eP746 - Biodesign® Fistula Plug: An Effective Alternate Strategy for Perianal Fistulae

Purpose/Background: Management of complex anal fistulae remains a difficult anorectal dilemma, with sphincter preservation critical to the of myriad approaches. Historically, fistula plugs showed limited success, with recent clinical practice guidelines suggesting less than 50% closure rates. The Biodesign® Fistula Plug (BFP) comprises a three-dimensional, decellularized, collagen-rich extracellular matrix (ECM) made from porcine small intestinal submucosa (SIS) that allows for intercalation of cells from patients own healing processes. The purpose of this study was to assess fistula closure rates using the BFP.Methods/Interventions: This is a multi-institutional retrospective review of patients with anal fistulae, treated with BFP. Patient demographics, baseline characteristics, comorbidities, and prior fistula interventions were abstracted. A standardized intraoperative fistula assessment was recorded and all patients were followed postoperatively. The primary endpoint was fistula closure.Results/Outcomes: A total of 86 patients were included in the study. The mean age was 45 ± 11.95, 57% were males. 9.3% of patients had Crohn’s disease and 2.3% had ulcerative colitis. The mean duration of fistula was 13.96 ± 15.58 (28, 8 – 20) months. 72.1% of patients had a draining seton in place at the time of surgery and of those the mean duration was 14.4 weeks. 41.9% of patients had undergone a prior surgery for anal fistula. The mean follow-up time was 6.1 weeks. Using the Parks Classification 74.4% of cases were noted to be transsphincteric fistulas. At follow-up, 58.1% (CI 47.6-68) of patients’ fistulas had closed. Twelve adverse events were reported and included abscess (2.3%), delayed or failed incorporation (4.7%), vaginal discharge (2.3%), extrusion (1.2%), infection (1.2%), pain (1.2%), or “other” (1.2%) reported as suspected device failure. Of these 12 there were no reports of de novo fecal incontinence.Conclusion/

Discussion: Not all fistula plugs are equal;the BFP remains a viable option for complex anal fistula management with successful closure in 58% of cases. Importantly, this option is safe and avoids the risk of fecal incontinence or sphincter injury inherent to other surgical modalities."Table 1 Patient demographics

Table 2 Operative details

Table 3 Patient follow-up data

Table 4 Rate of fistula closure
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