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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.

Objective The aim of this study was to investigate the predictive value of haemodynamic parameters on success of stenting or bypass surgery in patients with non-thrombotic or post-thrombotic deep venous obstruction. Methods EMBASE, MEDLINE and trial registries were searched up to 5 February 2016. Studies needed to investigate stenting or bypass surgery in patients with post-thrombotic obstruction or stenting for non-thrombotic iliac vein compression. Haemodynamic data needed to be available with prognostic analysis for success of treatment. Two authors, independently, selected studies and extracted data with risk bias assessment using the Quality in Prognosis Studies tool. Results Two studies using stenting and two using bypass surgery were included. Three investigated plethysmography, though results varied and confounding was not properly taken into account. Dorsal foot vein pressure and venous refill times appeared to be of influence in one study, though confounding by deep vein incompetence was likely. Another investigated femoral-central pressure gradients without finding statistical significance, though sample size was small without details on statistical methodology. Reduced femoral inflow was found to be a predictor for stent stenosis or occlusion in one study, though patients also received additional surgery to improve stent inflow. Data on prediction of haemodynamic parameters for stenting of non-thrombotic iliac vein compression were not available. Conclusions Data on the predictive value of haemodynamic parameters for success of treatment in deep venous obstructive disease are scant and of poor quality. Plethysmography does not seem to be of value in predicting outcome of stenting or bypass surgery in post-thrombotic disease. The relevance of pressure-related parameters is unclear. Reduced flow into the common femoral vein seems to be predictive for in-stent stenosis or occlusion. Further research into the predictive effect of haemodynamic parameters is warranted and the possibility of developing new techniques that evaluate various haemodynamic aspects should be explored.

Introduction Treatment of deep venous occlusive disease is gaining popularity, although the results and outcomes of various techniques are yet to be fully studied. Quality-of-Life (QoL) improvement is a valid and important outcome in medicine, but no specific QoL instruments for deep venous pathology exist up until now. We assessed the short term QoL effects of treated patients with post thrombotic syndrome after deep venous occlusion. Materials and methods Patients with proven venous occlusive disease referred to the outpatient clinic of our department of Venous Surgery in the Maastricht University Medical Centre were included. After inclusion, patients were treated by PTA and stenting and when indicated an endophlebectomy was performed and an AV fistula was made. QoL was assessed with the disease specific VEINES-QOL/Sym and the generic SF-36 questionnaires preoperatively at baseline and postoperatively at 3 and 12 months. Results 61 patients completed the 3 month follow-up period and 28 patients the 12 month follow-up period. VEINES-QOL and Sym scores improved after 3 months: 17.5 points for QOL (p = Conclusions Treating deep venous occlusive disease leads to short-term improvement of both disease specific QoL as well as generic QoL scores. Larger long-term follow-up studies are needed to corroborate these results.

Background Iliofemoral venous obstruction, caused by post-thrombotic disease, can be treated by percutaneous angioplasty and additional stenting with good results. However, no hemodynamic parameter determining the need for treatment has been defined. This article describes the preliminary results of a study investigating the pressure changes occurring in post-thrombotic deep venous obstruction. Methodology Four patients with post-thrombotic deep venous obstruction of the iliofemoral tract were identified. Intravenous pressure was pre-operatively measured in the common femoral vein and in a dorsal foot vein bilaterally. During these pressure measurements patients were asked to walk on a treadmill with a speed of 3.2 km/h and a zero per cent slope, with the slope increasing two per cent every two minutes. Results Four patients (two male, two female) with age varying from 23 to 40 were identified. In two patients, disease extended below the femoral confluence. Pressure in the dorsal foot vein was not notably different between the affected and the control side. Pressure in the common femoral vein was markedly higher in post-thrombotic limbs compared to the control limb, with ambulatory pressure increasing more in post-thrombotic limbs. Conclusions These preliminary results are highly illustrative for the hemodynamic effect of iliofemoral deep venous obstruction due to post-thrombotic disease, even though sample size is admittedly limited. Furthermore, these results suggest that pressure measurements of the common femoral vein, and not the dorsal foot vein, might be able to identify a significant outflow obstruction due to post-thrombotic disease, though further inclusion of patients is necessary.

The imaging quality of angiodynography (Quantum; Philips) in the ilio-femoral tract was compared with uniplanar angiography. One hundred ilio-femoral tracts were investigated with both translumbar conventional angiography and angiodynography. The ilio-femoral tract was divided into five parts; proximal and distal common iliac, proximal and distal external iliac and common femoral. Stenosis was scored from 0–24, 25–49, 50–74, 75–99 and 100% and the lengths of those of 25% or more were measured in centimetres. Because the thickness of the subcutaneous fat layer decreases the depth range (normally 11.5 cm) of the 5.0 MHz transducer it was also measured in centimetres. The results showed that a significantly larger number of vessels were not seen (especially the common iliac) with an increasing thickness of the subcutaneous fat. The results based on the real-time imaging quality alone of angiodynography showed a reasonable accuracy of 83.9% when detecting stenoses graded from 0–24, 25–49, 50–74, 75–99 up to 100%. The clinically more important discrimination between a haemodynamically important stenosis of more than 50% showed a sensitivity of 88% and specificity of 98% on visual information alone. By integrating the peak velocity measurements to the results, this sensitivity rose to 95% and the specificity became 99%. The correlation in length was within a range of 1 cm in 94% and within 1–2cm in 6% of the stenoses. In conclusion, angiodynography is a reliable technique for investigating the ilio-femoral tract.

Objective To compare end-to-side (ETS) and end-to-end (ETE) distal anastomoses for femoropopliteal bypasses. Design Prospective, randomized, multicenter trial. Methods Patients from 14 centers were randomized to either ETS or ETE distal anastomosis, with stratification according to center and four categories: venous and prosthetic above knee bypass, and venous and prosthetic below knee bypass. Follow-up, with history, physical examination, ankle-brachial pressure index and duplex scan was performed at 3 months, 6 months and every 6 months thereafter until 36 months postoperatively. Results A total of 328 femoropopliteal bypass operations were performed in 274 patients. Due to anatomical considerations at the time of surgery, 15 procedures (4.6%) were excluded from further analysis. Patient characteristics, cardiovascular risk factors, Rutherford classification and number of open run-off vessels were similar for both groups. Primary patency was 75 vs 74%, 65 vs 66% and 63 vs 55% for ETE vs ETS after 1, 2 and 3 years, respectively, ( p =0.26). During follow up major amputations were necessary in 20 ETE bypasses and in nine ETS bypasses ( p =0.028). Conclusion ETE distal anastomosis in femoropopliteal bypasses does not improve patency compared to ETS anastomosis. Major amputations, after failure of the bypass, were required more frequently for ETE distal anastomoses.

Morbidity and mortality related to coronary artery disease (CAD) is a significant problem during the perioperative phase of major noncardiac vascular surgery, i, 2 because of the high incidence of severe CAD in this particular population. 3 Routine coronary angiography prior to major vascular surgery, advocated by some authors, 3 is expensive, while the coronary anatomy does not accurately predict the extent of jeopardised myocardium in many cases. Moreover, performing coronary angiography in patients with severe peripheral vascular disease is characterised by a significantly higher rate of vascular complications. Therefore, there is a need for a non-invasive assessment of CAD in patients selected for major vascular surgery, in order to identify high risk patients, who are subsequently referred for coronary angiography and coronary revascularisation. Most of the non-invasive tests use maximal physical exercise with concurrent increases in myocardial oxygen demand and in coronary b lood flow. The presence of CAD can be detected by electrocardiographic changes, reflecting myocardial ischaemia, or by abnormal patterns of left ventricular perfusion and wall motion shown by scintigraphic techniques.

Objective: To establish the effect of exercise therapy in patients with intermittent claudication and to identifiy outcome predictors for exercise training. Design: A methodological study of randomised clinical trials. Methods: A quality assessment of all eligible studies was petformed, using a list of methodological criteria. A weighing scale for the criteria was developed, based on four main categories: study population, intervention, outcome variables and data presentation~analysis. Results: Ten studies were included in the analysis. Seven randomised clinical trials had a methodological score of 60 or more points (maximum 100), and were considered to be of good quality. The mean of the methodological score was 62.5 (s.D. 8.5). hnprovement in pain-free~maximum distance~time ranged from 28-210% (Yc 105, s.D. 55.8). Only one study evaluated outcome predictors for exercise therapy. Conclusions: All studies reported a positive effect of exercise therapy on walking distance in patients with intermittent claudication, but no predictive factors were clearly identified. Future research efforts should focus on improving the quality of clinical research for patients with intermittent claudication and developing optimal rehabilitation programs.

Background: Endovascular brachytherapy (EBT) has been shown to prevent restenosis after percutaneous transluminal coronary angioplasty (PTA) in both animal and clinical studies. However, as yet, the effect of EBT on peripheral arteries is unknown. Objective: This intravascular ultrasound scan (IVUS) study evaluates the effect of EBT on the extent of plaque growth and vascular remodeling after PTA of the femoropopliteal artery. Methods: Twenty-four patients with obstructive disease of the femoropopliteal artery underwent standard PTA. Patients were randomized to receive no additional therapy or additional EBT (192-Iridium) after PTA. IVUS investigation was performed after PTA and at 6-month follow-up. A comparison was made between patients without EBT (n = 16) and with EBT (n = 8) in the change in lumen, vessel, and plaque area and plaque dissections seen with IVUS at 6-month follow-up. Results: At follow-up, IVUS revealed a significant difference in lumen area change between patients without and with EBT (−9% and +23%, respectively; P = .03). This difference was the result of a significant difference in vessel area change (+2% and +19%, respectively; P = .05). In both groups of patients, a similar increase in plaque area (+12% and +16%, respectively; P = .80) was encountered. Plaque dissections encountered immediately after PTA were absent at follow-up in patients without EBT, whereas in four of the eight patients with EBT, a persistent dissection was encountered. Conclusion: This randomized IVUS study showed that γ-radiation after PTA has a positive effect on lumen dimensions at 6-month follow-up by inducing positive vascular remodeling (ie, vascular dilatation); γ-radiation seemed not to affect plaque growth. In addition, γ-radiation has an effect on the healing process of dissections after PTA. (J Vasc Surg 2002;36:318-24.)