Summer 1998 Newsletter

Vol. 1 No. 1 Summer 1998

An introduction by IEPR Steering Committee Chairman, Jonathan R. Jaffe, M.D.

    The past three decades have seen enormous progress in invasive techniques to treat patients with coronary heart disease (CAD), predominantly in improved coronary artery bypass techniques and in the evolution of both PTCA and Stenting. Enhanced external counterpulsation (EECP) is a noninvasive method that uses timed, sequential inflation of pressure cuffs on the legs to augment diastolic pressure, decrease left ventricular afterload and increase venous return. The initial work performed on counterpulsation during the late 1950’s at Harvard provided the first evidence that direct counterpulsation increased coronary flow and decreased left ventricular pressure. Building on this original work, the first external counterpulsation devices developed during the 1960’s featured cumbersome hydraulic inflation systems and non-sequenced pulsation to compress the calves and thighs simultaneously. Notwithstanding this the results of small-scale clinical studies showed increased survival in patients with post-myocardial infarction cardiogenic shock as well as a significant reduction in mortality rate during the acute period after myocardial infarction. The early hydraulic counterpulsation systems evinced both mechanical unreliability and high levels of patient discomfort. Together with a lack of large-scale commercial support, these factors combined to severely dampen the original enthusiasm and to stall further investigation. During the early 1980’s, a group of Chinese investigators developed and tested a pneumatic-sequenced external counterpulsation system. Clinical studies were performed in patients with both acute myocardial infarction and angina pectoris and published results documented long-term symptomatic relief of pain in better than 90% of patients with angina pectoris. These encouraging results led to the development , refinement and clinical testing in the USA of an updated system - the enhanced external counterpulsation or EECP device. Clinical studies performed in the US over the part 9 years have demonstrated sustained clinical relief in patients with angina pectoris. The must-EECP trial, a multi-center randomized double blind study (the gold standard of modern evidence based clinical medicine) further proved the clinical use of EECP. By necessity, however, randomized trials are carried out on restricted patient subsets. In order to obtain information on the widest possible patient population and to provide information concerning safety, efficacy, side effects etc. in everyday clinical practice a Registry is ideal. A multi-center, international registry can document exactly how EECP is being used by cardiologists in their practice. In the early 1980’s when balloon angioplasty was in its infancy the NHLBI PTCA Registry was initiated and became nationally accepted as the standard for describing clinical practice. The PTCA Registry became the basis for clinical guidelines and recommendations. This registry in modified form is still in existence today and collecting data not only on balloon angioplasty but on a whole range of new interventional devices. The International EECP Patient Registry has been established with these same concepts; to document the use of the device in clinical practice today; in office settings as well as hospital settings; not only in the US but in other countries. With the data obtained from the IEPR it may be possible to determine those patient subsets most benefiting from EECP, the rate of improvement of different patient subsets, the need for subsequent treatment, and other important clinical questions.


Introducing...... The IEPR Website!!

    Now on the internet at address: http://www.edc.gsph.pitt.edu/iepr You can browse through the participating centers, the directory of IEPR staff and clinical center listings. You can check the calendar for upcoming events or post a question or comment to the bulletin board! Coordinators from other centers would like to hear from you, give them a call or send them email! Learn more about IEPR!



    Also on the web: Vasomedical, Inc. is found at http://www.vasomedical.com. A sister site to Vasomedical on EECP is found at http://www.eecp.com


Abstract Submitted

    The following abstract was submitted for the American Heart Association scientific sessions in Dallas, November 1998:

    Newly Established International EECP Patient Registry Shows Effective Therapy for Patients with Severe Coronary Artery Disease

    Jonathan R. Jaffe, MD, Sheryl Kelsey, Ph.D., Elizabeth Kennard, Ph.D., Richard Holubkov, Ph.D., for the International EECP Patient Registry (IEPR) Investigators.


New IEPR Centers!

    We are proud to announce new centers to the registry: Bogota, Colombia which added to Lyford Cay Hospital in Nassau, Bahamas, truly makes it an international registry, The Cardio-Pulmonary Continuum in Manhasset, NY, the Nebraska Heart Institute in Lincoln, Nebraska, Brookville Hospital in Brookville, PA, and EECP Center of Nevada in Las Vegas, NV. Welcome aboard to Dr. Daniel Isaza-Restrepo & Susana Reyes and staff in Colombia, Dr. Perry Frankel & Leah Cervantes, RN and staff in Manhasset, and Dr. Steve Krueger & Pat VerMaas, RN, MSN staff in Lincoln, Dr. Jivan Patel & Jeanna Reinard, LPN and staff in Brookville, and Dr. Matthew McMahon & Linda Olson, CVT and staff in Las Vegas.


IEPR Coordinator Corner

    Every subsequent newsletter will feature a biography of a coordinator from one of the clinical IEPR centers. For the first newsletter, we have interviewed the coordinating staff at IEPR Central, the University of Pittsburgh and our Steering Committee Chairman, Jonathan R. Jaffe, M.D.

    Dr. Jaffe, Dr. Kelsey, Dr. Kennard, Dr. Holubkov and Ms. Dwyer.

    Jonathan R. Jaffe, M.D., IEPR Steering Committee Chairman



    Dr. Jaffe is Chief of the section of cardiology at Hollywood Medical Center and is also Director of the Broward Institute for Cardiovascular Research and Education (BICRE) at the same institution. Dr. Jaffe is the Medical Director for IEPR Center #99 Neurology & Cardiology Associates, P.A. in Hollywood, FL. He has participated in several clinical trials of cardiovascular therapeutics and has published numerous articles in this field.

    Sheryl Kelsey, Ph.D., IEPR Director



    Dr. Kelsey is a Professor of Epidemiology at the University of Pittsburgh Graduate School of Public Health. She is also the Deputy Director of the Epidemiology Data Center. She is involved with many other clinical trials and investigations such as BARI (Bypass Angioplasty Revascularization Investigation), WISE (Women's Ischemia Syndrome Evaluation), and NHLBI Dynamic Registry of Percutaneous Interventions.

    Elizabeth Kennard, Ph.D., IEPR Coordinator



    Dr. Kennard is a Research Associate in Epidemiology at the University of Pittsburgh Graduate School of Public Health. She is currently involved with the FDA Study (a continuation of NACI (New Approaches to Coronary Intervention) and AVERT (Artificial Valve Endocarditis Reduction Trial).

    Richard Holubkov, Ph.D., Biostatistician



    Dr. Holubkov is an Assistant Professor of Epidemiology at the University of Pittsburgh Graduate School of Public Health. Other projects that he is currently participating in are the NHLBI Dynamic Registry of Percutaneous Interventions, WISE (Women's Ischemia Syndrome Evaluation), BARI (Bypass Angioplasty Revascularization Investigation), and AVERT (Artificial Valve Endocarditis Reduction Trial).

    Nichole Dwyer, B.A., IEPR Data Manager



    Ms. Dwyer is a Research Specialist in the Epidemiology Data Center at the University of Pittsburgh Graduate School of Public Health. She started working with the IEPR in March 1998. She enjoys training and communicating with the coordinators and working with web design.


Recruitment:



Announcements:

    The American Heart Association is being held November 8-11, 1998 in Dallas, Texas.

    Anyone interested in contributing articles or information to the IEPR newsletter, please contact Nichole Dwyer at 412-624-3764 or email at dwyer@edc.gsph.pitt.edu.


Reminder:

    Data forms should be faxed to the Coordinating Center within a week of the date listed on the form. Screening Logs need to be faxed only once during the first week of each month. At the end of every month, a form compliance report is faxed to each coordinator stating which forms are due to the Coordinating Center for each patient as well as the forms already received. This helps to notify the centers which data forms are due on what date and which may have gotten lost in transit. Any questions, please call Nichole Dwyer at 412-624-3764 or Dr. Elizabeth Kennard at 412-624-5217. Thank you for faxing the data promptly!!!




International
EECP
Patient
Registry

Chairman of Steering Committee:
Jonathan R. Jaffe, MD

Editorial Staff: University of Pittsburgh
Nichole Dwyer, BA
Elizabeth Kennard, PhD

Design and Production:
Nichole Dwyer, BA; University of Pittsburgh

Sponsor Office: Vasomedical, Inc.
Anthony Peacock, Vice President of Clinical Affairs; Gudrun Lang, RN, BSN, Manager of Clinical Affairs

IEPR Coordinating Center:
Epidemiology Data Center, University of Pittsburgh Graduate School of Public Health