Extended Center for Vein Restoration study assessing comparative outcomes for the treatment of chronic venous insufficiency in Medicare- and non-Medicare-eligible patients.

BACKGROUND: We previously reported that chronic venous insufficiency treatment of Medicare-eligible patients achieved outcomes similar to those for non-Medicare-eligible patients. The goal of the present investigation was to assess the long-term treatment outcomes and the effect of race in a larger patient cohort. METHODS: From January 2015 to December 2019, we retrospectively reviewed the data from 131,268 patients who had presented for a lower extremity venous evaluation. We divided the patients into two groups by age: group A was aged ≥65 years and group B, <65 years. The treatments analyzed in each group were axial thermal ablation (TA), axial Varithena ablation (VA), TA plus phlebectomy, VA plus phlebectomy, and TA or VA with phlebectomy and ultrasound-guided foam sclerotherapy (UGFS). The treatment outcomes were assessed using the revised venous clinical severity score (rVCSS) and Chronic Venous Insufficiency Quality of Life 20-item questionnaire (CIVIQ-20) scores at the initial consultation and 1, 6, and 12 months after completion of the treatment plan. RESULTS: Of the 131,268 patients, 40,020 were in group A and 91,248 in group B, with an average age of 74.4 ± 6.6 and 49.9 ± 10.6 years, respectively. Of the 40,020 patients in group A, 15,697 (n = 25,234 limbs) had undergone TA and 1910 (n = 3222 limbs) had undergone VA. Of the 91,248 patients in group B, 35,220 (n = 53,717 limbs) had undergone TA and 2178 (n = 3672 limbs) had undergone VA. For the TA subgroups, all rVCSSs had significantly improved after treatment at each evaluation point (P ≤ .001). For the TA and VA plus phlebectomy with or without UGFS subgroup, the older patients (group A) required 6 months to develop the same degree of improvement as the younger patients (group B) at 1 month. When subdivided by race, all initial and 6-month rVCSSs and CIVIQ-20 scores within a race had improved and were better in group B, except for Asian and Hispanic patients (P ≤ .001). After TA or VA plus phlebectomy, with or without UGFS, the CIVIQ-20 outcomes had improved by 1 month in both groups, although the rVCSS lagged by 6 months in group A. No differences in the rVCSSs or CIVIQ-20 scores were observed between the groups treated with TA or VA. CONCLUSIONS: Medicare-eligible beneficiaries demonstrated improved outcomes similar to those of non-Medicare-eligible beneficiaries after ablation. When TA or VA plus phlebectomy with or without UGFS were examined, group A required 6 months to demonstrate rVCSSs equivalent to those of group B at 1 month. The CIVIQ-20 scores had improved by 1 month in both groups, regardless of the treatment modality. The difference in rVCSSs appeared to be driven by African American and white patients because Hispanic and Asian patients demonstrated equivalent results regardless of age. Patients treated with TA or VA demonstrated equivalent results.

Endothermal venous ablation of the saphenous vein on patients who are on anticoagulation therapy.

BACKGROUND: The purpose of this study was to evaluate the risks of bleeding, deep venous thrombosis (DVT), endovenous heat induced thrombosis (EHIT) and failure of ablation on patients who undergo ablation while on oral anticoagulation. METHODS: We compared 378 (3.4%) out of 11252 patients (group A) who had undergone 724 endovenous ablation of the saphenous veins from January 1, 2011 to September 30, 2014 while on oral anticoagulation to a randomly selected 375 patients (group B) who underwent 641endovenous ablation in the same time period but were not on anticoagulation. The demographic data, history of DVT, the Clinical, Etiologic, Anatomic, Pathologic (CEAP) classification and the VCSS (Venous Clinical Severity Score) scores were analyzed. The indications for anticoagulation, the anticoagulants used were recorded. The primary endpoints were bleeding, development of DVT or EHIT, and failure of ablation. RESULTS: Patients in group A were older, had more men, more history of DVT and PE, had higher CEAP and VCSS scores compared to group B. The type of anticoagulation used was warfarin in 77.2% direct oral inhibitors (DOIs) in 22.8%. The rate of failure of ablation at 3 days was 39 (5.6%) for Group A and 3 (0.5%) for Group B (P<0.0001) and at one month it was 46 (10.1%) vs. 27 (6.7%) (P=0.086). The number of EHIT cases in group A at 3 days was 2 (0.3%), compared to 6 (0.9%) in group B (P=0.016) and at 1 month it was 0 compared to 4 (1.0%) (P=0.0483). The DVT, SVT, hematoma and wound infection rates were similar in the two groups. CONCLUSIONS: Ablation of the saphenous veins in patients who are on oral anticoagulation is safe and does not increase the risk of bleeding or hematoma, but it may slightly lower the incidence of EHIT and increase the incidence of failure of ablation.

Incidence, progression, and risk factors for endovenous heat-induced thrombosis after radiofrequency ablation.

OBJECTIVE: Endovenous radiofrequency ablation has become an accepted mode of treatment for superficial venous reflux. In this study, we evaluated the incidence of endovenous heat-induced thrombosis (EHIT), its progression, and risk factors that may contribute to its formation. METHODS: This was a prospective study of all patients who underwent radiofrequency ablation of the great saphenous vein (GSV), accessory GSV, and small saphenous vein (SSV) from March 1, 2010, to September 30, 2011, from 12 of our affiliated vein centers in a primary vein practice. Demographic data, CEAP classification, previous history of deep venous thrombosis (DVT), body mass index, vein diameter, reflux time, catheter tip position, EHIT progression, number of stab phlebectomies, and Venous Clinical Severity Score of patients with EHIT were analyzed. RESULTS: Of the 6707 treated limbs, 4906 (73%) had GSV, 145 (2%) had accessory GSV, and 1656 (25%) had SSV ablation. EHIT developed in 201 limbs of 194 patients for an overall incidence of 3%. A nonfatal pulmonary embolism occurred in two patients (0.03%). Patients who developed EHIT were slightly older than those without EHIT (median age, 59 vs 56 years). In patients with EHIT, 34.8% were men, but only 25% were men among those who had no EHIT (P = .002). GSV, accessory GSV, and SSV diameters were larger in EHIT patients (P < .001 for all). Reflux time and catheter tip distance from the saphenous junctions were similar in those with and without EHIT. EHIT resolution occurred in 2 to 4 weeks in most patients, but EHIT worsening occurred in nine (4.5%) that all resolved ≤4 weeks. In the EHIT patients, 68% had multiple concomitant phlebectomies compared with 39.4% of those without EHIT (P < .0001). DVT history made no difference for EHIT development (P = .065). All but two class 1 and one class 2 EHIT patients were managed with observation and aspirin due to DVT history and physician concern. The Venous Clinical Severity Score was obtained only in the last 70 EHIT cases. The mean score was 5.92 preoperatively and improved to 2.08 at the 1-month follow-up. CONCLUSIONS: Large vein diameter, male sex, and multiple phlebectomies are risk factors for development of EHIT. We recommend that EHIT class 1 and 2 patients be managed with observation or antiplatelets, or both, but class 3 and 4 patients should be anticoagulated.

Case of the disappearing heat-induced thrombus causing pulmonary embolism during ultrasound evaluation.

We report a case of a 58-year-old male patient who underwent successful endovenous radiofrequency ablation of the left great saphenous vein for CEAP class 4a venous disease. On the third postoperative day, he had a duplex ultrasound scan for evaluation which showed successful occlusion of the great saphenous vein (GSV) with class 2 endovenous heat-induced thrombus (EHIT) that disappeared during the evaluation and caused a pulmonary embolism. To our knowledge, no case of pulmonary embolism has been reported to occur during postoperative follow-up duplex scanning. Relevant literature is reviewed and a possible mechanism for thrombus dislodgement is entertained.