April 24, 2026
2 min read
Key takeaways:
- Transcatheter deep venous arterialization conferred high rates of 6-month amputation-free survival in patients with CLTI.
- The minimally invasive procedure also improved patient-centric quality of life metrics.
Transcatheter deep venous arterialization was tied to high rates of limb salvage and wound healing in patients with “no option” chronic limb-threatening ischemia, a speaker reported.
The minimally invasive procedure (LimFlow) also improved patients’ quality of life, with many reporting fewer circulation-related concerns and returning to social activities, according to results of the PROMISE III trial presented at the Society for Cardiovascular Angiography & Interventions Scientific Sessions & Canadian Association of Interventional Cardiology/Association Canadienne de cardiologie d’intervention Summit.
Mehdi H. Shishehbor
“[Chronic limb-threatening ischemia] is the most advanced form of [peripheral artery disease]. There is significant morbidity and mortality with critical limb-threatening ischemia, but what’s forgotten in many of these patients is that they suffer from pain, poor quality of life, emotional distress, disruption of usual activities and social isolation because of the wounds and ulcers that they have in their feet,” Mehdi H. Shishehbor, DO, MPH, PhD, FSCAI, interventional cardiologist and president of University Hospitals Harrington Heart & Vascular Institute, said during a press conference. “Transcatheter deep venous arterialization has been shown to have significant clinical benefit for these patients, especially among those that are considered ‘no option’,” Shishehbor said during the presentation. “The standard of care is either surgical bypass or endovascular therapy, but about 20% to 30% of these patients are found to have no option and not qualify for surgical bypass or for endovascular therapy because of ‘desert foot’ and inability to cross these lesions. Transcatheter deep venous arterialization is for those patients that are considered no option.”
In the previous PROMISE II study, researchers used the novel transcatheter deep venous arterialization system to divert arterial flow from the tibial artery to the veins in 105 patients with critical limb-threatening ischemia (CLTI; mean age, 69 years; 69% men).
As Healio previously reported, approximately two-thirds of PROMISE II trial participants achieved amputation-free survival at 6 months.
Based in part on the results of PROMISE II, the arterialization system was approved by the FDA for treatment of CLTI in 2023.
Shishehbor presented the 6-month outcomes of transcatheter deep venous arterialization system in 100 patients with no-option CLTI who were Rutherford class 5 or 6 with a nonhealing ischemic ulcer in the setting of wound care (median age, 71; 73% men; 16% Black; 21% Hispanic).
Eighty-six percent of limbs treated had undergone prior intervention, according to the presentation.
Researchers reported procedural technical success in 97% of patients, with 72% of being discharged home after a median postprocedure hospital stay of 4 days.
At 6 months, 80.7% of patients were free from all-cause mortality and major amputation, and 86.5% were free from major above-ankle amputation, according to the presentation.
Researchers reported a 6-month survival rate of 93.8%.
Moreover, 80% of nonhealing ischemic ulcers were healed or in the process of healing; patients reported reductions in pain (P < .0001); and improvements in quality of life regarding circulation concerns, social activities, sleep and feelings of burden were reported at 6 months (P for all < .05).
“The limb salvage rate using the LimFlow system, the only FDA-approved system currently available, is 87%,” Shishehbor said during the press conference. “Interestingly, in PROMISE II, which we published in 2024, which led to the FDA approval, the limb salvage rate was 76%, so we are already seeing a learning curve and an improvement in how we commercially deliver this technology to our patients. There was a significant improvement in quality of life; there was a significant improvement in pain scores; and 80% of the patients had either healed their wounds or were healing.”
Sources/Disclosures
Source:
Shishehbor MH, et al. Late breaking clinical trials. Presented at: Society for Cardiovascular Angiography & Interventions Scientific Sessions & Canadian Association of Interventional Cardiology/Association Canadienne de cardiologie d’intervention Summit; April 23-25, 2026; Montreal.
Disclosures:
The study was funded by LimFlow. Shishehbor reports consulting for Abbott, ANT, Boston Scientific, Inquis, Medtronic and Stryker.
Ask a clinical question and tap into Healio AI’s knowledge base.
- PubMed, enrolling/recruiting trials, guidelines
- Clinical Guidance, Healio CME, FDA news
- Healio’s exclusive daily news coverage of clinical data
<
Leave a Reply