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Clinical Evidence   arrow

Since the early 1970’s the first successful clinical studies by Professor Zeng Zhengsheng from China demonstrated external counterpulsation (ECP) increased survival rates of patients during heart attacks and cardiogenic shock, as well as relieved angina pains. By 1990, 1800 ECP centres were operating successfully in China.

Open label studies on the safety and effectiveness of ECP in patients with chronic stable angina pectoris were conducted at the state University of New York at Stony Brook, beginning in 1989 and were reported by Lawson et al in American Journal of Cardiology in 1992. All of these patients had incapacitating symptoms, refractory to medical therapy and exertional myocardial ischaemia documented by thallium-201 perfusion imaging.

All patients in this study showed a substantial improvement in symptoms with most reporting a complete absence of angina during normal activity. In addition, the majority of the patients in this study showed a reduction in myocardial ischaemia, with two-thirds demonstrating a complete absence of reversible defects. These results were accompanied by a significant increase in the mean duration of exercise during maximal stress testing of between 95 and 112 seconds.

A large study in China of more than six thousand patients found an improvement of 90% of the participants. A long term cohort study found that 74% of ECP patients maintained improvements in angina symptoms seven years after completion of ECP therapy. These patients were four times less likely to suffer a cardiac death in eight years after receiving ECP treatments than cardiac patients treated with medication alone.1 The Bypass Angioplasty Revascularisation Investigation (BARI study) is the largest randomised clinical trial to compare bypass surgery and angioplasty. This study showed that 21% of bypass patients and 22% of angioplasty patients either died or suffered from heart attacks during the first five years after surgery. In addition, 8% of bypass patients and 54% of angioplasty patients had to undergo repeat surgery or other invasive procedures within the next five years.2 Subsequent studies taking 323 patients who were still symptomatic after medication, and undergoing invasive and surgical procedures, were treated with ECP. These patients were compared to 448 patients earlier in the progression of disease who underwent non-emergency angiograms. Results of the one year follow up study found that the survival rate in both groups is over 96%. The percentage of patients who underwent bypass surgery in both groups was approximately 5%. Repeat angioplasty rates were lower in the ECP group during the first year after completion of treatment (considering that the ECP group had less favourable baseline characteristics since they had already undergone angiograms and bypass).3 A study conducted by investigators at New York Medical College looked at patients’ maximum exercise ability before and after receiving ECP. The results of this study showed that 23 of the 25 patients (93%) had reduced or no symptoms of angina when exercising, and had improved abilities to carry out daily routine and leisure activities without limitation as compared to before ECP treatment. Stress tests also showed that patients were able to walk longer and at a faster rate on the treadmill than before.4 In 1995, a large randomized, controlled and double-blinded multicentre trial on the efficiency of ECP in patients with chronic stable angina (MUST-ECP) was undertaken at seven leading university hospitals in the U.S. The MUST-ECP trial results were published in the Journal of the American Cardiology in June 1999. A total of 139 patients were controlled in this study and randomly assigned to active or sham groups. Those assigned to the active group were given full pressure. Those randomized to the sham group were treated with low pressure .Patients enrolled in the study ranged from 21-81 years of age, were classified as having DDS’Class 1,11 or 111 angina and had documented coronary artery disease, including a positive exercise stress test within 4 weeks of beginning ECP therapy. Patients in the active ECP group demonstrated significantly increased time to exercise induced ST segment depression when compared to sham and baseline. Those in the active ECP group reported a significant decrease in the frequency of angina counts. Exercise duration increased significantly in both groups but was greater in the active ECP group.5 Hundreds of international studies were performed and published in medical journals by independent medical practitioners using multiple ECP machines, all studies showed a positive response to the treatment without a single incident reported to date.

References:

1.  Y.y Xu,D.Y.Hu,Z.S.  Zheng,   1990.   “External  Counterpulsation  –  Review Article,” Chinese Medical Journal 103 : 762 –71

2. The Bypass Angioplasty Revascularisation Investigation (BARI) Investigation, 1996. “Comparison of Coronary Bypass Surgery with Angioplasty in Patients with Multivessel Disease.” The New England Journal of Medicine335:217-25.

3. Holubkov R, Kennard E.D, Foris J.M, et al. 2002. “Comparison of Patients Undergoing Enhanced External Counterpulsation and Percutaneous Coronary Intervention for Stable Angina Pectoris,” The American Journal of Cardiology89:1182-6.

4. J. Tartaglia, J. Stenerson Jr., R. Charney, et al., 2003.  “Exercise Capability and Myocardial    Perfusion    in    Chronic   Angina    Patients   with    Enhanced    External Counterpulsation,” Clinical Cardiology 26 : 287 – 90

5.  Arora RR, Chou TM, Jain D, Fleishman B, Crawford L, McKiernan T, Nesto R. 1999.
The Multicenter Study of Enhanced External Counterpulsation (MUST-EECP): Effect of EECP on Exercise-Induced Myocardial Ischemia and Anginal Episodes. The Journal of the American College of Cardiology. Jun;33(7):1833-1840.