Co-Author(s):
Michael Andrawes, MD
Agnieszka Lesicka, MD
Grace Ha, MS
Kevin Heist, MD PhD
Dinxing Qin, MD
Kathryn Slattery, CRNA
Christopher Houghtaling, BS MA
Nathan Van Houzen, MD
Molly Campbell, DNP CRNA
Abraham Sonny, MD
Alexander Kuo, MD MS
Kenneth Shelton, MD
Jeremy Ruskin, MD
Adam Dalia, MD MBA
Michael Fitzsimons, MD
Moussa Mansour, MD
Massachusetts General Hospital
Cardiac Arrhythmia Service, Massachusetts General Hospital Bigelow Building 8 55 Fruit Street, Boston, MA, 02114
Introduction | Objectives: The DV8 probe (Minneapolis, Minnesota) consists of a shaped balloon that is inserted into the esophagus and inflated, which results in its deviation away from the left atrium. Prior studies have demonstrated that moving the esophagus by 1 cm away from the ablation location would result in significant reduction of esophageal heating. This study sought to evaluate the efficacy and safety of the DV8 tool in moving the esophagus.
Methods: This is a single center, open-label, single-arm study enrolling patients undergoing radiofrequency (RF) ablation for paroxysmal and persistent atrial fibrillation ablation (AF). The DV8 device was inserted at the beginning of the procedure. During pulmonary vein (PV) and posterior wall ablation, the DV8 balloon was inflated and deviated the esophagus to the contralateral side. The primary endpoint was the success rate of moving the closest edge of the esophagus by a minimum of 10 mm from the ablation line of the ipsilateral PV pairs. The secondary endpoints were the success rate of moving the esophagus by a minimum of 20 mm, the incidence of esophageal laceration as assessed by Barium swallow, incidence of PV reconnection 30 minutes after ablation, and procedure time.