Abstract
Abstract session 1: Risk prediction and superficial vein thrombosis
Paper 1.1
Mean platelet volume (MPV) as a predictor of venous thromboembolism (VTE) in colorectal cancer
1Department of Surgery, Faculty of Medicine, Ramathibodi Hospital, Mahidol University, Bangkok, Thailand
2Department of Surgery, Faculty of Medicine, Thammasat University Hospital, Thammasat University, Pathumthani, Thailand.
Back ground
MPV, CBC-parameter, is potential biomarker of platelet activity in cancer and VTE. However, recent CATS-study showed that high-MPV levels associated with a decreased VTE risk.
Aim
To investigate the role of MPV in VTE and colorectal-cancer.
Methods
A retrospective study was performed to analyze differences of MPV between patients with VTE, VTE and colorectal-cancer, and control.
Two reviewers independently extracted data for meta-analysis. Differences in MPV were expressed as unstandardized mean difference.
Results
Among 170 patients, 58-control, 54-VTE, and 58-VTE with colorectal-cancer, MPV was significantly higher in VTE groups(table1).
From 403 articles, 10 studies(5 cohorts and 5 case-controls) comprising 2,265 patients. MPV was significantly higher in those with VTE (mean difference 0.61 fL,95%CI 0.34–0.88,P < 0.001). Elevated MPV increased the relative risk of VTE (RR 1.319 ,1.061–1.641, I2 = 82.5%) (figure1).
Conclusions
Our evidence suggests that elevated MPV is associated with VTE and VTE with colorectal-cancer. A mechanistic study and RCT are required in order to use antiplatelet therapy.
Figure 1
Paper 1.2
The agreement between Caprini and Department of Health venous thromboembolism risk scores in urological patients
Department of Surgery and Cancer, Imperial College London, Charing Cross Hospital, London, UK
Aims
1 to 5% of patients undergoing major urological surgery experience symptomatic venous thromboembolism (VTE), with pulmonary embolism (PE) the commonest cause of post-operative death. Numerous scoring systems exist to assess patients’ risk of thromboembolism, dictating thromboprophylaxis regimes. These include the Caprini score and Department of Health (DoH) VTE score. The aim of this study was to assess agreements between these two assessment tools in pre-operative urology patients.
Methods
100 patients undergoing elective urological procedures were prospectively risk assessed using the Caprini score and DoH VTE score and categorized accordingly into low, medium or high risk. Inter-rater agreement was assessed using Cohen’s Kappa coefficient. Sub-group analysis was performed on patients with and without a diagnosis of cancer.
Results
There was a 71% agreement between the two scoring methods. Cohen’s kappa coefficient was 0.516 indicating ‘moderate agreement’. Of the 29 patients demonstrating a disagreement 18 were classified as medium risk by Caprini scoring and high risk by DoH standard. Three patients were classified as low risk by DoH standards and medium risk by Caprini scoring; four patients were classified low risk by Caprini score and medium or high risk by DoH standard. 37 patients had a diagnosis of cancer of which no patient was classified as low risk by either scoring method. There was 92% agreement between the two scoring methods for cancer patients and kappa coefficient was 0.528. For the 63 patients without cancer the level of agreement was 58.7% with a kappa coefficient of 0.409 indicating fair agreement.
Conclusions
We demonstrate a ‘moderate agreement’ between scoring methods in urological patients. The disagreement is most frequent in patients classified as high risk by DoH standards, where patients are considered medium risk using the Caprini score. Given that in both groups patients will be prescribed thromboprophylaxis this is unlikely to be of clinical relevance. However, the six patients scoring low in one group and medium or high in the second group would have only been prescribed thromboprophylaxis depending on which scoring method was used. All patients with a diagnosis of cancer were scored as medium or high with both scoring methods and would have received thromboprophylaxis whether the Caprini or DOH scoring methods were used. Patients without a diagnosis of cancer, however, had poorer agreement between scoring methods. It is in these patients that discrepancies in thromboprophylaxis prescription are likely to occur. Considering the morbidity and mortality associated with VTE and PE following urological surgery further work to assess the long term cost and health implications of using different scoring methods in these patients is needed.
Winner of the EVF Prize: 3rd Place
Paper 1.3
Risk adjusted DVT prophylaxis for ambulatory varicose vein procedures: how useful is the Caprini risk assessment model
The Vascular Unit, Worcestershire Royal Hospital, Worcester UK
Introduction
Postoperative deep vein thrombosis (DVT) is associated with significant morbidity and mortality. DVT rates of 0–16% are reported after local anaesthetic ambulatory varicose vein (LA-AVV) thermal ablation. This has led to inconsistent provision of low molecular weight heparin (LMWH) thromboprophylaxis in this high volume area of vascular practice. LMWH administration is best tailored to an individual’s DVT risk however there are no specific risk assessment models (RAMS) for this patient group. The Caprini score is a validated RAM for patients undergoing major surgery. This study aims to establish whether the Caprini score can be a useful predictive tool for DVT in patients undergoing LA-AVV procedures.
Methods
Pre-operative ‘Caprini risk-factors’ for patients undergoing LA-AVV radiofrequency ablations were retrospectively extracted from a prospectively maintained database and electronic patient records, and collated to obtain patients’ Caprini scores. The incidence of post-procedure DVT/ endovenous heat induced thrombosis (EHIT) on routine six-week duplex imaging and the clinical decision to administer LMWH were also recorded. We assessed correlation between Caprini scores and i) incidence of DVT/EHIT and ii) the preoperative clinical decision to give post-operative LMWH using statistical methodology.
Results
186 patients underwent radiofrequency ablation in the 12 months from 1st November 2014. Caprini classification for ‘highest risk’ (score ≥ 5); ‘high risk’ (score 3–4); ‘moderate risk’ (score 2) and ‘low risk’ (score 0–1) were 17 (9%), 71 (38%), 57 (31%) and 41 (22%) patients respectively. No DVTs occurred in this study however two patients developed non-occlusive EHITs. One had a Caprini score of 4 (age ≥ 75 + VVs) and the other had a score of 1 (VVs). There was no correlation between incidence of DVT/EHIT and Caprini score (coefficient −0.009). Clinicians gave LMWH to seven patients (4%) whose (later) calculated Caprini scores were 5 (1 patient), 3 (3 patients) and 2 (3 patients). There was no correlation between Caprini scores and LMWH administration (coefficient 0.038). Of 17 patients (9%) with ‘highest risk’ Caprini score only one (prior DVT history) was given LMWH and none developed DVT. It was notable that the two patients who developed EHIT had reduced mobility.
Conclusion
We have found no correlation between Caprini scoring and DVT/EHIT or clinician’s decision to give LMWH in patients undergoing LA-AVV procedures. The Caprini score is a poor predictive tool for DVT in patients undergoing LA-AVV procedures. Limited mobility (not a Caprini risk factor) may be an important predictor of DVT/EHIT in patients undergoing LA-AVV procedures and merits further study.
Paper 1.4
VTE Assessment scoring in patients undergoing superficial venous intervention – US and UK perspectives on risk stratification
1Section of Vascular Surgery, Department of Surgery and Cancer, Imperial College London
2North West London Hospitals NHS Trust, UK
Introduction
Venous thromboembolism (VTE) is a significant cause of preventable hospital acquired mortality and of chronic venous insufficiency caused by post-thrombotic syndrome (PTS).
The incidence is predicted to rise as a function of an ageing and increasingly obese population. Prevention is key in reducing VTE incidence, and is performed utilising scoring systems that enable to both assess risk and determine the need for pharmacological thromboprophylaxis. The UK and US employ the Department of Health (DoH) and Caprini risk assessment scores to estimate VTE risk in their patients. The aim of this study was to assess the concordance between these two risk assessment scores.
Methods
This was a prospective cohort study of patients undergoing day surgery procedures for superficial venous disease (foam, endovenous ablation, phlebectomies) at a single centre. Patients were scored prior to their procedure.
Results
200 patients (60% female) were recruited from August – December 2015. The mean age was 54.5 years. The most common risk factors identified by the DoH scoring system were: age (40%), comorbidities (28%), and BMI > 25 (55%). The Caprini risk score identified minor surgery (100%), varicose veins (96%) and BMI > 25 (55%).
The pre- risk distribution using the DoH score was: 31% (62/200) low risk (score 0), 33% (66/200) medium risk (score 1) and 36% (72/200) high risk (score > 1). According to the Caprini scoring system, 8.5% (17/200) were identified as having a low risk (score 0–2), 35% (70/200) medium risk (score 3–4), 50.5% (101/200) high risk (score 5–8) and 6% (12/200) highest risk (score > 8).
The level of agreement between the two scoring systems was defined as fair (Cohen Kappa statistic 0.267, p < 0.05). According to the DoH score, 69% of patients required pharmacological thromboprophylaxis, compared to 91.5% as assessed by the Caprini score.
Conclusions
The DoH and Caprini risk assessment scores have significant differences in their low vs medium/high risk stratification of patients undergoing interventions for venous disease. This finding has important clinical and cost-related implications, particularly with respect to the administration of pharmacological thromboprophylaxis. The impact of this difference and the role of these scoring systems in this patient cohort require further evaluation by means of a well-designed, large-scale, multi-centre study.
Paper 1.5
Patterns in the management of superficial vein thrombosis
1Department of Vascular Surgery, Faculty of Medicine, School of Health Sciences, University Hospital of Larissa, University of Thessaly, Larissa, Greece
2Department of Otorhinolaryngology, Faculty of Medicine, School of Health Sciences, University Hospital of Larissa, University of Thessaly, Larissa, Greece
Objective
The objective of this study was to highlight the current practice patterns in management of superficial vein thrombosis (SVT).
Methods
An electronic survey was conducted using the mailing lists of the Mediterranean League of Angiology and Vascular Surgery and European Venous Forum regarding SVT diagnosis, investigation and treatment.
Results
The response rate was 41% (175/430) and the majority of the participants were vascular surgeons practicing in a hospital. More experienced physicians considered SVT, as a medical issue of moderate seriousness (rs = .170, p < 0.05) and perform duplex ultrasound for confirmation of diagnosis (rs = .158, p < 0.05). Elastic stockings were recommended by 87% of the physicians and 57% prescribed nonsteroidal anti-inflammatory drugs. Eighty six percent advised anticoagulation, although a large disparity was showed regarding the regime, dose and duration. The majority of the physicians prescribed anticoagulation regardless the presence of varicose veins and location of SVT. Forty two percent considered that the administration of Fondaparinux for 45 days is a reasonable treatment regardless the thrombosis location. In contrast, 30% of the physicians prescribed anticoagulation only when SVT was confined to above knee segment. Most of vascular surgeons advised low molecular weight heparin in therapeutic doses (rs = .197, p < 0.05), while more experienced physicians prescribed 2.5 mg Fondaparinux for 45 days (r = .216, p < 0.01). Thrombophilia test was regularly suggested by 19% of the physicians. Ligation of the sapheno-femoral junction was the treatment of choice by those suggested intervention in the acute phase of SVT.
Conclusions
A great disparity exists in the management of SVT. The current guidelines have not been adopted by the physicians and more focused education and training is needed for those involved in the management of venous diseases.
Paper 1.6
Rivaroxaban for thrombosis prophylaxis in endovenous laser ablation with and without miniphlebectomy: a multicenter experience
1Department of Angiology, University Hospital, Basel, Switzerland
2Gefaesspraxis am See, St. Anna im Bahnhof, Lucerne, Switzerland
3Vascular Clinic, Rapperswil, Rapperswil, Switzerland
4Department of Angiology, Hospital of Limmattal, Limmattal, Switzerland
Objectives
Endovenous heat-induced thrombosis (EHIT) is a well described complication of endovenous laser ablation (EVLA). We report our centers experience on the efficacy to prevent EHIT (EHIT level ≥ 2 according to Kabnick classification) and the safety (observed major and minor bleeding events) of rivaroxaban for EHIT prophylaxis in EVLA with and without mini-phlebectomy.
Methods
Demographic, procedural and outcome data of all patients with EVLA of the great, accessory and/or small saphenous vein and EHIT prophylaxis with 10 mg/d rivaroxaban between 2012 and 2014 were reviewed and analysed in this investigator-initiated multi-center retrospective observational single-arm study.
Results
During a median (interquartile range) follow-up duration of 51 (41;68) days complete vein occlusion was achieved in 98.4% of 438 EVLA procedures in 306 patients. One patient had an EHIT level 2. No major and 6 (1.4%) minor bleedings were observed.
Conclusions
Rivaroxaban (10 mg/d) for 5–10 days seems to be an efficient and safe alternative for EHIT prophylaxis in EVLA with and without miniphlebectomy.
Paper 1.7
Treatment of superficial vein thrombosis with intermediate doses of tinzaparin – the seven study
1Department of Vascular Surgery, University Hospital of Larissa, Greece
2Department of Vascular Surgery, University Hospital of Patras, Greece
3Department of Vascular Surgery, University Hospital of Alexandroupolis, Greece
4Department of Vascular Surgery, “KAT” Hospital, Athens, Greece
5Vascular Surgery Unit, Department of Surgery, University Hospital of Ioannina, Greece
6Department of Vascular Surgery, University Hospital of Heraklion, Crete, Greece
7Department of Vascular Surgery, “ATTIKON” University Hospital, Athens
8Vascular Surgery Unit, Department of Cardio-Thoracic Surgery, “Papanikolaou” Hospital, Thessaloniki, Greece
Introduction
The role of low molecular weight heparins in the treatment of superficial vein thrombosis (SVT) is recommended but with low grade of evidence.
Aim
To assess the treatment outcomes in patients with acute SVT with Tinzaparin in intermediate dose.
Design
Retrospective analysis of medical records collected from 8 hospitals in Greece.
Methods
Inclusion criteria: Out-patients aged ≥ 18 years, with acute SVT ≥ 5 cm in length, confirmed with ultrasound, with symptoms < 10 days, without any treatment prior to initial diagnosis. Exclusion criteria: history of deep vein thrombosis (DVT) or pulmonary embolism (PE) in the past 6 months, SVT after sclerotherapy or indwelling catheters in the past 1 month or history of any intervention in the past 3 months, thrombus close to sapheno-femoral or -popliteal junction (<3 cm), BMI > 35 Kgr/m2, and known bleeding diathesis. Selected patients who treated with intermediate dose of Tinzaparin 0.5 ml (10.000 IU) for duration that was at the treating physician’s discretion were analysed. All patients had to have a follow-up of at least 12 weeks after treatment.
Results
296 patients (189 females) with a mean age of 57.4 years were included. Overweight or obese were 203(68.5%), long-standing or restricted mobility was reported in 96 (32.4%), varicose veins were present in 240 (81%) and history of treatment for vein thrombosis beyond the past 6 months from the index event was reported in 65 (22%). The majority of the patients (191/296, 64.5%) received treatment for about a month (mean 36.9 days) while the remaining patients (105/296, 35.5%) received short-duration treatment (mean 16.2 days). No difference was observed in patients’ characteristics between the two treatment groups. Presence of thrombus above the knee (p = 0.002) and restricted daily activity (p = 0.005) were the only factors associated with prolonged treatment. Within the 12-week period after initiation of treatment recurrence of SVT occurred in 14 (4.7%), DVT in 3 (1%) and thrombus progression in the superficial veins in 1 (0.3). Recurrence occurred in 4% of those with short treatment duration and in 8% of those with prolonged treatment (p = 0.46). Presence of varicose veins/ valvular incompetence was associated with a trend (p = 0.09) towards recurrent thrombosis.
Conclusion
Tinzaparin in intermediate dose seems to be an effective treatment for SVT. The location of thrombus (above the knee) and the status of patients' mobilisation may be related to the duration of treatment. These observations require confirmation from larger prospective randomized studies.
Paper 1.8
Deep venous stenting, a single centre experience
1Imperial College Healthcare NHS Trust, Imperial College, London, UK
2Imperial College, London, UK
Deep venous reconstruction through the use of stenting is growing in use for the treatment for venous outflow obstruction in the acute and chronic setting.
Aim
To review the outcomes of deep venous stenting at a major London hospital trust.
Method
A retrospective analysis of all patients receiving deep venous stenting between 2011 and 2015 as part of a service improvement and audit program. Only patients who had stents sited in the IVC, iliac or femoral veins were included. Those receiving stenting of the SVC and its associated branches and portal vein stenting were excluded. Data collected consisted of demographics, recorded anatomy of culprit lesion, chronicity of stenting, stent manufacturer, use of thrombolysis, type of anticoagulation used, and stent patency determined by ultrasound on follow up.
Results
A total of 37 patients (mean age 45.8), 14 (37.8%) male and 23 (62.2%) female, received venous stenting with a total of 70 stents placed (mean 1.9 stents per patient). All patients were discharged on anticoagulation or anti platelet therapy following their procedure. Ten patients (27.0%) were discharged on long-term coumarins, 21 (56.8%) on long-term rivaroxaban and 5 (13.5%) on long term LMWH. One patient received clopidogrel only (2.7%). 22 patients (59.5%) had stenting for left sided lesions, 6 (16.2%) for right, 8 (21.6%) for bilateral and 1 (2.7%) for an IVC lesion only. No mortalities were recorded secondary to stent insertion (one stent was inserted in the context of palliation). Twenty patients (54.1%) had stenting in the acute setting of a predisposing lesion following thrombolysis for ilio-femoral DVT. Seventeen (45.9%) patients were treated electively for post-thrombotic syndrome or direct venous compression without thrombosis from local malignancy and 1 patient for a failed stent at another institution. Three patients (8.1%) required re-intervention in the first 6 months for stent occlusion (total or partial). Four patients were lost to follow up. Primary patency was high, with only three patients needing re-intervention, with a primary patency rate of 92% and an assisted primary patency of 100%. Of the patients included in the follow up, 1-year patency and assisted patency rates were 76% and 88% respectively.
Conclusion
Our results demonstrate that venous stenting has a high success rate. Longer term data is needed to establish what anticoagulation agents would lead to an optimal patency rate, and appropriate quality of life data to investigate the effect venous stenting has on post thrombotic syndrome patients.
Abstract session 2: Varicose vein ablation
Paper 2.1
Endovenous heat-induced thrombosis after endovenous laser ablation with 1470 nm laser and radial fibers
1“Center of Laser Surgery”, Moscow, Russia
2“Garant Clinic”, Moscow, Russia
3 Moscow State First Medical University Hospital #4, Moscow, Russia
4“Plastic-C”, Korolev, Russia
Background
Endovenous thermal ablations are efficacy and safe for varicose vein treatment. Sometimes detected thermal coagulant protrusion (TCP) into deep vein described as endovenous heat-induced thrombosis (EHIT).
Objectives
To study the incidence, risk factors, management and clinical outcome of EHIT after endovenous laser ablation (EVLA) with radial fibers.
Methods
Observational case-control study provided from Jan 2011 to Dec 2015. The ELVA procedure performed e with the 1470-nm diode laser and “Radial”, “Slim”, “2-Ring” (“Biolitec” AG) radial fibers. Energy parameters were – continues mode, Power 5–7 watt, linear endovenous energy density (LEED) 70–90 J/cm, continuous automatic pullback with speed 0,7 mm/sec. Clinical outcomes assessed with duplex investigations within 1-day, 1-month, 3-month and 6-months after EVLA.
Results
2176 patients with 2819 legs (69% women and 31% men) suffering superficial venous disease got EVLA of the great saphenous vein (GSV)-73%, small saphenous vein (SSV)-16%, accessory saphenous vein (ASV)-11%. Technical success was 100%. No pulmonary embolism registered. In 40 cases (1.41%) clinically non-symptomatic EHIT were detected by duplex at 1-day after EVLA of GSV (39 cases) and SSV (1 case). In case of EHIT detection LMH or NOAC and 1-week duplex control regimen prescribed. After 1 month all EHIT were resolved. Age, sex, vein diameter, radial fiber type had no significant influence (p > .05) on EHIT formation.
Conclusions
EVLA with radial fibers is effective and safe with rare and clinical non-symptomatic complication rates. Despite of safety resolution of EHIT, more knowledge and experience needs to determine the main risk factors of EHIT formation.
Paper 2.2
Percutaneous ligation of the gsv with ultrasound guided foam sclerotherapy and miniphlebectomies
The Danish Vein Centres, Copenhagen Denmark
Introduction
Ultrasound guided foam sclerotherapy (UGFS) is widely used for ablation of the saphenous veins. The treatment is minimal invasive, safe and inexpensive. However, recanalization is more frequent compared to thermoablation and needs to be reduced. A novel minimal invasive technique is described, which combines 3 modalities for the treatment of the great and small saphenous vein (GSV, SSV) varicose veins, namely ultrasound guided foam sclerotherapy (UGFS) percutaneous ligation (PL) and miniphlebectomies.
Material and methods
Foam was prepared using Polydocanol 3% in a concentration of 1 mL + 4 mL of air. This was injected into the refluxing saphenous trunk using Venflons®. This was followed by percutaneous ligation performed through a 5 mm incision approximately 2 cm below the sapheno-femoral junction in local anaesthesia with Lidocaine and adrenaline. Ultrasound was used to locate the terminal segment of the GSV. This was lifted up through the skin incision with an Oesch® phlebectomy hook. Then the GSV was ligated with a non-absorbable nylon tie. Finally, mini-phlebectomies were performed to complete the treatment. The patients wore a postoperative compression bandage for 24 hours and a full length compression stocking thereafter for 5 days.
Results
One hundred consecutive patients with varicose veins (95 GSV, 5 SSV), C2-C4 were treated and reviewed at 3 months. The duration of the procedure was approximately 10 minutes.
Success was achieved in terms of saphenous closure in 94%. The remaining 6% were partly closed, patient satisfaction was 99% and absence of venous symptoms was seen in 96%. Complications were few and minor. Two patients developed infection in the groin incision, 5 developed superficial phlebitis, 1 developed numbness at base of the 1st toe and 1 developed a blister from the postoperative compression bandage.
Conclusion
Foam sclerotherapy with saphenous ligation is a promising treatment modality which has the potential to reduce the recurrence rate of varicose veins. It can be performed on the SSV and accessory veins as well as the GSV. The procedure of PL is simple and quick. The results are similar to glue or thermo-ablation, but the procedure is much cheaper and still minimal invasive. Longer term follow up for at least one year is mandatory before a randomized trial should be considered.
Paper 2.3
Novel biomatrix sclerofoam compared to endovenous laser – initial results and one year follow up
Angioclinic Vein Centers – Interventional Phlebology, Berlin – Munich, Germany – Zurich, Switzerland
Background
Common sclerofoams (Cabrera type including VariThena/BTG) are inferior to thermoocclusion in regard to primary and long-term results. Common foams are of low viscosity and stability, they will collapse rapidly within 60–240 seconds and loose effect. With increasing vein diameters common foams will less displace blood but float on it with zones of uncertain effects. A novel viscous microfoam using a biomatrix based on denatured autologous blood proteins with an in-vitro half life of > 60 minutes and fast disintegration within flowing blood was evaluated in the GSV using a safety setting to prevent foam migration via the junction.
Methods
120 patients (78 f, 42 m, 32 – 81 y.) with GSV insufficiency, diameters 6 – 24 mm (mean: 10.3 mm), were randomized to two modalities of treatment: A) combination of endovenous laser in coaxial perivenous anesthesia (EVL 810 nm, ball tip; junction + segment below, length 3–20 cm) and a novel biomatrix sclerofoam (BSF) using 1% Aethoxysklerol (Kreussler) for the adjacent GSV segment (28–35 cm, n = 60), or B) EVL alone for comparison, treated segment length 38 – 55 cm (n = 60). Both modalities used the same PTFE vein catheter (PhleboCath, 2.0–2.3 mm, OTW). BSF was deployed in case of proven proximal closure during catheter withdrawal. Postinterventional examinations with ultrasound were performed after 2 weeks and 2 – 6 – 12 months by independent investigators.
Results
Initial vein occlusion was obtained in all cases (120/120). There were no adverse events, in particular no thoracic or cerebral symptoms in the group receiving BSF. The patterns of echogenicity were similar in both groups at all presentations. Vein diameter regression was the same for EVL and BSF (+/- 5%). Concerning group A, the investigators were not able to discriminate any borderline of the methods. During one year follow-up, junction segments showed reperfusion in 2/60 cases (A, 3.33%) resp. 1/60 (B, 1.6%). The thigh-to-knee segments showed reperfusion in 5/60 cases (8.33%) after BSF and in 6/60 cases (10%) after EVL alone.
Conclusions
Apart from the GSV junction segment, BSF seems to provide a similar quality of vein occlusion like gold standard EVL. BSF is more convenient as no tumescence is required. As a next step, studies using BSF also in the junction with blocking devices (e.g. V-block) or hyaluronan vein compression (IntraShape project) will follow.
Paper 2.4
The impact on residual venous reflux and varicose vein at one month follow-up on the development of recurrence of varicose vein after 5 years saphenous ablation for primary varicose vein
Cardiovascular Surgery, Fukushima Daiichi Hospital, Fukushima, Japan
Purpose
In the long term follow up after the ablation of saphenous vein for varicose vein, the rate of recurrent varicose vein is high. The venous reflux sites of recurrent varicose vein is identified, however, fundamental reasons of recurrent varicose vein after correct saphenous ablation are still unclear. Persistent venous reflux after procedure may be considered as a primary reason of recurrence. This study was conducted to identify the impact of residual venous reflux and varicose veins at post-operative early periods for recurrent varicose veins after saphenous ablation with phebectomy of varicose veins.
Material and methods
484 (595 legs) consecutive patients (C2:230, C3:137, C4a:82, C4b:27, C6:8) underwent saphenous ablation (High ligation + stripping: 343 legs or Endovenous ablation: 252 legs, all endovenous ablations were performed using 980 nm diode bare fiber laser) with phebectomies for primary varicose veins from 2009-2010 were included in this study. Ablation was performed of 538 great saphenous veins and 57 small saphenous veins.
The patients underwent clinical assessment and duplex ultrasound scanning for venous reflux before surgery and 1month and 5 years after surgery. 31 % cases had complete follow-up up to 5 years after surgery, while 69 % of the cases lost to follow-up after 1 month operation were interviewed for varicose veins by phone at 5 years post operation
The residual varicose veins are defined as more than 3 mm visible varicose veins at one month follow-up, Recurrent varicose vein are defined as more than 3 mm size new varicose veins compared to the state of visible varicose veins at post-operative 1 month.
Results
378 of 595 legs had venous reflux or residual varicose veins at postoperative 1 month (Residual varicose vein without detection of venous reflux: 39 legs, Saphenous venous reflux alone: 273, Saphenous + deep venous reflux: 20, Deep venous reflux alone 46). 104 legs were diagnosed recurrent varicose vein until post-operative 5 years in this group. However, in no venous reflux and no residual varicose veins group (217 legs), 12 legs were found recurrent varicose vein.
Conclusions
Persistent and residual venous reflux and varicose veins after saphenous ablation become a big risk of recurrent varicose vein.
Paper 2.5
A comparison of five year treatment outcomes in patients with and without complications of superficial venous insufficiency
Academic Vascular Surgical Unit, Hull York Medical School, Hull, UK
Objective
Superficial venous insufficiency (SVI) can present on a spectrum of clinical severity ranging from telangiectasia, uncomplicated varicose veins to soft-tissue changes and, ultimately, venous ulceration. The long-term significance of pretreatment disease severity is unclear, although rationing often restricts treatment to only those with more advanced states on the CEAP classification system. This study investigates the outcomes of those with soft tissue changes in comparison to those with uncomplicated symptomatic varicose veins.
Methods
Two cohorts were taken from the HELP-1 study, a randomized clinical trial of open surgical ligation, stripping and phlebectomy versus endovenous laser ablation (EVLA) plus concomitant phlebectomy for the treatment of symptomatic Great Saphenous venous insufficiency. Patients with pre-treatment C2 disease were compared to those with soft tissue complications (C3-4). Outcomes measured up to 5 years included clinical recurrence and the requirement for additional procedures, and quality of life (Qol) [short form 36 (SF36), EuroQol (EQ5D), and Aberdeen Varicose Veins Questionnaire (AVVQ)].
Multivariable regression analysis was used to control for confounding factors.
Results
213 patients (154 C2 and 59 C3-4) attended five-year follow-up and were analysed.
Recurrence of clinically-evident varicosities was significantly lower in the C2 cohort (43%) than in the C3-4 cohort (70%), RR 0.62 (0.48–0.79), NNT = 4. This translated into a lower requirement for additional procedures in the C2 cohort (OR 0.256 (95% CI 0.103–0.635) p = 0.003).
Baseline QoL scores were similar in both groups, with significant improvements after treatment. AVVQ scores were significantly lower (better) in the C2 group than the C3-4 group up to two years (p = 0.008), but by five years this difference was lost (C2 median (iqr): 3.9(0.3–8.9) vs C3-4: 4.6(1.6–9.6) p = 0.402).
SF-36 physical health domain scores were significantly higher (better) in the C2 cohort than the C3-4 group over the first two years, with sustained Physical Functioning and General Health scores to five years.
Improved EQ5D scores were maintained in the C2 group over 5 years, whereas the C3-4 group returned to pre-treatment values by 2 years.
Multivariate regression analysis, controlling for patient demographics and treatment type (surgery or EVLA), revealed that treatment of C2 disease was associated with reduced long-term clinical recurrence (OR 0.289 (95% CI 0.142–0.588) P = 0.001), and requirement for additional procedures (OR 0.256 (95% CI 0.103–0.635) P = 0.003), and benefits in QoL improvement.
Conclusion
More severe states of SVI are associated with higher rates of clinical recurrence after treatment, a greater requirement for additional procedures and worse QoL outcomes. Intervention before the onset of skin changes is recommended.
Paper 2.6
Mechanochemical ablation (MOCA) in patients with severe superficial vein incompetence- a prospective report
Venous Centre, Malmö, Sweden
The treatment of varicose veins with endothermal techniques are successful but they all require general or local anaesthesia with the use of tumescent. This is normally well tolerated by the patients but a number find the distribution of tumescent quite painful. Due to this alternative methods to endothermal techniques have been developed. These techniques can normally be carried without any tumescent anaesthesia.
Methods
A prospective study on consecutive patients with a duplex verified venous incompetence in either the Great saphenous vein or the Small saphenous vein. All patients were classified according to the CEAP system to at least 3 b. 31 consecutive patients, 34 legs, were treated with MOCA with the Clarivein® system (Vascular Insights, Quincy, MA, USA). All patients left a verbal consent to participate. The patients were included in a protocol with a questionnaire previously developed at the clinic as a tool for quality measurements. The questionnaire consists of questions regarding pain, analgesic use and sore feeling over the treated vessel segment. Pain score is recorded according to the visual analogue scale (VAS) and the other questions are answered with yes/no. The questionnaire was countered at day 2, 7, 14 and 28 post treatment. 12 months post treatment a duplex US follow-up recorded occlusion rate and questions of improvement, measured according to the visual analogue scale, staining and if the patient would recommend this treatment to others. The results were compared with the results from 51 consecutive patients treated earlier with laserablation using VenaCure EVLT® System (Angiodynamics, Latham, NY, USA).
Results
All patients completed the questionnaire. One patient didn’t complete the duplex US follow-up.
Pain score according to VAS, EVLT (): Day 2; 1,19 (3,61), Day 7; 1,34 (3,66), Day 14; 1,19 (2,12), Day 28; 0,75 (1,1). Analgesic use, EVLT (): Day 2; 29% (66%), Day 7; 23% (55%), Day 14; 10% (24%), Day 28; 13% (3%). Sore feeling, EVLT (): Day 2; 29% (73%), Day 7; 29% (79%), Day 14; 29% (76%), Day 28; 15% (51%). 12 Months result: Staining frequency 16%. Improvement according to VAS 7,2. Occlusion rate 77% and 88% of the patients would recommend the treatment.
Conclusion
This is our first experience with the MOCA technique which can explain the relatively high recanalization frequency of 23%. The MOCA technique is easy to tolerate for the patients and the technique has a lower post treatment pain and discomfort level than treatment with 1470 laserablation. The technique could be an alternative treatment technique for patients with a known low pain threshold.
Paper 2.7
Randomised controlled trial comparing mechanochemical ablation to radiofrequency ablation: the multicentre Venefit™ versus ClariVein® for varicose veins (VVCVV) trial
1Academic Section of Vascular Surgery, Imperial College London, London, UK
2Department of Vascular Surgery, North West London Hospitals NHS Trust, Harrow, UK
Objective
Endovenous techniques are currently the recommended choice for truncal vein treatment. However, thermal techniques require tumescent anaesthesia, which can be uncomfortable during administration. Non-tumescent non-thermal techniques would therefore have potential benefits. This randomised controlled trial was carried out mainly to compare the degree of pain patients experience while receiving mechanochemical ablation (MOCA) or radiofrequency ablation (RFA). An early report of this trial has previously been published. The 6 months clinical outcomes are reported here.
Methods
Patients attending for primary varicose vein treatment were randomised to receive MOCA (ClariVein
Results
One hundred and seventy patients were randomised (51% in the MOCA group). Baseline characteristics, including demographics, CEAP classification, clinical scores and quality of life (QoL) scores were similar.
The maximum pain score was significantly lower in the MOCA group (24.3 mm ± 22mm) compared to the RFA group (34.8 mm ± 24mm; p = 0.005). Average pain score was, however, similar in the MOCA group (17.8 mm ± 21mm) and the RFA group (24.0 mm ± 18mm; p = 0.053).
Seventy-six percent of the patients attended follow-up at one month and 71% attended at six month. The VCSS score at 1 month was 2.7 for the MOCA group compared to 3.3 for the RFA group (p = 0.279), while, at 6 months, the corresponding scores were 2.5 for MOCA and 2.7 for RFA (p = 0.571). The EQ-5D scores were 0.807 for MOCA at 6 months compared to 0.691 for RFA (p = 0.039). The disease specific AVVQ scoring system was, however, not significantly different between the two groups at 6 months (12.9 for MOCA compared to 16.3 for RFA; p = 0.247).
The time to return to normal activities and to work was again comparable between the two groups. The complete or proximal occlusion rate at 6 month was 87.1% for the MOCA group and 93.2% for the RFA group (p = 0.483).
Conclusion
The results show that MOCA is less painful than RFA procedure. However, at 6 months, the clinical and specific quality of life scores showed similar improvement in both treatment groups, with comparable occlusion rates.
Paper 2.8
Cyanoacrylate closure of incompetent great, small and accessory saphenous veins without the use of post-procedure compression: a post-market evaluation of the VenaSeal system (WAVES trial): Preliminary one month data
Lake Washington Vascular Surgeons, Bellevue, Washington, USA
Introduction
A pivotal US study of proprietary cyanoacrylate closure (CAC) (VenaSeal™ Closure System, VCS) of the great saphenous vein (GSV) led to FDA approval in 2015 (the VeClose Study). There are no US published reports of CAC of the small saphenous vein (SSV), accessory saphenous veins (ASVs) or multiple saphenous veins in a single session. We report the one-month results of a prospective study examining performance of CAC in treating one or more symptomatic incompetent saphenous veins (GSV, SSV, ASV), with inclusion criteria to include larger veins (up to 20 mm).
Methods
Fifty subjects with symptomatic GSV, SSV and/or ASV incompetence were treated in one treatment session. Compression stockings were not used. Subjects returned to clinic at one week, one and three months. Procedural assessments included technical treatment parameters as well as pain experienced by the patient during the procedure. Post-procedure assessments included pain, QOL, return to normal activities, and adverse event assessments (AEs). The study’s primary endpoint was closure of the primary target vein (PTV) and all treated veins at one month assessed by duplex. No adjunctive procedures were allowed.
Results
Both mean GSV diameters (7.9 mm, ± 3.6) and initial revised venous clinical severity scores (rVCSS, mean 6.4 ± 2.2) were higher than those in the VeClose study. All targeted vein segments (TVS) (47 GSVs, 13 ASVs, 8 SSVs) were successfully treated. Pain during the procedure was mild (mean score 1.8 on a NRS of 1 to 10). One-month closure rates were 100% for the PTV and 100% for all TVS. Mean time to return to work and normal activities was 0.2 ± 1.1 and 2.4 ± 4.1 days respectively The mean rVCSS at one month was 1.8 ± 1.4, a significant improvement (p < .0001, paired t test). Phlebitis in the treatment area or side branches, occurred in 9 patients (18%), and was the most common AE. It was completely resolved in all but one patient (2%) by one month. 96% of patients were “completely” or “somewhat” satisfied and 4% “unsatisfied” with the procedure at one month, despite the protocol disallowance of concomitant side branch treatment.
Conclusions
CAC is effective for the treatment of one or more incompetent saphenous veins. Treatment of multiple incompetent vein segments in one treatment setting is safe and feasible. Closure rates were high, even in the absence of the use of compression stockings or side branch treatment. Time back to normal activities was short, comparing favorably to alternative treatment methods. Improvements in patient disease severity measures were significant.
Abstract session 3: Cost-benefit studies, epidemiology and anticoagulation complications
Winner of the EVF Prize: 1st Place
Paper 3.1
A cost comparison of treating those with and without the complications of SVI
Academic Vascular Surgical Unit, Hull York Medical School, Hull, UK
Objective
The long term economic costs of treating patients with simple varicose veins versus those with complex venous disease and associated tissue changes has yet to be reported. In some healthcare systems it is only those with advanced Superficial Venous Disease (SVI) who will be eligible for treatment. The aim of this study was to compare the costs of treating those with uncomplicated C2 disease and those with complicated C3 to C4, and to establish the cost effectiveness of such a policy.
Methods
The HELP-1 study randomised 280 patients with isolated, unilateral, symptomatic great saphenous insufficiency to conventional surgery or endovenous laser ablation (EVLA). Of these, 191 and 76 were of C2 and C3-4 disease respectively. Assessments were at 1, 6, 12, 52, 104, and 260 weeks. Any patients developing symptomatic clinical recurrence during this time were offered the options of conservative management (with or without compression) or an interventional treatment. Interventional treatments were offered on an individualised basis by an experienced surgeon with a special interest in the management of venous disease, and could include one or more combinations of phlebectomy, ultrasound guided perforator ligation, perforator ablation, UGFS, EVLA and open surgery. Costs were calculated using prospective data estimating the actual resource requirement in each case over 5 years. In addition health utilities were calculated and cost effective analysis performed as recommended by NICE.
Results
The primary treatment costs for both groups was similar (C2 £1137 (£133) vs C3-4 £1128 (£135) p = 0.633). Over five years the proportion of those requiring further treatment was higher among those with C3-4 disease (C2 n = 25 C3-4 n = 25 p < 0.001) and, despite similar costs for additional interventions, drove the mean costs significantly higher among the C3-4 group by five years. QALY health outcomes in those with C2 disease were better than those with C3-4 disease, with a greater AUC of 4.652 versus 4.393. This was not the case with the SF6D utility however (C2 4.096 vs 3.902). The ICER (£/QALY) using the EQ5D was measured at £-510, with an INB at £30,000 (the typical value set by NICE) around £5,316 and well within the accepted threshold for cost effectiveness. The probability of this being cost-effective was greater than 90% as determined on a CEA curve. A similar pattern was repeated using the SF6F, with an ICER of -£450 and an INB at £30,000 around £5,916.
Conclusion
It is more cost effective to treat patients early with less advanced disease than to delay until disease has progressed. Early treatment is associated with greater QoL gain and ultimately reduced expense.
Winner of the EVF Prize: 2nd Place
Paper 3.2
The relationship between social deprivation and referral to a vascular service for the assessment and diagnosis of varicose veins and leg ulcer before and after publication of NICE Clinical Guidelines 168
University of Birmingham Department of Vascular Surgery, Heart of England NHS Foundation Trust, Birmingham, UK
Introduction
In July 2013 the National Institute for Health and Care Excellence (NICE) published clinical guidelines (CG) 168 which recommended referral to a vascular service of all patients with symptomatic varicose veins (VV) and leg ulcers (LU) (the latter defined as a break in the skin present for more than 2 weeks).
Aim
To examine the relationship between social deprivation and referral to a vascular service for the management of VV and LU before and after publication of NICE CG 168 in July 2013.
Methods
All patients undergoing a venous intervention for VV or a LU, or referred because of a LU, during two 18-month periods before (group 1) and after (group 2) publication of CG 168 had their Index of Multiple Deprivation (IMD) (http://www.gov.uk/government/statistics/english-indices-of-deprivation-2010) calculated (IMD quintile 1 = least deprived, 5 = most deprived). Results were compared using χ2 and multinominal logistic regression.
Results
670 VV treatments were recorded (253, group 1; 417, group 2) with no difference between age and sex. There was no difference in VV treatments in terms of IMD quintile spread before and after CG168, confirmed with multinominal logistic regression.
566 LU patients were referred (253, group 1; 385, group 2). In LU patients after CG168 there was a significant increase in the proportion of IMD quintile 3 and reduction in quintile 5 patients, confirmed with multinominal logistic regression. There was no difference in IMD quintiles before and after CG168 between superficial venous insufficiency (SVI) ulceration, deep venous ulceration, arterial ulceration and non-vascular ulceration. SVI ulceration present for less than 6 months showed an increase in IMD quintile 1 after CG168. SVI ulceration present for greater than 6 months there was a higher proportion of IMD quintile 3 patients and a lower proportion of IMD quintile 5 patients after the guideline introduction.
Conclusion
Publication of CG168 does not appear to have disadvantaged socially deprived patients from access to VV treatments, with no change in distribution of IMD quintiles. There was a substantial increase in LU referrals after CG168 introduction, however this increase resulted mainly from IMD quintiles 1–4 and although more IMD quintile 5 patients were referred after CG168, the overall proportion was lower. This suggests community LU services favour the socially privileged and the need to improve access for patients from deprived areas with LU.
Paper 3.3
The prevalence of chronic venous disease worldwide. An epidiomological analysis. The final results of the VEIN consult program
1Department of Vascular Surgery, Sint-Andriesziekenhuis Tielt Belgium.
2Department of Public Health, Biostatistics unit, University of Ghent, Ghent, Belgium.
3Department of Vascular Surgery, University hospitals Leuven, Belgium.
4Department of Cardiovascular and Thoracic Surgery, University Hospital Mont-Godinne, Belgium.
5Department of Vascular Surgery, University Hospital of Brussels, Belgium
Purpose
The purpose of this study is to measure the prevalence of chronic venous disease worldwide and to look for intercontinental differences. Also the possible influence of risk factors was assessed.
Materials and methods
A survey was carried out in 22 different countries. Patient recruitment was done by general practitioners(GP). Each GP screened 10–20 consecutive patients older than 18 years. Patient characteristics, prevalence of risk factors, symptomatology and C-classification were noted. We looked for possible differences in prevalence and risk factors in different geographic areas: Asia(A), Eastern Europe(EE), Latin America(LA)and Western Europe(WE).
Results
In total 120338 patients were included. The average age was 52.3 years and the female predominance 69.32 %. In total 69.94 % of included patients were diagnosed having CVD (C1-C6). Chronic venous insufficiency(CVI) (C3-C6) was noted in 32.3% and advanced venous disease(AVD) (C5-C6) in 9.09%. The prevalence of respectively CVD (51.9% A, 70.18% EE, 68.11% LA, 73.36% WE), CVI (19.84% A, 29.9% EE, 26.62% LA, 36.45% WE) and AVD (1.28% A, 2.87% EE, 3.96 LA, 14.02% WE) was significantly higher in Western Europe. Estimated probabilities for having CVD, CVI and advanced VD, corrected for age and separately reported for gender, confirms the regional disparities. Estimated probability for a female patient (average age 52.3 y) having AVD was 6.4% in WE compared to 1.1% in A, 1.5% in EE, 1.8% in LA.
Risk factors such as age and body mass index (BMI), smoking, having regular exercise and having a positive family history differ significantly between regions. Patients in WE (median 55 years) and EE (median 56years) were significantly older than those from LA (median 43 years)and A (median 45 years).
A major risk factor, family history of CVD, varies significantly between the regions, with the highest rate in LA(50.27%) and lowest rate in A (19.97%). Model-based probabilities with age as a categorical variable(age groups 18–34 y, 35–50 y, 50–65 y, and < 65years) corrected for risk factors were calculated. Depending on the age-group and gender most risk factors had a significant effect on the probability for CVD. Only in the age group more than 65years old, significant differences in the probability of CVD, CVI and advanced VD, between the different regions could be found. The highest probability was noted in WE.
Conclusions
Chronic venous disease is very common and the prevalence differs between the different geographical area’s. However after correction for risk factors, only in the older female age group (>65 y)a significant difference in probabilities could be retained.
Paper 3.4
Bleeding risk of anticoagulants in the prevention of venous thromboembolism among Asians
Department of Surgery, University Putra Malaysia, Serdang, Malaysia
Background and aim
Despite the rising incidence of venous thromboembolism (VTE) in Asia, there is a reluctance to subscribe to routine chemoprophylaxis in high risk hospitalized patients. This is probably due to fear of bleeding risk in a population that is believed to have a lower incidence of VTE. There is also a belief that Asians are genetically different from Caucasians, in which the incidence of Factor V Leiden is lower and there is increased fibrinolysis in Asians. A systematic review on prophylactic use of anticoagulants for VTE among hospitalized medically ill and perioperative Asian patients, aims to determine bleeding risk of anticoagulants and to compare it with Caucasian studies.
Methods
All articles on bleeding risk of anticoagulants in VTE prevention among medically ill and perioperative patients in Asia, searched through MEDLINE and Cochrane Database of Systematic Reviews from January 1996 to December 2015, were included and reviewed.
Results
There were insufficient Asian cohort studies and randomized controlled trials on VTE chemoprophylaxis. Most data were extracted from international multicentre trials involving Asians. The MEDENOX trial showed no increase in bleeding risk with the prophylactic use of enoxaparin 40 mg and 20 mg among medical patients. Based on available evidence from large phase III trials in medical and orthopaedic patients, most of which included Asian patients (up to 20% of the safety population), significant bleeding rates in the order of < 5% were reported following prophylaxis with either low molecular weight heparin or novel anticoagulants. In patients undergoing total knee replacement, major bleeding was reported in 1.3% of patients receiving enoxaparin and 1.5% of patients on dabigatran. Other multicentre randomized controlled trials of enoxaparin, rivaroxaban, dabigatran, apixaban and edoxaban which included Asians have not reported increased adverse bleeding events involving this sub-group of patients when compared to the Caucasians. Phase III trials comparing edoxaban 30 mg with enoxaparin 20 mg daily in VTE prophylaxis after total hip and knee arthroplasties in Japan and total hip arthroplasty in Taiwan showed that rates of major and clinically relevant non major bleeding episodes ranged from 0.7 to 2.0% following total hip arthroplasty and 7.4 to 13.9% after total knee replacement. Renal impairment and low body weight were found to be risk factors for bleeding.
Conclusion
There is no evidence that Asians are at higher risk of bleeding after VTE chemoprophylaxis. The suggestion that lower body weight has increased bleeding risk and that lower dose of anticoagulant is equally efficacious warrants further investigations.
Abstract session 4: Investigations
Paper 4.1
Postural change of the saphenous diameter in chronic venous disease
Erasmus MC, Department of Dermatology, Rotterdam, The Netherlands
Objective
The aim of this study was to analyze the correlation between the extent of diameter change from standing to supine position, (‘postural diameter change’, PDC), and patient or duplex ultrasound (DUS) characteristics in lower limbs with and without saphenous trunk (ST) reflux.
Methods
measurements were carried out in 193 limbs with primary great saphenous vein, anterior accessory saphenous vein or small saphenous vein reflux and 48 control limbs without ST reflux. The inner diameter of the ST was measured with DUS in standing and lying position. The PDC, calculated as percentage, followed the formula: (standing diameter – lying diameter)/standing diameter × 100. Clinical findings (according to the highest ‘C’- of the CEAP classification), venous clinical severity score, body mass index (BMI), time of visit, inside and outside temperature were documented. Limbs were divided into two groups using the median value of PDC as cut-off to increase interpretability of the analysis.
Results
The median PDC of the ST was 19% in limbs with ST reflux compared to 24% in control limbs (p = .16).In limbs with and without ST reflux, only older age and increased BMI were independently associated with a low PDC of the ST (R-Squared 0.13). In limbs with ST reflux, median PDC was significantly lower in C4-C6 (16%, IQR 8 to 21) than in C0-C1 (23%, IQR 12 to 35) or C2-C3 limbs (21%, IQR 11 to 33) (p = .016). In addition, PDC was significantly lower in veins with a large diameter ( > 7 mm) than in those with a small diameter (p = .003).
Conclusion
Low PDC of the ST correlates with older age and increased BMI. Whether PDC might become a useful additional DUS tool to classify the severity of chronic venous disease and thereby influence the management strategy should be further investigated.
Paper 4.2
A body weight tranfer manoeuvre with minimal ankle movement significantly outperforms the tip-toe manoeuvre in assessing calf muscle pump function
1Josef Pflug Vascular Laboratory, Ealing Hospital & Imperial College, London, UK
2Hôpital Paris Saint-Joseph, Paris, France
3Vasculab Foundation ONLUS, Napoli, Italy
Aim
The tip-toe manoeuvre (TTM) has been promoted as the gold standard plethysmography test for measuring calf muscle pump (CMP) function for several decades. In common with the dorsiflexion manoeuvre (DFM), both rely on ankle range of movement to cause venous ejection. In contrast, body weight transfer manoeuvres (BWTMs), like the Paranà and Vasculab manoeuvre, rely on the weight of the body to cause venous ejection. The aim was to compare the TTM, DFM and a BWTM using the ejection fraction (EF) of air-plethysmography (APG) and evaluate which has the best pumping effect.
Method
Twenty-two legs from 11 healthy volunteers were tested with APG. The working venous volume (wVV) was established by the total increase in calf volume from 70 degrees elevation drainage to standing dependency with most of the weight on the other leg. At the point of maximum filling volume from the trace, prior to each manoeuvre, the subject was asked to perform x3 TTMs, x3 DFMs and finally x3 BWTMs. The TTM was performed with both legs, approximated together, and the subject's weight distributed equally. The DFM was performed non-weight bearing, by pivoting on the leading heel. The BWTM was a gentle rock forwards onto the leading foot and back again, simulating a walking step. The EF was calculated as the ejected volume/wVV and expressed as a percentage.
Results
Expressed as median [inter-quartile range], BWTMs resulted in a significantly greater % of EF than TTMs at 59.7[53.5–63.9] vs 42.6[30.5–52.6], P < .0005 (Wilcoxon). There was no significant difference in the EF between the TTM vs DFM, P = .615. Adjusted to a common median to detect only the variance between the x3 tests, the repeatability (CI: 95%) of 66 EF tests was excellent: TTM (41.44–43.76)%; DFM (36.94–39.46)%; BWTM (58.14–61.26)%.
Conclusion
The BWTM appears to be a better method of measuring the full potential of the CMP with a 40.1% relative increase in the EF compared to a TTM. Exercises which involve body weight transfers from one leg to the other may be more important in optimising calf muscle pump function than ankle movement exercises.
Paper 4.3
Quantification of reflux volume on the great saphenous vein by duplex ultrasound in patients with primary varicosities
1The Pirogov’s Russian National Research Medical University
2Clinical Hospital no.1 of the President’s Administration of Russian Federation Moscow, Russia
Aim
To quantitatively assess the reflux volume (RVo) on the great saphenous vein (GSV) by duplex ultrasound (DUS) and to evaluate the correlation between the RVo, severity of disease and quality of life in patients with primary varicosities.
Method
This was an observational cross-sectional study involving 80 patients (22 men and 58 women) with primary varicosity of the GSV and blood reflux that extended no less than mid-thigh. The patients were 18–81 years old (mean – 48.8 ± 12.7): 32 had C2, 33 had C3, five had C4, two had C5 and eight had C6 class according to CEAP classification.
All patients were assessed with VCSS and they filled disease-specific quality of life questionnaires CIVIQ-20 and VEINES Qol/Sym. The patients were then examined with DUS and Doppler. All measurements were made by one physician in upright position and repeated three times, and the average value was used. The measurements were made at three points of GSV: terminal valve of sapheno-femoral junction (SFJ), pre-terminal valve (PTV) and middle third of the thigh (MTT). The time and the flow volume of blood reflux were assessed during the Valsalva maneuver at SFJ and during the distal compression maneuver at PTV and MTT. The RVo (ml) was calculated as product of flow volume (ml/min) and time (sec/60) of blood reflux.
Results
The VCSS score was 2–20 (mean 6.9 ± 4.3), the CIVIQ score was 19–83 (41.6 ± 15.3), and the VEINES score was 30–104 (81.4 ± 16.1). The RVo decreased from SFJ through PTV to MTT (median, 25th and 75th percentile): 24 (13;55), 11 (5;30), and 7 (3;18) ml, p < 0.0001.
A low-strength significant correlation between RVo at SFJ and CEAP class (0,346, p = 0.005), VCSS score (0.385, p = 0.002), CIVIQ score (0.332, p = 0.008) and VEINES score (−0.295, p = 0.019) was found. A weak but significant correlation was found between CEAP class and RVo at PTV (0.254, p = 0.029) or MTT (0.277, p = 0.013).
It was found that RVo at all points significantly changes in accordance with CEAP class. From C2 to C4 it increases and then from C4 to C5-6 decreases. At MTT, the difference was most significant: 4 (2;11) ml in C2, 9 (5;13) ml in C3, 86 (23;123) ml in C4 and 5 (4;24) ml in C5-6 (p = 0.003).
Conclusion
There is a significant weak correlation between volume of blood reflux and CEAP class, VCSS, CIVIQ or VEINES score. The value of reflux volume depends on CEAP class and it is maximal at C4. Thus, blood reflux on GSV is not the only reason for the severe forms of chronic vein disorders or low quality of life.
Paper 4.4
Comparison of magnetic resonance venography and duplex scanning in the evaluation of post-thrombotic lesions of iliofemoral venous segment
Medical centre named after R.P. Askerkhanov, Makhachkala, Russia
Objectives
To investigate the results of an MRI venography on 1,5 Tesla scanner (1,5 T) and duplex scanning in patients with post-thrombotic lesion of iliofemoral venous segment
Method
From January 2014 to December 2015 were investigated 42 patients (33 women, 9 men, aged from 20 to 66 years) with unilateral post-thrombotic lesion of iliofemoral venous segment. There were C2-C5 patients under CEAP classification. All patients underwent duplex scanning and MRI venography of iliofemoral segment on 1.5 T scanner.
Results
According to the duplex scanning occlusion of iliofemoral segment was detected in 19 (45,2%) patients. After MRI venography occlusion of this segment was revealed in 11 (26,2%) patients and in the other cases had been diagnosed stenotic lesions.
Conclusions
MRI venography on 1.5 T scanner allows more precise than duplex scanning to visualize the degree of post-thrombotic lesions of iliofemoral venous segment.
Paper 4.5
Connexin Expression in Venous Disease: A Biomarker for Venous Ulceration
1Division of Surgery and Interventional Science, University College London, London, UK
2Department of Plastic Surgery, Royal Free Hospital, London, UK
3Department of Vascular Surgery, Royal Free Hospital, London, UK
4Lee Kong Chian School of Medicine, Nanyang Technological University, Singapore
Aims
Leg ulceration is a feared complication of venous insufficiency. Cellular communication via gap junctional proteins, specifically Connexins(Cx), are crucial in wound healing, upregulation of which is associated with poor wound healing. It is not known if patients with varicose veins are prone to poor wound healing. This study aims to determine and compare the principle epidermal Cx levels across stages of venous disease and further determine if Cx can be used as a biomarker for risk of venous ulceration.
Methods
Patients undergoing varicose vein intervention from four main stages of the CEAP classification were enrolled: C0(n = 12), C2(n = 12), C4(n = 12), and C6(n = 12). Paired 4 mm punch biopsies were taken from the avulsion site above the ankle (pathological) and the endovenous catheter insertion site above the knee (control). Tissues were stained for H&E and Immunohistochemistry for Cx43, Cx30 and Cx26 and imaged by confocal microscopy.
Results
H&E staining revealed progressive epithelial hyper thickening, increased depth and number of rete pegs, increased inflammatory cells, and loss of dermal architecture with disease progression in the diseased skin. Cxs were expressed increasingly and further down the epidermis with disease progression in the diseased skin as compared to the control. Cx43 had the highest mean expression (C2:2061.13, C4:4061.08, C6:11639.60, p < 0.0001). Cx26 had lesser expression in C2 and C4 but increased significantly in C6 (C2:120.21, C4:558.79, C6:11561.54, p < 0.001), similarly Cx30 (C2:145.16, C4:268.88, C6:8286.29, p < 0.0001). Significant increased expression of all Cx was seen early in the disease; C2 versus C6 (p < 0.005) and C4 versus C6 (p < 0.005).
Conclusion
Cx proteins were expressed increasingly with venous disease progression and the overexpression starts early in the disease, suggesting that skin is preconditioned in varicose veins for poor wound healing. The molecular and structural changes correlate with the clinical stage of the disease. Cx can hence be used as a biomarker for venous ulceration and poor wound healing.
Paper 4.6
Differences in levels of markers of inflammation and endotelial damage between the blood from varicose veins and systemic blood
Department of Vascular Disease, University Medical Centre Ljubljana, Ljubljana, Slovenia
Background
Varicose veins represent one of the most frequent vascular diseases and are in most cases benign. However, advanced disease is frequently associated with complications such as chronic venous insufficiency and thrombosis of the superficial veins. The pathogenic mechanisms are not well understood. Beside increased venous pressure probably local blood constituently triggers various mechanisms responsible for the progression of the disease and its complications.
The aim
of our study was to investigate changes of blood constituents in varicose veins and compare them to the systemic markers of inflammation and endothelial damage.
Methods
The study included 50 patients with primary varicose veins. Local blood samples were taken from the leg, obtained from the tortuous and dilated varicose great saphenous vein and systemic blood samples from the cubital vein.
Results
The values of basic biochemical findings were comparable between blood samples (varicose vs. systemic). In varicose veins, the following markers of inflammation and endothelial damage were significantly increased in comparison to systemic blood:) hsCRP (2,05 ± 1,84 mg/L vs. 1,96 ± 1,90 mg/L, p = 0,05), IL-6 (3.62 ± 2.74 ng/L vs. 2.30 ± 1.80 ng/L, p < 0,001), IL-8 (21,15 ± 15,28 ng/l vs. 18,74 ± 12,30 ng/L, p = 0,025), vWF (118.4 ± 27 % vs. 83.2 ± 22 %, p < 0.05), NGAL (316,93 ± 88,68 mg/mL vs. 299,18 ± 107,33 ng/mL, p = 0,002), TNFR1 (0,52 ± 0,13 ng/mL vs. 0,50 ± 0,15 ng/mL, p = 0,021. The levels of D-dimer (247,56 ± 410,24 ng/mL vs. 67,66 ± 325,74 ng/mL, p = 0,019) and PAI-1 (3,32 ± 3,56 IU/ml vs 2,99 ± 3,36 IU/ml, p = 0,043) were also significantly higher in blood samples taken from the leg varicose veins.
Most of the levels of inflammatory and endothelial dysfunction markers (hsCRP, D-dimer, TNFR-1) were significantly correlated with their levels in the systemic blood.
Conclusions
In the blood of varicose veins, some inflammatory markers and indicators of endothelial dysfunction are increased. This is most probably the consequence of deteriorated blood flow in dilated and tortuous superficial veins and increased venous pressure. Damage to the venous wall, which causes a chronic inflammatory response, together with the procoagulant properties of local blood may promote further progression of the disease and thrombotic complications.
Paper 4.7
Cancer-related vein thrombosis: prevalence, causes and diagnosis
Belarusian State Medical University, Minsk, Republic of Belarus
Objectives
To analyze the predictors underlying a possible malignancy and to determine an optimal strategy of cancer screening in all patients with venous thromboembolism (VT).
Methods
379 patients who suffered deep VT and were treated in the period between 2010 and 2013 in the General Surgery Units of the Minsk emergency clinical hospital were retrospectively analyzed. All patients with VT were divided into two groups: idiopathic deep VT group without a known malignancy, and secondary deep VT group with a known malignancy. A diagnostic screening workup including a clinical history, physical examination, laboratory tests, prostate-specific antigen, a chest X-ray and an abdomen-pelvic ultrasonography was performed in all patients with idiopathic deep VT.
Results
Among 379 patients with deep VT malignancy was detected in 42 (11.1%) cases. 26 (61.9%) patients were elder than 60 years. 36 (85.7%) from 42 patients with deep VT had history of malignancy, 10 (27.8%) of them had recurrent VT. In 6 (12.5%) patients with idiopathic VT a malignancy was diagnosed at the first time. VT was most often associated with neoplastic process, localized in the stomach, uterus and prostate. In 13 (31%) patients with VT occurred advanced neoplastic process (IV clinical group). VT that occurs in unusual sites is more frequently associated with malignancies.
Conclusions
VT can not be considered as an early manifestation of cancer. A diagnostic screening strategy has the capacity to identify the majority of the malignancies in patients with idiopathic VT. All persons with idiopathic VT need follow-up on the conventional algorithm.
Paper 4.8
Wound healing disorders following endophlebectomy of the common femoral vein and its impact on the patency rates of venous recanalization
European Vascular Center Aachen-Maastricht. 1Department of Vascular Surgery University Hospital Aachen, Germany
2Department of Vascular Surgery University Hospital Maastricht, Netherlands
Introduction
The post thrombotic syndrome, as one of the most important consequences of a deep vein thrombosis, is underestimated in literature regarding its clinical importance. A few years ago the medical treatment was restricted to anticoagulation and compression with stockings. Since a decade the interventional treatment of the post thrombotic changed iliac and femoral veins developed, presenting good results concerning patency and quality of life. If the common femoral vein with its inflow vessels is involved, the open surgical desobliteration or endophlebectomy has been described as an appropriate treatment in few case series. We present our results after venous recanalization including an endophlebectomy focussing on its complications.
Material and methods
A retrospective analyse of prospective record data of all patients who underwent a hybrid procedure for chronic obstruction of iliac and femoral veins or inferior vena cava between 2010 and 2015 in our two centres was performed. The patients received recanalization via stent- angioplasty of the iliac veins and/or the inferior vena cava and endophlebectomy with creation of an arteriovenous fistula. Data assessment focussed on complications and patency rates.
Results
This study includes 96 patients, thereof 58 females with a mean age of 44.1 years. The mean procedure time was 344 ± 140 minutes (range 124 to 663). Median follow-up time was 12.6 months, with a range from two till 33 months. Primary patency was 62.5 % (60/96) and secondary patency 89.5 % (86/96). Re- Intervention due to early occlusion within the first 30 days of the venous reconstruction was necessary in 37.5 % (36/96) of all cases. Besides bleeding complications, wound healing disorders, mainly classified as Szilagyi I, occurred in 33 % of all patients. No single risk factor could be identified in the presented cohort of patients. A significant correlation with a reduced secondary patency as well as an elongated length of stay after development of wound healing disorders could be confirmed.
Discussion
The combined approach of the interventional stent angioplasty with an endophlebectomy of the femoral vein is a safe and feasible treatment method for the chronic venous obstruction. Till now, no study of this magnitude reflects the complications of this hybrid technique. Wound healing disorders are the most challenging problem occurring in this young group of patients.
Abstract session 5: Compression. Leg ulceration and DVT
Paper 5.1
Interface pressure, stiffness and hemodynamic effectiveness of a new compression device
1Angiology Department, Clinica MD Barbantini, Lucca, Italy
2Medical University of Vienna, Austria
3PressCise AB, Herrljunga, Sweden
4Chalmers University of Technology, Gothenburg, Sweden
Background
Ejection fraction (EF) from the lower leg is severely impaired in patients with venous insufficiency and is improved by compression therapy. Inelastic compression (IC) is characterized by a high difference between supine and standing pressure and a strong massaging effect (produced by a high difference between diastolic and systolic pressure during walking). IC is significantly more effective in increasing EF than elastic compression (EC), characterized by a low difference between supine and standing pressure and by a weak massaging effect.
Aim
To assess pressure, stiffness and hemodynamic effectiveness of a new elastic bandage* which becomes inelastic by attaching stiff patches** made of a hook and loop material.
Method
EF was measured by means of strain gauge plethysmography in 18 patients with severe venous reflux in the great saphenous vein (CEAP C2-C5). The procedure was performed three times in a randomized sequence: 1) in baseline conditions, 2) with the elastic device applied to the leg with a pressure of 20 mm Hg and 3) after attaching the stiff patches to the elastic bandage.
The interface pressure of each bandage was measured using an air-filled pressure transducer in supine and standing position and in muscle systole and diastole during exercise. Static Stiffness Index (SSI) was calculated by subtracting supine by standing pressure. Walking Pressure Amplitude (WPA) was calculated by subtracting diastolic from systolic pressure.
Results
The patches produced a significant increase of standing and peak pressure during walking, with a very slight increase of the resting pressure which results in a significant increase of stiffness as reflected by a significant increase of SSI and WPA. This led to a significant improvement of the EF, which was severely impaired in our group of patients with great saphenous vein insufficinecy, compared both to baseline conditions and elastic bandage (Tab. I).
Conclusions
Median values (Interquartile ranges). R.P. = resting pressure, S.P. = standing pressure, SSI = Static Stiffness Index, WPA = working amplitudes; EF = ejection fraction (%).
LundaTex™.
PressPatch™.
Both LundaTex™ and PressPatch™ are manufactured by PressCise AB.
Paper 5.2
A method to increase working compression pressure without changing resting pressure
1PressCise AB, Herrljunga, Sweden
2Chalmers University of Technology, Gothenburg, Sweden
3Medical University of Vienna, Austria;
4Angiology Department, Clinica MD Barbantini, Lucca, Italy
Background
An ideal compression device is characterized by low, well tolerable resting pressure and a high working pressure. It has been found that compression products with a stiff, non-elastic material, are essential for an improved haemodynamic effect, indicating that low resting pressure and high working pressure is vital, in order to achieve the most effective and well tolerated compression treatment. However, one great challenge is that by applying a stiff bandage, either as a single component or as a part in a multi-component product, one always adds, a not so easily quantified, resting pressure. In order to achieve the most effective treatment it is easy to apply the bandage in a too tight and uneven manner, often resulting in painful resting pressures.
Aim
The goal is to find a method that increases working pressure without changing the resting pressure.
Method
Several patches (PressPatch™ by PressCise AB) made in a hook and loop material and with an optimal shape, were attached over an elastic compression bandage providing and maintaining a certain pressure level, as well as over a medical compression stocking. The patches adhere directly to the bandage/stocking material without increasing the resting pressure. Interface pressures were measured on point B1 on a leg-model whose diameter can be enlarged by 1 cm in order to measure stiffness (n = 9) and on human legs during lying and standing (n = 30). The pressure-measuring device used was PicoPress® (by Microlab Italia).
Results
The patches add the stiffness to the underlying material (bandage or stocking) and increases only the working pressure, resulting in a hemodynamic effect during movement. With the patches, resting pressure is close to the same pressue as before, however working pressure increases to significantly, leading to a greater static stiffness index (SSI).
Conclusions
The presented method is of considerable practical interest especially for those patients who should have a low controlled resting pressure, as e.g. patients with mixed arterial venous disease and for whom hemodynamically active pressures are desirable as soon the patient starts walking.
Paper 5.3
Compression film bandage added to medical compression stockings improves comfort and results of foam sclerotherapy
Angioclinic Vein Centers – Interventional Phlebology, Berlin – Munich, Germany – Zurich, Switzerland
Purpose
Foam sclerotherapy is a basic modality in phlebology, in particular for superficial varicosities. However, in spite of adequate wearing of medical compression stockings (MCS) inflammatory symptoms, indurations and stainings may occur in above 40% of the cases. Two main reasons are: 1) Compression stockings are not worn continuously, allowing refilling of the varices and 2) concentric pressure may not be sufficient. A novel self-adhesive compression film bandage (CFB) which is put on once and allowed to stay continuously for two weeks in addition to MCS could potentially solve both problems. Aims of evaluation were patient comfort, symptoms and effect on vein regression.
Methods
In a prospective study, a novel compression film bandage (Venartis/3 M) comprising a self-adhesive, elastic and breathable polymer film of d < 20µ was evaluated. 62 consecutive patients (26–78 y.) with 80 legs selected for foam sclerotherapy (Aethoxysklerol 1%) for superficial varicosities of 5–12 mm Ø were randomized to receive medical compression stocking only (MCS, n = 40, 28 d) for day over wearing, or MCS and CFB (n = 40, film 14 d + stocking 28 d). Vein diameters in both groups were equal (±10%). Follow-up included ultrasound and photography after 2, 4 and 8 weeks.
Results
Wearing time of both media (CFB, MSC) was completed adequately in all cases. Comfort was rated on a 10 degree scale (10 = best) by the patients 6.6 after CFB + MCS and 4.3 after MCS alone (week 2). Symptoms like pain, indurations or reddening along the treated vein were found in 22/40 (55%) in the MCS group, while in the group receiving additional CFB the incidence was 2/40 (5.0%; week 2). At week 8 examinations, the incidence of unwanted local side effects was 26/40 (65.0%) for the MCS group and 6/40 (15.0%) in the CFB + MCS group. Closure rates were 95.0 (38/40) after CFB + MCS and 87.5 (35/40) after MCS alone (week 8). Vein diameters were reduced by 31–68% (mean: 51.5%) with CFB + MCS and 28–52% (mean: 38.1%, week 8) with MCS.
Conclusions
The novel compression film bandage added to medical compression stockings significantly improves comfort and results of foam sclerotherapy of superficial varicosities. The reduction of vein diameter, inflammatory symptoms and esthetic side effects achieved with CFB is highly significant. Continuous wearing for two weeks is well tolerated.
Paper 5.4
Recalcitrant venous leg ulcers may heal by conservative outpatient treatment of venous disease even in the presence of concomitant arterial occlusive disease
1Angiology Department, MD Barbantini Hospital, Lucca, Italy
2Eurocenter Venalinfa, S. Benedetto del Tronto (AP), Italy
3Medical University of Vienna, Austria
Introduction
In patients with Venous Leg Ulcers (VLU) a coexisting peripheral arterial occlusive disease (PAOD) is reported in about 15–20%. In such cases arterial recanalization is often recommended as first therapeutical step and compression therapy is often considered a contraindication when Ankle-Brachial Pressure Index (ABPI) is < 0.8.
Aim
to compare the clinical outcomes of patients with recalcitrant VLU, both “pure” (pVLU) or associated with a moderate PAOD (“mixed leg ulcers “(MLU) by treating the venous disease with compression therapy and foam sclerotherapy of incompetent superficial veins without any surgical treatment of the arterial component.
Materials and Methods
Between January 2011 to July 2014 we retrospectively analyzed the records of 180 outpatients (43 men and 137 females; mean age was 74 ± 11.5 years; age ranged between 31–92 years) with recalcitrant ulcers (ulcer surface up to 100 cm2 showing no healing tendency after a 6 months treatment). 109 were affected by pVLU and 71 by MLU with moderate PAOD defined by a reduced Ankle Brachial Pressure Index (ABPI) between 0.5 and 0.8. In addition to the same local wound dressing the patients received foam sclerotherapy (sodium Tetradecyl sulfate 3%) of the superficial veins with reflux directed to the ulcer area and a modified inelastic compression applied with a pressure ≤ 40 mm Hg. No patient was referred to arterial revascularization. The patients were followed over more than one year and the healing rate was registered.
Results
Patients with pVLU and MLU showed comparable demographic chracteristics in terms of sex, age, venous pathophysiology, ulcer surface, duration, wound-bed conditions and recurrence. 25 patients were lost at follow-up and the outcomes were analysed in the remaining 155 patients (93 patients with pVLU (85.4%) and 62 patients with MLU (87.4%)).
The maximal time for complete healing was 48 weeks in pVLU group and 52 weeks in MLU (P = .009). The median healing time of patients with pVLU (23 weeks) was significantly shorter than that of patients with MLU (25.5 weeks) (P = .03).
Multiple linear regression analysis showed the factors which influenced the healing time: deep venous disease (P < .001), ulcer surface (P < .001), arterial disease (P = .002), and ulcer duration (P < .01).
Conclusion
In patients with mixed ulcers and moderate arterial disease, treating vein disease by means of foam sclerotherapy and modified compression may heal the ulcers.
We suggest this conservative treatment protocol to patients with mixed ulcers not complicated by severe arterial disease restricting arterial revascularization procedures to cases which will not heal.
Paper 5.5
Characteritics of isolated calf vein thrombosis in current clinical practice
Department of Cardiovascular Surgery, Kyorin University, Tokyo, Japan
Aim
As public and medical concern for the risk associated with deep vein thrombosis (DVT) has risen, the number of cases detected to have calf vein thrombosis (CVT), including asymptomatic condition, has increased in recent years. The aim of this study was to to investigate the characteristics of isolated CVT and to determine the patterns and distribution of calf vein thrombi in the current clinical practice.
Methods
Between January and December 2014, 1591 consecutive patients underwent duplex ultrasonography to seek definitive diagnosis of DVT. All deep veins from groin to ankle, excluding anterior tibial veins, were imaged and the location and extent of thrombi was verified by duplex scanning. Of the deep veins in the calf, the peroneal, the posterior tibial, the gastrocnemial, and the soleal veins were routinely examined.
Results
DVT was confirmed in 537 patients. Isolated CVT was detected in 590 limbs of 427 patients (150 men and 277 women; mean age 74 years). Of these, 341 (80%) were asymptomatic, 263 (62%) were surgical patients, and 239 (56%) were inpatients. Moreover, 184 patients (43%) had malignant disease. There was no significant difference in the limb preference (302 left vs 288 right). The soleal veins were most frequently involved, with 536 limbs (91%) affected, followed by the peroneal veins in 103 limbs (18%). Although thrombus confined to a single vein were found in 165 patients (39%), 77 cases (18%) had 5 or more veins involvement.
Conclusion
'This study revealed that there was a high prevalence of asymptomatic cases in our cohort, and a substantial number of the cases was associated with malignancy. The majority of calf vein thrombi was located in the soleal veins. Although the most frequent pattern was a single vein involvement, a considerable number of patients had several thrombi in the calf.
Paper 5.6
Comparison between frequency of calf dvt after earthquakes in japan and italy
1Niigata University Graduate School Of Medicine, Niigata, Japan,
2Finale Emilia, Modena, Italy,
3Hesperia Hospital, Modena, Italy
Purpose
We have reported that calf DVT increased after earthquake in Japan. We attempted to investigate calf DVT after Italian earthquake and compared the frequency of it after Japanese earthquake.
Subjects and Methods
We examined calf DVT in Modena province in Italy from 2013 to 2014 using ultrasound. Modena province had great earthquake (Emilia Earthquake) in 2012. We had examined it 2 years after Middle Niigata Prefecture Earthquake 2004. We compared the data from these. We also attempted to examine calf DVT by same methods in the area without earthquake in Japan (Yokohama) and Italy (Trento).
Results
We examined 447 residents (mean age; 54 ± 13 y.o.) in Finale Emilia, San Flice Sull Panallo, Cavezzo, Mirandola, Soriela, Guastalla, Concordia and Modena. 65% of these (297) slept in own small car after quake (car shelter). 49-calf DVT were recognized in these (10.7%). The frequency of DVT correlated with that of car shelter. We had examined 435 residents in Ojiya and Tokamachi 2 years after Mid Niigata Prefecture Earthquake 2004. 60% of these (259) slept in own small car. 44-calf DVT were recognized in these (10.1%). The frequency of calf DVT in the area without earthquake in Italy and Japan was 4.3% (64/1498) and 5.0% (2/40), respectively.
Conclusion
Frequency of Calf DVT after earthquake was the same as Japan and Italy. That may increase after earthquake in all over the world. In particularly, sleeping in small car after earthquake may have a risk of DVT. Further study is needed to clarify the mechanism of DVT increase after earthquake (large disaster).
Paper 5.7
Prevalence of chronic venous disease (CVD) and restless leg syndrome (RLS) in general population (Epidemiological study)
Phlebological Centre Antireflux, Moscow, Russia
Overweight, pregnancies, stress, depression, anatomical venous features and other factors influence the occurrence of CVD, thus requiring constant research in order to find the best treatment solutions.
Most of the phlebologic patients have discomfort in the lower extremities as a general symptom, being described as a blunt pain, heaviness, burning sensation. Some of them proceed to feel the same regardless the treatment they have had especially those with suspected depression or restless leg syndrome (RLS).
Objectives
To determine CVD distribution according to CEAP, prevalence of RLS and depression, prevalence and nature of patient’s complaints.
The total of 169 participants were enrolled into the study.
Methods
used were patient’s interview (complaints and disease history), clinical and duplex examination. Depression and RLS were defined using RLS and HADS questionnaires.
Results
Gender – 19% male , 81% female, average age – 56 years, mean duration of complaints – 7 years, mean height and weight -165 cm and 75 kg respectively.
C1 class was dominant according to CEAP (57%), C0-17%, C2 -13%, C3 -12 %, C4- 1 %.
Depression (clinical and subclinical forms) accounted 53%. RLS patients accounted 34%.
Dominant complaints mentioned were pain (19%), swelling (19%), cramps (19%) and heaviness (33%) in the legs.
We observed elevated amount of C2, C3, and C4 forms after pregnancies (deliveries) and in persons with elevated body mass index (BMI).
In a group of C0, C1 patients with positive leg symptoms depression was detected in 60% of cases, RLS was revealed in 38% of cases, whereas in the same group the absence of depression and RLS was marked in 40% of cases, and 62% of cases respectively.
Conclusions
Distribution of C- classes complies with the data from other epidemiological studies.
The high prevalence of depression and RLS in a C0, 1 class suggests their impact on the complaints nature. Pain, swelling, cramps and heaviness are the most prevalent symptoms among phlebological patients.
Abstract session 6: Deep venous reconstruction
Paper 6.1
Pelvic vein embolisation under local anaesthetic is feasible and safe in an outpatient clinic setting – 18 months experience of a new service
The Whiteley Clinic, London, UK
Introduction
Pelvic vein embolisation (PVE) is becoming increasingly used in venous practice for the treatment of pelvic venous reflux (PVR) causing pelvic congestion syndrome, varicose veins of the vulva, vagina, buttock or perineal area, or para-vulval veins refluxing into leg varicose veins.
In July 2014 we introduced a new "walk-in walk-out" outpatient service situated in a vein clinic remote from a hospital using local anaesthetic only and no sedation or other anaesthesia.
Methods
A prospective audit was kept of all patients treated with PVE. All patients had presented with symptoms of signs of conditions caused by, or associated with, PVR. All had been assessed with Transvaginal Duplex Ultrasound (TVS).
Pre-procedure assessment was a blood test for urea and electrolytes. Coils used were Interlock Embolisation Coils (Boston Scientific, USA) as they can be repositioned after deployment and before release. Previously published series of PVE had been in hospitals, using anaesthesia or sedation. Hence we analysed:
Safety Complications both during and post procedure Number of veins (territories) treated and number of coils used
Results
There were no major complications during or after the procedure and no patients were admitted or attended accident and emergency. The procedure was abandoned in 2 patients, one due to length of time and the other after 3 of 4 veins were embolised and the 4th vein had abnormal anatomy. The first patient had the procedure completed on another occasion and the second had symptomatic relief and refused further embolisation.
One patient had a bradycardia necessitating intravenous Atropine but proceeded successfully. One coil was removed during the procedure using a snare as it did not detach properly and it trailed into the common iliac vein.
Post operatively, many patient reported early discomfort in the pelvis. Non-steroidal anti-inflammatory drugs were effective in most cases. Some patients reported a “post-embolisation syndrome” feeling exhausted or “flu-like” for 2–5 days after the embolisation.
Conclusion
We report PVE in a remote out-patient facility outside of a hospital, using local anaesthesia only and no sedation or other anaesthesia. Despite being our learning curve, there were no major complications and only 2 cases were abandoned.
PVE appears to be feasible and safe under local anaesthetic in a walk-in, walk-out out-patient facility.
Paper 6.2
Neovalve construction surgery in postthrombotic syndrome and primary deep vein insufficiency
1Fukuoka Sanno Hospital, Vascular Surgery, Fukuoka, Japan.
2Fukushima Diichi Hospital, Fukushima, Japan.
Aim
Deep Venous reflux arises from three aetiologies, postthrombotic syndrome (PTS), primary deep valve incompetence (PDVI), and congenital valve aplasia. According to the aetiologies, several surgical techniques have been used to correct deep venous reflux reconstructing the valves. The main procedures described are internal or external valvuloplasty, femoral transposition, axillary vein transfer, or artificial valve. Maleti reported the effectiveness and clinical outcome of Neovalve construction in patients with deep venous insufficiency (DVI). The Neovalve technique is obtained by dissecting the vein wall to create a flap, which is positioned as a monocuspid or bicuspid valve. Since the principle of this surgery is creating a new valve in the deep venous system, this technique can be employed in not only PTS but PDVI and valve aplasia. This study reports our first case series and the short-term outcomes of the Neovalve construction in the patients with DVI affected by PTS and PDVI.
Materials and methods
From July 2013 to June 2015, the Neovalve construction was performed on 10 patients (8 PTS and 2 PDVI). The indications for this surgery were the patients who had DVI and persistent active ulcers even after suppression of the saphenous reflux and perforator insufficiency, and the compression treatment. The monocuspid valves were created on the femoral veins in 8 limbs, and bicuspid valves were created in 2 limbs. Postoperative evaluations were performed by duplex scanning and venography. Clinical results were determined by Venous Clinical Severity Score (VCSS) and Villalta Scoring.
Results
Ulcer healing was observed in all 10 limbs within 2 and 12 weeks after surgery (median, 6.5weeks) with two recurrent symptoms with a mean follow-up of 16.5 months (range, 6
Conclusion
In the postthrombotic lesion, the neovalve was created by using the thickened intraluminal septum after endophlebectomy. In comparison with PTS cases, it was much more challenging in PDVI because of the particularly thin wall, which required a delicate technique to dissect the intima layer. This study demonstrated that the Neovalve construction could be carried out in not only PTS but PDVI. Although the numbers were too small to analyze the outcomes, Neovalve seems to be feasible and effective in the patients with DVI affected by PTS and PDVI.
Paper 6.3
Venous stent stability index (VSSI): a guide for iliac vein stent sizing and prevention of migration in the treatment of symptomatic iliac compression
Arizona Heart Hospital, Phoenix, Arizona, USA
VENITI, Inc., Fremont, California, USA
Objective
Left common iliac veins can have a significant anterior-posterior compression from the right common iliac artery, an exaggerated transverse diameter, at the same level, and pre-stenotic dilatation of the vein proximal to the lesion. Multiple values of maximum and minimum diameter and area calculations contribute to the selection of stent size. We derived a methodical way to utilize IVUS measurements to facilitate sizing and mitigate stent migration in limbs with symptomatic iliac vein lesions. The Venous Stent Stability Index (VSSI) should assist all physicians in safely and effectively stenting iliac lesions of any type.
Methods
Symptomatic patients with lower extremity edema and/or pain were examined with duplex. Non-thrombotic patients with iliac stenosis or those with evidence of acute or chronic DVT were referred to a single endovascular physician for further evaluation and treatment. Venography and IVUS, utilizing 6F-8F Visions catheters (Volcano) were performed on all treated limbs. Maximum and minimum diameters plus area calculations were obtained at determined points; the proximal/distal common and external iliac veins. When the diameter was less than the selected stent diameter at 5/8 sites, the wall apposition quotient was great enough to assure stability. This calculation helps determine the stent diameter and length to use.
Results
Between Jan 2014 and February 2016, 53 patients, 47L/1R (5 bilateral) underwent iliac stenting. Eighteen had acute thrombosis and 35 had chronic DVT with CEAP distributions were 3(21), 4(9), 5(5) and 6(0). Twelve were enrolled in a clinical trial for a nitinol stent and 41 received Wallstents™. No migrations occurred after deployment of over 100 stents. Size ranged from 14
Conclusions
The index of 5/8 or 0.63 can be used to predict the likelihood of stent stability. With an index of < .63, migration is more likely. Pre-stenotic dilatation and exaggerated width, where the vein is compressed, can lead some to believe a very large stent is necessary. Stent oversizing alone fails to predict the likelihood of stent migration, particularly if a short length is used. Stenting across the internal iliac confluence is not detrimental and consideration of additional length to increase wall contact is important. The VSSI is a strong predictor of adequate wall apposition in stenting patients with iliac compression.
Paper 6.4
Systematic review of open and endovascular treatment of superior vena cava syndrome of benign etiology
1Department of Vascular Surgery, University of Athens Medical School, Attikon University Hospital, Athens, Greece
22nd Laboratory of Radiology, University of Athens Medical School, Attikon University Hospital, Athens, Greece
3Department of Surgery and Cancer, Imperial College, London, UK
Background
The increased use of central venous catheters, ports, pacemakers and defibrillators raised the incidence of benign superior vena cava syndrome (SVCS). The aim of this study is to review the results of open and endovascular treatment of SVCS.
Method
A MEDLINE search using PRISMA guidelines was performed for studies reporting the results of open and endovascular treatment of benign SVCS. Pooled primary patency with 95% confidence intervals (95% CIs) for open and endovascular treatment were calculated using fixed or random effects models after assessing between-study heterogeneity.
Results
Nine studies presented the results of endovascular treatment of SVCS including 139 patients. Causes of SVCS were: central venous catheters and pacemakers (80.6%), mediastinal fibrosis (13.7%), and other causes (5.6%). Technical success was 95.6%. Angioplasty (PTA) and stenting was performed in 73.6%, PTA only in 17.3%, and thrombolysis, PTA and stenting in 9%. Thirty-day mortality was 0%. Regression of the symptoms was reported in 97.3%. Patients were followed up for a mean of 11 to 48 months. Thirty two patients (26.6%) underwent 58 secondary procedures, 47 PTAs, 6 PTAs and stenting, 3 thrombolyses and 2 bypass grafts. Pooled estimated primary patency at 1, 12, 26 and 36 months was 90.7%, 71.2%, 58.1% and 48% respectively.
Four studies including 87 patients reported the results of open repair of SVCS caused by mediastinal fibrosis (58.4%), catheters and pacemakers (28.5%) and other causes (13%). Operations performed included SVC reconstruction with a spiral saphenous interposition graft, other vein graft, PTFE graft and human allograft. Thirteen patients required reoperations (15%) before discharge mainly for graft thrombosis. Thirty day mortality was 0%. Regression of the symptoms was reported in 93.5%. Follow up period was 30 months to 10.9 years. During follow up 24 patients (31.1%) underwent a total of 33 secondary procedures including 10 PTAs, 11 PTAs + stenting, 9 thrombectomies, 2 graft replacements and 1 thrombolysis. Pooled estimated primary patency at 1, 12, 26, 36, 48 and 60 months was 85.3%, 66.6%, 65.8% 65.3%, 58.4% and 58.4 respectively.
Primary patency was similar for open and endovascular treatment of SVCS at 1,12,26 months. Pooled primary patency of open repair was higher than patency of endovascular repair at 36 months (p = 0.05).
Conclusions
Endovascular is the first line of treatment for SVCS caused by intravenous devices, while surgery is most often performed for mediastinal fibrosis. There is a high incidence of reoperations before discharge after surgery. Both treatments show good results regarding regression of the symptoms. Mid-term primary patency is similar with a significant incidence of secondary interventions. Secondary interventions after initial endovascular treatment are mainly endovascular.
EVF Prize Session
PR 1
Hybrid operative thrombectomy is non-inferior to percutaneous techniques for the treatment of acute iliofemoral deep vein thrombosis
Department of Surgery, Vascular Surgery Division, St. Luke’s Memorial Hospital, Ponce Health Sciences University, Ponce, PR, USA
Purpose
Hybrid operative thrombectomy (HOT) is a novel technique for the treatment of acute iliofemoral deep vein thrombosis (IFDVT) and is an alternative to percutaneous techniques (PT) that utilize thrombolytics. In this study, we compare perioperative and intermediate outcomes of HOT versus PT as interventions for early thrombus removal.
Methods
From August 2008 to May 2015, 71 consecutive patient were treated with either PT (n = 31) or HOT (n = 40) for acute/subacute single limb IFDVT. HOT consisted of surgical thrombectomy, with balloon angioplasty ± stent. PT included catheter directed thrombolysis (CDT) ± pharmacomechanical thrombectomy (PMT) using the Trellis-8 system. Patients that presented with bilateral DVT, IVC involvement, or phlegmasia cerulea dolens were excluded. Perioperative outcomes, quality measures, and thrombus resolution were analyzed between the two treatment groups. CEAP classification, Villata score, and venous duplex at intermediate follow up were also analyzed.
Results
The left limb was the most common site of the IFDVT overall. Technical success (>50% resolution) was 100% for both groups, and greater than 80% resolution was achieved in all patients treated with HOT. There were 8 major bleeding events in the PT group as compared to 3 in the HOT group (p = 0.04). PT patients had a significantly longer length of stay (13.3 vs 10 days, p = 0.028) when compared to HOT. At 2 year duplex there was no difference between HOT vs PT in mean reflux times at the femoral-popliteal segment. At a mean follow up of 1.5 years the clinical CEAP classifications were lower for HOT (x2 = 6.34; p = 0.01). There was no difference between the groups in Villalta score (2.1 vs 1.9, p = 0.8).
Conclusion
In our experience, PT and HOT have both demonstrated very good outcomes in the perioperative and intermediate periods. HOT is non-inferior to PT as a technique for early thrombus removal, and has the advantage that thrombus resolution is established in one operation and LOS is significantly decreased. HOT avoids thrombolytic therapy, which may reduce major bleeding events.
PR 2
Is routine follow-up surveillance of iliac vein stents for iliocaval venous obstruction necessary?
University of Alabama, Birmingham, Alabama, USA
Objective
While iliac vein stenting has emerged as effective treatment for iliocaval venous obstruction (ICVO), the role of surveillance imaging remains unclear. The purpose of this study is to evaluate outcomes of iliac vein stents placed for ICVO and to determine if routine follow-up surveillance is warranted based on timing of stent failure.
Methods
All patients who underwent iliac vein stenting from 2003
Results
Seventy patients (74 limbs) were identified who underwent iliac vein stenting for ICVO. Thirty-six limbs (48.6%) were stented for nonthrombotic venous compression (Stent-VC), and 38 limbs (51.4%) were stented for venous thrombosis (Stent-VT). Twenty-four limbs (63.2%) of the Stent-VT group were treated for acute venous thrombosis requiring lysis with stent for underlying venous lesions. The median number of follow-up visits for the Stent-VC and Stent-VT groups were 2 (IQR = 1
Conclusions
Patients with iliac vein stents placed for nonthrombotic iliac vein compression had statistically higher patency than those placed for venous thrombosis, with all stent failures occuring within 6 months. Iliac vein stents placed for venous thrombosis continued with stent failure after 6 months and may benefit from extended surveillance.
PR 3
Improvement in varicose vein symptoms: Quantifying with the VVSymQ, an Electronic Patient-Reported Outcome (ePRO) instrument
Interventional Radiology, NY Presbyterian Hosptial-Weill Conrell Medical College, New York, NY, USA
Symptom relief is a patient-centric way to assess treatment success for varicose veins. The VVSymQ® instrument is an electronic PRO instrument that assesses duration of 5 varicose vein symptoms (heaviness, achiness, swelling, throbbing and itching) on a scale of 0 to 5 each day. It was developed following FDA PRO guidelines by modifying the VEINES-Qol/Sym (VQS) and was evaluated for content validity, reproducibility, and ability to detect change.
Materials and Methods
Content validity for the VVSymQ® instrument was first established by focus group and patient interviews. Psychometric properties were assessed by use in C2-5 patients along with VQS, VCSS, PA-V3 and CIVIQ-20 before/after treatment to ablate great saphenous veins (GSV). The tool was used before/in follow up in a 40-patient validation study and subsequently as a daily electronic diary in two Phase 3 (n = 511) (data not shown) randomized trials of polidocanol foam for GSV ablation. VQS and PA-V3PROs as well as CEAP and VCSS were also compared.
Results
The VVSymQ® instrument demonstrated excellent reproducibility (ICC = 0.96) and suitable internal consistency reliability (Cronbach’s alpha = 0.78) in the validation study. It discriminated among known groups created from VCSS (p < 0.05), and demonstrated moderate to strong construct validity with CIVIQ-20 and VQS at baseline. Pre- and post-treatment change scores for the VVSymQ® instrument yielded moderate to strong correlations (r = 0.56) with the CIVIQ-20 total score. Compliance with the VVSymQ® daily diary in the validation study was high ( ≥ 97%) for each of the 3 assessment periods.
Conclusion
Taken together, these data demonstrate the construct validity of the VVSymQ® PRO instrument, which performed well with respect to reliability, construct validity, and ability to detect change when assessing response to treatment for varicose veins.
PR 4
Thin-slice enhanced computed tomography for delineating the right adrenal vein before adrenal venous sampling
1Department of Radiology, Nippon Medical School, Tokyo, Japan
2Department of Radiology, Oarai Kaigan Hospital, Ibaraki, Japan
3Tokai University Hachioji Hospital, Tokyo, Japan
Purpose
This study compared anatomical variations between the presumed right adrenal vein (CT-RAV) on thin-slice enhanced computed tomography (TSCT) and the biochemically defined right adrenal vein (BD-RAV) detected by CT during angiography (Interventional-CT). Estimated rates of correct cannulation during right adrenal venous sampling (AVS) before interventional-CT were compared between cases with and without useful TSCT.
Materials and Methods
TSCT was performed in 72 of 151 consecutive patients undergoing AVS with interventional-CT. Successful right adrenal vein (RAV) cannulation during AVS with interventional-CT was defined biochemically by cortisol concentration. TSCT identification of the RAV was classified as certain, probable, and unclear, and studies with a certain or probable RAV identification were classified as useful. Anatomical features of the CT-RAV and BD-RAV were compared, including their position along the inferior vena cava (IVC), vertebral level, and the distance between the RAV and right kidney. Rates of successful RAV cannulation were compared between cases with and without useful TSCT before AVS.
Results
A total of 66 of 72 TSCT exams were classified as useful (50 certain, 16 probable). There was good correlation of anatomical features between the CT-RAV and BD-RAV (position along the IVC: r = 0.725, P < 0.001; vertebral level: r = 0.656, P < 0.001; distance to upper pole of right kidney: r = 0.687, P < 0.001). Rates of correct cannulation with and without useful TSCT were 92.4% and 82.4%, respectively.
Conclusion
TSCT identified the right adrenal vein before AVS and may be useful for promoting successful right AVS.
PR 5
Involvement of myofibroblasts in the pathophysiology of secondary lymphedema
Second Department of Surgery, Vascular Surgery, Hamamatsu University School of Medicine, Hamamatsu, Japan
Background
Secondary lymphedema arises as a consequence of surgical, radiation, inflammatory, or traumatic disruption of lymphatic vessels. The frequency of lymphedema after pelvic and genital cancer surgery was reported to be 20 to 40%. In chronic lymphedema, increased numbers of fibroblasts, inflammatory cells and increased amounts of collagen fibers were observed. However, the pathophysiology of secondary lymphedema remains unclear. Research progress in secondary lymphedema has been hampered by the lack of a suitable experimental animal model; therefore, we developed a novel animal model of secondary lymphedema in the rat hind limb. The objectives of this study were to evaluate our rat model and to investigate the pathophysiology of secondary lymphedema.
Methods
We used 12-week-old, male, Sprague-Dawley rats. A circumferential incision was made in the right groin, and lymph nodes dissection and ligation of lymphatic vessels were performed. Skin biopsy was performed on day 3, 7, 14, 28, 56, 84, 112, 140, and 168. Immunohistochemical staining and real-time PCR analysis were performed. We enrolled 5 patients with unilateral leg secondary lymphedema. Skin tissues were obtained from bilateral legs from the patients. Primary culture of skin fibroblasts from rat and human skin were also performed.
Results
The number of subcutaneous lymphaic vessels and macrophages increased in acute phase, and decreased in chronic phase. In acute phase, the mRNA expression of VEGF-C in skin tissues increased and infiltrated macrophages expressed VEGF-C. In chronic phase, the mRNA expression of collagen type I α1, type III α1, and TGF-β1 in skin tissues increased. Fibroblasts primarily cultured from lymphedema model expressed α-smooth muscle actin (α-SMA), TGF-β1, type I and III collagen. Fibroblasts cultured from secondary lymphedema patients also expressed α-SMA, TGF-β1, type I and III collagen.
Discussion
We focused on myofibroblasts and TGF-β1. Myofibroblasts and TGF-β1 are considered to be involved in the control of extracellular matrix synthesis and in fibrotic diseases such as liver cirrhosis and pulmonary fibrosis. TGF-β1 differentiates fibroblasts to myofibroblasts. Myofibroblasts express α-smooth muscle actin and produce collagen. Myofibroblasts also release TGF-β1 and stimulate fibroblasts in an autocrine fashion. We found out a novel pathogenesis of secondary lymphedema. In acute phase, infiltrated macrophages produce VEGF-C and stimulate lymphangiogenesis. The infiltrated macrophages also produce TGF-β1, and TGF-β1 differentiates fibroblasts to myofibroblasts. In chronic phase, myofibroblasts release TGF-β1 and accelerates myofibroblasts to synthesize collagen fibers in autocrine fashion to establish fibrosis. At this stage, lymphatic vessels decreased. Collagen mechanical compression in fibrosis may be attributable to the deterioration of lymph vessels. Inhibition of TGF-β1 may be a new therapeutic strategy to prevent the development of secondary lymphedema.