Outcomes in no-option chronic limb-threatening ischemia patients undergoing transcatheter arterialization of the deep veins: results from the PROMISE UK study.

Published Date: 01st September 2024

Publication Authors: Lechareas. S

Conference Abstract

Purpose: Around 20% of patients with chronic limb-threatening ischemia (CLTI) are unsuitable for conventional surgical or endovascular treatment approaches. These "no-option" patients often experience adverse outcomes including pain, non-healing wounds, major amputation, and high mortality rates. Transcatheter arterialization of the deep veins (TADV) offers an alternative approach in patients with no-option CLTI. The single-arm, prospective, multicenter, real-world PROMISE UK study (NCT03807661) evaluated outcomes in nooption CLTI patients who underwent TADV with the LimFlow System, the only commercially available device for the procedure.
Material(s) and Method(s): Patients with Rutherford class 5/6 and ineligible for open or endovascular revascularization options were enrolled. The primary endpoint was amputation-free survival (AFS) at 1 year, defined as both freedom from above-ankle amputation and all-cause mortality. Secondary endpoints included limb salvage, wound healing, and pain status (0-10 score) through 1 year.
Result(s): A total of 28 patients with no-option CLTI were enrolled and the TADV procedure was successfully performed in 27 (96.4%) patients. At 1 year, the AFS rate was 67.2% and the limb salvage rate was 81.2%. Wounds were completely healed in 70.6% of patients at 1 year and partially healed in the remaining 29.4% of patients. The median pain score at 1 year was 2.0, a decrease from 6.0 at baseline.
Conclusion(s): The PROMISE UK study demonstrates that TADV with the LimFlow System is a safe and effective treatment for limb salvage in CLTI patients with no option for other treatments.

Lechareas, S. (2024). Outcomes in no-option chronic limb-threatening ischemia patients undergoing transcatheter arterialization of the deep veins: results from the PROMISE UK study. CardioVascular and Interventional Radiology. 47(Supp &), p.S503. [Online]. Available at: https://dx.doi.org/10.1007/s00270-024-03850-6 [Accessed 4 February 2026].