1. What is Angina?

    Angina pectoris literally means, 'strangling in the chest'. It is the most common symptoms of coronary artery disease. The majority of patients with Angina complain of chest discomfort provoked by mental, physical or emotional stress. The discomfort can vary widely among patients who report shortness of breath, fatigue, indigestion, faintness, pain in the chest, arm, neck, or jaw and other symptoms. 

2. What causes Angina?

    Angina signals that a part of the heart muscle is not receiving an adequate supply of blood and oxygen. The heart requires a particularly rich blood supply because of its heavy workload, and receives this nourishing blood supply through the coronary arteries. When narrowed or blocked arteries restrict blood flow, oxygen supply to portions of the heart may at times be insufficient. Increase in oxygen demand can occur during exercise, fever, rise in emotion, periods of hypoglycemia, or after meals, triggering the onset of Angina. 

3. How does Angina affect people?

    Angina often occurs when exertion outstrips the ability of narrowed or blocked coronary arteries to supply blood to the heart muscle. Angina restricts activity for many patients. They are able to walk, but not uphill nor while carrying packages. For some, Angina is disabling as it interferes with their ability to work or engage in almost any activity. 

4. What is ECP treatment?

    ECP treatment is a non-invasive outpatient treatment that may relieve or eliminate Angina. 

5. What is EECP how is it different from ECP?

    EECP stands for Enhanced External Counter Pulsation it is the registered trademark of Vasomedical inc. USA., otherwise the treatment as such is called as ECP. Hence EECP treatment and ECP treatment have no difference.

6. What does the name External Counter Pulsation (ECP) mean?

   The term External Counter Pulsation (ECP) describes what happens during treatment. ECP treatment is 'external' because it happens outside of the body and doesn't require surgery or other invasive procedures.. Counter pulsation occurs between heartbeats. ECP system pumps when the heart is resting (the beginning of diastole) and relieves pressure just before the heart beats (the end of diastole). Counter pulsation increased blood flow to the heart muscle, decreased the heart's workload and creates greater oxygen supply while lowering oxygen demand. 

7. What are the advantages of ECP treatment over other treatments for Angina?

    Unlike procedures such as bypass surgery and balloon Angioplasty, ECP treatment can be administered in outpatient sessions, carries little or no risk, and is relatively comfortable. Some patients may require bypass surgery, External Counter Pulsation is an option for patients who are unsuitable for invasive procedures or unwilling to undergo them. For patients who have undergone multiple invasive procedures and for whom additional surgery carries excessive risk.  External Counter Pulsation may be the only way to obtain relief from crippling Angina. 

8. What happens during treatment?

    Patients lie on a padded table in a treatment room. Three electrodes are applied to the chest to record a constant ECG reading. A finger sensor called a plethysmograph, records a tracing that represents blood pressure. A set of cuff is wrapped around the calves, thighs and buttocks. The system used an ECG signal to electronically synchronize inflation and deflation of the cuffs. Patients experience a sensation of strong 'hug' moving upward from calves to thighs to buttocks during inflation followed by the rapid release of pressure on deflation.During ECP treatment, a display shows an ECG signal and a blood pressure tracing. An ECP therapist uses these readings to time Counterpulsation and monitor treatment.

9. Am I candidate for ECP treatment?

   Ask your physician to evaluate you. You may be a candidate for ECP if you: 
 - Have chronic stable Angina 
 - Are not receiving adequate relief from Angina by taking nitrates.
 - Do not qualify as a candidate for invasive procedures 
 - Have exhausted invasive treatments without lasting relief of symptoms. 
 - Are unwilling to undergo surgery or Angioplasty. 
 - Want to explore alternatives to bypass surgery or Angioplasty. 

10. How does ECP treatment work?

    Normal heart function depends on maintaining a balance between oxygen supply and demand. Oxygen consumption by the cardiac muscle is determined by how fast your heart is beating and how well it pumps. The amount of oxygen available is determined by blood flow. Approximately 80 percent of the blood flow to the cardiac muscle tissue occurs when the heart is resting. 
    Clinical studies indicate that ECP treatment may create a 'natural' bypass of blocked arteries. ECP treatment encourages blood vessels to open or form small channels that become extra branches. These channels or collaterals may eventually become permanent pathways to the heart muscle that was previously deprived of blood flow and adequate oxygen.

11. Are there downsides to the procedure?

    The length of treatment may be a consideration for some people. It can take between four to seven weeks to complete a course of ECP® treatment. During that time, patients must visit an outpatient clinic and receive treatment for one to two hours per day. Some patients with more extensive disease may require more than one course of therapy to achieve optimal relief 

12. What have studies shown about ECP treatment?

    Clinical studies have shown that ECP treatment is an effective treatment for Angina. A randomized, controlled, blind study showed a significant increase in the length of time that participants, who had received active treatment, were able to exercise. Additionally, participants who received active treatment experienced fewer attacks of Angina. 
Studies have demonstrated benefits including 
- Elimination or decrease in exercise
- induced signs of lack of oxygen to the heart muscle (ischemia). 
- Increased exercise tolerance 
- Elimination or decrease in episodes of Angina
- Decrease in need for anti-Anginal medication.

13. Would I feel better after having ECP treatment?

- Patients can walk farther, carry heavier packages and be more active without having Angina 
- Patients have fewer attacks of Angina 
- Episodes of Angina are less painful 
- Patients need less anti-Anginal medication
- Patients can return to work, go out to dinner, garden, travel or enjoy golf, tennis or bowling once again
- Patients feel more confident about participating in their social lives, volunteer activities and exercise without interference from Angina.

14. What are the risks?

    Some patients have experience minor skin irritation due to the pressure of the cuffs. You should consult with your physician regarding any risk and complication factors. 

15. Does ECP treatment eliminate the need for bypass surgery?

    Unlike procedures such as bypass surgery and balloon Angioplasty, ECP treatment is administered in outpatient session, carries little or no risk, and is relatively comfortable. 
    Some patient with more extensive disease or who have disease of the left main coronary artery may require bypass surgery. ECP treatment is an option for patients who are unsuitable for invasive procedures or unwilling to undergo them. For patients who have undergone multiple invasive procedures and for whom additional surgery carries excessive risk, ECP treatment may be the only way to obtain relief from crippling Angina.

16. How often will I be treated?

    Patients typically attend one-hour treatment sessions once a day, five days a week, for seven weeks. Many people have continued their employment while receiving treatment by scheduling their session before or after work. Patients with extensive atherosclerotic disease may require more than 35 hours of treatment to achieve optimal benefit. 

17. How long has ECP treatment been used to treat Angina?

    In 1989, researchers at State University of New York at stony brook began clinical studies of ECP treatment. Until the summer of 1995 ECP therapy was only available to patients participating in clinical studies. Today ECP treatment is available at treatment centers throughout the World. 

18. For what are the conditions FDA has cleared ECP?

19. What is the longest follow up study data available to show the benefit of ECP    treatment?

Data reported in the April 2000 issue of Clinical Cardiology showed a five-year survival rate for those who respond to ECP therapy of 88%, a rate similar to those seen in contemporary surgical bypass and angioplasty trials, despite the fact that many of the patients who underwent ECP therapy had already failed previous attempts at revascularization.

20. Is there any other larger study available to show the long time patient benefit?

International ECP Patient Registry at the University of Pittsburgh Graduate School of Public Health points to sustained lowering of Anginal severity and frequency of attacks at six, twelve and thirty- six months post-treatment.
Please refer the graphical forms to the doctors.

21. How popular is this treatment?

In USA 1996 ECP got FDA cleared and 1999 Medicare Insurance coverage. Leading Cardiology centers like Mayo clinic and Cleveland clinic has ECP center. In India after the company launched ECP a year ago now there are six centers including Escorts heart and research institute.
By 2006 there are approximately 2000 ECP systems installed worldwide.

22. When will the patient experience the clinical Improvement?

Usually the patients start experiencing the improvement by 10 to 15 days.  The clinical improvements are decrease or elimination of Anginal pain after exertion, more walking distance, Less intake of nitroglycerine, Improvement in quality of life, and Improvement in over all health status.

23. How can the cardiologist assess the patient's improvement?

The objective finding which the cardiologist can assess are improvement in Treadmill exercise time, time to ST segment depression, Improvement in stress perfusion study at same cardiac work load 83% (American Journal of Cardiology April 2002), Improvement in Ejection fraction, Improvement in end diastolic filling pressure. Improvement in regional ischemial regional myocardial blood flow reserve evaluated by ammonia positron emission tomography. 

24. What are the side effects of the treatment? How safe is the treatment?

ECP is a Non-Invasive and out patient treatment. When considering with other interventional procedures it is very safe. The completion or compliance of patients for 35 days treatment is above 90%. The only adverse effects reported in randomized trail are skin abrasion or lesions because of pressure.

25. Is there any Randomized control trail to show the benefit of ECP over the placebo group?

To show the safety and efficacy of ECP treatment over placebo group the first Multicenter Randomized Control trail of Enhance External Counterpulsation (MUST-ECP) was completed and published in 1999 on American Journal of Cardiology November 7th. The results clearly shows the reduction of angina and increase time to ST segment depression in active Counterpulsation group when compare the inactive or placebo group. The follow up data of this patients where published in Journal of Investigational medicine 2002. The patient's health related Quality of life improvement after the treatment sessions where not only maintained after 1 year but they are more pronounced.

26. Is there any comparison of ECP treatment with other interventional treatments like Bypass and angioplasty?

Even though the patients treated with ECP are sicker group when compare to the patient undergone interventional procedures the results are comparable in spite of the disparity of risk profile in the two groups.
The 5-year survivals of ECP patients are 88% similar to the results seen in contemporary Bypass and angioplasty trail. (April 2000 clinical cardiology)
Study comparing two ECP registries at Pittsburgh and Angioplasty registry at National heart lung and Blood institute (American Journal of Cardiology 2002 may 15th issue) shows the 1-year survival and adverse events results are comparable. But 17.2% of angioplasty patients went for repeat angioplasty procedure while only 6.3 % of ECP patients underwent repeats ECP. Also twice the no of patients in Angioplasty group reported to use Short time nitroglycerin when compare to ECP group.

27. What evidence is there to show ECP opens dormant collaterals and also stimulate new vessel formation (Angiogenesis)?

Pre and post thallium stress test has shown 83 percent improvement in stress nuclear perfusion study (American College of Cardiology 2002 April issue)
Increase in Vaso-Endothelial Growth factor a potent angiogenic factors have been recorded during and after 1 month of ECP treatment. (European Heart Journal 2001)

28. Is there any clinical study available about ECP treatment in leading cardiology journal?

From 97 onwards after FDA clearance for ECP treatment there are more than 45 journal publication and more than 75 abstracts, and editorials publication world wide about ECP treatment Hemodynamics, clinical efficacy, safety in heart failure and long time benefit.

29. What are all the clinical improvements the patient may experience after 35hrs of ECP treatment (1 course)? Do they need additional course?

After ECP treatment the patient will experience the following benefit
·        Increase exercise time with out chest pain.
·        Complete freedom from agonizing chest pain or decrease in the chest pain frequency and intensity
·        Improvement in overall health
·        Decrease or no need for anti Anginal medications. 
·        Patients feel more comfort for participating in social activities without fear of getting chest pain.
Some patients with severe three-vessel disease may need more than 35 hrs of treatment, which will be determined by his cardiologist by assessing his improvement. Usually one course of treatment is sufficient up to 5 yrs according to the available long time follow up study. Few patients may require additional course of treatment according to the severity of coronary artery disease.

30. What are the advantages of ECP over other conventional treatment?

ECP is the only treatment which is neither Invasive nor pharmacological. ECP is a completely Non-Invasive and outpatient procedure.
·        ECP treatment carries very low or no major adverse event during treatment
·        ECP is effective in small vessel of the heart those that are too small for bypass and angioplasty this is the main reason why ECP still be effective when other procedures have failed.
·        The effectiveness of ECP seems to be similar in both diabetes and non-diabetes. (Circulation 2000; 102-18)
·        ECP can be safely administered even in patients with left ventricular dysfunction with
ejection fraction lower than 35%.
·         ECP benefit seems to be similar in both Ischemic and Idiopathic Cardiomyopathy. (CHF. 2002; 204-208,227)
·        ECP is cost effective and very safe treatment. It is painless and need no hospitalization.

31. What are the objective evidences to show the ECP treatment benefit in Congestive Heart failure? 

·        Increase in exercise duration
·        Increase in peak oxygen uptake
·        Increase cardiac output
·        Reduce systemic vascular resistance
·        Improvement in preload-adjusted maximal power.
·        Improvement in ejection fraction
·        Decrease in heart rate
·        Improved diastolic filling pressure associated with decrease Brain Natriuretic peptide (BNP) 
·        Trend towards Normalization of Neurohormonal activation is noted. Increase in nitric oxide and decrease in endothelin.
·        Increase renal perfusion decreases plasma renin activity.  
·        Decrease renin-Angiotensin system axis activation.