July 2001 Newsletter Volume 3, Issue 4 July 2001 IEPR Coordinator Spotlight Molly March, RN York Hospital Cardiac Rehabilitation York, PA Site 95 This has been a very exciting project for our cardiac rehab. There are 6 nurses, including me, that work with EECP and cardiac rehab. Dr. Kevin McCullum, the medical director and a non-interventional preventative cardiologist, brought the program to York after his experience at Pittsburgh working with Dr. Larry Crawford. We have two treatment tables and can do 12 treatments a day. The program has been well received in the community. We have treated patients from Delaware, Harrisburg and Maryland who are willing to travel to York for their treatments. We opened in August of 1999 with one table and increased to two tables in January of 2001. It is the feeling of the staff and the majority of the patients that we have treated that this has been very helpful to the patients. We have treated about 70 patients and now many of the patients move from EECP to cardiac rehab and are doing more than they have done for a long time. This is very rewarding for the staff and the patients. Our cardiovascular services at York Hospital have offered state of the art interentional treatments and now we are proud to offer the same in non-interventional treatments as well. We are located in a medical center that is owned by the hospital. We are very close to York city but the center is in a rural setting - Apple Hill - it had been an orchard until the 1980's. The cardiologists offices are located in the same medical center so the cardiologists are present and supportive. Clinically we have learned a lot more about CVD and treatment and medications, especially diabetes. We had one patient that was on insulin at the start of his treatments. He took a total of 120 units of insulin a day. By the end of his treatments he was down to 10 units a day and his blood glucose levels are still in an appropriate range, a year later. He didn't really change anything else and no one understands what changed. The staff enjoys the opportunity to expand their knowledge to include EECP to supplement their extensive cardiac rehab training. Some of the patients do two treatments a day and have to spend extra time at Apple Hill. We have them walk in the medical mall and can gauge their improvement on this gradual increase in activity. One area that has been a problem for a few patients has been lower back discomfort. We have found that placing rolled towels under their knees and using sheepskin under their lower back affords them some relief. The towels are now placed under the knees on almost all the patients. We have not had any skin breakdown or adverse events. The close communication we have with Dr. McCullum, our medical director, has allowed us to really assist in the care of these patients - from medication changes to laboratory follow ups. It has been beneficial to the staff to know that our opinions and suggestions are taken seriously and we feel very much like part of a professional team and are treated like professionals. In August, Dr. McCullum will be presenting Grand Rounds to medical staff and residents on EECP and reporting on our excellent progress to date. This will more than likely increase our waiting list. The International EECP Therapists Association "Healing One Heart at a Time" The IETA membership hotline is 800-376-3321, ext. 140. IETA address is: P.O. Box 65005 Vero Beach, FL 32965-0005 "The International EECP Therapists Association is a multidisciplinary organization of EECP therapists, united with on professional voice to set and uphold standards of excellence in the delivery of Enhanced External Counterpulsation (EECP)" Off to the AHA! Congratulations to Cardiovascular Associates of Northern Wisconsin! Not only has Arlyne Frane, RN and her staff won the contest for the trip to AHA, but they are consistently at or above 100% compliance for form submission every month! Keep up the great work! Enjoy sunny Anaheim! Thanks to everyone for their remarkable efforts! Cardiovascular Specialists in Springfield, MO holds first EECP Patient Support Group Meeting On June 8, 2001, Cardiovascular Specialists held their first EECP Patient Support Group meeting. Of the thirty patients that attended, some had completed their treatments, some were in the process of receiving EECP therapy and some were considering it. The support group idea started with a few patients who would chat before and after their EECP sessions. Scott McFall, EMT, the EECP therapist, took the ideas of the patients and organized the first meeting. During the meeting, Dr. Paul Freiman, the EECP Medical Director, answered questions specific to EECP therapy and led the ensuing discussion focused on the future of the support group. Ideas for upcoming meetings were offered as was the creation of an email list of patients that had completed EECP. This listing would be a resource of patients willing to speak with those thinking about undergoing the treatment, or provide the means for contacting and chatting with fellow EECP graduates. The next meeting is scheduled for September 2001. IEPR Reaches Goal THE IEPR HAS REACHED 5000 PATIENTS, a historic milestone in the documentation of EECP clinical practice. Plans are already underway for Phase II and will be shared with all centers interested in participating once the protocol has been finalized. For those centers in Phase I, a new IRB approval will be needed to enroll patients in Phase II. Remember, only enrollment has closed; follow-up on ALL patients currently enrolled must continue up to and including three years post EECP treatment. Presentations at the British Cardiac Society May 21-24, 2001 Manchester, UK Primary Utilization to Improve Myocardial Perfusion with Enhanced External Counterpulsation (PUMPER) CP Fitzgerald, ED Kennard, WE Lawson, R Holubkov, University of Pittsburgh, PA, USA Enhanced External Counterpulsation (EECP) is a non-invasive circulatory assist device primarily used in the treatment of patients (pts) with chronic, refractory angina, who are unsuitable for further conventional revascularization. EECP improves stress perfusion, but there is no data on its effectiveness as a primary revascularization procedure. Methods: The International EECP Patient Registry includes pts who were candidates for CABG and/or PCI and chose EECP as primary therapy. There were 148 pts (out of 1934 pts or 7.7%) who were candidates for CABG (137 pts) and/or PCI (104 pts) and received EECP as primary therapy. Mean age was 68 years and 75% were male. Multivessel disease was present in 60% of patients, and angina was classified at severe (CCS Class III/IV) in 55% of cases; 42% had a previous MI. Concomitant disease was frequent with a histor of congestive heart failure (CHF) 14%, diabetes 29%; and non-cardiac vascular disease 21%. Pts were treated with EECP a total of 34 +/- 2 hours. There were 18 dropouts; 14 non-cardiac and 4 cardiac (1 MI, 2 worsening CHF, 1 worsening angina). Results: Of the 130 pts completing the recommended 35 hours of treatment, 66.1% improved their Canadian Cardiovascular Society angina class (35.9% to no angina, 29.2% to class I). Quality of life was reported to be significantly improved in 70% of pts, and nitroglycerin use was discontinued in 79% of the treated pts. Conclusions: Patients who are candidates for elective CABG or PCI respond to primary therapy treatment with EECP. However, long term follow-up will be needed to evaluate the duration of benefit and the impact on morbidity, mortality, and resource utilization associated with using EECP as the initial treatment for angina. Improvements in Exercise Tolerance Post Enhanced External Counterpulsation in Patients with Chronic Refractory Angina are Related to Diastolic Augmentation Brown, AS, Ho E, Heavey D, Dodd D, Horgan JHH. Department of Cardiology, Beaumont Hospital, Dublin, Ireland. Background: Enhanced External Counterpulsation (EECP) has been developed to augment diastolic blood flow and increase coronary artery perfusion thereby decreasing angina in patients with coronary artery disease. We used this technique in patients with refractory angina who were unsuitable for revascularization. Methods: Forty patients with a mean age of sixty-four years underwent a course of treatment consisting of 35 sessions. Exercise-testing, the SF-36 quality of life questionnaire and the Seattle angina questionnaire were performed pre- and post- the 7 week course. Diastolic augmentation was assessed using a finger plethysmogram. The ratio of the peak diastolic amplitude to peak systolic amplitude is given. Results: Exercise time (minutes) METS Canadian Class I/II Canadian Class III/IV Peak diastolic augmentation There was a positive correlation between the initial peak diastolic amplitude and the change in METS R=0.34 (p=0.04) and a significantly greater peak diastolic amplitude in those patients whose exercise tolerance improved compared to those who had no improvement (0.81 vs. 1.1, p=0.016), Quality of life assessment scoring showed a significant improvement in physical functioning (p<0.0001), general health (p=0.0024), energy (p<0.0001). In the 30 patients who had reached a year or more follow-up there was a significant reduction in the number of in-patient days following the course of EECP (14.5 days vs. 7.8 days, p=0.45). Conclusion: EECP is an effective treatment for patients with chronic refractory angina. The improvement in exercise tolerance seen is related to the initial peak diastplic amplitude. Efficacy of Enhanced External Counterpulsation in Experimental Myocardial Infarction: Histochemistry and Ultrastructure W Huang, Y Chen, ZS Zheng, WF Zhong, WE Lawson, JCK Hui, Sun Yat-Sen University of Medical Sciences, Guangzhou, China, State Univeristy of NY, Stony Brook, NY, USA Enhanced external counterpulsation (EECP) may be of benefit during acute myocardial infarction (MI) though a variety of mechanisms including: hemodynamic support, improved myocardial perfusion, decreased oxygen free radical production, and remodeling. An experimental dog MI model was used to assess the effects of EECP on the histochemistry and ultrastructure of infarct and non-infarct zones. Acute MI was induced in 14 dogs (6 controls and 8 EECP treated) by ligating the apical branch of the LAD. The EECP group was treated immediately after occlusion for 80 minutes and again for 60 minutes prior to sacrifice of both groups at 6 hours. Enzyme histochemical analysis of creatinine phosphokinase (CPK), malondialdehyde (MDA), and superoxide dismutase (SOD) and ultrastructural analysis by transmission electron microscopy (TEM) was performed. EECP resulted in significant preservation of myocardial CPK content, a decrease in oxygen free readicals (SOD), and a decrease in lipid peroxidation (MDA) in infarct zones. (see table). [insert table here] There were no significant histochemical differences in the non-infarct zones of Control and EECP treated groups. Ultrastructure analysis demonstrated characteristic severe irreversible injury in the Control group infarct zones including: mitochondria with loss of dense granules, clearing of the matrix, nuclear chromatin clumping; intracellular edema; sarcolemma breakage; relaxed myofibrils. By comparison, with EECP, infarct zones showed milder, potentially reversible ischemic changes. Conclusions: During acute MI, EECP promotes myocardial salvage by decreasing oxygen free radicals and lipid peroxidation, prserving myocardial cell structure and CPK content. Presentations at the American Diabetes Association June 23-26, 2001 Philadelphia, PA EECP Produces Angina Relief in Diabetic Patients Comparable to Non-Diabetic Patients: A Six Month Follow-up Study Linnemeier, Kennard, Lawson, Holubkov, HeartGen, Indianapolis, IN, University of Pittsburgh, Pittsburgh, PA Diabetic patients (D) with coronary artery disease have higher procedural morbidity and recurrent events with percutaneous coronary intervention (PCI) or coronary artery bypass surgery (CABG) than patients wihtout diabetes (ND). Enhanced external counterpulsation (EECP) is a noninvasive analogue of the intra-aortic balloon pump designed to increase myocardial perfusion pressure and decrease cardiac workload. EECP has been demonstrated to be safe and effective in treating angina; however, its long term safety and effectiveness in treating (D) is unknown. Methods: 1630 patients consecutively enrolled in the International EECP Patient Registry were divided into D (665) and ND (965). EECP was given 1-2 hours daily to both groups, with similar total treatment hours (mean, 34 hours) and completion rates. Patients were followed for six months to determine clinical outcome. Results: D differed significantly from ND in age (65.8 vs 67.2 years, p<0.01), female gender (28.9% vs 19.4%, p<0.001), and non-cardiac vascular disease (40.3% vs 22.2%, p<0.001). Both groups improved significantly in their Canadian Cardiovascular Society (CCS) angina class after EECP treatment, and continued to improve at six-month follow-up. At completion of treatment, 71.0% of D and 74.2% of ND, p=ns) had their CCS angina class reduced by 1 class, and this response increased at six months to 77.0% of D and 79.0% of ND (p=ns) for the combination of death, myocardial infarction, CABG, PCI; and there wree similar rates of cardiac hospitalization (13.1% for D vs 11.0% for ND, p-ns). D had higher rates of congestive heart failure 6.8% vs 3.1% (p<0.001), and required repeat EECP more often (12.9% vs 9,1%, p<0.05) than ND. Conclusions: EECP is safe and effective for the treatment of angina in diabetic patients with continued improvement at six months. The rates of major adverse cardiac events and the rates of cardiac hospitalization were comparable in both groups. EECP at the British Cardiac Society Meeting IEPR investigators Charles Fitzgerald and Angela Brown, Vasomedical personnel Gudrun Lang and John Hui and myself all traveled to Manchester, UK for the British Cardiac Society annual meeting. EECP was very well represented at the meeting. Dr. Fitzgerald presented results from the IEPR on patients who were suitable candidates for interventional revascularization, but who chose EECP for their first line treatment for angina. Dr. Brown of Dublin presented improvements in exercise tolerance post-EECP from the first 40 patients treated at her site. Dr. William Lawson and Dr. Hui presented results of the effects of EECP on experimental myocardial infarction in dogs. All three oral presentations provoked lively discussion, and the subsequent poster presentations were well attended. EECP is now being used in three sites in the UK (Dr. Peder Bagger at Hammersmith Hospital, Professor John Cleland at Hull Royal Infirmary and Dr. Michael Chester of the Cardiothoracic Center in Liverpool). It was interesting also to meet the people from Cardiac Services, UK distributor for Vasomedical. They had a very well attended booth at the meeting and hopefully we will soon have many more sites in the registry. Manchester fortunately didn't live up to its reputation at the rainiest city in England, and we enjoyed glorious weather during our stay. Manchester is a large bustling city, which like many U.S. cities seems to be in the middle of a building boom. There were large buildings in course of construction everywhere. Unfortunately the epidemic of foot and mouth disease limited excursions into the beautiful surrounding countryside. Lisa Kennard, PhD IEPR Coordinator Upcoming Presentations 2nd International Congress on Heart Disease Washington, D.C. July 21-24, 2001 Predictors of Adverse Outcomes in Treating Angina Patients with Enhanced External Counterpulsation Lawson, Fleishman, Manzo, Kennard, Holubkov, Kelsey Effects of EECP on Renin-Angiotensin System in Experimental MI Lu, Zheng, Wu, Lawson, Hui European Society of Cardiology Stockholm, Sweden September 1-5, 2001 Beneficial Effects of EECP on the Renin-Angiotensin System on Patients with Coronary Artery Disease Lawson, Hui Enhanced External Counterpulsation for the Treatment of Angina in the Elderly: Safety, Response, and Durability of Benefit Linnemeier, Lawson, Kennard, Holubkov Heart Failure Society of America Is Diastolic Augmentation an Important Predictor of Treatment Completion for Patients with Left Ventricular Dysfunction Undergoing Enhanced External Counterpulsation for Angina? Soran, Michaels, Kennard, Kelsey, Holubkov, Feldman What Factors Predict Congestive Heart Failure During Treatment of Angina Patients with Enhanced External Counterpulsation Lawson, Kennard, Holubkov, Roberts, Feldman, Strobeck Transcatheter Cardiovascular Therapeutics Washington, D.C. September 11-16, 2001 Efficacy of Enhanced External Counterpulsation (EECP) for Patients who are not Candidates for Coronary Revascularization: Immediate and One-year Outcomes from the International EECP Patient Registry Michaels, Kelsey, Holubkov, Kennard New IEPR Staff Member! Bradley Wulfkuhle has joined the IEPR Coordinating Center staff as part of the data management team. Brad recently graduated from the University of Pittsburgh with a Bachelor's degree in History and Political Science and will be attending graduate school in the fall for a Master's degree in Library Sciences. In his spare time, Brad enjoys playing and watching hockey, especially the Pittsburgh Penguins, as well as reading, going to the movies and concerts. Welcome Brad! International EECP Patient Registry Editorial Staff: University of Pittsburgh Nichole Dwyer, BA Elizabeth Kennard, PhD Design and Production Nichole Dwyer, BA Sponsor Office: Vasomedical, Inc. Tom Varricchione, Vice President of Clinical and Regulatory Affairs Gudrun Lang, RN, BSN, Director of Clinical Affairs IEPR Coordinating Center University of Pittsburgh Graduate School of Public Health Epidemiology Data Center Sheryl F. Kelsey, PhD, Principal Investigator, Registry Director Richard Holubkov, PhD, Biostatistician Elizabeth Kennard, PhD, Registry Coordinator Nichole Dwyer, BA, Data Manager Bradley Wulfkuhle, BS, Data Assistant