Percutaneous deep venous arterialization in an OBL setting

Percutaneous Deep Venous Arterialization in Patients with No-Option Critical Limb Ischemia Performed in an Office-Based Laboratory Setting

Clinical Question

Is percutaneous deep venous arterialization with commercially available devices safe and feasible in an office-based laboratory among patients with critical limb ischemia and no-option distal arterial occlusive disease?

Take Away Point

Percutaneous deep venous arterialization using commercially available devices in an office-based setting, despite having high rates of occlusion and reintervention, showed favorable rate of overall survival and amputation-free survival along with improved wound healing.

Reference

Shanmugasundaram S, Herman K, Rundback JH. Percutaneous deep venous arterialization in patients with no-option critical limb ischemia performed in an office-based laboratory setting. Journal of Vascular and Interventional Radiology. Published online October 2023. doi:10.1016/j.jvir.2023.10.003

Study Design

Retrospective, observation study consisting of 22 patients

Funding Source

No reported funding

Setting

Private, NJ Endovascular and Amputation Prevention Center, West Orange, New Jersey

Figure

Summary

Endovascular reconstructions have been one of the mainstays in addressing peripheral vascular disease. However, subsets of patients have severe degree of disease such that traditional approaches are not feasible due to lack of distal targets to re-establish flow, with high risks of amputation and mortality. The emergence of deep venous arterialization attempts to mitigate this challenge, and has evolved from a purely surgical technique to a percutaneous, office-based, procedure.

The authors of this paper performed a retrospective observational study to assess the safety and feasibility of percutaneous deep venous arterialization in an office-based laboratory for patients with no-option critical limb ischemia. The study consisted of 22 patients (10 males and 12 females) who underwent the procedure from January 2018 and November 2021. All 22 patients were classified as having no-option disease characterized as chronic total occlusion, previous failed endovascular/open surgical approaches, or absence of reconstituted arteries for surgical bypass in the lower leg or foot. Primary outcome was amputation-free survival at 6 months. Secondary outcomes comprised of primary and secondary graft patency of arteriovenous conduit, limb salvage, wound healing, change in Rutherford classification, reintervention rate and overall survival, all of which were tabulated at 30 days, 6 months, and 12 months. Technical success was defined as antegrade blood flow through the venous circuit. The technique is summarized in Figure 1.

The results demonstrated 95.5% technical success rate. While the primary graft patency significantly decreased over time and the reintervention rate subsequently increased, the amputation-free survival and overall survival plateaued at 70.3% and 83.6% respectively within the follow-up period. Furthermore, more than 75% of the patients in each time interval experienced improved wound healing and more than 50% experienced improvement in the Rutherford classification system throughout the 12 months.

These results show that percutaneous deep venous arterialization using commercially available devices helps delay amputation, improves survival, and enables wound healing. Of note, there are other larger trials which explored similar questions, namely PROMISE I, PROMISE II, and ALPS trial via Limflow system, and showed comparable results.

The occlusion rate of the arteriovenous conduit in a short period of time is a concern in this article as well as the aforementioned larger trials. The authors believe that the predominant cause is the progression of venous stenosis distal to the stent graft in the pedal venous outflow. As a result, self-expanding stents were used increasingly during posterior tibial percutaneous deep venous arterialization. The use of valvulotome in the Limflow system may also help address this. The other possible explanation for the high occlusion rate is that it is a consequence of venous arterialization akin to a hemodialysis fistula.

Despite the high occlusion rate of the arteriovenous conduit, the rate of wound healing was favorable across the 12-month span. The authors initially attributed the wound healing to retrograde flow through the presumed nonobstructed venous circuit into the retrograde capillary bed. The current hypothesis is that by promoting blood flow into the distal capillary beds of the leg/foot via intervention, oxygenation is improved and flow to hibernating collaterals is increased, leading to cascades of physiological responses including angiogenesis which promote wound healing.

The dissociation between high occlusion rates of the arteriovenous conduit and improved wound healing served as an important limitation of the study. It is unclear if the wound healing was attributed to the procedure alone or the improved wound care patients received through multidisciplinary approach. Additional limitation of the study was the retrospective nature of the study and inability to compare outcomes with a control group or those who underwent surgical deep venous arterialization. Additionally, multiple patients lost to follow-up over 12-month period made it difficult to assess the long-term effects or the durability of the procedure.

Commentary

The study investigated the feasibility of percutaneous deep venous arterialization in patients with critical limb ischemia. Despite the limitations of the study, the results were overall favorable to confidently allow appropriately trained specialists to offer it as an option to otherwise no-option patients with critical limb ischemia. More studies, such as the actively undergoing PROMISE III trial, can further aid in understanding of the intervention. If the Limflow system were to be approved for use in the United States, the dedicated valvulotome in the device can help combat the distal venous stenosis likely contributing to the high occlusion rate of the conduit.

One interesting aspect mentioned in the article is that it is unclear if the improved rate of wound healing was attributed to the procedure alone or the multidisciplinary approach of postprocedural wound care. My opinion is that this uncertainty actually highlights the effectiveness multidisciplinary approach can bring to the table. It fosters a holistic approach to patient care, enabling us to make tailored and coordinated clinical decisions to patients. In the long run, this integrates interventional radiology as an integral member of the treatment team and the proceduralists’ clinical opinions into consideration outside of the procedural room.

Post author

Naeem Patel, DO
Radiology Resident, PGY4
Department of Radiology, Interventional Radiology Division
Hartford Hospital, Hartford, CT
@Naeemp7Patel