Rahul Bhardwaj, Aditi Naniwadekar, William Whang, Alexander J Mittnacht, Chandrasekar Palaniswamy, Jacob S Koruth, Kamal Joshi, Aamir Sofi, Marc Miller, Subbarao Choudry, Srinivas R Dukkipati, Vivek Y Reddy

The goal of this study was to determine the safety and feasibility of a novel esophageal balloon retractor (DV8) for MED during PVI. The authors previously showed that mechanical esophageal deviation (MED) is feasible using an off-the-shelf metal stylet to allow uninterrupted ablation along the posterior left atrium during pulmonary vein isolation (PVI). Although it is an attractive strategy to avoid esophageal thermal injury, this technique was hampered by both the propensity for oropharyngeal trauma from the stiff stylet and the limited lateral esophageal displacement. In 200 consecutive patients undergoing atrial fibrillation ablation, the DV8 balloon retractor was used for MED; contrast was instilled into the esophagus to accurately delineate the trailing esophageal edge. Deviation was performed to maximize the distance from the trailing esophageal edge to the closest point of the ablation line (MEDEffective) and correlated to occurrences of luminal esophageal temperature elevation. In patients undergoing MED during a first-ever PVI of 304 vein pairs, the MEDEffective during right and left PVI were 21.2 ± 8.7 mm and 15.5 ± 6.8 mm, respectively. Deviation of at least 5 mm of MEDEffective was achievable in 97.7%. Luminal esophageal temperature increases universally occurred (100%) at MEDEffective <5 mm, less often (28%) at MEDEffective 5 to 20 mm, and rarely (1.9%) at MEDEffective >20 mm. There were no esophageal complications, but 2 patients experienced oropharyngeal bleeding due to trauma related to device placement. MED with the balloon retractor safely moved the esophagus away from the site of energy delivery during atrial fibrillation ablation.