Abstract
Comparison of iontronic sensor to PicoPress in in-vitro interface pressure measurement
1University of California, Davis, Vascular Center
2University of California, Davis, School of Engineering
Introduction, Objectives, and/or Purpose
Interface pressure is sine qua non for compression therapy but rarely utilized in the clinical setting. Pneumatic sensing device Picopress is one of the few commercially available interface pressure measuring devices. In this study, we intended to compare a flexible iontronic sensor (FITS) (Figure 1) to Picopress in functionality and performance.
Methods
This was an in-vitro experiment conducted in May 2019. The FITS sensor was characterized by membrane deformation as pressure was applied, and this caused an increase in capacitance and converted to pressure (mmHg). A cylinder model covered by a silicone foam (BISCO HT800, Roges Co, Rogers, CT), to mimic the human bodys skin and tissue, was used (Figure 2). The pressure cuff was inflated by an air pump and controlled by the microcontroller. Pressure curve to output was programmed from 20 to 120 mmHg with a stepwise of 10 mmHg. The stabilization time was 20s and the average was recorded. 3 trial runs were performed per pressure value. The FITS sensor and PicoPress were simultaneously tested on the same platform aforementioned. The true pressure (automated pump pressure) was recorded. One-sample paired t-test was used to compare the mean pressure value of FITS sensor to PicoPress (MATLAB, Version 2019a).
Results
The flexible iontronic sensor (FITS) demonstrated similar performance profile to PicoPress (P > 0.05; Graph 1). Standard deviation (SD) for PicoPress ranged from 0 to 1.36, and standard deviation for the FITS sensor ranged from 1.27 to 9.9.
Conclusion(s)
In this study, the flexible iontronic sensor (FITS) demonstrated similar in-vitro performance as PicoPress.
Flexible iontronic sensor (FITS) structure and appearance.
Experimental set-up.
Comparison of flexible iontronic sensor (FITS) to PicoPress.
Five-year extension study of patients from a randomized clinical trial (VeClose) comparing cyanoacrylate closure versus radiofrequency ablationfor the treatment of incompetent great saphenous veins
1Center for Vein Restoration
2Lake Washington Vascular
3The Venous Institute of Buffalo
4Laser Skin and Vein
5Inovia Vein Specialty Centers
Introduction, Objectives, and/or Purpose
Objective: The VenaSeal system versus Radiofrequency Ablation (RFA) for Incompetent Great Saphenous Veins trial (VeClose trial) showed that endovenous cyanoacrylate closure(CAC), a non-tumescent, non-thermal, non-sclerosant ablation technique was effective and non-inferior to RFA in vein closure with good 36 month outcomes. The aim of this extended follow-up of the VeClose study was to assess the long-term safety and efficacy of CAC and RFA for the treatment of incompetent great saphenous veins (GSV) at 5-years (60 months) of follow-up.
Methods
This 60-months extension study was conducted at 10 centers for all patients who completed the randomized controlled VeClose study and who were willing to participate. The pivotal VeClose study included patients aged 21 to 70 years, with symptomatic moderate to severe varicosities (Clinical, Etiologic, Anatomic, and Pathophysiologic [CEAP] class C2-C4b) and symptomatic GSV incompetence, who were randomly assigned (1:1) to either CAC or RFA. The primary outcome measure of this 60-month extension study was complete closure of the target vein with a non-inferiority margin was -10%. Secondary outcomes included: Venous Clinical Severity Score (VCSS); CEAP, EuroQol Five Dimensions (EQ-5D) and Aberdeen Varicose Vein Questionnaire (AVVQ); patient satisfaction with treatment;adverse events related to target GSV; and details of adjunctive procedures.
Results
A total of 89 patients completed the 60-month visit, which included 47 from the CAC group, 33 from the RFA group. The 60-month GSV closure rate was 94.6% for the CAC group and 100% for the RFA group (P = .264). Kaplan-Meier (K-M) estimates for freedom from recanalization in the CAC and RFA groups were 91.4% and 85.2%,respectively, demonstrating non-inferiority of CAC compared with RFA (non-inferiority established by one-sided 97.5% confidence interval with lower limit = −3.5%). Further, both groups demonstrated sustained improvements in EQ-5D and QoL through 60 months. The number of patients with advanced venous disease (CEAP 3-4b) was reduced from baseline to month 60 over time (from 18 to 7 cases). No long-term device- or procedure-related serious adverse events occurred in either group between 36- and 60-month follow-up.
Conclusion(s)
CAC and RFA were effective in achieving complete target vein closure of the GSV at long-term follow-up with CAC demonstrating continued non-inferiority to RFA as evidenced by the K-M analysis. CAC was also associated with sustained improvements in symptoms, QoL, and a high level of patient satisfaction without any serious adverse events between the 36 and 60-month follow-up visits.
Iliac Vein Stenting is Safe in an Office-Based Lab (OBL) Setting
Center for Vascular Medicine
Introduction, Objectives, and/or Purpose
Venous stenting for iliac vein outflow obstruction/stenoses are associated with excellent long-term stent patencies and low mortality and morbidity rates. However, the safety of iliac vein interventions in an office-based laboratory (OBL) setting is ill-defined. The purpose of this investigation is to determine the safety profile of iliac vein stenting in an OBL setting.
Methods
Data were prospectively collected in the Center for Vascular Medicines (CVM) electronic medical record system and retrospectively analyzed (NextGen Healthcare Information System, Irvine, California). Patient consultations, interventions (pre, intra and postoperative), and follow-ups at one week and six weeks were included in this analysis. Complications requiring hospitalization (including for observation) were classified as major complications while all others where patients could be safely discharged home were classified as minor. Patients treated in our OBL had EKG monitoring, pulse oximetry, monitoring by a nurse, local anesthesia for access and mild IV sedation with Versed and Fentanyl intra-operatively. Conscious sedatives are administered by a Registered Nurse with conscious sedation privileges while under the supervision of the interventionalist. Wallstents and intra-vascular ultrasonography were utilized in all patients.
Results
Between January 2015 and January 2019, 1223 iliac vein stents were placed in 1104 patients (23.7% male, 76.3% female). There were a total of 90 minor complications (7.36%) and 5 major complications (0.41%). Major complications included the following: one allergic reaction, one spontaneous atrial fibrillation, one episode of supraventricular tachycardia, one episode of chest pain, and one vasovagal episode. No complications were related to sedation. There were no episodes of acute renal failure. There were no mortalities. The most common minor complication was an access related hematoma.
Conclusion(s)
Major complications are extremely rare in the peri, intra and post-operative period following venous stenting. Most observed complications were minor hematomas and the majority of patients were safely discharged home. Based on these data, iliac vein stenting in an OBL setting is extremely safe and well tolerated.
Ultrasound Guided Foam Sclerotherapy: Are Advanced Practice Providers as Safe as Physicians?
Vein Clinics of America
Introduction, Objectives, and/or Purpose
The purpose of this study is to evaluate safety of ultrasound-guided foam sclerotherapy (UGFS) performed by advanced practice providers (APPs – Nurse Practitioners and Physician Assistants) compared to physicians by analyzing reported complication rates in a multi-practice phlebology network.
Methods
Retrospective analysis of reported complications for patients with lower extremity venous insufficiency who had outpatient ultrasound guided foam sclerotherapy performed by an advanced practice provider (APP) or physician between August 1, 2018 and November 30, 2018. Sclerotherapy cases performed in 62 clinics were identified by querying structured data in the electronic medical record. The initial study population included 45,551 patients. Filters were applied to the initial data set to remove incomplete data, visually guided sclerotherapy cases, and sclerotherapy cases performed in clinics that did not submit any incident reports during the study period.
Results
A total of 21,490 ultrasound guided foam sclerotherapy cases were included in this study. 5,038 patients were treated by APPs and 16,452 patients were treated by physicians. There was a total of 41 reported complications (0.19%) for the entire cohort. The overall complication rate for UGFS performed by APPs was 0.32% (N = 16), and by physicians was 0.15% (N = 25). This is statistically significant (p = 0.0298) There was no statistical significance between the two groups for any specific complication category -Deep Vein Thrombosis (p = 0.17), pulmonary embolism (p = 0.58), visual disturbance (p = 0.58), migraine (p = 0.531), cutaneous necrosis (p =0.696), allergic reaction (p = 0.531), adverse drug reaction (p = 0.959).
Conclusion(s)
While a statistically significant difference was noted in complication rates following ultrasound guided sclerotherapy performed by APPs compared to physicians, we submit that this was not clinically significant. The complication rates for both groups are lower than those published in literature. There are no established benchmarks for this comparison. Limitations of the study include possible under-reporting of post-procedure complications. An additional limitation is that the treating provider was not always correctly identified in structured data; Our EHR automatically populated the provider as the physician and the APPs must manually change the provider listed. This could lead to at least some of the procedures attributed to physicians were actually performed by APPs. Further analysis shows that if as few as 300 cases were re-classified as procedures performed by an APP, the difference in reported complication rates would no longer be statistically significant. The authors feel that complication risk of UGFS performed by APPS is not meaningfully different from the risk of UGFS performed by physicians. Based on the limitations of this study, a prospective analysis of complication rates following ultrasound guided foam sclerotherapy performed by APPs and physicians will be conducted.
A Comparison of the Efficacy and Safety of Polidocanol Foam with 1:2 Polidocanol to air ratio versus 1:4 ratio for the treatment of Reticular Veins of the Lower Extremities
Cosmetic Laser Dermatology
Introduction, Objectives, and/or Purpose
Sclerotherapy is the gold standard treatment of lower extremity reticular veins and telangiectasias. The use of polidocanol foam for the treatment of reticular veins is well established in the medical literature due to both efficacy and low adverse effects. Mixing room air with sclerosing solutions to create a foamed sclerosant allows for greater contact time between the sclerosant and the endothelial cells with a decrease in both the amount of sclerosing agent used and associated toxicity. The ratio of sclerosant to air according to the European consensus meeting recommendations and most experts is 1:4 when performing foam sclerotherapy treatments, but the effect of different liquid-gas ratios on foam stability and efficacy has been controversial. The primary objectives: 1. Evaluate the efficacy of two different polidocanol to air ratios, 1:2 vs. 1:4 for the treatment of reticular veins of the lower extremities 2. Compare the safety of two different polidocanol to air ratios, 1:2 vs. 1:4 for the treatment of reticular veins of the lower extremities.
Methods
This was a prospective, single-center, randomized, double-blinded, split-leg study to evaluate the use of two different polidocanol to air ratios, 1:2 vs. 1:4, for the treatment of reticular veins. 30 patients between the ages of 25-70 years old with bilateral and symmetric lower extremity reticular veins and telangictasias classified as CEAP Class 1 were enrolled between May 2018 and March 2019. Lower extremities were randomized to treatment with 0.5% polidocanol mixed with 4 ml of room air for one lower extremity or 0.5% polidocanol mixed with 2 ml of room air for the other lower extremity. Telangiectasias over both lower extremities were then immediately treated with 70% glycerin solution mixed 2:1 with 1% lidocaine with epinephrine 1:100,000. Subjects and a blinded-investigator evaluated adverse events immediately post-sclerotherapy, and on days 21 and 90. Improvement on left and right lower extremities was addressed by subject and a blinded-investigator on days 21 and 90.
Results
Thirty subjects completed the study through day 90. Subjects and blinded-investigator ratings showed a mean improvement between 0% to 50% at day 21, and 26% to 75% at day 90, which was not significantly different between extremities. There was no statistically significant difference in adverse events between the two different polidocanol to air ratios by investigator assessment. Subjects reported significantly greater swelling on day of treatment and days 4 and 5 in legs treated with 4ml air versus 2 ml area (p = 0.03). There were no other adverse events with a statistically significant difference between groups at any time point per subject assessment.
Conclusion(s)
Based on our preliminary results, the two different polidocanol to air ratios, 1:2 vs. 1:4, were similarly efficacious and safe for the treatment reticular veins of the lower extremities.
3 photos were uploaded in one file above as they all apply to the RESULTS section. The associated image label is underneath each.
Pharmaco-mechanical prophylaxis for postoperative venous thromboembolism in extremely-high-risk patients: the results of the IPC SUPER study
1Pirogov Russian National Research Medical University
2Central State Medical Academy of the Presidents Administration of Russian Federation
Introduction, Objectives, and/or Purpose
Postoperative venous thromboembolism (VTE) is a common medical problem related to significant socioeconomic burdens. The standard VTE prophylaxis is based on the patients risk stratification. The best instrument for this purpose is a Caprini score, which divides individuals into low-, medium-, high-, and very high-risk groups and suggests adequate preventive measures. However, the subsequent increase in Caprini score demonstrates the subsistence of the extremely-high-risk group (scores of 11 and greater) in which the standard prophylaxis (anti-embolic stockings and heparin injections) is not enough, and the frequency of asymptomatic postoperative VTE may be as high as 50%. The way to improve VTE prophylaxis in extremely-high-risk patients is to combine pharmaco-prophylaxis and mechanical prophylaxis via an intermittent pneumatic compression (IPC) device. The aim of the study was to assess the efficacy and safety of an IPC device in combination with anti-embolic stockings and low-molecular-weight heparin injections in the prevention of postoperative VTE in extremely-high-risk patients.
Methods
This study was an open, randomized, blinded clinical trial of patients at extremely high risk for postoperative VTE (Caprini scores 11) approved by a local IRB. All participants were placed into one of two groups: one group (control) received standard prophylaxis with elastic compression stockings and subcutaneous enoxaparin injections (40 mg) and the other (experimental) received an IPC device (SCD Kendall 700) in addition to standard prophylaxis. Patients were followed-up during the hospital stay and at one and six months after surgery. Duplex ultrasound scanning was performed at baseline and after surgery during inpatient treatment. All the deceased patients were autopsied. The studys primary endpoint was if asymptomatic venous thrombosis occurred during the hospital stay. The main secondary endpoints were the occurrence of symptomatic and asymptomatic VTEs during inpatient treatment or one or six months after surgery; leg skin injury; bleeding; and IPC device compliance.
Results
From February 2017 to January 2018, 812 surgical patients at high risk for postoperative VTE were examined. Among them, 407 individuals were enrolled in the study after they gave their informed consent. They were randomized into either the experimental or control groups (204 and 203, respectively). This study included 160 men and 247 women, with a mean age of 68.8 ± 9.8, who underwent abdominal (68.3%), thoracic & neck (7.9%), gynecological (8.6%), urological (7.3%), or cranial (7.9%) surgery with a mean duration of 165.3 ± 77.7 min. The mean Caprini score was 11.4 ± 1.9. The presence of a malignant tumor was an indication for surgery in 83% of the patients. The groups were comparable according to the main demographic and clinical data. The median hospital stay duration was 10 days in both groups. All 407 participants were observed during inpatient treatment. The compliance with IPC was calculated as a proportion of the investigators visits to the patients beds (scheduled 5 visits a day) and the number of detected IPC applications and turning on if the patient was on bed rest. The compliance was calculated as 95%. The primary endpoint was detected in 1 of 204 patients (0.5%; 95% CI: 0.1-2.7%) in the experimental group and 34 of 203 patients (16.7%; 95% CI: 12.2-22.4%) in the control group (p < 0.0001). Calf muscle vein thrombosis occurred once in the IPC group, whereas calf muscle vein thrombosis (n = 15), extended distal DVT (n = 9), femoral-popliteal DVT (n = 3), iliac DVT (n = 2), and superficial vein thrombosis (n = 5) occurred in the control group. The PE incidence was 0% vs. 2.5% (p = 0.030) and the fatal PE incidence was 0% vs. 1.5% (p > 0.05). Leg skin injury was detected in 12.3% vs. 7.4% and bleeding in 3.4% vs 5.4% of patients in the experimental and control groups, respectively (p > 0.05). The observed frequencies of primary and secondary endpoints are represented in Table I. At one month 95% of all the participants were observed. The 30-day incidence rates of VTE were 0.5% and 18% in the IPC and control groups, respectively (p < 0.0001). At six months, 80% of all the patients received followed-ups, and no new VTE events were registered.
Conclusion(s)
IPC in addition to standard prophylaxis allows the reduction of the incidence of postoperative VTE in extremely-high-risk patients without any increase in the rates of leg skin injury or bleeding.
Five Year Experience of Comprehensive Ultrasound-guided foam sclerotherapy in varicose veins treatment
1American Vein and Lymphatic Society
2FACS
3ARDMS
Introduction, Objectives, and/or Purpose
We report our experience utilizing comprehensive ultrasound-guided foam sclerotherapy (CUSGFS) over a five year period.
Methods
Comprehensive ultrasound-guided foam sclerotherapy (CUSGFS) with sodium tetradecyl sulfate (STS) of the large and medium size varicose veins.
Results
We report 5000 patient encounters with one thousand patients who underwent comprehensive ultrasound-guided foam sclerotherapy with over 50,000 CUSGFS injections performed (5 to 30 injections per patient per session). All patients required more than one session of USGFS. No patients required phlebectomy. Patients received CUSGFS for tributary reflux following primary endovascular venous laser ablation (EVLT). Over 85% of these cases were either primary greater saphenous vein (GSV) and/or lesser saphenous vein (LSV) EVLT closure. Tributary vein closure was performed for the remainder. Patient follow-up rate over five years was greater than 98%. Closure rates were over 99%. Complications included four ulcerations, one transient ischemic event (ocular TIA), one deep vein thrombosis (DVT) of the femoral and popliteal vein, and one pulmonary embolus (PE) of un-diagnosed etiology. Patient compliance and satisfaction was very high. Tolerance for numerous sessions was also very high in order to avoid more invasive procedures (phlebectomy). Most patients had extensively researched other treatment options before choosing our method.
Six-month follow up post-EVLT GSV & SSV and CUSGFS for saphenous tributaries
Conclusion(s)
Comprehensive ultrasound-guided foam sclerotherapy (CUSGFS) is a very safe and effective method for the treatment of varicose veins, and in our experience has replaced more conventional surgical procedures.
High intensity focused ultrasound (HIFU) in the treatment of incompetent superficial veins and perforating veins – a report of our early experience
The Whiteley Clinic
Introduction, Objectives, and/or Purpose
Background: The traditional treatment for varicose veins is ligation and stripping. Over the last to decades, open surgery hss been replaced by catheter endovenous thermal ablation, non-thermal ablation and ultrasound-guided foam sclerotherapy. All of these techniques involve catheterisation of the vein and treatment is intraluminal. High intensity focused ultrasound (HIFU) is a non-invasive method of focusing ultrasound energy through the skin to produce thermal damage deep to the surface. Using real-time B-mode imaging, the focal point and hence area of thermal ablation can be precisely located. HIFU has been used to ablate thyroid and breast tumours. Recently we have started treating incompetent veins with HIFU. This report outlines are early experience and learning curve with this new technique of ablating venous incompetence.
HIFU treatment of a calf incompetent perforating vein
Methods
We started HIFU vein treatment (Sonovein, Echopulse, Theraclion, France) in May 2019. At the time that this abstract is being written, 12 patients (M:F 6:6 age 37-80 mean 58.8) had undergone 13 treatment sessions. We have treated incompetent truncal and perforator veins as enumerated as in the table. The machine recognises the skin surface to ensure that the skin is not damaged from the passage of the focused ultrasound beam. This is achieved by ensuring adequate depth of the treated vein. A cooling cushion is incorporated into the treatment head which keeps the skin cooled. Focused ultrasound pulses were passed into the vein and the number of pulses noted. All treated veins required local anaesthetic to be injected around them. Occlusion was assessed immediately, one hour later and one week later. Continuing assessments will be made over the next three years.
Results
We started HIFU vein treatment (Sonovein, Echopulse, Theraclion, France) in May 2019. At the time that this abstract is being written, 12 patients (M:F 6:6 age 37-80 mean 58.8) had undergone 13 treatment sessions. We have treated incompetent truncal and perforator veins as enumerated as in the table. We started off using the recommended sequence of imaging the veins using a hand held probe and then stopping the probe for the robotic HIFU with imaging device incorporated. The machine recognises the skin surface to ensure that the skin is not damaged from the passage of the focused ultrasound beam. This is achieved by ensuring adequate depth of the treated vein. A cooling cushion is incorporated into the treatment head which keeps the skin cooled. Focused ultrasound pulses were passed into the vein and the number of pulses noted. All treated veins required local anaesthetic to be injected around them. Occlusion was assessed immediately, one hour later and one week later. Continuing assessments will be made over the next three years. Results: One patient who had been nervous about Sonovein asked to try to have her anterior accessory vein treated without any local anaesthetic. She found it uncomfortable and withdrew from the treatment before proceeding to treatment with local anaesthetic. All the other patients completed the treatment that was planned. All targeted sections of truncal veins and all incompetent perforating veins were successfully ablated on the one hour and 1 week follow up scans (Figure 2 and 3). One patient had 2 operations one week apart (small saphenous vein and perforators on each occasion). During both he was fully anti-coagulated on warfarin four atrial fibrillation. He did not have any bruising not haematoma formation on either occasion. None of the patients had any perioperative or post-operative complications.
Before and 1 hour after HIFU treatment of an incompetent small saphenous vein – patient fully anti-coagulated for atrial fibrillation
Before and 1 hour after HIFU treatment of an incompetent perforating vein
Conclusion(s)
This is an early report of a new non-invasive ablated technique for the treatment of superficial venous reflux. It has shown that it is technically possible to close incompetent truncal and incompetent perforating veins, even in patients on full anticoagulation. Clearly as this is so new, there are no medium or long-term results. As with all new technologies, there will need to be further research to show that the thermal ablation produced by HIFU is sufficient to permanently close the treated veins. Furthermore, further research will be needed to identify exactly which patterns of venous disease are most suitable for this technique. Whether HIFU as a future in the treatment of superficial venous reflux will depend on many factors including efficacy, patient acceptability, cost-benefit analysis, ease-of-use and time per treatment. However, this early report shows that certainly in the very short term, HIFU appears able to close incompetent truncal and perforating veins noninvasively in the short term.
Percutaneous injection of cyanoacrylate filler glue with difficult patients for transcatheter cyanoacrylate adhesive closure
1Edogawa Hospital
2Juntendo University Hospital
3Tokyo Vascular and Vein Clinic
Introduction, Objectives, and/or Purpose
Transcatheter cyanoacrylate adhesive closure (CAC) is still contraindicated for tortuous and larger veins, because a single catheter access is difficult in such patients. In addition, it is reported that larger veins (more than 6.6 mm in diameter) are a risk factor for recanalization. Since the repeat procedures would be challenging after unsuccessful CAC, the percutaneous ultrasound guided sclerotherapy is the only option to close the bloodstream channel in the glued vein lumen. However, the efficacy of sclerotherapy after unsuccessful CAC is unknown. Mixture of n-butyl cyanoacrylate (NBCA) and the contrast ethiodized oil has been used for transcatheter embolization in patients with arteriovenous malformations or traumatic bleeding. This glue acts as a filler to occlude the bloodstream channel but does not work as an adhesive. Thus, the percutaneous injection of filler cyanoacrylate is complementary to adhesive occlusion for larger vein and more effective for the treatment of recanalization after unsuccessful transcatheter CAC. Percutaneous cyanoacrylate filler closure (CFC) could be a new strategy with difficult patients for CAC. Objective/Purpose: (1) To assess the efficacy and safety of CFC with CAC compared with the transcatheter CAC. (2) To evaluate the short-term outcome up to three months.
Methods
A retrospective observation study was conducted for a one year period (May 2018-July 2019) at multiple institution of patients (n = 140) with GSV reflux. Transcatheter CAC in 50 legs and percutaneous CFC and CAC in 90 legs were conducted. Two kinds of Turkish adhesive glues (unapproved yet) were used with transcatheter or percutaneous injection. NBCA (off-label) and the contrast ethiodized oil (approved) were mixed into a1:3 ratio as a filler. Patients demographics, CEAP clinical class, VCSS, mean truncal GSV diameter, largest vein diameter, cyanoacrylate volumes were recorded. Anti-inflammatory medication was prescribed for one week after procedure, but no compression stocking was necessary. Anatomical success (complete, partial, recanalization) and clinical success by VCSS were evaluated up to 3 months. Phlebitis-like skin reaction with pain and hypersensitivity reaction defined as the persistent and painless skin redness or itchy dermal reaction were monitored.
Results
140 of GSVs were treated for one year. The patients included 87 females (62.1%) and 53 males (37.9%) with a mean age of 66.8 years (SD 10.6), and a median VCSS of 4 (SD 2.0). There was no significant difference with gender and age between percutaneous CFC and transcatheter CAC. Median VCSS with percutaneous CFC was 5 (SD 2.4) and it was relatively higher than that of transcatheter CAC (p = 0.027). Mean truncal GSV diameter was 8.0 mm (SD 2.2) and patients with percutaneous CFC showed relatively greater truncal diameter of 8.3 (SD2.8) than that of transcatheter CAC (p = 0.651). The largest GSV diameter was 33.1 mm and 24.4 mm respectively. CEAP clinical classes in total were 48 of C2, 61 of C3 and 31 of >C4. Distribution of clinical class showed no significance between the two procedures. There were no significant factors identified when comparing with or without CFC except total cyanoacrylate volume (3.0 mL versus 1.8 mL) shown in Table 1. CFC was indicated as follows; unsuccessful CAC in 9 patients (10%) and difficult GSVs for transcatheter technique with larger diameter or tortuosity in 81patients (90%). In unsuccessful CAC, CFC was done in the same session with 12 patients and in the second session with 9 patients. CAC was performed before CFC with 79 patients (87.8%) by percutaneous injection and 11 patients (12.2%) by transcatheter technique. CFC is necessary to compress for 30 seconds after percutaneous injection. Under the ultrasound observation, a translucent amorphous shadow occupied the remaining blood channel surrounding the formerly administrated adhesive cast. Then, the blood channel was occluded with filler glue cast with lower echogenicity than that of adhesive cast. 78 patients (96.3%) out of 81 patients, who were underwent CFC and CAC treatment in the same session, felt less pain during the filler glue injection than the adhesive injection. Phlebitis-like skin reaction, including self-limited >moderate pain, skin redness, induration and skin discoloration, occurred with 4 patients (2.9%) under anti-inflammatory medication, while hypersensitivity reaction occurred with 2 patients (1.5%), followed by anti-allergic medication. After 3 months, treated veins in total were completely occluded with 127 patients (90.7%), and partially occluded with 10 patients (7.1%). Although there was no significance between both procedures, percutaneous CFC showed a better complete recanalization-free rate (98.9% versus 90.0%, p = 0.014) shown in Figure1.
Conclusion(s)
(1) Transcatheter CAC was feasible and effective, however 9 patients (16.0%) showed incomplete occlusion. (2) Percutaneous CFC resulted in 95.6% of complete occlusion in patients with relatively higher VCSS and larger GSV diameter. (3) Percutaneous CFC showed the no inferiority of adverse effects such as phlebitis-like skin reaction and hypersensitivity, compared with transcatheter CAC. (4) Although this study is a short-term observation, CFC showed an encouraging result to prevent and recover from recanalization after CAC in patients with difficult veins.
The role of visualization of the lymphatic system in the diagnostics and treatment of the lower limb lymphedema
1National Medical Research Center for the Rehabilitation and Balneology of the Ministry of Health of Russia
2AV Vishnevsky National Medical Research Center of Surgery of the Ministry of Health of Russia
3United Hospital and Polyclinic of the Administration Management of the President of the Russian Federation, Moscow
Introduction, Objectives, and/or Purpose
Introduction: The effectiveness of the treatment of lymphedema is based on the principle of personification. Individual rehabilitation programs can be implemented after visualization of lymphatic outflow disorders using radioisotope lymphoscintigraphy (LSG). The aim of the study was the development of clinical criteria for the diagnosis of lymphedema of the lower extremities, based on the morpho-functional disorders of the lymphatic transport, detected in LSG.
Methods
60 patients with lymphedema of the lower extremities (45 women and 15 men; average age – 45 ± 1.64 years; from 17 to 78 years) were examined using isotope LSG. The number of limbs – 120. LSG Method: All patients received an intradermal injection of technetium labeled colloidal isotope (Tc-99m), at a dose of 600 MBq in the first interdigital space of both legs. The lymphatic transport of macromolecules was monitored using a hybrid SPECT-CT scanner (Simens Symbia T16, Germany). Evaluation of the accumulation and removal of radiopharmaceutical from the lymph nodes (LN), as well as lymphatic transport of the radiopharmaceutical. Quantitative LSG was estimated with a transport index (TIS) determined by the Kleinhans method (1985) for each limb with a score calculation on a scale from 0 to 9 points.
Results
The normal pattern of LSG on 18 asymptomatic limbs is a symmetrical timely evacuation and movement of radiopharmaceutical in the limbs, visualization of lymphatic collectors throughout the limb, early visualization of regional lymph nodes: within 15-20 minutes. The average value for intact, in relation to the lymphatic transport of the extremities, TIS = 4.2 ± 0.66. The LSG results were prospectively analyzed and the TIS for each limb was calculated. The rate of propagation of the radiopharmaceutical was normally less than 20 minutes. Quantitative LSG allows you to clearly define the clinical diagnosis: stage I of Lymphedema – the evacuation rate of the radiopharmaceutical is normal - < 20 min; reduced number of LN and collectors; regional LN accumulate radiopharmaceutical well; there is no depot of the radiopharmaceutical in the distal limb 2 hours after the stress method with physical exercise; TIS -8.68 ± 0.60; Stage II of lymphedema – slowdown in the rate of evacuation of radiopharmaceutical 20 min; decrease in% accumulation of radiopharmaceutical in LN from 25% to 45%; 2 hours after the exercise stress test, there remains a small depot of the radiopharmaceutical in the distal extremities; TIS – 18.69 ± 1.31; Stage III of lymphedema regional LN are not visualized; lack of visualization of lymphatic reservoirs; 2 hours after the stress test with physical activity, there remains a pronounced depot of the radiopharmaceutical in the distal limb; TIS – 31.08 ± 1.56; IV stage of lymphedema – the visualization of LN and lymphatic collectors is completely absent; when inspected 2 hours after the stress test with physical activity, there is a pronounced diffuse radiopharmaceutical at the injection site; the distribution of radiopharmaceutical in the form of “depot” in the soft tissues of the proximal and distal extremities; TIS – 42 ± 0.64.
Conclusion(s)
Thus, the results of isotope LSG should be used for the subsequent personification of the conservative treatment of patients with lymphedema. The goal of quality LSG is to visualize the morphology of the lymphatic system. Quantitative LSG is used to measure the speed of lymphatic transport and can be a sensitive way to diagnose lymphatic dysfunction. Personalized rehabilitation programs should include the integrated application of various non-drug methods, in their specific sequence, taking into account the assessment of the degree of functional state of the regional LN.
Improper Potency and Impurities in Compounded Polidocanol
1Innova Dermatology
2Dermatology, Laser & Vein Specialists of the Carolinas
3Center for Vein Restoration
4Weill Cornell Vein Treatment Center
Introduction, Objectives, and/or Purpose
CommerCommercially available polidocanol is a U.S. Food and Drug Administration (FDA)-approved sclerosant indicated for the treatment of uncomplicated spider veins and reticular veins in the lower extremities. In contrast, compounded polidocanol are essentially copies of commercially available products. These compounded formulations are not FDA-approved and have not undergone FDA premarket review for safety, effectiveness, and quality. Despite FDA restrictions against compounding drugs, polidocanol remains available from compounding pharmacies, potentially exposing patients to series health risks. There are numerous cases of injury resulting from improperly compounded medications, prompting a nationwide governmental review of compounding pharmacy policies in 2013. Prior studies have demonstrated the lack of potency and purity of compounded sclerosants. The objective of this study was to obtain and analyze samples of compounded polidocanol for potency and purity.
Methods
Seven samples of compounded polidocanol were obtained from three compounding pharmacies, through routine ordering procedures. Labeled concentrations of polidocanol ranged from 1.5% to 5%. Each sample was analyzed for potency of lauromacrogol 400 (polidocanol) and purity with reversed-phase high pressure liquid chromatography (HPLC) with refractive index (RI) detection (Chemische Fabrik Kreussler & Co. GmbH, Wiesbaden, Germany). The results were compared with an FDA-approved polidocanol 0.5% and 1% product (Asclera® Injection, Merz North America, Raleigh, NC).
Results
Among the seven samples analyzed, six were below the labeled concentration and one was above the labeled concentration. Five contained a 10-fold excess of foreign fatty alcohol ethoxylate impurities and four exceeded the limit for unknown impurities. With respect to potency and purity, none of the tested samples were equivalent to the commercially marketed product.
Conclusion(s)
Seven analyzed samples of compounded polidocanol had concentrations that differed from their labeled concentrations. In addition, five samples had excessive contaminant levels. Unreliable potency and the presence of impurities most importantly poses a significant risk to patient safety and treatment efficacy, but also presents medico-legal implications for the practitioner in cases of adverse outcomes.
Safety of ultrasound guided foam sclerotherapy utilizing sclerosant from a 503b pharmacy compounded with room air to treat venous insufficiency: Post-procedure complication rates and medication errors
Vein Clinics of America
Introduction, Objectives, and/or Purpose
Diluting an FDA approved sclerosant is by definition compounding, and requires aseptic processes, additional labeling and immediate use. Using sclerosants from a 503b pharmacy ensures standardized labeling, sterility, and strength versus in-office compounding of brand sclerosants. The purpose of this study is to evaluate the incidence of medication errors and complication rates after ultrasound guided foam sclerotherapy (UGFS) with 2% polidocanol from a 503b pharmacy compounded with room air.
Methods
Retrospective review of reported complications for patients with venous insufficiency who had outpatient ultrasound-guided foam sclerotherapy with 2% polidocanol supplied by a 503b pharmacy compounded with room air in a ratio of 1 part sclerosant to 3 or 4 parts room air using the Tessari method in a silicone-free syringe. These procedures were performed between August 1, 2018 and November 30, 2018. Sclerotherapy cases performed in 62 clinics were identified by querying structured data in the electronic medical record. The initial study population included 45,551 patients. Filters were applied to the initial data set to remove incomplete data, any sclerotherapy performed with sodium tetradecyl sulfate, visually-guided sclerotherapy, and sclerotherapy cases performed in clinics that did not submit any incident reports during the study period.
Results
A total of 21,363 ultrasound guided foam sclerotherapy cases performed in 43 clinics were included in this study. There was a total of 41 reported post-procedure complications (0.19%) for the entire cohort. UGFS reported complication rates: DVT (0.15%), PE (0.005%), Visual Disturbance (0.005%), Migraine (0.005%), Allergic Reaction (0.005%), Cutaneous Necrosis (0.01%), Adverse Drug Reaction (0.01%). There was one medication error related to sclerosants reported during the data-g thering period (0.004%). In that case there was an error in medication administration technique (foam sclerosant administered instead of liquid).
Conclusion(s)
The authors submit that utilizing microfoam prepared from 2% polidocanol sourced from a 503b compounding pharmacy and compounded with room air is safe. The reported complication rates for UGFS in this study are lower than those published in literature. Using a 503B pharmacy to source medications has significant clinical and regulatory advantages over in-office dilution and compounding, which the authors will discuss. There are no formal benchmarks for a comparison of complication rates, nor is there significant literature discussing medication errors in phlebology practices. The authors plan to proceed with a prospective observational study to improve the quality of the data in the future.
Venous Disease and Total Mortality: The San Diego Population Study
1University of California San Diego and La Jolla Vein Care
2University of California San Diego
3La Jolla Vein Care
Introduction, Objectives, and/or Purpose
The aim of this study was to assess the association between different categories of lower extremity venous disease and mortality.
Methods
At baseline (1996 to 1999), 2,404 adult participants of the San Diego Population Study with ages 40-79 years were examined by visual inspection and duplex ultrasound for bilateral lower extremity venous disease. Visual inspection was performed to place patients into mutually exclusive hierarchical categories of normal, telangiectasia/spider veins, varicose veins, edema and trophic skin changes. Duplex ultrasound was used to assess the superficial and deep systems for reflux and/or obstruction. From the duplex findings, patients were classified as having functional disease if an abnormality in the superficial or deep system was detected. After the baseline visit, the participants were followed until December 2017 for mortality. A series of multivariable cox regression models were created to assess the association of venous disease categories with total mortality.
Results
At baseline, the mean age was 59.3 (SD 11.4) years, 1,580 (65.7%) were female, 1,436 (59.7%) were white, 353 (14.7%) were Hispanic, 323 (13.4%) were black and 292 (12.2%) Asian. For visible disease, 525 (21.8%) were normal, 1,274 (53.0%) had telangiectasia/spider veins, 389 (16.2%) had varicose veins, 102 (4.2%) had edema and 114 (4.7%) had trophic skin changes. On duplex ultrasound, 687 (28.6%) had superficial or deep functional disease. Over a mean follow up of 18.2 years, there were 594 deaths (24.7%). After adjustment (see Table) for age, sex, race/ethnicity, systolic blood pressure, antihypertensive medication use, smoking status, cigarette pack year history, total/HDL cholesterol ratio, BMI, cancer history, and history of DVT/PE, and compared to individuals with no visible/functional disease, those with functional disease and varicose veins (HR 1.57, 95% CI, 1.11-2.22, p = 0.01), or trophic skin changes (HR 1.71, 95% CI, 1.10-2.64, p = 0.02) had significantly higher risk for total mortality. Further adjustment for physical functioning significantly attenuated the effect size for those with functional disease and varicose veins (HR 1.40 (95% CI, 0.98-2.01, p = 0.07) but not functional disease and trophic skin changes (HR 1.58 (95% CI, 1.01, 2.47, p = 0.04).
Conclusion(s)
Varicose veins and trophic skin changes with underlying functional disease on duplex ultrasound are associated with increased risk for mortality. This increased risk may, in part, be due to a decrease in physical functioning experienced by those with advanced venous disease. Further research is needed to determine if treatment of the underlying venous disease decreases mortality risk.
Iliac vein stenting do we have a problem for the solution? Real world data from a German vein centre
German Society of Phlebology, European Venous Forum Tobias
Introduction, Objectives, and/or Purpose
Interventional recanalization has been conducted on post-thrombotically obstructed and non-thrombotically obstructed iliac veins for around 20 years. In response, manufacturers have developed stents with a higher radial force and better flexibility. Stenting chronic iliac vein occlusions has been shown to lower pain and oedema levels and heal venous ulcers with low rates of complication. American guidelines recommend iliac vein stenting for primary and post-thrombotic iliac vein obstruction at CEAP stages C3 C6 (level IB). The patency rate depends on the technical execution of the procedure. Both ends of the stent need to be placed in healthy vein segments to ensure long-term treatment success. This limits the target group to patients suffering from post-thrombotic syndrome (PTS) following isolated deep-vein thrombosis from the distal inferior vena cava to the inguinal ligament, and patients with non-thrombotic compression syndromes. Epidemiological data on PTS indicates that only few patients profit from interventional recanalization. Real-world register data confirms this.
Methods
531 PTS patients (ICD 10 I87.00) were screened from 1/2014 – 12/2017. Twenty-one patients had isolated iliac vein obstructions. Eleven were excluded due to the absence of a landing zone, lack of compliance or individual patient decision; hence, a total of 10 patients received intervention. The underlying thromboses had occurred one to 24 years prior. Symptoms included pressure pain and tension in the thigh during prolonged sitting, varicosis of the pudendal vein and dyspareunia. One patient had edema and one suffered from venous claudication. The distal vasculature was free of postthrombotic residuals in all patients. In nine cases the left iliac vein was stented. One case involved non-thrombotic paraneoplastic compression of the right iliac vein. Venous occlusion plethysmography, phlebodynamometry and the Villalta score were used to assess the hemodynamics and symptoms.
Results
Only 10 of the 531 PTS patients (1.9%) were suitable for iliac vein stenting. After treatment they reported clinical improvement but no complete absence of symptoms. Three experienced stent thrombosis. Phlebodynamometry showed only minor deviations from the norm in all of the studies – both in terms of pressure reduction and replenishment time. Occlusion plethysmography revealed an improvement in venous efflux in eight of the subjects. No patient achieved values consistent with the healthy limb. The collapse of the collaterals correlated with a regression of the suprapubic varicose veins.
Conclusion(s)
Iliac vein stenting is effective in treating PTS and non-thrombotic venous obstructions in eligible patients. The small patient cohort and realistic patency rates require prudent selection and a strict indication. Clinical and diagnostic selection criteria require further development.
Association Between Clinical Anatomical Presentation and Venous Reflux Characteristics in Patients with Chronic Venous Insufficiency in Northwest China
1Xijing Hospital
2University of California Davis Vascular Center Sacramento
Introduction, Objectives, and/or Purpose
The aim of this study was to compare anatomical, hemodynamic, and clinical outcomes based on venous reflux patterns in patients with chronic venous insufficiency (CVI) in northwestern China.Methods: A total of 531 consecutive patients presented to the Department of Ultrasound in Xijing Hospital between September 2017 and July 2019 with lower extremity spider and varicose veins were analyzed according to the highest Clinical Etiology Anatomy Pathophysiology (CEAP) stage. Reflux time, mean diameter of great saphenous and small saphenous veins based on duplex ultrasound (DUS) findings were evaluated based on CEAP, Venous Clinical Severity ScoresVCSSand HASTI scoring.
Methods
A total of 531 consecutive patients presented to the Department of Ultrasound in Xijing Hospital between September 2017 and July 2019 with lower extremity spider and varicose veins were analyzed according to the highest Clinical Etiology Anatomy Pathophysiology (CEAP) stage. Reflux time, mean diameter of great saphenous and small saphenous veins based on duplex ultrasound (DUS) findings were evaluated based on CEAP, Venous Clinical Severity ScoresVCSSand HASTI scoring.
Results
There were 531 patients with a total of 766 limbs for the analysis53% males, with mean age of 58 years and mean body mass index (BMI) of 25.74. Overall 2.5%, 40.7%, 8.8%39%, 5.5% and 3% were of CEAP stage C1, C2, C3,C4, C5 and C6, respectively. 97% were of primary varicose veins and 3% secondary varicose veins. 56% with unilateral limb and 44% with bilateral limb involvement. A total of 2% of patients had superficial venous intervention, 17% wore compression stockings and 20% managed with medication. Previous deep vein thrombosis (DVT) was reported in 11% and major leg trauma in 14% of patients. Based on CEAP 1-6 stages, mean HASTI scores were as followed: 5.11 ± 5.80, 7.65 ± 5.20, 9.00 ± 8.50, 9.75 ± 7.11, 11.70 ± 4.22, 13.50 ± 5.22respectively (Table 1). HASTI score had a strong correlation with CEAP stage (r = 0.980, p < 0.001), and the differences in HASTI score at all levels of CEAP were statistically different (F = 6.372, p < 0.001) (Table 1). The VCSS of C1-6 levels were as followed: 1.73 ± 3.32, 3.45 ± 3.53, 5.65 ± 8.24, 6.86 ± 3.28, 12.87 ± 4.21, 16.71 ± 7.45, respectively (Table 1).VCSS score positively correlated with the CEAP score (r = 0.936, p < 0.001), and VCSS score at all levels of CEAP had a statistically significant difference (F = 58.1, p < 0.001) (Figure 4). A total of 567 (74%) limbs had venous reflux: 2.6%, 36.6%, 9%, 42.8%, 6% and 3% of C1-6 levels respectively. The mean diameter of GSV according to C1-6 was as followed: 6.12 ± 3.22 mm7.02 ± 2.82 mm, 8.22 ± 3.62 mm, 8.75 ± 4.12 mm, 9.07 ± 4.22 mm, 17.78 ± 4.52 mm, respectively. Patients with C5 and C6 had a statistically significant (p < 0.01) larger diameter compared to those with C4. The reflux time (RT) of the GSV was 4.62 ± 3.22s, 3.33 ± 2.82s, 3.08 ± 3.62s, 2.99 ± 4.12s, 3.48 ± 4.22s, 2.53 ± 4.52s, respectively. The RT was not statistically different between C1-6 stages (Table 1). (p > 0.05). The mean diameter of SSV was 3.91 ± 3.52 mm, 4.06 ± 2.92 mm, 4.57 ± 3.82 SMM, 4.28 ± 4.22 mm, 4.33 ± 4.62 mm, 6.01 ± 4.72 mm, respectively. The RT of SSV was 2.11 ± 3.00s, 1.98 ± 3.12s, 2.40 ± 3.82s, 2.20 ± 3.92s, 3.12 ± 3.92s, 2.44 ± 4.42s, respectively. Neither the diameter of SSV nor the RT according to C1-6 stages was statistically significant (Table 1). (diameter of SSV p> 0.05; RT p> 0.05).
Conclusion(s)
According to this cohort analysis, both the VCSS and HASTI correlated with CEAP. The higher the CEAP stage, the greater the VCSS and HASTI scores. Moreover, the mean GSV diameter correlated with progression of CEAP but RT of GSV did not. As for mean diameter of SSV and RT of SSV, neither correlated with CEAP stage.
Economic advantages of an advanced pneumatic compression device in a population of high-risk lymphedema patients with 2 infections
1Health Advances, LLC
2Niecko Health Economics LLC
3Cardiovascular Center Tufts Medical Center; Tactile Medical
Introduction, Objectives, and/or Purpose
On average, 10% to 25% of lymphedema (LED) patients experience infections (INFs) and INFs recur in one half of these patients. Previous studies have shown that INF is a prime driver of LED treatment costs. The initial phase of LED treatment usually consists of conservative therapy (CONS), including therapist-administered manual lymphatic drainage, multilayer bandaging, compression garments, decongestive exercises, and education on lifelong lymphedema management practices. The initial LED treatment phase may also include use of a pneumatic compression device (PCD). The subsequent maintenance phase of LED therapy is patient-administered. PCDs are often used during this phase to help patients manage their LED symptoms. This study examined a large private healthcare insurance dataset to examine whether use of a specific advanced PCD (FLX: HCPCS code E0652) reduced INF-related treatment costs compared with use of no PCD among LED patients who experienced 2 infections.
Methods
De-identified HIPAA-compliant commercial administrative claims data were analyzed from 20122016. Patients were first identified based on one inpatient or two outpatient primary or secondary LED diagnosis codes. Patients were then divided into 2 treatment groups: 1) CONS alone, or 2) CONS plus FLX. Propensity score matching was used to control for demographic and clinical variables. Primary or secondary diagnosis codes for cellulitis were used to enumerate INF episodes after initiation of the two types of treatment. Costs were calculated per patient per year (PPPY) for home health, emergency, inpatient, outpatient hospital, outpatient PT/OT, physician office, lab, and other service locations. Overall costs (excluding device purchase) and costs specific to infections were analyzed using a general linear model with gamma distribution and log link while controlling for age and gender. Distribution shape and transformation assessed by modified Park test and Box-Cox test, respectively.
Results
Among patients with 2 INFs, FLX was associated with a statistically significant lower INF-related per patient per year (PPPY) total cost of care compared with CONS, resulting in a savings of $8,625. The majority of this cost savings (>80%) was related to reduced inpatient hospital costs. (See Table 1 Results).
Conclusion(s)
The use of FLX in the high-risk LED population of 2 INF was associated with a statistically significant reduction in INF-related health expenditures.
Compression Following Sclerotherapy A Systematic Review
Imperial College London
Introduction, Objectives, and/or Purpose
Compression therapy following sclerotherapy is commonly used, though the evidence base for this is unclear; regular provision of compression following intervention represents an expenditure to the national health service. There is therefore a need for a comprehensive review of evidence to clarify the impact of compression therapy post-sclerotherapy to inform clinical practice.
Methods
A systematic review was performed. PubMed and EMBASE databases were searched up to 30th June 2019. Reference lists of shortlisted papers were searched for other relevant articles. Studies were included if they were reported in English and assessed comparisons between compression type and/or duration in adult patients undergoing both liquid and foam sclerotherapy for chronic venous disease. Study selection and reference search were performed independently by two reviewers (MT, SS).
Results
Nine studies were identified (seven RCTs, one non-randomised controlled trial, one cohort study, 29-120 patients) (Figure 1). Five studies focused on liquid sclerotherapy, three reported on foam sclerotherapy and the remaining study used both liquid and foam sclerotherapy. Studies had short term follow-up (range 4 weeks to 6 months) and reported on clinical outcomes (e.g. vessel disappearance, symptom resolution), patient satisfaction and quality of life, and side effects (e.g. post-sclerotherapy pigmentation, phlebitis). Patient compliance to compression regimens, when reported, was generally poor. Heterogenous comparisons and outcome measures precluded meta-analysis. In C1 patients undergoing liquid sclerotherapy, two studies showed that any duration of compression stockings (20-30 mmHg) significantly decreased number and size of vessels on visual inspection when compared to no compression but disagreed on its impact on post-sclerotherapy pigmentation. No difference was shown between 8-hours and 6-weeks of compression bandaging in C2 patients, but higher clinical success rates and lower thrombophlebitis rates were seen with stockings compared to bandaging. Another study disagreed, showing no significant difference in thrombophlebitis when comparing stockings against stockings plus bandaging. No significant difference in post-sclerotherapy pigmentation rates were seen between groups in both studies. In foam sclerotherapy of C2-6 patients, one study showed higher grade stockings (35 mmHg v.s. 23 mmHg) to significantly improve post-treatment symptoms such as pain from phlebitis and dysesthesia. However, there was no significant difference in clinical success rates or changes in quality of life in the three studies comparing compression duration.
PRISMA diagram showing the study selection process.
Conclusion(s)
Current literature suggests that compression following liquid or foam sclerotherapy may have beneficial effects in terms of clinical outcomes at short term follow-up. However, evidence is lacking regarding the type, class and length of compression hosiery or bandages as well as the duration for which compression should be applied following sclerotherapy. Further trials are required to assess these factors to guide the optimal management of post-sclerotherapy patients.
The global prevalence of Chronic Venous Disease (CVD)
Imperial College London
Introduction, Objectives, and/or Purpose
Chronic Venous Disease (CVD) is an important cause of patient morbidity however estimates of the global burden of CVD can be heterogenous. This review aims to provide an updated estimate of the global prevalence of CVD.
Methods
A systematic review through Ovid MEDLINE identified 2534 articles. Full text articles, available in English reporting point prevalence of CVD in general populations were included. The year each population was studied ranged from 1987-2015. Statistical analysis was performed through MetaXL.
Results
Twenty six articles were identified reporting the prevalence of CVD across 4 continents (Europe, Asia, North America, South America). Twelve utilised community surveys, eleven identified patients in primary care and three utilised electronic medical records. Average patient age ranged from 37.6 79.9 years. Overall pooled prevalence for each CEAP stage was: C0 (32.12%), C1 (27.93%), C2 (21.42%), C3 (17.74%), C4 (8.03%), C5 (1.41%), C6 (0.40%). The overall pooled prevalence of all CVD was 45.18% across all studies.
Conclusion(s)
CVD affects a significant proportion of the population globally however estimates are heterogeneous due to different study design. The global burden of CVD must be better characterised to optimise service provision and permit workforce planning for patients with different stages of CVD.
Presentation patterns in women with pelvic venous insufficiency differ based on age of presentation
1Center For Vein Restoration
2Center for Vascular Medicine
Introduction, Objectives, and/or Purpose
Introduction: The incidence and presentation patterns in women with pelvic venous insufficiency (PVI) at various ages is currently ill-defined. The purpose of this investigation is to determine if the types of pelvic/lower extremity signs, symptoms and interventions vary with age progression.
Methods
Data were prospectively collected at the Center for Vascular Medicines (CVM) electronic medical record system (NexGen Healthcare Information System, Irvine, California) and retrospectively analyzed. Patients were grouped into the following age categories: 20–29, 30–39, 40–49, 50–59 and greater than 60. Medical/Surgical co-morbidities, presenting pelvic and lower extremity symptoms, CEAP class and types of interventions were all assessed. Differences in treatment groups were analyzed utilizing chi square, analysis of variance and regression analysis with Graphpad Prism 8 statistical software (GraphPad Software Inc, La Jolla, California).
Results
From January 2015 to December 2018, 1190 women were treated for PVI. The average ages in each treatment group were the following: 26.94 ± 2.93 (n = 66), 35.92 ± 2.76 (n = 215), 45.54 ± 2.88 (n = 307), 55.04 ± 2.79 (n = 293) and 69.32 ± 6.12 (n = 309). The prevalence of PVI by age group was 5.55%, 18.07%, 25.80%, 24.62% and 25.97%. There were no differences in medical and surgical comorbidities. Differences in the prevalence of pelvic symptoms, dyspareunia, dysmenorrhea, vulvar varices, swelling, heaviness, restless legs, varicose veins and ulcers were observed across all age groups (p0.001). The prevalence of CEAP 0-2 is similar regardless of age, CEAP 3 progressively increases with age and CEAP 4-6 is predominantly observed in patients older than 50. Regression analysis indicated that with each decile increase in age, the incidence of leg symptoms increased (r2 = . 9239) with a reciprocal decrease in pelvic symptoms (r2 = . 5941). All intervention types were infrequent in twenty year olds. There was a linear increase in the incidence of stenting procedures with each decile increase in age. The incidence of ovarian vein embolization was similar across all age groups.
Conclusion(s)
The prevalence of PVI is lowest in patients in their twenties. Differences in pelvic and lower extremity symptoms were observed with increasing age groups. PVI and leg symptoms are reciprocally related with PVI decreasing and leg symptoms increasing with progression of age. Similarly, severe chronic venous insufficiency is primarily observed in patients older than 50 years of age. Finally, venous stenting progressively increases with each decile of age whereas the prevalence of ovarian vein embolization is similar regardless of age.
Sclerotherapy of Gluteal Venous Malformations for the Treatment of Sciatic Neuropathy: A Case Series
1University of Arkansas for Medical Sciences
2University of Washington Medical Center
Introduction, Objectives, and/or Purpose
1) To describe 4 patients presenting with symptoms of sciatic neuropathy that were found to have gluteal venous malformations on the affected side. 2) To describe successful treatment and follow-up of 4 patients with sciatic symptoms secondary to venous malformations treated with sclerotherapy using sodium tetradecyl sulfate under ultrasound and/or fluoroscopic guidance.
Methods
Four patients presenting with symptomatic sciatic neuropathy due to venous malformations surrounding the sciatic nerve in the gluteal region and/or thigh between the years 2014 and 2019 were retrospectively reviewed. There were 2 male and 2 female patients with a mean age of 49 years ranging from 44 to 69 years. Symptoms included lower extremity weakness and paresthesia, vaginal bulge with leg pain, thigh pain radiating to the calf and buttocks, and gluteal cleft pain radiating to the thigh. All patients were known to have chronic venous disease and a negative workup for spinal causes of neuropathy. Venous malformations were diagnosed on pre-procedure imaging workup including ultrasound and MRI, and were confirmed during procedural venography. All patients were treated by sclerotherapy using 3% sodium tetradecyl sulfate and coil embolization. Follow-up after treatment ranged from one month to three years. Successful treatment was defined as an improvement in symptoms by patient report.
Results
Symptoms were significantly improved or had completely resolved in all four patients at one month. Mean patient follow-up was 18 months ranging from 6 months to 3.4 years. Patient 1 has not reached one-year follow-up but reports an improvement in pain and neurologic symptoms at one-month follow-up. Patient 2 was lost to follow-up after eight months, but reported no further pain or neurologic symptoms at that time. Patient 3 reported no symptoms at one month and one-year follow-up. Patient 4, although initially asymptomatic at one month, had a return of symptoms at one year (consisting of left lower extremity pain, swelling and minor sensory and motor deficits). He underwent repeat sclerotherapy during three different sessions over three years to improve his symptoms or prevent them from worsening.
Venography of Patient 4 demonstrating left sciatic varices pre-sclerotherapy (black arrow).
Conclusion(s)
Patients with signs and symptoms of sciatic neuropathy should be considered for a vascular etiology after more common, degenerative causes have been ruled out. In the current literature, most patients found to have vascular etiology of sciatic neuropathy have been treated with surgical exploration. In these four cases, venography followed by sclerotherapy allowed for both the diagnosis and treatment with all four patients reporting at least a temporary relief of symptoms. Longer follow-up of this group will be required to determine the long-term benefit. This treatment merits further investigation as a non-surgical option for patients with sciatic neuropathy due to venous malformations.
Long term evaluation of the superficial vein reflux below the knee after varicose vein surgery
Introduction, Objectives, and/or Purpose
Using minimal invasive techniques in the treatment of varicose veins, the great saphenous vein (GSV) below the knee remains untreated. In this study we present our experience with radio frequency ablation (RFA) treatment of varicose veins with now more than 10 years of follow up and the changes over time of the reflux of the GSV below the knee.
Methods
Between 01/2007 and 12/2008 RFA was used in 60 patients with varicose veins, 352 patients were treated with ligation of the sapheno-femoral/-popliteal junction and stripping, out of them stripping above the knee was performed in 24 patients. For RFA ClosureFast® catheter from Covidien® was used. Compression stocking was used for 6 weeks after interventions. Patients received clinical exam one day after intervention, clinical exam and duplex sonography after 1 day, 1 week, 6 months and annually during follow up. Follow up ranged 1 month 12 years, mean follow up was 6.9 years.
Results
Technical success after RFA was 100%, recanalization occurred during follow up in 7/60 (12%). 9/60 (15%) patients developed recurrent varicose veins after RFA, 2/24 (8.3%) after stripping above knee and 40/328 (12%) after stripping of the entire GSV. Reflux in the GSV below the knee after RFA or stripping above knee was abolished in 82/84 (98%). 2/84 patients developed progress of the GSV insufficiency below knee with indication for intervention.
Conclusion(s)
In almost all patients the reflux of the GSV below knee was abolished during follow up, with no impact on the recurrence of varicose veins.
Imaging findings of Pelvic Venous Insufficiency in a Postural Orthostatic Tachycardia Syndrome Patient Population
1Mayo Clinic Arizona
2Vascular and Interventional Radiology Professionals
3AMITA Health Medical Group Heart and Vascular Institute
Introduction, Objectives, and/or Purpose
Chronic pelvic pain (CPP) is a major cause of disability in women that can have an unequivocally negative impact on quality of life. It is estimated that 40% of CPP is attributable to pelvic venous insufficiency (PVI, also called pelvic congestion syndrome). Reflux into the ovarian or internal iliac veins and/or obstruction of iliac vein outflow, as evidenced by CT and/or MRI studies, is thought to be the underlying cause of PVI. Patients with dysautonomic conditions, such as postural orthostatic hypertension (POTS), may have a decrease in blood return with upright posture (thoracic hypovolemia). A noted improvement in dysautonomia symptoms occurring in some patients treated for PVI was the genesis of this imaging review. The objectives of our multicenter patient cohort study are: 1) To evaluate the presence of left common iliac vein obstruction on imaging in patients with POTS 2) To determine the proportion of significant LCIV compression on imaging in this patient cohort compared to an age-matched control group 3) To determine the presence of ovarian vein insufficiency on imaging in patients with POTS
Methods
A 5 year retrospective chart review of patients with POTS was performed at two separate medical institutions. IRB approval was obtained at both sites. Cross sectional imaging, MR or CT was reviewed. Quantitative vascular analysis was performed by 2-3 separate radiologists at each site in order to determine percent stenosis of LCIV as the right common iliac artery crosses over at the bifurcation. The ipsilateral distal CIV was used as a reference. Significant stenosis was defined as LCIV compression greater than 50%, as described in the VIDIO trial. The presence of ovarian vein insufficiency, defined as greater than 5 mm, was also reviewed. The control group included healthy female patients aged 20-40 who had undergone CT imaging as part of a renal donor workup. The number of patients with significant LCIV compression were then quantified in both the POTS and the control group. Chi squared test was performed to determine differences between the POTS cohort and the control group.
Results
Cross sectional imaging of 237 patients with POTS was reviewed. 31/237 (13%) patients had MR imaging and the remainder of patients 206/237 (87%) had undergone CT of the abdomen and pelvis. 71/237 (30%) patients had less than 50% left common iliac vein compression (LCIV); 166/237 (70%) patients had more than 50% LCIV compression. In the control group of 25 patients, 38% had greater than 50% narrowing compared to 70% in the female POTS group. A Chi squared test rejects the hypothesis that significant iliac vein compression is independent of POTs at p < 0.005, with x2 = 10.56 and 1 degree of freedom. Of those patients who had positive findings of compression, only 9/166 (.05%) patients had imaging findings of ovarian vein insufficiency.
Conclusion(s)
A greater than 50% left common iliac vein stenosis was noted in 70% of our POTs patients, which was statistically significant. These observations indicate that the incidence of an iliac venous obstruction in this subgroup of patients is higher than in a normal patient population. Ovarian vein insufficiency was not seen as a contributory factor in this patient population. Our findings suggest that POTS patients who have symptoms of chronic pelvic pain should be evaluated for pelvic venous outflow lesions or reflux as a possible contributing factor. While our findings suggest that the impaired orthostatic return of blood from the lower body noted in POTS patients may be related to venous obstruction in the pelvis, more studies are needed to support this.
Potential relationship between Venous insufficiency and Orthostatic Hypotension
Vein Clinics of Lake county LLC
Introduction, Objectives, and/or Purpose
Background: Symptoms of Orthostatic Hypotension have been well-documented for decades, but identifying the cause is often elusive. While many cases are attributed to an autonomic dysfunction, drug side effects, and systemic diseases, there remain a significant number of cases where a clear etiology is not found. Aim: To evaluate postoperative impacts of ablative treatment of venous insufficiency on sit to stand decrease of systemic blood pressure (systolic or diastolic) and on increase in sit to stand heart rate, and to determine, its potential role in Orthostatic Hypotension.
Methods
We measured the degree of decrease in systolic BP, diastolic BP, as well as increase in heart rate associated with change of position from sit to stand. They were flagged as positive if the values from sitting to standing showed at least a 20 mmHg systolic drop, 10 mmHg diastolic drop, or 10bpm heart rate increase.
Results
Treatment of venous insufficiency involved ablation of truncal varicosities using Laser or Radiofrequency ablation procedures and chemical ablation using foam sclerotherapy to large residual varicosities. A total of 646 patients were selected based on the original orthostatic vital signs with 178 flagged as positive based on selection criteria. Of the 178 positive patients, 59 showed a Systolic drop of 20 mmHg or greater, 24 showed a Diastolic drop of 10 mmHg or greater, and 123 showed a rise in heart rate by 10bpm or greater. Data regression showed that after ablative vein treatments, the magnitude of drop in BP (systolic or diastolic), or increase in HR, were significantly reduced (systolic pressure (p 0.001), diastolic pressure (p 0.001), and heart rate spike (p 0.001).
Conclusion(s)
Our data strongly supports that ablative treatments playing potentially significant role in improving orthostatic vital signs. In this study positive patients, postoperatively, showed statistically significant improvement of their orthostatic vital signs. Although Orthostatic Hypotension can result from autonomic dysfunction or other systemic conditions, those with concomitant venous insufficiency may have a more dramatic blood pressure drops due to the large lower extremity venous reservoir. In such cases, venous assessment and treatment of venous insufficiency may offer a potential venue to patients with resistant orthostatic hypotension.
Reducing hyperpigmentation After Sclerotherapy (RHyAS): Preliminary results of a randomized, controlled, clinical trial
Sociedad Mexicana Angiologia y Cirugia Vascular, Society Vascular Surgery
Introduction, Objectives, and/or Purpose
Sclerotherapy is the most frequent procedure performed for the treatment of varicose veins, with a reported incidence of hyperpigmentation up to 30%, although a minor side effect, it is an important cause of patient dissatisfaction in a procedure that is mostly done for cosmetic purpose. We previously reported the results of a single centre, prospective, clinical trial showing that by using sulodexide, a drug with antithrombotic properties already used for the treatment of chronic venous disease, we could reduce the incidence of hyperpigmentation in patients after sclerotherapy. Trying to confirm this result, we underwent a new 2-year study with a larger population; herein we report the preliminary results.
Hyperpigmentation area 1 month after sclerotherapy
Methods
This is a prospective, multicentric, randomized, controlled, clinical trial, using a parallel-group design; so far including 584 patients with telangiectasia, reticular and/or varicose veins who were candidates for sclerotherapy, patients with saphenous vein reflux were excluded. 298 patients were assigned to group A who received a standard sclerotherapy protocol, and 286 patients to group B who received sulodexide 500 LSU/d, beginning 7 days prior to starting the standard sclerotherapy protocol and continued for 3 months. Polidocanol was used as a sclerosing agent following manufacturer-recommended dose and compression stockings were used in both groups for 7 days. In each patient, the area treated was photograph and follow up was done at 1 and 3 months using computer software to compare variables of incidence of pigmentation, the total area of pigmentation, skin-tone increase in pigmented area, vein disappearance and presence of major bleeding. a confidence interval of 95% was used.
Measurement of pigmented area and change of skin tone using computer software
Results
A total of 473 patients have a completed 3-month follow-up in 5 different vein centres whit similar demographics in both groups; 93% of participants were female with an average age of 43 years (19-69 years), the typical patient had a combination of different size of affected veins to be treated, of all participants telangiectasia(1 mm), was present in 85%, reticular veins(1-3 mm) in 97% and varicose (+3 mm) in 66%; n = 242 were included in group A and n = 231 in group B. The Incidence of pigmentation was 15% in group A vs 9% in group B (P= 0.001), group A develop an average area of pigmentations of 17.23% vs 11.58% in Group B at 1-month (p = 0.004) and persisted 10.4% vs 6.6% at 3 months (P = . 002). The skin-tone of pigmentation increased 18% compared to normal skin tone in group A compared to 15% in group B at 1 month (p= 0.02) and 14% in group A vs 9% in group B at 3-months. Overall vein disappearance was similar in both groups. There was no major bleeding reported in any group.
Patient with telangiectasia, reticular and varicose veins
Conclusion(s)
This preliminary analysis shows the benefit of using Sulodexide after sclerotherapy by reducing the incidence of hyperpigmentation, a smaller affected area and a less intense tone when it does appear (which favours a faster disappearance over time), without affecting vein clearance rate or increasing the risk of major bleeding. This finding is relevant because it increases patient satisfaction in a procedure that is most commonly performed in women who seek a cosmetic improvement.
Low concentration sclerotherapy (casonis method) and systemic effects on cytokines and immunoglobulins
1Vein Center Ippocrate
2University of Urbino
Introduction, Objectives, and/or Purpose
Sclerotherapy has wide applicability in treating venous disease at every stage of clinical disease. The various sclerosant drugs and formulations each have unique properties, utilities, and side effects. Sclerosants destroy the venous endothelium and possibly additional regions of the vein wall. After successful sclerotherapy and in the long term, the veins are transformed into a fibrous cord (sclerosis). The purpose of sclerotherapy is not to achieve thrombosis of the vessel per se, but definitive transformation into a fibrous cord. In recent years, sclerosing foam has been introduced in sclerotherapy with the goal of increasing the efficacy in the treatment of varicose veins Since the first reports on foam sclerotherapy, multiple studies have been conducted to determine the physical properties and behavior of foams. Several studies have characterized its effects on circulating blood cells and endothelial cells lining the vessel wall, but relatively little is known about their biological effects on the time-course release of inflammatory cytokines and chemokines after foam sclerotherapy. The aim of this study was to determine the efficacy and safety of the sclerosant polidocanol in foam form according to the patented Casonis method, using ad hoc diluted buffered solution at a low concentration from 0,05 to 0,10% of commercially available Polidocanol, analyzing the time-course of release of interleukins in blood.
Methods
Prospective observational study to assess efficacy/safety of Casoni foam sclerotherapy. Limbs of 12 patients affected by venous disorders were submitted to Casonis method foam sclerotherapy of the small reticular and telangectatic veins. Foam (median 20 mL) was injected with a 1:1 ratio and with a 30 G needle under vein viewer assistance. Clinical and color duplex ultrasound investigation was performed at T0 and in follow up every two months. Before treatment (T0) and 1 day (T1), 7 days (T7) and 30 days (T30) after the treatment, serum samples were assayed for 27 cytokines (IL-1, IL-1ra, IL-2, IL-4, IL-5, IL-6, IL-7, IL-8, IL-9, IL-10, IL-12 (p70), IL-13, IL-15, IL-17, bFGF, Eotaxin, G-CSF, GM-CSF, IP-10, MCP-1 (MCAF), MIP-1,MIP-1, PDGF-BB, RANTES, IFN-, TNF-, VEGF) using a multiple immunomagnetic assay. The levels of immunoglobulins were also tested The statistical analyses were performed using Friedman + Dunns Multiple Comparison tests.
Results
One (T1) and seven (T7) days post-treatment, most symptoms were significantly milder, especially pain and heaviness at T7 and at day 30 (T30). Ambulation, medical compression stocking stability/tolerability and skin texture were significantly better at T30. No clinical side effects were recorded in the group, even we treated with this method more than 1500 patients and the side effects rate (local or systemic) appears significantly reduced in comparison with the literature data. The levels of 22 out 27 cytokines resulted assayable in all serum samples, with exception of IL-2, IL-10, IL-15, GM-CSF and MCP-1/CCL2 which resulted undetectable. Any parameters analyzed herein resulted statistically different in T1 vs T0, suggesting that the Casonis method probably does not induce an endothelial or tissue damage able to lead a consistent inflammatory reaction. The levels of pro-inflammatory cytokines (IL-1, IL-12p70), the anti-inflammatory IL-1ra, the chemokine MIP-1/CCL4, and VEGF were significantly increased after seven days (T7) vs T0, suggesting the presence of a late response to the foam treatment. For all the other parameters, although no significant differences were reached, an interesting trend was observed among T0, T1 and T7, suggesting a temporarily inflammatory response at brief/mid term. There were no significant differences of cytokine levels between T7 vs T30, suggesting a limited long term induction of inflammatory reaction. Interestingly, IL-12 (a well known pro-inflammatory cytokine) show a time-dependent increase and release in serum, with significantly different levels at T7 and T30 vs T0. On the contrary, the IL-7 showed a time-dependent significant decrease starting from T1 to T30. For what concerns Immunoglobulin profiles, we revealed a significantly decreased levels at T30 vs T7 and T0, suggesting that the possible absence of immunogenic reactions induced by buffered-diluted Polidocanol solution of Casoni Method. Moreover, the aspecific time-dependent decrease of all Ig analysed suggests tho onset of a possible low-dose tolerance obtained by buffered-diluted Polidocanol solution of Casoni Method, probably mediated by modification of T and B lymphocyte population.
Conclusion(s)
Buffered-diluted Polidocanol solution of Casoni Method may represent an effective and safe sclerosing treatment. The rates of side-effects were lesser than other sclerotherapy methods. The efficacy to clear the small varicose veins and telengiectases with buffered-diluted polidocanol foam of Casoni Method seems to be more successful than with classic foam polidocanol, although it is early to declare the superiority of the Casoni method. Nevertheless, for the first time we demonstrated that buffered-diluted polidocanol foam sclerotherapy by Casoni Method was able to modulate the inflammatory and immunological responses. Although we need to confirm our data on a larger cohort of CVD patients, our results suggest that Polidocanol sclerotherapy of Casoni Method did not act solely at cell and tissue levels but also on biomolecular targets, modifying mid and long term immunological and inflammatory signaling in patients affected by chronic venous disorders.
90 ways to a lesion-specific saphenous vein therapy
Angioclinic Vein Centers Europe
Introduction, Objectives, and/or Purpose
Novel high-resolution ultrasound systems (16 32 MHz) allow new insights in venous anatomy, physiology and pathophysiology, in particular for small structures like vein valves and low-flow phenomena (B-flow mode). This study was performed to classify vein valve lesions in early stages according to their different morphology and function.
Methods
1300 consecutive patients, age 6 92 y., were examined with newest high-resolution ultrasound systems (16 23 MHz: Zonare One Pro, Mindray M9; Siemens Juniper 16 MHz, Vevo MD peak 32 MHz), with focus on the saphenous veins and their valves. Video loops of the intra- and epifascial system were recorded for evaluation by independent investigators.
Results
Three groups of vein valve lesions could be sonographically detected, obviously with totally different origins: First, embryonic defects showing commissural mismatch, incomplete or missing cusps. Relevant lesions were detected in 47% of candidates 6 8 years of age, comprising just one or two valves in 78% of the cases. They appeared in similar shape but enlarged in patients during adolescence (9 18 y.) and could be identified in age groups of 18 40 y., usually with larger diameters or focal eccentric bulging. Severity, due to physical reasons, mainly depends on the length of refluxive segments, correlating with the number of insufficient or missing valves in a row. A basic classification may be given by E1, E2, and E3 for one, two or there and more concerned valves in a row. A second detected mechanism was pressure-related valve decompensation, marked by progredient dilatation and loss of functional reserve. It was seen after the age of 25 y., mainly concerning terminal GSV valves or medial perforators (76%). A classification, again according to physical endpoints, could differentiate threatening (P1, functional reserve < 10%), temporary (P2) or permanent (P3) decompensation. A third mechanism was stasis-related valve degeneration, with a typical sonographic marker called persistent aggregates blocking the valve sinus: Stages 1 – 4 begin with minor limitations of cusp function (S1-3), gradually increasing unto aggregate-mediated cusp fixation and onset of reflux (S4). Stages S5 represents reflux with sclerotic cusp degression and finally (S6) total loss of valve structures. Stages S5-S6 correlate to a history of venous disease of at least 30 years. A fourth mechanism, phlebitis, was mainly detected secondary to pre-existent insufficiency and predominantly subclinical, marked by a thrombotic layer, periphlebitis or wall thickening (non-occlusive, T1, or occlusive, T2). The detected vein valve patterns were sufficient to explain the saphenous vein status unto the age of 40, while above 40 years of age interactions and superpositions of all effects increasingly blurred their true origin.
Conclusion(s)
High-resolution transcutaneous ultrasound allows identification of three different types of vein lesions related to insufficiency, even in preclinical stages. Supposing that GSV and SSV are regulated by at least 6 valves, each of them either being normal or relatable to one of the 12 named lesions patterns, there are 90 combinations, possibly requiring different approaches for therapy. Future leg vein analysis should be based on valve analysis instead of just quantifying reflux. Lesion-specific modalities for prevention and therapy now have to be evaluated.
A Bibliometric Survey of Journals Relevant to Venous Disease Management
University of Toronto
Introduction, Objectives, and/or Purpose
Introduction: Publications in scholarly journals are a foundation for researchers to disseminate their work and practitioners to support up-to-date patient care. Awareness of the character of such published material is of relevance to both groups. Whereas researchers may be targeting submissions to high impact or prestigious journals, practitioners are interested in efficient sourcing of quality, reliable information to guide practice. Measures of such activities are determined by bibliometric analysis of publication databases. This project aims to identify the scope of publications relevant to venous disease management (VDM) and its implications for the profession.
Methods
Major databases (Web of Science, Google and SCOPUS) were surveyed to identify the range of publications relevant to VDM. The topics, sources and relevance of the publications were noted along with recognized impact factors, citation indices and other parameters. A list of target journals was created from analysis of the top 100 articles in specified VDM topics. These journals were assessed for bibliometric parameters, total number of articles and articles specific to VDM. All results were collated and analyzed.
Results
The Web of Science database (Clarivate Analytics) was used to identify 13614 venous articles over 681 pages; of these, analysis of the top 100 articles revealed that the majority of work was presented in 11 journals (2 venous, 4 vascular surgery, 2 vascular medicine, 5 others). The venous journals (Phlebology and JVS Venous and Lymphatic Disease) showed ranking of 156/322 and 57/203 with citation scores of 1.41 and 1.64 with SJR of 0.596 and 0.635 and SNIP of 0.886 and 1.203 respectively. The other groups of journals showed variable scores. Of the targeted journals, Phlebology (96 articles/year) and JVS VLD (300 articles/year) published the most articles with relevant to VDM (100%). Of the others, venous content was 5 to 20%. The most frequent activities were scientific articles (50-66%), reviews (4-10%), editorials (10%), cases (12%) and other (18%). The topics were ablation (24%), thrombosis (16%), compression (16%), ulceration (10%), QoL (4%), venous practice (4%), basic science (12%) and other (14%).
Conclusion(s)
Of the targeted journals, 2 were dedicated to venous topics and serve as a primary source for environmental scanning or information on VDM for clinical practice. They have similar bibliometric characteristics. Other journals have limited content and variable parameters. Choice of journal for publication should be determined by potential audience rather than the journal itself.
The changing face of vascular procedural volume from a venous perspective
1Tufts Medical Center
2Cardiovascular Center Tufts Medical Center, Tactile Medical
Introduction, Objectives, and/or Purpose
There have been major shifts in arterial case volume in Medicare (CMS) patients with a 23% decline in the total of abdominal aortic aneurysm (AAA) repairs from 2002-2013, while the number of carotid procedures has been halved from 91,712 to 46,533. By contrast, lower extremity revascularization has increased by 13% during that period, predominantly due to a 37% increase in endovascular procedures. If sustained, these numbers may have major work force implications. To provide additional insight into total case volume of vascular specialists we sought to define the trends in the volume of three venous interventional procedures in the CMS population, as well as possible shifts in the specialties performing them.
Methods
The CMS database from 2012 through 2016 was queried to determine the number of all percutaneous venous procedures/year: endovenous thermal ablation (EVTA); insertion of an inferior vena cava filter (IVCF); and venous stenting (STENT). Also, specialty designations for vascular surgery (VS), radiology (RAD) and cardiology (CARD) were identified for the proportion of these three procedures performed
Results
From 2012 through 2016 there was a 48% increase in EVTAs, while STENT also increased moderately (18%) over a shorter interval. By contrast, IVCF declined 38% from 2012 to 2016 (Table 1). In 2016, VS performed a relatively comparable proportion of EVTAs to CARDS, while RAD performed the greatest percentage of IVCF and STENT procedures. See table.
Conclusion(s)
In contrast to two key arterial procedures, the volumes of two venous procedures (EVTA; STENT) in CMS patients have increased. In 2016 VS was the lead individual specialty for EVTA and 2nd for STENT. RAD has assumed a greater role in IVCF and STENT procedures. These observations may have important implications for the training of future vascular specialists, as well as for the medical device industry.
Relevance of Cosmetic or Functional Surgery for Varicose Veins in Elderly Patients
Riviera Veine Institut
Introduction, Objectives, and/or Purpose
Because of the evolution of life expectancy in western countries the demand of surgical procedures for cosmetic or functional concern is increasing in elderly population. We wanted to evaluate the relevance of the surgical treatment of varicose veins performed in our practice for cosmetic or functional indications in elderly patients.
Methods
We reviewed the results and side effects of the surgical procedures performed for varicose veins in patients over 80 years old in our institute during the last decade. We have excluded the cases of acute superficial thrombosis and the patients with C4, C5 and C6 CEAP class C classification.
Results
A total of 239 surgical procedures have been performed on 239 limbs in 158 patients from 80 to 97 yrs (average 83,2 yrs, median 83 yrs). The 239 limbs treated were classified C2 in 218 cases (91.2%) and C3 in 21 cases (8.8%) on the CEAP class C Classification. Symptoms were present in 70.3% of the cases. The patients were preoperatively under VKA or anti-platelet agent in respectively 2.5% and 5% of the cases. The hemodynamics assessment showed a reflux on the great saphenous vein in 124 cases (51.9%), on the short saphenous vein in 9 cases (3.8%), an absence of reflux on a saphenous axis in 54 cases (22.6%) and a recurrent reflux after stripping in 52 cases (21.8%). The surgical procedures consisted in a surgical or endovenous ablation of the saphenous vein with concomitant phlebectomy (18.4%), an ASVAL procedure (59.8%) or a redo surgery after stripping (21.8%). All surgeries were done under tumescent local anesthesia in an ambulatory fashion. A postoperative low molecular weight heparin treatment was prescribed at prophylactic dose in 45 cases (18.8%). The only complication observed was a lymphocele on the limb which was spontaneously resolved in 3 months. At one year a relief of the symptoms was observed in 85.1% of the cases and a cosmetic improvement in 91.6%.
Conclusion(s)
In our experience the performance of varicose veins surgery is relevant for the relief of cosmetic or functional concern in elderly patients because of the good ratio benefit/risk after a mini-invasive surgical procedure.
Reflux Patterns in Chronic Venous Disease A Systematic Review
Imperial College London
Introduction, Objectives, and/or Purpose
Venous reflux is implicated in the development of chronic venous disease (CVD). Symptoms and clinical signs of CVD have been linked to various patterns of reflux in the deep, superficial and perforator venous systems. A review of the evidence was undertaken to determine if a relationship exists between reflux patterns and clinical manifestations of CVD.
Methods
A systematic review was performed by searching two databases (Medline and EMBASE) from 1946 up to the end of June 2019. Reference lists of shortlisted papers were searched for other relevant articles. Studies were included if they were in English, include participants 16 years of age, and documented reflux patterns in at least two of the following: deep, superficial and/or perforating venous systems and related the patterns to clinical presentation or severity. Study selection and reference search were performed independently by two reviewers.
Results
21 studies were identified (17 cross-sectional, two cohort, two case-control studies) with a total of 14,099 participants (range 55 to 3,016). Studies observed reflux pattern relationships to CEAP clinical class, CVI grade according to the Basle classification (grades 1, 2, and 3 corresponding to CEAP clinical class C1, C4, and C5-6 respectively), risk of advanced CVD (e.g. skin changes, ulceration) and CVD progression. There were heterogenous descriptions of reflux patterns based on venous systems, venous segments, or specific vein reflux. Higher CEAP clinical classes (C4-6) were associated with a higher prevalence of superficial, deep and perforator reflux when compared to C1-3 participants, with four, two and three studies showing statistical significance for superficial, perforator and deep reflux, respectively. Pooled analysis, however, showed significant odds ratios (OR) for C4-6 disease when deep (OR 2.22, 95% CI 1.28-3.86) or perforator reflux (OR 2.48, 95% CI 1.90-3.25) were present (Figures 1-2), but not for superficial reflux (OR 1.90, 95% CI 0.63-5.76) (Figure 3). A regression model showed superficial (p < 0.001), perforator (p = 0.026) and deep perforator reflux (p < 0.001) to be significant factors for predicting clinical class. There was conflicting evidence as to whether combined reflux (defined as reflux in 2 systems) was associated with C4-6 disease, with three studies reporting significance and two studies dissenting. CVI grade was associated with higher prevalence of reflux in all deep and superficial segments, with one study showing significant OR when associating superficial (OR 9.83, 95% CI 6.25-15.45) and deep reflux (OR 3.31, 95% CI 2.07-5.30) to severe CVI. In two studies, higher CVI grade was also associated with combined reflux of the deep and superficial, and superficial and perforator systems. Only one study showed no difference in incompetence patterns between CVI classes. Univariate OR for developing venous ulceration was significantly associated to deep (OR 6.60, 95% CI 2.46-17.73) and combined reflux (OR 6.04, 95% CI 1.65-22.13). This was also seen for skin changes, with higher relative risk with common femoral, popliteal and great saphenous venous reflux. The highest risk of CVD progression was shown by two studies to be related to combined deep and superficial reflux.
Forest plot showing pooled odds ratio for C4-6 disease when deep (figure 1), perforator (figure 2) and superficial reflux (figure 3) is present.
Conclusion(s)
This study demonstrates that reflux pattern is a significant predictor of clinical class, and that higher CEAP stages are associated with a higher prevalence of superficial, deep and perforator reflux. Deep and combined reflux also appears to predict the onset the leg ulceration. However, the heterogeneous nature of the included studies is a limitation of this analysis.
Effect of Weight Loss on Body Composition, Metabolic Function and Immune Expression in Women with Lipede
1Laser Lipo and Vein Center Patricia
2Washington University School of Medicine
Introduction, Objectives, and/or Purpose
Introduction/Background: Lipedema is characterized by symmetrical subcutaneous enlargement of the arms and legs that spares the feet. Clinicians have noticed that disproportionate excess subcutaneous tissue in the legs of lipedema patients persists after weight loss. There are no controlled studies of the effects of weight loss and metabolism and body composition in lipedema patients. The purpose of this study was to 1) characterize the body composition, insulin sensitivity, adipose tissue biology, and immune function in women with lipedema, and compare these results with those obtained from BMI-matched women with obesity; and 2) determine the effect of 8%-10% diet-induced weight loss on the parameters listed above. The results from this study will provide important insights into the mechanisms responsible for lipedema and evaluate the efficacy of diet therapy in managing this disease.
Methods
Baseline testing of body composition using Dual Energy X-ray Absorptiometry (DEXA), Magnetic Resonance Imaging (MRI). Baseline metabolic assessment with the measurement of Intrahepatic Triglyceride, IHTG, content, Oral Glucose Tolerance Tests, OGTT, and insulin sensitivity with Euglycemic Insulin Clamp, EIC. Abdominal and femoral adipose tissue biopsies were collected for immune function. Patients were placed on a balanced diet to achieve 8-10% weight loss. After the weight loss achieved the body composition and metabolic studies were repeated.
Results
Prior to intervention, lipedema patients have a greater percentage body fat in their legs, lower IHTGs, lower glucose levels on OGTT and a greater insulin sensitivity measured by EIC compared to the age and BMI individuals. Distribution of vascular endothelial growth factor was between Lipedema and Obese individuals achieved total body fat loss and leg fat loss with 8-10% weight loss. The greater percentage of leg fat in the lipedema patient did not change. We also measured a differential distribution of vascular endothelial growth factor receptors (VEGFR-1,-2,-3) in adipocytes and the stromal vascular fraction (SVF) between the abdominal and femoral adipose depots. Women with lipedema show infiltration of mast cells and T cells in femoral adipose tissue compared to abdominal adipose depot.
Conclusion(s)
Patients with lipedema have a greater percent of fat in their legs and behave metabolically different than BMI-matched obese individuals without lipedema. Patients with lipedema can lose fat from their legs with weight loss, but the greater percent fat in the legs persists. There are VEGFRs and inflammatory cell changes in the subcutaneous tissue of lipedema. VEGFRs are important for adipose tissue function and homeostasis and the VEGFR changes might explain the remodeling and expansion observed in these populations.
Early Experience Using a Novel Metallic Tip Crossing Catheter for Venous Obstruction
St. Lukes Medical Center
Introduction, Objectives, and/or Purpose
Post thrombotic syndrome (PTS) is the most common and under appreciated complication of chronic deep venous thrombosis (DVT), occurring in at least 30% of patients with multisegmental DVT. After DVT, recanalization of the thrombosed veins is often incomplete, resulting in residual venous obstruction and damage to venous valves, leading to venous hypertension, which creates post thrombotic, fibrous obstructions or occlusions of the vein which manifest as PTS. Although venoplasty and stenting have a role in the treatment of these lesions, many chronic obstructions are recalcitrant and difficult to cross using catheters, which prevents treatment with interventional tools. Especially challenging obstructions are due to in-stent stenosis (ISS), which defy passage of catheters. The objectives of the current study is to 1) Utilize a unique metallic tipped, over the wire crossing catheter to cross challenging venous obstructions in the lower 2) Assess the safety of the crossing catheter 3) Evaluate the efficacy of the crossing catheter to enable subsequent endovenous therapy.
Methods
From October 2018 to June 2019, 9 patients (4 female, mean age 52 years old) with PTS of the lower extremities and chronic venous obstruction were treated using two types of FDA approved crossing catheters (abrasion tip (left) and blunt tip (right), see figures). Successful crossing is defined as crossing that enabled subsequent venoplasty with or without stenting. All patients were symptomatic with CEAP clinical scores ranging from 3 to 6. Lesions traversed multiple venous segments including the IVC, iliac, femoral, and popliteal. The lesion length was >15 cm for 7 of the 9 patients. All lesions were severe (> 50% stenosis) including 7 complete occlusions of which 6 were wire impassable. 3 cases included iliac ISS. The crossing catheter was used after standard catheters failed to cross. Access sites included popliteal (6), femoral (2), and tibial (1).
Abrasion Tip (left) and Blunt Tip (right) Crossing Catheters
Results
The crossing catheters successfully crossed lesions in 8 of the 9 patients enabling subsequent venoplasty and stenting. Two of the three obstructions due to ISS were crossed successfully. There were no instances of vein rupture and no other complications attributable to the crossing catheters.
Conclusion(s)
The blunt and abrasion tip crossing catheters appear to be well suited to cross challenging post thrombotic venous obstructions. Once a pilothole has been created with the crossing catheter, a guidewire may then be advanced across the lesion, followed by venoplasty and stenting to resolve the outflow obstruction. The catheter body has very strong columnar support and tolerates the application of strong manual forward force without buckling. The metallic tip, particularly the abrasion configuration, fully engages the fibrous venous lesion and disrupts it without losing traction within the lesion, thereby crossing and enabling endovenous therapy. There were no complications from the crossing catheters. This initial series demonstrates promising results with a safe, novel device. Further study is warranted in a venous registry, including patients with upper extremity and central venous obstruction.
Natural History of Calf Vein Thrombosis
Stony Brook Medicine
Introduction, Objectives, and/or Purpose
Present and examine the natural history of calf deep vein thrombosis (DVT) with robust and complete data that can be used as a pilot for future randomized trials.
Methods
Consecutive patients diagnosed with first episode of calf DVT were included in the study. All deep and superficial veins from the external iliac vein to the ankle were evaluated. Those with thrombus in the popliteal vein or higher, chronic luminal changes or documented past DVT were excluded. Anticoagulation was used depending on physician preference. Patients were followed with repeat bilateral lower extremity duplex ultrasound at 3, 6, 12, 18, 24, 30, and 36 months. Computed tomography angiography or ventilation perfusion scan were performed only in symptomatic patients. The outcome of the study is to measure proximal propagation, venous thromboembolism (VTE) recurrence, pulmonary embolism, and death over 36 months.
Results
There were 117 limbs in 104 patients. The mean age was 54 ± 7 years, ranging from 21 to 86 years. Of the 104 patients, 49 were male and 55 were female. Of the 117 limbs, 91 (91/117, 80%) were symptomatic. Unilateral calf DVT was found in 91 patients (91/104, 87.5%) and bilateral in 13 patients. The prevalence of thrombosis in the different veins was: peroneal (49/117, 41.8%), soleal (37/117, 31.6%), posterior tibial (32/117, 27.3%), gastrocnemius (26/117, 22.2%), and anterior tibial (2/117, 1.7%). Thrombus propagation to popliteal or more proximal veins occurred in 16 limbs (16/117, 13.6%). Of the limbs that had propagation, 37.5% originated in the peroneal vein (6/16), 25% in soleal (4/16), 31.2% in posterior tibial (5/16), 6.2% in gastrocnemius (1/16%), and 0% in anterior tibial (0/16). VTE recurred in the ipsilateral or contralateral limb in 12 cases (12/117, 10.2%). Of the 104 patients, 1.9% had a pulmonary embolism (2/104) and 8.6% died (9/104) within 36 months follow-up. Pulmonary embolism was uncommon and never fatal at initial presentation. Although 2 cases of pulmonary embolism were confirmed on imaging, 15 patients showed clinical signs of pulmonary embolism (15/104, 14.4%). Causes of death included cancer (4/9, 44.4%), myocardial infarction (3/9, 33.3%), stroke (1/9, 11.1%), and pulmonary embolism (1/9, 11.1%). No death occurred within 1 year of the initial study. Risk of mortality was 5.7% at 2 years (6/104) and 8.6% at 3 years (9/104).
Conclusion(s)
The incidence of proximal propagation was 13.6%. VTE recurrence occurred in 10.2%, pulmonary embolism in 1.9%, and death in 8.6%. Calf DVT in many patients has a benign outcome but it may have a significant impact in about 1 out of every 6 patients.
Women with stage 3 lipedema experience abnormal venoaterial reflex and neuropathy
TREAT Program
Introduction, Objectives, and/or Purpose
The venoarterial reflex (VAR) is a signal that exists in all tissue which serves as a form of communication between arteries and veins, indicating when to contract or expand depending on changes in posture. This prevents fluid from entering the extravascular system. Lipedema is a fat disorder which is characterized as fluid stagnating in the connective tissue of the body. Women with lipedema experience painful fat tissue and fluid on the lower extremities; the arms are less affected. Last year we investigated VAR among women with lipedema, and found that VAR impairment increases with stage. The progressiveness of the impairment suggests structural damage to the blood vessels or weakening of the peripheral nervous system. Many women with stage 3 lipedema complain of numbness in addition to pain; an attribute of neuropathy. The aim of this study is to establish further the trend of VAR impairment and to investigate the existence of neuropathy of women with late stage 2 and stage 3 Lipedema, which may indicate a relationship between the impairment of VAR and neuropathy. Objective 1: Perform venoarterial measurements for the fingers and toes of women with lipedema and controls. Objective 2: Analyze the results of the measurements and compare it among the existing data. Objective 3: Perform neuropathy test measurements for women with stage 2 and 3 Lipedema and analyze among this population
Overall hand ratio. Using the Wilcoxon signed rank test, each median of the groups were compared to the value of one. The controls, and Stage 1, 2, 3 were all significantly less than the value one.
Methods
At the Fat Disorders Research Conference in Baltimore Maryland April 12-14, 2019, we recruited 45 subjects for VAR measurements. An iphone app called iPhysioMeter was used to measure pulse volume (PV). The subject covered the camera and flash with the index finger and big toe for 60 seconds. Measurements were taken with the arm at heart level and to the side, and with the leg elevated and relaxed. The VAR was calculated as the PV of the limb down, over the PV of the limb up; normal VAR was determined as a ratio < 1. Difference among groups were calculated by Wilcoxon signed rank test. Alpha of < 0.05 was considered significant. 19 women with lipedema participated in the neuropathy test. DPNCheck device was placed behind the right ankle bone. The device sent electric pulses to the subject resulting in an amplitude and conduction velocity reading; which analyzed using the provided chart to determine neuropathy. More analysis will occur before the AVLS meeting in Phoenix in November 2019.
Overall feet ratio. Using the Wilcoxon signed rank test, each median of the groups were compared to the value of one. The controls, and Stage 1 and 2 were all significantly less than the value one. Stage 3 was not as explained by the p value.
Results
When combining the results from 2018 and 2019, comparison of blood volume when limbs were down compared with blood volume when limbse were up by paired t-tests displayed significance for hands and feet for all groups demonstrating a normal response when positions of the limbs are changed. Among all groups (controls lipedema Stages 1, 2, 3) the hands had median VAR ratios that were significantly < 1 and therefore were normal. The median VAR of the feet was also significantly < 1 for controls and women with lipedema Stages 1 and 2, but not for women with lipedema Stage 3 whose median VAR was not significantly < 1 and therefore was abnormal. The significant difference between the control group and Stage 3 supports that VAR worsens as the condition of lipedema does. Among the Lipedema 3 subjects roughly 37% had a VAR ratio above the value of 1. One of 4 women with Stage 2 lipedema had neuropathy by DPNcheck. Furthermore, out of the 15 participants with stage 3 lipedema, 12 had neuropathy which is 80% of the tested population.
Conclusion(s)
The results of the VAR study further supports last years findings in that VAR is abnormal in women with lipedema. These data suggest that women with lipedema do not have an abnormal VAR that causes lipedema but that as women progress in stage, the VAR can become abnormal worsening the disease. Moreover, the median hand VAR being normal for all groups supports that lipedema targets primarily the lower extremities. The neuropathy study for women with lipedema demonstrates that neuropathy may be a common occurrence for women with Stage 3 lipedema and therefore women with lipedema should be assessed for neuropathy. It can be hypothesized since neuropathy and abnormal VAR both occur in women with lipedema, that the impairment in the VAR of the blood vessels may be a nervous system issue rather than a structural one.
Figures, Graphics, and Tables
Neuropathy results. The table is divided by condition and the DPN check reading for each subject. Based on the reading, neuropathy is determined using the DPN check chart, subjects with neuropathy were assigned the value of 1, subjects without were assigned the value of 0.
VenaSeal versus Ablation with Endothermal Laser or Radiofrequency for Saphenous Vein Incompetence: a Comparison of Utilization of Adjunctive Phlebectomy (VenaSeal Value)
Lake Washington Vascular
Introduction, Objectives, and/or Purpose
Saphenous incompetence can be treated with endothermal (ETA) and non-endothermal non-tumescent ablation (NTNT) techniques. Tributary/branch treatment can be performed in a concomitant or staged fashion, with potential advantages to each approach. Considerations in terms of staged vs concomitant branch treatment is the overall cost of treatment of a limb and incidence of adverse events (AEs). In cases of staging where the branches regress to the point that they do not require treatment, or may be treated with sclerotherapy rather than phlebectomy, the total cost of treatment for that limb may be reduced1-5. The primary objectives of this study are to: 1. Compare the frequency of medically indicated phlebectomy and adjunctive procedures either in a concomitant or staged manner in limbs with GSV and/or SSV incompetence treated with either ETA (radiofrequency or laser ablation) or cyanoacrylate closure (CAC- VenaSeal Closure System). 2. Compare AEs unscheduled visits and unscheduled imaging exams between groups. 3. Compare the total cost of treatment of each limb including index and adjunctive procedures as well costs of unscheduled visits and imaging.
Methods
The study is a single site retrospective review of limbs with symptomatic vvs treated at a single site (six surgeons) from 10/2015-3/2019. CAC treatment was performed on 327 limbs. Excluded limbs included those treated for recurrent superficial thrombophlebitis and veins where the only treated vein was an ASV. A random sampling of 327 ETA-treated limbs (13% of all limbs treated with ETA during the study time period) was collected as the comparator group. Demographics, CEAP clinical class, revised Venous Clinical Severity Scores, and procedural details were recorded for each treated limb. AEs were collected from EMR and phone logs. Adjunctive procedures occurring concomitantly and/or up to six months following the index procedure were assessed. A cost analysis was performed which included costs of the index procedure, adjunctive procedures, unscheduled visits and non-routine imaging. Categorical variables were assessed with z-score or X2 analysis and numeric variables with t-tests.
Figure 2. Venaseal limbs.
Results
The VenaSeal group was older than the ETA group (mean age of 58 compared to 54, p < .001). The ETA group included 223 limbs treated with radiofrequency ablation and 104 treated with laser ablation. There were no other differences in demographic measures, veins treated (GSV, SSV, ASV), CEAP class and VCSS at presentation and at 3 months (Table 1). The ETA group was significantly more likely to undergo simultaneous phlebectomy (47.7% v. 6.1% of limbs, p < .001), and sclerotherapy (40.4% v. 6.7%, p < .001) compared to the CAC group. Bilateral leg treatment on one day occurred in 32.3% of the CAC group compared to 1.6% in the ETA group (p < .001).The need for additional phlebectomy and sclerotherapy at later timepoints was no different between the groups with 1.5% of ETA patients undergoing secondary phlebectomy compared to 2.8% of the CAC group (p = .28) and 14% of ETA patients undergoing secondary sclerotherapy compared to 19% of the CAC group (p = .10) as shown in Table 1, and Figures 1 and 2. Change in VCSS from the beginning to the end of treatment was the same comparing ETA and CAC groups (5.0+/−.39 v. 4.7+/−.31, p = .19). The ETA group had significantly more unscheduled visits (8.6% v. 3.4%, p = .005) and unscheduled ultrasounds (6.7% v.2.1%, p = .004). The proportion of limbs with adverse events were equal between the two groups (64 ETA v. 62 CAC, p = .84). Eight of the limbs treated with ETA had two AES, while all of the CAC limbs with AEs had only a single AE. Total number of AEs was 71 for the ETA group and 61 for the CAC group, but the nature of the AES was different. The ETA group had more thrombotic events (ETA: 5 calf and tibial vein DVTs, 14 thrombus extensions-EHIT v. CAC: 1 EHIT), wound and stocking complications (ETA: 26 v. CAC: 1) and nerve injuries (ETA 9 v. CAC 0) and the CAC group had more phlebitis of saphenous vein (ETA 4 v. CAC 16) and of branch varicosities (ETA 9 v. CAC 25) and hypersensitivity reactions (ETA 0 v. CAC 18). There was a trend toward an increase in AEs in limbs treated with phlebectomy in the ETA group (24% phlebectomy limbs v. 16% non-phlebectomy limbs, p = .07) but there was no increase in the CAC group with or without phlebectomy (p = .3). The incidence of AEs was not increased in patients where both limbs were treated in one day (p = .35), by which vein(s) were treated. The mean total cost of limb treatment was 6.7% higher in the VenaSeal group (mean $2485 +/− $67 v. $2328 +/− $49, p < .001). The cost of treatment per limb in patients with AEs compared to those without AEs was significantly higher in the ETA group (mean $2482 +/− $107 v. 2291+/− $54, p = .002) but not in the VenaSeal group (mean $2559 +/− $143 v. $2468+/− $76, p = .298 v. $2468+/− $76).
Conclusion(s)
The VenaSeal patients were similar to the ETA group with the exception that they were older. Adjunctive procedures were more commonly performed in limbs being treated with ETA compared to CAC. The performance of staging in most VenaSeal patients did not increase the need for secondary procedures at a later date compared to the ETA patients. Despite having fewer adjunctive procedures, the VenaSeal group had a similar improvement in VCSS compared to the ETA group. Both groups had equal numbers of adverse events, but the types of events were different. ETA patients were more likely to have unscheduled visits and imaging, and adverse events in this group increased the cost of care. Overall cost of care was somewhat higher in the VenaSeal group.
The Anterior Accessory Great Saphenous Vein presents with significant morbidity and is not a red headed step child
1Indiana Vascular Associates, LLC
2Vein Clinics of America
3Purdue University
Introduction, Objectives, and/or Purpose
Background Access to vein care has become restricted to few common patterns. This study was designed to investigate frequency and prevalence of Anterior Accessory Great Saphenous Vein (AAGSV) pathology compared to Great Saphenous Vein (GSV) reflux in the American Vein & Lymphatic Society PRO Vein Registry.
Methods
Methods We analyzed data for all 1st and 2nd encounters for unique patients entering a vein practice. We pulled patient specific features of age, sex, body mass index (BMI), clinical class of Clinical Etiology, Anatomy, and Pathophysiology classification (CEAP) scores, revised Venous Clinical Severity Scores (rVCSS), presence of superficial thrombotic events, evidence of prior surgical intervention, and duplex values for each limb. Data was further scrutinized according to duplex pathology, removing patients with normal studies and those with deep vein thrombotic events. We compared patients with primary reflux patterns vs. patients with prior intervention and specific subgroups with AAGSV reflux, GSV reflux above the knee, and combined AAGSV and GSV reflux above the knee.
Results
Results There were 6836 unique patients with Duplex patterns of either AAGSV or GSV above the knee or both AAGSV/GSV in either primary reflux disease or prior intervention. Of the 6836 patients, 2604 had recorded scores for both CEAP and rVCSS, representing 2664 patient limbs in the final data set. AAGSV was proportionately more common among those with primary reflux disease (78/563 vs. 209/2101, p < 0.01). Patients with primary reflux disease demonstrated a significantly higher rVCSS (6.95 vs. 6.10, p < 0.01) than those with prior intervention. Patients with primary reflux disease also demonstrated a significantly higher incidence of more advanced (C4 and above) CEAP scores (43.1% vs. 24.8%, p < 0.0001) than those with prior intervention. Patients with primary reflux disease demonstrated a significantly higher rVCSS (6.95 vs. 6.10, p < 0.01) than those with prior intervention. The mean rVCSS score for GSV patients (7.22) was also significantly higher than that of AAGSV patients (5.63, p < 0.01). The incidence of superficial vein thrombosis for the AAGSV patients (6.41%) was significantly higher than that of the GSV patients (2.17%, p < 0.05). Subjects with prior intervention shared no significant difference in age, gender proportions, mean BMI, nor average rVCSS. Surprisingly the proportion of AAGSV limbs with thrombotic events (12.9%) was significantly higher than that for GSV (2.7%, p < 0.01).
Conclusion(s)
Conclusions Anterior accessory great saphenous vein reflux is common and carries similar morbidity to great saphenous vein reflux in primary disease and in patients with prior superficial intervention. The alarming presence of superficial vein thrombosis in AAGSV pattern raises concerns as payers restrict access to care for this all too common anatomic presentation.
Thromboprophylaxis for varicose vein surgery A Brazilian national survey
1Clínica de Veias
2Clinica Villas Boas
3Clínica de Veias, Hospital de Base do DF
4UERJ
Introduction, Objectives, and/or Purpose
Introduction: Venous thromboembolism is rare following varicose vein surgery, but uncertainty about its incidence combined with a lack of evidence-based clinical guidelines regarding thromboprophylaxis has led to doubt about best practice. We conducted a national survey to investigate current practice among Brazilian vascular surgeons.
Methods
An anonymous online questionnaire was emailed to all members of the Brazilian Society of Angiologistis and Vascular Surgeons (SBACV) and the Vascular Forum whatsapp group in Brasil.
Results
Response rate was 15% (394). With regard to procedure type, 30,5% of respondents use only endovenous techniques and 18,1% use a combination of open and endovenous. Formal duplex imaging on all patients is obtained by 92,6%. With regard to VTE prevention, 31,1% always give thromboprophylaxis. For those who give it selectively, a variety of factors were considered as risks. Pharmacological agents used are enoxaparin in 85,1% of cases, and 47,1% use a single dose (either 20/40/60 mg). DOACS have been used off label in 11,7% of the cases and rivaroxaban was the most chosen in 94,7%. If patients are taking contraceptive pills, this is continued by 62,1% of respondents. Routine post procedure duplex imaging is carried out by 10,5% of recipients and 97,4% review patients clinically. Moreover, 74,4% of respondents claim to know their post- operative VTE rate and the main varies from 0% (25,7%), 1% (49,8%) 2 a 5% (13,2%) with 4,1% reported mortality cases.
Conclusion(s)
The majority of respondents use thromboprophylaxis periprocedurally for varicose vein surgery, mainly enoxaparin in a single dose. DOACS heve been used off label in 11,7% of the cases. VTE and death rates reported are low but the true incidence may be higher.