Quantification of Hemodynamic Changes and Wound Healing Following Transcatheter Arterialization of the Deep Veins (TADV) in No-Option Chronic Limb-Threatening Ischemia.

Objective

Transcatheter arterialization of the deep veins (TADV) is a novel therapy for no-option chronic limb-threatening ischemia (CLTI) that delivers oxygenated blood to the foot via the venous system and has demonstrated favorable limb salvage outcomes in several studies, including the PROMISE II trial. The present study characterizes circuit maturation in the PROMISE II cohort by examining its longitudinal hemodynamic development and associated wound healing, with the goal of better defining the mechanism of action of TADV.

Methods

PROMISE II (NCT03970538) was a prospective, multicenter study on TADV in patients with no-option CLTI due to "desert foot" arterial anatomy. The objective was to evaluate longitudinal changes following TADV including hemodynamics from duplex ultrasound, distal perfusion, and wound healing over time. Clinical outcomes, perfusion metrics, and serial duplex ultrasound data were collected through 1 year using standardized protocols. Duplex studies evaluated volume flow and spectral Doppler parameters across the TADV circuit. Distal perfusion was assessed using toe-brachial index (TBI) and toe pressures. Duplex-derived waveforms were categorized as low- or high-resistance, and longitudinal hemodynamic changes were analyzed. Circuit maturation was assessed using characteristics such as waveform achieving high-resistance configuration and decreased acceleration time indicating vascular remodeling.

Results

A total of 105 patients from PROMISE II were included in the analysis. Limb salvage was 68.7% at 1 year. Among patients with adjudicated wound data, 75.5% were healed/healing at 1 year; patients with worsening status decreased from 52.6% to 14.3%, while complete healing increased to 46.9%. Circuits transitioned from low- to high-resistance waveforms (7.9% at baseline, 24.6% at 3 months, 37.7% at 6 months, 81.1% at 1 year, p<0.0001). At 1 year, in patients with high-resistance circuits, healed/healing wound status was 86.7%, TBI ≥0.3 was 57.1%, and toe pressure ≥40 mmHg was 78.3% indicating greater distal perfusion.

Conclusions

TADV promotes limb salvage through staged hemodynamic maturation demonstrated with duplex, microvascular remodeling, sustaining perfusion, and supporting its durable benefit in no-option CLTI.