October 20, 2004
Contact: Bob Beard
(434) 982-4490
U. Va. Health System First to Implant Frontier™ II Pacemaker
Only FDA-Approved Device to Synchronize Left and Right Heart Ventricles
The University of Virginia Health System has implanted the first Frontier™ II bi-ventricular pacemaker in the U.S. to treat heart failure and atrial fibrillation (A-fib), the most common type of abnormal heart rhythm. Manufactured by St. Jude Medical, Inc., St. Paul, Mn. (NYSE: STJ), the Frontier II Model 5586 (and previously released Frontier™) is the only FDA-approved device that synchronizes the left and right ventricles (biventricular pacing) in patients with A-fib and NYHA Class II or III heart failure (HF) who undergo AV nodal ablation.
“The nodal ablation procedure combined with the sophisticated pacing technology in this new device may enhance the lives of thousands of patients with cardiomyopathies and atrial fibrillation,” said Dr. J. Michael Mangrum, assistant professor of internal medicine and director of the UVa Atrial Fibrillation Center, who performed the ablation and installed the pacemaker in Mary Jo Crisman of Edinburg, Va. “This device paces, or synchronizes, both right and left ventricles of the heart simultaneously. Pacing the right ventricle alone can worsen heart failure in patients like Ms. Crisman,” he said.
Cardiomyopathy causes an enlarged heart that does not work efficiently. A-fib causes the top chambers of the heart, the atria, to quiver at a high rate.
Patients receiving the new Frontier II must first undergo cardiac ablation, in which a catheter is threaded from the groin to the heart. Part of the heart muscle, called the AV node, is burned with electrical energy, slowing the heart’s rate. AV nodal ablation is usually recommended when rapid, unsynchronized heart rhythms cannot be pharmacologically managed.
Crisman said that her cardiomyopathy and A-fib left her exhausted, full of fluid, and sometimes depressed. An office manager of the Farmer’s Livestock Exchange in Winchester, Va., Crisman said she returned to work two days after undergoing the procedures. She said that she is now breathing easier, and that some of the fluid is gone.
“UVa’s Atrial Fibrillation Center is a worldwide leader in the research and development of techniques to treat A-fib and heart failure,” said Mangrum. “We are proud that St. Jude Medical chose
Jude Medical chose UVa as the site for the first U.S. implant of its latest biventricular device.”
About 2.2 million people in the U.S suffer from atrial fibrillation, according to the American Heart Association, making it the most common type of abnormal heart rhythm. There are 160,000 new cases diagnosed every year. Symptoms can last for days and usually include:
- heart palpitations
- lack of energy
- dizziness
- chest discomfort
- shortness of breath
A-fib is associated with a two-fold increase in mortality. The condition can also cause strokes from blood clots dislodging from the atrium and traveling to the brain.
UVa was among the first academic medical centers in the U.S. to perform a special type of cardiac ablation to eliminate A-fib. Over 100 of these special procedures were performed at UVAHS in 2003. Other treatments for A-fib are medications, implantable devices and surgery. For more information on the Frontier II device, check the FDA’s website: http://www.fda.gov/cdrh/mda/docs/p030054.html or www.sjm.com.
Approximately 37,000 AV nodal ablation (ablate and pace) procedures were performed in the U.S. in 2003. According to Health Research International, that number is expected to nearly double in the next five years.
About the University of Virginia Health System
The University of Virginia Health System, Charlottesville, Va., ranks among the top medical research facilities in the U.S., with 23 medical research centers, more than 611 physicians, and four components: The U. Va. Medical Center, the U. Va. School of Medicine, the U. Va. School of Nursing and the Claude Moore Health Sciences Library.
Nine U. Va. medical specialties were ranked in U.S. News & World Report's 2004 edition of "America's Best Hospitals:" endocrinology (hormonal disorders) (5); ear nose and throat (18); urology (19); digestive disorders (24); gynecology (27); cancer (32); orthopedics (33); neurology and neurosurgery (37); and kidney disease (49). Web site: www.uvahs.com.
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