Pietzsch JB,  Ederhof M, Geisler BP, Schneider PA Cost-effectiveness of percutaneous deep vein arterialization for patients with no-option chronic limb-threatening ischemia: an exploratory analysis based on the PROMISE I Study. J Crit Limb Ischem. 2021;1(4):E148-E157. Epub 2021 July 26.

Background. As the most advanced stage of peripheral arterial disease (PAD), chronic limb-threatening ischemia (CLTI) is associated with a high risk of lower-limb loss and mortality. Percutaneous deep vein arterialization (pDVA) is a promising new treatment alternative for CLTI patients who cannot be treated with conventional revascularization techniques. Our study objective was to explore the potential cost-effectiveness of treatment with the LimFlow pDVA system (LimFlow SA) in the United States healthcare system. 

Methods. We developed a decision-analytic Markov model to project costs and outcomes over the patients’ lifetimes, together with the corresponding incremental cost-effectiveness ratio (ICER) in dollars per quality-adjusted life year (QALY) gained. Amputation-free survival (AFS), reintervention, and wound healing data for pDVA and for the status quo treatment were obtained from 1-year data of the recent PROMISE I study, from a historical control identified through systematic search and meta-analysis, and from other published data. Treatment costs were obtained from Medicare claims and published sources. Extensive sensitivity and scenario analyses were conducted to explore the effects of uncertainty about long-term outcomes and of a potential add-on reimbursement for the pDVA system. 

Results. The 12-month AFS rates for the pDVA and status quo groups were 69.7% and 33.3%, respectively. In the base case analysis, pDVA added 1.45 QALYs (2.80 vs 1.35) and incurred $23,903 in additional costs ($122,341 vs $98,438), resulting in an ICER of $16,522 per QALY gained. Incorporating a new technology add-on payment of $15,000 for pDVA increased the ICER to $26,891 per QALY gained. The pDVA procedure remained cost-effective across all tested scenarios, including scenarios for which pDVA was assumed not to have a survival benefit beyond 12 months when compared with the status quo treatment (range of QALY gains in scenarios, 0.30-1.93). 

Conclusion. This study indicates that pDVA performed with the LimFlow system, based on preliminary data, may contribute substantial improvements in clinical outcomes at incremental costs that would render it a cost-effective, high-value intervention.