Below-the-Knee Endovascular Revascularization: A Position Statement.

Patients with chronic limb-threatening ischemia, the terminal stage of peripheral artery disease, are frequently afflicted by below-the-knee disease. Although all patients should receive guideline-directed medical therapy, restoration of inline flow is oftentimes necessary to avoid limb loss. Proper patient selection and proficiency in endovascular techniques for below-the-knee revascularization are intended to prevent major amputation and promote wound healing. This review, a consensus among an international panel of experienced operators, provides guidance on these challenges from an endovascular perspective and offers techniques to navigate this complex disease process.

Drug-Eluting Resorbable Scaffold versus Angioplasty for Infrapopliteal Artery Disease.

BACKGROUND: Among patients with chronic limb-threatening ischemia (CLTI) and infrapopliteal artery disease, angioplasty has been associated with frequent reintervention and adverse limb outcomes from restenosis. The effect of the use of drug-eluting resorbable scaffolds on these outcomes remains unknown. METHODS: In this multicenter, randomized, controlled trial, 261 patients with CLTI and infrapopliteal artery disease were randomly assigned in a 2:1 ratio to receive treatment with an everolimus-eluting resorbable scaffold or angioplasty. The primary efficacy end point was freedom from the following events at 1 year: amputation above the ankle of the target limb, occlusion of the target vessel, clinically driven revascularization of the target lesion, and binary restenosis of the target lesion. The primary safety end point was freedom from major adverse limb events at 6 months and from perioperative death. RESULTS: The primary efficacy end point was observed (i.e., no events occurred) in 135 of 173 patients in the scaffold group and 48 of 88 patients in the angioplasty group (Kaplan-Meier estimate, 74% vs. 44%; absolute difference, 30 percentage points; 95% confidence interval [CI], 15 to 46; one-sided P<0.001 for superiority). The primary safety end point was observed in 165 of 170 patients in the scaffold group and 90 of 90 patients in the angioplasty group (absolute difference, -3 percentage points; 95% CI, -6 to 0; one-sided P<0.001 for noninferiority). Serious adverse events related to the index procedure occurred in 2% of the patients in the scaffold group and 3% of those in the angioplasty group. CONCLUSIONS: Among patients with CLTI due to infrapopliteal artery disease, the use of an everolimus-eluting resorbable scaffold was superior to angioplasty with respect to the primary efficacy end point. (Funded by Abbott; LIFE-BTK ClinicalTrials.gov number, NCT04227899.).

Endovascular and Surgical Venous Arterialization for No-Option Patients With Chronic Limb-Threatening Ischemia: A Systematic Review and Meta-Analysis.

BACKGROUND: Chronic limb-threatening ischemia (CLTI) is known for its high rates of major amputation and mortality. Conventional revascularization techniques often fail in CLTI patients due to the heavily diseased arteries. Foot vein arterialization (FVA) has been proposed as an alternative technique to provide arterial blood to the foot by using the disease-free venous bed. OBJECTIVES: This systematic review and meta-analysis aimed to determine outcomes of surgical FVA (sFVA) and percutaneous FVA (pFVA) at 6 and 12 months post-procedure. DATA SOURCES: PubMed, Scopus, Web of Science, and the Cochrane Library databases were searched to identify papers reporting clinical outcomes of sFVA and pFVA published between January 1966 and March 2023. METHODS: Databases were searched for eligible studies. A meta-analysis was performed to evaluate the limb salvage rate, overall survival rate, and wound healing rate at 6 and 12 months. RESULTS: A total of 27 studies were included, with 753 patients and 793 limbs. Of the included studies, 16 analyzed the sFVA technique and 11 the pFVA technique. Of the included patients, 86.3% were Rutherford 5/6 in the sFVA group versus 98.4% in the pFVA group. The pooled limb salvage rate at 6 and 12 months was 78.1% and 74.1% in the sFVA group and 81.7% and 78.6% in the pFVA group, respectively. Wound healing rates were not reported in the sFVA group. In the pFVA group, the pooled wound healing rates were 48.1% and 64.5% at 6 and 12 months, respectively. CONCLUSION: This study showed promising results after FVA among a large population of CLTI patients. In high-risk patients, pFVA is a feasible option with favorable limb salvage and wound healing rates.

Postprocedural Management in Patients After Percutaneous Deep Venous Arterialization: An Expert Opinion.

CLINICAL IMPACT: After percutaneous deep venous arterialization (pDVA), the created arteriovenous circuit needs time to develop. Postprocedural care in patients after pDVA is essential in order to create optimal conditions for maturation of the circuit, and thus save the limb. However, current literature mainly focusses on the procedure itself, making postprocedural care an underexposed topic. Therefore, this study presents an overview of the available literature of postprocedural care of pDVA patients and provides recommendations based on expert opinion when current knowledge is limited.

Clampless 2 Device: Experimental Study of a Lateral Aorto-Prosthetic Anastomosic Device Without Clamping or Suturing.

BACKGROUND: To offer an alternative to conventional techniques of lateral prosthetic anastomosis on arteries which require a long training, and impose an extensive open surgery, we are proposing the clampless 2 device (C2D) implanted by a simple arterial puncture and allows a lateral implantation of a polytetrafluoroethylene (PTFE) vascular graft in an artery, without arterial clamping or suture. METHODS: C2D is a "T" shaped 25-mm long and 8-mm diameter Nitinol stent with a 6-mm PTFE graft prosthesis mounted laterally on the stent, and implanted in an artery, via a 21-French sheath, and a compliant balloon inflation. In vitro testing of the C2D was first performed on a bench including a segment of a 7-mm internal diameter pig abdominal aorta. A series of 5 consecutive C2D implantation was analyzed with evaluation of the implantation time and the fluid losses at a fluid pressure of 80 and 150 mm Hg. The C2D implantation was finally controlled by angioscopy. An aorto-iliac bypass was then secondly performed on 8 living sows, with a side-to-end C2D implantation in the infrarenal abdominal aorta, followed by a conventional end-to-end prosthetic left iliac trunk anastomosis. The C2D and distal conventional anastomotic times were evaluated, as well as the total operative time and blood loss. A postoperative angiogram was systematically performed. RESULTS: The C2D was successfully implanted in all 5 in vitro tests, with an average implantation time of 2'58 (range: 2'25-3'22). The mean value of fluid losses was 84 ml (range: 67-94 ml), with no fluid leakage occurring at 80- and 150-mm Hg pressure. All anastomoses were patent after macroscopic study by angioscopy with a perfect application of the stent in the aortic wall. In 8 living sows (mean weight: 42 kg, 37-50 kg), an aorto-left iliac bypass was successfully implanted in all cases, with a total mean procedure time of 101 min (range: 90-130 min), and an average fluid loss of 77 ml (range:20-120 ml). The mean implantation time was 4'39 (range 3'29-5'52) for C2D and 16 min (range 12-17 min) to perform the conventional distal prosthetic-iliac anastomosis. Systematic arteriographic and angioscopy control showed perfect patency of the C2D implantations. CONCLUSIONS: Preliminary in vitro and acute in vivo testing of C2D implantation show good early results, allowing further long-lasting pig experiments on the way to human homologation.

Long-term outcomes after paclitaxel-coated balloon angioplasty of femoropopliteal arteries in Asian patients of the IN.PACT Global Study.

OBJECTIVES: The long-term data on the use of drug-coated balloons (DCBs) for femoropopliteal atherosclerotic lesions in the real-world setting are limited, even more so for racially and geographically distinct populations. The present analysis reports the 5-year safety and effectiveness outcomes of a DCB in the Asian subset of the prospective, real-world IN.PACT Global Study. METHODS: The IN.PACT Global Study was a prospective, multicenter, international, single-arm study designed to assess the long-term safety and effectiveness of the IN.PACT Admiral DCB in real-world participants with femoropopliteal artery disease. The present analysis included 114 Asian participants (138 lesions) treated in South Korea and Singapore. Assessments through 5 years included freedom from clinically driven target lesion revascularization, the safety endpoint (a composite of freedom from device- and procedure-related mortality through 30 days; and freedom from major target limb amputation and clinically driven target vessel revascularization within 60 months after the index procedure) and major adverse events. RESULTS: In this prespecified Asian subset, there was a high incidence of diabetes mellitus (54.4%), hypertension (78.1%), coronary artery disease (43.9%), and concomitant below-the-knee vascular disease of target leg (39.5%). Mean lesion length was 17.4 ± 12.4 cm; 26.8% were in-stent restenosis, and more than half of the lesions were totally occluded (51.4%) and calcified (54.3%). The 5-year Kaplan-Meier estimate of freedom from clinically driven target lesion revascularization was 77.1% (95% confidence interval: 67.0%-84.5%). The safety composite endpoint was 76.0%; the cumulative incidence of all-cause mortality was 19.9%, and no major target limb amputations were reported through 5 years. CONCLUSIONS: This subset analysis of Asian participants from the IN.PACT Global Study demonstrated consistent results with the previously reported data of the IN.PACT Admiral DCB. The data confirm the durable clinical effectiveness and safety profile of the DCB through 5 years for femoropopliteal atherosclerotic disease in this real-world population.

The Retrograde Basilic Approach for Balloon-Assisted Maturation of Brachiocephalic Arteriovenous Fistulas.

PURPOSE: To assess the feasibility and outcomes of an approach utilizing transbasilic access for balloon-assisted maturation (BAM) of brachiocephalic arteriovenous fistulas (BCAVFs). MATERIALS AND METHODS: This retrospective analysis comprised 28 patients (mean age, 63 years ± 10.8) who underwent endovascular treatment of their immature BCAVFs via a basilic approach from December 2016 to December 2018. The mean age of the BCAVFs was 3.3 months ± 1.4 at the time of BAM. Other demographic data, vascular access characteristics, procedural data, technical and clinical success rates, and adverse events were also evaluated. RESULTS: All patients had inflow juxta-anastomotic stenoses, with 4 patients (14%) having concomitant outflow tract stenoses and 1 patient (4%) having a short-segment occlusion at the stenotic juxta-anastomotic segment. Technical success was achieved in 27 patients (96%). The mean diameter of the largest balloon used was 5.7 mm ± 0.6. Clinical success was achieved in 22 patients (79%), with 6 patients (21%) requiring a subsequent additional intervention before successful cannulation. No perioperative adverse events were observed. CONCLUSIONS: The retrograde basilic approach is feasible, safe, and effective for BAM of BCAVFs.

Novel technique of percutaneous bypass in a brachiocephalic arteriovenous fistula with cephalic arch occlusion: A case report.

OBJECTIVE: Arteriovenous fistulas are a principal mainstay of long-term dialysis access for patients with end stage renal failure. However, the patency of arteriovenous fistulas is limited, often requiring percutaneous transluminal angioplasty as a salvage procedure. We report a case of percutaneous method of arteriovenous fistula salvage. METHODS: A gentleman with brachiocephalic arteriovenous fistula created in 2015 was admitted under us for dialysis access issue. His fistula history was notable for recurrent and refractory venous outflow stenosis of the cephalic vein and the cephalic arch with multiple previous interventions. Ultrasound showed cephalic arch occlusion with high venous pressures. He underwent left brachicephalic fistula percutaneous bypass. We describe the percutaneous creation of a brachial-subclavian arteriovenous fistula via a bypass graft from a worsening brachial-cephalic fistula with cephalic arch occlusion that is not amendable to angioplasty. RESULTS: Final angiogram showed smooth flow to central vein. He is 2 years post procedure, and his fistula remained patent with no interventions required. CONCLUSION: Percutaneously created jump bypass grafts can reliably produce sustained long-term patency.

Development of a Prediction Model for the Occurrence of Stenosis or Occlusion after Percutaneous Deep Venous Arterialization.

Percutaneous deep venous arterialization (pDVA) is a promising treatment option in patients with chronic limb-threatening ischemia. Stenosis and occlusions, which are the Achilles' heel of every revascularization procedure, can be treated when detected early. However, frequent monitoring after pDVA is required because when stenosis or occlusions develop is unknown. Therefore, patients currently need to visit the hospital every 2 weeks for surveillance, which can be burdensome. Accordingly, we aimed to develop a model that can predict future stenosis or occlusions in patients after pDVA to be able to create tailor-made follow-up protocols. The data set included 343 peak systolic velocity and 335 volume flow measurements of 23 patients. A stenosis or occlusion developed in 17 patients, and 6 patients remained lesion-free. A statistically significant increase in the risk of stenosis or occlusion was found when duplex ultrasound values decreased 20% within 1 month. The prediction model was also able to estimate a patient-specific risk of future stenosis or occlusions. This is promising for the possibility of reducing the frequency of follow-up visits for low-risk patients and increasing the frequency for high-risk patients. These observations are the starting point for individual surveillance programs in post-pDVA patients. Future studies with a larger cohort are necessary for validation of this model.

Outcomes of the paclitaxel-eluting Eluvia stent for long femoropopliteal lesions in Asian patients with predominantly chronic limb-threatening ischemia.

The fluoropolymer-coated, paclitaxel-eluting Eluvia stent has shown promising results for the endovascular treatment of femoropopliteal artery lesions in patients with claudication. The aim of the current study was to evaluate efficacy and safety outcomes of the Eluvia stent for the treatment of long femoropopliteal lesions in Asian patients. This is a single-center, retrospective study. The primary endpoint was primary patency at 1 year. Secondary outcomes were 30-days complication rate, technical success, 1-year freedom from clinically driven target lesion revascularization (CD-TLR), limb salvage, survival, amputation-free survival (AFS), wound healing, and clinical improvement. A total of 64 patients with 67 femoropopliteal lesions were included; 78% suffered from diabetes and 84% had chronic limb-threatening ischemia (CLTI). Of those with ischemic wounds, 79% did not have run-off to the foot. Mean lesion length was 193 ± 128 mm and 52% were severely calcified. Primary patency at 1 year was 84% in the overall cohort and 91% in patients with complete lesion coverage with the Eluvia stent. Technical success was achieved in 100% of the cases and 30-day complications occurred in six patients. Twelve-month freedom from CD-TLR, limb salvage, survival, and AFS were 92%, 93%, 85%, and 80%, respectively. In 80% of patients, complete wound healing was experienced and 84% had clinical improvement after 1 year. The Eluvia stent showed promising 12-month patency and clinical results for femoropopliteal treatment in this CLTI-dominant patient population with severely calcified, long lesions. Patient numbers were, however, small; larger trials are required to validate these findings. Aneurysmal change seen in some cases also needs further investigation.

Mid-term outcomes of an everolimus-eluting bioresorbable vascular scaffold in patients with below-the-knee arterial disease: A pooled analysis of individual patient data.

Previous studies on everolimus-eluting bioresorbable vascular scaffolds (BVS) have shown promising 1-year primary patency rates in infrapopliteal arteries. Literature from large cohorts on long-term outcomes with the infrapopliteal Absorb BVS (Abbott Vascular) is lacking. The aim of this study is to pool published and unpublished data to provide a more precise estimate of the 24-month outcomes of Absorb BVS for the treatment of infrapopliteal disease. For the pooled analysis, updated original and newly collected data from three cohorts on treatment with the Absorb BVS for de novo infrapopliteal lesions were combined. The primary endpoint was freedom from restenosis. Secondary endpoints were freedom from clinically driven target lesion revascularization (CD-TLR), major amputation and survival. The pooled analysis included a total of 121 patients with 161 lesions, treated with 189 Absorb BVS in 126 limbs. The mean age of the patients was 73 years, 57% had diabetes mellitus, and 75% were classified as Rutherford-Becker class 5 or 6. Of the 161 lesions, 101 (63%) were calcified and 36 (22%) were occlusions. Successful deployment was achieved with all scaffolds. Freedom from restenosis was 91.7% and 86.6% at 12 and 24 months, respectively, and freedom from CD-TLR was 97.2% and 96.6%. Major amputation occurred in 1.6% of the limbs. Overall survival was 85% at 24 months. In conclusion, this pooled analysis represents the largest reported analysis of mid-term results of the Absorb BVS for the management of chronic limb-threatening ischemia. At 24 months, the Absorb BVS was safe with promising clinical outcomes for the treatment of infrapopliteal disease.

Infected femoral pseudoaneurysms in intravenous drug abusers: a decade of experience from a Singapore tertiary centre.

INTRODUCTION: A pseudoaneurysm (or false aneurysm) is a haematoma that communicates with an artery through a disruption in the arterial wall. The femoral artery is the most common injection site among drug users, and infected femoral pseudoaneurysms are the most common vascular complications. METHODS: A retrospective review of medical records of intravenous drug abusers (IVDAs) who presented with infected femoral pseudoaneurysms from January 2006 to December 2016 was carried out. Patients who had pseudoaneurysms due to other aetiologies or trauma were excluded. RESULTS: A total of 27 patients with infected femoral pseudoaneurysms were identified. The majority were male (92.6%) and of Malay ethnicity (55.6%). Median age was 50 (range 31-62) years. Commonly abused drugs were buprenorphine (or Subutex; 59.3%) and midazolam (or Dormicum; 51.9%). Groin pain and swelling (100.0%), fever (66.7%) and presence of a pulsatile mass (51.9%) were the most common presenting symptoms. Diagnosis was confirmed via computed tomography angiography in all patients. 25 patients underwent upfront arterial ligation with debridement, among whom three patients required concurrent surgical revascularisation. Only two patients underwent ultrasonography-guided thrombin injection - one eventually required surgery and the other was lost to follow-up. Postoperative complications included wound infection (42.3%), bleeding (11.5%) and necrotising fasciitis eventually resulting in limb loss (3.8%). There were no associated mortalities. CONCLUSION: Infected pseudoaneurysms in IVDAs pose a unique challenge to vascular surgeons. We found that simple ligation and debridement was a safe and effective option for such patients.

A systematic review and meta-analysis of bioresorbable vascular scaffolds for below-the-knee arterial disease.

INTRODUCTION: Different types of bioresorbable vascular scaffolds (BVSs) have been developed and used in below-the-knee (BTK) arterial diseases. This is the first study reviewing and analyzing the literature on BVS treatment for BTK arterial disease. EVIDENCE ACQUISITION: MEDLINE, Embase, and Cochrane were searched for studies published until October 21, 2019. The search, study selection, quality assessment, and data extraction were performed by 2 authors independently. Articles that studied the treatment of BTK arterial disease by using BVSs were eligible. Exclusion criteria were studies with a variant design (e.g. case reports <5 patients), non-BTK indications for BVS use, and nonhuman studies. Primary endpoint was 12-month primary patency. Secondary endpoints were 12-month freedom from clinically driven target lesion revascularization (CD-TLR), limb salvage, survival, and amputation-free survival (AFS). Study quality was assessed by the Methodological Index for Non-randomized Studies score. EVIDENCE SYNTHESIS: Five studies representing 155 patients with 160 treated limbs met the inclusion criteria. Pooled 12-month primary patency per limb was 90% (143/160; 95% confidence interval [CI]: 0.84-0.95), freedom from CD-TLR 96% (124/130; 95% CI: 0.91-0.99), limb salvage rate 97% (156/160; 95% CI: 0.94-1.00), survival rate 90% (112/125; 95% CI: 0.82-0.96), and AFS rate 89% (110/125; 95% CI: 0.81-0.94). Subgroup analyses of included Absorb BVS studies showed similar results. All studies were assessed as moderate quality. CONCLUSIONS: This meta-analysis of case series showed good 12-month patency and clinical results with BVSs for BTK arterial disease, even in patients with multimorbidity and short but complex lesions. These results encourage a revival of this scaffold.

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

Percutaneous deep venous arterialization (pDVA) is a developing technique for limb salvage in patients with chronic limb-threatening ischemia by creating an arteriovenous (AV) circuit. After pDVA, patency of the AV circuit is evaluated using duplex ultrasound (DUS) imaging. Peak systolic velocity (PSV) and volume flow (VF) values for maintaining a patent AV circuit are undefined; therefore, guidance about when a reintervention should be performed is lacking. The objective of this study was to interpret post-pDVA PSV and VF values in relation to AV circuit preservation. This was performed by analyzing DUS results of 22 post-pDVA patients. A total of 670 PSV and 623 VF measurements were collected. A PSV value of ≤55 cm/s and a VF value of ≤195 mL/min were found predictive for failure. The reliability of PSV and VF measurements in patent AV-circuits was good (intraclass correlation coefficient; PSV, 0.85; VF, 0.88). In conclusion, this study is the first to analyze DUS measurements in post-pDVA patients and showed that DUS can be used to anticipate for failure. The thresholds found can be used to help interpret DUS measurements in post-pDVA patients. More research in a larger patient population is needed to prospectively validate these thresholds.

The direct extravascular calcium interruption arterial procedure technique for heavily calcified vessels.

Severely calcified lesions continue to plague endovascular interventions by negatively affecting the acute and long-term results. A new technique was developed to allow balloon crossing or to treat persistent recoil. In the direct extravascular calcium interruption arterial procedure technique, an artery forceps is percutaneously introduced to modify the plaque after conventional techniques have failed. In this initial experience, the direct extravascular calcium interruption arterial procedure technique was successful as a bailout option in patients in whom balloon crossing was impossible or recoil was untreatable even with high-pressure balloons.

Early and Midterm Experience With the Absorb Everolimus-Eluting Bioresorbable Vascular Scaffold in Asian Patients With Chronic Limb-Threatening Ischemia: One-Year Clinical and Imaging Outcomes From the DISAPEAR Registry.

Purpose: To report an experience with the Absorb bioresorbable vascular scaffold (BVS) in an Asian cohort with chronic limb-threatening ischemia (CLTI) from the DISAPEAR (Drug Impregnated Bioresorbable Stent in Asian Population Extremity Arterial Revascularization) registry. Materials and Methods: A retrospective analysis was conducted of 41 patients (median age 64 years; 23 men) with CLTI owing to >50% de novo infrapopliteal lesions (n=53) treated with the Absorb BVS between August 2012 and June 2017. The majority of patients (37, 90%) had diabetes, 24 (59%) had ischemic heart disease, and 39 (95%) had Rutherford category 5/6 ischemia with tissue loss. The mean lesion length was 22.7±17.2 mm; 10 (24%) lesions were severely calcified. Assessments included technical success, primary patency, freedom from clinically-driven target lesion revascularization (CD-TLR), amputation-free survival, limb salvage, complete wound healing, resolution of rest pain, and resolution of CLTI without TLR at 6 and 12 months after the index intervention. Results: Overall, 69 scaffolds were implanted in the 53 lesions, with 100% technical success. There were no deaths within 30 days of the index procedure. The primary patency rates at 6 and 12 months were 95% and 86%, respectively. The corresponding rates of freedom from CD-TLR were 98% and 93%, respectively. Freedom from major amputation was 98% at both time points, and amputation-free survival was 93% and 85% at 6 and 12 months after the index procedure. Wound healing occurred in 31 patients (79%) with Rutherford category 5/6 ischemia by the end of 12 months. Conclusion: The Absorb BVS demonstrated good 1-year patency and clinical outcomes in CLTI patients with complex infrapopliteal disease.

High-pressure, non compliant balloon angioplasty for long and calcified infrapopliteal and inframalleolar lesions is feasible.

BACKGROUND: To evaluate the safety, feasibility and effectiveness of high-pressure, noncompliant balloon angioplasty in the management of long infrapopliteal calcified lesions. METHODS: Consecutive patients, presenting with chronic limb-threatening ischemia (CLTI) and long (>100 mm) calcified infrapopliteal lesions who were treated with a high pressure, noncompliant balloon (JADE, OrbusNeich, Hong Kong) between January 2016 and July 2016 were retrospectively analyzed. Angioplasty was performed by inflating the balloon to a pressure of 22 to 24 atm for 90 seconds. Primary outcome was technical success. Secondary outcomes were procedure-related complications, limb salvage, amputation-free survival (AFS), wound healing, overall survival, freedom from clinically driven target lesion reintervention (CD-TLR), and resolution of CLTI at 2 and 3 years. RESULTS: Overall, 23 lesions in 21 limbs of 20 patients were treated. All patients had tissue loss (Rutherford 5 or 6). The mean lesion length was 374.8 mm. Of all lesions, 56.5% were occlusions, 91.3% were classified as TransAtlantic Inter-Society Consensus (TASC) C and D lesions, and 78.3% had severe calcification classification. Of all lesions, 52.2% extended into the below-the-ankle arteries. Technical success was achieved in 22 lesions (95.7%). There were no procedure-related complications. No bailout stenting was required. At 2 and 3 years, limb salvage was 84.7% and 78.7%, AFS was 71.4% and 56.1%, wound healing was 81.0% and 85.7%, overall survival was 75.0% and 64.3% and freedom from CD-TLR was 77.6% and 63.5%, respectively. Resolution of CLTI without TLR was 81.0% at 2 and 3 years. CONCLUSIONS: This study is the first to analyze safety and feasibility of a high-pressure, noncompliant balloon for long, calcified infrapopliteal and inframalleolar lesions.

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

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.