Deep vein arterialization for chronic limb-threatening ischemia: from PROMISE to practice

Area of Science:

• Vascular Surgery
• Interventional Cardiology
• Regenerative Medicine

Background:

• Chronic limb-threatening ischemia (CLTI) presents limited options for many patients, often leading to amputation.
• Deep venous arterialization (DVA) is an emerging strategy to salvage limbs by rerouting arterial blood through the venous system.
• The LimFlow System's FDA approval has increased interest in DVA for

Purpose of the Study:

• To evaluate the effectiveness of deep venous arterialization (DVA) as a limb salvage strategy for "no-option" patients with CLTI.
• To compare outcomes from prospective studies with real-world data for percutaneous DVA.
• To identify factors influencing the discrepancy in DVA outcomes between clinical trials and routine practice.

Main Methods:

• Analysis of prospective studies and real-world Medicare data on percutaneous DVA for CLTI.
• Review of amputation-free survival and limb salvage rates at 6 months and 1 year.
• Identification of patient selection, operator experience, and institutional resources as key variables.

Main Results:

• Prospective studies show 6-month amputation-free survival of 66% and limb salvage of 76% after DVA.
• Real-world Medicare data reveal significantly lower 6-month (42%) and 1-year (33%) amputation-free survival.
• Outcomes are notably worse for dialysis-dependent patients.

Conclusions:

• A significant gap exists between DVA trial results and real-world effectiveness, likely due to patient selection and practice variations.
• Further research, including randomized controlled trials and patient-reported outcomes, is needed to define DVA's role.
• DVA is a promising option for select CLTI patients at specialized centers with comprehensive care capabilities.