Volume 4, Issue 2, March 2002
-
Karen Manzo, RN
Cardiovascular Research Institute, Inc.
Site 13
My husband Mark and I have been married for 12 years. We have three beautiful children. Halie is 4 years old and our twins, Cole and Allie are 2. As you can imagine, being a full-time wife, mother and clinical director of EECP therapy and the Cardiovascular Research Institute, Inc., my days and nights are full. In our spare time (ha ha!), we love to ski, hike, go to hockey games and vacation when we can.
Currently, I am the Clinical Director of our EECP Center at HeartCare, Inc. I have been involved in EECP therapy since the autumn of 1995, when I was at the Beth Israel/Deaconess Hospital in Boston. My husband and I moved to Columbus in the spring of 1996 when Dr. Bruce L. Fleishman and I started the EECP therapy program at HeartCare, In. In coordination with Dr. Fleishman and Dr. Arnold Good, we also started the Cardiovascular Research Institute, Inc. in September 1999, for which I am the Clinical Director. It is a non-profit organization dedicated to providing excellence in cardiovascular research.
I have been a registered nurse since 1979 with extensive experience and knowledge in cardiovascular medicine and research. I am published in many areas of cardiology including coronary agnioscopy, coronary laser, soluble fibrin, thromolytic therapy, and intravascular ultrasound, to name a few. I enjoy public speaking and have presented my abstracts at AHA, ACC and the American Society for Laser Medicine and Surgery. I have been invited to speak throughout the country, as well as internationally in places such as Montreal, Brussels, and Nice on cardiology-related topics, including EECP therapy. I also spent three years working for a cardiology company as a product/marketing manager. I have been very fortunate, am grateful for my career thus far and have great hopes and dreams of many fulfilling years to come. I would not have been able to do so without the help of many wonderful people, my husband, Dr. Fleishman, and my colleagues at the Beth Israel/Deaconness Research Group.
My EECP therapy experience has been and continues to be great. I was conducting invasive cardiology research trials in Boston when Vasomedical, Inc. came to us in 1995 to discuss participation in the MUST-EECP trial. When the Principal Investigator, Dr. Richard Nesto presented it to me, I really wasn't interested in a non-invasive approach to angina/coronary artery disease. When I first saw the EECP system, I thought "this is strange". The more I thought about the concept of increasing coronary perfusion and decreasing the workload of the heart much like the invasive intra-aortic balloon pump, but in a non-invasive way, the more appealing it became. We became a research site for MUST-EECP. After moving to Columbus and starting the program here, we also participated in the trial. It was amazing to see the difference in those patients being treated with EECP and those in the sham group. Since that time, from a research standpoint, we have participated in the feasibility trial for EECP in Heart Failure and are currently participating in the PEECH trial. There is so much promise for EECP; hopefully this trial will show that EECP may restore hope in those patients suffering with heart failure.
I have been involved in EECP therapy for almost seven years. Besides the participation in the research trials, we started treating patients at HeartCare, Inc. in the spring of 1996. Patients had to pay for treatment because insurance did not cover it. It was very hard to see patients take out a second mortgage, sell a car, borrow from a credit card or whatever they had to do to pay for this treatment. I can honestly say, not one patient has regret. I am proud to say, that Dr. Fleishman, along with Vasomedical, Inc., and another physician, were instrumental in getting HCFA to approve coverage for this therapy. We have come a long way since those early days.
We provide EECP in a hospital setting. Today, we have four systems at our center at HeartCare, Inc. in Columbus, Ohio and one system at Samaritan Hospital in Ashland, Ohio where our physicians see office patients twice a week. Our center in Columbus treats patients from 7am to 7pm. It is staffed with two full-time therapists. Qiang Zhao has been with us for almost 6 years. As a practicing cardiologist in China, Zhao worked with EECP for seven years prior to coming to the United States. Her tremendous cardiac knowledge, EECP experience and dedicated work ethic makes Zhao a great asset to our group. Jen Albrigo joined us in the summer of 2001 with a degree in Exercise Science. She has great experience in cardiac rehabilitation, prevention, fitness and wellness. Her "people" skills, professional skills are exceptional. Jen is truly an asset to our team. Cheri Loudermilk, our project coordinator, schedules patients, pre-certifies them for insurance coverage and manages patient follow-up as well as the International EECP Patient Registry data forms. She has been with us for almost four years. Her organization and communication skills, quality of work, and productivity are excellent. She is a wonderful asset to our team. I am so thankful to our staff for the experience, expertise, and dedication they have to EECP therapyp. Currently, we are treating 19 commercial patients a day with a capacity for 21. We work up to four PEECH Trial patients in as they get randomized to EECP therapy. We have done hundreds of patients to date.
On October 27, 2001, we had a 5-year Anniversary Party for our patients and families. What a great time! The patients loved getting together again with us as well as other patients. Gudrun Lang joined us from Vasomedical, Inc. We appreciated having a representative from the company, especially Gudrun, since she and I have worked together since 1995. Our Vasomedical Sales Representative, J.D. Staley also provided support for the party and we are grateful. Dr. Fleishman presented our EECP data. I presented EECP; past, present, future. We had a great heart-healthy breakfast and luncheon. We had EECP-related trivia games and crossword puzzles. Prizes were given away and everyone left with an EECP memento. It was so much fun and enjoyed by all. We have had patients call us and ask when are we going to have another party. We are thinking of making it an annual event.
I have seen a lot of wonderful things happen to those patients treated with EECP therapy. Besides the decrease in agina; increase in energy; increase in evercise tolerance; decrease in medications; and iprovement in their quality of life, there have been many anecdotal experiences. We have a follow-up form that we mail to patients at one, three, six and twelve months, then every year for three years after completing EECP. Patients have documented such things as:
My night vision is better.
I can hear a clock again.
I can feel my cat rubbing against my legs for the first time in years.
I can feel the carpet under my feet again.
I can drive a car again. (CAD patient with Parkinson's)
I can sign my name. (CAD patient with Parkinson's)
My sexual performance has improved.
I didn't have to get my toe amputated. (CAD patient with Diabetes)
I can walk without my cane.
The list goes on and on.
I honestly believe there is so muich promise for EECP therapy and what it can do. No matter what changes we see with therapy, the improvement in the patient's quality of life is the greatest. If they can get out and do some of the things they have not been able to do, then that says a lot. I am so glad that on that day in 1995 when Vasomedical, Inc. came to us about EECP therapy, and I was skeptical, I opened my mind and listened to them about this treatment. It has not only made a believer out of me and our patients, but also has allowed so many to enjoy life again. Thank you very much.
(L to R: Dr. Bruce Fleishman and Karen Manzo, RN at the Cardiovascular Research Institute, Inc.)
IEPR Contest Winners Visit Sunny California and the Land of Disney!
As winner of the IEPR 100% Compliance Contest, our EECP center was invited to attend the American Heart Association Scientific Sessions in Anaheim, California, as well as the IEPR and Vasomedical meetings. I was accompanied by the EECP coordinator from our office, Trish Folta.
Trish and I were just two of more than 32,000 professionals worldwide to experience the latest in cardiovascular research and how it applies to our practice. We were also given the wonderful opportunity to discuss issues we face and different techniques used in EECP with other therapists, coordinators, and physicians involved with EECP.
The data presented by the IEPR was informative and encouraging regarding the benefits of EECP. The IEPR staff appreicated our effort in achieving 100% compliance as it is from this data that we learn the benefits of EECP.
Trisha and I had an enjoyable time visiting Disney and other area sites as well as meeting the Vasomedical staff. We would like to thank Nichole Dwyer, IEPR Data Manager and Lisa Kennard, IEPR Coordinator, for their warm welcome and would like to thank the IEPR for the educational and enjoyable trip to the AHA Scientific Sessions.
Kris Frane, LPN, EECP Therapist
Trisha Folta, RN, EECP Coordinator
Cardiovascular Associates of Northern Wisconsin
In Press:
A Comparison of Patients Undergoing Enhanced External Counterpulsation and Percutaneous Coronary Intervention for Stable Angina Pectoris
R Holubkov, E Kennard, J Foris, S Kelsey, O Soran, D Williams, D Holmes
American Journal of Cardiology, May 2002
Relation of the Pattern of Diastolic Augmentation During a Course of Enhanced External Counterpulsation (EECP) to Clinical Benefit [from the International EECP Patient Registry(IEPR)]
M Lakshmi, E Kennard, S Kelsey, R Holubkov, A Michaels
American Journal of Cardiology, June 2002
Enhanced External Counterpulsation as Treatment for Chronic Angina in Patients with Left Ventricular Dysfunction: A Report from the International EECP Patient Registry (IEPR)
O Soran, E Kennard, S Kelsey, R Holubkov, J Strobeck, A Feldman
Congestive Heart Failure, July 2002
American College of Cardiology
Atlanta, GA
March 2002
Safety and Efficacy of Enhanced External Counterpulsation in Hypertensive Patients with Refractory Angina Pectoris: Short and Long-Term Follow-Up
R Arora, A Malone, M Carlucci, J Orlando, E Kennard
Do Women with Refractory Angina Respond as Well as Men to Treatment with Enhanced External Counterpulsation?
W Lawson, E Kennard, G Linnemeier, R Holubkov, M Mehra
EECP Reduces Angina and Improves Quality of Life in Elderly Unrevascularizable Patients
G Linnemeier, E Kennard, W Lawson
2nd European Conference on Management of Coronary Heart Disease
Nice, France
April 2002
Enhanced External Counterpulsation Provides Angina Relief in Diabetic Patients Who are Not Candidates for Coronary Revascularization - A Six Month Clinical Outcome Study from the International EECP Patient Registry
G Linnemeier, E Kennard, S Kelsey
British Cardiac Society
Harrogate, UK
May 2002
Enhanced External Counterpulsation Provides Relief from Severe Angina in Diabetic Patients - A Six-Month Clinical Outcome Study from the International EECP Patient Registry
G Linnemeier, E Kennard, W Lawson
Recent Presentations:
Oral Presentation at 4th International Congress on Coronary Artery Disease
Prague, Czech Republic, October 2001
A Report from the International Enhanced External Counterpulsation Patient Registry
R Holubkov, E Kennard, S Kelsey, O Soran
Introduction: Enhanced external counterpulsation (EECP) has recently been gaining acceptance as a treatment for angina symptoms. Since January 1998, the IEPR, which includes over 100 international centers, has been enrolling consecutive patients undergoing EECP.
Methods: We assessed baseline profile, acute results, and 1-year status among the first 3309 consecutively enrolled patients.
Results: Baseline Presentation. Mean age was 67 yrs, 75% were male, 85% had history of surgical or catheter-based intervention, 66% had prior infarction, and 30% congestive heart failure. 42% had history of diabetes, 69% hypertension. Angina at entry was Canadian Cardiovascular Society Class I in 4%, Class II 16%, Class III 56%, and Class IV 24%. Mean LV ejection fraction was 46% and 78% of patients had blockages in mutliple vessels. 80% were not candidates for either CABG or PCI treatment. Patients underwent a mean 34 hours of EECP; 83% completed their full prescribed regimen. At the time of treatment, 72% of patients had decrease in angina of at least on Class, and 54% reported discontinuing use of nitroglycerin. 1-Year Outcome. Of the initial 674 patients eligible for 1-year follow-up, information is complete on 610 (90.5%). 31% report freedom from all anginal symptoms, and 78% report Class I, II or no angina. Major 1-year event rates are low: 6% death, 4% CABG, 6% PCI. 16% of patients had repeat course(s) of EECP.
Conclusions: EECP demonstrates both acute and longer-term effectiveness in the relief of angina in a severely symptomatic, high-risk population of patients.
Presentation at AHA 2001
Anaheim, California, November 2001
Enhanced External Countepulsation Promotes Angiogenesis Factors in Patients with Chronic Stable Angina
D Masuda, Ooba Hospital, Kyoto, Japan; R Nohara, Grad. Sch. of Med., Kyoto, Japan; K Kataoka, Kyoto, Japan
Background: Enhanced external countepulsation (EECP) recently was reported to improve both exercise tolerance and anginal symptoms in patients with chronic stable angina (AP). But, the mechanism of EECP therapy is still much to be known. Our previous paper (Eur Heart J, in press) reported the development of functional collateral vessles and improvement of coronary flow reserve would be one of the mechanisms using 13N-ammonoa positron emission tomography. Furthermore, several angiogenesis factors are necessary for the development of functional collateral, and the major trigger to release angiongenesis factors is considered to be the shear stress. The features of EECP are both decrease of systolic pressure and augmentation of diastolic pressure, and this unusual wave pattern includes shear stress. We hypothesized that EECP promotes the release of angiogenesis factors by this stimulation. The aim of this study is to evaluate whether angiogenesis factors promotes by EECP therapy.
Methods: Eleven patients (M/F: 8/3, age:61.6+/-9.7) with AP were treated with EECP therapy for total 35 times (1hr/sessions, once or twice daily). Blood samples wre collected from a brachial vein, before and after EECP therapy. Prior to each collection, patients were fasting, and remained supine for 30 minutes. The VEGF, HGF, bFGF, and MCF-1 were assessed by radio immunoassay.
Results: HGF, bFGF, and VEGF after EECP therapy increased by 26.6% (HGF: before:1457.8 +/-485.5 pg/ml, after: 1968.0+/-590.4 pg/ml, P<0.04), 18.8% and 15.6% compared with those before therapy, respetively. But, MCP-1 didn't increase after EECP therapy. 66.6% of patients increased HGF and bFGF after EECP and 33.3% increased MCP-1 and VEGF.
Conclusion: In patients with AP, EECP therapy increased angiogenesis factors, especially HGF. These results suggest that EECP therapy promotes angiogenesis factors with shear stress, and develops the functional collateral vessels.
Introducing the IEPR Working Group
Current Members:
Georgiann Linnemeier, MD - CHAIR; HeartGen Centers, Indianapolis, IN
Peder Bager, MD; Hammersmith Hospital, London, UK
Gregory Barsness, MD; Mayo Clinic, Rochester, MN
Bradley Bart, MD; Hennepin County Medical Center, Minneapolis, MN
Charles Fitzgerald, MD; Heartcare Clinic; Little Rock, AR
Bruce Fleishman, MD; Cardiovascular Research Institute, Columbus, OH
Gordon Fung, MD; University of California at San Francisco, San Francisco, CA
William Lawson, MD; State University of New York at Stony Brook, Stony Brook, NY
Andrew Michaels, MD; University of California at San Francisco, San Francisco, CA
Ronald Schutz, MD; Heart Centers of America, LLC, Portland, OR
Ozlem Soran, MD; University of Pittsburgh Medical Center, Pittsburgh, PA
This article will serve as an introduction to the IEPR Working Group, its members and its activities. The IEPR Newsletter will preiodically publish updates on the Working Group's activities in order to keep all participants of the Registry informed about ongoing projects. The group was formed in March 2000 at the invitation of the IEPR Steering Committee. The mission of the Working Group is to provide clinical input to members of the IEPR Coordinating Center so that the design and interpretation of IEPR data can be put to best use by clinicians involved in providing EECP as well as the medical community in general. All physicians in the Working Group are actively involved in the clinical supervision of EECP programs.
Suggestions for registry form design, as well as the development of focused ancillary studies are discussed at periodic Working Group meetings. Currently, there are several ancillary studies under development in addition to those ongoing; the DASI and the Diabetes studies. Paramount to the generation of this very exciting and interesting data is its analysis, interpretation, and dissemination to those interested in EECP. With the very competent assistance of Lisa Kennard, Nichole Dwyer and Sheryl Kelsey, members of the Working Group prepare abstracts for major medical meetings and manuscripts for publication, which are of the highest scientific quality. It is through the publication of these high quality abstracts and manuscripts that knowledge of EECP and its benefits, as well as its limitations, continues to grow both for practitioners, as well as, those who may be interested in the future. We will use the newsletter to keep readers informed about current Registry publications; and, as always, we thank you for your support and encourage all participants to be diligent in providing complete and accurate data. I invite anyone interested in joining the Working Group to contact Lisa Kennard or myself.
Georgiann Linnemeier, MD
IEPR Working Group Chair
My Ode to EECP
When I first discovered EECP, I pondered, what could it do for me?
Having suffered from angina for several years, unfortunately I could hardly endure the tears.
Dr. Bonazinga analyzed my heart and then responded, "When do you want to start?"
Thanks to his knowledge and great concern, I was ready at last to take my turn.
I entered the EECP lab for an hour's ride, knowing that pressure would be my guide.
In the lab with Judy, Mary, Karen, and Susan too, I realized that I was commencing to feel like new!
The office staff of Kathy, Sue, and Hope, gave me the inspiration and dared me not to mope!
Each journey to Rutland was several hours, and now I feel like smelling the flowers!
Judy, my wife of 41 years, traveled with me to help allay my fears.
Now I can walk hills with less pain, knowing now that I can stand the strain!
Your kind, caring, compassionate words rang true in my thoughts and were always heard.
My sincere thanks to all at Rutland, VT EECp, you have made a new man out of me.
8 Commons Street will always have a place in my heart to eternity!
EECP Graduate - August 1, 2001 - Spetember 11, 2001
A happy day for me, but a sad one for our country
International EECP Therapists Association
"Healing the World, One Heart at a Time"
On behalf of the IETA Board of Directors, I would like to take this opportunity to thank all of our 2001 Charter Members for their support and patience through our first year of operation. We faced many challenges throughout the year and have accomplished all of our planned goals for the year 2001. Our Charter Membership drive was very successful, with the final total at 125 members. Because of the support of our members, we were able to set up a post office box, open checking accounts, establish our organization with the IRS as a non-profit entity, send out newsletters to all memebrs, and pioneer a website helping to network EECP therapists throughout the nation and the world. Our website is listed in the Yahoo!, Google and AOL directories. Our webmaster has made it easy to locate, even if web surfers are browsing under such topics as health, cardiology, general medicine, and organizations. The website also has direct links to Vasomedical, and the International EECP Patient Registry. Our web address is www.ietaonline.com. Log on and leave a message! There is a place to leave web mail for all the IETA Board members. We also have a telephone line voluntarily manned by the Board of Directors. You can leave a message at 1-800-376-3321, ext 140.
Special membership cards were developed and sent out, with the addition of a gold seal for Charter members. Due to several printing problems, we were not able to send out the 2001 membership cards until November 2001. Thanks to all our members for their understanding and patience. The 2002 membership cards have been mailed and we have included a 2002 appointment calendar. If you have not renewed your 2002 membership, dues and forms must be received by March 1, 2002.
On March 16, 2002, we will be having our 2nd Annual General Membership Meeting in Atlanta in conjunction with the American College of Cardiology (ACC) Scientific Sessions. There will also be a workshop after the meeting. Log onto the website for more details. Items with the IETA logo will be for sale on the website, and available after the ACC.
Our primary goal for 2002 is credentialing for EECP Therapists We are planning a credentialing committee. If anyone would like to participate on this or any one of our other committees, please contact any Board member via the website or by phone. We welcome any and all participation. Be on the front line of moving IETA into the future! New faces, new ideas, more growth!
See you in Atlanta!
Looking forward for the EECP therapist in 2002.
Sincerely,
Louanne Tempich
President, IETA
"The International EECP Therapists Association is a multidisciplinary organization of EECP therapists, united with one professional voice to set and uphold standards of excellence in the delivery of Enhanced External Counterpulsation (EECP).
Next Newsletter: June 2002