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 SMART-AF and SMART-SF 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 SMART-AF 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 SMART-AF 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 August 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.
(Source: PR Newswire)
