April 2001 Newsletter Volume 3, Issue 1 April 2001 IEPR Coordinator Spotlight Denise Nesdale, RGN Hammersmith Hospital London, UK Site 81 Two years ago I would never have envisaged that I would be living and working in London and at that time I had never heard of EECP. My husband was offered a position in London in late 1999 and with one month's notice we resigned from our jobs in New Zealand, rented our home, packed 4 suitcases and arrived on the other side of the world. Coronary Care nursing has always been my great love and I had worked for the previous 11 years at Wellington Hospital in an 8-bedded CCU and then a 23-bedded unit. During this time I completed a CCU/Cardiothoracic Course, a Bachelor of Arts majoring in Nursing and a Cardiac Rehabilitation Diploma. I have always had a great interest in various aspects of cardiology including the management of refractory angina, cardiac rehabilitation and Implantable Cardioverter Defribillators. As you can imagine arriving in London was somewhat of a challenge. For the first year I worked as an agency nurse in a variety of CCU's across the city to give me an overview of the healthcare system in the UK. In July 2000, a position becmae available at the Hammersmith Hospital to be primarily responsible for EECP and I was delighted to be given the opportunity. When I commenced the role, EECP has been up and running for 5 months and we are now 13 months down the track. Being an EECP coordinator outside of the USA has certainly been made much easier with the support and guidance of Gudrun Lang and Deirdre Dodd who is based in Dublin, Ireland. They have always been available for guidance, advice and sanity when experiencing difficulties obtaining a good trace or when a new clinical situation arises. The Hammersmith is a large public hospital which serves the West of London and consists of a large Asian (Indian/Pakistani/Middle Eastern) population. We have experienced some difficulties in terms of recruiting patients because public transport to the hospital is difficult and for some of the patients English has been a second language. Despite these obstacles, the patients we have treated have all experienced an improvement in their angina. The improvements range from being unable to shower in the morning without requiring assistance/using nitrates to being able to climb a flight of stairs or walk for an hour without experiencing angina. To all of the patients these improvements no matter how small, have had a huge impact on their quality of life and what they can achieve on a daily basis. This has to be the most rewarding aspect of being involved in EECP. A majority of the patients undergoing EECP have a number of cardiac risk factors that have predisposed them to coronary artery disease. During the 35 hours of treatment, the opportunity arises to be able to discuss a variety of issues including their condition, medications, exercise, and diet. This time spent with the patient and often their family, is an invaluable opportunity for regular assessment and vital patient education. The relationship and rapport you build with your patient, the opportunity for education and being able to witness first hand the improvement in a patients' quality of life provides daily job satisfaction. We are hoping the EECP service at the Hammersmith will continue to expand so as an increasing number of patients can experience the benefits. The International EECP Therapists Association Inaugural Meeting "Healing One Heart at a Time" The inaugural meeting of the IETA was held on Sunday, March 18, 2001, during the American College of Cardiology Scientific Sessions in Orlando, FL. IETA President Louanne Tempich conducted the well-attended meeting following Robert's Rules of Order. Spirited discussion preceded porposed amendments to and final acceptance of the By-laws. Future general meetings are planned to coincide with the annual ACC Scientific Session, and will include guest speakers, workshops, and discussion groups. The formal meeting was followed with the awarding of four Honorary Lifetime Memberships in the IETA to D. Michael Deignan, President and CEO of Vasomedical, John CK Hui, Ph.D., Senior Vice President; Thomas R. Varricchione, RRT, MBA, Vice President of Clinical and Regulatory Affiars; and Gudrun M. Lang, RN, BSN, Director of Clinical Research, for their support of the founding of the IETA. It was a moving experience for the honorees and the realization of a long-held dream. Food and wine were plentiful and enjoyed by all as was the lively conversation exchanging 'war stories'. Immense enthusiasm and professional pride were evident at this gathering. Membership applications were distributed and eagerly completed. Revenues will be applied to development of a web site, newsletter, reference handbooks on EECP and the organization of local IETA chapetes. 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)" (The IETA at ACC (l to r): Secretary Joanne Giordano, Honorary Member Dr. John Hui, President Louanne Tempich, and By-laws Chairperson Ellen Longmoore) IEPR Substudies Begin IEPR-DASI (Duke Activity Status Index) This substudy began March 1, 2001 to compare the functional capacity of patients as they begin EECP with improvements in functional capacity immediately post-EECP and at six months after completion of treatment. The patients is asked to respond to questions focusing on activities of daily living. The Duke Activity Status Index is a short (12 question) self-administered questionnaire developed and validated by Dr. Mark Hlatky, Stanford University. The DASI correlates significantly with peak oxygen uptake, New York Heart Association funcational classificiation and the Canadian Cardiovascular Society Classification for Angina. The goal of this IEPR substudy is to acquire more precise information about the effect of EECP therapy on the functional capacity of a group of angina patients that often present with significant comobidities and a long history of cardiovascular disease. IEPR-DM (Diabetes Mellitus) This substudy is scheduled to begin May 2001, with center participatoing dependent on local IRB approval. An additional data form and the collection of a pre-treatment urine sample to test for microalbuminuria (using the MICRAL dipstick test) are required. Previous research had shown microalbuminuria to be an important predictor of outcome after revascularization procedures. This IEPR substudy seeks to determine predictors of successful outcomes for angina patients with a diabetes co-morbidity treated with EECP. Any questions regarding these two sub-studies can be directed to either Dr. Lisa Kennard at 412-624-5217 or Nichole Dwyer at 412-624-3764. Upcoming Presentations British Cardiac Society Manchester, UK May 2001 Primary Utilization to Improve Myocardial Perfusion with Enhanced External Counterpulsation Revascularization (PUMPER) Fitzgerald, Kennard, Lawson, Holubkov The Improvements in Exercise Tolerance Post-EECP in Patients with Chronic Refractory Angina are Related to Diastolic Augmentation Brown, Ho, Heavey, Dodd, Horgan Efficacy of EECP in Experimental Myocardial Infarction: Histochemistry and Ultrastructure Huang, Chen, Zheng, Lawson, Hui American Diabetes Association Philadelphia, PA June 2001 EECP Produces Angina Relief in Diabetic Patients Comparable to Non-Diabetic Patients - A Six Month Follow-Up Study Linnemeier, Kennard, Lawson, Holubkov EECP Poster Presentations American College of Caridology March 18-21, 2001 Orlando, FL Patients with Non-Cardiac Vascular Disease and Chronic Angina Benefit from Enhanced External Counterpulsation Bazaz, Kennard, Holubkov, Dwyer, Crawford Background:Enhanced External Counterpulsation (EECP) is a non-invasive, non-pharmocological based therapy for patients with refractory chronic angina. EECP has been demonstrated to decrease angina in patients with coronary disease randomized, placebo-controlled trials. Patients with non-cardiac vascular disease (NCVD) are often excluded from EECP therapy because of presumed ineffective counterpulsation effect. Methods:Patients enrolled in the International EECP Patient Registry were divided into those with a history of non-cardiac vascular disease (NCVD 584 patients) and those without (non-NCVD 1499 patients). Baseline characteristics, degree of augmentation and clinical outcome both post-EECP and at six month follow-up were examined. Results:NCVD were older(68.3 yrs vs. 65.7 yrs, p<0.001), had higher incidence of diabetes (54.8% vs 34.9%, p<0.001) and congestive heart failure (35.0% vs. 24.6%, p<0.00). Coronary artery disease was of longer duration (11 yrs vs 10 yrs, p<0.05) and multivessel disease was more frequent (81.3% vs 76.4%, p<0.05). NCVD had more frequent severe Canadian Cardiovascular Society Classification III/IV) angina (81.4% of NCVD reduced by one CCS class vs. 81.4% of non-NCVD, p=NS). This reduction was maintained at six months in 82.9% of NCVD vs. 84.12% of non-NCVD, and the rate of MACE (death, MI, CABG, PCI) was also similar (7.9% for NCVD vs. 7.1% for non-NCVD, p=NS). Conclusion:Patients with non-cardiac vascular disease, despite poorer diastolic augmentation ratios, derive clinical benefit from EECP therapy in a comparable manner to those without NCVD, and should not be excluded from further studies involving this therapy. Intervention for Stable Angina: A Multicenter Comparison of Consecutive Patients Undergoing Enhanced External Counterpulsation (EECP) and PCI Holubkov, Kennard, Kelsey, Soran, Holmes Background:Many patients with CAD and stable symptoms who are treated with EECP are also suitable for percutaneous coronary intervention (PCI). Assessment of EECP outcome in these pts requires comparison of risk profiles as well as follow-up status to patients with comparable symptoms who undergo PCI. Methods:We compared baseline presentation and one-year outcome in two multicenter cohorts of consecutive pts with stable angina: 148 PCI candidates undergoing EECP (International EECP Patient Registry) and 411 pts undergoing nonemergent PCI in the NHLBI Dynamic Registry. Results:PCI candidates undergoing EECP were older with more previous intervention and higher risk profile. At one year follow-up, mortality was comparable (2.1% EECP vs 2.2% PCI) as were rates of subsequent CABG (5.2% EECP vs. 5.1% PCI). During follow-up, 9.6% of those initially undergoing EECP, 17.0% underwent repeat PCI during follow-up. Angina was reported at one year in 60% of EECP pts vs 26% of the PCI cohort (p<0.001). However, reported rates of severe angina (Class III, IV, or unstable symptoms) were 11% among EECP pts nad 8% among PCI pts (p=NS). Conclusions:PCI candidates undergoing EECP for stable symptoms have a markedly higher risk profile than patients with stable angina who undergo PCI. While angina is substantially more prevalent one year post EEPC, more severe symptoms are reported relatively infrequently with each of the two treatments. Are the Initial Benefits of Enhanced External Counterpulsation Sustained at One Year? Hui, Lawson, Kennard Background:Enhanced External Counterpulsation (EECP) has been shown to be safe and effective treatment of angina in several small University hospitals case series, with clinical benefits lasting up to five years in follow-up. However, there is no data on the long term effectiveness of EECP in routine clinical practice. Methods:The International EECP Patient Registry (IEPR) was initiated in January 1998 at the University of Pittsburgh to sequentially track angina patients (pts) treated with EECP for up to 3 years across a broad spectrum of providers and practice settings. The registry records: pt demographics, Canadian Cardiovascular Society (CCS) Angina class, adverse cardiovascular evernts (MACE - including hospitalization, death, infarction (MI), revascularization (PCI and CABG)). The IEPR first year follow-up is analyzed. Results:The IEPR includes 734 angina pts on year post EECP, with completed follow-up availale on 589 pts. Patients were predominantly male (75%) with a mean age of 68 years. Pre treatment history was significant for: multivessel disease - 77.6%, prior angioplasty - 58.3%, prior CABG - 56.5%, prior MI - 63.5%, history of congestive heart failure - 26.1%. The pts received a mean 34 hours of treatment with 83% completing the full course of treatment. Events occurring during the treatment period included: unstable angina in 2.5%, MI in 0.4%, death in 0.1%, CABG 0.5%, PTCA in 0.1%. CCS Angina class immediately post-EECP improved in 73.4% of pts and 61.6% of pts discontinued nitroglycerin use. The improvement in angina was maintained at 6 and 12 months included: death 5.0%, Mi 4.2%, CABG 3.0%. PTCA 4.2%, cardiac hospitalizations 17.2% (mean number 1.5 and duration 5.5 days). By 12 mos., 22.8% of pts had undergone additional hrs of EECP treatment. Conclusions:In a cohort of high risk cardiac pts, EECP produced immediate and sustained improvement in CCS angina class in the majority of pts with MACE comparable to historical treatment trials. Enhanced External Counterpulsation for Chronic Angina is Associated with Improved Outcome at 6 months Barsness, Schnell, Holmes Background:There is a growing population of patients with severe ischemic chest pain (CP) who are not amenable to traditional revascularization strategies. EECP is a non-invasive, outpatient treatment that promotes diastolic augmentation and may reduce angina symptoms. Methods:35 patients with severe angina (CCS angina class 3 or 4) despite optimal medical therapy underwent 35 one hr EECP treatments over a 7 week period. Clinical characteristics, symptoms and follow-up events were recorded at baseline, at end of treatment and at 3, 6, and 12 months. The DASI score, a prospectively validated, semiquantitative assessment of cardiovascular functional status, was also measured via a self-administered questionnaire. Results:Patients were elderly (median 69 yrs), primarily men (83%), with a history of diabetes (31%), hypertension (76%), tobacco use (67%), heart failure (16%), mi (48%), PCI (69%), and CABG (92%). 4 patients had prior TMR (3) or heart transplantation (1). Adverse treatment effects included local skin irritation in 2 patients. Angina measures improved during treatment with persistent benefit to 6 months. Throughout treatment and follow-up there were 13 clinical events, including 4 CP hospitalizations without MI, 2 NQWMI, 1 CHF, 5 PCI, and 1 CVA, but no deaths. Conclusions:Non-invasive EECP treatment was associated with significant improvement in angina and functional status with few adverse effects in this high-risk cohort. These benefits were maintained at 6 months. Clinical event rates remain low through 6 months. Further evaluation of mechanism and longer-term durability of effect are warranted. IEPR/Clinical Issues Meeting The IEPR/Clinical Issues Meeting was held in conjunction with the ACC in Orlando, FL in March 2001. The meeting was well attended and provided interesting presentations both scientifically analyses from the registry, and clinical descriptions from physicians. Dr. Holubkov's presentation of a comparison between IEPR patients and those treated with PCI in the Dynamic Registry was well received. Although this study describes a very small group of registry patients (those who were suitable for PCI), they are a very important group. Dr. Charles Fitzgerald later in the meeting gave a more clinically oriented discussion of these patients which provoked some lively discussion Dr. Nancy Cho of Vero Beach, FL gave an excellent presentation on 'Selection and Management of Patients for EECP' in which she discussed how to select patients, optimize EECP treatment, detect and anticipate problems and long term follow-up. The meeting started with an interesting presentation by Registry Director, Dr. Sheryl Kelsey, on changing baseline characteristics over the three years of the IEPR. There are significant trends in baseline characteristics such as severity of angina and comorbidities. The good news is that treatment success remains high and adverse events at a very low level. There was a general discussino of learning curve effects, and changes in reimbursement and referral patients. Dr. Kelsey also announced that the initial registry goal of 5000 patients would be reached during the latter half of 2001. I know I learned a lot from all those presentations. If you were not able to attend this meeting, I do urge you to try and make the next meeting which is to be held in association with the AHA Scientific Session in Anaheim, CA in November 2001. Hope to see you there! --Lisa Kennard, Ph.D. IEPR Coordinator Joe Winterman, RN writes about his ACC 2001 experience! Director and Therapist, EECP Clinic The Angina Center @ Ohio Valley Health Care Dear Nichole: Having just returned from the ACC Sessions in Orlando, I would like to encourage those able to attend such meetings to do so. I was very impressed by the variety of subjects covered in the various sessions and the opportunity to contribute to discussions. Perhaps even more impressive, was the spectrum of products displayed in the exhibitor's hall. I knew there would be numerous companies with parmaceuticals, electronics, etc., but I didn't think about or expect the number of physician recruiters, publishers, food producers, computer software sales, etc. I expected lines at the phones, not so. Though there were numerous free use PC stations, the lines were like those at the women's bathrooms at a NASCAR race. Probably the best part of this particular convention was the opportunity to meet and talk with other involved in EECP. IEPR will benefit us all for along time with the data they have been able to accumulate. I was also priviledged to be there at the beginning of the IETA. I strongly encourage all those eligible to join, to do so. I truly feel this organization will some day help us to be recognized as the specialized professionals we are. I am happy there was someone out there willing to put in the time and effort needed to get the IETA off the ground. Though it was a subtle feeling and not directly mentioned, it felt good to see so many people that truly care about the welfare of their patients. Thanks for all your efforts, hope to see you again soon, and now back to work! Sincerely, Joe Winterman, RN The IEPR is truly 'international' as EECP comes to Turkey! Dr. Ozlem Soran, Assistant Professor of Medicine, Research at the UPMC Cardiovascular Institute brought EECP to Ankara, Turkey. The Medkar Heart Center began treating patients in September 2000, and has enrolled 31 patients in the IEPR. Dr. Soran returned to Turkey after completing work on EECP and other research projects at UPMC. Dr. Soran has presented data on EEPC in left ventricular dysfunction patients at major domestic and international cardiology meetings, is an active member of the IEPR Working Group, and a strong proponent of EECP therapy. It's great to have Dr. Soran back in Pittsburgh! 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