January 2001 Newsletter Volume 3, Issue 2, January 2001 IEPR Coordinator Spotlight Richard Mynatt, LPN Knoxville Cardiovascular Group Knoxville, TN Site 96 I have lived in Knoxville, Tennessee most of my adult life, and I am very fond of this area, and can think of nowhere else that I would rather call home. My home is in a small suburb of Knoxville called Halls Crossroads, a pleasant 20-minute commute to my job. My hobbies include classis muscle cars, tennis, and yardwork. I am also fortunate enough to live close to the Great Smoky Mountains National Park, which is great for a quick getaway from day to day stress. I graduated from a local LPN program in 1989, after working as a press operator for several years at a local printing company. Working in health care had always been of interest to me, as my father is a practicing psychiatrist in Oklahoma, and I have an older brother who is an RN at an area hospital in Maryville, TN. Currently I have the priviledge of being an EECP therapist for Knoxville Cardiovascular Group in Knoxville. I am responsible for the day to day operation of the EECP clinic, located within out offices, next door to one of the largest teaching hospitals in this area. When I was offered this position in May of 2000, I was unclear as to exactly what EECP was. I began to do some research on the internet and was immediately very enthused about this new career opportunity, and could not wait to begin. This office was actually the first EECP program to be offered in the state of Tennesse. Of course it didn't take long for other facilities to catch on to a good thing. Being the first to offer this also meant a great change for patient teaching, and to educate a whole new group of people suffering from chronic angina. We have treated approximately thirty patients since May 2000, and I can honestly say that they have all improved to some degree. As we are in an office setting, my patients must make such a time commitment to this, I have tried to make our treatment room a pleasant environment. They may watch TV, listen to CDs, or some prefer just to carry on conversation during the sixty minute session. Getting to know our patients is an added bonus to this job, on that I never tire of. It's hard to express the feeling you get as an EECP therapist when you see a patient, who has lived such a restrictive life for so long, begin to realize that they are improving as a result of the treatment. Some of my patients have even expressed excitement about being able to do such tasks as their own laundry, or mowing their lawn again, things that most of us take for granted and even dread having to do. Publishing the Results of the IEPR Lisa Kennard, Ph.D. IEPR Coordinator Although EECP for the treatment of chronic angina was cleared for use by the FDA in 1995, this technique is still unknown and unexplored by many practitioners in the wider cardiology community. In order to widen the knowledge and acceptance of EECP publication of research investigations is essential. The results from investigations of new therapies ar emade known to the community in two important ways. The first is by presentations at the major cardiology meetings. All major cardiology meetings are attended by cardiologists not just from the United States, but from Europe, Japan, and other countries. These meetings offer a wonderful opportunity to present the results from the registry. The year 2000 was an important year for the IEPR in this respect. For the first time IEPR investigators prsented registry data at major meetings, both in the United States and abroad. Two presentations were made last summer at the European Society of Cardiology Congress in Amsterdam. The first of the presentations, by Dr. Andrew Michaels of the University of California, San Francisco, converned the ffect of diastolic augmentation on outcome, and the second by Dr Ozlem Soran concerned the use of EECP in patients with impaired left ventricular function. Both of these presentations were well received and generated much discussion. Dr. Soran also prsented at the fall metting of the Heart Faulire Society of America. Dr. William Lawson of the State University of New York at Stony Brook presented results on a study of EECP in patients with a history of congestive heart failure. At the American Heart Association meetings in New Orleans in November 2000, Dr. Rohit Arora of the College of Medicine and Dentistry of New Jersey presented a poster describing treatment with EECP in patients with unstable angina, and Dr. Lawson presented the results of a study to determine predictors of successful response to EECP. The year 2001 promises to be an even more productive one. Already three presentations have been accepted for the meeting of the American College of Cardiology in Orlando in March 2001. The first of these concerns the important issue of treatment of patients with periperal vascular disease, and will be presented by Dr. Subash Bazaz of the University of Pittsburgh Medical Center. The second is by Dr. Lawson describing the results one year after EECP treatment, and Dr. Richard Holubkov of the University of Pittsburgh will compare results from the NHLBI Dynamic Registry with IEPR data. Please try and attend this important meeting and lsiten to these presentations. Registry investigators have also submitted abstracts for consideration at meetings of the British Cardiac Society and the American Diabetic Assocation. Work is in progress for abstract submission to the European Society of Cardiology Congress in Stockholm in August 2001; the 2nd International Congress on Heart Disease, Washington, DC, July 2001; the Heart Failure Society of America, September 2001, also in Washington, DC; and the American Heart Association Scientific Meetings, in November 2001. The second important avenue for disseminating information is by publishing manuscripts in refered journals. The first two publications from the IEPR will be appearing soon in Clinical Cardiology. The first presents the baseline results from the registry, and the second authored by Dr. Michaels is on diastolic augmentation. We are eagerly looking forward to seeing our first registry results in print. All registry investigators and coordinators are invited to prepare abstracts from the registry data for submission to appropriate meetings, and to author manuscripts. The latest data freeze which containcs all registry data received through 12.31.00 was completed January 20th, and all sites were sent an invitation to submit anlysis requests. There is still time to submit ideas for the meetings listed above. Please take the time to look though the registry data that you have been sent and let us know your ideas. With everyone's participation, 2001 will be an even more productive and successful year for the IEPR. ACC Poster Presentations American College of Cardiology March 18-21, 2001 Orlando, FL IEPR Poster Presentations: Patients with Non-Cardiac Vascular Disease and Chronic Angina Benefit from Enhanced External Counterpulsation S Bazaz, E Kennard, R Holubkov, N Dwyer, L Crawford Intervention for Stable Angina: A Multicenter Comparison of Consecutive Patients Undergoing Enhanced External Counterpulsation R Holubkov, E Kennard, S Kelsey, O Soran, D Holmes Are the Initial Benefits of Enhanced External Counterpulsation Sustained at One Year? J Hui, W Lawson, E Kennard EECP Poster Presentation: Enhanced External Counterpulsation for Chronic Angina is Associated with Improved Outcome at Six Months G Barsness, T Schnell, D Holmes IEPR Presentations and Posters American Heart Association November 12-15, 2000 New Orleans, LA The Safety and Efficacy of Enhanced External Counterpulsation as Therapy for Unstable Angina R Arora, M Timoney, E Kennard, B Peart The International Enhanced External Counterpulsation Patient Registry is a multicenter study of enhanced external counterpulsation (EECP) for the treatment of chronic angina. The registry tracks patients characteristics, records adverse events, relief of angina, medication use and quality of life parameters. While EECP has been effective in stable angina pectoris (A) there is paucity of information about the application of this therapy to patients with unstable angina (UA). To date 832 patients have been enrolled in the IEPR. This report compares the treatment and outcomes of 811 patients with A and 21 patients with UA. Demographics, risk factors, medical history, angina classification, extent of coronary disease, and quality of life pre-EECP treatment were similar in both groups, except previous CABG was more prevalent in the UA group (p< 0.01). In addition, UA had lower left ventricular ejection fraction (36.2% vs. 46.4%, p<0.01) and more multi-vessel coronary artery disease (95.2% vs. 76.9%, p<0.05), and poor overall health status (38.1% vs. 17.6%, p<0.05) 83% of patients in A completed 34.3 hours of treatment versus 73% in UA completed 30.9 hours of treatment. The degree of diastolic augmentation was higher in the A group vs. the UA group both at initiation (area ratio 0.9 vs. 0.7, p<0.05) and at completion (area ratio 1.3 vs. 1.0, p<0.1) Adverse events during treatment were not statistically different between the two groups. Both groups showed substantial reduction in angina with 74% of A vs. 80% of UA reporting a decrease in angina by at least one Canadian class. Both groups demonstrated similar reduction in sublingual nitroglycerin use post-EECP therapy. Qulisty of life parameters pre and post EECP therapy also demonstrated similar improvements. In conclusion, EECP is a safe and effective treatment for both unstable and stable angina with similar magnitude of improvements. Predictors of Responses to Enhanced External Counterpulsation Treatment of Angina Pectoris W Lawson, E Kennard, J Hui, R Holubkov, S Kelsey Objectives:Enhanced External Counterpulsation (EECP) has been demonstrated to improve Canadian Society of Cardiovascular Angina Class (CCS). However, which patients (pts) benefits most and how many hours of treatment are required remained unclear. Data of 1819 consecutive pts enrolled in the International EECP Patient Registry between 1/98 and 3/00 were analyzed to determine patient characteristics at baseline associated with angina relief after treatment. Results:Mean age was 66 years old, 76% were male, 65% had previous MI, 82% previous CABG or PCI, and 75% were judged not suitable for further invasive revascularization. Risk factor prevalence was high with 76% with family history of CAD, 68% hypertension, 75% hyperlipidemia, 42% diabetes, and 28% congestive heart failure. 77% had CCS class III/IV angina. After a mean treatment time of 34+/- 10 hrs. angina was reduced by at least one class in 73% of patients. Multivariate analysis showed independent factors associated with at least one class reduction in angina as shown in table (all P<0.05): (table inserted here) Conclusion:Pts who are older, with CHF and diabetes are less likely to achieve angina reduction, whereas the higher the angina class and longer the duration of treatment, chances for pts to improve their angina status increase. Intermittent Shear Stimuli by Enhanced External Counterpulsation (EECP) H Urano, S Iida, K Fukami, R Sugano, A Satoh, S Kanaya, Y Otsuka, H Matsuoka It has been shown that EECP relieves angina and improves exercise tolerance in patients with chronic angina pectoris. The mechanisms responsible for its beneficial effects have been undefined. EECP induces tremendous shear stress in vascular beds throughout the body, by sequential inflation and deflation of compressive cuffs synchronously to cardiac cycles. Since shear stress is one of the most pivotal stimuli to upregulate endothelial nitric oxide (NO) synthase, we hypthesized EECP may improve ischemic symptoms via restoring endothelial function. To test this hypothesis, we examined flow-mediated vasodilation (FMD) of the brachial artery by high resolution ultrasonography as a non-invasive measure of endothelial function before and after EECP in patients with coronary heart diseases. EECP was performed for on-hour per day for a total of 35 hours in patients with chronic stable angina who showed significant stenosis in major coronary arteries and had exercise-induced myocardial ischemia. Approximately one month of EECP treatment improved exercise tolerance, estimated by exercise duration and time to 1-m ST-segment depression (p<0.01). Although baseline FMD was blunted and a single session of EECP had no effects on vascular function, chronic EECP significantly improved FMD by 3-fold of the baseline (from 4.0+/- 1.9 to 12.4+/- 6.1%, p<0.01) , whereas endothelium-independent vasodilation by nitroglycerin was not changed. Thus, chronic EECP improved exercise capacity and restored FMD in patients with coronary artery diseases. Our results suggest that intermittent shear stimuli by EECP may ameliorate myocardial ischemia via augmenting biological activities of endothelium-derived NO. My Experience at the American Heart Association Scientific Sessions 2000 As an EECP coordinator, I have the chance to positively impact the lives of my patients everyday. To complement this experience, there is nothing like the American Heart Association Scientific Session! During these meetings, definitions and EECP concepts are explored in depth. These allow me the opportunity to relate to my patients. When I can explain a particular procedure to patients, it puts them more at ease, and allows me to connect at a more human level-beyond the 'patient-therapist' relationship. In essence, the American Heart Association Scientific Sessions combine theory and practice quite well! Although this was my second IEPR meeting, it was my first visit to New Orleans. It was phenomenal! I had the pleasure of getting a grand tour of the city from none other than Steve Sklavounos, Director of Cardiovascular Services at Mount Sinai-Miami Heart Institute (who had previously visited the city several times). The city is so rich in culture and in tradition. One only hears of the excitement of the French Quarter-but to actually live it? It was an outstanding experience-talk about life outside the classroom! I also enjoyed meeting Nichole Dwyer, as well as Vasomedical's Louis Ekaireb and Jeffrey Steele. We have spoken so many times via telephone, but had never actually met. It was nice to finally have the faces to the names! During the upcoming sessions, I would like to meet with fellow coordinators to share thoughts, ideas and patient success stories. We can forge professional relationships and a network that would allow us to be sounding boards for each other. Through this opne line of communication, we can provide better patient care. On a scale of 1-10, I would rate these meetings a nine; but why settle for less than perfect? After all, there is no room for less than perfect in cardiology. So next time, let's strive for a perfect 10! Of course, for all this to happen, we must urge coordinators to attend these power sessions! From personal experience, I can say that what would entice coordinators to attend, would be interesting lectures, hands-on activities, travel opportunities and sightseeing. These provide a combination of professional development, camaraderie among coordinators and a little R & R! Broadening one's horizaona, profession and cultural, was the best part of attending the 2000 Scientific Sessions The early 6:00 am meetings, however, is the one things I would change. We can honestly be much more attentive if we did not have to get up so early. I look forward to attending future IEPR meetings, since I have found them to be so beneficial to the well-being of my patients. Dania Tabares, RCVT IEPR Coordinator at Mount Sinai-Miami Heart Institute Center 30 International EECP Patient Registry Chairman of Steering Committee Jonathan R. Jaffe, MD, FACC 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