The History of EECP
The device used for EECP was invented in the late 1950s at Harvard University.
The History of EECP
Harken and Associates and Birtwell developed counterpulsation techniques at Harvard University.
In Mid 1960s
Several scientists evolved counterpulsation to a noninvasive technique using a primitive external device that applied pressure generated by a hydraulic system.Studies with early non-invasive machines demonstrated the potential to increase survival in patients with myocardial infarction, cardiogenic shock and angina pectoris. Pneumatic devices soon replaced the cumbersome hydraulic machines.
In the late 1960s
External Counterpulsation (ECP) was developed in the 1960s as a circulatory assist device to support patients in acute myocardial infarction and cardiogenic shock. In the next five years, Dr. Z.S. Zheng in China developed a pneumatic sequential counterpulsation system ushering the modern era of Enhanced ECP.
During the 1970s
Zheng and colleagues at Sun Yat Sen University in China reported studies with a newly designed sequenced pulsation system using four sets of compression bladders on the patient’s legs, buttocks and arms. In these trials, effects of the sequenced system were studied in patients with angina pectoris and acute myocardial infarction. In more than 90 percent of the 200 patients with angina pectoris, this device provided long-term symptomatic relief with minimal relapse (excerpted from the University of San Francisco web site).
Favorable results reported by Chinese investigators, led scientists at the Health Sciences Center at the State University of New York at Stony Brook, to reassess the efficacy of external counterpulsation in treatment of patients with chronic angina pectoris. Their studies were performed using a newly developed and “enhanced” counterpulsation system.
The FDA approved EECP for treatment of cardiogenic shock and my ocardial infarction (heart attack).
EECP was in use for acute myocardial infarction and cardiogenic shock. The U.S. Food and Drug Administration cleared EECP in:
China began developing extensive technological advancements with EECP and continues to make positive strides.
researchers from the State University of New York at Stony Brook determined that enhanced external counterpulsation continued to show helpful effects on patients even three years after treatment.
EECP was approved by the FDA for chronic stable angina pectoris.
The Health Care Financing Administration (HCFA) denied , manufacturer of EECP technology, application to approve EECP for angina. The given reason was that HCFA required a double-blind clinical study and publication of research in peer-review journals.
Sara Soulati began treating patients with EECP working at EECP West Inc, the only clinic in the U.S. outside of Stony Brook in New York. EECP West introduced EECP treatment to Dr. Julian Whitaker. Sara treated many patients with all types of illness referred by Dr. Whitaker’s practice.
Sara Soulati worked with various manufacturing companies like Nicore and Cardiomedics. Sara Soulati teamed with HealthSouth sports rehabilitation facility in Los Angeles to study the effect of EECP on athletes’ recovery from injury.
Sara Soulati became the leading sales person for Vasomedical and tried to open the EECP marketplace so people could receive treatment by selling the technology and educating physicians.
On December 16, 1998
Vasomedical presented to HCFA results of its Multicenter Study of EECP (MUST Trial) featuring seven medical centers and 139 patients in a double-blind study relating to Class I, II and III angina. HCFA’s Grant Bagley, MD, director of HCFA Coverage and Analysis, again denied coverage stating results of the MUST Trial needed to be published in a peer-review journal.
Sara Soulati became business partner at Cardiac Renewal Centers of America, a privately held management company for 10 EECP centers in Southern California.
The Center for Medicare Services guidelines for EECP approved. Enhanced External Counterpulsation (EECP) is a non-invasive treatment developed for treatment of end-stage angina pectoris that is refractory to conventional therapy, (i.e. surgery, angioplasty), acute myocardial infarction, cardiogenic shock. A person’s coronary anatomy is not readily amenable to such procedures.
After CMS failed to approve EECP for angina again, Wallace Haselton, a former member of Vasomedical’s board of directors, went head-to-head with HCFA to secure coverage of EECP for angina. He called Senator Edward Kennedy (D-Mass.), and together they petitioned the Senate Finance Committee, regulators, legislators and anyone they could enlist to help change the outcome for EECP at HCFA.
HCFA changed all references of EECP to ECP in written materials. These coverage guidelines issued by HCFA went unchallenged by the medical industry or manufacturers of EECP technology. These limited coverage guidelines remain in force today.
Sara Soulati works with Los Angeles Avengers Arena Football team to further her study of EECP and elite athletes. Sara Soulati writes clinical research paper with UCLA cardiologist on EECP and sports.
Winning Edge Technologies, Inc. is a Sara Soulati company.
Sara Soulati launches Global Cardio Care® Inc. working with physician practices that deliver EECP care so people suffering from cardiovascular disease could finally get the treatment they needed.
The American Heart Association and the American College of Cardiology issued guidelines on treating angina stating that more studies are required on EECP before it can be recommended as a standard treatment for angina. So far, EECP has not been widely accepted in clinical practice.
In June 2002
the FDA approved EECP for treatment of congestive heart failure.
several studies also found that EECP shows some benefit for patients with stabilized heart failure.
CMS denied the request by Vasomedical to approve Medicaid reimbursement of EECP for congestive heart failure, advanced stages of angina, ardiogenic shock or coronary artery disease.
clinical researchers have continued to publish studies on the efficacy of EECP in support of disease treatment.
December 20, 2005
Vasomedical released results of its Prospective Evaluation of Enhanced External Counterpulsation in Congestive Heart Failure (PEECH) study for congestive heart failure and published results in a peer-review journal. This study found that patients with mid- to moderate-severe heart failure experienced an improvement in their New York Heart Association (NYHA) class after counterpulsation. However, the long-term safety and effects of EECP are unknown among these patients and more long-term studies are needed.
Significant Landmark Study January 1, 2010
“EECP is a Regenerative Therapy,” published in Frontiers in Bioscience magazine, clinical researchers from Texas A&M Health Science Center College of Medicine and Cardiology showed that EECP therapy is likely to regenerate circulatory stem cells of diseased organs in the body.
Sara Soulati opened a new EECP center, Global Cardio Care—West Los Angeles.
At Global Cardio Care centers, the history of EECP is shared with people who have a variety of diseases (not only end-stage cardiovascular disease). Cardiovascular diseases can be treated with EECP therapy. We focus on prevention of cardiovascular disease and education, not just end-stage of life treatment. That’s how we differentiate Global Cardio Care services over other institutions. 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:
- University of California Los Angeles
- University of California San Diego
- Duke University Medical Center
- University of Pittsburgh Medical Center