Purpose: To report the outcomes of the Biodesign Fistula Plug as an alternative treatment for enterocutaneous fistulae by presenting our institutional experience from 2013 to 2020.
Materials and methods: A retrospective review of all attempted fistula closures utilizing the Biodesign Fistula Plug at a single institution from 2012 to 2020 was performed under IRB approval and in compliance with HIPAA. Patient demographics were obtained including age at the time of the procedure, etiology, location of the fistula, history of malignancy, prior chemotherapy or radiation, and history of prior surgery or other interventions. Patient follow-up was performed through 7/2020 to evaluate for fistula closure, complications, or subsequent treatments.
Results: There were 25 patients who underwent 35 Biodesign Fistula Plug placements. Of these, 7 procedures were successful, defined as closure of the fistula, and 28 procedures were unsuccessful, defined as persistent fistula output or requiring further intervention on the EC fistula. There were 7 major complications, SIR classification D = 3, E = 2 and F = 2. No statistically significant risk factors were found predicting fistula plug failure although there was a trend towards patients with malignancy having unsuccessful outcome (p = 0.057). The average number of procedures for patients with successful closure was 1.4 versus 4.22 for those with unsuccessful closure. The average time to plug failure was 27.8 days (range 3-163 days), and the average time to fistula closure following plug placement was 21.4 days (range 14-30).
Conclusion: Enterocutaneous fistulae are complex and morbid with no good treatment options. These findings demonstrate the Biodesign Fistula Plug can be successful in select patients, however, should be used with great caution due to high rate of failure and complications including two patient deaths.
Keywords: Biodesign fistula plug; Enterocutaneous fistula; Gastrointestinal interventions.
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