BACKGROUND: While the body of evidence showing the benefit of contact force (CF)–sensing catheters in improving atrial fibrillation ablation success rate is growing, real-world safety data of this technology are limited.
OBEJCTIVE: The aim of this study was to report the complication rate in patients undergoing ablation using a specific CF-sensing catheter (TactiCath Quartz CF ablation catheter, Abbott, St. Paul, MN) in a large worldwide database.
METHODS: User-reported adverse event data from January 1, 2014 to December 31, 2015 were reviewed for the ablation catheter. These adverse events included cardiac perforation, cerebrovascular accident, atrioesophageal (AE) fistula, steam pop, and death. Rates of these adverse events, including geographic and temporal relationships, were calculated.
RESULTS: Adverse events were reported in 178 of 41,709 patients (adverse event rate 0.427%). Adverse events included 117 cardiac perforations (0.281%), 5 cerebrovascular accidents (0.012%), 10 AE fistulas (0.024%), 53 audible steam pops (0.127%), and 13 deaths (0.031%). The total event rate in European countries was 0.53% vs 0.38% in the United States (P = .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 to the initial US release, subsequent increased use, and training on the manufacturer recommended settings.
CONCLUSION: Complication rates while using the 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 radiofrequency catheters.