January 2000 Newsletter Volume 2, Issue 2 January 2000 IEPR Coordinator Spotlight Jeanna Reinard, LPN Brookville Hospital Brookville, PA Site 37 In the 17 years I've been in the health care field, I've seen a lot of change. New medications, procedures, treatment and diets have come and gone. There is always something new. When I first heard of EECP, I was curious to see how it worked, who it would benefit, and how it would be possible to have a successful center in our small rural area. As of December, we have 35 patients who have completed full courses of treatment, with very good results. We have seen patients using as many as 30 nitro a week at the beginning go to using none at completion. We recently heard from our first graduate (he completed EECP in July 1998), he has had only 'a few pains'. The family's biggest concern now is keeping him off the 4-wheel ATV (he'll soon be 84). Another of our graduates tells me he has been roller-skating weekly. The biggest challenge we have encountered is trying to make the patient understand that they should still limit their physical activity. It seems that they feel so good and have so much energy, it is hard to make them understand that the heart damage is still very real. I believe that EECP works. We have seen the results, and I feel that once more people become aware of the effects and the benefits, that we will be extremely busy. We have been enrolled in the IEPR since we opened our center in July of 1998. Because of our center's perfect form compliance, I was chosen to attend the American Heart Association meeting in Arlanta in November 1999. I was told it was a large conference, but never would I have imagined what would be taking place. There were thousand of vendors, with lots of information. Dinner buffets, breakfast meetings, seminars, reports, statistics.... oh, what an experience! The three days passed quickly. I would recommend that anyone who has the opportunity to attend, do so, it is an unforgettable experience. My husband attended the conference as well. He too was surprised at the enormous amount of information available. I would just like to thank everyone involved for making me feel so comfortable, and giving me the opportunity to attend. Jeanna is the coordinator for Center 37 at Brookville Hospital. She lives with her husband, Denny, in Brookville, a small town about 100 miles northeast of Pittsburgh. They have 2 grown children. Y2K Catch-Up Contest Winners! The IEPR is proud to announce our latest contest winners. The following center made the extra effort to catch-up with all data submission, including screening logs and follow-up. The coordinator were awarded with a small prize. Congratulations and thanks to all these hard-working centers! Anthony Viscui, President and CEO (retired), Vasomedical, Inc. Farewell message to the IEPR community While the clamor surrounding the world's entry into an arbitrarily defined third millenium has not yet subsided, the International EECP Patient Registry (IEPR) is quietly and efficiently moving into the third year of its existence. When developing its first strategic plan, the management of Vasomedical recognized that the most important initiatives for the scientific validation of the EECP therapy would be the conduct of a multicenter, prospective, randomized, blinded, controlled study (MUST-EECP) and the establishment of a patient registry based on a detailed scientific protocol and maintained by an internationally recognized data center. We were fortunate and priviledged that the Epidemiology Data Center of the Graduate School of Public Health of the University of Pittsburgh agreed to take charge of IEPR. As you all know, this data coordinating center is highly regarded for its registry studies published in peer-review medical journals, including The New England Journal of Medicine. IEPR relies on cardiologist members to submit duly completed case report forms for consecutive patients commencing, but not necessarily completing, EECP treatment. For the purposes of IEPR, the absolute numbers are less important than the quality of the data. The participating cardiologists are, in fact, viewed as principal investigators, and their names will appear on the publications that will eventually result from an analysis of IEPR data. Such publications will be invaluable in the process of establishing EECP therapy firmly as a standard of care int he management of coronary artery disease. IEPR has already demonstrated its value in advancing the acceptance of EEPC therapy. We know that when HCFA officials decided to cover EECP therapy for Medicare beneficiaries they arrached almost as much importance to IEPR as to MUST-EECP. The data provided by IEPR demonstrate that improvements with EECP therapy are attainable to a high degree outside investigational settings, where patients are carefully selected and outcomes are not necessarily predictive of clinical results obtained under normal conditions of daily medical practice. IEPR confirms that EECP therapy can be expected to improve the net health outcome of almost two-thirds of patients and that it represents the only proven alternative for patients who have exhausted other available therapies. In the long term, IEPR will become the most important EECP database. It will provide an understanding of the profiles and responses of coronary artery disease patients, and will help define optimal treatment strategies for specific subsets of patients more clearly and usefully that can trials carried out in academic settings. While data from patient registries would not in themselves to obtain regulatory approvals, they do provide weighty and convincing evidence of efficacy and safety, because of the large numbers and the broad range of patients treated. I am, therefore, extremely pleased and grateful that more than 60 EECP treatment centers have already qualified for participation in IEPR and that more than 2000 patients have already been enrolled. This is a great achievement that would not have been possible without the dedication of cardiologists in this country and overseas who have agreed to follow a rigourous protocol and, thus, add to our objective knowledge of the benefits that EECP therapy can bring to scores of patient candidates. Following a suggestion made by Dr. Arthur M. Feldman, Director of the Cardiovascular Institute of the University of Pittsburgh Medical Center Health System, and President of the Heart Failure Society of America, a panel of experts will be assembled from among providers of EECP, for the purpose of formulating and publishing treatment guidelines. Given that EECJP therapy is expected to be used more widely in the future I am sure that they will base their consensus guideline on daily clinical experience and common sense, but also on data derived from IEPR. I cannot end this message without acknowledging with profound gratitude the role played by the IEPR Coordinating Center in making this patient registry such a useful and respected source of clinical data. I wish to thank, in particular, Dr. Sheryl Kelsey, the Director of the Coordinating Center, but also Dr. Lisa Kennard and Dr. Richard Holubkov, and the entire staff of the center. They have set high scientific standards and given an example of professionalism tha confer value and credibility to the IEPR data. As a group they combine old-world grace with efficiency of our technological age. It has been a priviledge to be associated with them. In stepping down from my position as President and CEO of Vasomedical to go into my second and definitive retirement, I carry with me the satisfaction that IEPR, one of our major initiatives, has been truly successful. I extend to the Coordinating Center and participating EECP treatment centers best wishes of continued success in the new and following years. Clinical Tips From Joanne Giordano, LPN Cardiology & Associates, Inc. Vero Beach, FL, Center 29 Joanne says that incidents of skin irritation have dwindled to virtually none since she initiated this innovative skin care technique. At this EECP center all the patients apply a light coat of a water-based body cream (Nivea, Vaseline Intensive Care Lotion) to their legs (front and back) and wear pantyhose under their treatment tights. Needless to say, some of the men are a bit hesitant about wearing pantyhose, but go along with the program and everyone has a good laugh (especially the wives!). Joanne describes the result as "marvelous". She has treated 24 patients using this protocol and has had no skin problems in this group, even with the brittle diabetic patients. From Bruce Fleishman, M.D. Cardiovascular Research Institute, Inc. Columbus, OH At the recent IEPR/Clinical Issues Meeting held at the AHA in Atlanta, Dr. Fleishman indicated that allowing patients with left ventricular dysfunction to lie down for 5 or 10 minutes before beginning EECP allows time for a fluid shift with the change in position from standing to reclining that promotes better tolerance of the EECP treatment. From Larry Liebman, Director of Sales and Customer Service From many different perspectives, the IEPR is considered by the Vasomedical sales team to be a very significant factor in the successful acceptance and establishment of EECP as a standard of care for patients suffering with heart disase. The generation and sharing of clinical data by EECP clinicians is an integral part of the future of EECP. From a customer satisfaction perspective, the collection of data and the reporting of it in abstracts, publications and IEPR documentation is invaluable. As the number of centers and patients in the IEPR grows, customers receive on -going confirmation of their belief in EECP therapy, serving to make their initial belief ever stronger. That, in turn, often convinces other physicians to consider, support and refer patients for EECP therapy. To many of our customers, the IEPR is viewed as a significant support, assisting them with information on patient demographics and treatment outcomes. This is closedly aligned with Vasomedical's strategy of customer support. Those not yet familiar with EECP therapy and Vasomedical, initially view buying EECP as simply the sale of a medical device, a piece of equipment rather than a comprehensive treatment and customer support program. Nothing could be further from the company philosophy. Vasomedical's goal, in alignment with our customers' goals, is to obtain the best possible therapeutic outcome for every patient and to support the economic success of the EECP center. To realize this mutual goal, a number of services are provided with the treatment system as part of Vasomedical's unique and comprehensive product offering. The value of the clinical training program implemented by our staff of Clinical Applications Specialists cannot be overstated. The initial on-site training of EECP therapists and the follow-up support assits each EECP center in delivering effective and safe Enhanced External Counterpulsation. At the recent American Heart Association Meeting in Atlanta, the Clinical Issues meeting was combined with the IEPR meeting, providing a forum for a highly successful interchange of experiences and ideas. Vasomedical, s Patient Recruitment Program, which is introduced to the prospective customer during the sales process and supported on an on-going basis, is designed to introduce and promote the newly established EECP center within its patient referral base in the immediately medical community and then to expand the center's marketing opportunities to a broader audience. Vasomedical recognizes the importance of the economic viability of each EECP center, whether the center is part of a practice, an outpatient department or a stand-alone clinic. Therefore, we consider reimbursement support vital to an EECP center's financial success. This support may be provided in the form, of billing and payment information (and the sharing of successful experiences), or by Vasomedical attending presentations to insurance carriers in support of the EECP provider's claim. Last, but certainly not least, Vasomedical field service support, and precentive maintenance serives are designed to ensure minimal downtime and maximum equipment performance and are considered an integral part of the product offering. Together we have demonstrated that we can make a positive difference in people's lives. The Vasomedical team looks forward to working with you, as the ever-growing EECP family meets the challenges of tomorrow. I would like to take this opportunity to thank you for your support and participation in the IEPR and for your continued commitment and enthusiasm as we begin the new millenium. IEPR/Clinical Issues Meeting AHA in Atlanta, Georgia November 9, 1999 The annual Scientific Sessions of the American Heart Association and the American College of Cardiology are the largest gatherings of clinicians and scientists working on heart disease. It is thus appropriate that the International EECP Patient Registry should organize their investigators' meeting in conjunction with these larger events. In the Registry meetings we have tried to provide a conside update to investigators and coordinators of Registry issues, recruitment, data management, form compliance, and to present results of both baseline, post-EECP and follow-up data analyses. At these same scientific sessions, Vasomedical has always has a Clinical Issues meeting where specific questions concerning patient treatment have been addressed. This past November in Atlanta, Georgia at the American Heart Association Scientific Sessions, it was decided to combine the two meetings. I think everyone who attended this meeting will agree that this format was an unqualified success. Jonathan Jaffe, Chairman of the IEPR, welcomed everyone, and was followed by Dr. Sheryl Kelsey, Registry Director, who outlined current and future plans for publication of the Registry data. I then presented an update on the recruitment and compliance numbers, and discussed some of the analyses carried out at the coordinating center, describing baseline, post-EECP, and six-month follow-up results. Although most of the patients presenting for EECPJ therapy are not candidates for the more conventional revascularization techniques such as percutaneous coronary interventions or bypass surgery, about one quarter of the patients in the registry are candidates for these conventional treatments, but choose to have EECP therapy. The analysis presented focused on the differences between these two groups of patients. The group of patients who were candidates for revascularization were significantly less likely to have had a previous revascularization or a previous myocardial infarction. They had less multivessel disease, and less history of congestive heart failure, with less impaired left ventricular function as measured by ejection fraction. They had less severe angina as measured both by Canadian Cardiovascular Society Classification (CCSC) and by angina counts and use of nitroglycerin. This group of patients also acheived a mean diastolic augmentation which was higher than in the non-revascularizable group. However, despite these baseline differences there were no significant differences in the proportions completing a full course of EECP treatment, and reduction of angina post-treatment, with approximately 70% of both groups showing a decrease in angina by one CCSC class, and over half of the patients discontinuing the use of nitroglycerin. These impressive results were still apparent at six months. Although the patients who were not candidates for revascularization had a slightly higher rate of cardiac events such as myocardial infarction in the follow-up period, the angina reduction was maintained in about 80% of all patients. Thus it seems that excellent results can be obtained on all patients irrespective of their revascularization status. There was a lively discussion and some very intersting suggestions were made concerning directions for further analyses. Tony Peacock, VP of Clinical Affairs, Vasomedical, Inc., then introduced three speakers, each of whom discussed a specific patients group, and treatment issues associated with the use of EECP in these groups. Dr. Ozlem Soran presented results of treatment of patients with left ventricular dysfunction and angina; Dr. John Strobeck discussed issues arising during the treatment of patients with permanent pacemakers, and Dr. William Lawson spoke on patients with valvular disease. It appeared that all three of these topics were of considerable interest to the clinicians present. For myself, I really enjoyed learning more about the clinical issues involved in EECP treatment, and I do hope that the investigators and coodinators who atteneded the meeting learned more about the data management and data analysis in the Registry. We are planning the next IEPR/Clinical Issues meeting in conjunction with the American College of Cardiology Scientific Meetings in Anaheim in March 2000 (at the slightly more civilized hour of 12 noon). I would really enourage everyone to attend these meetings and share their experiences, while perhaps learning from others. Lisa Kennard, Ph.D. Registry Coordinator New IEPR Centers! Shands Hospital in Gainesville, FL; led by Dr. C. Richard Conti and coordinator Sonia Gonzalez Advanced Heart Care in Dallas, TX; led by Dr. Jeffrey Gladden and coordinator Dianne Roberts Cardiovascular Associates of Northern Wisconsin in Wausau, WI; led by Dr. Paul Leutmer and coordinator Arlyne Frane, RN JFK Medical Center in Atlantis, FL; led by Dr. Bijan Kashenien and coordinator Angelica Patten, 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