Experts Share Practical Tips for Treating Complex CLI/PAD

Hollywood, FL (January 25, 2020) — In an afternoon session at the International Symposium on Endovascular Therapy, presenters reviewed practical tips and techniques for treating patients with complex critical limb ischemia (CLI) and peripheral arterial disease (PAD).

Fadi Saab, MD, discussed when to start recanalization from a retrograde approach. He explained the tibiopedal arterial minimally invasive retrograde revascularization (TAMI) procedure, which does not involve groin access and uses the pedal approach for crossing and delivering therapy.

“A lot of physicians are concerned about what you can do via pedal approach. Is it limited? Is it unlimited?” Dr. Saab said.

To address those concerns, he shared case examples illustrating best practices, concluding that the TAMI procedure is a safe and effective procedure for the treatment of PAD and CLI. Additionally, the implications for technical success are significant and exceed 90% of cases. Other benefits include potential time savings and an increase in safety profile. “Starting with pedal access may potentially be the standard of care as experience is gained among operators,” said Dr. Saab.

George Adams, MD, spoke about tibial recoil and learning how to recognize and treat this serious obstacle. Recoil continues to impede on the success of revascularization, particularly in tibial vessels, he noted.

“Personalization of care along with device selection may aid in reduction of recoil,” Dr. Adams said. However, he cautioned audience members, “don’t neglect other factors. Restenosis is also an important failure mechanism and biologic delivery may be aided with adequate vessel preparation.”

In the next presentation, John Rundback, MD, reviewed tibial scaffolds and study results, including TOBA II BTK 6-month pivotal data on the below-the-knee (BTK) use of the Tack Endovascular System (Intact Vascular). Tibial scaffolds are currently predominantly bailout technologies, he said, but Tack implants have the potential to allow more aggressive, “optimized” balloon angioplasty, he said. New platforms may allow primary treatment of longer and more complex lesions to improve clinical outcomes.

Dr. Saab returned to the podium to update the audience on the SAVAL tibial stent trial, which compared the Saval drug-eluting stent (DES) BTK vascular stent system (Boston Scientific) vs percutaneous transluminal angioplasty (PTA) for treating infrapopliteal lesions in patients with CLI. “It's a unique design where the tapering of the device distally is smaller than proximally. It's really designed for the tibial vessels,” he said. The stent is also self-expanding and flexible, and it has a drug coating so the paclitaxel is not just sprayed on the stent itself.”

He added, “Clinical studies suggest DES may be effective for treating infrapopliteal lesions, and dedicated research is underway.”

Next, Paul Michael, MD, imparted tips on understanding wires. He used the mnemonic ABCD (Access, Backup, Crossing, Delivery) to structure his advice. “When it comes to the tip [of the wire], it's all about the penetration power,” he said.

Regarding delivery, the device selected depends on what is being treated and becomes a functional selection of devices. Dr. Michael shared cases to illustrate his method, concluding, “When you get familiar with the properties and these wires, [selection] is just as easy as ABCD.”

Robert Lookstein, MD, evaluated whether long lesion infrapopliteal stent placement is effective. Long everolimus-eluting stents in infrapopliteal vessels are feasible following failed angioplasty, he noted. “In a real-world cohort with mean lesion length of over 10 cm, excellent freedom from clinically driven target lesion revascularization (CD-TLR) was maintained for Rutherford 4/5 patients at 12 months (83%),” he said. “Proximal edge lesions appear to be a frequent failure mechanism, so proximal/ostial disease may be best suited for this technology.” Overall, Rutherford 4 and 5 patients maintain the greatest clinical benefit.

Dr. Lookstein described how he personally approaches the use of the stents. “In my practice, I do not perform this as primary therapy. We still do long lesion, prolonged angioplasty, based on all the evidence available and the fact that this is obviously off-label use.”

“We use balloon-expandable DES for either short lesions throughout the infrapopliteal circulation or for proximal long lesions as bailout in the setting of acute recoil or flow-limiting dissection. I personally reserve atherectomy usually for dense calcification to facilitate other tools to be able to deliver to the target lesion.” He concluded, “I am eagerly awaiting dedicated implants for below the knee [use] in the United States.”

Jos van den Berg, MD, PhD, spoke on deep venous arterialization and patient selection and technique in patients with desert foot. Patient selection, as always, is important, he emphasized. Among other criteria, Dr. van den Berg recommends selecting patients with acceptable heart function and life expectance, absence of infection, and necrosis that has not advanced to the metatarsal bones.

Endovascular venous arterialization is safe and feasible, he said, and preliminary experience with endovascular venous arterialization yields similar results as surgical or hybrid procedures in patients with “no-option” CLI.

Continuing the conversation on deep venous arterialization, Richard Neville, MD, noted that up to 20% of patients with CLI are in need of revascularization. He discussed the surgical approach and reviewed the history of deep venous arterialization, going back to pioneers in the field such as Alex Carrel from the early twentieth century.

Dr. Neville shared current case examples of the pioneering technique, including a patient that he treated several weeks ago and who has been able to maintain their limb.