Unlicensed stent use creating the need for additional procedures

We congratulate Gupta et al. on managing to remove a partially covered Ultraflex stent after fixation by epithelial hyperplasia [1].

However, only fully covered removable stents are licensed for benign conditions. Specifically, this stent was used off-label contravening the specific instructions by the manufacturer, which clearly detail it is only for malignant strictures [2]. Can the authors state whether the stent was placed intentionally, and did the patient consent procedure cover this off-label application and the expected difficult removal?

While coagulating the ingrowth is a useful adjunct in managing complications of esophageal stenting, using partially covered stents in benign conditions cannot be advocated as good practice. They are designed to allow epithelial hyperplasia for fixation and may be impossible to remove. This patient was put through four separate removal procedures, including two stent-in-stent placements with all their inherent risks. The stent-in-stent technique is problematic with an Ultraflex because of its unique tulip-shaped configuration that prevents good compression of the hyperplastic tissue.

There are many fully covered, removable stents designed and licensed for temporary stenting of benign conditions, and also much easier to deploy. In the absence of an associated stricture, obviously an oversized or very conformable stent must be chosen.

Many operators have little understanding of the wide range of devices and are limited to the stents sold by the suppliers of their endoscopic equipment. Users of the “covered” Ultraflex are commonly unaware it is only partially covered and not designed for removal. In our experience it is the stent with the most unmanageable late complications, precluding simple revision by exchange. In one case this led to death from aspiration pneumonia due to hyperplasia occluding the stent. This was after failed attempts at removal by the original operator and while awaiting stent-in-stent removal in our department. The book by Kozarek et al. [3] deals with all aspects of stenting and is essential reading.

Publication History

Article published online:
28 November 2024

• References

• 1 Gupta S, Whitfield A, Tang A. et al. Snare-tip soft coagulation to treat esophageal stent epithelial hyperplasia. Endoscopy 2023; 55: E572-E573
• 2 Boston Scientific. Ultraflex Esophageal NG. 2017 Accessed May 13, 2024 at: https://www.bostonscientific.com/content/dam/bostonscientific/endo/portfolio-group/wallflex-esophageal-stent/ENDO-402101-AB-bsci-sheet-dfu-ultraflex-esophageal.pdf
• 3 Kozarek RA, Baron T, Song HY. Self-expandable stents in the gastrointestinal tract. New York: Springer; 2013.