Enhanced External Counterpulsation (EECP) May 8, 2001 Connie Burket Senate Plaza, One North Pennsylvania Blue Shield P.O. Box 890089 Camp Hill, PA 17001-9902 RE: Enhanced External Counterpulsation (EECP) Dear Ms. Burket: Enhanced external counterpulsation (EECP) is a noninvasive outpatient procedure that is designed to reduce the symptoms of angina pectoris in patients with chronic angina. It is my understanding that Highmark/Pennsylvania Blue Shield will be re-evaluating the status of enhanced external counterpulsation (EECP) in the near future. I therefore submit the following statements at the request of the PA Chapter of the American College of Cardiology. EECP has been approved by HCFA for coverage in patients who have been diagnosed with disabling angina (class III or class IV, Canadian Cardiovascular Society Classification, or equivalent classification) and who, in the opinion of a cardiologist or cardiothoracic surgeon, are not amenable to revascularization either percutaneously or by cardiac bypass because: 1) Their condition is inoperable, or at high risk of operative complications or postoperative failure; 2) Their coronary anatomy is not readily amenable to such procedures; or 3) They have co-morbid states which create excessive risk. Enhanced external counterpulsation involves sequential inflation and deflation of compressive cuffs that are wrapped around the patient's calves, lower thighs, and upper thighs. Inflation and deflation of these cuffs are triggered by events in the cardiac cycle. The hemodynamic effects achieved through EECP are similar to that of intra-aortic balloon counterpulsation. Patients receive EECP treatments for 60-minute sessions each day, 5 days a week, for a total of 35 hours. The exact mechanisms of benefit have not been clearly elucidated; however, they may include stimulation of angiogenesis and collateral growth. At the present time, a growing body of evidence has accumulated supporting the use of EECP in patients with refractory angina. The MUST-EECP study published in the Journal of the American College of Cardiology in 1999 was the first randomized study in patients with class I, II, and III angina. It showed that EECP reduced angina and extended the time to exercise-induced ischemia in patients with symptomatic coronary artery disease. Another study at SUNY, StonyBrook suggested that the treatment benefits of EECP may be seen long-term, and up to five years. Furthermore, in an effort to evaluate the safety and efficacy of EECP, the International EECP Patient Registry (IEPR) was initiated in 1998 at the University of Pittsburgh Medical Center. The Registry has been following the characteristics, demographics, and outcomes of all angina patients treated with EECP. The plan is to enroll 5,000 patients with angina and follow them for three years. Currently there are over 100 participating centers, with approximately 4,000 patients enrolled. The data from the IEPR at the present time is consistent with that obtained in previous trials, including the MUST-EECP trial, in that EECP treatment has been found to be safe and effective for reducing chronic angina, with few adverse effects. More importantly, EECP has been found to be effective in improving angina by at least one anginal class in over 70% of patients enrolled in the Registry. The improvement in anginal class has been maintained at 6 and 12 months post treatment. The patients have also noted significant improvement in their quality of life immediately post EECP, and this has been maintained at 6 and 12 months follow up. Based on the data to date, and my own experience, I contend that EECP therapy is not experimental or investigational. As a provider of EECP therapy, I have found this procedure to be equally effective in my own practice in treating patients with refractory angina who, in many cases, have no other treatment options available to them. I strongly feel that EECP is safe and efficacious in treating patients with refractory angina pectoris, and I feel that reimbursement coverage should be available for this procedure as it is for all therapies that have been shown to reduce angina pectoris. Sincerely, John J. Szawaluk, M.D., FACC JJS/mrm C: James MacKrell, M.D. Joseph Cacchione, M.D. Howard Herrmann, M.D. Maria Elias