biosense webster

Texas Cardiac Arrhythmia Institute (TCAI) at St.David’s Medical Center is the first facility in the US to use Biosense Webster’s ThermoCool SmartTouch catheter, following its US Food and Drug Administration (FDA) approval in February.

On February 26 Dr Andrea Natale, cardiac electrophysiologist and executive medical director of TCAI, performed the first procedure using the catheter.

TCAI was also part of the clinical trial which was designed to evalaute the use of the ThermoCool SmartTouch catheter to treat atrial fibrillation, a common heart rhythm disorder.

The catheter is designed to enhance the physician’s ability to more precisely control the amount of contact force applied to the heart wall during radiofrequency catheter ablation procedures.

Dr Natale said: "Previously, during catheter ablation, it was difficult for physicians to determine whether or not they were maintaining good contact with the tissue

"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."

Catheter ablation is a minimally invasive procedure in which physician threads 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), radiofrequency energy is delivered to the heart wall to create lesions that block faulty electrical impulses that can cause heart rhythm disorders.

"Knowing how much pressure you are applying against the heart wall results in the creation of better lesions."

The use of contact force-sensing technology has emerged as a critical tool in delivering optimal outcomes in the treatment of patients with atrial fibrillation and represents a major advancement for the clinical community.

The clinical data from the SMART-AF Trial demonstrated that consistent and stable application of contact force has a significant impact on patient outcomes. The one-year data from the trial showed a 74% overall success rate with the ThermoCool SmartTouch device.

The success rate rose to 88% when physicians stayed within a targeted range at least 85% of the time.

Around 3 million people in the US suffer from atrial fibrillation, a progressive disease that increases in severity and frequency if left untreated and can lead to chronic fatigue, congestive heart failure and stroke.

Only half of the estimated patients are able to control their abnormal heart rhythm with drugs.

The American College of Cardiology and the American Heart Association suggest catheter ablation as a safe and effective treatment option, when medication proves to be unsuccessful.


Image: The first facility in the US to use FDA-approved ThermoCool SmartTouch catheter. Photo: courtesy of Biosense Webster /Business Wire.