Procedure Is Part of Ongoing Clinical Trial of Watchman® Device as Potential Alternative to Blood-Thinner Coumadin
Patients with Atrial Fibrillation Have Six-Fold Increased Risk of Stroke
Nov 9, 2006
In a New York City first, interventional cardiologists at NewYork-Presbyterian Hospital and Columbia University Medical Center implanted the Watchman® stroke-prevention device in a patient with chronic atrial fibrillation (AF), an irregular heartbeat associated with a six-fold increased risk of stroke. The procedure is part of a Phase II multicenter clinical research trial comparing the investigational device to the standard treatment, the blood-thinner Coumadin.
The minimally invasive procedure, which took less than an hour, involved placement of the device by catheter in the heart's left atrial appendage, a thumb-sized vestigial structure, like the tailbone, that has no function and is a major source of stroke for AF patients. The device is designed to "plug" the appendage thus preventing clot formation in the first place, with the intention of eliminating the need for Coumadin (warfarin) which patients in AF currently use to reduce the risk for stroke.
More than two million Americans have AF. The American Heart Association (AHA) estimates that 20 percent (120,000/year) of all strokes result from AF and tend to be more debilitating than strokes from other sources.
"The ability to isolate, and functionally eliminate, the left atrial appendage as a source of clot and stroke without major surgery offers many potential clinical advantages to our AF patients. Specifically, this procedure and technology could significantly reduce the need for blood-thinning medications which, while effective in preventing stroke in AF, require routine blood testing and carry risks of bleeding, especially in the elderly population in whom AF is most prevalent," says Dr. William Gray, the trial's principal investigator at NewYork-Presbyterian and Columbia University Medical Center. "In addition, diet and drug interactions cause many patients to stop taking the drug, thus leaving them at a significant risk for stroke." Dr. Gray is an interventional cardiologist at NewYork-Presbyterian/Columbia and associate clinical professor of medicine at Columbia University College of Physicians and Surgeons.
The clinical trial is open to patients with atrial fibrillation who are good candidates for Coumadin. Patients will be randomized to groups taking the drug or those receiving the device. Those in the device group will be weaned from the drug. 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 provided funding for the new research study.
NewYork-Presbyterian offers heart patients several treatment options for preventing stroke. In addition to drug-based medical therapies, other interventional procedures include PFO closure and carotid stenting.
For more information, patients may call 866-NYP-NEWS.
Atrial fibrillation (AF or afib) is the most common abnormal heart rhythm (cardiac arrhythmia) and involves the two small, upper heart chambers (the atria). Atrial fibrillation is an irregular, disorganized, electrical activity of the upper chambers of the heart (atria) 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 increasing age: it affects as many as 5 percent of persons above the age of 65 years. When the atrium loses its ability to contract with the heart in AF, blood pools in the appendage, providing an environment for blood to clot. These clots can then break lose and migrate through the bloodstream and up to the brain causing a stroke. Atrial fibrillation is often asymptomatic, but may result in symptoms of (a) palpitations, (b) fainting and (c) chest pain, and ultimately heart failure. Symptoms of atrial fibrillation may be treated with medications which slow the heart rate.
NewYork-Presbyterian Hospital – based in New York City – is the nation's largest not-for-profit, non-sectarian hospital, with 2,224 beds. It provides state-of-the-art inpatient, ambulatory and preventive care in all areas of medicine at five major centers: NewYork-Presbyterian Hospital/Weill Cornell Medical Center, NewYork-Presbyterian Hospital/Columbia University Medical Center, Morgan Stanley Children's Hospital of NewYork-Presbyterian, NewYork-Presbyterian Hospital/Allen Pavilion and NewYork-Presbyterian Hospital/Westchester Division. One of the largest and most comprehensive health-care institutions in the world, the Hospital is committed to excellence in patient care, research, education and community service. It ranks sixth on U.S. News & World Report's guide to "America's Best Hospitals," has the greatest number of physicians listed in New York magazine's "Best Doctors" issue, and is included among Solucient's top 15 major teaching hospitals. The Hospital has academic affiliations with two of the nation's leading medical colleges: Joan and Sanford I. Weill Medical College of Cornell University and Columbia University College of Physicians and Surgeons. For more information, visit www.nyp.org.
Columbia University Medical Center
Columbia University Medical Center provides international leadership in pre-clinical and clinical research, in medical and health sciences education, and in patient care. The medical center trains future leaders and includes the dedicated work of many physicians, scientists, nurses, dentists, and public health professionals at the College of Physicians and Surgeons, the College of Dental Medicine, the School of Nursing, the Mailman School of Public Health, the biomedical departments of the Graduate School of Arts and Sciences, and allied research centers and institutions. For more information, visit www.cumc.columbia.edu.