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J Vasc Surg ; 74(5): 1626-1635, 2021 11.
Article in English | MEDLINE | ID: mdl-34019990

ABSTRACT

OBJECTIVE: We report the 6- and 12-month outcomes of the PROMISE I early feasibility study after treatment of no-option chronic limb-threatening ischemia (CLTI) with percutaneous deep vein arterialization (pDVA) using the LimFlow System. METHODS: Thirty-two patients with no-option CLTI, previously offered major amputation, were enrolled in this single-arm early feasibility study of the LimFlow pDVA System. No-option CLTI was defined as being ineligible for surgical or endovascular arterial revascularization. Patients were assessed for clinical status, pain, wound healing, and duplex ultrasound at 30 days, 6 months, and 12 months post-treatment. Primary endpoint analysis was amputation-free survival (AFS) at 30 days and 6 and 12 months. AFS was defined as freedom from above-ankle amputation of the index limb and freedom from all-cause mortality. Secondary endpoints evaluated included technical success of the procedure, and wound healing at 6 and 12 months. RESULTS: Of 32 enrolled patients, 31 (97%) were successfully treated with the LimFlow System at the time of the procedure, and two (6.3%) were lost to follow-up. The 30-day, 6-month, and 12-month AFS rates were 91%, 74%, and 70% respectively. The wound healing status of fully healed or healing was 67% at 6 months, and 75% at 12 months. Reintervention was performed in 16 patients (52%) with 14 (88%) of the maintenance reinterventions occurring within the first 3 months. The majority of reinterventions (n = 12; 75%), involved the arterial inflow tract proximal to the stented LimFlow circuit, and no in-stent stenoses were determined to have been the cause of reintervention. CONCLUSIONS: The LimFlow pDVA System was utilized in treating patients with no-option CLTI. A high technical success rate was observed, with a significant percentage of patients surviving free of major amputation at 12 months. These results suggest early safety and provide an initial assessment of the efficacy of the LimFlow pDVA System that supports the expansion of carefully executed studies to determine whether this is a viable option that can be used in this critically disadvantaged and growing patient population.


Subject(s)
Blood Vessel Prosthesis Implantation/instrumentation , Blood Vessel Prosthesis , Endovascular Procedures/instrumentation , Ischemia/surgery , Lower Extremity/blood supply , Peripheral Arterial Disease/surgery , Stents , Vascular Access Devices , Aged , Aged, 80 and over , Amputation, Surgical , Blood Vessel Prosthesis Implantation/adverse effects , Chronic Disease , Endovascular Procedures/adverse effects , Feasibility Studies , Female , Humans , Ischemia/diagnostic imaging , Ischemia/physiopathology , Limb Salvage , Male , Middle Aged , Peripheral Arterial Disease/diagnostic imaging , Peripheral Arterial Disease/physiopathology , Prospective Studies , Regional Blood Flow , Retreatment , Time Factors , Treatment Outcome , United States , Vascular Patency
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