PO-01-119 CATHETER STABILITY ANALYSIS IN ABLATION OF PAROXYSMAL ATRIAL FIBRILLATION: IMPACT OF A NOVEL FLEXIBLE ELECTRODE TIP

Abstract

Catheter electrode stability is a key factor of a successful radiofrequency (RF) ablation lesion formation. Current techniques to enhance or monitor catheter stability include the use of steerable introducers, high-frequency jet ventilation, and the incorporation of objective lesion marker placement via Electroanatomic Mapping (EAM) Systems. In addition to automatic lesion marker placement, the EnSite™ AutoMark Module records catheter location during RF energy delivery, providing insight into catheter electrode stability during ablation. To demonstrate improved stability during ablation with a flexible laser cut tip electrode vs. a solid-6-hole electrode tip during de novo PVI ablation for the treatment of PAF and concomitant CTI-lines for the treatment of typical AFL. AutoMark™ ablation data gathered during the TactiFlex AF IDE NCT04356040 (flex tip catheter) and TactiSense IDE NCT03354663 (solid tip catheter) trials was analyzed (FIGURE). Both trials were prospective, non-randomized multicenter clinical studies which enrolled 355 and 150 subjects worldwide, respectively. PVI and CTI lesions from point-by-point ablation style operators with discrete lesions were included. Anatomic region assignment of each RF episode was accomplished using machine learning. Average distance and standard deviations of the ablation electrode movement from the mean positional centroid were calculated for each RF episode. Stability was evaluated as the percent of time during an RF episode where the ablation electrode remained within 2.5mm of the ablation lesion centroid. A total of 10285 flexible tip and 2141 solid tip RF episodes were analyzed from 112 and 21 cases, respectively. The average RF episode duration for the flexible tip and solid tip lesions, was 10.6 ± 4.8 and 17.1 ± 9.8 seconds, respectively. The flexible tip and solid tip catheters remained positionally stable within a 2.5 mm sphere for 85.3% ± 22.7 and 79.9% ± 26.1 of the RF episode duration, respectively, (p <0.001) (FIGURE). In the subset of lesions <10 seconds, the difference in stability was even more pronounced (TABLE). A flexible tip ablation catheter (TactiFlex™ SE) demonstrated greater stability than a solid tip ablation catheter (TactiCath™ SE) during ablation of atrial fibrillation and CTI-dependent atrial flutter. Greater stability during lesion formation may result in more durable lesions and better patient outcomes.Tabled 1Catheter# RF EpisodesRF Episode Duration, sec (SD)Mean (SD)Median [Q1, Q3]p-valueAll RF EpisodesFlexible Tip1028510.6 (4.8)85.3% (22.7)96.9% [79.9, 100]< 0.001Solid Tip214817.1 (9.8)79.9% (26.1)92.6% [66.7, 100]< 0.001RF Episodes < 10 secFlexible Tip43406.4 (2.8)85.0% (24.2)98.7% [80.7, 100]< 0.001Solid Tip5427.3 (2.3)73.6% (32.9)89.8% [51.7, 100]< 0.001Stability of a solid tip (TactiCath™ Contact Force Ablation Catheter, Sensor Enabled™) versus flexible tip (TactiFlex™ Contact Force Ablation Catheter, Sensor Enabled™), reported as the percent time the catheter tip remained within a 2.5 mm radius sphere. Open table in a new tab