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1-Year Outcomes of Transcatheter Arterialization of Deep Veins: PROMISE II and Pooled PROMISE Studies

Mehdi H Shishehbor1, Hany Zayed2, Anahita Dua3

  • 1University Hospitals Harrington Heart and Vascular Institute, Cleveland, Ohio, USA.

JACC. Cardiovascular Interventions
|July 16, 2025
PubMed

Insights

Transcatheter arterialization of the deep veins (TADV) offers hope for chronic limb-threatening ischemia (CLTI) patients ineligible for conventional treatments. The LimFlow System demonstrated durable limb salvage and improved symptoms at one year in a large patient cohort.

Area of Science:

  • Vascular Surgery
  • Interventional Cardiology
  • Regenerative Medicine

Background:

  • Chronic limb-threatening ischemia (CLTI) affects up to 20% of patients who are ineligible for traditional revascularization.
  • These
  • no-option

Purpose of the Study:

  • To evaluate the 1-year outcomes of transcatheter arterialization of the deep veins (TADV) using the LimFlow System in patients with CLTI.
  • To present findings from the PROMISE II trial and a pooled analysis of PROMISE I, II, and UK studies.

Main Methods:

  • A single-arm, multicenter prospective study (PROMISE II) included patients with Rutherford class 5/6 CLTI.
  • Outcomes assessed included amputation-free survival (AFS), limb salvage, survival, Rutherford classification, pain scores, and wound healing at 1 year.

Main Results:

  • In PROMISE II (105 patients), 1-year AFS was 54.2%, limb salvage was 68.7%, and survival was 79.0%.
  • The pooled analysis (137 patients) showed 1-year AFS of 66.1%, limb salvage of 74.4%, and survival of 88.9%.
  • Clinical symptoms and wound healing improved through 1 year.

Conclusions:

  • Transcatheter arterialization of the deep veins (TADV) with the LimFlow System provides durable amputation-free survival and limb salvage in no-option CLTI patients.
  • The procedure also led to significant improvements in clinical symptoms and wound healing.
  • TADV represents a viable option for CLTI patients facing high amputation or palliative care rates.
Abstract

Keywords:
CLTIPROMISETADVamputation-free survivallimb salvageno-option CLTI

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