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Background Established condition-specific patient-reported outcome measures for varicose veins are limited to the measurement of health status and function. A treatment satisfaction measure is needed to understand patient satisfaction with different treatment options. The aim of this study was to design a Venous Treatment Satisfaction Questionnaire (VenousTSQ) that would be ready for large-scale data collection and psychometric evaluation. Methods Relevant items were selected from the -TSQ Item Library and new items were designed where necessary. A draft VenousTSQ was prepared using the existing AneurysmTSQ as a template. Fifteen interviews were conducted from 4 days to 16 months after the procedure. The interviews were designed to elicit important sources of satisfaction or dissatisfaction before completion of draft questionnaires. The VenousTSQ drafts were modified between sets of interviews until no further changes were required. Results The final VenousTSQ consists of two questionnaires: VenousTSQ early (VenousTSQe) and VenousTSQ status (VenousTSQs). Items that need be asked only once are in the VenousTSQe, whereas those that can usefully be asked more than once are in the VenousTSQs. Of the 16 unique items forming the VenousTSQ, 12 were from the -TSQ Item Library. Only 1 of these 12 required significant modification. Conclusions The VenousTSQ represents a condition-specific psychological outcome measure for varicose veins, enabling patient satisfaction or dissatisfaction with such treatments to be measured. Large-scale data collection is under way to establish optimal scoring, quantitative validity, and reliability of the VenousTSQ.

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.

Background: Iliofemoral venous obstruction is recognized with increasing frequency as the underlying cause of lower extremity symptoms including edema, pain, skin changes, and, in advanced cases, ulceration. This study sought to evaluate the safety and effectiveness of the Abre venous self-expanding stent system for the treatment of symptomatic iliofemoral venous outflow obstruction. Methods: The ABRE Study (A Multi-Center, Non-Randomized Study to Evaluate the Safety and Effectiveness of the Abre Venous Self-Expanding Stent System in Patients With Symptomatic Iliofemoral Venous Outflow Obstruction) is a single-arm, multicenter, prospective study that included 200 subjects from 24 global sites. The primary end points were 12-month primary patency and major adverse events within 30 days. Secondary end points included lesion and procedure success, primary-assisted and secondary patency, major adverse events, stent migration, stent fracture, and quality of life changes. End point-related adverse events and imaging studies were adjudicated by independent clinical events committee and core laboratories, respectively. Results: Venous obstruction cause was classified as acute deep vein thrombosis (16.5%, 33/200), post-thrombotic syndrome (47.5%, 95/200), or nonthrombotic iliac vein lesion (36.0%, 72/200). The common iliac and external iliac veins were stented in 96.0% (192/200), 80.5% (161/200) of subjects, respectively. Stent implant into the common femoral vein was required in 44.0% (88/200). Primary patency at 12 months was 88.0% (162/184). Four (2.0%) major adverse events occurred within 30 days. Twelve-month primary-assisted and secondary patency were 91.8% (169/184) and 92.9% (171/184), respectively. No stent fractures or migrations were reported. Mean target limb Villalta score decreased from 11.2±5.6 at baseline to 4.1±4.8 at 12 months, and the mean target limb revised Venous Clinical Severity Score decreased from 8.8±4.7 at baseline to 4.3±3.6 at 12 months. Clinically meaningful improvements in quality of life and venous functional assessment scores from baseline were demonstrated through 12 months in all measures. Conclusions: Symptomatic iliofemoral venous obstruction can be successfully treated with an Abre venous stent. Study outcomes demonstrated a high patency rate with a good safety profile. Patients demonstrated a significant reduction in clinical symptoms and improvement in quality of life that was maintained through 12-month follow-up. Registration: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT03038438.

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.

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.

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.

Airborne transmission is predicted to be a prevalent route of human exposure with SARS-CoV-2. Aside from African green monkeys, nonhuman primate models that replicate airborne transmission of SARS-CoV-2 have not been investigated. A comparative evaluation of COVID-19 in African green monkeys, rhesus macaques, and cynomolgus macaques following airborne exposure to SARS-CoV-2 was performed to determine critical disease parameters associated with disease progression, and establish correlations between primate and human COVID-19. Respiratory abnormalities and viral shedding were noted for all animals, indicating successful infection. Cynomolgus macaques developed fever, and thrombocytopenia was measured for African green monkeys and rhesus macaques. Type II pneumocyte hyperplasia and alveolar fibrosis were more frequently observed in lung tissue from cynomolgus macaques and African green monkeys. The data indicate that, in addition to African green monkeys, macaques can be successfully infected by airborne SARS-CoV-2, providing viable macaque natural transmission models for medical countermeasure evaluation.

A new coronavirus (SARS-CoV-2) emerged in the winter of 2019 in Wuhan, China, and rapidly spread around the world. The extent and efficiency of SARS-CoV-2 pandemic is far greater than previous coronaviruses that emerged in the 21st Century. Here, we modeled stability of SARS-CoV-2 on skin, paper currency, and clothing to determine if these surfaces may factor in the fomite transmission dynamics of SARS-CoV-2. Skin, currency, and clothing samples were exposed to SARS-CoV-2 under laboratory conditions and incubated at three different temperatures (4°C± 2°C, 22°C± 2°C, and 37°C ± 2°C). We evaluated stability at 0 hours (h), 4 h, 8 h, 24 h, 72 h, 96 h, 7 days, and 14 days post-exposure. SARS-CoV-2 was stable on skin through the duration of the experiment at 4°C (14 days). Virus remained stable on skin for at least 96 h at 22°C and for at least 8h at 37°C. There were minimal differences between the tested currency samples. The virus remained stable on the $1 U.S.A. Bank Note for at least 96 h at 4°C while we did not detect viable virus on the $20 U.S.A. Bank Note samples beyond 72 h. The virus remained stable on both Bank Notes for at least 8 h at 22°C and 4 h at 37°C. Clothing samples were similar in stability to the currency. Viable virus remained for at least 96 h at 4°C and at least 4 h at 22°C. We did not detect viable virus on clothing samples at 37°C after initial exposure. This study confirms the inverse relationship between virus stability and temperature. Furthermore, virus stability on skin demonstrates the need for continued hand hygiene practices to minimize fomite transmission both in the general population as well as in workplaces where close contact is common., Author summary A new coronavirus (SARS-CoV-2) emerged in the winter of 2019 in Wuhan, China, and rapidly spread around the world. It is still unclear why and how this particular coronavirus has spread with greater efficiency around the world than previous emerging coronaviruses. It is also unclear what potential role surfaces and direct contact have with virus transmission. We attempted to determine if SARS-CoV-2 remained infectious on a series of tested surfaces for longer periods compared with other coronaviruses. Our studies indicate that when we inoculate SARS-CoV-2 on skin, the virus can remain infectious for up for 96 hours at room temperature. Clothing and bank notes where not as hospitable for virus stability as skin across all three tested temperatures. Refrigerated conditions also enhance stability of SARS-CoV-2 across all tested surfaces. These studies demonstrate the continued need for strict public health measures to combat the ongoing pandemic particularly during cold weather months.

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.

BACKGROUND: Patients with peripheral artery disease have an increased risk of cardiovascular morbidity and mortality. Antiplatelet agents are widely used to reduce these complications.METHODS: This was a multicentre, double-blind, randomised placebo-controlled trial for which patients were recruited at 602 hospitals, clinics, or community practices from 33 countries across six continents. Eligible patients had a history of peripheral artery disease of the lower extremities (previous peripheral bypass surgery or angioplasty, limb or foot amputation, intermittent claudication with objective evidence of peripheral artery disease), of the carotid arteries (previous carotid artery revascularisation or asymptomatic carotid artery stenosis of at least 50%), or coronary artery disease with an ankle-brachial index of less than 0·90. After a 30-day run-in period, patients were randomly assigned (1:1:1) to receive oral rivaroxaban (2·5 mg twice a day) plus aspirin (100 mg once a day), rivaroxaban twice a day (5 mg with aspirin placebo once a day), or to aspirin once a day (100 mg and rivaroxaban placebo twice a day). Randomisation was computer generated. Each treatment group was double dummy, and the patient, investigators, and central study staff were masked to treatment allocation. The primary outcome was cardiovascular death, myocardial infarction or stroke; the primary peripheral artery disease outcome was major adverse limb events including major amputation. This trial is registered with ClinicalTrials.gov, number NCT01776424, and is closed to new participants.FINDINGS: Between March 12, 2013, and May 10, 2016, we enrolled 7470 patients with peripheral artery disease from 558 centres. The combination of rivaroxaban plus aspirin compared with aspirin alone reduced the composite endpoint of cardiovascular death, myocardial infarction, or stroke (126 [5%] of 2492 vs 174 [7%] of 2504; hazard ratio [HR] 0·72, 95% CI 0·57-0·90, p=0·0047), and major adverse limb events including major amputation (32 [1%] vs 60 [2%]; HR 0·54 95% CI 0·35-0·82, p=0·0037). Rivaroxaban 5 mg twice a day compared with aspirin alone did not significantly reduce the composite endpoint (149 [6%] of 2474 vs 174 [7%] of 2504; HR 0·86, 95% CI 0·69-1·08, p=0·19), but reduced major adverse limb events including major amputation (40 [2%] vs 60 [2%]; HR 0·67, 95% CI 0·45-1·00, p=0·05). The median duration of treatment was 21 months. The use of the rivaroxaban plus aspirin combination increased major bleeding compared with the aspirin alone group (77 [3%] of 2492 vs 48 [2%] of 2504; HR 1·61, 95% CI 1·12-2·31, p=0·0089), which was mainly gastrointestinal. Similarly, major bleeding occurred in 79 (3%) of 2474 patients with rivaroxaban 5 mg, and in 48 (2%) of 2504 in the aspirin alone group (HR 1·68, 95% CI 1·17-2·40; p=0·0043).INTERPRETATION: Low-dose rivaroxaban taken twice a day plus aspirin once a day reduced major adverse cardiovascular and limb events when compared with aspirin alone. Although major bleeding was increased, fatal or critical organ bleeding was not. This combination therapy represents an important advance in the management of patients with peripheral artery disease. Rivaroxaban alone did not significantly reduce major adverse cardiovascular events compared with asprin alone, but reduced major adverse limb events and increased major bleeding.FUNDING: Bayer AG.

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).

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.

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.

Pelvic venous incompetence can cause symptomatic varicose veins in the perineum, buttock, and thigh. Presentation, symptom severity, and response to treatment of pelvic source varicose veins are not well defined. Currently available tools to measure the severity of lower extremity venous disease and its effects on quality of life may be inadequate to assess disease severity in these patients. The purpose of this study was to evaluate the histories, demographics, and clinical presentations of women with pelvic source varicose veins and to compare these data to a population of women with nonpelvic source varicose veins.A total of 72 female patients with symptomatic pelvic source varicose veins were prospectively followed up. Age, weight, height, parity, and birth weights of offspring were recorded. Both pelvic source varicose veins and saphenous incompetence were identified by duplex ultrasound. Patients were queried as to their primary symptoms, activities that made their symptoms worse, and time when their symptoms were most prominent. Severity of disease was objectively evaluated using the revised Venous Clinical Severity Score (rVCSS) and 10-point numeric pain rating scale (NPRS).Compared with women without a pelvic source of varicose veins (N = 1163), patients with pelvic source varicose veins were younger (mean, 44.6 ± 8.6 vs 52.6 ± 12.9 years; P .001), had lower body mass index (mean, 21.9 ± 2.8 vs 25.8 ± 6.2; P .001), and had larger babies than the U.S. population mean (mean, 3656 ± 450 g vs 3389 ± 466 g; P .001). The most common symptoms were aching (68%), throbbing (47%), and heaviness (35%). In premenopausal patients, 70% noted that symptoms were worst during menses. NPRS score varied from 0 to 8 (mean, 4.9). The correlation between rVCSS (mean 5.6 ± 1.9) and NPRS was small (r = 0.26; P = .03). There was a modest correlation between older age and lower NPRS scores (r = -0.39; P .001).Women with pelvic source varicose veins are a unique subset of patients. They are younger and thinner than those with nonpelvic source varicose veins, have larger infants than the general U.S. population, and have an inverse correlation between age and pain. As the majority of premenopausal patients have increased symptoms during menses, this may be due to hormonal influence. As it is poorly associated with patient-reported discomfort, the rVCSS is a poor tool for evaluating pelvic source varicose veins. A disease-specific tool for the evaluation of pelvic source varicose veins is critically needed, and this study is a first step in that endeavor.

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.

Researchers reviewing fire conditions at the Coconut Grove Night Club and the Beverly Hills Supper Club found occupant behavior was a factor in loss of life (Chertkoff & Kushigian, 1999). For this study, a virtual environment (VE) was created and subjects were randomly assigned to experience one of six virtual reality (VR) simulations. Wayfinding performance was scored on a four point scale: no errors, errors with self–recovery, errors requiring re–reading to recover, and failure to reach an exit. Subjects’ responses to survey questions were statistically analyzed against their VR performance using ANOVA and Chi–Square. Sixty–nine 1 8–24 year old college students (female N = 37; male N = 32) served as the sample population. Results suggest that the describability of landmarks provided a positive influence to route communication. Post hoc analyses revealed that participants using describable landmarks (DL) had a significantly lower (faster) total time than those with no landmarks (NL). Several gender relationships were found in this study. In the NL condition, males re–read less frequently compared to females; while males re–read in greater proportion than females in the non–describable landmark (NDL) condition. In the NL condition, females visited more sub–areas than males; whereas females visited fewer sub–areas in the DL and NDL conditions. This study provides valuable conclusions about wayfinding that can be applicable in the design of schools, dormitories, and other facilities used primarily by young adults.

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.