(IP159) A Novel Scoring Method that Predicts Immediate Pain in Transcatheter Arterialization of Deep Veins

Objectives: No-option chronic limb-threatening ischemia (CLTI) is characterized by intractable pain, non-healing wounds, and gangrene often leading to major amputation. Transcatheter arterialization of the deep veins (TADV) from the pivotal PROMISE II study demonstrated an encouraging 6-month limb salvage rate of 76% (Shishehbor et al., NEJM, 2023). However, no-option CLTI presentations are highly variable, and early postoperative responses frequently involve increased ischemia and pain. We implemented a novel TADV scoring system integrating pre-TADV arteriographic assessment and the proposed TADV donor artery plan to predict perioperative risk of ischemia and pain risk.

Methods: PROMISE II was a prospective, multicenter trial of TADV in no-option CLTI patients with Rutherford classification 5/6, screened by an independent committee of Vascular Surgeons. In this randomly selected pilot cohort of PROMISE II subjects, two experienced, blinded evaluators analyzed pre- and post-procedural angiograms using the novel scoring rubric to assess the effect of arteriovenous crossing sites on post-TADV ischemia-related pain. The TADV score integrates signage and magnitude (Figure 1), with higher scores indicating more severely impaired foot perfusion, and ranges from -4 to +4. Clinical outcomes, including limb salvage (LS), amputation-free survival (AFS), and pain (0-10) were evaluated at 1 and 3 months. Linear regression analysis explored the relationship between TADV scores and patient-reported pain outcomes.

Results: PROMISE II enrolled 105 TADV patients with a median age of 70 years, 69% were male, and 59% patients were at a high amputation risk per SVS WIfI score. In the pilot cohort of 43 TADV patients, at 1 and 3 months, respectively, the LS rates were 92.4% (95% CI: 84.4–100.0%) and 76.5% (64.2–91.2%) and AFS rates were 81.4% (95% CI: 70.6–93.9%) and 65.1% (95% CI: 52.3–81.0%). The median TADV score was 2 (range: -1, 4). The median pain scores decreased to 3.0 (range: 0.0, 10.0) at 1 month and 2.0 (0.0, 10.0) at 3 months from a baseline pain score of 5.5 (0.0, 10.0). Regression analysis (Figure 2) revealed an inverse relationship between TADV scores and pain scores, with significance observed at 1 month (p=0.032) and at 3 months (p=0.004).

Conclusions: The proposed TADV scoring system predicts immediate, post-TADV pain outcomes. Higher scores were associated with lower pain, suggesting ischemic-driven pain. Maintaining baseline perfusion is critical to minimize postoperative pain following TADV. Incorporating pedal flow into the scoring framework will enhance its utility in prospective studies, exploring broader treatment outcomes in no-option CLTI patients.