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Outcomes Following Deep Venous Arterialization In Medicare Patients With Chronic Limb Threatening Ischemia
Jeremy D. Darling, MD, MS, Siling Li, MSc, Camila R. Guetter, MD, MPH, Patric Liang, MD, Mark C. Wyers, MD, Marc L. Schermerhorn, MD, Eric A. Secemsky, MD, Lars Stangenberg, MD, PhD.
Beth Israel Deaconess Medical Center, Boston, MA, USA.
OBJECTIVES: Despite advances in the management of chronic limb-threatening ischemia (CLTI), a large proportion of these patients are not candidates for traditional revascularization. Given this medically complex and “no option” patient population, Deep Venous Arterialization (DVA) has recently been revitalized as a limb salvage technique whereby an arteriovenous fistula in the lower leg is created to supply more oxygenated blood via the venous system to the foot. The recent PROMISE II trial demonstrated a 6-month amputation-free survival (AFS) rate of 66% following DVA. With this trial in mind, our study aims to evaluate the real-world outcomes of this procedure.
METHODS: The study population included all patients undergoing a DVA from January 1, 2021 through December 31, 2023, among fee-for-service (FFS) beneficiaries identified in the Medicare FFS Carrier Claims file. DVA procedures were identified using CPT 0620T. Outcomes included limb salvage, freedom from major adverse limb events (MALE; defined as major amputation or re-intervention within the DVA circuit), survival, and AFS. Cumulative incidences for outcomes that include death were estimated from traditional Kaplan-Meier methods; for non-death endpoints, outcomes were estimated from the cumulative incidence function, accounting for the competing risk of death.
RESULTS: Between 2021 and 2023, 134 patients underwent a DVA for CLTI. Among these, the median age was 70 years and the majority of patients were male (66%), white (63%), had tissue loss (72%), hypertension (99%), hyperlipidemia (96%), chronic kidney disease (89%), and diabetes (83%). Following a DVA for CLTI, six-month and one-year AFS incidences were 42% and 33%, respectively. One-year incidences of limb salvage, freedom from MALE, and survival were 53%, 52%, and 65%, respectively (Figure I).
CONCLUSIONS: Among patients with no traditional options for revascularization, our data demonstrate that DVA is a procedure that is, by its nature, performed in high-risk individuals who continue to have a high risk of limb loss and mortality. Importantly, AFS in our analysis is notably worse than those reported in PROMISE II and, as such, raises questions about the generalizability of the randomized trial. Further investigation is needed regarding patient selection criteria for and the clinical utility of the DVA procedure.
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