Program Director IR/DR University of Alabama At Birmingham
Eric Bready, MD: No financial relationships to disclose
Peter R. Bream, MD FSIR, Jr.: No financial relationships to disclose
Andrew Gunn, MD: Boston Scientific: Consultant (Ongoing), Speaking and Teaching (Ongoing); Penumbra: Research Grant Recipient (Ongoing); Varian: Consultant (Ongoing), Research Grant Recipient (Ongoing), Speaking and Teaching (Ongoing)
Purpose: To assess the safety, technical success, and clinical efficacy of a commercially-available, bioabsorbable enterocutaneous fistula plug (ECFP) comprised of lyophilized porcine intestinal submucosa
Materials and Methods: A single center retrospective analysis of all adult patients with enterocutaneous fistulas (ECF) treated with an ECFP by interventional radiology was approved by the local IRB. Patient demographics and baseline characteristics of the ECF, including cause of fistula, type of fistula, fistula output, and length and width of fistula were recorded. Details and outcomes of the ECFP procedure were recorded including technical success, clinical success, and adverse events. Clinical success was defined as either cessation of fistula output or reduction in output to a level deemed acceptable by the patient. Adverse events were categorized by SIR criteria.
Results: 11 primary ECFP placements in 10 patients (50% females; mean age: 57.7 (range:36-75) were included. One patient had two separate fistulas. All fistulas were post-surgical in nature with seven (63%) and four (37%) fistulas to small bowel and stomach, respectively. Eight (73%), two (18%), and one (9%) fistulas had < 200mL/day, >500mL/day, and 200-500mL/day of output, respectively. Mean fistula length and width were 29mm (range:10-75) and 3.7mm (range:2-5), respectively. Technical success was 100%. Primary clinical success was achieved in eight (73%) patients. Of the three patients that did not achieve primary clinical success, one underwent a second ECFP that was successful, one went to surgery, and one was managed conservatively (secondary clinical success: 82%, n=9/11). Fistula recurrence occurred in three patients (37%). Of these, one patient had a second successful ECFP procedure, one was treated with endoscopy, and one underwent surgery. One patient (9%) had a major adverse event, consisting of an abscess at the site of ECFP placement requiring drain placement.
Conclusion: ECFP placement has a high rate of both technical and clinical success with an acceptable safety profile, thus representing an effective, minimally-invasive option for a difficult clinical problem.