One-Year Clinical and Lifetime Cost-Effectiveness Outcomes of Transcatheter Arterialization for No-Option CLTI in the U.S.

Wednesday, April 2, 2025

8:14 AM – 8:21 AM CT

Location: Music City Center, General Session Hall B

Presenting Author(s)

Nicholas Petruzzi, MD

Interventional Radiologist
Vascular Institute of Atlantic Medical Imaging, United States

Author/Co-author(s)

DC

Daniel G. Clair, MD

Professor and chair
Vanderbilt University Medical Center, United States
MS

Mehdi H. Shishehbor, PhD, DO, DO, MPH

Professor of Medicine, President
UH Harrington Heart and Vascular Institute, United States
AD

Anahita Dua, MD

Associate Professor of Surgery (Vascular Surgery)
Massachusetts General Hospital/Harvard Medical School, United States
JP

Jan B. Pietzsch, PhD

President and CEO
WingTech, Inc., United States

Purpose: Patients with chronic limb-threatening ischemia (CLTI) present with non-healing ischemic ulcers, gangrene, or both. Up to 20% of these patients are considered “no-option” because they are ineligible for conventional open or endovascular treatment options and are at a high risk for major amputation. Recently, transcatheter arterialization of the deep veins (TADV) has demonstrated positive outcomes in this challenging population. We compare clinical and economic outcomes in a pooled cohort of TADV patients treated with the LimFlow System (Inari Medical, Irvine, CA, USA) in PROMISE I and II versus patients from the concurrent CLariTI natural history registry, using propensity-score matching.

Materials and Methods:

PROMISE I and II were single-arm, multicenter, prospective studies evaluating the safety and effectiveness of TADV for no-option CLTI patients, as assessed by an independent committee. Eligibility criteria for the PROMISE studies and CLariTI included Rutherford class 5/6. Propensity score matching was performed on 137 TADV patients and 180 CLariTI patients using 4 baseline variables: age, sex, diabetes, and Rutherford classification. Patients on dialysis at baseline were excluded from the analysis. Outcomes assessed through 1 year included limb salvage, overall survival, and amputation-free survival using Cox regression or Kaplan-Meier. Lifetime cost-effectiveness, measured as the incremental cost-effectiveness ratio (ICER) in $ per quality-adjusted life year (QALY) gained, was estimated by Markov model with contemporary U.S. cost data including consideration of the new technology add-on payment granted for TADV.

Results: A total of 228 patients (114 matched pairs) were identified through propensity-score matching. At 1 year, in patients treated with TADV vs matched patients from CLariTI, the limb salvage rate was 74.6% vs 57.8% (p=0.003), the survival rate was 86.4% vs 71.1% (p=0.013), and the amputation-free survival rate was 64.9% vs 39.1% (p < 0.001). Over a patient’s lifetime, TADV added 1.09 QALYs (2.25 vs 1.16) with a resulting ICER of $33,011 per QALY gained. The total projected survival gain with TADV was 2.18 life years.

Conclusion: TADV was associated with significantly improved limb salvage, survival, and amputation-free survival at 1 year compared to contemporary benchmark for no-option CLTI patients. These outcome enhancements were achieved at an incremental cost, positioning TADV as a cost-effective, high-value intervention in a model-based analysis.