Deep venous arterialization may benefit patients with severe CLI
In the single-arm PROMISE I study of deep venous arterialization in patients with severe critical limb ischemia, seven of 10 survived and were free from amputation at 1 year, according to data presented at the virtual VIVA 20.
The researchers used the system (LimFlow system, LimFlow) on 32 patients (mean age, 71 years; 66% men) with severe CLI not considered candidates for endovascular or surgical revascularization. Among the cohort, 69% had diabetes, 88% had hypertension and 34% had renal insufficiency.
“The study is an assessment of diversion of arterial flow from the tibial artery into the tibial veins, and directing that blood flow into the venous anatomy of the foot utilizing a purpose-built catheter, which is introduced from the arterial end to deliver and cross over from the arterial system into the venous system,” Daniel Clair, MD, chair of the department of surgery at Prisma Health-University of South Carolina Medical Group in Columbia, said during a presentation. “There is an antegrade valvulotome as part of this device, which allows us to lyse the valves all the way in to the foot itself, and then there are purpose-built covered self-expanding stents that extend from the foot all the way back to the crossover point.”
The population “was some of the most sick and most severely incapacitated patients that we deal with,” Clair said. “These are patients that we deem have no option for surgical or endovascular revascularization. [They] were nonrevascularizable from any approach.”
At 1 year, the rate of amputation-free survival was 70%, Clair said, noting that 91% of patients were still alive and 77% were free from amputation.
Average wound size dropped from 9.6 cm2 at baseline to 3.5 cm2 at 1 year and 0.5 cm2 at 2 years, he said.
According to core-lab results, 56% of patients had their wounds fully healed at 1 year, with 75% having fully healed or healing wounds. At 2 years, 75% of wounds were fully healed and 88% were fully healed or healing, Clair said.
“The lessons we learned include treat inflow arterial lesions effectively and monitor them after the procedure, access the pedal venous anatomy as distal as possible, maintain the preexisting arterial vessels and provide direct flow to the most distal portion of the foot or to the area of oxygenated flow needs,” he said.
“Clearly, the lessons we’ve learned from this initial trial will be valuable as we move forward with and continue to enroll patients in the PROMISE II trial,” Clair said. “We continue to gain insight into technical issues to improve outcomes for these patients.”
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Clair D, et al. Late-breaking clinical trials. Presented at: VIVA 20; Nov. 6-8, 2020 (virtual meeting).
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