Evaluating the dual-energy Thermocool SmartTouch SF catheter in the treatment of atrial fibrillation.
Abstract
Background
The Dual-Energy THERMOCOOL SMARTTOUCH® SurroundFlow (DE STSF) catheter combines radiofrequency (RF) and pulsed field ablation (PFA) within a single contact force-sensing, irrigated-tip focal platform, fully integrated with the CARTO® 3 three-dimensional mapping system.
Methods
We reviewed available preclinical and clinical evidence on the DE STSF catheter, including the first-in-human SmartfIRE trial and supporting preclinical studies.
Results
Preclinical data established comparable lesion durability between focal PF and RF ablation, superior scar maturity with PFA, a validated PF ablation index based on contact force and pulse count, and synergistic lesion depth enhancement with sequential RF+PFA delivery. In the SmartfIRE study (n = 149, 9 European centers), acute procedural success was 100%, with no atrio-esophageal fistula, phrenic nerve palsy, or stroke reported. Freedom from atrial arrhythmia recurrence at 12 months reached 71.5% overall and 86.9% in patients treated with high adherence to the dual-index guided workflow.
Conclusion
The DE STSF catheter offers a clinically flexible, index-guided dual-energy approach with a favorable safety profile and promising mid-term efficacy, although this evidence derives from a single-arm study lacking randomized or head-to-head comparative data and should be considered hypothesis-generating. Evidence remains limited to paroxysmal AF, and dedicated comparative studies in persistent AF and ventricular arrhythmias are warranted.