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.