Daniel Clair, MD
Professor and Chair
Department of Vascular Surgery
Vanderbilt University Medical Center
Nashville, Tennessee
dan.clair@vumc.org
Disclosures: Advisory and consultant to Boston Scientific, Bard Peripheral Vascular, Medtronic, and Inari LimFlow.

Factors such as advancing age,1 increasing diabetes prevalence,2 and rates of renal insufficiency3 are leading to a large number of patients with lower extremity arterial occlusive disease. These disease processes progressively lead to arterial calcification and impair outcomes of revascularizations performed in these patients.4 The ability of vascular specialists to address an increasing population of patients with chronic limb-threatening ischemia and poor options for revascularization challenges even those with the greatest skill. These patients, who often need amputation despite attempts at revascularization, can be left with no hope and persistent pain.5

Transcatheter arterialization of deep veins (TADV) with Inari LimFlow offers patients hope and the opportunity for limb preservation, which for many of these patients offers the chance to continue living an independent life.

Results from the PROMISE II trial reveal that not only can limb salvage be achieved, but a competent vascular specialist working in conjunction with meticulous wound care can quickly learn to repeat these results.6 In some patients, recognition of the poor circulation in the foot and the lack of adequate “collateral circulation” may allow this procedure to be offered prior to revascularization into a “dead-end” vessel that does not adequately provide circulation to the diseased area of the foot. Currently, patients with no distal target or no usable vein for revascularization are managed with wound care alone until pain is too severe, the wound becomes infected, and tissue infection leads to amputation or, in a minority of patients, until healing can be achieved.

This technique changes the paradigm in a way that nothing else to date has done. Revascularization can be achieved through the venous system with a percutaneous intervention in most situations; while limb salvage success is not as high as might be expected were the patients to have arterial revascularization options, it is clearly improved from the alternative expectant management.

Based on these results, I have been able to redefine what a “threatened limb without option” means for my practice. Whereas it used to mean the absence of a means of revascularization, that barrier has been lifted and it is now defined as uncontrolled infection.

Moving forward, this technique will become a part of every vascular specialist’s armamentarium for limb salvage, and facilities aiming to be centers for limb salvage will need to have this option available for their patients.

1. Wetrogan SI. Projections of the population of states, by age, sex, and race: 1988 to 2010. Curr Popul Rep Popul Estim Proj. 1988:1-124.

2. Lovic D, Piperidou A, Zografou I, at al. The growing epidemic of diabetes mellitus. Curr Vasc Pharmacol. 2020;18:104-109. doi: 10.2174/1570161117666190405165911

3. Eggers PW. Has the incidence of end-stage renal disease in the USA and other countries stabilized? Curr Opin Nephrol Hypertens. 2011;20:241-245. doi: 10.1097/MNH.0b013e3283454319

4. Lanzer P, Hannan FM, Lanzer JD, et al. Medial arterial calcification: JACC state-of-the-art review. J Am Coll Cardiol. 2021;78:1145-1165. doi: 10.1016/j.jacc.2021.06.049

5. Liu IH, Wu B, Krepkiy V, et al. Pedal arterial calcification score is associated with hemodynamic change and major amputation after infrainguinal revascularization for chronic limb-threatening ischemia. J Vasc Surg. 2022;76:1688-1697.e3. doi: 10.1016/j.jvs.2022.07.009

6. Shishehbor MH, Powell RJ, Montero-Baker MF, et al; PROMISE II Investigators. Transcatheter arterialization of deep veins in chronic limb-threatening ischemia. N Engl J Med. 2023;388:1171-1180. doi: 10.1056/NEJMoa2212754