Abstract 4364722: Arterial Duplex Ultrasound Impacts Endovascular Outcomes: Unintended Consequences of Patient Harm From the 2023 and 2025 Amputation Reduction and Compassion Act

Abstract

Background: The Amputation Reduction and Compassion (ARC) Act of 2023 and 2025 supports arterial duplex ultrasound (DUS) as an initial screening tool to detect and treat peripheral arterial disease (PAD) to reduce amputations. Our prior research found use of DUS in PAD management was associated with higher rates of atherectomy procedures, questionable interventions, and worse surgical outcomes when compared to the use of ankle-brachial index (ABI) with toe-brachial index (TBI). Given DUS’s higher false-positive rate, we hypothesize DUS may be associated with higher vascular complications of claudication, chronic limb threatening ischemia (CLTI), major amputations, and increased endovascular intervention. If confirmed, the ARC Act’s recommendation for DUS may have unintended consequences of patient harm. Methods: Using the TriNetx de-identified database from April 2010–2025, we performed a retrospective cohort study. Inclusion criteria were: a) PAD diagnosis; b) at least one PAD risk factor (diabetes, hypertension, hyperlipidemia, smoking); c) an endovascular procedure (atherectomy, stenting, or angioplasty) performed within two years of both PAD diagnosis and PAD risk factor. Cohorts were assessed for PAD diagnosis by ABI/TBI alone (Cohort A), DUS alone (Cohort B), or both (Cohort C). After propensity score matching for age, gender, and race, we compared Cohorts A-B, A-C, and B-C, to assess for vascular complications, including chronic kidney disease/renal failure and lower extremity CTA, within five years of intervention. Results: Cohort A-B (n=9,180) displayed claudication (RR=1.334, p<0.0001) and re-interventions (RR=1.407, p<0.0001) in Cohort B. Cohort A-C (n=27,833) displayed claudication (RR=2.152, p<0.0001), CLTI (RR=1.687, p<0.0001), amputation (RR=1.286, p<0.0001), lower extremity CTA (RR=1.977, p<0.0001), and re-interventions (RR=1.817, p<0.0001) in Cohort C. Cohort B-C (n=9,683) displayed claudication (RR=1.724, p<0.0001), CLTI (RR=1.487, p<0.0001), amputation (RR=1.385, p<0.0001), lower extremity CTA (RR=1.987, p<0.0001), and re-interventions (RR=1.286, p<0.0001) in Cohort C. After excluding PAD diagnosis as a confounder, major amputation increased (RR=1.156, p<0.0072) in Cohort A. Conclusion: This is the second research group study linking DUS with increased and questionable interventions. These results highlight the risk for greater public harm if DUS is used as a screening tool, as detailed in the 2023 and 2025 ARC ACT.