Clinical Trial Helps Atrial Fibrillation Patients

Main Category: Heart Disease
Also Included In: Cardiovascular / Cardiology;  Clinical Trials / Drug Trials
Article Date: 06 May 2009 - 1:00 PDT

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Kimberly Skelding, M.D., FACC, FAHA, FSCAI, associate, Interventional Cardiology at Geisinger Medical Center, director of Cardiovascular Genomics and Cardiovascular Research at the Sigfried and Janet Weis Center for Research and director of Women's Heart and Vascular Health Program, is one of 17 doctors in the country who is implanting the Watchman LAA device in patients with nonvalvular atrial fibrillation (AF) as part of a nationwide clinical trial.

The device is designed for AF patients who are on the medication Coumadin (warfarin) to prevent a stroke. AF is a condition that causes an abnormal heart rhythm, and is the leading cause of stroke.

Coumadin had previously been the only protocol for treating AF, but it comes with its own issues. As a blood thinner, patients are at risk for severe bleeding. Also, the patient faces the inconvenience of blood draws every few weeks to monitor its effects on the body and dosage changes.

The Watchman device, which is implanted through a minimally invasive procedure into the heart where clots could form, will control AF while allowing patients to live without the medication and its risks. Most patients are typically taken off the medication 45 days after the device is implanted.

"Patients no longer have to worry about falling, getting cuts or having surgery," said Dr. Skelding, lead investigator of the Watchman trial. "Prior to this device, patients were facing a lifetime on Coumadin and a lifetime of worry."

The Food and Drug Administration advisory panel has recommended the device be approved as an alternative to Coumadin for the prevention of stroke in AF patients.

"All the patients I've implanted with the Watchman LAA device are doing really well and are excited about its possibilities," said Skelding.

About Geisinger Health System

Founded in 1915, Geisinger Health System is one of the nations largest integrated health services organizations. Serving more than 2.6 million residents throughout central and northeastern Pennsylvania, the physician-led organization is a nationally recognized leader in the use of electronic health records, patient access and engagement in their healthcare, and in medical education for the next generation. Geisinger is comprised of three medical center campuses, a 740-member group practice, a not-for-profit health insurance company and research that extends across our large system- all dedicated to creating new models for scientific discovery, quality patient care, and successful clinical outcomes. Geisinger's Weis Center, Center for Health Research and Center for Clinical Studies include basic science, population-based and clinical trials research, complemented by collaborative relationships with top academic centers. Geisinger Ventures, the system's for profit entrepreneurial arm, seeks and promotes opportunities to speed the delivery of medical innovation to benefit patients.

Source: Geisinger Health System