SCOTTSDALE AZ, December 8, 2006. - A new device under study may help prevent strokes in patients with atrial fibrillation and free them from a lifetime of taking often problematic blood thinning medications.
Cardiac electrophysiologists at Scottsdale HealthCare Osborn hospital implanted the WATCHMAN stroke-prevention device in three patients with atrial fibrillation (AF), an irregular heart rhythm associated with a six to seven -fold increased risk of stroke.
Dr. Vijay Swarup, a cardiac electrophysiologist with Arizona Arrhythmia Consultants, is leading the clinical trial at Scottsdale HealthCare Hospitals as part of a national study involving patients with AF. This Phase II multicenter clinical research trial is comparing an investigational device to standard treatment with the blood thinner Coumadin/Warfarin. The goal is to determine if this investigational procedure may give patients a better quality of life, without a lifetime of taking blood-thinning medications with the risks and inconveniences that may be associated with them.
The research involves a minimally-invasive procedure to implant an investigational umbrella-shaped device in the opening of the left atrial appendage. The appendage is a thumb-sized vestigial structure, that has no function but is a major source of clot formation and stroke in AF patients. The body soon begins to form tissue over the implant, permanently closing off the appendage, eliminating the risk of forming life-threatening blood clots there. The intention is to eliminate the need for Coumadin/Warfarin, which is currently used in patients with AF to reduce the risk of stroke.
Atrial fibrillation is the most common heart rhythm disorder and affects over 2.8 million people in the United States. The American Heart Association (AHA) estimates that every year at least 120,000 Americans and several million outside the United States suffer strokes (20% of all strokes) because of this common irregular heart rhythm.
"Our ability to eliminate, the left atrial appendage as a source of clot and stroke using only low risk - minimally invasive techniques will likely offer major advantages to our patients with AF. If it works, this procedure and technology will greatly impact patient safety and quality of life by significantly reducing the need for blood-thinning medications. Coumadin/Warfarin use, while effective in preventing strokes in AF, requires frequent blood testing and carries increased risk of bleeding, especially in our elderly population," says Dr. Vijay Swarup, the trial's principal investigator.
"In addition, minor bleeding, drug interactions, risk of injury and inconvenience will cause many patients to stop taking the blood thinning medications, leaving them at a significant risk of major stroke." adds Dr. Swarup.
At this time, participation in the clinical research trial is the only way to obtain the WATCHMAN device. The clinical trial is open to patients with atrial fibrillation who are still able to take Coumadin/Warfarin. Patients will be randomized to groups taking the drug or those receiving the device. The two groups will be compared over a period of approximately two years.
The Watchman left-atrial appendage system was developed by Atritech Inc., based in Minneapolis, and the company provides funding for the new research study.
Atrial Fibrillation
Atrial fibrillation (AF or afib) is the most common abnormal heart rhythm and involves the upper heart chambers (the atria). Atrial fibrillation is irregular, disorganized, electrical activity resulting in ineffective pumping action of the atria. AF occurs in 1 to 2 percent of the population, with a prevalence that increases markedly with age: it affects as many as 5 percent of persons above the age of 65 years. When the atrium loses its ability to contract in AF, blood pools in the appendage (a thumb-sized vestigial structure in the left atria), providing a milieu for blood to clot. These clots can then break loose and travel through the bloodstream to the brain causing a stroke. Atrial fibrillation is often associated with symptoms of palpitations, fainting, chest discomfort, and if untreated even heart failure. Symptoms of atrial fibrillation are often treated with medications which regulate or slow the heart rate. Blood thinners are commonly used to decrease the risk of stroke. Curative RF ablation techniques are also now available.
Arizona Arrhythmia Consultants
Arizona Arrhythmia Consultants - based in Phoenix/Scottsdale - is one of the nation's largest cardiac arrhythmia practices. They provide state-of-the-art inpatient, ambulatory and preventive care in the field of heart rhythm disorders at five major centers in the Phoenix Valley: Scottsdale HealthCare Hospitals (Osborn and Shea), Arizona Heart Hospital, Sun Health Boswell Hospital, Chandler Regional Hospital and Banner Desert Medical Center. For more information, visit www.azrhythm.com.
Study: 'PROTECT AF' - WATCHMAN Left Atrial Appendage System for Embolic PROTECTion in Patients With Atrial Fibrillation
Design: Prospective, randomized study comparing the WATCHMAN device to long term warfarin therapy.
The WATCHMAN left atrial appendage (LAA) system is made of nitinol (a self expanding metal) with the atrial facing surface covered with a thin permeable polyester material. The device is constrained within a catheter until delivery in the LAA and is available in multiple sizes to accommodate the unique anatomy of each patient.
This study is currently recruiting patients:
Arizona Arrhythmia Consultants, Scottsdale, Arizona, 85251, United States
Michelle Denuit 602-234-2800 mdenuit@azrhythm.com
Bianca Vandermate 602 234 2800 bvandermate@azrhythm.com
Vijay Swarup, MD, Principal Investigator
More Information
Sponsor: Atritech, Inc., Plymouth, Minnesota, USA. www.atritech.net
