August 20, 2016
AUSTIN, Texas—On Aug. 31, 2016, 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® SF Catheter after it was approved by the U.S. Food and Drug Administration (FDA) earlier 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® SF Catheter to treat Atrial Fibrillation, or A Fib, a common heart rhythm disorder.
The THERMOCOOL SMARTTOUCH® SF 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.
During catheter ablation, doctors insert a therapeutic catheter through a small incision in the groin, where it is then weaved up to the heart through a blood vessel. Once it reaches the left upper chamber of the heart (atrium), radiofrequency energy is delivered 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. Too much contact force may damage the tissue.
“The THERMOCOOL SMARTTOUCH® SF Catheter represents a significant advancement for the clinical community,” Dr. Natale said. “Numerous trials, including the SMARTAF and SMARTSF studies, have proven that this technology enables physicians to achieve targeted stability in the defined contact force range, leading to shorter procedure times and enhanced results without compromising safety.”
The THERMOCOOL SMARTTOUCH® SF Catheter is the only approved device pairing contact force technology with a porous tip designed to optimize efficiency by providing uniform cooling at half the flow rate of earlier generation irrigated catheters, easing the fluid management process.
The catheter is seamlessly integrated with the CARTO® 3 System, which combines contact force technology, 3D mapping, and advanced navigation capabilities to provide active measurement of stable contact force and catheter tip location.
Clinical data have proven the safety of the device when used to treat drug refractory paroxysmal A Fib. The SMARTAF trial, a multicenter, prospective study of the earlier generation THERMOCOOL SMARTTOUCH® technology, revealed no unanticipated adverse events and demonstrated a success rate of greater than 80 percent, with increased stability within the contact force range. The more recent SMART SF study, which tested the newest generation THERMOCOOL SMARTTOUCH® SF Catheter, demonstrated excellent safety results as well. The study found an 18.7 percent reduction in overall procedure time and a 14.2 percent reduction in overall ablation time when compared to the SMARTAF study. It also demonstrated a 55.2 percent reduction in total fluoroscopy time, limiting radiation exposure to patients.
The THERMOCOOL SMARTTOUCH® SF Catheter, manufactured by Biosense Webster, was approved by the FDA for use in the U.S. on Aug. 15, 2016.
A Fib is the most prevalent heart rhythm disorder and a leading cause of stroke among people 65 years and older. An estimated 3 million people in the United States and 20 million worldwide are affected by A Fib, and its prevalence is projected to increase significantly as the population ages. A Fib is a progressive disease and increases in severity and frequency as patients get older. Left untreated, it can lead to heart valve disease, sleep apnea, chronic fatigue, congestive heart failure and stroke. Public health implications of A Fib are a growing concern because those with A Fib are at an increased risk of morbidity and mortality, as well as a reduced quality of life. The disorder is estimated to be responsible for 88,000 deaths each year.
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. TCAI is part of St. David’s HealthCare, one of the largest health systems in Texas, which was recognized with a Malcolm Baldrige National Quality Award in 2014.
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 2014 with a Malcolm Baldrige National Quality Award. 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, Heart Hospital of Austin and St. David’s Georgetown Hospital.
Located in central Austin, St. David’s Medical Center includes a 350-bed acute care hospital and a 64-bed rehabilitation hospital providing comprehensive inpatient and outpatient care. It is home to the internationally renowned Texas Cardiac Arrhythmia Institute and St. David’s Neuroscience & Spine 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; complex surgical services; a comprehensive Bariatric Surgery Center; and a 24-hour emergency department.
St. David’s Medical Center was recently ranked among the top hospitals in the nation by earning a five-star rating by the Centers for Medicare and Medicaid’s (CMS) new Overall Hospital Quality Star Rating system, and it was named among the nation’s 100 Top Hospitals by Truven Health Analytics from 2010 to 2016. Truven also named St. David’s Medical Center to the list of 50 Top Cardiovascular Hospitals in 2013, 2015 and 2016. The hospital earned a national distinction for patient safety from The Leapfrog Group from 2012 to 2016, and it received the 2016 Distinguished Hospital Award for Clinical Excellence from Healthgrades for the fifth consecutive year, as well as Healthgrades’ 2016 America’s 100 Best Hospitals Award™ for the second consecutive year.