Alternatives for “no option” patients with severe CLI

Important points:

• Transcatheter arterialization of deep veins is safe and can be successfully performed in patients with severe severe limb ischemia.
• This technology has the potential to ameliorate race-based disparities in care.

Data from the PROMISE II trial show that approximately two-thirds of adults with severe critical limb ischemia were treated with a transcatheter deep venous arterialization system and achieved amputation-free survival at six months.

In the single-arm PROMISE II study, researchers used a novel system (LimFlow) designed to divert arterial flow from the tibial artery to the tibial vein.As Helio previously reported, the study included 105 participants (mean age, 69 years, 69% male) with ‘no option’ CLI and Rutherford class 5 or 6 who underwent deep venous arterialization . Stable patients undergoing dialysis were eligible. The primary endpoint was amputation-free survival at 6 months, with a performance target of 54% based on previous literature.

The findings exceeded the researchers’ expectations. Technical success was achieved in 99% of his surgeries, and the primary endpoint was achieved in 66% of patients (post hoc mean 0.66; 95% Bayes confidence interval 0.565-0.745; P = .005). Limb preservation was achieved in 67 patients (76% according to Kaplan-Meier analysis). Wounds healed completely in 25% of participants and were in the process of healing in 51% of participants.

“With this study, we are now giving these patients great hope.” Mehdi H. Shishehbor, DO, MPH, PhDThe president of the University of Cleveland Hospital Harrington Cardiovascular Institute told Healio. It shows that it can be saved. ”

Healio spoke with Shishehbor about the rigorous PROMISE II research protocol, how LimFlow works, and how new techniques can be deployed to ameliorate racial disparities in CLI.

New data for PROMISE II were first reported at VIVA 22. New England Journal of Medicine.

Hello: W.What is the general outlook for these patients with severe severe limb ischemia?

Siche ball: Patients with CLI (those with ulcers or gangrene) are at risk of amputation. These are diabetic patients with severe calcification and suffering from severe distal tibia and small vessel disease. These patients now have two options available to improve blood flow to prevent amputation. One option is surgery—bypass. Another option is intravascular. Unfortunately, due to the complexity of the disease, neither approach will allow him to help these patients 20% to 30% of the time. We refer to these patients as ‘no-choice patients’. The only options they have are below-knee or above-knee amputations. We don’t consider disconnects optional, so we call them “no options”. These are the people who were told there was nothing available.

As previously mentioned, the current standard of care is bypass or endovascular treatment. However, these procedures must be able to find a target in the foot to avoid blockage.In diabetes there is often no target and nowhere to go. The arteries are highly calcified, have occlusions 30 or 40 cm long, and cannot be crossed with wires or balloons. It is no use chasing these arteries.

This made us wonder: Is there another system that could deliver oxygenated blood to the distal tissues of the foot?

Hello: How does LimFlow work?

Siche ball: We know that veins are not affected by diabetes. We thought that the arterial blood flow would flow into the calf veins of the lower extremities, reversing the blood flow of these veins and not sending the oxygenated blood of the distal leg into the veins. Take the vein that is supposed to return to the heart and reverse the blood flow with this procedure, diverting oxygenated blood from the tibial artery in the calf to the tibial vein. This causes the veins to carry oxygenated blood to the legs in reverse order.

Hello: The PROMISE II findings showed that the salvage of these limbs numberssecondssurprise you?

Siche ball: When we started this study, we knew that these patients were very sick patients who would otherwise have had an amputation. But I thought I could save 1 out of 10 people. When in 6 months he was 76% successful and with a new technically challenging procedure he was 99% technically successful, to be honest I was dumbfounded. This sick-of-sick success rate was incredible.

Some might say “no options” is in the eye of the beholder. For this trial, the FDA required a multidisciplinary team to review all cases. A panel of experts, after reviewing the angiograms, had to come to a consensus that these patients really were the patients with no other choice. was a team. All patients had to be approved by an independent expert panel. This was not the investigator who made the decision. This is an important point.

Hello: you mentionEd This procedure is technically difficult. Where do you and your colleagues go from here? This procedure is not currently FDA-approved in the US, so what are your next steps?

Siche ball: We are optimistic because of the technical success rate. The 20 sites that participated in PROMISE II were advanced operators. We believe that once this is approved, we will be able to educate and train operators to safely perform this procedure. I was able to gain a lot of knowledge through PROMISE I and PROMISE II. Now you can share that knowledge with new operators learning this technique.

This device is not currently FDA cleared. The company has launched a new research project, PROMISE III. It’s a registry of 25 sites in the United States, one of which is a university hospital, with about 200 patients enrolled to receive the technology. Patients did not want to miss this opportunity while waiting for FDA approval. We are pleased that the FDA has allowed this new registry to continue.

Healio: In this cohort, momore than half of participants are black again Hispanic.Please tell us about the racial disparities in patients with severe CLI.?What can it How does this novel technology improve parallax?

Siche ball: Amputation has significant disparities associated with it. African-American and Hispanic adults are four times more likely to undergo amputation and four times more likely to undergo revascularization. They are also people who present later in the disease, often due to lack of access to treatment or other factors. They are unable to receive the care they need early in their illness. If they do exist, they are more likely to be ‘no-choice’ patients. This is an underserved population. At PROMISE II, nearly 50% of participants were from underrepresented backgrounds, yielding successful results. We hope this limb-saving technology can help bridge this disparity gap.

Hello: AnyWhat else would you like to mention about this study??

Siche ball: It’s important not to take amputation lightly. Amputation should be a last resortWhen patients have exhausted all options, clinicians consider second and third opinions and turn to these sites that offer cutting-edge technology like LimFlow to help patients avoid amputation. There is now evidence that transcatheter deep venous arterialization systems offer hope and opportunity.

reference:

For more information:

Access to Mehdi H. Shishehbor, DO, MPH, PhD. [email protected]; twitter: @Sishem.