves Arterial Wall Properties and Wave Reflection Characteristics in Patients With Refractory Angina Nichols WW, Estrada JC, Braith RW, Owens K, Conti CR. Journal of the American College of Cardiology Sep 19;48(6): Epub 2006 Aug 25. Summary: 34, 1-hour EECP treatments in 20 stable angina patients caused a significant decline in the augmentation index and an increase in reflected wave travel time, demonstrating improvement in endothelial function.

9 Clinical Research Number of CD34+/KDR+ Cells Per 10 5 peripheral blood mononuclear cells 35.1 p=0.430 Control (N=10) Pre-EECP 29.7 Post-EECP p=0.049 Treated (N=15) Endothelial Progenitor Cell Release The Effect of External Counterpulsation Therapy on Circulating Endothelial Progenitor Cells in Patients with Angina Pectoris Yosef O, Rosenthal E, Barbash IM, Matetzky S, Tal R, Bentancur AG, Sela BA, Nagler A, Leor J. Cardiology. 2008;110(3): Epub 2007 Dec 4. Summary: Circulating endothelial progenitor cells (EPCs) positive for CD34 measured by flow cytometry and kinase insert domain receptor (KDR) measured by the number of colony-forming units in 25 patients with angina pectoris randomized to 35 daily 1-hour EECP treatment sessions (n=15) and control (n=10) were significantly increased in the EECP-treated group and not in the control group. Patients in the EECP-therapy group also improved their anginal score from 3.0 pre-eecp therapy to 2.0 post EECP therapy (p<0.001). The improvement of angina post EECP treatment is associated with an increased number of colony-forming capacities of circulating EPCs. Bibliography At Vasomedical, there is a bibliography of clinical research and evidence-based documentation proving benefit of EECP treatment. Studies are available on many of the following: Hemodynamic Effects of EECP Therapy Endothelial Cell Function Arterial Stiffness Inflammatory Markers Endothelial Progenitor Cell Release MUST Trial PEECH Trial Perfusion to Ischemic Region

Prescribe EECP For Your Patients at Global Cardio Care! Call today to schedule your patients for a Free EECP trial and to enroll them for a course of 35 EECP treatments and more.

10 Prescribe EECP For Your Patients at Global Cardio Care! Call today to schedule your patients for a Free EECP trial and to enroll them for a course of 35 EECP treatments and more. info@globalcardiocare.com GlobalCardioCare.com Wilshire Blvd 405 S Westgate Ave Barrington Ave Bundy Dr S Westgate Ave Armacost Ave Santa Monica Blvd Global Cardio Care West Los Angeles Wilshire Blvd. Los Angeles, CA Global Cardio Care Centers is the leader in providing EECP therapy. It is the largest, out-patient, stand alone center that delivers EECP treatment. 405 W Florence Ave W Manchester Blvd N La Brea Ave Global Cardio Care Inglewood Aerick Street Inglewood, CA N Hillcrest Blvd N Prairie Ave N Prairie Regent Aerick Queen W Manchester Blvd

11 Get Squeezed For Life! GlobalCardioCare.com Background, clinical studies and supporting documentation herein provided by written permission of Vasomedical, Inc. EECP and NaturalBypass are registered trademarks of Vasomedical, Inc. Global Cardio Care is a registered trademark of Global Cardio Care, Inc

External Counterpulsation

External Counterpulsation Presented by Dr Rakesh Mohanlall 2011 14 September ASPECTS Overview of ECP The Place of ECP in the Medical Arena Economic Impact of ECP & Cost Benefits Academic Impact of ECP