Search

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.

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.

Deep venous arterialization (DVA) is a new and developing technique with promising outcomes. The DVA procedure can be performed surgically in a hybrid fashion or percutaneously. Over the last years, the hybrid and percutaneous techniques have been further developed and have become a focus of many DVA studies. Between 2017 and 2021, 5 different percutaneous deep venous arterialization (pDVA) techniques, and 2 hybrid procedures have been investigated. In total, 9 cohort studies and 2 case reports have been performed to evaluate their outcomes. Understandably, these studies mainly focused on the technique, patency, and outcomes after DVA. However, postprocedural management can be as challenging as the procedure itself but has not been a priority for further investigation. This review summarizes the different techniques proposed, and the follow-up care provided in literature. Follow-up care includes postoperative medication, edema occurrence and treatment, pain management, patency assessment, reintervention techniques, a staged amputation strategy if necessary, and appropriate wound care. Evidence from literature and own clinical experience was combined to provide recommendations for care after DVA. 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.

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 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.

Objectives 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.

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.

Purpose: To describe a preliminary experience in treating no-option critical limb ischemia (CLI) patients with a hybrid foot vein arterialization (HFVA) technique combining open plus endovascular approaches. Materials and Methods: Between May 2016 and January 2018, 35 consecutive patients (mean age 68±12 years; 28 men) with 36 no-option CLI limbs underwent HFVA in our center. All limbs had grade 3 WIfI (Wound, Ischemia, and foot Infection) ischemia, and the wound classification was grade 1 in 4 (11%) limbs, grade 2 in 4 (11%), and grade 3 in 28 (78%). Surgical bypass was done on the medial marginal vein or a posterior tibial vein, followed by endovascular removal of foot vein valves and embolization of foot vein collaterals. A “tension-free” surgical approach was used to treat foot lesions. Results: At a mean follow-up of 10.8±2 months, limb salvage was achieved in 25 (69%) limbs and wound healing in 16 (44%); 9 patients presented an unhealed wound. Eleven (31%) patients underwent a major amputation (2 below the knee and 9 thigh). One patient with an unhealed wound and open bypass died of myocardial infarction. Conclusion: HFVA is a promising technique able to achieve acceptable rates of limb salvage and wound healing in no-option patients generally considered candidates for an impending major amputation. Further studies are needed to standardize the technique and better identify patients who can benefit from this approach.

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.

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.

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.

Abstract. Patients with critical limb ischaemia have a poor life expectancy. Aggressive revascularization is accepted in order to preserve their independence in the final phase of their lives. Bypass surgery and more recently endovascular interventions with angioplasty and stenting have become the treatment of choice to prevent amputation and to resolve pain. However, as many as 20 % of patients with critical limb ischaemia are unsuitable candidates for a vascular intervention because of extensive occlusions of outflow in the crural and pedal vessels. Such “no-option critical limb ischaemia” may be treated with venous arterialization. In the present review, we discuss the history of the venous arterialization procedure, the mechanisms, the different techniques, and complications of venous arterialization.

IntroductionThe aim of this prospectively collected case series is to demonstrate a novel technique of using the ClariVein® catheter for pharmacomechanical thrombolysis of thrombosed hemodialysis grafts.MethodsThe analysis comprised 11 procedures in 9 patients from 1 July to 31 December 2016 in which the ClariVein catheter was used in combination with urokinase. Demographic data, procedural data, technical and clinical success rates, and complications were evaluated. The primary and secondary patency rates at 1 and 3 months were also analyzed.ResultsIn the 11 procedures performed, the technical and clinical success was 100%. The mean procedural time was 66.8 minutes (range 50-90 minutes), and the mean amount of urokinase administered was 87,000 units. The primary unassisted patency rates at 1 and 3 months were 81.8% and 63.6%, respectively. The secondary patency rates at 1 and 3 months were 90.9% and 81.8%, respectively. Perforation occurred after balloon angioplasty in 1 (9.1%) of the 11 procedures, for which covered stenting was performed. No major complications occurred.ConclusionsThe combination use of the ClariVein catheter with urokinase for pharmacomechanical thrombolysis in thrombosed hemodialysis grafts is a feasible and safe method that can be performed in a relatively short duration. Our early results have shown 100% technical and clinical success. This case series serves as a platform for an upcoming prospective study to further evaluate this method.

Background Critical limb ischaemia (CLI) is the end stage of peripheral artery disease (PAD) and is associated with high amputation and mortality rates and poor quality of life. For CLI patients with no revascularisation options, venous arterialisation could be a last resort for limb salvage. Objective To review the literature on the clinical effectiveness of venous arterialisation for lower limb salvage in CLI patients with no revascularisation options. Method Different databases were searched for papers published between January 1966 and January 2016. The criteria for eligible articles were studies describing outcomes of venous arterialisation, published in English, human studies, and with the full text available. Additionally, studies were excluded if they did not report limb salvage, wound healing or amputation as outcome measures. The primary outcome measure was post-operative limb salvage at 12 months. Secondary outcome measures were 30 day or in-hospital mortality, survival, patency, technical success, and wound healing. Results Fifteen articles met the inclusion criteria. The included studies described 768 patients. According to the MINORS score, methodological quality was moderate to poor. The estimated pooled limb salvage rate at one year was 75% (0.75, 95% CI 0.70–0.81). Thirty day or in-hospital mortality was reported in 12 studies and ranged from 0 to 10%. Overall survival was reported in 10 studies and ranged from 54% to 100% with a mean follow-up ranging from 5 to 60 months. Six studies reported on patency of the venous arterialisations performed, with a range of 59–71% at 12 months. Conclusion In this systematic review on venous arterialisation in patients with non-reconstructable critical limb ischaemia, the pooled proportion of limb salvage at 12 months was 75%. Venous arterialisation could be a valuable treatment option in patients facing amputation of the affected limb; however, the current evidence is of low quality.

Background Ruptured abdominal aortic aneurysms (RAAAs) are associated with a high overall mortality (up to 25% to 35%) ≤30 days when offered surgical treatment. Risk prediction models can provide valuable information on surgical risks, guide clinical decision making, and help identify patients who should not be operated on to prevent futile surgery. Finally, they can be used to evaluate clinical outcome. Different aneurysm scores are available. New ones (with only four parameters) are being developed, such as the Dutch Aneurysm Score (DAS). This study analyzed and compared these scoring models. Methods The study selected consecutive patients who presented with RAAA in two large vascular centers (Medisch Centrum Alkmaar and St. Antonius Nieuwegein) between 2005 and 2015. Variables necessary to retrospectively evaluate the scoring systems were registered in the patients' medical files. The discriminatory power and calibration were assessed using the receiver operating characteristic curve and the Hosmer-Lemeshow χ 2 test. Results The study included 347 consecutive patients with RAAA. There were 298 men (85.9%), and the mean ± standard deviation age was 72.6 ± 8.1 years. The receiver operating characteristic curves were developed for the DAS, Glasgow Aneurysm Score (GAS), Edinburgh Ruptured Aneurysm Score, Vancouver Scoring System (VSS), and Hardman Index. The area under the curve was better for the VSS (0.716; 95% confidence interval [CI], 0.647-0.786) than for the other scoring systems. Areas under the curve for the DAS (0.664; 95% CI, 0.592-0.736), Hardman Index (0.664; 95% CI, 0.592-0.736), Edinburgh Ruptured Aneurysm Score (0.621; 95% CI, 0.543-0.700), and GAS (0.591; 95% CI, 0.517-0.665) were slightly smaller, although only the difference between the VSS and GAS was statistically significant. Calibration showed a good fit for all models. Conclusions The performance of the tested models for the prediction of mortality in RAAA patients was comparable, with only a statistically significant difference between the VSS and the GAS in favor of the VSS. However, an almost perfect prediction is needed to withhold intervention, and no existing scoring system is capable of that.

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.

Background Critical limb ischemia (CLI) is the clinical end stage of peripheral artery disease and is associated with high amputation, mortality rates and poor quality of life. For CLI patients with no revascularization options, venous arterialization could be an alternative technique for limb salvage. A systematic review and meta-analysis published in 2017 concluded that venous arterialization may be considered a viable alternative. A recent development, is the Percutaneous Deep Vein Arterialization (pDVA), that is CE-marked and currently under investigation of the FDA. This procedure, called LimFlow, is a novel, minimally invasive, endovascular approach to perform a venous arterialization procedure. The limited evidence for its use necessitates a scientific judgement of the pDVA. Therefore, we initiated a prospective clinical post market trial to investigate the outcome of the pDVA in no-option critical limb ischemia. Methods/design The objective of this prospective study is to collect “real-life” clinical data among a population of patients treated with the pDVA in order to evaluate the clinical effectiveness and safety of the LimFlow System in patients with no-option critical limb ischemia. This study is a single-arm, open-label, prospective, post-market follow-up study to be conducted on up to fifty (50) eligible patients with a twelve-month follow-up period. The Primary endpoint is measured by amputation free survival. Secondary endpoints are complete wound healing, primary and secondary patency, limb salvage, renal function and technical and procedural success. Patients will be assessed at regular intervals during one year after the initial percutaneous deep vein arterialization procedure through clinical evaluation and self-completed questionnaires. Discussion The last decade several studies have been published with promising results and the number of treated patients has considerably grown. Venous arterialization could be a valuable treatment option in patients with often no other options than amputation of the affected limb. The first results in men are promising although more research and long term follow up is needed to establish the efficacy of this new treatment modality. With this prospective study, we evaluate the clinical effectiveness and safety in patients with no-option CLI treated with the pDVA (LimFlow System). Trial registration NCT03321552.

Background Critical limb ischemia (CLI) is the presentation of end stage peripheral arterial disease and typically presents with rest pain, ulceration and gangrene. The outcome of conservative treatment is poor and often leads to amputations. Arterial revascularization plays an important role in amputation prevention. Unfortunately, a significant percentage of CLI patients cannot be revascularized and subsequently end up with a palliative amputation. This has led to the need and exploration of new treatment options in this no option subgroup of CLI. Deep venous arterialization (DVA) is one of them and has been reported as a save and feasible novel and promising alternative to amputation. The goal of DVA is to provide arterialized blood in significant volumes and pressure to the plantar venous arch and ischemic tissue to enable wound healing. Selecting the right patients is critical for successful DVA and requires that extra attention is paid to the wounds as well as arterial and venous vascular status. Methods The procedure was previously described in our initial experience in the first-in-man study performed on 7 patients with NOP-CLI. The angiographic goal of the procedure is to deliver arterialized blood to the plantar venous arch in significant volumes and pressure, circumventing the numerous valves in the process. The clinical goal is to achieve wound healing. Results Technical success was achieved in all patients. Flow in the plantar arch was achieved in 5 of the 7 patients. One patient with chronic rest pain became pain free within 48 hours after the procedure. Complete wound healing was achieved at 12 months in 5 of the 7 patients. Reinterventions were performed in 5 of 7 patients to maintain patency. Of the 7 study patients, five underwent minor amputation of one or more toes, and two underwent major amputations within 12 months (limb salvage, 71%). Conclusions The LimFlow system is currently the only registered device a total percutaneous DVA can be performed with. In addition to the percutaneous creation of an arteriovenous fistula (AVF), it also allows disruption of the veins with a dedicated valvulotome.

Background Guidelines recommend routine patching after carotid endarterectomy (CEA) on the basis of a lower restenosis rate and presumed lower procedural stroke rate than with primary repair. Underlying evidence is based on studies performed decades ago with perioperative care that significantly differed from current standards. Recent studies raise doubt about routine patching and have suggested that a more selective approach to patch closure (PAC) might be noninferior for procedural safety and long-term stroke prevention. The objective was to review the literature on the procedural safety and perioperative stroke prevention of PAC compared with primary closure (PRC) after CEA. Methods MEDLINE, Embase, and Cochrane Central Register of Controlled Trials databases were searched from January 1966 to September 2017. Two authors independently performed the search, study selection, assessment of methodologic quality, and data extraction. Articles were eligible if they compared PAC and PRC after CEA, were published in English, included human studies, and had a full text available. Methodologic quality for nonrandomized studies was assessed using the Methodological Index for Non-Randomized Studies score; randomized controlled trials were assessed using Grading of Recommendations Assessment, Development, and Evaluation. Nonrandomized studies with a score ≤15 were excluded. The primary outcome measure was 30-day stroke risk. Secondary outcome measures were long-term restenosis (>50%) and postoperative bleeding. Results Twenty-nine articles met the inclusion criteria, 9 randomized studies and 20 nonrandomized studies, for a total of 12,696 patients and 13,219 CEAs. Overall 30-day stroke risk was higher in the PRC group (odds ratio [OR], 1.9; 95% confidence interval [CI], 1.2-2.9). After exclusion of nonrandomized studies, this difference was not statistically significant anymore (OR, 1.8; 95% CI, 0.8-3.9). The restenosis rate was higher after PRC (OR, 2.2; 95% CI, 1.4-3.4). There were no differences in bleeding complications. Methodologic quality of the nonrandomized studies was moderate, and seven were excluded. Quality of the evidence according to Grading of Recommendations Assessment, Development, and Evaluation was moderate for restenosis, 30-day stroke, and bleeding. Conclusions In this systematic review, on the basis of moderate-quality evidence, perioperative stroke rate was lower after PAC compared with PRC. The rate of restenosis was higher after PRC, although the clinical significance of this finding in terms of long-term stroke prevention remained unclear.

First rib resection for thoracic outlet syndrome (TOS) is clinically successful and safe in most patients. However, long-term functional outcomes are still insufficiently known. Long-term functional outcome was assessed using a validated questionnaire. A multicenter retrospective cohort study including all patients who underwent operations for TOS from January 2005 until December 2016. Clinical records were reviewed and the long-term functional outcome was assessed by the 11-item version of the Disability of the Arm, Shoulder, and Hand (QuickDASH) questionnaire. Sixty-two cases of TOS in 56 patients were analyzed: 36 neurogenic TOS, 13 arterial TOS, 7 venous TOS, and 6 combined TOS. There was no 30-day mortality. One reoperation because of bleeding was performed and five patients developed a pneumothorax. Survey response was 73% (n = 41) with a follow-up ranging from 1 to 11 years. Complete relief of symptoms was reported postoperatively in 27 patients (54%), symptoms improved in 90%, and the mean QuickDASH score was 22 (range, 0–86). Long-term functional outcome of surgical treatment of TOS was satisfactory, and surgery was beneficial in 90% of patients, with a low risk of severe morbidity. However, the mean QuickDASH scores remain higher compared with the general population, suggesting some sustained functional impairment despite clinical improvement of symptoms.

Purpose: To report the initial clinical experience with percutaneous deep vein arterialization (PDVA) to treat critical limb ischemia (CLI) via the creation of an arteriovenous fistula. Methods: Seven patients (median age 85 years; 5 women) with CLI and no traditional endovascular or surgical revascularization options (no-option CLI) were recruited in a pilot study to determine the safety of PDVA. All patients were diabetic; 4 had Rutherford category 6 ischemia. Six were classified at high risk of amputation based on the Society for Vascular Surgery WIfI (wound, ischemia, and foot infection) classification. The primary safety endpoints were major adverse limb events and major adverse coronary events through 30 days and serious adverse events through 6 months. Secondary objectives included clinical efficacy based on outcome measures including thermal measurement, transcutaneous partial pressure of oxygen (TcPO2), clinical improvement at 6 months, and wound healing. Results: The primary safety endpoints were achieved in 100% of patients, with no deaths, above-the-ankle amputations, or major reinterventions at 30 days. The technical success rate was 100%. Two myocardial infarctions occurred within 30 days, each with minor clinical consequences. All patients demonstrated symptomatic improvement with formation of granulation tissue, resolution of rest pain, or both. Complete wound healing was achieved in 4 of 7 patients and 5 of 7 patients at 6 and 12 months, respectively, with a median healing time of 4.6 months (95% confidence interval 84–192). Median postprocedure peak TcPO2 was 61 mm Hg compared to a preprocedure level of 8 mm Hg (p=0.046). At the time of wound healing, 4 of 5 of patients achieved TcPO2 levels of >40 mm Hg. There were 2 major amputations, 1 above the knee after PDVA thrombosis and 1 below the knee for infection. Three patients died of causes unrelated to the procedure or study device at 6, 7, and 8 months, respectively. Limb salvage was 71% at 12 months. Conclusion: PDVA is an innovative approach for treating no-option CLI and represents an alternative option for the “desert foot,” potentially avoiding major amputation. Our results demonstrate its safety and feasibility, with promising early clinical results in this small cohort.

Endothermal treatment of the great saphenous vein (GSV) has become the first-line treatment for superficial venous reflux. Nonthermal ablation has potential benefits for acceptability by patients and decreased risk of nerve injury. We performed a systematic review and meta-analysis to evaluate the efficacy of mechanochemical endovenous ablation (MOCA) and cyanoacrylate vein ablation (CAVA) for GSV incompetence.MEDLINE, Embase, Cumulative Index to Nursing and Allied Health Literature, and Cochrane databases were searched for papers published between January 1966 and December 2016. Eligible articles were prospective studies that included patients treated for GSV incompetence and described the primary outcome. Exclusion criteria were full text not available, case reports, retrospective studies, small series (n 10), reviews, abstracts, animal studies, studies of small saphenous vein incompetence, and recurrent GSV incompetence. Primary outcome was anatomic success. Secondary outcomes were initial technical success, Venous Clinical Severity Score, Aberdeen Varicose Vein Questionnaire score, and complications.Fifteen articles met the inclusion criteria. Pooled anatomic success for MOCA and CAVA was 94.7% and 94.8% at 6 months and 94.1% and 89.0% at 1 year, respectively. Venous Clinical Severity Score and Aberdeen Varicose Vein Questionnaire score significantly improved after treatment with MOCA and CAVA.These results are promising for these novel techniques that could serve as alternatives for thermal ablation techniques. However, to determine their exact role in clinical practice, high-quality randomized controlled trials comparing these novel modalities with well-established techniques are required.

Patients with critical limb ischemia have a poor life expectancy, and aggressive revascularization is accepted to maintain their independence in the end stage of life. Bypass surgery and, more recently, endovascular interventions with angioplasty and stenting have become the treatment of choice to prevent amputation and resolve rest pain. Up to 20% of patients with critical limb ischemia are not suitable candidates for a vascular intervention because of extensive occlusions of the outflow in the crural and pedal vessels. This "desert foot" can be treated with a venous arterialization. In this review, we discuss the mechanism, the techniques, outcome, and complications of venous arterialization.

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.

Objectives Mechanochemical endovenous ablation is a novel technique for the treatment of great saphenous vein and small saphenous vein incompetence which combines mechanical injury of the endothelium with simultaneous infusion of liquid sclerosant. The main objective of this study was to evaluate early occlusion. Methods All consecutive patients who were eligible for the treatment with mechanochemical endovenous ablation were included. Inclusion period was from the introduction of the device in the hospitals (September 2011 and December 2011) until December 2012. Results A total of 449 patients were included representing 570 incompetent veins. In 506 treated veins, duplex ultrasonography was performed at follow-up: 457 veins (90%) were occluded at a follow-up of 6 to 12 weeks. In univariate and multivariate analysis, failure of treated great saphenous vein was associated with saphenofemoral junction incompetence (OR 4; 95% CI 1.0–17.1, P = 0.049). Conclusions The Clarivein device proves to be safe and had a high short-term technical effectiveness.

Minimally invasive endothermal techniques, for example, radiofrequency ablation (RFA), have revolutionized the treatment of insufficient truncal veins and are associated with an excellent outcome. The use of thermal energy requires the instillation of tumescent anesthesia around the vein. Mechanochemical endovenous ablation (MOCA™) combines mechanical endothelial damage, using a rotating wire, with simultaneous infusion of a liquid sclerosans. Tumescent anesthesia is not required as no heat is used. Prospective studies using MOCA™ in both great and small saphenous veins showed good anatomical and clinical results with fast postoperative recovery. The MESSI trial (Mechanochemical Endovenous ablation versus radiofrequency ablation in the treatment of primary Small Saphenous vein Insufficiency) is a multicenter randomized controlled trial in which a total of 160 patients will be randomized (1:1) to MOCA™ or RFA. Consecutive patients with primary small saphenous vein incompetence, who meet the eligibility criteria, will be invited to participate in this trial. The primary endpoint is anatomic success, defined as occlusion of the treated veins objectified with duplex ultrasonography at 1 year follow-up. Secondary endpoints are post-procedural pain, initial technical success, clinical success, complications and the duration of the procedure. Initial technical success is defined as the ability to position the device adequately, treat the veins as planned and occlude the treated vein directly after the procedure has been proven by duplex ultrasonography. Clinical success is defined as an objective improvement of clinical outcome after treatment, measured with the Venous Clinical Severity Score (VCSS). Power analyses are conducted for anatomical success and post-procedural pain. Both groups will be evaluated on an intention-to-treat principle. The hypothesis of the MESSI trial is that the anatomic success rate of MOCA™ is not inferior to RFA. The second hypothesis is that post-procedural pain is significantly less after MOCA compared to RFA. Trial registration: NTR4613 Date of trial registration: 28 May 2014.

In emergency endovascular repair (EVAR) of ruptured aneurysms of the aorta (rAAA), anatomical suitability must be determined. Semiautomatic three-dimensional assessment of the aortoiliac arteries has the potential to standardise measurements. This study assesses the fitness for purpose of such a semiautomatic approach for rAAA and determined interobserver agreement on suitability. Interobserver study with six trained observers (4 vascular surgeons, 2 radiologists) blindly assessing preoperative computed tomography angiography scans of 50 consecutive patients with rAAA. A central lumen line (CLL) was generated, and perpendicular diameters, length along the CLL, and EVAR suitability were determined using dedicated sizing software (3mensio; 3mensio Vascular; Bilthoven, The Netherlands). Success of generating a CLL, time of assessment, and interobserver agreement was determined. In the majority of the patients (median 76 %, range 64–78 %), a CLL was semiautomatically generated. The median duration of CLL generation and performance measurements was 7.5 min (interquartile range 5.5–10.6). Agreement on suitability was moderate for the entire group (Fleiss’ κ = 0.55, confidence interval 0.48–0.62) and ranged from moderate to good (Cohen’s κ = 0.40–0.72) between observer pairs. Assessing EVAR suitability of rAAA patients using dedicated sizing software is possible in the majority of patients. The measurements can be performed in a reasonable amount of time, and the agreement of suitability for EVAR in patients with rAAA is moderate. Improvements and additional research are necessary to replace the current axial measurement.

Objectives Patients with critical limb ischemia (CLI) have a poor life expectancy, and aggressive revascularization is accepted as a means to maintain their independence in the end stage of life. The goal of this case-control study was to evaluate the clinical outcome of distal venous arterialization and compare this with pedal bypass surgery in patients with CLI, and to identify potential risk factors that could be used to effectively identify patients at high risk of graft occlusion and amputation. Methods A retrospective cohort of patients was treated for CLI using venous arterialization or pedal bypass between 2007 and 2012. Kaplan-Meier and Cox regression analyses were used to evaluate predictors for limb salvage and patency. Results In 40 patients with CLI, 21 venous arterializations and 19 pedal bypasses were performed. In the venous arterialization group, early occlusion was 15%, 1-year patency was 71%, and limb salvage was 53%. In the PB group, early occlusion was 23%, one-year patency was 75% and limb salvage was 47%. The only independent risk factor for limb salvage in multivariate analysis was bypass occlusion ( P Conclusions Limb salvage after venous arterialization was equal to limb salvage after pedal bypass surgery in this clinical comparative study.

OBJECTIVE: To determine whether intraoperative diuresis, postoperative recovery, and early graft function differ between laparoscopic open nephrectomy (LDN) and open donor nephrectomy (ODN). SUMMARY BACKGROUND DATA: Laparoscopic donor nephrectomy can reduce donor complications in terms of decreased pain and shorter convalescence. Although its technical feasibility has been established, concerns have been raised about the impaired renal function resulting from pneumoperitoneum and short- and long-term function of kidneys removed by LDN. METHODS: Between December 1997 and December 2000, 89 LDNs were performed at the authors' institution. These were compared with 83 conventional ODNs performed between January 1994 and December 1997. Graft function, intraoperative variables, and clinical outcome were compared. RESULTS: Laparoscopic donor nephrectomy was attempted in 89 patients and completed in 91% (81/89). Length of hospital stay was significantly shorter in the laparoscopic group. During kidney dissection, the amount of fluids administered and intraoperative diuresis were significantly lower for LDN. In recipients, mean serum creatinine was higher after LDN compared with ODN 1 day after surgery. From postoperative days 2 until 28, there were no differences in serum creatinine. Graft survival rates were similar for LDN and ODN. CONCLUSIONS: Donors can benefit from an improvement in postoperative recovery after LDN. Assessment of an adequate perioperative hydration protocol is mandatory to ensure optimal kidney quality during laparoscopic procurement. The initial graft survival and function rates justify continued development and adoption of LDN.