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Percutaneous deep vein arterialization system safe, effective for ‘no-option’ CLI
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Early clinical results in a small cohort demonstrate safety and feasibility of a percutaneous deep vein arterialization system for the treatment of patients with critical limb ischemia who have no traditional endovascular or surgical revascularization options.
The data, published in the Journal of Endovascular Therapy, highlight the benefits of the LimFlow Percutaneous Deep Vein Arterialization System, which utilizes uses an endovascular method to achieve venous arterialization. The system features ultrasound-guided catheters and covered nitinol stents to bypass diseased arteries and divert blood flow into the tibial vein, according to a company release.
“Percutaneous deep vein arterialization is an innovative approach for treating no-option CLI and represents an alternative option for the ‘desert foot,’ potentially avoiding major amputation,” Steven Kum, MD, from the department of surgery at Changi General Hospital in Singapore, stated in the release. “Our results demonstrate its safety and feasibility with promising early clinical results in this small cohort.”
The small pilot study included seven patients (five women; median age, 85 years). All of the patients had diabetes and four had Rutherford category 6 ischemia. Six patients were classified as having high risk for amputation, based on the Society for Vascular Surgery WIfI (wound, ischemia and foot infection) classification.
Thirty-day major adverse limb events, 30-day major adverse coronary events and serious adverse events through 6 months were the primary safety endpoints of the study.
Technical success was achieved in all patients (100%).
At 30 days, the researchers reported no evidence of device-related death, above-the-ankle amputation or major reintervention in the seven patients. Two MIs occurred within the 30-day period, but the researchers noted minor clinical consequences. Due to causes unrelated to the procedure or device, three patients died within 8 months, according to the results.
Symptomatic improvement with formulation of granulation tissue, rest pain resolution, or both, was achieved in all patients, according to the results.
Complete wound healing was observed in four patients at 6 months and five patients at 12 months. The median healing time was 4.6 months.
Transcutaneous partial pressure of oxygen was a secondary outcome of the trial. Median peak transcutaneous partial pressure of oxygen was 8 mm Hg before the procedure compared with 61 mm Hg after the procedure (P = .046). Four of five patients had levels greater than 40 mm Hg at the time of wound healing.
Two major amputations occurred during the study period. One amputation was above the knee after the occurrence of percutaneous deep vein arterialization thrombosis and the other was below the knee as a result of infection, according to the results.
At 12 months, the researchers reported a limb salvage rate of 71% among all patients.
“In this small cohort of patients, percutaneous deep vein arterialization appears to be effective in improving limb oxygenation, encouraging wound healing and potentially avoiding major amputation,” Kum and colleagues wrote in the study. “Although these initial results are promising, they need to be verified in larger studies, though it will remain challenging to prove the concept in this complex group of patients.”– by Dave Quaile
Disclosure: Kum reports receiving consultant fees from LimFlow.
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