September 1999 Newsletter Volume 2, Issue 1 September 1999 IEPR Coordinator Spotlight Brenda L.P. Shepherd, RN Heart Centers of America, LLC Portland, OR Site 59 When I was first approached about starting a clinic providing EECP treatment, I was skeptical. I had my doubts about how or if this treatment actually worked. But Dr. Ronald Schutz, our medical director, kept talking, giving me articles to read, tapes to view and names of people to talk to. Over time I kept hearing the same three words from EECP therapists across the country: "It just works". After seeing the treatment performed for myself and talking to some patients, I decided that this was definitely something to take seriously. I officially started working for Heart Centers of America in January of this year. Being a freestanding clinic, ther was a lot of set-up required before we could open the doors. Remodeling, setting up accounting and billing sytems, coordinating equipment delivery, training, etc. I'm grateful to all the therapists who gave me a helping hand as I was getting started. I couldn't have done it without their assistance. It has been exciting and challenging to get the clinic up an running. We officially started treating our first patient April 28th and are currently treating our sixth patient. Being the first center in the Pacific Northwest, we've had to work hard to educate the local physicians about EEPC. Steadily, we are receiving more referrals. Some local TV news and newpaper coverage has helped us along. But always our patients are definitely our best advertisement. It has been very gratifying to see the patients improve. And even during the short time I've been involved with EECP, it has progressively gained credibility in the eyes of the medical community as a treatment for CAD. It will be a great day when we are considered a first line treatment for angina. On the treatment end of things, I have learned a lot since starting. Many thanks go to the Vasomedical clinical slpecialists and especially to Gudrun Lang for all of the advice and support she and others have given me. I've learned from them that warm fingers are the absolute key to plethysmograph readings (nitroglycerin before treatment really works for the tough cases), padding is everything when it comes to skin breakdown(the foam pads used for gardening work great) and that electrode placement is crucial. I've also discovered that binder clips are good for almost anything. Their uses range from holding the thigh cuffs together while the patient is getting on the treatment table to holding the ECG electrode wires in place and everything in between. Clearly, one of the keys to providing this treatment is being creative and innovative. I'm finding that being an EECP therapist is a very rewarding job. I enjoy getting to know the patients and it's so gratifying to see them improve. Very few jobs provide such a tangible reward. I think we all have more work ahead educating the patients and the medical community about EECP treatment. But I look forward to the day when this becomes a first line treatment for CAD instead of the last option. As Machiavelli said, "There is nothing more difficult to take in hand, more perilous to conduct, or more uncertain in its success than to take the lead in the introduction of a new order of things, because the innovator has for enemies all those who have done well under the old condition and lukewarm defenders in those who may do well in the new one." Brenda has been the Clinical Director for Heart Centers of America, LLC since January 1999. She is recently engaged and busy planning a late October wedding. Leisure times finds Brenda scuba diving, flying (yes, she is a pilot!) traveling, gardening, kite flying, antiquing, doing all kinds of crafts and laughing! Winner of Compliance Contest! Jeanna Reinard, LPN from center 37, Brookville Hospital in Brookville, PA is the winner of our 6-month compliance contest. The center had 100% on all forms and was chosed randomly from amongother centers with perfect compliance. Jeanna will be traveling to the American Heart Association meeting in November, courtesy of Vasomedical, Inc. Congratulations, Jeanna! Y2K Catch-up Contest! The logo states, The International EECP Patient Registry "documents EECP clinical practice". The medical community has watched with great interest as the number of centers and the number of patients increase and the data becomes ever more meaningful. The IEPR is almost two years old and there are many patients availeble for 6 month and one year follow-up. Unfortunately, the data on these patients is not coming in to the coordinating center and this vital information is missing. "Catching up" would be a great way to celebrate the Registry's second birthday. To make the catching-up push more fun, all the centers that are back on track with 100% 6 month and one year follow-up compliance by Dec. 1st will be rewarded for this extra effort with a prize and the knowledge tht the IEPR is truly "documenting EECP clinical practice". The Registry will greet the new millenium proudly achieving its stated purpose. Everyone is doing so well with pre and post treatment data submission; let's complete the circle by completing the (six month, one year) data, making the IEPR a reflection of your special effort and your on-going commitment to your patients and the future of EECP. Thanks to Everyone! Good Luck! Society for Clinical Trials 20th Annual Meeting Anaheim, CA May 1999 Lisa Kennard and I attended the Society for Clinical Trials (SCT) meeting in Anaheim, California to present a poster entitled, "Ensuring Compliance in a Voluntary, Post-Marketing Device Registry". The SCT focuses on the methodology of research, providing clinicans, coordinators and statisticians opportunities to compare notes and sxchange ideas on the many topics related to their areas of interest from randomization and informed conset to data collection and methods of analysis. Paperless data entry using the internet, a new data collection method, provoked some lievely discussion on security and data integrity. Clinical procedures and policies covering everyting from protecting patients' rights to ethics of data safety and monitoring during surgery provided fuel for some interesting and stimulating debates. There was a lot of interst in our poster as many of the researchers were not familiar with EECP. We thus had the opportunity to relay our knowledge about this technique as well as discuss methodological issues of registries. On a more personal note, attending the SCT meeting afforded me, as a data manager, a unique opportunity to learn more about current research methods, data collection and analysis. - Nichole Dwyer A message from Tony Peacock, VP of Clinical Affairs, Vasomedical, Inc. In the last issue, I wrote about the importance we place on the major cardiology meetings for keeping in touch with our customers - present and prospective. Along the same lines, I would like to inform you further of recent events and those we are planning. With regard to recent events, there were two major meetings in which we partook. The first was the European Society of Cardiology (ESC) in Barcelona, Spain. After the American College of Cardiology and American Heart Association meetings, the ESC is the 3rd largest meeting in terms of attendance, but is equal to the others in terms of scientific news events. The Barcelona meeting was our second involvement with the ESC; we introduced EECP to a European audience at the ESC in Vienna, Austria last year. We have been particularly gratified by the ready acceptance of EECP by the Europeans and ascribe it to a more diverse set of cultures and practices where many things are unusual. Also, there is a climate of experimentation searching aggressively to alleviate the many inadequacies that continue to plague the medical systems in most countries. These same problems will hinder our progress in Europe but this year we will have units in Italy, the United Kingdom, Turkey, as well as Germany, Ireland, Colombia and Argentina. Next year will probably see a more rapid expansion. All of these centers will participate in the IEPR and will add both patients and, we expect, scientific curiosity; meaning that they will be eager to interrogate our outstanding IEPR database for publishable information, an opportunity, I remind you, that is open to all members. The other event I wish to mention is the Heart Failure Society of America (HFSA) Annual Scientific Meeting. This year's meeting was held mid-Spetember in San Francisco and was only the third such gathering. Although this is a smaller event, the atmosphere is between the supporting companies' people and the clinicians and scientists present, a circumstance that makes this meeting very productive for us. Again, participants in this meeting seem to accept EECP readily with much interest in the progress of our heart failure studies. At the most recent meeting, in addition to our exhibit demonstrating EECP, we had two abstracts concerning EECP in CHF patients accepted for poster presentations. One was derived from the IEPR database and described the effects of EECP on patient groups with low left ventricular ejection fractions (LVEF less than 35%) compared to those with preserved LVEF. The data showed that both groups benefited equally. The second abstract was the first public presentation of data from the pilot safety study of EECP for patients with CHF. The data presented were preliminary but are most encouraging. Copies of both abstracts to readers of the IEPR newsletter accompany this issue so I won't go into further detail here. The AHA and ACC meeting remain or busiest. In addition to our exhibit, we usually have items such as oral persentations and poster presentations on the program. There are also investigator meetings and meetings for our customers. As discussed in the previous issue, among these are the IEPR and Clinical Issues meetings. In future, mostly because we need to accomodate a larger audience, we are considering combining these two meeting with the format changed from roundtable to seminar styles. We very much want to encourage questions, discussion and debate among panel members and audience. We hope everyone going to the AHA or ACC meetings who is interested in EECP will put aside the time to particpate in the EECP Clinical Seminar. Abstracts Accepted for Poster Presentations (HFSA) Efficacy and Safety of Enhanced External Counterpulsation in Mild to Moderate Heart Failure: A Preliminary Report Ozlem Z. Soran, Teresa DeMarco, Lawrence E. Crawford, Virginia Schneider, Paul-Andre de Lame, William Grossman, Arthur M. Feldman, University of Pittsburgh Medical Center, Pittsburgh, PA. Enhanced external counterpulsation (EECP) is a non-invasive therapy for symptomatic ischmeicheart disease. By inflatin sequentially 3 pairs of pneumatic cuffs wrapped around the legs and buttocks, EECP produces hemodynamic effects similar to those of intra-aortic baloon pumping, including increased diastolic and decreased systolic blood pressure, decreased afterload, and increased coronary perfusion. EECP has recently been shown to benefit patients with ischemic heart disease and anecdotal data suggest that i might be useful in patients with heart failure (HF). Thus, this study was initiated to assess formally the efficacy and safety of EECP in HF. Eligible patients had NYHA class II or III symptoms, an ejection fraction (LVEF) of <%35%> or less, and were clinically stable. Medical treatment was optimal according to accepted standards. The study intervention consisted of 35 1-hour EECP sessions over a 7-week period. Six subjects (mean age 61.3 +/- 11.2) were enrolled at 2 sites. The etiology of HF was ischemic cardiomyopathy in 5 subjects and dilated idiopathic cardiomyopathy in 1 patient. Therapy began after a 2-week baseline assesment period. One subject discontinued after 21 sessions because of worsening back pain. Follow-up data were obtained for all remaining subjects one week after the last EECP session. VO2max (ml/kg/min), the primary parameter, increased to 18.7% from 13.63+/-1.54 (mean +/-SE)at baseline to 15.89 +/-2.14 (p=0.004). Exercise duration (sec) increased 33.9% from 592.5 +/- 96.26 to 756.0 +/- 132.0 (p=0.008). All subjects were in NYHA class II at baseline. At follow-up, all but 1 were in NYHA class I. Quality of life score measured by the Minnesota Living Heart Failure Questionnaire improved 35.3%(36.3 +/- 10.2 at baseline to 22.3 +/- 6.0 after treatment). Clinical status remained stable in all study subjects during the application of EECP. Conclusion: These preliminary data, although limited, support the hypothesis that EECP may be efficacious and well tolerated in heart failure patients int he short term. Six-month follow-up data are being collected to document the long-term effect of this intervention in heart failure. The results need confirmation in a controlled trial. Enhanced External Counterpulsation is a Safe and Effective Treatment for Angina in Patients with Severe Left Ventricular Dysfunction. John E. Strobeck, Robin Reade, Elizabeth D. Kennard, Sheryl F. Kelsey, Ozlem Soran and Arthur M. Feldman. The Heart-Lung Center, Hawthorne, NJ and University of Pittsburgh, Pittsburgh, PA. The International Enhanced External Counterpulsation (EECP) Patient Registry (IEPR) tracks acute and long term outcome for consecutive patients treated with EECP for chronic angina. While EECP has proven value in patients with sever ischemic and preserved left ventricular function (PLVF) (EF>35%) who are not good candidates for revascularization by CABG or PTCA, little is known of the safety and efficacy in patients with angina and sever left ventricular dysfunction (LVD) (EF=35%). This report describes 705 patients enrolled in the IEPR for their first EECP treatment who had recorded values for ejection fraction pre-EECP. LVD occurred in 169 (24.0%) of patients and PLVF in 536 (76%). Demographics, were similar in both groups, while prior MI, prior CABG, multivessel disease, severity of angina, and use of ACE inhibitors, calcium channel blockers and angiotensisn receptor blockade were more prevalent in the LDV group. The LVD group also reported a much poorer quality of life. Al full course of EECP (mean duration 38 hours) was completed by 141/169 (83%)of LVD vs. 451/536 (84%) of PLVF. Diastolic blood pressure augmentation during EECP treatment was similar in both groups. Adverse events during treatment were infrequent and similar in the two groups. Treatment was stopped because of worsening CHF in 4.1% of LVD vs. 0.9% of PLVF (p less than .001). For those completing treatment mean anginal class pimproved significantly from 3.1 to 1.7 in the LVD group, and from 2.8 to 1.3 in the PLVF group, and both groups showed reduction in sublingual nitroglycerin use post-EECP. Overall patient assessment of uality of life post-EECP demonstrated improvements of 65-70% over pre-EECP. In conclusion, EECP is a safe and effective treatment for angina in patients with severe left ventricular dysfunction who are not good candidates for revascularization by CABG or PTCA. New IEPR Centers! Ocean View Medical Group in Santa Monica, CA; led by Dr. Monroe Rosenthal and coordinator Martin Turner. Kaiser Permanente in Denver, CO; led by Dr. David Flitter and coordinator Debra Clemetson, RN. The Heart Center, c/o Boone Clinic in Columbia, MO; led by Dr. Robert Doroghazi and coordinator Alicia Glenn, RN. Cardiac Disease Specialists, PC in Atlanta, GA; led by Dr. Harvey Sacks and coordinator Shelley Holt, RN. Christ Hospital and Medical Center in Oak Lawn, IL; led by Dr. Marc Silver and coordinator Carol Pisano, RN. Central Cardiovascular Associates in Pittsburgh, PA; led by Dr. Thomas Pinto and coordinator Louanne Tempich, LPN. Chandra Cardiovascular Consultants in Dakota Dunes, SD; led by Dr. Yunus Moosa and coordinator Mary Schaumacher, RN. HeartGen - South in Indianapolis, IN; led by Dr. Michael Eads and coordinator Theresa Eaton, RN. North Suburban Cardiology Group, Ltd. in Arlington Heights, IL; led by Dr. Alan Kogan and coordinator Sally Jacobs, RN. Staten Island Heart in Staten Island, NY; led by Dr. James Lafferty and coordinator Laura Ferrara, RN. Welcome aboard! Recruitment Chart 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. Anthony Peacock, Vice President of Clinical Affairs Gudrun Lang, RN, BSN, Manager 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