January 11, 2002
Genesis Participates In National Research Trial
Davenport Man First In Nation To Receive Investigational Device
Davenport, IA - For more than 30 years, Mike Raes of Davenport, suffered from irregular heartbeats that shook his body so violently that at times someone would have to throw themselves on top of him to help control the tremors. Now he's looking forward to enjoying life's simple pleasures thanks to a groundbreaking investigational device implanted at Genesis Medical Center.
Mr. Raes is the first person in the United States to be implanted with a Guidant manufactured automatic implantable cardioverter defibrillator (AICD) that detects and treats abnormally fast heartbeats in both the upper and lower chambers of the heart. "I have had days when my heart is in arrhythmia 9/10ths of the time," says the 52-year old, who works at Deere Harvester Works. "If I stayed home from work every time it happened, I would only work one out of every 10 days."
Atrial fibrillation is an irregular heart rhythm (arrhythmia) that affects about 2 million Americans. When atrial fibrillation occurs, the two upper chambers of the heart, called the atria, quiver instead of beating effectively. Blood isn't being pumped completely out of these chambers when the heart beats, which can cause the blood to pool and clot. If a clot leaves the atria and becomes lodged in an artery in the brain, a stroke may result. About 15 percent of strokes occur in people with atrial fibrillation.*
The AICD, known as the Guidant VENTAK® PRIZMTM AVTTM, is an investigational device that is designed to detect and treat abnormal rhythms in the upper chambers of the heart (atrial arrhythmias) while also treating abnormal rhythms in the lower chambers (ventricular tachycardias), a normal function of all AICDs.
This experimental device is part of a nationwide research trial sponsored by Guidant Corporation, the manufacturer and a world leader in the treatment of cardiovascular and vascular disease. Guidant selected Genesis Medical Center as one of 30 sites in the United States to study a total of 110 patients over the next 12 to 18 months. The purpose of the research trial is to determine the safety and effectiveness of the device.
"This defibrillator will provide the patient day-to-day, minute-by- minute improvements in his quality of life," says Michael Giudici, M.D., Electrophysiologist with Cardiovascular Medicine P.C. Dr. Giudici is the principal investigator for this study at Genesis Medical Center and a member of the Genesis Heart Institute. "Normal defibrillation is like a safety net. If you fall off the tightrope, you don't hit the ground. This device doesn't let you fall, therefore adding to the patient's quality of life, which is the most important improvement we can make."
For Mr. Raes, that improvement was seen immediately after the November 26 procedure. "We're still in awe of the whole thing," he adds. "I'm not use to my heart doing what it's suppose to do." Simple daily activities, such as mowing the grass or walking a round of golf once exacerbated his condition. "We tried everything," Mr. Raes explains. "From various medications to experimental procedures at the University of Chicago. Nothing seemed to work." However after this implant, Dr. Giudici says Mr. Raes' heart is in a normal rhythm for the first time in 30 years. He's now looking forward to having more energy and stamina.
As a participant in this research study, Mike Raes will continue to do quarterly follow-up visits with Dr. Giudici to review his condition and confirm that the AICD is working properly. That review will consist of a device check and a check to see if any treatment was delivered. This will be done by placing an electronic wand on the skin over the defibrillator. It will read and record the information stored in the AICD and tell researchers if the device is working properly.
Once the nationwide results of this study are tabulated they will be submitted to the Food and Drug Administration (FDA) for commercial approval. The data may also be used for international regulatory submissions, including the Japanese Ministry of Health and Welfare. Participants in this study must meet protocol requirements.
To find out more about the clinical evaluation of Guidant VENTAK® PRIZMTM AVTTM automatic implantable cardioverter defibrillator or other cardiac research studies visit the Genesis Heart Institute website at www.genesisheart.com.
The Genesis Heart Institute is a multidisciplinary network of regional physicians who are committed to providing compassionate and quality health care to all those in need while collaborating on the best approach to manage and treat cardiovascular diseases both here and in communities outside the Quad Cities.
* Information supplied by the American Heart Association.
