Abstract
Background: The aim of this study was to evaluate the ‘real-world’ impact of a novel contact force-sensing catheter (SmartTouch, Biosense Webster, USA) coupled with an advanced catheter location system (ACL) which essentially allows visualisation of the catheter shaft and hence orientation. The impact of this technology on procedure time, fluoroscopy time and fluoroscopy dose was assessed for cathter ablation of atrial fibrillation (AF). Methods: This was an observational cohort study of prospectively collected data for 1441 consecutive patients undergoing paroxysmal (PAF) and persistent AF (PerAF) ablation at a single institution between 2009 and 2014. All procedures involved pulmonary vein isolation, with additional targeting of fractionated potentials and/or linear ablation for persistent AF. Patients undergoing AF ablation with the SmartTouch catheter and ACL (SmartTouch group, n=510) were compared to those undergoing AF ablation without this technology (Control group, n=1005). The primary outcomes were fluoroscopy time (min) and fluoroscopy dose as measured by dose area product (mGycm2). Secondary endpoints included procedure time, total ablation time, and major cardiac complications (focusing on sequelae of cardiac perforation i.e. tamponade). Results: The SmartTouch group had significantly lower fluoroscopy times (9.5 min vs. 41 min, p<0.001), radiation doses (1044 mGycm2 vs. 3571 mGycm2, P<0.001) and shorter procedure time (195min vs. 240min, P<0.001) compared to Controls. This was statistically significant across all sub-groups including both PAF and PerAF ablations and for both de novo and redo AF procedures. To examine whether fluoroscopy times were already reducing due to other technology advancements, the 500 cases were compared before and after the introduction of SmartTouch/ACL. This showed thatfluoroscopy times were already decreasing at a rate of approximately 4-19% per year (P<0.001) before SmartTouch/ACL was introduced. However, after the introduction of the technology, there was a significant 37% reduction in fluoroscopy time in the first 100 SmartTouch procedures (P<0.001) followed by a further 35% reduction in the next 100 consecutive cases (P<0.001), followed by a further 46% decrease in the next 100 cases (P<0.001). Thereafter, the rate of fluoroscopy reduction did not change significantly and fluoroscopy time plateaued with a median fluoroscopy times of 3.5 min (IQR 6) for the final 200 procedures. There was no difference in the rate of cardiac tamponade which was static at approximately 1.5% each year in the study period. Conclusion: Use of SmartTouch contact force sensing catheters with ACL during catheter ablation of AF significantly reduces fluoroscopy times by 77%, radiation dose by 71% and procedural time by 19%, but does not improve overall safety in terms of the risk of tamponade.
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