Big Data Analysis: Dehydrated Human Amnion/Chorion Membrane Allografts Demonstrate Improved Outcomes of Venous Leg Ulcers and Reduced Health Care Resource Utilization Among Medicare Enrollees Advances

Venous leg ulcers (VLUs) affect an estimated 500,000 to 600,000 people in the United States every year, accounting for roughly $3.5 billion in health care spending, with more than $1.1 billion of that expenditure coming from Medicare in 2019. Incidences of VLUs have also been on the rise, increasing 25% between 2014 and 2019. Meanwhile, rates of recurrence within 2 years are as high as 78%.

The cycle of leg ulceration, infection, remission, and recurrence begins with chronic venous insufficiency (CVI), and patients with CVI often present with multiple comorbidities that further complicate wound healing. While prophylactic treatments can prevent ulcer formation or recurrence, relatively few patients receive these therapies. Moreover, despite previous studies that show improved rates of healing with the use of advanced therapies (ATs), often known as cellular, acellular, matrix-like products (CAMPs), most VLUs among Medicare enrollees are not treated using ATs, and many of those that are do not follow the parameters for use, resulting in suboptimal outcomes.

In this study, researchers reviewed Medicare Limited Data Standard Analytic Hospital Inpatient and Outpatient Department Files to identify patients diagnosed with CVI who experienced 1 or more VLU episode between October 1, 2015, and October 2, 2019. Patients were included in the study if they had a confirmed diagnosis of CVI as well as at least 1 VLU episode, and exclusion factors included a lack of complete data, patients on dialysis, treatment within 90 days of death, and treatment with multiple CAMPs. This resulted in an eligible sample group of 112,400 VLU episodes.

Eligible chronic VLU episodes were then divided into 2 cohorts: those who did receive treatment with an AT (AT group, 27.2% of eligible VLU episodes) and those who did not receive an AT (NAT group, 72.8% of eligible VLU episodes). The AT group was further broken into 4 groups as follows: VLUs that received treatment with dehydrated human amnion/chorion membrane (DHACM) (EPIFIX, MIMEDX Group Inc., US), VLUs treated with an AT other than DHACM, VLUs treated with an AT that was administered following parameters for use (FPFU), and those that specifically received DHACM FPFU. These 4 AT treatment cohorts were then propensity matched to the same number of NAT episodes using data from the Medicare LDS files and a comprehensive set of 119 covariates, which was ultimately narrowed down to 29 factors.

Notably, DHACM is “the single most widely used Medicare-approved placental-derived allograft for lower extremity diabetic ulcers.”

Secondary complications, including infection and amputation, are not uncommon among patients with chronic VLUs. Among those VLU episodes in which ATs were not used, more than 30% experienced such a complication. By comparison, this complication rate dropped to 21.8% for VLUs treated with DHACM FPFU.

Further, the study found that VLU complications lead to excessive health care utilization such as hospital admissions or readmissions and emergency department (ED) or intensive care unit visits. Over 56% of patients in the NAT group had a related ED visit, while 45.8% of the DHACM FPFU group visited the ED.

The data suggest that using DHACM FPFU, including earlier implementation of the AT, followed by applications weekly or biweekly, results in a significant reduction in overall length of treatment. Outpatient treatments for VLU episodes in the DHACM FPFU group required on average of 14.3 fewer treatment days compared with the NAT group, while also resolving more episodes in 1 year (85.5% vs 73.2%, respectively). A shorter treatment time also means reductions in the risk of infection, hospitalization, pain, and negative impacts on quality of life.

In this study, 79% of VLU episodes that received AT treatment were not treated FPFU, displaying a great need for patient and provider education in the application of these high-cost treatments. Early intervention and treating patient comorbidities are also key in preventing or identifying VLUs before they become chronic. But when a patient with CVI presents with a chronic VLU, providers must consider the treatments most likely to lead to wound closure in less time with fewer complications. As the authors note in their conclusions, “Compared to patients who received NAT, patients who received AT experienced the best outcomes, particularly when their treatment was FPFU (initiated early and applied regularly).”

Reference:

Tettelbach WH, Driver V, Oropallo A, et al. Treatment patterns and outcomes of Medicare enrollees who developed venous leg ulcers. J Wound Care. 2023;32(11):704-718. doi:10.12968/jowc.2023.32.11.704