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Deep vein arterialization for chronic limb-threatening ischemia: from PROMISE to practice
Patrick Heindel1, Jeremy Darling1, Camila R Guetter1
1Division of Vascular and Endovascular Surgery, Department of Surgery, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, USA.
Insights
Deep venous arterialization (DVA) offers limb salvage for chronic limb-threatening ischemia patients. Real-world outcomes lag behind trial data, highlighting the need for careful patient selection and experienced centers.
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.
Abstract:
A subset of patients with chronic limb-threatening ischemia (CLTI) lack viable options for traditional arterial revascularization - often termed "no-option" patients - and have historically faced primary major amputation as the default treatment. Deep venous arterialization (DVA) has emerged as a potential limb salvage strategy for this challenging population, involving the creation of an arteriovenous fistula to deliver oxygenated blood via the venous system to the ischemic foot. The approval of the LimFlow System by the United States Food and Drug Administration (FDA) in 2023, following the PROMISE II trial, has generated considerable interest in this approach. Prospective studies report 6-month amputation-free survival of 66% and limb salvage of 76% after percutaneous DVA. However, real-world Medicare data demonstrate substantially inferior outcomes, with 6-month amputation-free survival of only 42% and 1-year amputation-free survival of 33%. This discrepancy likely reflects differences in patient selection, operator experience, and institutional resources between clinical trials and routine practice. Outcomes are particularly poor in dialysis-dependent patients. Critical evidence gaps remain, including the absence of randomized controlled trials comparing DVA to intensive wound care alone, limited patient-reported outcome data, and undefined cost-effectiveness. Despite an evolving evidence base, DVA represents a promising treatment for carefully selected no-option patients at centers capable of providing comprehensive wound care, close surveillance, and timely reintervention.
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