Nov. 21, 2001 PITTSBURGH, – The University of Pittsburgh Medical Center (UPMC) is one of nine centers in the United States to evaluate an experimental surgical "pen" for the treatment of the most common cardiac rhythm disorder, atrial fibrillation. UPMC is the second center in the United States to perform surgery using the Medtronic Cardioblateä RF Surgical Ablation System, a device that allows surgeons to "draw" lines on the heart's upper chambers, essentially creating a maze that blocks the irregular rhythms. To date, UPMC surgeons have performed the surgery in three patients.
Atrial fibrillation (AF) is an abnormal heart rhythm originating in the right and left atria. Rapid and chaotic beats, independent of the ventricles, cause patients to experience palpitations, dizziness, fatigue, chest discomfort and/or shortness of breath. Such inefficient pumping in the atria can cause blood flow to be sluggish, increasing the likelihood that clots will form that result in stroke.
AF affects more than 5.5 million worldwide. Its prevalence increases with age -- almost 70 percent with AF are between 65 and 85 years of age. More than a third of those affected are considered to have "chronic" AF and have failed medical treatments that include drugs and cardioversion techniques designed to restore normal rhythm.
The Cardioblate pen was designed to simplify an otherwise complicated and tedious surgical procedure to treat AF. While highly effective, few surgeons perform the surgery, called the Maze, because of its complexity; the surgery involves making more than 34 incisions on the inside surface of the atria and suturing these incisions to create a "maze" that interrupts the pathways of erratic electrical impulses. Using the Cardioblate pen, which at its tip delivers a cool irrigation fluid and radiofrequency energy, surgeons can "draw" lines, creating deep lesions or scars, instead of making incisions.
"With this device we think we can achieve the same effect as with the traditional Maze procedure. And without the tedious cutting and sewing, the pen allows us to draw the same sort of pattern, but in less than 15 minutes. Importantly, as with the traditional Maze operation, the surgeon has access to the left atria, where most of the irregular impulses originate. Outpatient ablation techniques can only address problems in the right atrium," said Marco A. Zenati, M.D., assistant professor of surgery, division of cardiothoracic surgery, University of Pittsburgh School of Medicine, and principal investigator for the Pittsburgh study. Dr. Zenati is among only 10 or so surgeons in the United States trained to perform the modified Maze with the Cardioblate pen.
Currently, use of the device is limited to those who meet criteria for entry into the study as well as to those who require cardiac surgery to correct another heart problem besides AF.
Medtronic expects data of the U.S. study, as well as data collected in Europe, to lead to approval of the device by the U.S. Food and Drug Administration (FDA) early next year. Approval would mean the device would be indicated for patients with AF.
"FDA approval will allow us to treat patients with AF as their only heart problem. It will also allow us to further develop the procedure to be done minimally invasively as well as on a beating heart, without the use of a heart/lung machine," said Dr. Zenati, who is working with Medtronic to develop the next generation of technology.
"To be able to offer a surgical treatment for patients adds to our armamentarium of options for this complicated yet common cardiac problem, " said David Schwartzman, M.D., associate professor of medicine, Cardiovascular Institute, and director of the UPMC Health System's Atrial Arrhythmia Center. Dr. Zenati is the center's co-director.
UPMC's Atrial Arrhythmia Center is the only center in which a cardiologist and a cardiac surgeon work collaboratively to individualize and combine therapeutic strategies for all types of atrial arrhythmias, including AF. In addition, it is the only center in the region that uses radiofrequency catheter ablation, an outpatient procedure, to treat AF as well as the only one to implant a pacemaker-like device specifically designed to treat AF. UPMC has the world's largest experience implanting this device.
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