Author + information
- Received December 5, 2017
- Revision received March 5, 2018
- Accepted April 5, 2018
- Published online May 30, 2018.
- Rahul Bhardwaj, MDa,b,
- Aditi Naniwadekar, MDa,
- William Whang, MDa,
- Alexander J. Mittnacht, MDa,
- Chandrasekar Palaniswamy, MDa,c,
- Jacob S. Koruth, MDa,
- Kamal Joshi, MDa,
- Aamir Sofi, MDa,
- Marc Miller, MDa,
- Subbarao Choudry, MDa,
- Srinivas R. Dukkipati, MDa and
- Vivek Y. Reddy, MDa,∗ ()
- aHelmsley Electrophysiology Center, Icahn School of Medicine at Mount Sinai, New York, New York
- bDepartment of Cardiology, Loma Linda University, Loma Linda, California
- cDepartment of Cardiology, University of California, San Francisco–Fresno, Fresno, California
- ↵∗Address for correspondence:
Dr. Vivek Y. Reddy, Helmsley Electrophysiology Center, Icahn School of Medicine at Mount Sinai, One Gustave L. Levy Place, Box 1030, New York, New York 10029.
Objectives The goal of this study was to determine the safety and feasibility of a novel esophageal balloon retractor (DV8) for MED during PVI.
Background We 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.
Methods 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.
Results 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.
Conclusions MED with the balloon retractor safely moved the esophagus away from the site of energy delivery during atrial fibrillation ablation.
Drs. Dukkipati, Mittnacht, and Reddy hold equity interest in Manual Surgical Sciences Inc. Dr. Dukkipati has also received research grants from Biosense Webster. Dr. Reddy holds equity interest (stock options) in Circa Scientific, Inc. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
All authors attest they are in compliance with human studies committees and animal welfare regulations of the authors’ institutions and Food and Drug Administration guidelines, including patient consent where appropriate. For more information, visit the JACC: Clinical Electrophysiology author instructions page.
- Received December 5, 2017.
- Revision received March 5, 2018.
- Accepted April 5, 2018.
- 2018 American College of Cardiology Foundation
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