Initial clinical results with the ThermoCool® SmartTouch® Surround Flow catheter

Area of Science:

• Electrophysiology
• Cardiovascular Medicine
• Medical Device Technology

Background:

• The Biosense Webster ThermoCool® SmartTouch® Surround Flow (STSF) catheter, introduced in May 2015, replaced the ThermoCool® SF catheter.
• The STSF catheter features Surround Flow (SF) technology for enhanced cooling and integrated force sensing for precise tissue contact quantification.

Purpose of the Study:

• To compare the safety and efficacy of the novel STSF catheter against the previously used SF catheter.
• To evaluate the performance of the STSF catheter in a prospective cohort of 100 ablation procedures.

Main Methods:

• Prospective data collection for 100 STSF catheter procedures.
• Matched case-control analysis comparing STSF procedures with 100 SF catheter procedures from a database of 654.
• Matching criteria included procedure type, operator experience, patient age, and gender.

Main Results:

• Shorter fluoroscopy duration in the STSF group (mean 25.8 min vs. 30.0 min, P=0.03).
• No complications occurred with the STSF catheter, versus two complications (pericardial effusion, permanent pacing) in the SF group.
• The composite endpoint of procedure failure or acute complication was significantly lower in the STSF group (2 vs. 8, P=0.05).
• Complete procedural success was high in both groups (98% STSF vs. 94% SF, P=0.15).

Conclusions:

• The STSF catheter is a safe and effective tool for treating various cardiac arrhythmias.
• The STSF catheter demonstrates a trend towards an improved safety-efficacy profile compared to the SF catheter.