Texas Cardiac Arrhythmia Institute at St. David’s Medical Center Part of Clinical Trial to Study Device, Leading to FDA Approval in February
AUSTIN, Texas — On Feb. 26, 2014, the Texas Cardiac Arrhythmia Institute (TCAI) at St. David’s Medical Center became the first facility in the United States to use the ThermoCool® SmartTouch® Catheter after it was approved by the U.S. Food and Drug Administration (FDA) this month. The procedure was performed by Andrea Natale, M.D., F.H.R.S., F.A.C.C., F.E.S.C., cardiac electrophysiologist and executive medical director of TCAI. TCAI was also part of the clinical trial to study the use of the ThermoCool SmartTouch Catheter to treat Atrial Fibrillation, or A Fib, a common heart rhythm disorder.
The ThermoCool SmartTouch Catheter enables doctors to accurately control the amount of contact force applied to the heart wall during radiofrequency catheter ablation procedures. This can increase the effectiveness and safety of the procedure for patients.
“Previously, during catheter ablation, it was difficult for physicians to determine whether or not they were maintaining good contact with the tissue,” Dr. Natale said. “Maintaining close contact with the tissue and knowing how much pressure you are applying against the heart wall results in the creation of better lesions and ultimately means better outcomes for the patients.”
During a minimally invasive catheter ablation procedure, doctors insert a therapeutic catheter through a small incision in the groin, where it is then guided up to the heart through a blood vessel. Once it reaches the left upper chamber of the heart (atrium), the catheter delivers radiofrequency energy to the heart wall to create lesions that block faulty electrical impulses that can cause heart rhythm disorders. Providing doctors with the ability to apply stable contact force during catheter ablation has been shown to improve patient outcomes, as poor tissue contact force may result in incomplete lesion formation that could result in the need for additional treatment, and too much contact force may damage the tissue.
One-year results from a clinical trial that studied the safety and effectiveness of the device showed that patients experienced a 74 percent success rate after treatment with the ThermoCool SmartTouch Catheter. Importantly, data from the trial showed higher success rates the longer physicians stayed within a targeted contact force range, with one-year results demonstrating an 88 percent success rate when physicians stayed within a targeted range 85 percent of the time or more.
An estimated 3 million Americans suffer from A Fib, a progressive disease that increases in severity and frequency if left untreated. Left untreated, A Fib can lead to chronic fatigue, congestive heart failure and stroke. While most A Fib patients today are treated with drugs, about half of patients are not able to control their abnormal heart rhythm with drugs or find they cannot tolerate the side effects. When medication proves to be unsuccessful, the American College of Cardiology and the American Heart Association suggest catheter ablation as a safe and effective treatment option. Clinical studies show that success rates for A Fib treatments such as catheter ablation decrease the longer the disease is left untreated, so early intervention is recommended.
Texas Cardiac Arrhythmia Institute
Texas Cardiac Arrhythmia Institute (TCAI) at St. David’s Medical Center is one of the world’s preeminent centers dedicated to the latest treatment advances for correcting abnormal heart rhythms such as Atrial Fibrillation (A Fib). The center is led by Executive Medical Director Andrea Natale, M.D., a world-renowned expert in the field. Natale is at the forefront of advancing treatment for A Fib, leading numerous clinical trials and participating in the development of new technologies and procedures. For more information, please visit TCAInstitute.com.
St. David’s Medical Center
St. David’s Medical Center is part of St. David’s HealthCare, one of the largest health systems in Texas, which was recognized in January 2012 as one of the top 15 health systems in the U.S. by Thomson Reuters, a leading provider of information and solutions to improve the cost and quality of healthcare. Founded in 1924, St. David’s Medical Center is a full-service medical center offering comprehensive medical care at three locations—St. David’s Medical Center, located at 919 East 32nd Street in Austin; Heart Hospital of Austin, located at 3801 North Lamar Blvd.; and St. David’s Georgetown Hospital, located in Georgetown at 2000 Scenic Drive. The three campuses offer a full range of medical specialties, as well as many other innovative healthcare services.
St. David’s Medical Center in central Austin includes a 350-bed acute care hospital and a 64-bed rehabilitation hospital providing comprehensive inpatient and outpatient care. St. David’s Medical Center is also home to NeuroTexas Institute and the internationally renowned Texas Cardiac Arrhythmia Institute. The hospital provides a complete range of women’s services, including its acclaimed maternity unit, maternal-fetal medicine, a high-risk maternal and neonatal transport team, the region’s largest and most sophisticated Neonatal Intensive Care Unit and The Breast Center; a fertility center; complex surgical services; a comprehensive Bariatric Surgery Center; and a 24-hour emergency department.
St. David’s Medical Center was named among the nation’s 100 Top Hospitals by Truven Health Analytics (formerly Thomson Reuters) for four consecutive years, from 2010 to 2013. In October 2012, Truven Health Analytics also named St. David’s Medical Center to the list of 50 Top Cardiovascular Hospitals. The hospital earned a national distinction for patient safety from The Leapfrog Group, an independent national nonprofit run by employers and other large purchasers of health benefits, in 2012 and 2013. For more information, please visit StDavids.com.