Introduction: Contact-force sensing (CF) radiofrequency (RF) ablation catheters allow direct real-time assessment of contact force between catheter tip and cardiac tissue. This technology has the potential to improve both efficacy and safety of RF ablation. Recently published analysis of the Manufacturer and User Facility Device Experience (MAUDE) database, however, showed that 5.4% (65 of 1202) of all adverse event reports for CF sensing catheters used in atrial fibrillation (AF) ablation involved atrio-esophageal fistulas (AEF), versus only 0.9% (13 of 1487) of all adverse event reports for non-CF sensing (NCF) catheters. To further characterize this phenomenon, we performed a systematic meta-analysis of complications reported between CF and NCF catheters used in AF ablation and compared this data to the MAUDE database.
Methods: Twenty-two published studies comparing the rates of complications between CF and NCF catheters during AF ablation were included in this systematic meta-analysis. Randomized and non-randomized observational studies comparing ablation of AF with CF and NCF catheters were identified using the Cochrane Library, EMBASE, and PubMed. This data was compared with the MAUDE database.
Results: A total of 22 studies were identified (n=4,122). There were 138 complications, 53 (3.15%) in the CF arm and 85 (3.49%) in the NCF arm. There were no significant differences in the rates of pericardial effusion (OR 0.78, 95% 0.36-1.72), pericarditis (2.07 [0.39-10.98]), cardiac tamponade (0.92 [0.44-1.93]), groin-related complications (0.99 [0.54-1.83]), phrenic nerve palsy (0.62 [0.10, 3.82]) or AEF (0.66 [0.03-16.38]). One AEF event was reported and occurred in the NCF sensing arm.
Conclusions: We found no statistically significant difference in complications between CF and NCF catheters used in AF ablation. Amongst published clinical trials, there were no AEF complications reported using CF catheters. However, AEF accounted for 5.4% of all adverse event reports associated with CF catheters in the MAUDE database. This discordance suggests a disparity between published and actual complication rates of CF catheters. Our study highlights the need for creation of a national registry to assess device-specific AF ablation complications.