Aims: This study aimed to evaluate feasibility and safety as well as 1-year clinical outcome of pulmonary vein isolation (PVI) using a unique radiofrequency ablation catheter ("Thermocool SmartTouch SurroundFlow"; STSF) incorporating both, contact force (CF) sensing technology and enhanced tip irrigation with 56 holes, in one device.
Methods: A total of 110 patients suffering from drug-refractory atrial fibrillation underwent wide area circumferential PVI using either the STSF ablation catheter (75 consecutive patients, study group) or a CF catheter with conventional tip irrigation ("Thermocool SmartTouch", 35 consecutive patients, control group). For each ablation lesion, a target CF of ≥ 10-39 g and a force time integral (FTI) of > 400 g s was targeted.
Results: Acute PVI was achieved in all patients with target CF obtained in > 85% of ablation points when using either device. Mean procedure time (131.3 ± 33.7 min in the study group vs. 133.0 ± 42.0 min in the control group; p = 0.99), mean fluoroscopy time (14.0 ± 6 vs. 13.5 ± 6.6 min; p = 0.56) and total ablation time were not significantly different (1751.0 ± 394.0 vs. 1604.6 ± 287.8 s; p = 0.2). However, there was a marked reduction in total irrigation fluid delivery by 51.7% (265.52 ± 64.4 vs. 539.6 ± 118.2 ml; p < 0.01). The Kaplan-Meier estimate 12-month arrhythmia-free survival after the index procedure following a 3-month blanking period was 79.9% (95% CI 70.4%, 90.4%) for the study group and 66.7% for the control group (95% CI 50.2%, 88.5%). This finding did not reach statistical significance (p = 0.18). Major complications occurred in 2/75 patients (2.7%; one pericardial tamponade and one transient ischemic attack) in the study group and no patient in the control group (p = 18).
Conclusion: PVI using the STSF catheter is safe and effective and results in beneficial 1-year clinical outcome. The improved tip irrigation leads to a significant reduction in procedural fluid burden.
Keywords: Atrial fibrillation; Catheter ablation; Contact force.