Abstract
OBJECTIVE: Despite advances in the management of chronic limb-threatening ischemia (CLTI), a large proportion of these patients are not candidates for traditional revascularization and may be destined for major amputation. Given this medically complex and no-option patient population, deep venous arterialization (DVA) has been recently 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. Recently, PROMISE II (Percutaneous Deep Vein Arterialization for the Treatment of Late-Stage Chronic Limb-Threatening Ischemia) demonstrated a 6-month amputation-free survival (AFS) rate of 66% after DVA. With this trial in mind, our study aimed 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 beneficiaries identified in the Medicare Fee-for-Service Carrier Claims file. DVA procedures were identified using Current Procedural Terminology code 0620T. Outcomes included limb salvage, freedom from major adverse limb events (defined as major amputation or ipsilateral reintervention), survival, and AFS. Cumulative incidences for outcomes that include death were estimated from traditional Kaplan-Meier methods; for non-death end points, 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%), and had tissue loss (72%), hypertension (99%), hyperlipidemia (96%), chronic kidney disease (89%), and diabetes (83%). After a DVA for CLTI, the 6-month and 1-year AFS incidences were 42% and 33%, respectively. One-year incidences of limb salvage, freedom from major adverse limb events, and survival were 53%, 36%, and 65%, respectively.
CONCLUSIONS: Among patients with no traditional options for revascularization, our data demonstrate that DVA is a procedure that is, by its nature, performed on high-risk individuals who continue to have a high risk of limb loss and mortality. Importantly, AFS in our analysis was notably worse than that reported in PROMISE II and, as such, raises questions about the generalizability of this procedure in real world practice. Further investigation is needed regarding patient selection criteria for and the clinical usefulness of the DVA procedure.