Midterm Outcomes of Percutaneous Deep Venous Arterialization With a Dedicated System for Patients With No-Option Chronic Limb-Threatening Ischemia: The ALPS Multicenter Study

Abstract

Purpose: To evaluate the midterm results of patients suffering from no-option chronic limb-threatening ischemia (CLTI) treated with a dedicated system for percutaneous deep venous arterialization (pDVA). Materials and Methods: Thirty-two consecutive CLTI patients (mean age 67±14 years; 20 men) treated with pDVA using the Limflow device at 4 centers between 11 July 2014 and 11 June 2018 were retrospectively analyzed. Of all patients, 21 (66%) had diabetes, 8 (25%) were on immunosuppression, 4 (16%) had dialysis-dependent renal failure, 9 (28%) had Rutherford category 6 ischemia, and 25 (78%) were deemed at high risk of amputation. The primary outcome was amputation-free survival (AFS) at 6 months. Secondary outcomes were wound healing, limb salvage, and survival at 6, 12, and 24 months. Results: Technical success was achieved in 31 patients (96.9%). The median follow-up was 34 months (range 16–63). At 6, 12, and 24 months, estimates were 83.9%, 71.0%, and 67.2% for AFS, 86.8%, 79.8% and 79.8% for limb salvage, and 36.6%, 68.2%, and 72.7% for complete wound healing, respectively. Median time to complete wound healing was 4.9 months (range 0.5–15). The DVA circuit occluded during follow-up in 21 patients; the median time to occlusion was 2.6 months. Reintervention for occlusion was performed in 17 patients: 16 because of unhealed wounds and 1 for a newly developed ulcer. Conclusion: This study represents the largest population of patients with no-option CLTI treated with pDVA using the LimFlow device with midterm results. In this complex group of patients, pDVA using the LimFlow device has been shown to be feasible, with a high technical success rate and AFS at 6 up to 24 months coupled with wound healing. In selected patients with no-option CLTI, pDVA could be a recommended treatment to prevent amputation and heal wounds.

Volume Flow and Peak Systolic Velocity of the Arteriovenous Circuit in Patients after Percutaneous Deep Venous Arterialization

“…The pDVA procedure seems to be a promising option for patients with no-option CLTI [ 7 , 10 ]. Early detection of flow problems is required to prevent failure of the AV circuit.…”

“…Inclusion criteria for the pDVA procedure were Rutherford category ≥4, no angiographically evident distal target artery for endovascular therapy or a distal bypass, and at least 1 patent tibial artery in the proximal segment. Exclusion criteria were acute limb ischemia, extensive tissue loss or infection that precluded limb salvage, known deep vein thrombosis, allergy to aspirin or clopidogrel, and/or contraindication to anticoagulation [ 7 ]. Patient suitability for the pDVA procedure was assessed by an independent committee from Syntactx, including an experienced vascular surgeon and interventionalist.…”

“…The procedure was performed using the LimFlow device, as described in detail previously [ 4 , 7 ]. In brief, antegrade arterial access and distal venous access were achieved by ultrasound-guided puncture of the femoral artery and target tibial vein at the ankle, respectively.…”

More Data Are Needed to Elucidate the Achilles’ Heel of Percutaneous Deep Venous Arterialization

“…We read with interest the article published by Schmidt et al 1 reporting midterm outcomes of percutaneous deep venous arterialization (pDVA) in patients with no-option chronic limb-threatening ischemia (CLTI). We would like to congratulate the authors for reporting their relatively good 2-year amputation-free survival and wound healing rates.…”

“…Out of the 21 patients who had an occluded pDVA circuit, 81% (17/21) of patients required reinterventions for occlusion using a variety of techniques such as thrombolysis or mechanical thrombectomy. 1 The authors, however, did not report specifically how many total reinterventions were performed and stated only how many patients required reinterventions. With a median time to occlusion of only 2.6 months, we can expect some patients to have had multiple reinterventions performed.…”