PO-02-076 AN INVESTIGATION OF LESION EFFICACY AND SAFETY WITH THE TACTIFLEX™ SE ABLATION CATHETER

Treatment of cardiac arrhythmias by the creation myocardial lesions utilizing RF current is well established as an effective mode therapy in clinical electrophysiology laboratory. Efficacy, however, should be evaluated concert with safety considerations, passive resistance tissue creates heating that can lead to adverse events (e.g., steam pops). A bench top bovine model allows for comparative testing ablation TactiFlex™ SE Ablation Catheter (test device) and a commercially available solid-tip catheter uniform irrigation profile (control device), analyzed respect both efficacy safety. To generate statistics lesion dimension (maximum width depth) pop likelihood control designs. In this model, recently harvested ventricles were sectioned placed body-temperature saline solution (∼37oC). holding fixture was contact at predefined force using independent gauge. energy applied tissue; (N=288 trials) created three different power levels (30W 30s or 50s, 40W 12s 20s, 50W 6s 10s), occurrences noted. Applied fixed either 5g 20g. After ablation, stained 1% Triphenyltetrazolium chloride (TTC). Lesions measured maximum depth. linear regression depth vs. design, power, duration, orientation. The trials did not result significantly widths between designs (p = 0.137); refer Figure 1 dimensions duration. Trials yielded shallower (p=0.018) compared device, but bias only 0.2mm. Logistic demonstrated pops less likely (p=0.002). Steam occurred 1.4% (2/144 versus 9.7% design (14/144 trials). are clinically similar size those significant reduction likelihood.