2132. A Single Center Pilot Study of Circumferential Anal Canal Radiofrequency Ablation (RFA) to Treat Anal High-Grade Dysplasia
Session: Poster Abstract Session: HIV: Cancers, HPV, Dysplasia
Saturday, October 29, 2016
Room: Poster Hall
Posters
  • B253_IDweek_POS_Final_2132.pdf (177.1 kB)
  • Background: HIV+ individuals are at high risk for anal high-grade squamous intraepithelial lesions (HSIL), the cancer precursor. Most dysplasia occurs at the squamocolumnar junction (SCJ). Targeted HSIL ablation can decrease progression to cancer but recurrence remains high. Circumferential RFA for esophageal dysplasia is safe, decreasing dysplasia recurrence over targeted ablation. We endeavored to determine if this is true in the anus.

    Methods: A prospective trial investigated efficacy of circumferential anal RFA using BarrxTM 60 focal catheters (Medtronic) in subjects with ≥1 anal SCJ HSIL. The entire SCJ was ablated (3 x 12 J/cm2 per site) to treat baseline and occult HSIL(s). A post-RFA biopsy was taken. Subjects were assessed with high-resolution anoscopy at 3, 6, 9, and 12 months. Mandatory lesion site biopsies occurred at month 12. Recurrence was retreated with focal RFA.

    Results: Ten males (9 HIV+), median age 52 years, enrolled. Median T-cell count and viral load were 730 cells/mcL and 38 copies/mL. Median years with HIV were 24.5. At baseline, subjects had a mean 2.7 HSIL’s (range 2-8). Median time for treatment was 6.5 (5-13) minutes. Lesion persistence occurred in 4 subjects (3 at 3 months, 1 at 6 months). Recurrence at a new site (metachronous) occurred in 1 subject at 3 months. No lesion persisted after retreatment. All subjects were dysplasia free at 12 months. Immediate post RFA biopsy of a treated lesion showed dysplasia in 50% and 2 recurred. Eight subjects were healed by 3 months and one each had asymptomatic granulation tissue and superficial erosion. All healed by 9 months. Two device-related mild adverse events (AE) occurred in one subject each (externally thrombosed hemorrhoid and soft anal stricture). Both resolved conservatively (stricture dilated in office with an anoscope). No serious AE occurred.

    Conclusion: Circumferential anal canal RFA is safe and quick producing total HSIL eradication with ≤2 treatments. Depth of destruction might be inadequate with one treatment. A second targeted focal ablation resulted in no further dysplasia. Metachronous recurrence is rare. Circumferential RFA appears more effective than targeted ablation especially in HIV+ subjects and obviates the need to identify all lesions.

    Stephen Goldstone, MD, Dept. of General Surgery, Icahn School of Medicine at Mount Sinai, New York, NY, Janet Miller, BS, Medtronic, Mansfield, MA and Shirin Hasan, MSc, Medtronic, Sunnyvale, CA

    Disclosures:

    S. Goldstone, Medtronic: Consultant , Consulting fee
    Medtronic: Investigator , Research support

    J. Miller, Medtronic: Employee , Salary

    S. Hasan, Medtronic: Employee , Salary
    Medtronic: Shareholder , Stock options

    Findings in the abstracts are embargoed until 12:01 a.m. CDT, Wednesday Oct. 26th with the exception of research findings presented at the IDWeek press conferences.