Treatment of clinically uninfected diabetic foot ulcers, with and without antibiotics.

OBJECTIVE: Current guidelines do not recommend the use of antibiotics to treat clinically uninfected ulcers. However, physicians continue to prescribe antibiotics for clinically uninfected ulcers with the rationale 'better to be safe than sorry'. Yet, antibiotic resistance is increasing, side-effects are common and treatment costs are rising. Evidence is needed to identify whether antibiotic treatment for clinically uninfected ulcers can be justified or we should stop prescribing them. The aim of this study was to evaluate whether antibiotic treatment in cases of clinically uninfected ulcers improved ulcer healing compared to treatment without antibiotics. METHOD: Consecutive patients treated in the outpatient clinic for clinically uninfected diabetic foot ulcer both in 2015 and in 2017 were retrospectively analysed. Primary outcome was ulcer healing at one year. Secondary outcomes were limb salvage, freedom from any amputation, amputation-free survival (AFS) and survival. RESULTS: A total of 102 ulcers of 91 patients were included for final analyses. The non-antibiotics and antibiotics groups both consisted of 51 ulcers. Ulcer healing at one year was 77.3% in the non-antibiotics group and 74.7% in the antibiotics group (p=0.158). No difference was found for limb salvage (93.8% versus 95.9%, respectively; p=0.661), freedom from any amputation (85.6% versus 85.6%, respectively; p=1.000), AFS (85.4% versus 79.1%, respectively; p=0.460) or survival (89.6% versus 83.7%, respectively; p=0.426). CONCLUSION: In this study, no benefits of antibiotic treatment over non-antibiotic treatment for clinically uninfected ulcers were identified. The findings of this study emphasise the recommendation of current guidelines to not treat clinically uninfected ulcer with antibiotics.

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.

Twelve-Month Outcomes of Intravascular Lithotripsy for Treatment of Calcified Popliteal and Infrapopliteal Lesions in Patients With Chronic Limb-Threatening Ischemia.

PURPOSE: Vessel calcification is estimated to be present in 30% to 50% of patients with peripheral arterial disease (PAD) and is one of the main challenges in endovascular treatment. The popliteal artery is unique compared with other arteries due to its exposure to significant deformation and biomechanical stress during knee motion. Intravascular lithotripsy (IVL) is a novel technique that uses acoustic pressure waves to cause microfractures within the intimal and medial wall calcification. Intravascular lithotripsy is safe in femoropopliteal and infrapopliteal lesions, but follow-up studies are lacking. Therefore, the purpose of this study was to describe the first follow-up outcomes of IVL in popliteal and infrapopliteal arterial disease. METHODS: This prospective, multicenter cohort study included all patients treated with IVL in the popliteal and infrapopliteal arteries at 4 sites. Standardized follow-up with duplex ultrasonography was scheduled at 6 to 8 weeks and 12 months. The primary safety endpoint was a composite of major adverse events (MAEs) at 30 days. Primary efficacy endpoints were primary patency, limb salvage, and amputation-free survival (AFS) at 12 months. Secondary endpoints were primary-assisted patency and freedom from target lesion revascularization (TLR). Endpoints were distributed for patients with chronic limb-threatening ischemia (CLTI) and intermittent claudication (IC) and estimated using the Kaplan-Meier method. RESULTS: Between April 2021 and March 2023, 29 patients with 30 limbs were treated. Diabetes mellitus (DM) and CLTI were present in 62.1% and 80.0% of patients, respectively. Within the 32 treated lesions, severe calcification was present in 84.4% and bailout stenting was necessary in 12.5% of the lesions. Four MAEs occurred within 30 days: 1 closure device failure, 1 major amputation, and 2 deaths, neither of which was related to the study device. The primary patency, primary-assisted patency, freedom from TLR, limb salvage, and AFS at 12 months were 68.8%, 90.0%, 93.3%, 83.9%, and 57.1% for CLTI patients, respectively. No events occurred in restenosis, re-occlusion, TLR, major amputation, or mortality in patients with IC. CONCLUSIONS: This first-ever analysis on follow-up outcomes of IVL in the popliteal and infrapopliteal arteries demonstrated promising safety and efficacy outcomes with a low rate of bailout stenting. CLINICAL IMPACT: Vessel calcification is a common feature in peripheral arterial disease (PAD) and is one of the main challenges in endovascular treatment. The popliteal artery is subjected to biomechanical stress during knee motion, which makes stenting unappealing and often leads to worse clinical outcomes. This study aimed to describe the first follow-up outcomes of IVL in popliteal and infrapopliteal arterial disease. As in line with previous studies, no relevant procedural complications were found and the rate of bail-out stenting was only 12.5%. Moreover, in a complex patient population, this study demonstrated promising safety and efficacy outcomes. The comparison of IVL with angioplasty alone or other vessel preparation devices for popliteal and infrapopliteal arterial disease is warranted.

The Dutch chronic lower limb-threatening ischemia registry (THRILLER): A study protocol for popliteal and infrapopliteal endovascular interventions.

INTRODUCTION: Chronic limb-threatening ischemia (CLTI) is the end stage of peripheral arterial disease (PAD) and is associated with high amputation rates, mortality and disease-related health care costs. In infrapopliteal arterial disease (IPAD), endovascular revascularization should be considered for the majority of anatomical and clinical subgroups of CLTI. However, a gap of high-quality evidence exists in this field. The aim of the Dutch Chronic Lower Limb-Threatening Ischemia Registry (THRILLER) is to collect real world data on popliteal and infrapopliteal endovascular interventions. METHODS: THRILLER is a clinician-driven, prospective, multicenter, observational registry including all consecutive patients that undergo a popliteal or infrapopliteal endovascular intervention in seven Dutch hospitals. We estimate that THRILLER will include 400-500 interventions annually. Standardized follow-up visits with wound monitoring, toe pressure measurement and duplex ultrasonography will be scheduled at 6-8 weeks and 12 months after the intervention. The independent primary endpoints are primary patency, limb salvage and amputation free survival. Patients must give informed consent before participation and will be included according to predefined reporting standards. A data log of patients who meet the inclusion criteria but are not included in the registry will be maintained. We intend to conduct the first interim analysis two years after the start of inclusion. The results will be published in a scientific journal. DISCUSSION: Despite innovations in medical therapy and revascularization techniques, patients with CLTI undergoing endovascular revascularization still have a moderate prognosis. Previous prospective cohort studies were hampered by small sample sizes or heterogeneous reporting. Randomized controlled trials (RCTs) have high costs, potential conflicts of interest and give a limited reflection of daily practice. THRILLER aims to provide the largest prospective well phenotyped up-to-date dataset on treatment outcomes in CLTI patients to answer multiple underexplored research questions regarding diagnostics, medication, patient selection, treatment strategies and post intervention follow-up.

A comparison of patient-reported outcome measures following technical success and technical failure in the treatment of great saphenous vein incompetence using ClariVein: A subanalysis of a multicenter randomized controlled trial comparing 2% and 3% polidocanol.

OBJECTIVE: This study aimed to compare patient-reported outcomes after technical success (TS) and technical failure (TF) in treating great saphenous vein incompetence (GSV) with ClariVein. METHODS: A subanalysis of a previous trial was conducted on symptomatic GSV incompetence patients who received ClariVein treatment with 2% or 3% polidocanol (POL) and were followed for 6 months. Blinding was implemented for observers and patients, and data from both POL groups were combined. TS was defined as at least 85% occlusion of the treated vein, while TF indicated failure to meet TS criteria. Secondary outcomes included Venous Clinical Severity Score (VCSS), Aberdeen Varicose Vein Questionnaire (AVVQ), and Short-Form 36 Health Survey Questionnaire (SF-36). RESULTS: Among the 364 patients included, the TS rate was 64.5%. Comparison of VCSS, AVVQ, and SF-36 scores between TS and TF groups did not yield significant differences. CONCLUSION: This study indicates no significant variation in VCSS, AVVQ, and SF-36 scores between patients experiencing TS and TF following ClariVein treatment for GSV insufficiency.

Improving Bioactive Characteristics of Small Diameter Polytetrafluoroethylene Stent Grafts by Electrospinning: A Comparative Hemocompatibility Study.

Polytetrafluoroethylene (PTFE) is a commonly used biomaterial for the manufacturing of vascular grafts and several strategies, such as coatings, have been explored to improve the hemocompatibility of small-diameter prostheses. In this study, the hemocompatibility properties of novel stent grafts covered with electrospun PTFE (LimFlow Gen-1 and LimFlow Gen-2) were compared with uncoated and heparin-coated PTFE grafts (Gore Viabahn®) using fresh human blood in a Chandler closed-loop system. After 60 min of incubation, the blood samples were examined hematologically and activation of coagulation, platelets, and the complement system were analyzed. In addition, the adsorbed fibrinogen on the stent grafts was measured and the thrombogenicity was assessed by SEM. Significantly lower adsorption of fibrinogen was measured on the surface of heparin-coated Viabahn than on the surface of the uncoated Viabahn. Furthermore, LimFlow Gen-1 stent grafts showed lower fibrinogen adsorption than the uncoated Viabahn®, and the LimFlow Gen-2 stent grafts showed comparable fibrinogen adsorption as the heparin-coated Viabahn®. SEM analysis revealed no sign of thrombus formation on any of the stent surfaces. LimFlow Gen-2 stent grafts covered with electrospun PTFE exhibited bioactive characteristics and revealed improved hemocompatibility in terms of reduced adhesion of fibrinogen, activation of platelets, and coagulation (assessed by ß-TG and TAT levels) similar to heparin-coated ePTFE prostheses. Thus, this study demonstrated improved hemocompatibility of electrospun PTFE. The next step is to conduct in vivo studies to confirm whether electrospinning-induced changes to the PTFE surface can reduce the risk of thrombus formation and provide clinical benefits.

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.

A systematic review and meta-analysis of treatment modalities for anterior accessory saphenous vein insufficiency.

OBJECTIVE: To investigate and compare the outcomes of the available treatment modalities for anterior accessory saphenous vein (AASV) incompetence. METHODS: A systematic literature search was performed in MEDLINE, Embase, and the Cochrane Library. Studies reporting the outcomes of patients who were treated for primary AASV incompetence were included. The methodologic quality of the articles was assessed using the Methodological Index for Non-Randomized Studies (MINORS). A random-effects model was used to estimate anatomic success, defined as AASV occlusion. The secondary outcomes were pain during and after treatment, venous clinical severity score, quality of life, esthetic result, time to return to daily activities, and complications. RESULTS: The search identified 860 articles, of which 16 met the inclusion criteria. A total of 609 AASVs were reported. The included studies were of poor or moderate quality according to MINORS score. The pooled anatomic success rates were 91.8% after endovenous laser ablation and radiofrequency ablation (EVLA, RFA, 11 studies), 93.6% after cyanoacrylate closure (3 studies), and 79.8% after sclerotherapy (2 studies). The non-pooled anatomic success rate was 97.9% after phlebectomy and 82% after CHIVA. Paresthesia was seen after EVLA in 0.7% of patients (6 studies). Phlebitis was seen in 2.6% of patients after RFA (2 studies), 27% after sclerotherapy (1 study), and 12% after the phlebectomy (1 study). Deep venous thrombosis and skin burn did not occur. CONCLUSION: Treatment of AASV incompetence is safe and effective. Despite limited evidence, occlusion of the AASV can be achieved with endovenous thermal ablation and cyanoacrylate. There does not appear to be a benefit of EVLA compared to RFA regarding treatment efficacy. Phlebectomy shows promising results if the saphenofemoral junction is competent. Lower results are seen after sclerotherapy and CHIVA. However, studies with sufficient sample sizes of solely treatment of AASV incompetence are needed to draw firm conclusions.

Ten-year follow-up of a randomized controlled trial comparing saphenofemoral ligation and stripping of the great saphenous vein with endovenous laser ablation (980 nm) using local tumescent anesthesia.

OBJECTIVE: The long-term results of saphenofemoral ligation and stripping (SFL/S) were compared with 980-nm bare fiber endovenous laser ablation (EVLA) for the treatment of great saphenous vein (GSV) incompetence. METHODS: This was a single-center, randomized, controlled trial with a follow-up time of 10 years. Patients with GSV incompetence were randomized to undergo SFL/S or EVLA under tumescent anesthesia. The primary outcome was recurrence of groin-related varicose veins seen on duplex ultrasound imaging and clinical examination. The secondary outcomes were (changes or improvement in) CEAP clinical class, venous symptoms, cosmetic results, quality of life, reinterventions, and complications. RESULTS: Between June 2007 and December 2008, 122 patients (130 limbs) were included; of these, 68 limbs were treated with SFL/S and 62 limbs with EVLA. The 10-year estimated freedom from groin recurrence as seen on duplex ultrasound imaging was higher in the SFL/S group (73% vs 44% in the EVLA group; P = .002), and the same trend was seen for clinically evident recurrence (77% vs 58%, respectively; P = .034). Nine reinterventions (17%) were deemed necessary in the SFL/S group vs 18 (36%) in the EVLA group (P = .059). All reinterventions in the SFL/S group consisted of foam sclerotherapy. Reinterventions in the EVLA group included foam sclerotherapy (n = 5), crossectomy (n = 2), and endovenous procedures (n = 11). There was no significant differences in quality of life and relief of venous symptoms. Cosmetic appearance improved, with a better cosmetic rating in the SFL/S group compared with the EVLA group (P = .026). One patient in the SFL/S group had a persisting neurosensory deficit remaining at 10 years. CONCLUSIONS: This study showed no clear long-term advantage of EVLA with a 980-nm wavelength and bare-tip fiber over high ligation and stripping of the GSV under local tumescent anesthesia.

A systematic review and meta-analysis of mechanochemical endovenous ablation using Flebogrif for varicose veins.

OBJECTIVE: In the present study, we reviewed and analyzed the currently available data on the Flebogrif device (Balton, Warsaw, Poland) to define its role in the global varicose vein treatment devices market. METHODS: A systematic literature search was performed in MEDLINE, Embase, and the Cochrane Library. Studies were eligible if they had included patients treated using the Flebogrif for saphenous vein incompetence, had been reported in English, and had the full text available. The methodologic quality of the studies was assessed using the methodologic index for nonrandomized studies (MINORS) score. A random effects model was used to estimate the primary outcome of anatomic success, defined as the occlusion rate of the treated vein. The estimates are reported with the 95% confidence intervals (CIs). The secondary outcomes were clinical success, complication rate, pain during and after the procedure, and time to return to work. RESULTS: Five articles met the inclusion criteria, reporting 348 procedures in 392 patients. Four studies reported the 3-month anatomic success, and three studies reported the 12-month anatomic success. The pooled 3-month anatomic success rate was 95.6% (95% CI, 93.2%-98.0%). The 12-month anatomic success rate was 93.2% (95% CI, 90.3%-96.1%). The only major complication reported within 3 months was deep vein thrombosis, which developed in 0.3% of the patients. The minor complications of thrombophlebitis and hyperpigmentation had occurred in 13.3% to 14.5% and 3.3% to 10.0% of patients, respectively, within 3 months. The methodologic quality of the included studies was moderate. CONCLUSIONS: Mechanochemical ablation using the Flebogrif device is a safe and well-tolerated procedure for the treatment of saphenous vein insufficiency. However, well-designed studies of sufficient sample size and follow-up are required to compare the effectiveness with other endovenous treatment modalities and define the definitive role of the Flebogrif device.

A multicenter, randomized, dose-finding study of mechanochemical ablation using ClariVein and liquid polidocanol for great saphenous vein incompetence.

BACKGROUND: The purpose of the present study was to identify the ideal polidocanol (POL) concentration for mechanochemical ablation (MOCA) of the great saphenous vein (GSV) using the ClariVein system (Merit Medical, South Jordan, Utah). METHODS: We performed a multicenter, randomized, controlled, single-blind trial with a follow-up period of 6 months. Patients with symptomatic primary truncal GSV incompetence were randomized to MOCA + 2% POL liquid (2% group) or MOCA + 3% POL liquid (3% group). The primary outcome was technical success (TS), defined as an open part of the treated vein segment of ≤10 cm in length. The secondary outcomes were alternative TS, defined as ≥85% occlusion of the treated vein segment, postoperative pain, venous clinical severity scores, Aberdeen varicose vein questionnaire scores, and short-form 36-item health survey questionnaire scores, and complications. RESULTS: From 2012 to 2018, 364 patients (375 limbs) were included, of which, 189 limbs were randomly allocated to the 2% group and 186 to the 3% group. The TS rate at 6 months was 69.8% in the 2% group vs 78.0% in the 3% group (P = .027). A higher overall TS rate was seen in GSVs of ≤5.9 mm compared with GSVs >5.9 mm (84.3% vs 59.5%, respectively; P < .001). The alternative TS rate at 6 months was 61.4% in the 2% group and 67.7% in the 3% group (P = .028). The venous clinical severity scores, Aberdeen varicose vein questionnaire scores, and most short-form 36-item health survey questionnaire domains had improved in both groups (P < .002). Postprocedural pain was low. Two pulmonary embolisms and two deep vein thromboses were seen. Superficial venous thrombosis had occurred more often in the 3% group (18 vs 8 in the 2% group; P = .033). CONCLUSIONS: The results from the present study showed a higher success rate for MOCA with 3% POL liquid than for MOCA with 2% POL liquid at 6 months of follow-up. However, the difference in quality of life was not significant. Long-term follow-up studies are required to investigate whether these results will be sustained in the future.

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.

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.

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.

Editor's Choice - Drug Coated Balloon Angioplasty vs. Standard Percutaneous Transluminal Angioplasty in Below the Knee Peripheral Arterial Disease: A Systematic Review and Meta-Analysis.

OBJECTIVE: The aim was to review and analyse the literature on clinical outcomes of drug coated balloon (DCB) vs. standard percutaneous transluminal angioplasty (PTA) for the treatment of infrapopliteal arterial disease. METHODS: This is a systematic review and meta-analysis. The MEDLINE, EMBASE and Cochrane Database of Systematic Reviews were searched for studies published between January 2008 and November 2018. Two authors independently performed the search, study selection, assessment of methodological quality and data extraction. Studies were eligible when reporting PTA and DCB outcomes in infrapopliteal arteries, published in English, human studies, and full text was available. Methodological quality was determined by MINORS and Cochrane risk of bias tool. GRADE methodology was used to rate the evidence for observed outcomes. The primary outcome was the 12 month limb salvage rate. Secondary outcomes were 12 month survival, amputation free survival (AFS), restenosis, and target lesion revascularisation (TLR) rates. Inclusion criteria for pooling data were randomised controlled trials and comparative studies with 12 month outcomes. RESULTS: Ten studies representing 1593 patients met the inclusion criteria. The quality was assessed as moderate or low. Data from five studies were pooled, and 12 month outcomes for DCB vs. PTA were limb salvage rate, 94.0% vs. 95.7% (odds ratio (OR), 0.92; 95% confidence interval (CI), 0.39-2.21); and survival rate, 89.8% vs. 92.9% (OR 0.69; 95% CI 0.39-1.21). Data from four studies were pooled, and 12 month outcomes for PTA vs. DCB were restenosis rate, 62.0% vs. 32.9% (OR 2.87; 95% CI 0.83-9.92); and TLR rate, 27.8% vs. 14.0% (OR 2.76; 95% CI 0.90-8.48). Pooled data from two studies showed 12 month AFS rate for DCB vs. PTA; 82.5% vs. 88.7% (OR 0.79; 95% CI 0.23-2.75). No statistically significant differences were found. CONCLUSION: Based on this systematic review and meta-analysis no significant differences in limb salvage, survival, restenosis, TLR, and AFS rates were found when DCB angioplasty was compared with standard PTA.

The effect of a multidisciplinary outpatient team approach on outcomes in diabetic foot care: a single center study.

BACKGROUND: Recent studies showed no reduction in major amputation rates after introduction of a multidisciplinary team (MDT) approach for the treatment of diabetic foot ulcer. The efficacy of MDTs in the current standard of care is being questioned. This retrospective single-center study evaluated the efficacy of an outpatient MDT approach on limb salvage and ulcer healing in treating diabetic foot ulcers. METHODS: Patients with a diabetic foot ulcer treated before (2015) and after (2017) implementation of an MDT in a single center were compared. The MDT met weekly and consisted of a vascular surgeon, physiatrist, internist, shoe technician, wound care nurse, nurse practitioner, cast technician, and podiatrist. The primary outcome was limb salvage at 1 year. Secondary outcomes were ulcer healing, amputation-free survival, freedom from any amputation, and overall survival. Multivariable Cox regression models were used to assess predictors for major amputation. RESULTS: A vascular surgeon treated 104 patients with 148 ulcers in 2015, and the multidisciplinary team treated 133 patients with 188 ulcers in 2017. Limb salvage (90.9% vs. 95.5%, P=0.050), freedom from any amputation (56.5% vs. 78.0%, P<0.001), and ulcer healing (48.3% vs. 69.2%, P<0.001) were significantly lower in the non-MDT group than in the MDT group. Amputation-free survival and overall survival did not differ significantly between the groups. Predictors for major amputation were University of Texas Wound Classification 3D (hazard ratio, 2.8; 95% confidence interval, 1.17-6.45) and being treated in the non-MDT group (hazard ratio, 3.7; 95% confidence interval, 1.25-11.08). CONCLUSIONS: This retrospective study found an MDT dedicated to diabetic foot care was highly effective in increasing limb salvage and ulcer healing. We advise that such an MDT is an integrated part of the patient's chain-based care.

Below-the-Ankle Angioplasty in Patients with Critical Limb Ischemia: A Systematic Review and Meta-Analysis.

PURPOSE: To evaluate the safety and effectiveness of below-the-ankle (BTA) angioplasty and to assess whether additional BTA angioplasty after below-the-knee (BTK) angioplasty would improve clinical outcomes in patients with critical limb ischemia. MATERIALS AND METHODS: Two authors independently performed the search, study selection, assessment of methodological quality, and data extraction for this systematic review and meta-analysis. MEDLINE, Embase, and the Cochrane Database of Systematic Reviews were searched. Articles were eligible if it was reported that BTA angioplasty was performed and if the articles were published in English and had the full text available. Methodological quality was assessed using the Methodological Index for Non-Randomized Studies (MINORS) score. The primary outcome was 12-month limb salvage rate. Secondary outcomes were 12-month amputation-free survival, technical success, complications, survival, and freedom from reintervention. RESULTS: Ten articles met the inclusion criteria, reporting a total of 478 patients with BTA angioplasty performed in 524 legs. Three of the 10 included studies compared BTK angioplasty only to BTK angioplasty and additional BTA angioplasty. The pooled 12-month limb salvage rate was 92% (95% confidence interval [CI], 0.88-0.96). No statistically significant difference was found in limb salvage when additional BTA angioplasty was compared to BTK angioplasty only (odds ratio [OR], 1.23; 95% CI, 0.61-2.49). The pooled 12-month amputation-free survival was 78% (95% CI, 0.69-0.87). No statistically significant difference was found in amputation-free survival rate when additional BTA angioplasty was compared to BTK angioplasty only (OR, 1.58; 95% CI, 0.95-2.64). The methodological quality of the studies included was moderate, according to the MINORS score. CONCLUSIONS: This systematic review and meta-analysis showed that additional BTA angioplasty is a safe and feasible procedure, with a 92% pooled proportion of limb salvage at 12 months.

Comparing Venous Reconstructions and Antimicrobial Graft Reconstructions in Mycotic Abdominal Aortic Aneurysms and Aortic Graft Infections.

BACKGROUND: The perioperative mortality and morbidity rates of surgical repair of mycotic abdominal aortic aneurysms and aortic graft infections are high, and the appropriate treatment is debated. This retrospective study compared venous and antimicrobial prosthetic aortic graft reconstructions. METHODS: All patients of the Northwest Clinics and St. Antonius Hospital who were treated for mycotic abdominal aortic aneurysms or aortic graft infections between January 1, 2008, and January 1, 2018, were analyzed. Exclusion criterion was treatment other than venous or antimicrobial reconstructions. Primary end points were 30-day complications and mortality rates and 3-year overall survival. Secondary end points were reintervention-free survival, persistent infection and reinfection rates, and hospital length of stay. RESULTS: Fifty-one patients met the inclusion criteria, of whom 32 underwent venous reconstructions and 19 antimicrobial prosthetic aortic graft reconstructions. Baseline characteristics did not differ significantly between these groups, except for duration of surgical repair, which was longer in the venous group. The 30-day and 1-year mortality rates, reinfection rates, complication rates, and hospital length of stay did not significantly differ between the groups. The 3-year overall survival was 77% for venous reconstruction compared with 66% for antimicrobial reconstruction (P = 0.781). The 30-day reintervention rate was 19% for the venous group compared with 42% for the prosthetic group (P = 0.071). Reintervention-free survival at 3 years was 46% for the venous group compared with 52% for the prosthetic group (P = 0.615). CONCLUSIONS: Venous reconstruction tends to have better 3-year overall survival and lower 30-day reintervention rates compared with antimicrobial prosthetic graft reconstruction in patients with mycotic abdominal aortic aneurysms or abdominal aortic graft infections. In the acute setting, antimicrobial prosthetic graft reconstruction is a valuable solution due to the shorter operation time and similar 30-day mortality and complication rates.