CHICAGO—Deep venous arterialization (DVA) using the LimFlow system (Inari Medical) may offer a substantially more economical alternative to conventional bypass grafting for patients with no-option chronic limb-threatening ischemia (CLTI), according to a study presented at the 2025 Clinical Congress of the American College of Surgeons.
Such patients, who have exhausted all revascularization options, face high rates of amputation, mortality, and healthcare utilization.
“We were inspired to conduct this study because patients with chronic limb-threatening ischemia who have exhausted all revascularization options face an unacceptably high risk of major amputation,” said Anahita Dua, MD, an associate professor of surgery at Massachusetts General Hospital and Harvard Medical School, in Boston.
“Transcatheter arterialization of deep veins (TADV) with the LimFlow system has emerged as a promising solution for this high-risk population, but there has been a critical gap in understanding whether this novel therapy is cost-effective compared to traditional bypass surgery,” Dr. Dua added. “Given the profound clinical and economic consequences of limb loss, we felt it was essential to generate rigorous, lifetime cost-effectiveness evidence to inform clinicians, payors, and policymakers.”
The study used a Markov cohort-state analysis model incorporating health states including successful procedure, reintervention, amputation, and death over a lifetime horizon. Transition probabilities were derived from institutional data and published literature, with costs based on hospital billing records. Utility values were taken from peer-reviewed sources, and sensitivity analyses were conducted to account for uncertainty.
A total of 36 patients treated between 2020 and 2024 were included; 18 received DVA and 18 underwent bypass grafting. DVA resulted in markedly lower lifetime costs of $879,598 versus $1,387,602 for bypass, driven by fewer amputations and lower initial procedural costs.
Although bypass grafting generated slightly higher total quality-adjusted life-years, the incremental cost-effectiveness ratios (ICERs) favored DVA—$138,529 per QALY gained for DVA versus $150,022 for bypass. DVA remained cost-effective under a wide range of model assumptions, and it retained cost-effectiveness at success rates as low as 65%. At a willingness-to-pay threshold of $50,000 per QALY, DVA was cost effective in 88.3% of simulations.
“The key message is that TADV is not only clinically beneficial for no-option CLTI patients, but it is also economically advantageous,” Dr. Dua said. “Our analysis shows that TADV is a dominant strategy—providing higher quality-adjusted life expectancy at substantially lower lifetime cost compared to bypass surgery. For eligible patients, TADV should be strongly considered as the preferred treatment option.”
Dr. Dua noted that further real-world and comparative data will be important.
“While our findings strongly support the long-term value of TADV, the study highlights several important areas for future research,” she said. “Additional work should examine real-world variation in outcomes across diverse practice settings, and future studies should compare TADV with LimFlow for not only high-risk patients, but also for intermediate-risk [patients].”