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  1. Advancing Regulatory Science

Real world short and intermediate-term safety outcomes following atrial fibrillation ablation

CERSI Collaborators: Joseph Akar, MD, PhD, Peter Noseworthy, MD, Joseph Ross, MD, MHS, Lindsey Sangaralingham, MPH, Nilay Shah, PhD, Xiaoxi Yao, PhD

FDA Collaborators: Jun Dong, MD, Rebecca Ward, MPH

CERSI In-Kind Collaborators: University of Wisconsin School of Medicine- James Hummel, MD (Now at Yale Univ.), University of California, San Francisco- Sanket Dhruva, MD, MHS

Project Start Date to End Date: December 2017- December 2020

Regulatory Science Challenge

Atrial fibrillation (AF) is the most common sustained abnormal heart rhythm (arrhythmia) in humans and increases the risk of stroke, heart failure and other heart-related complications. Over the last two decades, catheter ablation, a minimally invasive surgery where heat or cold energy is delivered through the tip of a thin, flexible tube (called catheter) to destroy the heart issue responsible for the arrhythmia, has become an important treatment option in patients with AF. Its use has been rapidly increasing, especially with the introduction of new technology that allows for real-time monitoring of contact force between the ablation catheter and the heart tissue being treated and therefore more effective treatment. However, the “real-world” incidence of short- and intermediate-term complications following AF ablation is not well-characterized where contact force-sensing catheters are widely used. Moreover, there are concerns that the use of contact force-sensing catheters may increase certain procedural risks such as atrio-esophageal fistula – formation of an abnormal connection between the heart and the esophagus (food pipe) – which is a rare but deadly complication of an AF ablation procedure. It is widely believed that the diagnosis of atrio-esophageal fistula is often missed and/or underreported, and that the true incidence of atrio-esophageal fistula in the “real-world” is higher than the limited study data suggest.

Project Description and Findings

This project aimed to examine whether the introduction of force-sensing catheter technology was associated with a change in the short (30 days)- and intermediate (90 days)-term acute care use, complications and mortality following AF ablation, with an emphasis on the incidence of atrial-esophageal fistula. Adult patients included in a large US administrative claims database (OptumLabs Data Warehouse) who received ablation for AF between January 2011 and September 2017 were examined in a retrospective analysis. 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 atrio-esophageal fistula were compared among patients receiving ablation before (3470 patients) and after (5772 patients) market introduction of contact force-sensing catheters.

The analysis showed that complication rates were low and did not differ between the periods before and after market introduction of contact force-sensing catheters. The 30-day and 90-day mortality did not change, and the 90-day rates of all-cause acute care use decreased after introduction of force sensing technology. Moreover, there was no difference in 30-day and 90-day risk of atrio-esophageal fistula before and after market introduction of contact force-sensing catheters.


Catheter-related complications and mortality of atrial fibrillation ablation following introduction of contact force-sensing technology. Akar JG, Hummel JP, Yao, Sangaralingham L, Dhruva S, Dong J, Ward R, Shah ND, Ross J, Noseworthy PA. BMJ Surg Interv Health Technol. 2020 Dec 29; 2(1).


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