Clinical evaluation of a novel 12-hole irrigated tip catheter ablation system for the treatment of typical atrial flutter—results from the Duo FLAIR clinical study

Abstract

Higher current density at the proximal end of a six-hole catheter is not irrigated and thus could lead to uneven heating and possibly coagulum and charring. This study tested a novel 12-hole irrigated catheter with six additional holes at the proximal end that provides more uniform cooling during atrial flutter (AFL) ablation. A total of 188 patients (28 females, 66 ± 11years) were treated for typical AFL at 22 sites in the USA and Canada using Cool Path Duo at 50W and 45°C at an irrigation rate of 13ml/min. The results were compared to historical data from an AFL study which used a six-hole catheter with similar design. A total of 2,725 RF lesions were applied in 188 patients with a mean RF duration of 18.2 ± 11.7min per procedure. Procedural success was achieved in 96.3% (181 of 188) acutely and 98.3% (173 of 176) patients at 3months. Steam pops occurred in 0.6% of lesions (15 of 2,725) without coagulum or charring… Compared to the six-hole irrigated tip catheter, the Cool Path Duo catheter delivered more power (33.8 ± 5.9 vs. 29.7 ± 5.2W, p < 0.0001) at a lower average tip temperature (34.7 ± 1.5 vs. 37.2 ± 2.1°C, p < 0.0001) with no statistical differences in either 3-month AFL recurrence or complications. Cool Path Duo™ irrigated tip catheter is safe and effective in treating typical AFL. When compared to a six-hole irrigated tip catheter, the Cool Path Duo catheter delivers more power at a lower temperature.