A study, published online ahead of print in Pacing and Clinical Electrophysiology (PACE), concluded that using Hansen Medical, Inc.'s Sensei® Robotic System with the Thermocool® SmartTouch® Catheter (BioSense Webster, Diamond Bar, CA) for persistent atrial fibrillation is associated with statistically significant improved success rates when compared with manual ablation with Thermocool SmartTouch.
The study found that a combination of remote robotic navigation (RRN), using Sensei, and catheter-based contact force sensing (CFS) using Thermocool SmartTouch, is associated with improved 12 month success rates (64% versus 36%, p=0.01) and shorter fluoroscopy times (41% reduction, p < 0.0005) than Manual/CFS ablation. There were no significant differences in rates of major or minor complications or procedure time.
"Prior research has shown that adequate contact between the catheter tip and heart tissue during ablation leads to improved patient outcomes," said lead investigator Prof. Richard Schilling, M.D., FRCP, Barts Health NHS trust, London. "Results from our study found ablation with Sensei to be associated with higher and more stable contact force. These are very compelling data for Sensei, as it translated to significant benefit for patient outcomes compared with manual ablation."
Prof. Richard Schilling and his colleagues conducted the study to compare remote robotic navigation, using Sensei, and Manual CFS ablation. Investigators performed a retrospective analysis of 200 patients with persistent atrial fibrillation across six hospitals in the United Kingdom and South Africa.
"These are very promising results for Sensei," said Cary Vance, President and Chief Executive Officer of Hansen Medical. "Hansen's vision is to develop technology that enables physicians to deliver enhanced patient care, and we are excited about Sensei's potential to improve patient outcomes for ablation procedures."
Cardiac arrhythmias are abnormal electrical signals in the heart. Atrial fibrillation is the most common form of cardiac arrhythmia, affecting nearly 3 million people in the United States alone. In radiofrequency catheter ablation, a catheter is inserted into left atrium and radiofrequency energy is delivered to the heart tissue to create scars, which are intended to block erratic electrical impulses so the left atrium can beat normally.
Research has shown that the quality of scar tissue is based on a combination of the contact between the catheter tip and heart wall, the power of the applied radiofrequency energy, and the amount of time the energy is applied. The Thermocool SmartTouch contact force sensing ablation catheter provides an objective measure of contact for optimal lesion creation. The stability and precision of the Sensei catheter have the potential to improve contact between the catheter tip and heart wall.
About Sensei® X Robotic Catheter System
Sensei X Robotic Catheter System combines advanced levels of 3D catheter control and 3D visualization. This unique, state of the art technology has been used in over 14,000 patients, and is powered by a robotically controlled arm that allows for catheter navigation, stability and positioning within the patient's heart atria. The Sensei X Robotic Catheter System, control catheters and accessories are intended to facilitate manipulation, positioning and control of Hansen Medical's robotically steerable catheters for collecting electrophysiological data within the heart atria with electro-anatomic mapping and recording systems, using specified percutaneous mapping catheters. The Sensei System is powered by a robotically controlled arm that allows for catheter navigation and stability. The safety and effectiveness of this device for use with cardiac ablation catheters, in the treatment of cardiac arrhythmias including atrial fibrillation, have not been established.