Objectives Contact force-sensing catheters allow real-time catheter-tissue contact force monitoring during atrial fibrillation. These catheters were rapidly adopted into clinical practice following market introduction in 2014, but concerns have been raised regarding collateral damage such as esophageal injury. We sought to examine whether the introduction of force-sensing catheters was associated with a change in short-term and intermediate-term acute care use, complications and mortality following atrial fibrillation ablation. Design Retrospective cohort analysis. We used inverse probability treatment weight matching to account for the differences in baseline characteristics between groups. Setting We examined patients included in the OptumLabs Data Warehouse who underwent ablation for atrial fibrillation before (2011-2013) and after (2015-2017) the market introduction of contact force-sensing catheters. Main outcome measures We examined 30-day and 90-day rates of all-cause acute care use, including hospitalizations and emergency department visits, as well as death and hospitalization for catheter-related complications, including atrioesophageal fistula, pericarditis, cardiac tamponade/perforation and stroke/transient ischemic attack. Results Our sample included 3470 and 5772 patients who underwent atrial fibrillation (AF) ablation before and after market introduction of contact force-sensing catheters, respectively. Complication rates were low and did not differ between the two periods (p>0.10 for each outcome). The 30-day and 90-day mortality was 0.1% and 0.3%, respectively after market introduction and unchanged from prior to 2014. The 90-day rates of all-cause acute care use decreased, from 27.0% in 2011-2013 to 23.9% in 2015-2017 (p<0.001). Conclusions AF ablation-related catheter complications and mortality are low and there has been no significant change following the introduction of force-sensing catheters.
|Original language||English (US)|
|Journal||BMJ Surgery, Interventions, and Health Technologies|
|State||Published - Dec 29 2020|
- ablation devices
- real world evidence
ASJC Scopus subject areas
- Biomedical Engineering