In the 1950s, counterpulsation techniques were invented at Harvard University featuring hydraulic compression. With technological advancements, pneumatic cuffs were invented that revolutionized counterpulsation therapy.
Later, after introduction of heart bypass surgery in the U.S., EECP was adopted by Chinese researchers as a technique to treat cardiovascular disease. In the 1990s, U.S. scientists began anew to discover benefits of EECP and advance disease treatment with more clinical research about the benefits of EECP.
Researchers continue to prove the efficacy of EECP as a non-surgical disease treatment and along the way new discoveries about the power of EECP are becoming well known.
In this section you can see the historical timeline, a bit about the controversy surrounding EECP and many of the research studies in support of EECP as a credible treatment for cardiovascular and other diseases.
The precursor to EECP technology was a water hydraulics system, developed at Harvard University in the 1950s.
In modern EECP technology blood-presssure type cuffs sequentially pulse using pneumatic compression.
In the late 1950s, Harken and Associates and Birtwell developed counterpulsation techniques at Harvard University.
In the 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, scientists at the National Institutes of Health suggested enhanced results due to the sequential pulsation of blood from the extremities rather than the non-sequenced pulsation being used by hydraulic machines.
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.
In the 1970s, the FDA approved EECP for treatment of cardiogenic shock and myocardial infarction (heart attack).
In 1980, China began developing extensive technological advancements with EECP and continues to make positive strides.
In 1989, 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.
In 1995, EECP was approved by the FDA for angina pectoris.
After 1995, the Health Care Financing Administration (HCFA) denied Vasomedical, Inc.’s, 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.
On Dec. 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.
In 1999, 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.
In January 2000 (five years after the FDA), Grant Bagley, MD, finally approved EECP for reimbursement, BUT only for these advanced conditions:
- Canadian Class III or class IV angina (FDA approval is for Canadian Class I, II, III, IV angina)
- A person’s condition is inoperable or at high risk of operative complications or post-operative failure.
- A person’s coronary anatomy is not readily amenable to such procedures.
- A person has co-morbid conditions which create excessive risk.
- A prescription by a cardiologist or cardiothoracic surgeon.
- The treatment program is limited to 35 hours maximum.
In February 2000, 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.
In 2002, 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.
In 2004, several studies also found that EECP shows some benefit for patients with stabilized heart failure.
In January 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.
On December 20, 2005, CMS denied the request by Vasomedical to approve Medicaid reimbursement of EECP for congestive heart failure, advanced stages of angina, cardiogenic shock or coronary artery disease.
Since 2005, clinical researchers have continued to publish studies on the efficacy of EECP in support of disease treatment.
In a 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.