April 2000 Newsletter Volume 2, Issue 3 April 2000 IEPR Coordinator Spotlight Deirdre Dodd (R.G.N. Hdip Critical Care) Beaumont Hospital Dublin, Ireland Site 37 Nursing in Cardiology for the last seven years has always been a challenging and satisfying job. One of the few downsides of working in the same area for a long period of time is that you tend to form a close relationship with those patients which you treat on a regular basis. These are the chronic angina patients who have inoperable vessel disease and increasing angina with loss of quality of life. It has been very difficult, almost impossible, to treat these people with satisfactory results, and they are often depressed and have little hope for a brighter future. When we commenced the EECP program here in Beaumont Hospital, as well as expanding my role as a nurse, and giving me a greater challenge in my job, it also gave the cardiology team and myself a great opportunity to be able to offer these chronic angina sufferers some hope for an improved quality of life and a reduction in angina. The success of the program outdid all our expectations here and it now is in great deman throughout the cardiology unit. We maintain a very thorough follow-up after treatment in our day ward area of the unit, so this gives us great feedback on our past patients progress post-EECP. To date we have treated 35 patients with 100% compliance. We have experienced post treatment reduction in angina episodes, increase in exercise tolerance and all in all a better quality of life for those on the program. Perhaps the most rewarding part of running a program like this is the real job satisfaction of seeing people improve and regain their enthusiasm for life. They talk about getting out and doing things that they had previously given up on, such as gardening, or going back to work, going abroad on holidays or other similar things. The treatment has certainly added very positively to the service given to these patients and it offers a lot of hope for a better quality of life in the future, with a reduced level of angina. EECP: Improvemnt Against All Odds Charles Fitzgerald, MD Very often, in our experience with EECP at the Heartcare Clinic of Arkansas, patients will come with very little, if any, hope of improvement prior to the start of their therapy. A remarkable patient in this regard, Mr. B, is a 73 year-old gentleman who was found at diagnostic catheterization to have advanced three-vessel coronary artery disease affecting primarily his distal vessels, in the presence of moderately reduced left ventricular function (ejection fraction 35%-40%) and a hypertrophic left ventricle. He had been noted to having increasing degrees of dyspnea on an outpatient basis prior to his catheterization; a right heart catheterization was also performed at the time of his initial evaluation which revealed a significant degree of pulmonary hypertension, wtih pressures of aproximately 65/35 in his pulmonary circuit. He required the use of oxygen in order to leave the hospital after his initial evaluation, as he would desaturate with simple ambulation from resting oxygen saturations of approximately 93%-94% down to 86%-88%. Mr. B was recommended for EECP and after a total of 35 treatments, has done remarkably well. He was able to discontinue his use of oxygen with ambulation, and within 3 months of completing EECP, has discontinued his use of oxygen at night as well. He has returned to normal activites without limitation; he came here for his one-year follow-up stress test, revealing him capable of exercising through the first stage of the standard Bruce protocol without evidence of ischemic electrographic changes or chest discomfort. His echocardiographic image reveals a hypertrophic left ventricle with uniform segmental wall motion, all areas of the heart at maximal exercise and an ejection fraction of approximately 45%, His right heart contour remains enlarged. Mr. B is representative, I suspect, of many of the patients that we see; indeed, both medical and surgical therapy offered little for him and it is EECP that has allowed him to return to an active and vigorous lifestyle. Indeed, with his pulmonary hypertension, he was truly inoperable prior to his start of EECP. It should be noted that he does continue regular medical therapy with agents designed to reduce pulmonary hypertension (the calcium channel blocker amlodipine, 5.0mg per day and Coumadin therapy, with an INR in the range of 2.5). However, he is illustrative of the fact that EECP certainly stands "in the gap" for many patients who, otherwise, would have very little, if any, hope of significant improvement. For this reason, as a practitioner of cardiovascular medicine, EECP certainly stands as one of the most gratifying things in which I have been involved, and certainly my staff feels the same. With many patients coming in on a daily basis(a number of them have had advanced three-vessel disease with numerous interventions and/or repeat coronary artery bypass operations as well as those who are inoperable, like Mr.B), we have been able to witness significant improvement and clinical stabilization in approximately 80% of the 250 patients we have treated since starting therapy in August 1997. Approximately 15%-18% of these patients have required additional therapy, received in 10-hour increments, with stress echo evaluation at the end point, objectively "treating to target" the relief of angina. We have had a discontinuation rate of approximately 2% for patients who have been unable to complete the treatment. I certainly hope that this experience, as related about Mr. B, may be typical of the responses that you are seeing in your clinics as well. Certainly, the whole issue of whether or not EECP would be widely applicable in patients with pulmonary hypertension, would be an interesting and promising goal, one in which many of us can participate if we can begin to monitor patients for indices of pulmonary hypertension as part of our routine IEPR monitoring scheme. I know that this is a subject of discussion, as to what parameters to watch with such patients, and pulmonary hypertension would be nearly an ideal one to observe. I truly believe that EECP centers, indeed, those of us in the registry, are helping blaze a trail of discovery to new and permanent applications of counterpulsation; and, as such, it makes for a very exciting time to be involved in one of the newest and most efficacious forms of therapy, which renders patients a good prognosis which would have, otherwise, not existed. Better and Better Another American College of Cardiology Scientific Sessions has come and gone. This, held in Anaheim, CA, was the fifth since we introduced EECP in March 1995. From my point of view, they have been getting better and better. Perhaps the most striking feature of this meeting was the intensity of interest in EECP. I don't think we had many more than usual visitors to our booth but the discussions about EECP were most certainly more penetrating. Another uplifting item was the election of Dr. George Beller (University of Virginia) to the Presidency of the College. Dr. Beller is a member of the EECP Scientific Council and is very interested in exploring the potential for EECP. The EECP center at the University of Virginia is among the very best facilities in the country, spacious, well appointed, and is very ably run by Ellen Longmoore. We made much progress in our Investigators meetings too. As you know, we are now completing our pilot (safety) CHF study and getting ready to begin a major randomization trial in CHF patients. In about two weeks, the last patient in the pilot study will have completed the six-month follow-up and we will be able to make our full report to the FDA. Another EECP highlight at the meeting was Dr. John Gorcsan's presentation of his sub-study results. This was an eight patient sub-study of the CHF pilot looking at the effects of EECP on the heart's ability to pump. Dr. Gorcsan use echocardiography to measure pump performance before, soon after and 6 months after a course of EECP treatment. His conclusions were that EECP was associated with significantly improved pump function and a lower heart rate. The improvements were still present 6 months later. Last, but certainly not least, was the combined IEPR/Clinical Issues meeting. This too was a great success and very well attended. Dr. Kennard gave us the latest analysis with 2000 patients entered. Improvements in Canadian Class were of the same order as previously but about 70% of the patients also have an analysis for six months after treatment. It was very satisfying to see that 80% of these patients had retained the initial benefit. Dr. Holubkov also presented a new and most encouraging analysis comparing some one-year post-treatment EECP registry data with those of the Registry of Percutaneous Interventions(NHLBI Dynamic Registry). It was obvious from the IEPR data that the disease severity of the population being given EECP is greater than that of the PCI population. We also had presentations from Dr. Andrew Michaels of University of California at San Francisco and Dr. Gregory Barsness from the Mayo Clinic. Dr. Michaels presented an analysis of IEPR data on degree of diastolic augmentation and Canadian Class improvements. Dr. Barsness presented a very interesting case at the Mayo Clinic where a completely disabled patient who was unable to be helped by other mean, had a remarkable response to EECP. We also allowed time for questoins and discussion. Of course, the perennial question about why 35 hours got another airing. It was pointed out that the registry data help confirm that this length of time is still given to most patients to achieve a good response. About 13% of patients have one or more treatments. The more experienced cardiologists now treat to a target result but most still give a time-limited course. Another intense discussion was about degree of diastolic augmentation and its importance. Most agreed that while almost any degree of diastolice augmentation is beneficial, we should continue to aim for a 1:1 ration or better at every treatment session. Separately, we held the first (organizational)meeting of the IEPR Working Group. Again, the participation and commitment of so many skillful physicians eager to reach into the IEPR database for material needing urgent publication was another uplifting moment. As I said, better and better. Meet the Vasomedical Clinical Applications Specialists! William Seychell, RN, BA I am currently married with twin seven year old daughters and a one year old beagle (who drives me nuts.....). I'm a retired NYPD, Narcotics Division, Detective Sergeant. I also worked as a nurse in NYC's Bellevue Hospital, Emergency Dept., Intensive Care Unit, Post Anesthesia Recovery Unit. Other previous jobs of mine have helped give me a platform for helpig and treating people: high school English teacher, NYC EMS-EEMT, lifeguard, YMCA Aquatics Program Director - swimming, lifeguard training and CPR instructor. In my spare time, I enjoy the beach, bicycling, swimming, and ocean kayaking. I am presently the Senior Clinical Applications Specialist. I help to establish treatment centers and to assist centers with patient selection, treatment, and troubleshooting across the United States, in Ireland and in Japan. As the Senior Clinical Applications Specialist, I train EECP therapists and Clinical Applications Specialists. I can also be found attending the ACC and AHA meetings regularly. The best part of being a Specialist is the friends we make and the lives we impact upon along the way. We meet and work with people across the country. We get together and establish a new treatment program; frequently EECP is someting they have nvber heard of until they were given this assignment. We get to meet and treat some very sick patients and profoundly have a positive impact on the quality of their lives. The difficult part is the travel. Changes have been made thanks to Tony Peacock, Barry Zakar and primarily to Gudrun Lang our CLinical Manager. Working out of our homes on non-travel days has made this position far more manageable. In my tenure as a specialist, community percetions have changed. More people are learning about EECP and asking for treatment. More physicians are interested, are referring patients, and are becoming providers. Perceptions have gone from crticisms, finger pointing, and laughter to curiosity, understanding, firm belief, and enthusiasm. I believe in EECP, otherwise I wouldn't be a part of it. We are bringing this new modality for the treatment of heart disease to the forefront of medical science. As a team, we of Vasomedical are joining with cardiologists, nurses, therapists, across the country and around the world in developing and informing the public of this therapy. I believe that EECP has worked well in just about any setting. I've found that it is at its best in an out-patient treatment center associated with, or part of, cardiac rehabilitation centers. I persoanlly see EECP as a strong bridge for patients to rehabilitation and then to personal exercise programs moderated by cardiologists or professional medical programs. From my experience the key to a successful EECP program is a dedicated, educated, enthusiastic, and energetic EECP coordinator/primary therapist. EECP is not a mechanical system; it's a therapy. The integrity and professionalism of these therapists in utilizing this system, nursing patients, managing needs, and administering appropriate treatment, is what makes this therapy work. I enjoy being a CLinical Specialist. I appreciate the rewards of working with and helping people. I enjoy teaching, bringing something new to therapists, watching them learn and understand, then go on to treat and explain EECP to others. When I started there were approximately thirty treatment centers across the country. There are now over a hundred. We are growing at a rapid pace. These are exciting times. Interest is growing. People are becoming more educated regarding their treatment options. Physicians have become open to presenting EECP as an option, then after referring patients; they develop interest in becoming providers. There is an overwhelming enthusiasm displayed by patients, therapists, and physicians. I'm confident that EECP will become an integral part of standard medical practice in this country and around the world. Thomas Riedman, RN, BSN I have been practicing nursing since graduating from State University of New York in 1995. I began at Beth Israel Hospital in Boston working on cardio-thoracic surgical step-down unit. After the contract was up, I moved back to Long Island, NY with my wife to be closer to family. In my search for a new job, I came across Vasomedical. I have been married to my wife Kathie, also a nurse, for three and a half years and we are expecting out first child by the end of April. In what little spare time I do have, I enjoy spending time with my wife and our dog. I was hired by Vasomedical in 1998 as a Clinical Applications Specialist. My responsibilities include assisting in establishing new EECP centers as well as supporting existing EECP providers with training, clinical support, and physician education at times. I usually attend the two major cardiovascular scientific conferences, the ACC and AHA. Last year I also attended the TCT (Transcatheter Cardiovascular Therapeutics) conference held in Washington, D.C. The most enjoyable aspect of my job is to hear patients' experiences of their symptomatic improvement in angina and quality of life. While the frequent traveling can become tiresome at times, this clinical position is very exciting and rewarding. Just in the year and a half that I have been with Vasomedical, EECP has received considerable recognition in the mainstream and medical press. I feel such awareness is vital so that patients and healthcare providers are knowledgeable in making good decisions regarding what is available to them as patients and clinicians. From the first time I read about EECP, on the Internet, it just made sense to me. The clinical resarch made it even more believable to me, and in speaking with actual patients, one knows that EECP is having a postive impact on some very disabled people. Everyone at Vasomedical, I am sure, would like to be able to present data putting the naysayers to rest, but still EECP has made great strides in being recognized as a legitimate therapy in cardiovascular medicine. I feel that future research endeavors will continue to validate EECP as a therapeutic threatment option for chronic angina and heart disease. I think that I joined Vasomedical at a very exciting time. I have great admiration for all those people at Vasomedical who believed in EECP from the beginning and struggled through the lean years when physicians came to the Vasomedical booths at the ACC and AHA and just laughed at EECP. Now they come by with interest and understand that we are for real. I have had the pleasure to work with many wonderful people from my co-workers to therapists and physicians. I am always meeting new pople, many of whom are very enthusiastic about EECP which helps to make my job that much easier. I feel that the most effective site for an EECP program is anywhere that allows for therapists to be dedicated to EECP therapy. It is always great to work at a center that had hired someone specifically for EECP, though I understand that this is not always possible. The EECP therapist has a tremendous influence on the success of an EECP program from patient recruitment to patient outcomes. Furthermore, I feel that physician involvement is also very important for a variety of reasons, but maybe most importantly to help reinforce the support provided to patients and their families. From my experience, those centers with dedicated EECP therapists and strong physician involvement have been able to develop the best EECP programs and achieve the best patient outcomes. To all the EECP therapists I have worked with, I hope I have served you well and supported you as best as possible so as to help make your experience and that of your patients as positive as can be. Stephanie Collins, RN, BSN I joined the Vasomedical team in May of 1999. I have been a Registered Nurse for almost ten years. I worked in a hospital in Atalanta for nine years in CCU and the Cardiac Cath Lab. I grew and up and still live in the Atlanta area. When I am not working, I enjoy spending time with my boyfriend and all of my friends that I don't see when I am traveling. A year ago, I would have said that traveling was one of my hobbies, now I guess staying home is one of my hobbies! I enjoy cooking and gardening and being outdoors. My job with Vasomedical as a Clinical Applications Specialist was a big change for me! The traveling has been the best and worst part of this job! My favorite thing about being a CAS is meeting and working with all of the therapists. I learn something new from each person I meet! It's fun to go to large and exciting cities, but I enjoy going to small towns and seeing parts of the country that I have never seen just as much. In the short time that I have been with Vasomedical, I have seen many positive changes. I think EECP is getting more widely accepted as a viable treatment for angina. I must admit that I was a little skeptical before I saw for myself what a great therapy this is! Most of the therapists tell me that the most rewarding part of their job is seeing the tremendous improvement in the quality of life in this patient population. I think, generally speaking, that patients that are trearted with EECP are some of the "sickest" patients with coronary artery disease. Seeing that EECP helps these patients makes it very excirting, and I think proves that there is a promising future for EECP. I've visited many of the EECP centers and look forward to visiting all of them. At the ACC, many of the doctors that showed interest in EECP asked what type of setting works best. Each center is unique in its own way, and different set-ups work well for different centers. One common thread I see is that the therapists are very involved with thier patientts. (After thirty-five hours, I guess you know someone pretty well!) I believe that this relationship is important to the patient's successful outcome. I believe that participating in the IEPR offers centers a great amount of information and access to important statistics, as well as the ability to confer with other therapists and doctors. I try to encourage all new centers that I train to become involved. In the future, I would like to see more of the " question and answer" interaction at the meetings. I think the meetings are a good opportunity for EECP providers to share information with others. Anticipating your next opportunity to win a contest? Due to the low compliance percentages for 6-month and 1-year follow-up data, we are holding another contest! Rules are: You must not have won in any IEPR contest Fax in your follow-up forms from May 1st to May 31st Bring your center's compliance up-to-date! Winners will receive a prize and also be mentioned in the summer issue of the newsletter! European Society of Cardiology August 2000 Abstracts Submitted Six Month Outcome of Patients with Left Ventricular Dysfunction Treated with Enhanced External Counterpulsation for Chronic Angina O Soran, E Kennard, R Holubkov, J Strobeck, A Feldman The Safety and Efficacy of Enhanced External Counterpulsation as Therapy for Unstable Angina R Arora, E Kennard, M Timoney, B Peart EECP and PCI: A Comparison of Baseline Presentation and One-Year Outcome between the IEPR and the NHLBI Dynamic Registry of PCI R Holubkov, E Kennard, A Feldman Does Optimal Diastolic Augmentation Predict Clinical Benefit from Enhanced External Counterpulsation (EECP)?: Data from the International Enhanced Counterpulsation Patient Registry A Michaels, E Kennard, S Kelsey, R Holubkov, S Spence, T Chou Heart Failure Society of America September 2000 Abstracts Submitted Benefit and Safety of Enhanced External Counterpulsation in the Treatment of Ischemic Heart Disease with History of Congestive Heart Failure W Lawson, J Hui, E Kennard, R Holubkov, S Kelsey, J Strobeck, A Feldman Six Month Outcome of Patients with Left Ventricular Dysfunction Treated with Enhanced External Counterpulsation (EECP) O Soran, E Kennard, R Holubkov, J Strobeck, A Feldman Oral Presentation at American College of Cardiology Scientific Sessions Anaheim, CA March 2000 Improvement in Left Ventricular Performance by Enhanced External Counterpulsation in Patients with Heart Failure John Gorsan III, Lawrence Crawford, Ozlem Soran, Hao Wang, Donald Severyn, Paul-Andre de Lame, Virginia Schneider, Arthur Feldman, University of Pittsburgh, Pittburgh, PA, USA Background:Enhanced External Counterpulsation (EECP) is a novel noninvasive therapy consisting of gated diastolic sequential leg compression producing similar hemodynamic effects as an intra-aortic balloon pump. Although preliminary data suggest that EECP has favorable effects on exercise capacity in patients with heart failure (HF), its effects on LV function has not been characterized. Methods: To test the hypothesis that EECP may have beneficial effects on LV performance in HF, 8 patients with NYHA Class II or III HF and ejection fraction (EF) less than 40% were studied. Preload-adjust maximal power(PAMP) was assessed as a relatively load independent measure of LV performance before and after EECP treatment consisting of 35 x 1-hr sessions over 7 weeks. Medical therapy was unaltered during this time. Pressure volume relations were simultaneously estimated using echocardiographic automated border detection as a surrogate for LV volume and photoplythesmography as a surrogate for LV ejection pressure to calculate PAMP noninvasively. Results:Significant increases in PAMP were observed after EECP therapy from 4.2 1.6 to 5.4 2.0*mW/cm4, *p less than 0.05 vs. baseline. EF also increaesd from 25 10 to 29 8*% and heart rate decreased from 73 5 to 65 5*min-1, p* less than 0.01 vs. baseline. Conclusions:EECP therapy was associated with improvements in PAMP and EF along with decreases in heart rate in these HF patients. EECP appears to be beneficial to LV function in HF patients and may be a useful adjunct to medical therapy. 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