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BACKGROUND 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. METHODS 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. RESULTS 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 less then .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. CONCLUSIONS 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. BACKGROUND Insurance approval for saphenous vein ablation is generally limited to junctional reflux involving the great saphenous vein (GSV) or small saphenous vein. This study was designed to investigate prevalence and disease severity of anterior accessory GSV (AAGSV) compared with GSV disease in patients presenting to dedicated outpatient vein centers. METHODS Deidentified data were pulled from the American Vein & Lymphatic Society PRO Venous Registry for first and second patient encounters. Variables included age, sex, and body mass index (BMI); clinical class of Clinical, Etiology, Anatomy, and Pathophysiology (CEAP) classification; revised Venous Clinical Severity Score (rVCSS); and duplex ultrasound values for each limb. Data were further scrutinized according to duplex ultrasound findings. Patients with normal findings on duplex ultrasound examination or evidence of acute or chronic thrombosis were excluded. Patients were further characterized into two groups. The primary group had no prior vein treatan BMI. The mean rVCSS for GSV of these patients (7.22) was significantly higher than that of AAGSV patients (5.63; P less then .01). The incidence of superficial vein thrombosis for the AAGSV patients (6.41%) was significantly higher than that of the GSV patients (2.17%; P less then .05) in the progressive group. Patients in the progressive group demonstrated no significant difference in age, sex proportions, mean BMI, or average rVCSS. The proportion of AAGSV limbs with superficial thrombosis events (37/287 [12.9%]) was significantly higher than that for GSV (59/2214 [2.7%]; P less then .01). CONCLUSIONS AAGSV reflux is common and carries similar morbidity to GSV reflux. It is manifested with an alarming presence of superficial vein thrombosis. BACKGROUND Chronic venous disease (CVD) affects >20 million people in the United States. read more Despite this huge prevalence, there are few data on whether the effectiveness of current CVD therapies for symptomatic superficial vein reflux is affected by race. The goal of this investigation was to evaluate CVD treatment outcomes in various races in the United States. METHODS From January 2015 to December 2017, we retrospectively reviewed and prospectively collected data from 66,621 patients who presented for CVD evaluation. We divided patients into five racial groups African American, Asian, Hispanic, other (race not recorded), and white. Presenting signs and symptoms, treatment modalities, number of procedures per patient, and preintervention and postintervention revised Venous Clinical Severity Scores (rVCSSs) were evaluated. All racial groups were stratified by Clinical, Etiology, Anatomy, and Pathophysiology (CEAP) class for subgroup analysis. RESULTS The average age of the entire cohort was 56.8 ± 14.7 years, wiith age in all racial groups except whites. Hispanics required the fewest procedures and African Americans required the most for optimal results. Postintervention rVCSSs equalized in all races when ablations were combined with phlebectomies and ultrasound-guided foam sclerotherapy. 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 (11) to either CAC or RFA. The primary outcome measure of this 60-month extension study was co 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.
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