Results:
A total of 43 patients underwent DV8 device placement. The primary
endpoint was reached in 42 patients (success rate 97.7%) with a mean
deviation distance of 15.3 ± 4.3 cm. Nine patients achieved a mean
deviation distance of ≥ 20 mm. There was no esophageal injury found
during the Barium swallowing tests. The incidence of PV reconnection
with adenosine, isoproterenol infusion, and waiting 30 minutes after
ablation was 23%. Mean fluoroscopy, total procedure, and ablation times
were 23 ± 6, 211 ± 32, and 53 ± 15 minutes, respectively. The median
follow-up time was 369 days. AF recurred in 9 patients during the
follow-up period (freedom from AF recurrence of 72.3%). None of the
patients had any long-term complications that were related to DV8 device
placement.
Conclusions: In this single-center prospective study, we report that use of the DV8
device for esophageal deviation during AF ablation is effective and
safe.