Optimizing acute limb ischemia treatment with a percutaneous-first approach

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Jayer Chung

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Acute limb ischemia (ALI) management is evolving as new thrombectomy technologies expand the role of endovascular intervention. Jayer Chung, MD, Professor and Medical Director in the Division of Vascular Surgery and Endovascular Therapy at Baylor College of Medicine, discusses why he favors a percutaneous-first approach, the evidence behind it and where he sees ALI treatment heading next.

Vascular Specialist: What is the state of ALI treatment and the current standard of care?

Jayer Chung, MD: The current standard of care is in a bit of flux. Open surgical strategies remain the gold standard but have become somewhat historical. Open surgical strategies include open embolectomy and/or bypass. However, over the last two decades, we’ve witnessed a proliferation of newer devices, such as aspiration thrombectomy and basket thrombectomy devices. These have expanded the range of patient presentations that are now able to be treated successfully via percutaneous means, to the point where many centers have shifted towards a percutaneous first approach for all ALI presentations.

Vascular Specialist: What is your preferred treatment strategy for ALI? Can you walk us through your decision-making process when choosing between different interventions?

Chung: My preferred treatment strategy is to try a percutaneous first approach. The base of the pyramid is percutaneous aspiration thrombectomy, followed by other percutaneous modalities as needed after reestablishing at least some minimal amount of flow. I reserve open surgical revascularizations for isolated emboli that present with signs and symptoms of concurrent compartment syndrome. The best example of this is if patients have an embolus to their tibial perineal trunk, with very severe either Rutherford 2B or 3 ischemia, with concurrent compartment syndrome. Since I’m making the incisions anyway, there’s minimal additional morbidity to the dissection required for a thrombectomy. I reserve the other modalities of percutaneous revascularization, (such as thrombolysis), for when the initial percutaneous aspiration thrombectomy fails (very rare) or provides a suboptimal result.

The percutaneous aspiration first technique has several benefits. One, it can immediately restore at least some flow to the foot and obviate the urgency of the danger of limb loss. Two, it provides better visualization of the anatomy, where blockages are and if there’s any underlying problems that can be corrected. It also reestablishes some antegrade flow which can alleviate the ischemia and also make other adjuncts like lysis work better.  Finally, since most can be achieved with moderate sedation, it avoids the complications associated with general anesthesia.

Vascular Specialist: You recently presented data at VAM 2026. Can you give an overview of the study and its key findings?

Chung: We presented a two-center retrospective cohort analysis with our colleagues from the University of North Carolina at Chapel Hill (Drs. McGinigle and Pascarella). The gap that we were trying to address was the paucity of literature that directly compares large modern cohorts of endovascular first versus open first revascularizations. Until our paper, there were no recent large cohorts with sufficient follow up comparing open versus endovascular revascularization in ALI.  Hence, we studied this over a nine-year period. We had 367 patients and 394 limbs. A little less than 30 were bilateral. Our median age was 65 and a little more than half were male.

The key findings were that at 90 days, the endovascular first and open first strategies had very similar outcomes with respect to amputation-free survival, mortality and limb salvage. At last follow-up, the endovascular first cohort experienced some interesting advantages with respect to amputation-free survival, driven mostly by the improved overall survival of the cohort.

It’s important to note that there were some baseline differences between the two cohorts. Embolic etiologies and more advanced ischemic presentations were more common in the open first cohort. However, the endovascular first cohort overall had a higher prevalence of atherosclerotic risk factors.

This also captured the evolution of the learning curve using endovascular first approaches. Over time, even for more severely ischemic presentations, both of the centers transitioned towards an endovascular first approach. It’s important to note this because we didn’t have an overarching protocol that dictated how people were supposed to revascularize patients.

Vascular Specialist: How does this data affect the treatment protocol for ALI patients?

Chung: This helps to expand the application of percutaneous first approaches towards a broader segment of the ALI population. There are some caveats to that. There’s a learning curve with percutaneous first approaches.  Second of all, there are some center specific effects, like the availability of all the devices, balloons, drugs, nursing staff, imaging capabilities.  But overall, in terms of the treatment algorithm, it shows that an endovascular first approach is at least as safe as and efficacious as an open first.

It also requires emphasis that the prospective randomized control trials that provide a lot of the foundational elements of our guidelines are 30 years old, which means that the data collected for them are probably closer to 40 years old. There’s been significant device evolution, drug evolution and other critical care evolution that has ensued since. Moreover, the natural history of the disease and the etiologies have changed. It’s less frequently due to an embolic source and is now more frequently due to a thrombotic source and in situ thrombosis and is therefore perhaps more amenable to percutaneous first strategies. It’s time we have a new set of studies with larger, more comprehensive, prospectively gathered data to compare open first versus endovascular first strategies.

Vascular Specialist: What is Lightning Bolt® and how does it differ from other mechanical thrombectomy systems?

Chung: Lightning Bolt capitalizes on computer assisted vacuum thrombectomy (CAVT™). There are several main advantages of the Penumbra system versus other devices.  The Lightning Bolt 7 catheter is different from other catheters as it’s constructed from stainless steel hypotube, with laser-cut etchings to provide both columnar strength while maintaining graduated flexibility. The

Lightning Bolt Console incorporates proprietary algorithms that analyze material passing through the aspiration tubing in real time to differentiate thrombus from blood and adjust aspiration accordingly.

The final thing is the modulated aspiration which occurs in the Lightning Bolt console with the infusion of saline. Lightning Bolt uses saline to vent between vacuum and ambient pressure to modulate aspiration and break down clot for faster removal. This is designed to minimize blood loss historically associated with vacuum thrombectomy. This alternating of saline and aspiration also helps to dislodge any impacted thrombus at the tip, designed to reduce the potential for tip occlusion observed with earlier catheter designs. This makes the removal of thrombus, more technically feasible while striving to keep  blood loss to a minimum.

Vascular Specialist: What are you hoping to see in the next three to five years for ALI treatment?

Chung: This field is ripe for a lot of study. As I said before, the foundational randomized control trial data for this is at least 40 years old. It begs the question of how to best study the device and therapeutic evolution. I think there’s two ways to look at this. One is what new devices do we need? And two, what clinical trials do we need in the future to best answer the question of whether or not endovascular first versus open first is best?

With regard to devices, I would love to see a marriage between aspiration thrombectomy and the basket retrieval systems. There’s always going to be some cases where one tool just doesn’t work and another one will. But if we can marry the two, we can capitalize on the advantages of both without increasing morbidity.

With regard to clinical studies, at the very least, we need larger, multicenter, prospectively maintained databases that track and compare outcomes between newer devices and therapeutics as they evolve. The question of whether we need a prospective randomized control trial for this, I’m a little uncertain about. Since prospective randomized control trials have become the standard teaching in most medical schools, this is what moves the needle most. I would also argue that since that time, there’s been rapid evolution in computer processing capabilities, AI algorithms and therefore the ability to perform advanced biostatistics on real time data that may obviate the need for an actual prospective randomized control trial.

Procedural and operative techniques and considerations are illustrative examples from physician experience. Physicians’ treatment and technique decisions will vary based on their medical judgment. The clinical results presented herein are for informational purposes only and may not be predictive for all patients. Individual results may vary depending on patient-specific attributes and other factors. 

Caution: Federal (USA) law restrictions these devices to sale by or on the order of a physician. Prior to use, please refer to the Instructions for Use for complete product indications, contraindications, warnings, precautions, potential adverse events, and detailed instructions for use. Please visit https://www.penumbrainc.com/pdf/brief-summaries-risk-statement/ for the complete IFU Summary Statements. Please contact your local Penumbra representative for more information.

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