No-Option CLTI Patients Report Better QoL After Blood Flow Diversion Therapy: PROMISE III

MONTREAL, Canada—In patients with chronic limb-threatening ischemia (CLTI) who have run out of treatment options, a blood flow-diverting procedure in the foot improves several measures of quality of life (QoL) in addition to lowering the risk of major amputation, according to a secondary analysis of the PROMISE III trial.

At 6 months, patients reported being less bothered about poor circulation in their legs compared with before the procedure, as well as more participation in social activities, better sleeping habits, and fewer daily burdens associated with having open wounds.

“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,” noted Mehdi H. Shishehbor, DO, PhD (University Hospitals, Cleveland, OH), who presented the findings here at the Society for Cardiovascular Angiography and Interventions (SCAI) 2026 meeting.

The procedure, known as transcatheter arterialization of the deep veins (TADV), involves the LimFlow (LimFlow SA) self-expanding covered stent. By creating an arteriovenous fistula proximal to atherosclerotic tibial arteries, blood bypasses the area of atherosclerosis and establishes arterial blood flow into the venous system of the foot. The goal is to reduce pain and potentially avoid above-ankle amputation for those who have traditionally been referred to as “no-option patients.”

To TCTMD, Shishehbor said it does appear that diverting flow itself is directly tied to the QoL improvements reported.

“I think if you didn’t have the wound data, you could question that,” he said.  ”You can imagine as people’s wounds are healing or have healed, that their quality of life will improve—meaning that now they can wear regular shoes, they don’t have to go every week or every other week to the podiatrist, they don’t have to do wound care, they don’t have smelly and draining wounds.

“So yes, I do think that is a direct correlation or association between the fact that we were able to revascularize these patients, . . . help them heal their wounds, and reduce their pain, which led to improvement in quality-of-life data,” Shishehbor explained.

As Shishehbor showed, 80% of patients had either healed or healing wounds at 6 months, with low percentages of stable or worsening wounds.

Session moderator Sahil Parikh, MD (NewYork-Presbyterian/Columbia University Irving Medical Center, New York, NY), who served as the discussant for the presentation, congratulated the PROMISE investigators on creating “a paradigm-shifting technology” for CLTI. However, he noted that the first few months after successful TADV “can be rough and requires a very, very coordinated effort of care for these patients.”

They suffer from pain, poor quality of life, emotional distress, disruption of usual activities, and social isolation. Mehdi H. Shishehbor

Shishehbor acknowledged that the PROMISE trials have been a learning experience with regard to understanding best practices for wound care after undergoing TADV.

“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,” he continued.

For instance, a dressing that is too tight can cause the arterialized veins to become necrotic.

“There has to be a lot of education at the level of wound care and podiatry to make sure there’s no staples used. All of these wounds we allow to heal by secondary intention. So, we don’t put sutures, we don’t close the flaps, we don’t allow tight dressing,” Shishehbor added.

Since the procedure requires access through the plantar vein at the sole of the foot, TADV represents a challenge even for experienced interventionalists both in achieving the atypical access route and developing the technical dexterity needed to cross the venous arch, he noted.

“If you don’t have the arch, the conduit will close because you don’t have outflow. So, I would say two components are probably the [most] challenging: getting a lateral plantar access and obviously getting the arch open,” Shishehbor said.

Clinical and QoL Benefits

PROMISE III follows the success of the PROMISE II trial, which led to US Food and Drug Administration approval of the LimFlow device in 2023 for no-option CLTI patients. PROMISE III enrolled 100 patients (median age 71 years; 27% women; 16% Black; 21% Hispanic or Latino) at 24 sites in the United States.

The cohort had high rates of comorbidities, with 80 having diabetes, 95% hypertension, and 46% chronic kidney disease. One-quarter of patients were Rutherford class 6, with the remainder being Rutherford class 5. The mean duration of wounds prior to the procedure was 5.4 months, and 86% of patients had undergone a prior limb intervention. Anticipated life expectancy at baseline was less than 1 year.

Investigators have previously announced that PROMISE III met its primary endpoint of amputation-free survival (AFS), with 81% of patients alive at 6 months with no major amputation. Additionally, the rate of limb salvage was 86.5% and freedom from all-cause mortality was 94%.

On a scale of 0 to 10, median pain scores fell from 6 at baseline to 2 at 6 months (P < 0.0001). Concerns about poor circulation in their legs fell from 90% to about 45%, significant challenges with social activity due to wounds/poor circulation fell from 70% to almost 35%, sleeping problems fell from 80% to 40%, as did concerns about needing amputation.

Some patients in PROMISE III needed other procedures on their limb after TADV. To TCTMD, Shishehbor said while about two-thirds of patients needed other interventions in PROMISE II, the number was much lower, at about 15-17%, in PROMISE III.

“I think that has to do with technical improvement, better understanding of the technology and better patient selection also in this population,” he added.

Parikh noted that accessibility of the TADV technology has been limited by its cost, which has become an issue in many health systems in the United States for operators seeking to use it for their no-option CLTI patients.

“In my opinion, if you want to have a serious limb salvage program, you have to have this on the shelf,” Shishehbor responded. “There is a lot of level 1 data . . . that we have published in top-tier journals, so I think you have a lot of evidence to support you with your [value analysis committee]. And lastly, obviously it is FDA approved, and I know that the company is working with [the Centers for Medicare & Medicaid Services] to try to get some reimbursement so that it’s reasonable and feasible financially for the organizations to have.”