N'Dandu: PROMISE II Update on Deep Vein Arterialization With LimFlow

August 11, 2021 — In a session entitled “Feet Matter. Pedal Arteries Matter,” Zola N’Dandu, MD, Section Head of Cardiology at Ochsner Medical Center-Kenner (Louisiana) presented on best practices and patient identification for deep vein arterialization (DVA) for critical limb-threatening ischemia (CLTI). He also provided the in-person and virtual AMP attendees an update on the PROMISE II trial.

“CLTI destroys lives,” said N’Dandu. “It has a five-year mortality that is worse than colon cancer, breast cancer, and prostate cancer combined. We see 50% of our patient dying between 12 and 24 months.”

“Deep vein arterialization…really applies for folks that all of us have come across. That patient that has had multiple interventions, whether because of poor outflow, recurrent tibial restenosis extremely calcified vessels, or ‘unreconstructible’ vessels—patients without bypass options…but who still have a viable foot that can be saved,” explained N’Dandu.

DVA with the LimFlow system is the first new option for “no-option” CLTI patients ineligible for further endovascular or surgical procedures to avoid amputation. It uses an endovascular, minimally invasive procedure to create an arteriovenous connection to arterialize the pedal veins and restore blood flow to the foot. 

The PROMISE (Percutaneous Deep Vein Arterialization for the Treatment of Late-Stage Chronic Limb-Threatening Ischemia) I trial was an early feasibility study of the LimFlow System for percutaneous DVA in no-option CLTI.

Of 32 CLTI patients previously offered a major amputation, 31 underwent the procedure resulting in 74% and 70% amputation-free survival at 6 and 12 months, respectively. Core lab adjudicated wound healing status of fully healed or healing 67% at 6-months and 75% at 12-months.

Twelve-month data from the PROMISE I were published in May 2021 in the Journal of Vascular Surgery.

In an exploratory cost-effectiveness analysis published in late July in the Journal of Critical Limb Ischemia, Jan B. Pietzsch, PhD, and colleagues concluded that LimFlow “may contribute substantial improvements in clinical outcomes at incremental costs that would render it a cost-effective, high-value intervention.”

Integrating lessons learned from PROMISE I that include a more refined product (6 Fr instead of 7 Fr, among other changes), the PROMISE II trial is currently enrolled at 18 sites in the United States and 4 in Japan. The trial is 65% enrolled.

The trial’s primary endpoint is amputation-free survival (AFS) at 6 months, defined as freedom from above-ankle amputation of the index limb and freedom from all-cause mortality.

Asked what role he expects the LimFlow system to one day play in revascularization in critical limb ischemia, Dr. N’Dandu said this:

“I think DVA is here to stay. We’re going to get better at doing it and it’s going to be part of our armamentarium. The reason why I say this is because we have an aging population, diabetes is not going anywhere, obesity is not going anywhere, and that’s the perfect recipe for the patients that we see.”

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