Pressure and stiffness of a new air-inflated compression wrap.

OBJECTIVE: To report pressure and stiffness, in healthy volunteers, of a new compression device with an air bladder inflated by a pump to regulate pressure. METHODS: The device was applied to 60 legs of 30 volunteers and set to exert different pressures of 20-50 mmHg. The exerted pressure was measured in supine and standing positions and during simple physical exercises; static stiffness index, dynamic stiffness index, and walking pressure amplitudes were calculated. RESULTS: The exerted pressure showed a good correlation with the expected pressure at each pressure range. The stiffness indices were >10 mmHg in the range of inelastic materials. The device was considered very easy to apply and use by the testing researchers. CONCLUSIONS: The device stiffness is in the same range as the inelastic bandages. Consequently, similar hemodynamic effectiveness could be expected but must be proved. Unlike inelastic bandages, this device was easy to apply and use.

The Anterior Saphenous Vein. Part 2. Anatomic considerations in normal and refluxing patients. Endorsed by the American Vein and Lymphatic Society, the American Venous Forum and the International Union of Phlebology.

BACKGROUND: The term Anterior Accessory of the Great Saphenous Vein suggest this is a branch tributary vein despite this vessel's anatomic features of a truncal vein. A multisocietal group suggested to designate this the Anterior Saphenous Vein (ASV). This study was aimed to evaluate its ultrasound anatomy in normal and varicose limbs. METHODS: The clinical anatomy of the ASV was evaluated by narrative review of the literature. Additionally, the course of the ASV was evaluated in 62 limbs with no evidence of venous disease and 62 limbs with varicosities. RESULTS: The ASV length, patterns of origin and termination are reported in both normal and patients with varicose veins. Discussion of the patterns is supported by the narrative review of the literature. CONCLUSIONS: The ASV must be considered a truncal vein and its treatment modalities should be the same that for the great and small saphenous veins rather than a tributary vein.

The anterior saphenous vein. Part 3. Systematic review of the literature and payor coverage policies. Endorsed by the American Vein and Lymphatic Society, the American Venous Forum and the International Union of Phlebology.

OBJECTIVE: The objective of this study is to systemically review the literature on Anterior Saphenous Vein (ASV) reflux treatment and insurance impediments to treatment coverage. METHODS: A literature search was performed using a PRISMA framework. In addition, a cross-sectional analysis of insurance policies for ASV treatment was evaluated. RESULTS: Published evidence and treatment considerations in the literature for ASV treatment are discussed. In 155 of 226 (68.6%) insurance policies reviewed coverage of ASV ablation was allowed while 62/226 (27.4%) did not specify coverage and 9/226 (4.0%) specified ASV treatment was not covered. Of the 155 that provide ASV coverage, 98 (62.2%) provide coverage with criteria such as requiring prior treatment of the great saphenous vein. CONCLUSIONS: Vein treatment experts should continue to advocate to insurance carriers to update their varicose vein treatment policies to reflect the substantial clinical evidence so that patients with ASV reflux can be appropriately treated.

The anterior saphenous vein. Part 4. Clinical and technical considerations in treatment. Endorsed by the American Vein and Lymphatic Society, the American Venous Forum, and the International Union of Phlebology.

BACKGROUND: The decision to treat a refluxing anterior saphenous vein (ASV) should be a clinical decision based on the assessment on the ASV's contribution to patient's signs and symptoms. Once the decision to treat has been made, there are anatomic, clinical, and technical considerations in treatment planning. METHODS: Clinical scenarios were discussed by a panel of experts and common anatomic, clinical, and technical considerations were identified. RESULTS: There are unique clinical considerations such as whether both the great saphenous vein (GSV) and ASV should be concomitantly treated, if a normal ASV should be treated when treating a refluxing GSV and when and how to treat the associated tributary varicose tributaries. Being aware of the anatomic, clinical, and technical considerations allows development of a treatment plan that optimizes long-term outcomes in patients with ASV reflux. CONCLUSIONS: Ultimately the treatment plan should be tailored to address these types of variables in a patient-centered discussion.

The anterior saphenous vein. Part 3. Systematic review of the literature and payor coverage policies. Endorsed by the American Vein and Lymphatic Society, the American Venous Forum, and the International Union of Phlebology.

OBJECTIVE: The objective of this study is to systemically review the literature on Anterior Saphenous Vein (ASV) reflux treatment and insurance impediments to treatment coverage. METHODS: A literature search was performed using a PRISMA framework. In addition, a cross-sectional analysis of insurance policies for ASV treatment was evaluated. RESULTS: Published evidence and treatment considerations in the literature for ASV treatment are discussed. In 155 of 226 (68.6%) insurance policies reviewed coverage of ASV ablation was allowed while 62/226 (27.4%) did not specify coverage and 9/226 (4.0%) specified ASV treatment was not covered. Of the 155 that provide ASV coverage, 98 (62.2%) provide coverage with criteria such as requiring prior treatment of the great saphenous vein. CONCLUSIONS: Vein treatment experts should continue to advocate to insurance carriers to update their varicose vein treatment policies to reflect the substantial clinical evidence so that patients with ASV reflux can be appropriately treated.

The anterior saphenous vein. Part 2. Anatomic considerations in normal and refluxing patients. Endorsed by the American Vein and Lymphatic Society, the American Venous Forum, and the International Union of Phlebology.

BACKGROUND: The term Anterior Accessory of the Great Saphenous Vein suggests this is a branch tributary vein despite this vessel's anatomic features of a truncal vein. A multisocietal group suggested to designate this the anterior saphenous vein (ASV). This study was aimed to evaluate its ultrasound anatomy in normal and varicose limbs. METHODS: The clinical anatomy of the ASV was evaluated by narrative review of the literature. Additionally, the course of the ASV was evaluated in 62 limbs with no evidence of venous disease and 62 limbs with varicosities. RESULTS: The ASV length, patterns of origin and termination are reported in both normal and patients with varicose veins. Discussion of the patterns is supported by the narrative review of the literature. CONCLUSIONS: The ASV must be considered a truncal vein and its treatment modalities should be the same that for the great and small saphenous veins rather than a tributary vein.

The clinical and economic impact of chronic venous insufficiency-associated lymphedema and the prevalence of persistent edema after venous intervention.

OBJECTIVES: To determine the demographics, outcomes, and healthcare utilization of patients with chronic venous insufficiency-associated lymphedema (CVI-LED) and the prevalence of lymphedema-specific therapy use after venous intervention. METHODS: The IBM MarketScan Commercial and Medicare Claims Databases were examined for patients with CVI-LED. Patient demographics and the use of lymphedema-specific therapy before and after venous intervention were collected. RESULTS: Of 85,601 LED patients identified, 8,406 also had a diagnosis of CVI. In the CVI-LED group, 1051 underwent endovenous ablation or venous stent placement. The use of lymphedema-specific therapy before and after venous intervention was 52% and 39%, respectively (p < .05). The mean time of initiation of LED-specific therapy following venous intervention was 265 days after ablation and 347 days after stent placement. CONCLUSION: Treating venous hypertension improves certain venous-related signs and symptoms of CVI. However, a significant proportion of patients have persistent edema which may reflect underlying, sub-optimally treated LED.

The anterior saphenous vein. Part 1. A position statement endorsed by the American Vein and Lymphatic Society, the American Venous Forum, and the International Union of Phlebology.

BACKGROUND: There is a lack of clarity regarding the terminology of the anterior accessory saphenous vein (AASV) that can impact treatment outcomes. Although use of the word "accessory" implies that the vein is a superficial tributary, evidence supports its role as a truncal vein, similar to the great and small saphenous veins, and warranting a change in terminology. METHODS: A multisocietal panel was convened by the American Vein and Lymphatic Society (AVLS), the Union International of Phlebology (UIP), and the American Venous Forum (AVF). The group was charged with reviewing the existing anatomic and clinical literature pertaining to the term "anterior accessory saphenous vein" and to consider the need for alternative terminology. CONCLUSION: Based on the insights gathered from the literature review and extensive discussions, the panel recommends changing the terminology such that the "anterior accessory saphenous vein" (AASV) now be designated the anterior saphenous vein (ASV).

Effect of junctional reflux on the venous clinical severity score in patients with insufficiency of the great saphenous vein (JURY study).

OBJECTIVE: Effective treatment options are available for chronic venous insufficiency associated with superficial venous reflux. Although many patients with C2 and C3 disease based on the CEAP (Clinical-Etiological-Anatomical-Pathophysiological) classification have combined great saphenous vein (GSV) and saphenofemoral junction (SFJ) reflux, some may not have concomitant SFJ reflux. Several payors have determined that symptom severity in patients without SFJ reflux does not warrant treatment. In patients planned for venous ablation, we tested whether Venous Clinical Severity Scores (VCSS) are equivalent in those with GSV reflux alone compared with those with both GSV and SFJ reflux. METHODS: This cross-sectional study was conducted at 10 centers. Inclusion criteria were: candidate for endovenous ablation as determined by treating physician; 18 to 80 years of age; GSV reflux with or without SFJ reflux on ultrasound; and C2 or C3 disease. Exclusion criteria were prior deep vein thrombosis; prior vein ablation on the index limb; ilio-caval obstruction; and renal, hepatic, or heart failure requiring prior hospitalization. An a priori sample size was calculated. We used multiple linear regression (adjusted for patient characteristics) to compare differences in VCSS scores of the two groups at baseline, and to test whether scores were equivalent using a priori equivalence boundaries of +1 and -1. In secondary analyses, we tested differences in VCSS scores in patients with C2 and C3 disease separately. RESULTS: A total of 352 patients were enrolled; 64.2% (n = 226) had SFJ reflux, and 35.8% (n = 126) did not. The two groups did not differ by major clinical characteristics. The mean age of the cohort was 53.9 ± 14.3 years; women comprised 74.2%; White patients 85.8%; and body mass index was 27.8 ± 6.1 kg/m2. The VCSS scores in patients with and without SFJ reflux were found to be equivalent; SFJ reflux was not a significant predictor of VCSS score; and mean VCSS scores did not differ significantly (6.4 vs 6.6, respectively, P = .40). In secondary subset analyses, VCSS scores were equivalent between C2 patients with and without SFJ reflux, and VCSS scores of C3 patients with SFJ reflux were lower than those without SFJ reflux. CONCLUSIONS: Symptom severity is equivalent in patients with GSV reflux with or without SFJ reflux. The absence of SFJ reflux alone should not determine the treatment paradigm in patients with symptomatic chronic venous insufficiency. Patients with GSV reflux who meet clinical criteria for treatment should have equivalent treatment regardless of whether or not they have SFJ reflux.

The anterior saphenous vein. Part 1. A position statement endorsed by the American Vein and Lymphatic Society, the American Venous Forum, and the International Union of Phlebology.

BACKGROUND: There is a lack of clarity regarding the terminology of the anterior accessory saphenous vein (AASV) that can impact treatment outcomes. Although use of the word "accessory" implies that the vein is a superficial tributary, evidence supports its role as a truncal vein, similar to the great and small saphenous veins, and warranting a change in terminology. METHODS: A multisocietal panel was convened by the American Vein and Lymphatic Society (AVLS), the Union International of Phlebology (UIP), and the American Venous Forum (AVF). The group was charged with reviewing the existing anatomic and clinical literature pertaining to the term "anterior accessory saphenous vein" and to consider the need for alternative terminology. CONCLUSIONS: Based on the insights gathered from the literature review and extensive discussions, the panel recommends changing the terminology such that the "anterior accessory saphenous vein" (AASV) now be designated the anterior saphenous vein (ASV).

The anterior saphenous vein. Part 4. Clinical and technical considerations in treatment. Endorsed by the American Vein and Lymphatic Society, the American Venous Forum, and the International Union of Phlebology.

BACKGROUND: The decision to treat a refluxing anterior saphenous vein (ASV) should be a clinical decision based on the assessment on the ASV's contribution to patient's signs and symptoms. Once the decision to treat has been made, there are anatomic, clinical, and technical considerations in treatment planning. METHODS: Clinical scenarios were discussed by a panel of experts and common anatomic, clinical, and technical considerations were identified. RESULTS: There are unique clinical considerations such as whether both the great saphenous vein (GSV) and ASV should be concomitantly treated, if a normal ASV should be treated when treating a refluxing GSV and when and how to treat the associated tributary varicose tributaries. Being aware of the anatomic, clinical, and technical considerations allows development of a treatment plan that optimizes long-term outcomes in patients with ASV reflux. CONCLUSION: Ultimately the treatment plan should be tailored to address these types of variables in a patient-centered discussion.

Clinical Impact of Severe Obesity in Patients with Lymphoedema.

OBJECTIVE: With the rate of obesity increasing worldwide, patients with lymphoedema with and without a concomitant diagnosis of severe obesity (SO) were compared in regard to their baseline demographics, health related characteristics, treatment plans, and patient outcomes. METHODS: This was a retrospective observational cohort study. The IBM MarketScan database was examined (2013 - 2019) for patients with a new diagnosis of lymphoedema. Of 60 284 patients with lymphoedema identified, 6 588 had SO defined by a body mass index > 40 kg/m2. The demographics and other characteristics of SO were compared with patients with lymphoedema without SO. RESULTS: SO and lymphoedema diagnosis increased two fold from 2013 to 2019. The lymphoedema SO+ group was younger (57.8 vs. 60.8 years, p < .001) and with a higher proportion of men (37.7% vs. 24.9%, p < .001) than the lymphoedema SO- group. More comorbidities were observed in the lymphoedema SO+ group than the lymphoedema SO- group: diabetes 46.0% vs. 24.9 % (p < .001), heart failure 18.3% vs. 7.4% (p < .001), hypertension 75.0% vs. 47.6% (p < .001), and renal disease 24.8% vs. 11.9% (p < .001). Use of diuretics in the lymphoedema SO+ group was greater: 57.6% vs. 38.0% (p < .001). Patients with lymphoedema SO+ had higher risk of cellulitis: 34.5% vs. 13.5% (p < .001). Specific lymphoedema treatment was given more often to lymphoedema SO-: 66.3% vs. 64.3% (p = .003). This was significant for manual lymphatic drainage (46.6% vs. 40.0%; p < .001) and physical therapy (55.4% vs. 51.6%; p<.001), but not for compression garments (18.2% vs. 17.7%; p = .38). However, more patients with lymphoedema SO+ received pneumatic compression device treatment: 20.9% vs. 13.7% (p < .001). CONCLUSION: There was an increase in SO associated lymphoedema. Patients with lymphoedema SO+ have over a two and half fold increase in cellulitis incidence, with a significant increase in medical resource use and cost. Despite this, patients with lymphoedema and SO receive less specific therapy such as compression, which has proven to reduce cellulitis incidence.

Chameleon™ PTA balloon catheter: A single device in managing thrombosed AV access.

Thrombectomy is a common procedure for maintenance of arteriovenous (AV) access and is critical to prolong access life. Techniques for performing thrombectomy are incredibly diverse, ranging from open surgical procedures to percutaneous interventions. Percutaneous interventions include a combination of thrombectomy devices to clear the thrombus and balloon angioplasty to treat the underlying lesion. In this case report we describe a novel technique using a single device, the Chameleon™ PTA balloon catheter (Medtronic, Minneapolis, MN) balloon catheter, to safely and efficiently perform a percutaneous intervention.

Immediate and delayed complications of inferior vena cava filters.

OBJECTIVE: Inferior vena cava (IVC) filter placement has increased dramatically in the past two decades. However, literature supporting the efficacy of these devices has been limited and controversial. In the present study, we have evaluated the predictors and rates of technical complications after IVC filter insertion in a large national database. METHODS: The Vascular Quality Initiative registry was explored (January 2013 to December 2020). Immediate complications were defined as venous injury requiring treatment, filter misplacement (failure to open, deployed >20 mm from intended site or in wrong vein, embolized to the heart), angulation >20°, and insertion site complications. Delayed complications were defined as migration, angulation >15°, fracture, caval and/or iliac thrombosis, filter thrombus, fragment embolization, and perforation. The Pearson χ2 test was used to compare the baseline characteristics between the patients who had developed immediate and/or delayed complications and those who had not. The predictors of these complications were evaluated using multivariable logistic regression, Cox proportional hazard regression, and Kaplan-Meier survival analysis. RESULTS: A total of 14,784 patients were included in the present analysis, with a median follow-up of 11 months (interquartile range, 4-16 months). The rate of immediate and delayed complications was 1.8% and 3.1%, respectively. Angulation (1.2%) was the most common immediate complication, and filter thrombosis (1.6%) was the most common delayed complication. Compared with the patients with no immediate complications, those with immediate complications were more likely to have had abnormal anatomy (6.0% vs 1.7%; P < .001) and a landing zone other than infrarenal (7.0% vs 4.2%; P = .02). Compared with their counterparts, those with delayed complications were less likely to have received statins (21.0% vs 29.5%; P = .006) and were more likely to have a family history of venous thromboembolism (8.0% vs 5.1%; P = .047). Logistic regression analysis revealed that renal vein visualization was associated a 50% reduction (adjusted odds ratio [aOR], 0.50; 95% confidence interval [CI], 0.27-0.92; P = .027) in the odds of immediate complications and female sex and abnormal anatomy were associated with a 41% (aOR, 1.41; 95% CI, 1.08-1.85; P = .013) and 244% (aOR, 3.44; 95% CI, 1.66-7.16; P < .001) increase in the odds of immediate complications, respectively. Immediate (P = .21) and delayed (P = .51) complications did not result in increased mortality. CONCLUSIONS: The immediate and delayed IVC filter complication rates were 1.8% and 3.1%, respectively, but the occurrence of complications was not associated with increased mortality. Female sex was associated with an increase in the development of immediate complications. The incidence of immediate complications might be mitigated if advanced imaging were used for renal vein visualization before IVC filter deployment. Delayed complications might be avoided if IVC filter retrieval were performed in a timely fashion and institutional retrieval protocols were optimized.

Routine use of concurrent fluoroscopic imaging during superficial endovenous interventions: A position statement of the International Union of Phlebology, the Australasian College of Phlebology, the Australia and New Zealand Society for Vascular Surgery, the American Venous Forum, the American Vein and Lymphatic Society, the European College of Phlebology and the Interventional Radiology Society of Australasia.

International evidence-based guidelines recommend preoperative duplex ultrasound mapping in the assessment of chronic venous disease, and concurrent ultrasound imaging to guide superficial endovenous interventions such as endovenous laser ablation, radiofrequency ablation, cyanoacrylate adhesive closure, and sclerotherapy (ultrasound-guided sclerotherapy). Other imaging modalities such as venography, alone or in combination with computed tomography scan or magnetic resonance imaging, may be included in the preoperative assessment of a small and select group of patients to exclude central venous obstruction, certain deep venous pathologies, pelvic origin extrapelvic varices, and complex vascular malformations. The signatory scientific and medical societies recommend against the routine use of fluoroscopy and other radiation-based imaging in the investigation and treatment of superficial venous disease.

Routine use of concurrent fluoroscopic imaging during superficial endovenous interventions: A position statement of the International Union of Phlebology (UIP), the Australasian College of Phlebology (ACP), the Australia and New Zealand Society for Vascular Surgery (ANZSVS), the American Venous Forum (AVF), the American Vein and Lymphatic Society (AVLS), the European College of Phlebology (ECoP) and the Interventional Radiology Society of Australasia (IRSA).

International evidence-based guidelines recommend preoperative duplex ultrasound mapping in the assessment of chronic venous disease, and concurrent ultrasound imaging to guide superficial endovenous interventions such as endovenous laser ablation, radiofrequency ablation, cyanoacrylate adhesive closure, and sclerotherapy (ultrasound-guided sclerotherapy). Other imaging modalities such as venography, alone or in combination with computed tomography scan or magnetic resonance imaging, may be included in the preoperative assessment of a small and select group of patients to exclude central venous obstruction, certain deep venous pathologies, pelvic origin extrapelvic varices, and complex vascular malformations. The signatory scientific and medical societies recommend against the routine use of fluoroscopy and other radiation-based imaging in the investigation and treatment of superficial venous disease.

The American Venous Forum, American Vein and Lymphatic Society and the Society for Vascular Medicine expert opinion consensus on lymphedema diagnosis and treatment.

BACKGROUND: Lymphedema imposes a significant economic and social burden in modern societies. Controversies about its risk factors, diagnosis, and treatment permeate the literature. The goal of this study was to assess experts' opinions on the available literature on lymphedema while following the Delphi methodology. METHODS: In December of 2019, the American Venous Forum created a working group tasked to develop a consensus statement regarding current practices for the diagnosis and treatment of lymphedema. A panel of experts was identified by the working group. The working group then compiled a list of clinical questions, risk factors, diagnosis and evaluation, and treatment of lymphedema. Fifteen questions that met the criteria for consensus were included in the list. Using a modified Delphi methodology, six questions that received between 60% and 80% of the votes were included in the list for the second round of analysis. Consensus was reached whenever >70% agreement was achieved. RESULTS: The panel of experts reached consensus that cancer, infection, chronic venous disease, and surgery are risk factors for secondary lymphedema. Consensus was also reached that clinical examination is adequate for diagnosing lymphedema and that all patients with chronic venous insufficiency (C3-C6) should be treated as lymphedema patients. No consensus was reached regarding routine clinical practice use of radionuclide lymphoscintigraphy as a mandatory diagnostic tool. However, the panel came to consensus regarding the importance of quantifying edema in all patients (93.6% in favor). In terms of treatment, consensus was reached favoring the regular use of compression garments to reduce lymphedema progression (89.4% in favor, 10.6% against; mean score of 79), but the use of Velcro devices as the first line of compression therapy did not reach consensus (59.6% in favor vs 40.4% against; total score of 15). There was agreement that sequential pneumatic compression should be considered as adjuvant therapy in the maintenance phase of treatment (91.5% in favor vs. 8.5% against; mean score of 85), but less so in its initial phases (61.7% in favor vs. 38.3% against; mean score of 27). Most of the panel agreed that manual lymphatic drainage should be a mandatory treatment modality (70.2% in favor), but the panel was split in half regarding the proposal that reductive surgery should be considered for patients with failed conservative treatment. CONCLUSION: This consensus process demonstrated that lymphedema experts agree on the majority of the statements related to risk factors for lymphedema, and the diagnostic workup for lymphedema patients. Less agreement was demonstrated on statements related to treatment of lymphedema. This consensus suggests that variability in lymphedema care is high even among the experts. Developers of future practice guidelines for lymphedema should consider this information, especially in cases of low-level evidence that supports practice patterns with which the majority of experts disagree.

Procedural comparison of a standard PTA balloon for fistula and graft maintenance procedures with the novel Chameleon™ PTA balloon catheter.

INTRODUCTION: The incidence of cephalic arch (CA) and central venous (CV) stenosis has been reported in the range of 30% in the literature. The purpose of this study is to compare contrast use, fluoroscopy time, and procedure time between standard imaging by injection of contrast through the access sheath versus injection of contrast through a novel PTA balloon with an integrated injection port. METHODS: A multi-centered, retrospective evaluation of consecutive patients treated for CA and CV stenosis was performed. Data captured included demographics, co-morbidities, lesion characteristics/location, procedural details, volume of contrast used, fluoroscopy time, and procedure time. The control group was imaged and treated using standard practice with pre and post imaging performed through the sheath and intervention using standard PTA balloon. Imaging and treatment were performed using the Chameleon™ PTA catheter in the treatment arm. RESULTS: A total of 68 consecutive patients were included. There were 34 patients in Group A and 34 patients in Group B. Average age was 65.2 versus 66.5 (p = 0.284), respectively. There were no significant gender differences between groups. Prevalence of co-morbidities of hypertension, coronary artery disease, and diabetes was similar to national rates in both groups. Contrast volume, fluoroscopy time, and procedure time in Group B were significantly less when compared by multiple regression to Group A, correcting for potential confounders (p = 0.0001, 0.0180, and 0.0008, respectively). CONCLUSION: Use of a PTA balloon with an integrated injection port shows potential for significant reduction in contrast dose, fluoroscopy time, and procedure time.