To the Editor:
We read with interest the VideoGIE article by Storm et al1 from Mayo Clinic Rochester. The case shows the unique benefits of Hemospray in offering durable hemostasis for bleeding that is resistant to conventional treatments, even in the setting of dual antiplatelet therapy. We commend the authors for their persistence in providing a positive outcome for this patient. However, we noted several errors that should be corrected because they do not accurately reflect the potential adverse events that may result from Hemospray treatment.
In summarizing the risks of Hemospray, the authors note that “bowel obstruction from bentonite impaction in the colon has been reported and theoretically may cause biliary obstruction, cholangitis, or both, if used within the bile duct and periampullary duodenum.2 Contrary to the authors’ statement, there has never been a report of bowel obstruction from Hemospray impaction in the colon, including in the article by Arena et al.2
The authors correctly note that transient obstruction of a postsphincterotomy biliary orifice has been reported.3 However, cholangitis from Hemospray obstruction after treatment of postsphincterotomy bleeding has never been reported and remains only a theoretical risk, along with colon obstruction and embolization. These risks, other cautionary statements, and the U.S. Food and Drug Administration clinical summary are included in the Instructions for Use for Hemospray, which can be found at https://hemospray.cookmedical.com.
We respectfully request that these corrections be made or noted and linked to the article and video presentation to assure the actual product risks are not misrepresented.
Disclosure
The authors are employees of Cook Medical, manufacturers of Hemospray.
References
- 1.Storm A.C., Sawas T., Higging T. Step-by-step use of hemostatic powder: treatment of a bleeding GI stromal tumor. VideoGIE. 2019;4:5–6. doi: 10.1016/j.vgie.2018.10.003. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 2.Arena M., Masci E., Eusebi L.H. Hemospray for treatment of acute bleeding due to upper gastrointestinal tumours. Dig Liver Dis. 2017;49:514–517. doi: 10.1016/j.dld.2016.12.012. [DOI] [PubMed] [Google Scholar]
- 3.Moosavi S., Chen Y.I., Barkun A.N. TC-325 application leading to transient obstruction of a post-sphincterotomy biliary orifice. Endoscopy. 2013;45:E130. doi: 10.1055/s-0032-1326370. [DOI] [PubMed] [Google Scholar]
