Safety of Catheter Ablation for Atrial Fibrillation Using Fiber Optic Based Contact Force Sensing.

While the body of evidence showing the benefit of contact force (CF) sensing catheters in improving AF ablation success rate is growing, real-world safety data of this technology are limited.The aim of this study is to report the complication rate in patients undergoing ablation using one specific CF sensing catheter (TactiCath™Quartz Contact Force Ablation Catheter (Abbott, St Paul, MN)) in a large worldwide database.- User-reported adverse event data from January 2014 - December 2015 was reviewed for the ablation catheter. These adverse events included cardiac perforation, cerebrovascular accident (CVA), atrio-esophageal (AE) fistula, steam pop, and death. Rates of these adverse events, including geographic and temporal relationships were calculated.- Adverse events were reported in a total of 178 patients out of 41,709 cases (adverse event rate 0.427%). Adverse events included: 117 (0.281%) cardiac perforations, 5 (0.012%) CVA, 10 (0.024%) AE fistulas, 53 (0.127%) audible steam pops, and 13 (0.031%) deaths. The total event rate in European countries was 0.53% vs. 0.38% in the US (P = 0.0082). The AE fistula event rate peaked in late 2014 and early 2015 at 0.06% and decreased over time to a steady-state 0.01%, corresponding with the initial US release, subsequent increased use, and training regarding the manufacturer recommended settings.- Complication rates while using TactiCath CF Ablation Catheter appear to decrease with training and experience. The major complication rate associated with this technology is low in the context of similar reports of conventional RF catheters.