Transcatheter Arterialization of Deep Veins (TADV)

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Mehdi H. Shishehbor, DO, MPH, PhD^1,2; Shilpkumar Arora, MD, MPH^1
1University Hospitals Harrington Heart & Vascular Institute, Cleveland, Ohio; ²Professor of Medicine, Case Western Reserve University School of Medicine, Cleveland, Ohio

Disclosures: Dr. Mehdi Shishehbor reports he is a member of the global advisory board for Medtronic, Abbott Vascular, Boston Scientific, Inari Medical, ANT, and Inquis Medical. Dr. Shilpkumar Arora reports no conflicts of interest regarding the content herein.

The authors can be contacted via Mehdi H. Shishehbor, DO, MPH, PhD, at mehdi.shishehbor@uhhospitals.org.

Chronic limb-threatening ischemia (CLTI) represents the most advanced stage of peripheral artery disease (PAD), characterized by chronic ischemic rest pain, non-healing wounds, or gangrene in the lower extremities.¹ Despite advancements in surgical and endovascular treatments, up to 20% of CLTI patients are not candidates for revascularization due to the lack of suitable arterial targets or conduits for bypass surgery. These patients face a high risk of major amputations, with a 50% mortality rate within one year in patients over 65 years old.² The LimFlow system (Inari Medical) provides a new option by creating an arteriovenous fistula proximal to the diseased tibial arteries using a covered stent. This redirects oxygenated blood from the tibial arteries to the tibial veins, leveraging the venous system to deliver arterial blood to ischemic tissues, aiming to prevent major amputations and promote wound healing.³ The PROMISE II study has demonstrated the safety and efficacy of the LimFlow technique, showing high procedural success rates and significant improvements in amputation-free survival and wound healing among patients without conventional revascularization options.⁴

A 76-year-old female with a past medical history of heart failure with reduced ejection fraction, diabetes mellitus, atrial fibrillation on coumadin, chronic obstructive pulmonary disease, and left lower extremity CLTI (wound image, Figure 1A) presented for a second opinion following multiple failed surgical and endovascular revascularization attempts by experienced operators. The initial ankle-brachial index and toe brachial index is shown in Figure 1B. Given the lack of further surgical or endovascular options for revascularization, we proceeded with transcatheter arterialization of the deep veins (TADV) using the LimFlow system.

In the cardiac catheterization lab, the patient was sedated and anticoagulation was maintained with heparin (activated clotting time [ACT] >300). Ultrasound guidance was employed for vascular access. Access to the left lateral plantar vein was obtained using a micropuncture needle (Cook Medical) and a Command 14 wire (Abbott) was advanced cranially to the left popliteal vein. A 4-5 French 10 cm Glidesheath (Terumo) was placed in the left lateral plantar vein. Concurrently, left common femoral artery access was achieved under fluoroscopy, and a 7 French 55 cm Ansel sheath (Cook Medical) was advanced to the left popliteal artery from the left common femoral artery.

Plantar venography confirmed a complete plantar venous arch (Figure 3A). Angiography showed an ostial occlusion in the left posterior tibial artery. The ostial posterior tibial artery lesion was crossed with a Command 14 wire and CXI microcatheter (Cook Medical), and then dilated with a 3.0 mm x 120 mm

peripheral balloon (Figure 3B). Repeat angiography indicated a potential crossover segment at the proximal posterior tibial artery. A 5 mm x 100 mm peripheral balloon was advanced from the left lateral plantar vein to the left cranial posterior tibial vein to cross over the segment, and was dilated to mark the posterior tibial vein. Using the ARC device (LimFlow), the Nitrex wire (Medtronic) was crossed from the posterior tibial artery to the posterior tibial vein under fluoroscopy guidance (Figure 3C). The posterior tibial artery-posterior tibial vein crossover site was dilated with a 3.5 mm x 120 mm balloon (Figure 3D). Vector valvulotome (forward-cutting) (LimFlow) was used to destroy the valves of the posterior tibial vein. The posterior tibial vein-lateral plantar vein was stented with 5.5 mm x 150 mm (LimFlow) covered stents (two stents were placed) (Figure 4A). The posterior tibial artery-posterior tibial vein crossover site was stented with a 3.5 mm x 60 mm tapered covered stent (LimFlow) (Figure 4A). The stents were dilated with a 5.0 mm x 150 mm peripheral balloon in the venous segment and a 3.5 mm x 120 mm peripheral balloon in the arterial segment (Figures 4B-C).

The Nitrex wire was removed, and the plantar venous arch was crossed with a Command 14 wire and CXI microcatheter. The arch was dilated with a 3.0 mm x 80 mm peripheral balloon, and the lateral plantar vein sheath was removed, achieving hemostasis simultaneously (Figure 4D). The final angiogram demonstrated brisk flow through the TADV covered stent graft to the plantar venous arch without any flow-limiting residual stenosis, dissection, or perforation (Figure 5). Complete wound healing occurred over six months with extensive podiatry care (Figure 6).

Discussion

The treatment of chronic limb-threatening ischemia (CLTI) remains a significant challenge, particularly for patients who have exhausted

conventional revascularization options. In these “no-option” patients, the risk of major limb amputation is high, with substantial associated morbidity and mortality. Recent advancements, including transcatheter arterialization of deep veins (TADV), have shown promise in addressing this critical need.

Midterm outcomes from the ALPS study 5 support the effectiveness of TADV using the LimFlow device. This study included 32 patients with no-option CLTI and reported amputation-free survival rates of 83.9% at six months, 71.0% at 12 months, and 67.2% at 24 months. Limb salvage rates were similarly high, with 86.8% at six months, and 79.8% at 12 and 24 months. These outcomes were achieved despite the complexity of the patient population, which included a high prevalence of diabetes, renal insufficiency, and immunosuppression.⁵

The PROMISE II study further evaluated the safety and efficacy of the LimFlow system in a larger, multicenter cohort of 105 patients with no-option CLTI. The results showed a high technical success rate of 99%, with amputation-free survival rates of 66.1% at six months, significantly exceeding the performance goal of 54%. The study also reported substantial improvements in limb salvage and wound healing, with complete wound healing observed in 25% of patients and partial healing in 51%.⁴

Data from multiple centers further underscore the technical success and potential durability of the LimFlow procedure. High rates of limb salvage and wound healing were observed, with significant improvement in clinical outcomes. However, reintervention for circuit occlusion was relatively common, highlighting the need for ongoing monitoring and potential additional procedures to maintain patency.⁴

The current body of evidence underscores the potential of TADV to significantly improve outcomes in no-option CLTI patients. Existing studies highlight the importance of patient selection, procedural expertise, and comprehensive post-procedure care, including wound management, and monitoring for potential complications such as graft occlusion and venous hypertension.

Conclusion

The LimFlow procedure provides a promising alternative for patients with no-option CLI, potentially reducing the need for major amputations. This case demonstrates the potential of TADV in achieving limb salvage and highlights the importance of patient selection and procedural expertise. Future research should focus on long-term outcomes and optimization of this innovative technique. 

References

1. Conte MS, Bradbury AW, Kolh P, White JV, Dick F, Fitridge R, et al; GVG Writing Group for the Joint Guidelines of the Society for Vascular Surgery (SVS), European Society for Vascular Surgery (ESVS), and World Federation of Vascular Societies (WFVS). Global vascular guidelines on the management of chronic limb-threatening ischemia. Eur J Vasc Endovasc Surg. 2019; 58(1S):S1-S109.e33. doi:10.1016/j.ejvs.2019.05.006

2. Shishehbor MH, White CJ, Gray BH, Menard MT, Lookstein R, Rosenfield K, Jaff MR. Critical limb ischemia: an expert statement. J Am Coll Cardiol. 2016;68:2002-2015. doi:10.1016/j.jacc.2016.04.071

3. Clair DG, Mustapha JA, Shishehbor MH, Schneider PA, Henao S, Bernardo NN, Deaton DH. PROMISE I: early feasibility study of the LimFlow System for percutaneous deep vein arterialization in no-option chronic limb-threatening ischemia: 12-month results. J Vasc Surg. 2021;74:1626-1635. doi:10.1016/j.jvs.2021.04.057

4. Shishehbor MH, Powell RJ, Montero-Baker MF, Dua A, Martínez-Trabal JL, Bunte MC, Lee AC, Mugglin AS, Mills JL, Farber A, Clair DG; 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

5. Schmidt A, Piorkowski M, Görner H, Steiner S. Midterm outcomes of percutaneous deep venous arterialization with a dedicated system for patients. J Endovasc Ther. 2020;27(4):581-588. doi:10.1177/1526602820922179