A novel device for ablation of abnormal esophageal mucosa (with video).

BACKGROUND

Current ablation devices for Barrett's esophagus are effective but have significant limitations.

OBJECTIVE

To evaluate a new ablation device.

DESIGN AND SETTING

Laboratory and animal model evaluation of the CryoBalloon, a compliant balloon that is simultaneously inflated and cooled by liquid nitrous oxide delivered by using a small, disposable, handheld unit.

INTERVENTION

Cryoablation of esophageal mucosa was performed in 11 swine. Multiple ablations were created in each animal at various ablation times.

MAIN OUTCOME MEASUREMENTS

Animals were euthanized at 4 days (n = 6) or 28 days (n = 5), and histological assessments were performed. At 4 days, the percentage of esophageal mucosa successfully ablated was measured. At 28 days, the circumference of the esophagus at the center of the ablation zone was measured to assess for stricture formation.

RESULTS

The CryoBalloon was simple to operate, and balloon contact with tissue was easily maintained. As the ablation time was increased from 6 to 12 seconds, the percentage of mucosa ablated increased from below 60% to above 90%. Maximal effect on the mucosa was reached at 12 seconds. Ablation of up to 14 seconds resulted in minimal luminal narrowing. As the ablation duration increased from 14 to 22 seconds, there was progressive stricture formation evident at 28 days. All of the animals tolerated the treatments without difficulty and, regardless of ablation duration, were able to continue oral intake and gain weight after the procedure.

LIMITATIONS

Ablation of normal porcine squamous mucosa may differ from that of human Barrett's esophagus.

CONCLUSION

The CryoBalloon device enables circumferential mucosal ablation in a 1-step process by using a novel, through-the-scope balloon. The maximal effect on the mucosa is achieved with a 12-second application time. Because of its ease of use, this new device merits further study so that we can find its possible role in the treatment of Barrett's esophagus.