Phlebology: The Journal of Venous Disease

Ultrasound guided foam sclerotherapy (UGFS) is a flexible and highly utilised tool in the treatment of varicose veins (VVs), both as a primary treatment and as an adjunct to other treatments. Concern remains regarding the risk of neurological adverse events (AEs) such as migraine, visual disturbance and serious adverse events (SAEs) such as cerebrovascular accident that have been reported after UGFS treatments.

To determine the incidence of neurological AEs and SAEs after UGFS.

A prospective, multicentre, post-authorisation safety study across Europe (both private and government) was performed between January 2015–2020. Neurological adverse events after UGFS with Fibrovein® (Sodium Tetradecyl Sulfate) 1 and 3% physician generated foam.

8056 patients underwent treatment. There were 46 AE (including 5 SAEs), 30 (65%) SAEs were in female patients. Mean age was 55 years with mean body mass index (BMI) of 27. Univariable logistic regression demonstrate that UGFS only treatment (i.e. no adjunctive treatment), liquid-to-gas ratio, gas type and total foam volume (1% sodium tetradecyl sulfate, STS) were significantly associated with the odds of experiencing the outcome. Multivariable logistic regression model exhibits that migraine and total foam volume (1% STS) maintained statistical significance thus associated with the odds of adverse events.

This study demonstrates that UGFS with Fibrovein is safe with a very low incidence of neurological AEs and SAEs. Past history of migraine, use of physiological gas (O₂/CO₂) and increasing volumes of 1% foam increase the risk of AEs.

The aim of this study was to assess occlusion rates of saphenous veins treated with the VariClose vein sealing system.

A retrospective analysis including a total of 64 patients from four centres from the Czech Republic. Occlusion was defined as a non-compressible vein with absence of flow with exception to the first 3 cm from the saphenofemoral or saphenopopliteal junction on duplex ultrasound.

In 64 patients a total of 79 veins were treated. Technical success of the procedure was achieved in 74 (94%) of cases. The mean follow-up was 5.5 months. The closure rates calculated by the Kaplan-Meier method at 1, 3, 6 and 12 months were 94%, 85%, 69% and 36%, respectively, and there were no significant differences between centers. The average difference in VCSS score before and after the procedure was 1.8.

The present study demonstrated surprisingly worse occlusion rates than the current literature.

Current minimally invasive techniques for ablation in superficial venous reflux are limited to thermal based systems requiring tumescent anesthesia, non-thermal chemical sclerosants and permanent glue implantation. The aim of this feasibility study was to determine the safety and efficacy of a novel mechanical-only ablation (MOA) device called EnVena, in a recognised large animal model with chronic follow up.

Venous ablation of six lateral saphenous veins in three sheep was performed using the EnVena device. Luminal patency and vein wall fibrosis were evaluated by histologic analysis at 51 and 89 days.

All treated veins demonstrated fibrotic occlusion in contiguous segments at 51 and 89 days on histological analysis. From 45 consecutive segments spanning the treatment length across the six treated veins, 26 (57%) were fully occluded, 7 (16%) were impinged or partially occluded and 12 (27%) were open. There were no device related complications during the follow up period.

A purely mechanical approach to superficial venous ablation demonstrated safety and efficacy in a recognized large animal model based on histological findings.

The objective was to investigate the delay between the onset of DVT symptoms and start of anticoagulation in common practice, assess whether this has any impact on the recanalization of venous thrombosis over one year follow up.

A prospective observational study on 76 consecutive patients (39 men, 51.3%) with DVT diagnosed using compression ultrasound (CUS). Timing was classified as very early treatment ≤72 hours, early treatment ˂7 days and late treatment ≥7 days from onset of symptoms. Further development of the disease was monitored by CUS in scheduled visits 1, 3, 6 and 12 months after the start of treatment.

Mean delay from symptom onset to the start of anticoagulation was 11.1 days (median 7 days, range 1-42 days) with significant difference (p˂0.05) between proximal (12.9 days, median 30 days) and distal DVT (6.5 days, median 2 days). In less than 25% of all patients, with both proximal and distal DVT, treatment was started very early (≤72 hours), 40 patients (52.6%) received late treatment ≥7 days. There was a positive correlation between delay, average time of complete recanalization (≤72 hours 4.2 months, ≥7 days 5.3 months, p˂0.05) and rate of incomplete recanalization (≤72 hours 7.3%, ≥7 days 30.9%, p˂0.01) in proximal DVT, not in distal DVT.

There was a delay of ≥7 days in treating in more than half of our patients. The mean interval between clinical onset and start of treatment was significantly shorter and a delay ≥7 days significantly less frequent in patients with distal DVT compared to patients with proximal DVT. A very significant positive correlation between delay in treatment and rate of incomplete recanalization of proximal and distal thrombosis indicates that delayed anticoagulation could be a signal risk factor for the incomplete recanalization and development of PTS.

Functional impairment is a common complaint in patients with venous malformations. Equinus can occur when the venous malformation involves the lower limb, a challenging condition with only a few studies to guide treatment choices. This study was aimed to investigate the operative management of equinus associated with lower limb venous malformations.

Between August 2015 and September 2017, a total of 12 patients presented with equinus associated with lower limb venous malformations and underwent surgical correction. Preoperative and postoperative clinical symptoms, physical examination and orthopaedic evaluation were retrospectively reviewed. 8 patients who experienced pain underwent percutaneous sclerotherapy prior to the operation. Surgical management included gastrocnemius intramuscular aponeurotic recession, Z-lengthening of the Achilles tendon, Hoke technique and Taylor Spatial Frame external fixation.

There were eight female and four male patients with a mean age of 14.3 ± 5.9 years. The mean follow-up period was 34.8 ± 9 months. The range of motion of ankle dorsiflexion (with knee extended) improved for each patient (mean, 25.4 degrees; standard deviation, 8.5 degrees). No neurovascular complications were observed.

Operative correction of equinus associated with lower limb venous malformations is safe and effective. Selective preoperative sclerotherapy is necessary for optimal outcomes.

Lack of physical activity represents a risk factor for both cardiovascular and chronic venous diseases (CVD), nevertheless a specific exercise protocol for CVD patient is still missing. This investigation was aimed to assess the impact of a standardized exercise protocol in a thermal water environment on physical fitness and quality-of-life (QoL) in CVD patients.

Sixteen (16) CVD patients performed 5 standardized exercise sessions in a thermal water pool. Before starting the exercise protocol, the cohort filled International Physical Activity Questionnaire (IPAQ) to determine their physical activity level. At baseline and at the end of the exercise program, leg volume, QoL, musculoskeletal and cardiovascular physical fitness were assessed by means of water plethysmography, validated questionnaire and functional test, blood pressure and heart rate at rest were also reported.

All the patients were categorized as physically inactive: average activity time 235.6 (155.2) MET-minutes per week. At the end of the study, a significant leg volume reduction was found (−16%; p < .002). Significant improvement in lower limb strength (p < .0001), endurance (p < .006), rapidity and balance (p < .05) together with decrease in resting heart rate (−1.8%, p < .0001) and systolic blood pressure (−1.1%, p < .04) were reported, significant improvement in bodily pain (p < .0005) and social function (p < .002) QoL items were observed.

The proposed exercise protocol in thermal aquatic environment demonstrated to be an effective treatment modality improving both cardiovascular and musculoskeletal outcomes and QoL in sedentary CVD patients. Aquatic environment investigations require proper analysis of the various factors involved, in a standardized and reproducible way. The herein report can be a reference for further studies on different health related conditions.

To assess the postoperative pain and midterm results of patients undergoing internal perivenous compression with internal compression therapy (ICT) for venous insufficiency at the saphenofemoral junction (SFJ)

Patients managed with ICT between April and October 2019 for grade 4 venous reflux at the SFJ were retrospectively evaluated. The venous clinical severity score (VCSS) was calculated preoperatively and 1, 3, and 6 months postoperatively. Postoperative pain was assessed with the visual analog scale (VAS). Control Doppler ultrasound imaging was performed 6 months postoperatively.

Forty-five patients [14 (31%) males and 31 (69%) females; mean age, 47 ± 13 years] were included. The median preoperative VCSS was 7 (5–8.5). The median VCSS at 1, 3, and 6 months postoperatively was 6 (4–7.5), 4 (3–5.5), and 3 (2–4), respectively, and these values were significantly lower than the preoperative score (p = 0,001, p < 0.001, and p < 0.001, respectively). The postoperative VAS score was 0 in 6 patients (13%), 1 in 17 patients (38%), 2 in 6 patients (13%), 3 in 15 patients (33%), and 4 in 1 patient (2%). At 6 months, reflux was absent in 9 (20%), grade 1 in 20 (44%), and grade 2 in 16 (36%) patients. A vena saphena magna diameter of >6.7 mm predicted grade >1 reflux at 6 months [87.5%, with an area under the curve of 0.78 (p < 0.001)]. No complications occurred.

ICT alleviated symptoms and reduced reflux grade in patients with venous insufficiency at the SFJ. This therapy can be applied with satisfactory patient comfort.