EECP Clinical Studies

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Study Published in American Journal of Cardiology Compares EECP Therapy With Angioplasty for Patients With Symptomatic Coronary Artery Disease.

Study suggests that EECP may be an appropriate treatment option for patients who would otherwise undergo angioplasty for relief of symptoms.

May 15th issue of the American Journal of Cardiology.

Entitled “Comparison of Patients Undergoing Enhanced External Counterpulsation and Percutaneous Coronary Intervention for Stable Angina Pectoris,” was coordinated by The University of Pittsburgh.

Analyzed two groups of patients considered candidates for PCI but treated differently.

323 patients were treated with EECP therapy: 448 patients underwent PCI.

43.7% of patients who underwent EECP were angina free at one year.

73.4% of patients who underwent PCI were angina free at one year.

However, the EECP treated patients had a significantly higher risk patient profile compared to the PCI treated group, including a higher incidence of previous coronary artery bypass surgery and prior catheter-based interventions, double the rate of prior heart attacks, and a greater history of congestive heart failure and diabetes.

Rates of severe symptoms at one-year post treatment were 15.5% for the higher risk EECP treated patients versus 9.5% for the PCI treated group.

Rate of survival and major adverse events at one-year were shown to be comparable between the patients treated with noninvasive EECP therapy and those treated with PCI, even with the disparity of risk profiles in the two groups.

A substantially higher proportion of patients in the PCI treated group underwent additional PCI’s during the one-year follow-up period compared to the EECP treated group. (17.2% versus 6.3%)

Twice the number of patients with persistent angina symptoms at one year in the PCI group reported use of short-acting nitrates compared to those in the EECP treated group.

Ozlem Soran, M.D. , Research, Assistant Professor in Medicine at the Cardiovascular Institute University of Pittsburgh and co-author of the study, commented “Despite some of the limitations inherent in this analysis, these and other recent data suggest that perhaps we need to re-examine our treatment algorithm for symptomatic coronary artery disease patients and opt of EECP first in select patient subsets rather than using EECP as a last resort strategy.” “Based on our experience with EECP to date, I believe there are many angina patients who would consider having EECP if it meant that they could avoid or at least defer having a more invasive procedure performed.”

 

Study Suggests EECP Therapy May Improve Cardiac Function in Patients With Ischemic Cardiomyopathy.

Presented at the American Federation for Medical Research, April 2002.

24 patients with symptomatic coronary artery disease received 35, one-hour treatments of EECP therapy.

Cardiovascular function was assessed in each patient prior to the start of treatment and again just prior to the final hour of EECP therapy utilizing the BioZ â impedance cardiography.

19 patients had EF>35%: 5 patients had EF<35% prior to treatment with EECP.

Both groups had dramatic reduction in their angina. 79% in EF>35% group and 60% in EF<35% group.

Both groups experienced an improvement by at least one Canadian Cardiovascular Society angina class.

The 5 patients with EF<35% pre-EECP demonstrated a significant improvement in cardiac function, as measured by stroke volume and cardiac output.

 

Study Published in The American Journal of Cardiology Supports the Hypothesis That EECP Therapy Improves Myocardial Perfusion Through Angiogenesis

The American Journal of Cardiology (Vol. 89 April 1, 2002)

Effects of Enhanced External Counterpulsation on Stress Radionuclide Coronary Perfusion and Exercise Capacity in Chronic Stable Angina Pectoris.

155 men; 20 women; at seven EECP centers world wide received a 35-hour course or EECP.

Results of radionuclide perfusion treadmill stress tests (RPST’s) prior to EECP and within six months post EECP were compared.

Four of the centers performed post-EECP RpST’s to the same level of exercise and the pre-EECP stress test. The other three centers performed maximal RPSTs with patients exercising to a maximal level of exertion.

Results showed that 85% of patients improved by at least one Canadian cardiovascular Society (CCS) angina class.

83% of patients in whom post-EECP RPST’s were performed at the same level of exercise as the pre-EECP stress tests and 54% of patients who underwent maximal post-EECP stress tests showed a significant improvement in their perfusion images.

Those who underwent maximal RPST’s post-EECP showed a significant improvement in exercise duration with little or no change in the double product. (defined as peak systolic Blood Pressure X Peak Heart Rate.)

Those who underwent RPST’s at the same level as pre-EECP, achieved a significantly lower double product, signifying less demand on the heart for a given level of exertion.

In summary, EECP was effective in improving stress myocardial perfusion in patients with chronic stable angina at both comparable and maximal exercise levels. Our study supports the hypothesis that EECP improves myocardial perfusion via collateral recruitment or development (angiogenesis).

 

Study in the American Journal of Cardiology Confirms Benefits of EECP® Across the Whole Spectrum of Angina Sufferers

Study published in the September 11, 2001 (Vol. 88, Issue 5, Supplement 1) issue of the American Journal of Cardiology.

1578 patients from the International EECP Patient Registry (IEPR) at the University of Pittsburgh Graduate School of Public Health.

423 patients were considered good candidates for angioplasty, coronary stenting, and bypass surgery, but elected to undergo a course of EECP therapy were compared with those 1145 patients for whom such procedures were not considered an option, both immediately after and at one year following EECP treatment.

75% of patients in both groups experienced a one or more class reduction in their angina immediately following and this improvement was sustained at one year.

Andrew D. Michaels, MD of the University of California at San Francisco and Lead author of the study entitled, Efficacy of Enhanced External Counterpulsation (EECP) for Patients who are Not Candidates for Coronary Revascularization: Immediate and One-Year Clinical Outcomes from the International EECP Patient Registry stated, "These data show that EECP is an effective treatment approach not only for those who anatomy or overall condition make them ineligible for the more traditional Revascularization procedures, but also for those who would prefer a noninvasive approach."

Except for a narrowly defined set of blockage patterns, PCI (percutaneuous coronary interventions) and bypass have never been shown to reduce mortality.

Reveals that EECP® is as effective for patients who were candidates for revascularization procedures such as angioplasty, coronary stenting, and bypass surgery as it was for those who were not deemed candidates for these procedures. This study shows that EECP should not be reserved exclusively for the no option patient.

Suggests that EECP® could be used as a primary treatment strategy for many patients with ischemic heart disease.

 

Vasomedical Reports, Published Study is First to Link Benefit of EECP® To Development and Recruitment of Collateral Vessel in the Heart."

Published in the August 15th, 2001 issue of the European Heart Journal concluded that the sustained improvement in myocardial perfusion and relief of angina symptoms following a course of EECP® therapy were most likely related to the development and recruitment of collateral vessels in the heart and improvement in coronary dilatation and blood flow.
D. Masuda, MD of the Graduate School of Medicine at Kyoto University in Japan, evaluated myocardial perfusion in 11 patients following a course of EECP therapy using N13 ammonia positron emission tomography (PET).
The results of this study showed statistically significant improvement in coronary flow reserve during treadmill testing and while at rest, as well as a significant increase in exercise time and time to ST segment depression.
An increase in the levels of nitric oxide, a vasodilator, and a decrease in neurohumoral factors were also observed

 

The Multicenter Study of Enhanced External Counterpulsation (MUST-EECP)

The purpose of this study was to assess safety and efficacy of enhanced external Counterpulsation (EECP®)

  • A multicenter, prospective, randomized, blinded, controlled trial was conducted in seven university hospitals in 139 outpatients with angina, documented CAD and positive exercise treadmill test.
     
  • Patients were given 35 hours of active Counterpulsation (active CP) or inactive Counterpulsation (inactive CP).
     
  • More active-CP patients saw a decrease and fewer experienced and increase in angina episodes as compared with inactive-CP patients.
     
  • NTG usage decreases in active-CP but did not change in the inactive-CP group.
     
  • Overall, EECP® reduces angina and extends time to exercise-induced ischemia in patients with symptomatic CAD.
     
  • Treatment was relatively well tolerated and free of limiting side effects in most patients. (j Am Coll Cardiol 1999;33:1833-40)

 

University of Pittsburgh Study Shows EECP® Improves Left Ventricular Function

  • Presented by John Gorcsan III, M.D., associate professor of medicine, Anesthesiology and Critical Care Medicine at the University of Pittsburgh School of Medicine and director of the Echocardiography Laboratories at UPMC Presbyterian Hospital.
     
  • Eight patients had New York Heart Association Class II or III heart failure and a heart ejection fraction rate of less than 40%.
     
  • Following 35, one-hour sessions of EECP® treatment over 7 weeks, all of the patients showed significant increases in their left ventricular function and the ejection fraction.
     
  • Patients also experienced a decrease in their heart rate.
     
  • “EECP appears to be beneficial to left ventricular function in heart failure patients and may be a useful adjunct to medial therapy,” said Dr. Gorcsan.

 

EECP® May Reduce Restenosis Following Angioplasty

July 24th, 2001--The study entitled “Safety and effectiveness of Enhanced External Counterpulsation in Improving Angioplasty Restenosis” was presented at the Second International Congress on Heart Disease in Washington, DC. (Tomascz P. Stys, M.D.)

  • 1 million patients worldwide undergo a PCI each year such as angioplasty and stent placement.
     
  • Restenosis occurs in approximately 30% of patients within the first six months.
     
  • 15 of 24 patients who had undergone PCI received a course of EECP® following their procedures.
     
  • 6 months post PCI, MACE recurrence of ischemia documented by radionuclide stress scintigraphy were observed.
     
  • 44% of the control group versus 13% of the group that received EECP® therapy exhibited Restenosis.

 

Primary Utilization to Improve Myocardial Perfusion with Enhanced External Counterpulsation (PUMPER)

Study presented May 22-24, 2001 by Charles P. Fitzgerald, M.D., Medical Director of the Heart Care Clinic in Little Rock, Arkansas.

  • Examined 3037 consecutive patients entered into the International EECP® Patient Registry (IEPR).
     
  • Compared 188 patients who had never undergone bypass surgery or angioplasty, buy who , at the time of enrollment, were considered good candidates for such procedures.

 

Five -Year Follow-Up Study

Five -Year Follow-Up Study •William E. Lawson, M.D.,John C.K. Hui, PH.D.,Peter F. Cohn, M.D. Division of Cardiology and Department of Surgery, SUNY at Stony Brook, Stony Brook, New York, USA

  • Evaluation of the effect of EECP® on long term prognosis in such patients.
     
  • Major adverse cardiovascular events (MACE) were tracked in 33 patients with CAD treated with EECP®
     
  • Patients were sub grouped based on whether or not they demonstrated an early improvement in radionuclide stress perfusion imaging (Responders vs.. Non responders) and followed for MACE over a mean follow-up of 5 years.
     
  • Patient population included 73% with multi vessel disease; 45% with prior myocardial infarctions(s);61% who had undergone either coronary artery bypass grafting (CABG) or percutaneous transluminal coronary angioplasty (PTCA), or both.
     
  • 26 of 33 (79%) Responders; 7 or 33 (21%) Non responders.
     
  • Non responders had significantly more MACE (6/7 or 86%) than Responders (6/26 or 23%).
     
  • Overall, 21 of the 33 (64%) patients remained alive and without MACE and the need for revascularization 5 years post EECP® treatment.

 

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