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Background The cyanoacrylate closure (CAC) procedure is a safe and effective modality for the treatment of an incompetent saphenous vein. Thrombus extension into the deep vein, known as endovenous glue-induced thrombosis (EGIT), may be a worrisome complication of the procedure. However, the incidence, classification, and risk factors of EGIT have not been elucidated. We report, herein, the incidence, classification, and risk factors of EGIT following the CAC procedure for an incompetent saphenous vein. Methods A retrospective review was performed of prospectively collected data of CAC patients. Preoperatively, the diameter, reflux time, and peak reflux velocity of the saphenous vein were measured. The CAC procedure was performed as per the instructions for use. Postoperative follow-up was conducted at 1 week, 3 months, 6 months, and 1 year after the procedure. Postoperative duplex scanning was performed to evaluate the occlusion of the target vein and presence of EGIT. Demographic data, risk factors, procedure details, and follow-up data were also obtained. A four-tier classification system and recommended treatment plan were developed based on the EGIT grade. All statistical analyses were performed using SPSS version 22.0 (IBM, Armonk, NY). A P value of Results During the study period, the CAC procedure was performed in 191 patients (126 females [66.0%]). The mean age was 56.1 ± 11.7 years (range, 19-84) years. After the procedure, pain, the Revised Venous Clinical Severity Score, and the Aberdeen Varicose Vein Questionnaire score were significantly improved (P Conclusions EGIT is not an uncommon complication of CAC. A small diameter of the saphenous vein (

Objective The proprietary cyanoacrylate closure (CAC) system vs radiofrequency ablation (RFA) trial (VenaSeal Sapheon Closure System Pivotal Study [VeClose]) showed that CAC, a nontumescent, nonthermal, nonsclerosant ablation technique, was effective and noninferior to RFA in vein closure with good 36-month outcomes. Conducted under a separate protocol, the aim of this extended follow-up was to assess the long-term safety and effectiveness of CAC and RFA for the treatment of incompetent great saphenous veins (GSV) at 5 years (60 months) of follow-up. Methods This 60-month extension study was conducted for all patients who completed the randomized VeClose study and who were willing to participate. The pivotal VeClose study included patients with symptomatic moderate to severe varicosities (Clinical, Etiology, Anatomy, and Pathophysiology [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 planned exploratory analysis of noninferiority. Secondary outcomes included CEAP class; completion of the Venous Clinical Severity Score, EuroQol-Five Dimension survey, and Aberdeen Varicose Vein Questionnaire; patient satisfaction with treatment; adverse events (AEs) 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, and 9 CAC roll-in patients. No new recanalization events have been observed in the groups between 36 and 60 months of follow-up. At 60 months, Kaplan-Meier estimates for freedom from recanalization in the randomized CAC and RFA groups were 91.4% and 85.2%, respectively, demonstrating noninferiority of CAC compared with RFA. Both groups demonstrated sustained improvements in EuroQol-Five Dimension and quality of life measures through 60 months. Whereas patients assigned to C0 or C1 clinical class were excluded from the original study, more than half of all returning patients (64% [57/89]) were now assigned to C0 or C1, suggesting an improved clinical class from baseline. Furthermore, 41.1% of returning CAC patients and 39.4% of returning RFA patients are presently at least two CEAP clinical classes lower than at baseline. No long-term device- or procedure-related serious AEs occurred in either group between 36- and 60-month follow-up. Conclusions CAC and RFA were effective in achieving complete target vein closure of the GSV at long-term follow-up, with CAC demonstrating continued noninferiority to RFA. CAC was also associated with sustained improvements in symptoms and quality of life, lower CEAP class, and high level of patient satisfaction without serious AEs between 36 and 60 months.

Objective Hypersensitivity reaction presenting as a distinctive erythematous rash has been reported following VenaSeal™ cyanoacrylate adhesive closure. We report the frequency of hypersensitivity reactions, time to onset, duration, and severity of symptoms in patients treated with cyanoacrylate adhesive closure at a single institution. Patient and procedural factors associated with hypersensitivity reactions were evaluated. Methods A combined retrospective/prospective review of cyanoacrylate adhesive closure-treated patients was conducted over five years. Data collected from electronic medical records were reviewed for the presence of hypersensitivity reactions along with the time of onset, duration of symptoms, and severity of reaction. Severity was classified as mild if no treatment or over the counter medication was provided, moderate if steroids were required, and severe if the reaction lasted >30 days or required vein excision. Results Three hundred and seventy-nine limbs were treated in 286 patients (313 treatment days). Hypersensitivity reactions occurred in 18 patients (5.8% treatments, 6.3% patients). Thirteen were mild (4.2%), four were moderate (1.3%), and one was severe (0.3%). No patient or procedural predictive factors for hypersensitivity reaction were identified other than a trend towards decreased hypersensitivity reactions in patients with Clinical, Etiologic, Anatomic, Pathophysiologic (CEAP) clinical class C4–C6 (p = .06). Second limb treatment on a subsequent day was performed in 27 patients, and no hypersensitivity reactions occurred. Symptom onset time ranged from 1 to 23 days, with a mean of 13 days (confidence interval (CI) ±3.5 days). Duration of symptoms ranged from 3 to 28 days (mean 10.8 CI ±4.9 days). Conclusions Hypersensitivity reactions occurred in 6.0% of patients treated with cyanoacrylate adhesive closure, but most were mild and self-limited. Severe reactions were uncommon. No predictive patient or procedural factors were found to be associated with hypersensitivity reactions other than a trend towards decreased risk in patients with advanced CEAP clinical class. Previous cyanoacrylate adhesive closure treatment was not a predictive factor for hypersensitivity reaction in patients undergoing treatment at a later date.

This Practice Guidelines document has been co-published in Phlebology [DOI: 10.1177/0268355521999559] and Journal of Vascular Surgery: Venous and Lymphatic Disorders [DOI: 10.1016/j.jvsv.2020.12.084]. The publications are identical except for minor stylistic and spelling differences in keeping with each journal’s style. The contribution has been published under a Attribution-Non Commercial 4.0 International (CC BY-NC 4.0), (https://creativecommons.org/licenses/by-nc/4.0/) With the support of the American College of Obstetricians and Gynecologists, the American Vein & Lymphatic Society, the American Venous Forum, the Canadian Society of Phlebology, the Cardiovascular and Interventional Radiology Society of Europe, the European Venous Forum, the International Pelvic Pain Society, the International Union of Phlebology, the Korean Society of Interventional Radiology, the Society of Interventional Radiology, and the Society for Vascular Surgery As the importance of pelvic venous disorders (PeVD) has been increasingly recognized, progress in the field has been limited by the lack of a valid and reliable classification instrument. Misleading historical nomenclature, such as the May-Thurner, pelvic congestion, and nutcracker syndromes, often fails to recognize the interrelationship of many pelvic symptoms and their underlying pathophysiology. Based on a perceived need, the American Vein and Lymphatic Society convened an international, multidisciplinary panel charged with the development of a discriminative classification instrument for PeVD. This instrument, the Symptoms-Varices-Pathophysiology (“SVP”) classification for PeVD, includes three domains—Symptoms (S), Varices (V), and Pathophysiology (P), with the pathophysiology domain encompassing the Anatomic (A), Hemodynamic (H), and Etiologic (E) features of the patient’s disease. An individual patient’s classification is designated as SVPA,H,E. For patients with pelvic origin lower extremity signs or symptoms, the SVP instrument is complementary to and should be used in conjunction with the Clinical-Etiologic-Anatomic-Physiologic (CEAP) classification. The SVP instrument accurately defines the diverse patient populations with PeVD, an important step in improving clinical decision making, developing disease-specific outcome measures and identifying homogenous patient populations for clinical trials.

Objective To evaluate the 36-month efficacy and safety of cyanoacrylate closure for the treatment of incompetent great saphenous veins in comparison with radiofrequency ablation. Methods In this multicenter, prospective, randomized controlled trial, 222 symptomatic subjects with incompetent great saphenous veins were assigned to either cyanoacrylate closure or radiofrequency ablation. The primary endpoint, complete closure of the target great saphenous vein, was determined using duplex ultrasound examination starting from three-month visit. Results At month 36, the great saphenous vein closure rates were 94.4% for the cyanoacrylate closure group and 91.9% for the radiofrequency ablation group. Stable improvement in symptoms and quality of life was observed in both groups. Adverse event rates between the 24- and 36-month visits were similar between the groups as were serious adverse events which were infrequent and judged unrelated to either the device or the procedure in both groups. Conclusions This trial continues to demonstrate the safety and efficacy of cyanoacrylate closure for the treatment of great saphenous vein incompetence with great saphenous vein closure rate at 36 months similar to that of radiofrequency ablation, indicating non-inferiority of cyanoacrylate closure to radiofrequency ablation. The improvement in quality of life outcomes were also sustained and similar between the two treatment groups.

Purpose Studies examining cyanoacrylate closure of saphenous veins with the VenaSeal™ System have not allowed concomitant procedures for tributaries at the time of the index procedure. Outside of clinical trials, however, concomitant procedures are frequently performed in conjunction with endovenous ablation. We report on the frequency of need for saphenous tributary treatment three months after cyanoacrylate closure of the treatment of great saphenous vein, small saphenous vein, and/or accessory saphenous vein. Methods Fifty subjects with symptomatic great saphenous vein, small saphenous vein, and/or accessory saphenous vein incompetence were treated with no postprocedure compression stockings. Concomitant procedures were not allowed. Treating physicians predicted the type and nature of any concomitant procedures that they would usually perform at the time of ablation, if not limited by the constraints of the study. Evaluations were performed at one week, one and three months and included duplex ultrasound, numeric pain rating scale, revised venous clinical severity score, the Aberdeen Varicose Vein Questionnaire, and time to return to work and normal activities. At the three-month visit, the need for and type of adjunctive procedures were recorded. Results Complete closure at three months was achieved in 70 (99%) of the treated veins (48 great saphenous veins, 14 accessory saphenous veins, eight small saphenous veins). Revised venous clinical severity score improved from 6.4 ± 2.2 to 1.8 ± 1.5 (P Conclusions Closure rates were high in the absence of the use of compression stockings or side branch treatment. Improvement in quality of life was significant, and the need for and extent of concomitant procedures was significantly less than had been predicted by the treating physicians.

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. Treating physicians should be aware of the differences between agents, accounting for disease presentation, vein characteristics, and patient comorbidities when selecting the appropriate sclerosing agents. Successful outcomes rely on proper patient evaluation and assessment for contraindications to sclerotherapy. Thorough patient education regarding realistic expectations with sclerotherapy in terms of symptoms relief, recurrence, and improvement in appearance is of chief importance.

Treatment of pathologic perforator veins (PPVs) can shorten time to healing and reduce recurrence of ulcers in patients with advanced venous disease. Because of limited clinical evidence and device options, widespread adoption of PPV treatment is controversial. The objective of this study was to evaluate the safety and efficacy of endovenous laser therapy using a 400-μm optical fiber to treat PPVs.This study was a single-arm, prospective, seven-center, nonblinded clinical study examining patients with advanced skin changes or healed or active ulceration (Clinical, Etiology, Anatomy, and Pathophysiology clinical class C4b, C5, and C6). Patients received treatment with a 1470-nm laser. Procedural technical success and 10-day primary closure were evaluated. All device-related adverse events were reported. Follow-up of patients was continued for 12 months after initial ablation.The primary PPV closure (at 10-day visit) rate was 76.9% (95% confidence interval, 70.3%-82.4%). Successful primary closure rates of 75.7%, 70.3%, 62.1%, 68.8%, and 71.3% of PPVs were achieved at 1 month, 3 months, 6 months, 9 months, and 12 months, respectively. Statistically significant improvements (P .05) were seen in patients' quality of life at 1 month, 3 months, 6 months, 9 months, and 12 months compared with screening. The percentage of patients with ulcers (22.9% at screening, 14.1% at 1 month, 13.7% at 3 months, 10.1% at 6 months, 12.3% at 9 months, and 11.1% at 12 months) displayed improvement during the course of the study. Tibial deep venous thrombosis and procedural pain were the only device-related adverse events observed.Endovenous laser therapy for PPV using the 400-μm optical fiber with the 1470-nm laser yielded safe and effective outcomes with no major adverse sequelae.

The American College of Phlebology Guidelines Committee performed a systematic review of the literature regarding the clinical impact and treatment of incompetent accessory saphenous veins. Using an accepted process for guideline developments, we developed a consensus opinion that patients with symptomatic incompetence of the accessory great saphenous veins (anterior and posterior accessory saphenous veins) be treated with endovenous thermal ablation (laser or radiofrequency) or ultrasound-guided foam sclerotherapy to eliminate symptomatology (Recommendation Grade 1C).

Objectives A randomized, placebo-controlled, multicenter study was conducted to evaluate the safety and efficacy of polidocanol endovenous microfoam (1%, Varithena® [polidocanol injectable foam], BTG International Ltd.). Methods Patients (n = 77) with symptomatic, visible varicose veins were randomized to treatment with either Varithena 1% or placebo. Results Varithena provided greater mean changes from Baseline in patient-reported assessments of symptoms (e.g., heaviness, achiness, swelling, throbbing, itching [HASTI®] score 30.7 points vs 16.7 points, p = 0.0009, primary endpoint; and modified Venous Insufficiency Epidemiological and Economic Study-Quality-of-Life/Symptoms [m-VEINES-QOL/Sym; p 0.9, p ≤ 0.001). Adverse events included contusion, incision-site hematoma, and limb discomfort. Venous thrombus adverse events were reported as mild and generally resolved without sequelae. Conclusions Varithena provided significantly greater symptom relief and improvement in leg appearance compared with placebo. Adverse events were generally mild and transient. ( www.clinicaltrials.gov [NCT00758420]).

BACKGROUND: Coronary artery disease is a major cause of morbidity and mortality worldwide, and is a consequence of acute thrombotic events involving activation of platelets and coagulation proteins. Factor Xa inhibitors and aspirin each reduce thrombotic events but have not yet been tested in combination or against each other in patients with stable coronary artery disease.METHODS: In this multicentre, double-blind, randomised, placebo-controlled, outpatient trial, patients with stable coronary artery disease or peripheral artery disease were recruited at 602 hospitals, clinics, or community centres in 33 countries. This paper reports on patients with coronary artery disease. Eligible patients with coronary artery disease had to have had a myocardial infarction in the past 20 years, multi-vessel coronary artery disease, history of stable or unstable angina, previous multi-vessel percutaneous coronary intervention, or previous multi-vessel coronary artery bypass graft surgery. After a 30-day run in period, patients were randomly assigned (1:1:1) to receive rivaroxaban (2·5 mg orally twice a day) plus aspirin (100 mg once a day), rivaroxaban alone (5 mg orally twice a day), or aspirin alone (100 mg orally once a day). Randomisation was computer generated. Each treatment group was double dummy, and the patients, investigators, and central study staff were masked to treatment allocation. The primary outcome of the COMPASS trial was the occurrence of myocardial infarction, stroke, or cardiovascular death. This trial is registered with ClinicalTrials.gov, number NCT01776424, and is closed to new participants.FINDINGS: Between March 12, 2013, and May 10, 2016, 27 395 patients were enrolled to the COMPASS trial, of whom 24 824 patients had stable coronary artery disease from 558 centres. The combination of rivaroxaban plus aspirin reduced the primary outcome more than aspirin alone (347 [4%] of 8313 vs 460 [6%] of 8261; hazard ratio [HR] 0·74, 95% CI 0·65-0·86, pINTERPRETATION: In patients with stable coronary artery disease, addition of rivaroxaban to aspirin lowered major vascular events, but increased major bleeding. There was no significant increase in intracranial bleeding or other critical organ bleeding. There was also a significant net benefit in favour of rivaroxaban plus aspirin and deaths were reduced by 23%. Thus, addition of rivaroxaban to aspirin has the potential to substantially reduce morbidity and mortality from coronary artery disease worldwide.FUNDING: Bayer AG.

Objective We previously reported 3-month and 12-month occlusion rates after treatment of clinically symptomatic saphenous vein reflux with either cyanoacrylate closure (CAC) using the VenaSeal Closure System (Medtronic, Dublin, Ireland) or radiofrequency ablation (RFA) in a randomized, multicenter, clinical trial, VenaSeal Sapheon Closure System vs Radiofrequency Ablation for Incompetent Great Saphenous Veins (VeClose). Herein we report the 24-month follow-up results of the VeClose trial. Methods There were 222 patients with symptomatic great saphenous vein (GSV) incompetence who were randomly assigned to receive either CAC (n = 108) or RFA (n = 114). Patients were not allowed to receive adjunctive treatment of tributary varicosities until after the 3-month visit. Duplex ultrasound of the target vein was performed at day 3 and months 1, 3, 6, 12, and 24 after treatment, and closure was assessed by ultrasound by the treating physician. Overall 24-month success rates were compared; in addition, time to first reopening of the target vein was evaluated using survival analysis. End points such as Venous Clinical Severity Score, EuroQoL-5 Dimension, and Aberdeen Varicose Vein Questionnaire were evaluated. Results Of 222 randomized patients, 171 completed the 24-month follow-up, which included 87 from the CAC group and 84 from the RFA group. The 24-month complete closure rate was 95.3% in the CAC group and 94.0% in the RFA group, demonstrating continued noninferiority of CAC compared with RFA (P = .0034). Symptoms and quality of life improved similarly in both groups. No clinically significant device- or procedure-related late adverse events occurred. Conclusions Both CAC and RFA were effective in closure of the target GSV, resulting in similar and significant improvements in the patient’s quality of life through 24 months. These results suggest that CAC of the GSV is safe and durable out to 2 years.

Objective Endovenous cyanoacrylate closure (CAC) is a new U.S. Food and Drug Administration-approved therapy for treatment of clinically symptomatic venous reflux in saphenous veins. The device is indicated for the permanent closure of lower extremity superficial truncal veins, such as the great saphenous vein (GSV). Early results from a randomized trial of CAC have been reported previously. Herein we report 1-year outcomes. Methods There were 222 subjects with symptomatic GSV incompetence randomly assigned to receive either CAC (n = 108) or radiofrequency ablation (RFA; n = 114). After the month 3 visit, subjects could receive adjunctive therapies aimed at treating visible varicosities and incompetent tributaries. Vein closure was assessed at day 3 and months 1, 3, 6, and 12 using duplex ultrasound. Additional study visit assessments included the Venous Clinical Severity Score; Clinical, Etiology, Anatomy, and Pathophysiology classification; EuroQol-5 Dimension; and Aberdeen Varicose Vein Questionnaire. Both time to closure and time to first reopening of the target vein were evaluated using survival curve analysis. Adverse events were evaluated at each visit. Results Of 222 enrolled and randomized subjects, a 12-month follow-up was obtained for 192 (95 CAC and 97 RFA; total follow-up rate, 192/222 [86.5%]). By month 1, 100% of CAC subjects and 87% of RFA subjects demonstrated complete occlusion of the target vein. By month 12, the complete occlusion rate was nearly identical in both groups (97.2% in the CAC group and 97.0% in the RFA group). Twelve-month freedom from recanalization was similar in the CAC and RFA groups, although there was a trend toward greater freedom from recanalization in the CAC group (P = .08). Symptoms and quality of life improved equally in both groups. Most adverse events were mild to moderate and not related to the device or procedure. Conclusions In patients with incompetent GSVs, treatment with both CAC and RFA results in high occlusion rates. Time to complete occlusion was faster with CAC, and freedom from reopening was higher after CAC. Quality of life scores improved equally with both therapies.

Objective This report summarizes the findings of the consensus panel based on the results of the comprehensive questionnaire of US American College of Phlebology annual congress attendees and results of the systematic meta-analysis of the literature and provides quality improvement guidelines for the use of endovenous foam sclerotherapy (EFS) for the treatment of venous disorders, as well as identifies areas of needed research. Methods Based on the above data, quality improvement guidelines were developed and reviewed by the ten US consensus panel members and approved by their respective societies. Results EFS is effective for the treatment of truncal and tributary varicose veins, both as primary treatment and for treatment of recurrence. It may improve the signs and symptoms associated with varicose veins including pain and swelling. EFS is contraindicated in patients who have experienced an allergic reaction to previous treatment with foam or liquid sclerosant, and in patients with acute venous thrombosis events secondary to EFS. Conclusion These guidelines for the use of EFS in the treatment of venous disorders provide an initial framework for the safe and efficacious use of this therapy, and the impetus to promote the evaluation of the questions remaining regarding the use of EFS through well-designed randomized and cohort studies.

Purpose Cyanoacrylate closure of the great saphenous vein with the VenaSeal™ Closure System is a relatively new modality. Studies have been limited to moderate-sized great saphenous veins and some have mandated postoperative compression stockings. We report the results of a prospective study of cyanoacrylate closure for the treatment of great saphenous vein, small saphenous veins, and/or accessory saphenous veins up to 20 mm in diameter. Methods Fifty subjects with symptomatic great saphenous vein, small saphenous veins, and/or accessory saphenous veins incompetence were each treated at a single session. Compression stockings were not used post-procedure. Subjects returned to clinic at week 1 and again at one month. Post-procedure evaluations were performed at seven days and one month and included numerical pain rating score, revised venous clinical severity score, the Aberdeen Varicose Vein Questionnaire score, and time to return to work and normal activities. Duplex ultrasound was performed at each visit. Findings Procedural pain was mild (numerical pain rating scale 2.2 ± 1.8). All treated veins (48 great saphenous vein, 14 accessory saphenous veins, and 8 small saphenous veins) had complete closure by duplex ultrasound at seven days and one month. Mean time to return to work and normal activities was 0.2 ± 1.1 and 2.4 ± 4.1 days, respectively. The revised venous clinical severity score was improved to 1.8 ± 1.4 ( p Conclusions Cyanoacrylate closure is safe and effective for the treatment of one or more incompetent saphenous or accessory saphenous veins. Closure rates were high even in the absence of the use of compression stockings or side branch treatment. Time back to work or normal activities was short and improvements in venous severity scores and QOL were significant, comparing favorably with alternative treatment methods.

Cyanoacrylate closure (CAC) was shown in the recently published VenaSeal Sapheon Closure System vs Radiofrequency Ablation for Incompetent Great Saphenous Veins (VeClose) randomized clinical study to be an effective and noninferior option (in terms of both safety and effectiveness) to radiofrequency ablation (RFA) in the treatment of incompetent great saphenous veins. The objectives of this analysis were to report the efficacy and safety outcomes of the VeClose roll-in (training) group treated with CAC by physicians who had received device use training but had no prior treatment experience with the technique and to compare the outcomes with those from the randomized RFA and CAC groups.The first two subjects at each participating site (n = 20) were roll-in cases (ie, not randomized but instead treated with CAC) to ensure the physician's familiarity with the procedure. Subsequent eligible subjects were randomized to either CAC or RFA. After treatment, all subjects returned for assessment on day 3 and months 1, 3, 6, and 12. The study's primary end point was complete closure of the target vein at month 3. Secondary analyses included patient-reported intraprocedural pain and investigator-rated ecchymosis at day 3. Additional assessments included procedure time, quality of life surveys, and adverse events.Mean procedure time was longer in the roll-in group (31 minutes) compared with the randomized groups (24 minutes for CAC and 19 minutes for RFA; P .0001). Procedure time decreased in both the CAC and RFA groups over time, plateauing at about 22 minutes for CAC and 15 minutes for RFA. In the roll-in group, the 3-month complete occlusion rate was 100%. Reported intraprocedural pain ratings were similar between the roll-in and randomized groups. Other clinical assessments, including quality of life improvement and adverse events, were similar between the roll-in and randomized groups. Increasing procedure number did not affect clinical outcomes.The results from the VeClose study roll-in group demonstrate that despite the physician's lack of prior experience, initial treatment with CAC leads to comparable efficacy and safety results to RFA and is associated with a relatively short learning period.

Background Foam generated by manual agitation of liquid sclerosant with air or gas is routinely utilized to treat refluxing veins. Although generally well tolerated, serious neurological events have been reported. The composition and properties of the foam, including bubble size and gaseous components, may contribute to the potential for microcirculatory obstruction and cerebral ischemia. We tested an ultra-low nitrogen polidocanol endovenous microfoam with controlled bubble size and density and hypothesized that patients at risk due to the presence of middle cerebral artery (MCA) bubble emboli during microfoam injection would not demonstrate evidence of clinical or subclinical cerebral infarction. Methods Patients with great saphenous vein incompetence were treated with ultra-low nitrogen (≤0.8%) polidocanol endovenous microfoam injected under ultrasound guidance. Patients with right-to-left shunt were included to evaluate the safety of cerebral arterial bubbles. All patients with MCA emboli detected by transcranial Doppler during endovenous microfoam ablation received intensive surveillance for microinfarction, including brain magnetic resonance imaging and measurement of cardiac troponin-I. Results MCA bubble emboli were detected in 60 of 82 treated patients; 22 patients had no detectable emboli. Among patients with MCA bubbles detected, 49 (82%) had ≤15 bubbles. No patients developed magnetic resonance imaging abnormalities, neurological signs, or elevated cardiac troponin. Conclusions Patients treated with foamed liquid sclerosants are commonly exposed to cerebrovascular gas bubbles. In this series of 60 high-risk patients with MCA bubble emboli during or after treatment with ultra-low nitrogen polidocanol endovenous microfoam, there was no evidence of cerebral or cardiac microinfarction. The results of this study cannot be generalized to foams compounded using bedside methodologies, since the composition of these foams is substantially different.

We have previously shown that resident fibroblasts from human chronic wounds are phenotypically abnormal, displaying an impaired response to TGF-beta 1, decreased TGF-beta Type II receptor expression, and decreased phosphorylation of Smad2, Smad3, and p42/44 MAPK. We now report that these human cells delay healing by approximately 30% when implanted in mouse incisional wounds and in a dorsal flap model. These new findings point to the need for the transplantation of new healthy cells in human chronic wounds. Bioengineered living skin constructs can deliver new cells to chronic wounds, at least for a limited period of time. However, most available bioengineered skin constructs consist of already differentiated allogeneic cells, which do not allow for the possibility of engraftment and reconstitution of wound structures. Recently, in a preliminary report, we have shown that autologous bone marrow-derived cells can dramatically enhance the healing of recalcitrant chronic wounds when all other treatments have failed. Our present efforts are now focused on characterizing the bone marrow cells involved in this stimulation of wound healing and in developing better ways for their topical delivery to the wound. Here we present evidence that a fibrin construct may be an ideal way of applying bone marrow-derived cells to human chronic wounds. Autologous bone marrow cells are allowed to grow in culture under conditions favoring the survival and proliferation of mesenchymal stem cells (MSC), as shown by surface markers and functional studies. This usually requires two weeks after bone marrow harvesting. The cellular component is then placed in a fibrinogen solution which, when simultaneously combined with thrombin through a CO2 driven flow, delivers a fine cell-containing fibrin polymer film to the wound. In vitro and in vivo experiments, both in mouse models and in human wounds, show the feasibility of this approach.

Literature shows that traditional creative methods may reinforce repetitive and habitual behavior resulting in ineffective environmental design solutions (Lawson, 1980; Lang, 1987; Laseau, 1989). Two case studies explored the use of an automated system called cyber–ideation (Gibson, 2000b) as a method to stimulate idea generation. This procedure employed individual and team involvement, recursive and linear exploration, and manual and digital processes. Analysis compared students’ production using traditional ideation processes with that resulting from cyber–ideation. Results from this case study found that: 1) digital creation was more linear when evaluated against traditional ideation output, 2) cyber–ideation had a positive impact on team dynamics, and 3) automated output possessed greater surface delineation when compared with subjects’ manual sketching.

Objective The study was conducted to assess the efficacy and rate of complications of endovenous laser treatment (EVLT) of the short saphenous vein (SSV). Methods During a 17-month period, 210 (187 patients) with SSV incompetence documented by duplex ultrasound studies were treated with EVLT using a 980-nm diode laser. Duplex ultrasound examinations were performed on the day of the procedure, within the first week, and 2 to 11 months after the procedure (mean follow-up, 4 months). Clinical examinations were performed at 2 weeks and 6 weeks. Patients were assessed for deep venous thrombosis (DVT), nerve injury, and resolution of symptoms. Results All procedures were technically successful, and in the 126 patients (60%) who completed final follow-up scanning, 96% of SSVs remained closed. Three patients (1.6%) had numbness at the lateral malleolus at the 6-week follow-up. DVT, defined as a tail of thrombus protruding into the popliteal vein, was not detected in any limbs at the initial duplex study, but was noted in 12 limbs (5.7%) at the 1-week follow-up examination. Nine patients were treated with 3 days to 3 months of fractionated heparin and Coumadin (Bristol-Myers Squibb, Princeton, NJ), and there were no DVT extensions or pulmonary emboli. The anatomic configuration of the saphenopopliteal junction was the only factor predictive of DVT. Conclusions Intermediate-term results of EVLT of the SSV demonstrate that the technique is effective at eliminating SSV reflux and affording symptomatic relief. The incidence of nerve injury is low, but the incidence of DVT is higher than reported for the great saphenous vein. Anatomic features of the SSV may predict patient risk for DVT.

Introduction Isolated aneurysms of the superficial femoral artery (SFA) are rare, and their etiology is not yet fully understood. Although not as common as abdominal aortic or popliteal artery aneurysms, they pose a serious threat of rupture and/or thrombosis. Because of their atypical presentation, they can be easily misdiagnosed. Methods A 58-year-old man presented with a painful lump over his left medial thigh, first noted 6 months previously. The patient was asymptomatic in regards to claudication. The findings of magnetic resonance imaging suggested a vascular mass versus pseudoaneurysm of the SFA. The patient was referred to the vascular laboratory and underwent duplex evaluation. This revealed an 8.3–cm long SFA aneurysm with a maximum diameter of 5.9 cm with extensive mural thrombus present. Angiography confirmed a true aneurysm, with an estimated length of 5 cm and luminal diameter of 2.5 cm. Result The patient underwent open aneurysmorrhaphy with a femoral to popliteal reverse saphenous vein bypass graft. Upon direct visualization, the aneurysm was estimated to measure 8 cm length and 6 cm in diameter. The patient recovered without incident and has normal ankle brachial indices. Conclusion True isolated aneurysms in the SFA are rare, and the exact cause is not yet known. Proper diagnosis and identification are crucial to patient outcome. In our case, duplex ultrasound yielded a more accurate measurement of the true aneurysm size when compared with the angiogram. This is attributable to the angiogram measuring the flow channel of the residual lumen while not visualizing the thrombus filled sac. Endovascular stent grafts or open repair with bypass grafts (vein or prosthetic) are the accepted methods of treatment with good patient outcome. Allowed to progress untreated, these aneurysms often rupture or thrombose, which can ultimately lead to limb loss. Because of the increased incidence of aneurysmal disease elsewhere in the body, these patients should undergo additional screening.

We performed a retrospective review of patients admitted to two Level I trauma centres over a 15-year period with arterial injuries (excluding primary amputations). Preoperative factors analysed included mechanism of injury, site and type of arterial and venous injury and repair, time to operating room, initial blood pressure, evidence of ipsilateral limb fracture and/or extensive tissue damage, status of preoperative pulses and angiographic data. One hundred and fifty-one arterial injuries were treated (80 penetrating). Overall mortality was 10 (6.6%) and limb loss 16 (10.6%). Only two factors that might possibly be modified by specific interventions were noted. The incidence of limb loss was higher in patients who developed compartment syndrome (41% versus 7% without, P=0.003) and in those who did not receive intra- or immediately postoperative anticoagulation (15% without versus 3% with, P=0.02). Unfortunately, no factor was found that reliably predicted the risk of compartment syndrome. In addition, patients who did not receive peri-operative anticoagulation were more severely injured than those that did were. Despite this, there were no bleeding complications associated with anticoagulation. These findings suggest that the primary interventions that may improve limb salvage include liberal use of fasciotomy (recognising that any patient may require this) as well as early use of anticoagulation.

BackgroundWhereas thermal ablation of incompetent saphenous veins is highly effective, all heat-based ablation techniques require the use of perivenous subfascial tumescent anesthesia, involving multiple needle punctures along the course of the target vein. Preliminary evidence suggests that cyanoacrylate embolization (CAE) may be effective in the treatment of incompetent great saphenous veins (GSVs). We report herein early results of a randomized trial of CAE vs radiofrequency ablation (RFA) for the treatment of symptomatic incompetent GSVs.MethodsTwo hundred twenty-two subjects with symptomatic GSV incompetence were randomly assigned to receive either CAE (n = 108) with the VenaSeal Sapheon Closure System (Sapheon, Inc, Morrisville, NC) or RFA (n = 114) with the ClosureFast system (Covidien, Mansfield, Mass). After discharge, subjects returned to the clinic on day 3 and again at months 1 and 3. The study's primary end point was closure of the target vein at month 3 as assessed by duplex ultrasound and adjudicated by an independent vascular ultrasound core laboratory. Statistical testing focused on showing noninferiority with a 10% delta conditionally followed by superiority testing. No adjunctive procedures were allowed until after the month 3 visit, and missing month 3 data were imputed by various methods. Secondary end points included patient-reported pain during vein treatment and extent of ecchymosis at day 3. Additional assessments included general and disease-specific quality of life surveys and adverse event rates.ResultsAll subjects received the assigned intervention. By use of the predictive method for imputing missing data, 3-month closure rates were 99% for CAE and 96% for RFA. All primary end point analyses, which used various methods to account for the missing data rate (14%), showed evidence to support the study's noninferiority hypothesis (all P

Objective: The objective of this study was to assess the prognostic value of hemodynamic parameters measured with duplex ultrasound scan, together with other important graft and patient characteristics, in predicting lower extremity vein graft thrombosis. Methods: A total of 165 lower extremity vein grafts were entered prospectively into a postoperative duplex ultrasound scan surveillance program with examinations performed at 1, 2, 3, 4, 6, 9, 12, 18, and 24 months, and annually thereafter. Duplex scan–derived blood flow velocity measurements were recorded at 1562 patient visits over 7 years. Graft patency was determined after each visit, and an analysis of factors predictive of vein graft thrombosis was performed with Poisson regression. Results: Thirty-two episodes of first-time graft thrombosis occurred, 23 of which were permanent. One-, 3-, and 5-year secondary graft patency rates were 90%, 86%, and 79%, respectively. In multivariate analyses, duplex scan velocity measurements predictive of lower extremity graft thrombosis included the maximum velocity ratio (Vr) in association with a graft stenosis and the mean graft peak systolic velocity (MGV) within nonstenotic portions of the body of the graft. The incidence of graft thrombosis among grafts without inflow/outflow stenoses, with Vr less than 3.5, and with MGV 50 cm/s or more, was 2.9% per year. Incidence rates were considerably higher among grafts with a of Vr of 3.5 or more (incidence rate ratio=7.0; 95% CI, 3.4-14.6) or an MGV less than 50 cm/s (incidence rate ratio=6.5; 95% CI, 3.3-13.1). In grafts without identifiable inflow, outflow, or graft stenoses, there was no association between MGV and the risk of graft thrombosis. Conclusion: Duplex scan velocity measurements are valid predictors of impending graft thrombosis. A Vr of 3.5 or more and an MGV less than 50 cm/s are the best predictive measures. Repair of correctable graft lesions with a Vr of 3.5 or more, or inflow, outflow, or graft lesions associated with an MGV less than 50 cm/s are recommended. Grafts without detectable inflow, outflow, or graft stenoses, regardless of MGV, may be safely followed. (J Vasc Surg 2001;33:24-31.)

Aneurysms of the superficial temporal artery are rare and most often traumatic in origin. In this case study we present an extremely rare occurrence of bilateral nontraumatic superficial temporal artery aneurysms. Spontaneous bilateral superficial temporal artery aneurysms have not been previously reported. The patient was a 49-year-old woman who presented to our outpatient vascular lab with pulsating masses noted over bilateral temporal regions. Duplex ultrasound revealed a 2.3 mm right and 4.5 mm left temporal artery aneurysm. The aneurysms were subsequently resected and the patient recovered without incident. Non-invasive duplex ultrasound is an effective method in identifying these rare aneurysms. A literature search revealed few published cases of non-traumatic STAs and of these cases none involved bilateral vessels.

Background Midline abdominal hernia is a common problem seen by the general surgeon. Recurrence rates are as high as 49% when an autogenous repair is performed, and as high as 11% when prosthetic mesh is used as a “bridge” or “onlay.” Methods This study analyzes results of midline abdominal hernia repair in 106 cases using prosthetic mesh, in the retrorectus position, as described by Stoppa and Wantz. Charts were reviewed, patient satisfaction determined by telephone interview, and recurrence rate by physician examination. Results Major systemic complications occurred in 17%. There were no deaths. Eighteen percent developed a wound complication, requiring a return to the operating room in 5%. There were three recurrences (3.5%). Conclusions Retrorectus placement of prosthetic mesh in the repair of midline abdominal hernia is effective and compares favorably with other methods. Significant complications are low, recurrence is rare, and patient satisfaction is high.

Our primary aim is to provide a descriptive approach to the analysis of counts of plaques and tangles by different readers. We wanted to find out whether subjects with minimal training can count plaques and tangles in histological specimens of patients with Alzheimer's disease and controls. Two experienced neuropathologists trained three student helpers to recognize plaques and tangles in slides obtained from autopsy material. After training, the students and pathologists examined coded slides from patients with Alzheimer's disease and controls. Some of the slides were repeated to provide an estimate of reliability. Each reader read four fields which were averaged to obtain estimates of plaque and tangle counts. Raters are compared on four aspects of concordance: location, scale, precision and accuracy. Precision and accuracy are combined to provide an estimate of concordance. We conclude that subjects with minimal training can be taught to count plaques and tangles. Concordance with the neuropathologists was somewhat greater for tangles. This paper also provides a methodology for comparing raters.

Chronic venous disorder is one of the most prevalent medical conditions in the US that carries significant economic and health burden. The knowledge into venous pathophysiology, how it develops, and the true quality of life benefits of various treatment options are largely unknown. A truly meaningful clinical data capture system specifically for venous disorder may provide answers to the paucity of data. We describe a modern system to capture research and best practice data using the state of art information technology.

ISSUE: To cultivate better designers and design researchers, should undergraduates test their own hypotheses concerning the built environment? APPLICATION: A third–year undergraduate student developed a research strategy to investigate how furniture placement affects human behavior. Two different furniture arrangements, one existing layout and one layout designed by the student, were used as the experiment's dependent variables. GOAL: Primary goals for this study were to demonstrate how research could be directly meaningful to the undergraduate educational experience in interior design and to increase understanding of the complexities of mentoring young design researchers. DESCRIPTION: The student was involved in all aspects of the research project from conceptualization and grant proposal writing to data analysis and presentation of results. The entire process occurred within a five–month period. CONCLUSION: This research experience provided the student with increased confidence and a broader theoretical background from which to analyze and challenge previously accepted viewpoints held by the design community. To lead the interior design discipline into the next century, young designers should be trained to assess critically and analyze new information and methods. Summary As we prepare today’ graduates for leadership roles, we must develop in them the ability for critical thought along with the aesthetic and technical skills stressed in the design studio. Design students, like students in any other discipline, need to know how to define a problem, collect data, draw valid conclusions, and communicate the results. If not taught these skills, the next generation of designers will be unable to distinguish between valid scholarly research and unsubstantiated beliefs. The future of the design discipline will depend on interior designers having the intellectual tools to find that “simple error and to provide an appropriate solution. The undergraduate research project is one method to provide the next generation of designers with the intellectual skills needed to make informed decisions.

Purpose To assess practice patterns of endovenous foam sclerotherapy (EFS) use in the USA. Methods A multidisciplinary panel of US experts was convened and developed a questionnaire to assess use of EFS. US attendees at the American College of Phlebology 2009 Annual Congress were asked to complete the questionnaire. Results Of 776 questionnaires distributed, 239 were completed (31%). The majority of respondents (87%) reported using EFS for the treatment of venous disorders. Foam sclerotherapy was used by a wide variety of specialists in every region of the USA. The most common indication was sclerosis of recurrent truncal or tributary veins of the leg. There was variation among practitioners in the indications for use, pre- and postprocedural evaluation and procedure methodology. Conclusions The results of this questionnaire show widespread usage of EFS and are important in the development of national quality improvement guidelines for the performance of EFS.

Background Varicose veins are common and increasingly are being treated by less invasive endoscopic methods such as foam sclerotherapy. Patent foramen ovale (PFO) is also common, present in approximately one-quarter of adults. PFO allows bubbles introduced by foam sclerotherapy to cross into the general circulation, potentially causing cerebral artery gas embolization with unevaluated consequences. Methods Men and women aged 18 to 60 years with symptomatic varicose veins (CEAP C 3-5 ) responded to an advertisement to recruit volunteers for a study on endovenous microfoam ablation (EMA). Participants' veins were screened by duplex ultrasound imaging, and those with isolated great saphenous vein (GSV) incompetence were tested for right-to-left (R-L) vascular shunt using transcranial Doppler (TCD) of the middle cerebral artery to detect the presence of bubble emboli after an injection of an agitated saline, blood, and air mixture as a contrast at rest and with the Valsalva maneuver. Results Of 221 participants tested for R-L shunt, 85 (38.5%) were positive at rest (95% confidence interval [CI], 32.5-45.2) and 114 (51.8%) were positive after the Valsalva maneuver (95% CI, 45.4-58.5). A total 130 patients (58.8%) were positive for R-L shunt at rest or after Valsalva (95% CI, 52.5%-65.1%). This is significantly higher than the reported 26% prevalence of PFO in the general population (95% CI, 24.4-30.1). Conclusions The prevalence of R-L shunt in patients with GSV incompetence CEAP C 3-5 in this study was higher than expected in the general population. TCD does not differentiate between intracardiac shunts and intrapulmonary shunts, so this observation needs further investigation. This link between R-L shunt and varicose veins is novel and, whether etiologic or functional, may improve the understanding of both conditions. The findings have importance in the treatment of varicose veins with foam sclerotherapy and EMA.

Endovenous laser treatment (EVLT) has become a standard therapy for the treatment of superficial venous insufficiency. It offers a rapid, office-based therapy with minimal patient downtime and an easier recovery than traditional surgical treatment. EVLT is effective and durable and can successfully treat saphenous truncal insufficiency and accessory branches with low complication rates. EVLT can increase patient satisfaction and enable the treatment of a wider variety of patients with a more efficient procedure compared with traditional techniques.

Objective The objectives of this study were to assess the durability of response to treatment with polidocanol endovenous microfoam (Varithena; Provensis Ltd, a BTG International group company) and to assess the long-term safety of the study patients. Methods This report presents efficacy and safety data from the day after visit 5/week 8 (the primary end point of the study) through the 1-year study visit. As the approved dose concentration is 1%, this analysis focuses on those patients who were randomized to polidocanol endovenous microfoam 1% at study visit 2. Because the objective of the 1-year analysis was to assess the durability of response to treatment with polidocanol endovenous microfoam 1%, the 1-year efficacy analyses based on the efficacy population included all patients who were randomized and received at least one treatment with polidocanol endovenous microfoam 1%. Efficacy end points in the Polidocanol Endovenous Microfoam Versus Vehicle for the Treatment of Saphenofemoral Junction Incompetence (VANISH-2) trial were evaluated at 1 year (n = 221; 96% of those completed the primary end-point measurement at week 8) and included the following: Varicose Vein Symptoms Questionnaire (VVSymQ, Provensis Ltd) score, an assessment of symptoms by patients using electronic daily diaries; Independent Photography Review: Visible Varicose Veins (IPR-V 3 ) and Patient Self-assessment of Visible Varicose Veins (PA-V 3 ) scores, the assessment of appearance by an Independent Physician Review panel and by patient self-assessment, respectively; duplex ultrasound response (physiologic response to treatment); Venous Clinical Severity Score (disease severity); and Venous Insufficiency Epidemiological and Economic Study on Quality of Life (VEINES-QOL) score (quality of life). Results Of the 230 patients who completed visit 5/week 8, 56 received polidocanol endovenous microfoam 1% at visit 2/week 0 and were subsequently assessed for efficacy at visit 5/week 8 and visit 10/1 year (one patient of the 57 who completed visit 5/week 8 received a nonpolidocanol endovenous microfoam intervention and was not included in the assessment). At 1 year after the first study treatment, patients treated with polidocanol endovenous microfoam demonstrated consistent, durable, and clinically meaningful improvements in symptoms, as measured by reductions in mean VVSymQ score; appearance, as measured by IPR-V 3 (clinician assessment) and PA-V 3 (patient self-assessment) scores; disease severity, as measured by the Venous Clinical Severity Score; and quality of life, as measured by the VEINES-QOL score. At 1 year, there were no new venous thrombus adverse events (VTAEs) and no clinically important sequelae in patients who had a VTAE in the study. In addition, there were no serious adverse events that were determined by the investigator to be related to the study drug. No new safety signals were identified. In patients who previously had a VTAE, none had a recurrence of thrombus or evidence of post-thrombotic syndrome at 1 year. Conclusions Treatment with polidocanol endovenous microfoam 1% led to durable, clinically meaningful, and ongoing improvements at 1 year in varicose vein symptoms and appearance. Serious adverse events were those expected during long-term follow-up of the population of patients studied and were unrelated to treatment.

This was a prospective, randomized, controlled clinical trial assessing the safety and efficacy of a living bilayered skin construct (BSC; Organogenesis, Canton, MA) in treating full-thickness surgical excision wounds. We enrolled 31 patients needing excision of a non-melanoma skin cancer. The patients consisted of 18 females and 13 males, with an average age of 67 years (range: 44 to 84 years). Patients were randomized to either receive a single application of BSC or to heal by secondary intention. Endpoints to assess efficacy included time to complete wound closure, intensity and duration of post-operative pain, cosmetic appearance, patient satisfaction, and quality of the healed wound. Endpoints to assess safety included infection at the wound site and rejection of the BSC. Findings indicate that BSC is safe in the post-operative treatment of acute surgical wounds for removal of non-melanoma skin cancer. The data also suggest that BSC may facilitate management by decreasing post-operative pain. It is unclear whether or not BSC decreases healing time of acute wounds or results in a better cosmetic outcome.

Objective: The study's aim was to evaluate access patency and incidence of revisions in patients initiating hemodialysis and to determine differences in access performance by type of access among patient subgroups. Methods: The study used data from the United States Renal Data System Dialysis Morbidity and Mortality Study Wave 2, which contained a random sample of dialysis patients initiating dialysis in 1996 and early 1997. Failures and revisions were evaluated among 2247 newly placed hemodialysis accesses by using Cox proportional hazards regression model and Poisson regression. Primary and secondary patency rates were estimated using the Kaplan-Meier method. Results: Fifteen hundred seventy-four prosthetic grafts, 492 simple autogenous fistulas, and 181 venous transposition fistulas were available for evaluation. Prosthetic grafts had a 41% greater risk of primary failure compared with simple fistulas (relative risk, 1.41; 95% CI, 1.22-1.64; P

The goal of hemodialysis access placement is long-term patency with as few revisions as possible. Autogenous fistulas have superior performance compared with prosthetic grafts, but up to 70% fail to mature sufficiently for dialysis. Accurate preoperative evaluation of arterial and venous anatomy can increase the successful use of autogenous fistulas, thereby increasing long-term access patency. Duplex ultrasonography has an important role in identifying usable autogenous conduit and detecting venous outflow disease, another important cause of access failure. The use of the vascular diagnostic laboratory in preoperative planning can increase the percentage of autogenous fistulas placed, increase the percentage that mature, and reduce the rate of negative explorations for vein at the time of surgery.

Assessment of a policy to reduce placement of prosthetic hemodialysis access.BackgroundThe aim of this study was to evaluate the determinants of access patency and revision, including the effects of reducing the placement of prosthetic hemodialysis access.MethodsA retrospective cohort study of all hemodialysis accesses placed at the Veteran's Administration Puget Sound Health Care System between 1992 and 1999 was conducted. A policy was instituted in 1996 that maximized the use of autogenous hemodialysis access. The impacts of the policy change, demographics, and comorbid factors on access type and patency, were examined. Primary and secondary patency rates were examined using the Kaplan–Meier method, and factors associated with failure and revision were examined using Cox proportional hazard models and Poisson regression.ResultsDuring the study, 104 accesses (61 prosthetic grafts and 43 autogenous fistulas) were placed prior to 1996, and 118 (31 prosthetic grafts and 87 autogenous fistulas) were placed after 1996. There was a significant increase in autogenous fistulas placed after 1996 (87 out of 118) compared with before 1996 (43 out of 104, P < 0.001). At one year, autogenous fistulas demonstrated superior primary patency (56 vs. 36%, P = 0.001) and secondary patency (72 vs. 58%, P = 0.003) compared with prosthetic grafts. After adjustment for age, race, side of access placement, and history of prior access placement, patients with a prosthetic graft were estimated to experience a 78% increase in the risk of primary access failure when compared with similar patients having an autogenous access [adjusted relative risk (aRR) = 1.78, 95% CI 1.21–2.62, P = 0.003)]. Similarly, the adjusted relative risk of secondary access failure for comparing prosthetic grafts with autogenous fistulas was estimated to be 2.21 (95% CI 1.38–3.54, P = 0.001). The adjusted risk of access revision was 2.89-fold higher for prosthetic grafts than for autogenous fistulas (95% CI 1.88–4.44, P < 0.001).ConclusionsAutogenous conduits demonstrated superior performance when compared with prosthetic grafts in terms of primary and secondary patency and number of revisions. A policy emphasizing the preferential placement of autogenous fistulas over prosthetic grafts may result in improved patency and a reduction in the number of procedures required to maintain dialysis access patency.

Objective Previous studies have correlated increasing great saphenous vein (GSV) diameter with increasing CEAP clinical classification. Some insurance carriers are currently using specific GSV diameters to determine coverage for treatment of axial venous insufficiency. The aim of this study was to investigate the correlation of patient quality of life (QOL) measures with GSV diameters in varicose vein patients with GSV reflux. Methods Data were collected from the records of 91 patients prospectively enrolled in two varicose vein trials. The patients had symptomatic varicose veins with saphenofemoral junction and proximal GSV reflux. Maximum GSV diameter was measured on duplex ultrasound imaging, with the patient standing, within 5 cm of the saphenofemoral junction. Chronic Venous Insufficiency Questionnaire 2 (CIVIQ-2; Servier, Neuilly-sur-Seine, France), Venous Insufficiency Epidemiological and Economic Study (VEINES) Symptom (Sym) and QOL assessments, and the Venous Clinical Severity Score (VCSS) assessment were completed before treatment of GSV insufficiency. Demographic information, patient weight, height, and body mass index were collected. Correlations between pairs of data were done using Pearson product-moment and Spearman correlation coefficients. Results The 91 study patients (19 men, 72 women) were a mean age of 45 years (range, 18-65 years). The mean GSV diameter was 6.7 mm (range, 2.2-14.1 mm). The mean VCSS score was 7.8 (range, 3-12). There was a weak correlation between increasing GSV diameter and VCSS ( r = 0.23; P = .03) and no correlation between GSV diameter and the CIVIQ-2 score ( r = 0.01), VEINES-QOL ( r = −0.07), and VEINES-Sym ( r = −0.1). Conclusions GSV diameter is a poor surrogate marker for assessing the effect of varicose veins on a patient's QOL; thus, using GSV diameter as a sole criterion for determining medical necessity for the treatment of GSV reflux is inappropriate. Further correlations between QOL measures and duplex-derived objective findings are warranted.