TADV Procedure Shows Significant Quality of Life Improvements in No-Option CLTI Patients
Key Insights
PROMISE III trial demonstrates that transcatheter arterialization of deep veins (search) (TADV) significantly improves quality of life measures in chronic limb-threatening ischemia (search) patients with no other treatment options.
Six months after TADV, patients reported substantial reductions in circulation concerns (90% to 45%), sleep problems (85% to 40%), and daily wound burden (79% to 39%).
The procedure achieved 81% amputation-free survival at 6 months and 86.5% limb salvage rate, offering hope for patients previously facing amputation.
Patients with chronic limb-threatening ischemia (search) (CLTI (search)) who have exhausted all traditional treatment options experienced significant quality of life improvements after undergoing transcatheter arterialization of the deep veins (search) (TADV), according to new data from the PROMISE III trial presented at the Society for Cardiovascular Angiography & Interventions (search) (SCAI (search)) 2026 Scientific Sessions in Montreal.
The findings represent the first comprehensive quality of life analysis from PROMISE III, a prospective, multicenter, single-arm study that enrolled 100 patients with the most severe forms of CLTI (search) for treatment with the LimFlow (search)™ System. The procedure offers new hope for approximately one in 10 CLTI patients who lack viable revascularization options due to age, damaged arteries, or high complication risks.
Substantial Quality of Life Improvements
Six months after TADV, patients demonstrated remarkable improvements across multiple quality of life measures using the VascuQoL-6 survey. Patients reporting concerns about poor circulation in their legs dropped from 90% at baseline to 45% at six months. Similarly, those experiencing challenges with social activities due to poor circulation decreased from 72% to 40%.
Sleep-related problems showed equally impressive improvements, with patients reporting trouble falling asleep, staying asleep, or sleeping too much declining from 85% to 40%. The daily burden of foot wounds fell dramatically from 79% to 39% of patients.
"There is significant morbidity and mortality with critical limb-threatening ischemia, but what's really forgotten in many of these patients is the fact 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," said lead researcher Mehdi H. Shishehbor, DO, MPH, PhD, FSCAI, an interventional cardiologist at University Hospitals (search) in Cleveland, Ohio.
Clinical Outcomes and Pain Reduction
The quality of life improvements correlated with strong clinical outcomes. PROMISE III met its primary endpoint of amputation-free survival, with 81% of patients alive at 6 months without major amputation. The limb salvage rate reached 86.5%, while freedom from all-cause mortality was 94%.
Pain scores showed significant reduction, falling from a median of 6 at baseline to 2 at 6 months on a 0-10 scale (P < 0.0001). Eighty percent of patients had either healed or healing wounds at 6 months, with low percentages showing stable or worsening wounds.
Understanding TADV Technology
TADV involves creating an arteriovenous fistula proximal to atherosclerotic tibial arteries (search) using the LimFlow (search) self-expanding covered stent. The procedure reroutes blood through healthier veins, bypassing blocked leg arteries and restoring blood flow to the foot. This minimally invasive approach targets patients who would otherwise face amputation.
The study enrolled patients with high comorbidity rates, including 80% with diabetes (search), 95% with hypertension (search), and 46% with chronic kidney disease (search). The median age was 71 years, with 27% women, 16% Black, and 21% Hispanic or Latino patients. One-quarter were classified as Rutherford class 6, with the remainder being Rutherford class 5.
Technical Challenges and Learning Curve
Shishehbor acknowledged that TADV requires specialized expertise and careful post-procedure management. The procedure demands access through the plantar vein (search) at the sole of the foot, presenting technical challenges even for experienced interventionalists.
"What we learned—and we lost a lot of legs because of this—[is that] the wound management and the wound care related to these patients is completely different than what we are used to in treating patients with CLTI (search)," Shishehbor explained. Proper wound care requires avoiding tight dressings that could cause arterialized veins to become necrotic, and allowing wounds to heal by secondary intention without sutures or closed flaps.
Clinical Impact and Future Directions
CLTI (search) affects over 20 million people worldwide and represents a severe stage of peripheral artery disease (search) where plaque buildup significantly narrows leg arteries. The condition traditionally leaves about 10% of patients without viable treatment options, often resulting in amputation.
"This is the first time PROMISE III's quality-of-life measurements have been modified to include patient-centric metrics. Our findings point to a promising new option for CLTI (search) patients, offering another tool in the toolbox for individuals who have no other treatment avenues," Shishehbor noted.
The PROMISE III results build on the success of PROMISE II, which led to FDA approval of the LimFlow (search) device in 2023 for no-option CLTI (search) patients. Session moderator Sahil Parikh, MD, from NewYork-Presbyterian/Columbia University Irving Medical Center (search), described the technology as "paradigm-shifting" for CLTI treatment, though he noted that post-procedure care requires "a very, very coordinated effort."