Role of allogeneic placental tissues in penile inversion vaginoplasty.

Background: The role of allogeneic placental tissue (APT) in genital gender-affirming surgery (GAS) is not well understood. Penile inversion vaginoplasty (PIV), the most common genital GAS, often results in tissue healing- or wound-related complications, including scarring and neovaginal stenosis. Surgical reoperation and revision vaginoplasty are common. The aim of this study was to evaluate the contribution of APT to postoperative outcomes in PIV. Methods: The authors performed a retrospective analysis of consecutive adult patients undergoing primary PIV during a 6-year period (September 1, 2014 to September 1, 2020). Subjects receiving intraoperative application of an APT biomaterial were compared to those undergoing primary PIV without APT. Postoperative outcomes-including wound healing morbidity and reoperation-were compared between groups. Short- and long-term complications were classified using Clavien-Dindo. Results: A total of 182 primary PIV cases were reviewed (115 conventional PIV; 67 PIV-APT). The postoperative follow-up time for the population averaged 12.7 months. All-cause and wound related complications were significantly lower amongst PIV-APT patients when compared to conventional PIV (P=0.002 and P=0.004, respectively). The rate of long-term complications was significantly lower in PIV-APT subjects: prolonged pain (P=0.001), prolonged swelling (P=0.047), and neovaginal stenosis (P<0.001). The PIV-APT group required significantly less reoperation for vaginal depth enhancement (P=0.007). Conclusions: Though its use in urogenital reconstruction has been limited, this study indicates that the placement of APT during PIV significantly lowered the risk of complications associated with poor wound healing. This supports a novel use for placental tissues in reducing complications in genital GAS.

Dehydrated human amnion/chorion membrane to treat venous leg ulcers: a cost-effectiveness analysis.

OBJECTIVE: To evaluate the cost-effectiveness of dehydrated human amnion/chorion membrane (DHACM) in Medicare enrolees who developed a venous leg ulcer (VLU). METHOD: This economic evaluation used a four-state Markov model to simulate the disease progression of VLUs for patients receiving advanced treatment (AT) with DHACM or no advanced treatment (NAT) over a three-year time horizon from a US Medicare perspective. DHACM treatments were assessed when following parameters for use (FPFU), whereby applications were initiated 30-45 days after the initial VLU diagnosis claim, and reapplications occurred on a weekly to biweekly basis until completion of the treatment episode. The cohort was modelled on the claims of 530,220 Medicare enrolees who developed a VLU between 2015-2019. Direct medical costs, quality-adjusted life years (QALYs), and the net monetary benefit (NMB) at a willingness-to-pay threshold of $100,000/QALY were applied. Univariate and probabilistic sensitivity analyses (PSA) were performed to test the uncertainty of model results. RESULTS: DHACM applied FPFU dominated NAT, yielding a lower per-patient cost of $170 and an increase of 0.010 QALYs over three years. The resulting NMB was $1178 per patient in favour of DHACM FPFU over the same time horizon. The rate of VLU recurrence had a notable impact on model uncertainty. In the PSA, DHACM FPFU was cost-effective in 63.01% of simulations at the $100,000/QALY threshold. CONCLUSION: In this analysis, DHACM FPFU was the dominant strategy compared to NAT, as it was cost-saving and generated a greater number of QALYs over three years from the US Medicare perspective. A companion VLU Medicare outcomes analysis revealed that patients who received AT with a cellular, acellular and matrix-like product (CAMP) compared to patients who received NAT had the best outcomes. Given the added clinical benefits to patients at lower cost, providers should recommend DHACM FPFU to patients with VLU who qualify. Decision-makers for public insurers (e.g., Medicare and Medicaid) and commercial payers should establish preferential formulary placement for reimbursement of DHACM to reduce budget impact and improve the long-term health of their patient populations dealing with these chronic wounds. DECLARATION OF INTEREST: Support for this analysis was provided by MiMedx Group, Inc., US. JLD, and RAF are employees of MiMedx Group, Inc. WHT, BH, PS, BGC and WVP were consultants to MiMedx Group, Inc. VD, AO, MRK, JAN, NW and GAM served on the MiMedx Group, Inc. Advisory Board. MRK and JAN served on a speaker's bureau. WVP declares personal fees and equity holdings from Stage Analytics, US.