RESUMEN
INTRODUCTION: Endovenous laser ablation (EVLA) is associated with an excellent outcome in the treatment of great saphenous vein (GSV) incompetence. However, the use of thermal ablation requires tumescent anaesthesia and is associated with a risk of thermal damage. Mechanochemical endovenous ablation (MOCA) is a non-thermal ablation (NTA) alternative, which combines mechanical endothelial damage with the infusion of a sclerosant liquid or foam. Tumescent anaesthesia is not required. Preliminary experiences with MOCA using the Clarivein device show less intraprocedural and postprocedural pain and a faster clinical improvement compared with EVLA. Flebogrif (Balton, Poland) is a relatively new MOCA device. To determine the role of MOCA using Flebogrif, a well-designed, randomised controlled clinical trial of sufficient sample size and follow-up time is required. In this article, we provide the study protocol for the REBORN trial, aiming to demonstrate that MOCA using Flebogrif is not inferior to EVLA for the outcome of anatomical success in the treatment of GSV incompetence. METHODS AND ANALYSIS: This multicentre, open-label, non-inferiority, observer-blinded, randomised controlled trial randomises patients who are diagnosed with GSV incompetence and aged 18-80 years between Flebogrif and EVLA. 310 patients in 3 participating centres (Northwest Clinics Alkmaar, Skin and Vein Clinic Oosterwal Alkmaar and Red Cross Hospital Beverwijk) will be included. The primary outcome is anatomical success at 12 months. Secondary outcomes are intraprocedural pain, operation time, technical success, postprocedural pain, safety, anatomical success during other follow-up moments, complications, clinical success, aesthetic result, disease-specific quality of life, reinterventions, anterior accessory saphenous vein reflux and neovascularisation. Patients will be followed up at 1 week, 1, 6, 12, 24 and 60 month(s) after treatment. ETHICS AND DISSEMINATION: The institutional review board (Medical Ethical Review Committee of the Vrije Universiteit Medical Center) approved this study on 17 May 2021 under case number 2020.0740. Written informed consent is obtained by the coordinating investigator from all participants prior to study enrolment. After completion of the trial, the results will be submitted to an international scientific journal for peer-reviewed publication. TRIAL REGISTRATION NUMBER: Overzicht van Medisch-wetenschappelijk Onderzoek in Nederland, NL-OMON25145, previously NL9527; Centrale Commissie Mensgebonden Onderzoek, NL74491.029.20.
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Procedimientos Endovasculares , Terapia por Láser , Vena Safena , Insuficiencia Venosa , Humanos , Vena Safena/cirugía , Insuficiencia Venosa/cirugía , Terapia por Láser/métodos , Terapia por Láser/efectos adversos , Procedimientos Endovasculares/métodos , Estudios de Equivalencia como Asunto , Resultado del Tratamiento , Estudios Multicéntricos como Asunto , Femenino , Adulto , Escleroterapia/métodos , Soluciones Esclerosantes/uso terapéutico , Soluciones Esclerosantes/administración & dosificación , MasculinoRESUMEN
We sought to assess the efficacy and safety of endovenous laser ablation utilizing a 980 nm device versus a 1470 nm device in the treatment of lower limb venous insufficiency. We performed a systematic review adhering to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) 2020 statement. A research on PubMed, Scopus and Web of science for articles published by January 2024 was conducted. The primary endpoint was great saphenous vein (GSV) and truncal vein occlusion. Eleven studies encompassing 3061 patients and 3193 truncal veins, were included. The 1470 nm device demonstrated superior truncal vein and GSV occlusion outcomes compared to the 980 nm device at the early, one-year, and medium to long-term follow-up intervals. Odds ratios (OR) were 2.79(95%CI:1.31-5.94), 2.22(95%CI:1.21-4.07), and 2.02(95%CI:1.24-3.29) for truncal veins and 2.54(95%CI:1.119-5.41), 2.06(95%CI:1.07-3.95) and 2.04(95%CI:1.25-3.33) for GSV, across the respective intervals. While both devices demonstrated minimal, deep vein thrombosis (DVT), endovenous heat-induced thrombosis (EHIT) ≥ 2, and burn estimates, the 1470 nm device exhibited improved paresthesia, risk ratio (RR), 0.51(95%CI:0.34-0.77) and pain outcomes, standardized mean difference (SMD), -0.62(95%CI:-0.99to-0.25). Subgroup analysis displayed enhanced occlusion outcomes with the 1470 nm device for the six-month and one-year intervals, irrespective of fiber type. Radial fibers were associated with improved paresthesia outcomes (ß=-0.9520,p = 0.03). This review emphasized the enhanced efficacy of the 1470 nm device over the 980 nm device, regardless of fiber type. Radial fibers showed promise for improved paresthesia outcomes, suggesting similar safety profiles for both systems. Conclusive remarks on pain outcomes were impeded by data limitations.
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Procedimientos Endovasculares , Terapia por Láser , Insuficiencia Venosa , Humanos , Procedimientos Endovasculares/instrumentación , Procedimientos Endovasculares/métodos , Procedimientos Endovasculares/efectos adversos , Terapia por Láser/instrumentación , Terapia por Láser/métodos , Terapia por Láser/efectos adversos , Resultado del Tratamiento , Insuficiencia Venosa/cirugíaRESUMEN
INTRODUCTION: Laser and radiofrequency ablation are two thermal ablation methods currently widely used to treat lower limb venous insufficiency. However, very few studies have been conducted on the use of microwaves, a form of thermal ablation, for the treatment of small saphenous vein (SSV) insufficiency. This study aimed to examine the efficacy and safety of endovenous microwave ablation (EMA) for the treatment of SSV insufficiency. METHODS: The clinical data of 126 patients (126 lower limbs) with SSV insufficiency (SSV trunk reflux time ≥ 500 ms on lower limb color Doppler ultrasound) treated at the Surgery Department of The Sixth People's Hospital of Zhuji from January 2020 to June 2022 were analyzed retrospectively; 64 patients underwent EMA and 62 underwent endovenous laser ablation (EVLA). The perioperative marker data [duration of surgery, duration of hospitalization, length of thermal ablation, duration of thermal ablation, number of incisions, and numerical pain rating scale (NPRS)], complication data [skin ecchymosis, skin burns, surgical site infection, paresthesia, deep vein thrombosis (DVT), and heat-induced thrombosis (EHIT)], venous clinical severity score (VCSS), chronic venous disease quality of life questionnaire (CIVIQ-20) before and 1, 3, 12 months after surgery, and SSV trunk occlusion rate at 12 months after surgery were compared between the two groups. RESULTS: No significant differences in the surgery or hospitalization durations were observed between the two groups. There were no significant differences in the length of the SSV that required thermal ablation between the two groups; however, the thermal ablation time was shorter in the EMA group than that in the EVLA group (6.14 ± 1.47 min vs 7.05 ± 1.16 min, P < 0.001). There were no statistical differences in the number of incisions, volume of tumescent solution used, or quantity of sclerosing foam used. The NPRS scores of the EMA group at 24 h and 72 h after surgery were significantly greater than those of the EVLA group (4.03 ± 0.98 vs 3.52 ± 1.28, P = 0.013; 3.78 ± 1.06 vs 3.15 ± 1.03, P = 0.001). Moreover, the two groups showed no significant difference in the NPRS score at 1 month (1.14 ± 0.84 vs 1.07 ± 0.75, P = 0.623). The EMA and EVLA group patients experienced similar postoperative complications. The VCSS and CIVIQ-20 score significantly improved at 1, 3, and 12 months after surgery. The VCSS and CIVIQ-20 scores were compared between the two groups at 12 months after surgery, and there were no significant differences (1.44 ± 0.63 vs 1.56 ± 0.56, P = 0.261; 24.24 ± 4.96 vs 25.19 ± 5.36, P = 0.304). There was no significant difference in the incidence of SSV trunk occlusion at 12 months after surgery between the two groups (95.31% vs 96.77%, OR 1.475; 95% CI 0.238-9.146, P = 1.000). CONCLUSION: EMA and EVLA are equally effective treatment methods for SSV insufficiency. EMA is associated with higher NPRS scores in the early postoperative period.
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Terapia por Láser , Microondas , Vena Safena , Várices , Insuficiencia Venosa , Humanos , Femenino , Vena Safena/cirugía , Masculino , Persona de Mediana Edad , Terapia por Láser/métodos , Terapia por Láser/efectos adversos , Várices/cirugía , Microondas/uso terapéutico , Estudios Retrospectivos , Insuficiencia Venosa/cirugía , Procedimientos Endovasculares/métodos , Resultado del Tratamiento , Adulto , Anciano , Ablación por Radiofrecuencia/métodos , Ablación por Radiofrecuencia/efectos adversos , Ablación por Catéter/métodos , Ablación por Catéter/efectos adversos , Técnicas de Ablación/métodos , Técnicas de Ablación/efectos adversos , Calidad de VidaRESUMEN
Varicosis is a chronic progressive disease characterized by varicose veins of the lower extremities. Pain, swelling and heaviness of the legs are typical symptoms. These symptoms are caused by a pathological venous reflux, arising from a weakness of the vein wall and progressive venous insufficiency. The indications for invasive surgery are the symptomatic clinical, etiological, anatomical, pathophysiological (CEAP) stages C2s-C6. Compression therapy and venoactive drugs can be recommended for conservative therapy. When it comes to surgical treatment conventional open vein surgery is associated with the best long-term results. Endovenous thermal ablation is associated with few postoperative complications and favors earlier mobilization of the patient. Sclerotherapy has become established with good clinical results for the ablation of reticular and telangiectatic veins, for recurrences and complicated vein anatomy.
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Terapia por Láser , Várices , Insuficiencia Venosa , Humanos , Resultado del Tratamiento , Várices/diagnóstico , Várices/cirugía , Escleroterapia/métodos , Insuficiencia Venosa/complicaciones , Insuficiencia Venosa/cirugía , Terapia por Láser/métodosRESUMEN
OBJECTIVE: The goal of this study was to analyze trends in treatment access for chronic superficial venous disease and to identify disparities in care. METHODS: This retrospective study was exempt from institutional review board approval. The American College of Surgeon National Surgical Quality Improvement Program database was used to identify patients who underwent vein stripping (VS) and endovenous procedures for treatment of chronic superficial venous disease. Endovenous options included radiofrequency ablation (RFA) and laser ablation. Data was available from 2011 to 2018 and demographic information was extracted for each patient identified by Current Procedural Terminology codes. For all racial and ethnic groups, trend lines were plotted, and the relative rate of change was determined within each specified demographic. RESULTS: There were 21,025 patients included in the analysis. The overall mean age was 54.2 years, and the majority of patients were female (64.8%). In total, 27.9%, 55.2%, and 16.9% patients underwent VS, RFA, and laser ablation, respectively. Patients who received laser ablation were older (P < .001). Hispanic ethnicity was associated with significantly lower odds of receiving endovascular thermal ablation (EVTA) over VS (odds ratio [OR], 0.71; 95% confidence interval [CI], 0.64-0.78; P < .001). American Indian/Alaska Native patients were more likely to receive EVTA over VS (OR, 4.02; 95% CI, 2.48-6.86); similarly, Native Hawaiian/Pacific Islander patients were more likely to receive EVTA over VS, although this difference was not statistically significant (OR, 1.44; 95% CI, 0.93-2.27). On multinomial regression, Hispanic patients were less likely to receive RFA over VS, whereas American Indian/Alaskan Native patients were more likely to receive RFA over VS. In all racial and ethnic groups, the percentage of endovenous procedures increased, whereas vein stripping decreased. CONCLUSIONS: Based on a hospital-based dataset, demographic indicators, including age, sex, race, and ethnicity, are associated with differences in endovenous treatments for chronic superficial venous insufficiency suggesting disparities in obtaining minimally invasive treatment options among certain patient groups.
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Bases de Datos Factuales , Procedimientos Endovasculares , Disparidades en Atención de Salud , Terapia por Láser , Extremidad Inferior , Insuficiencia Venosa , Humanos , Insuficiencia Venosa/cirugía , Insuficiencia Venosa/etnología , Insuficiencia Venosa/terapia , Femenino , Masculino , Persona de Mediana Edad , Estudios Retrospectivos , Disparidades en Atención de Salud/etnología , Disparidades en Atención de Salud/tendencias , Enfermedad Crónica , Estados Unidos , Factores de Tiempo , Resultado del Tratamiento , Extremidad Inferior/irrigación sanguínea , Accesibilidad a los Servicios de Salud , Anciano , Factores Raciales , Adulto , Factores de RiesgoRESUMEN
OBJECTIVE: Endovenous thermal ablation (EVTA) is a prevalent treatment option for patients with severe venous disease. However, the decision to intervene for patients with less severe disease (CEAP [clinical, etiology, anatomy, pathophysiology] C2 and C3) is less clear and becomes further complicated for patients with obesity, a pathology known to increase venous disease symptom severity. Therefore, the objective of this study was to use the Society for Vascular Surgery Vascular Quality Initiative database to evaluate outcomes after EVTA in obese patients with CEAP C2 and C3 venous insufficiency. METHODS: Using the Society for Vascular Surgery Vascular Quality Initiative database, we retrospectively analyzed the initial procedure of all patients with a CEAP clinical class of C2 or C3 who underwent EVTA from January 2015 to December 2021. Patients were grouped by obesity, defined as a body mass index of ≥30 kg/m2. The primary outcome was the change in venous clinical severity score (VCSS) from the procedure to the patient's initial follow-up. The secondary outcomes included the change in patient-reported outcomes at follow-up via the HASTI (heaviness, achiness, swelling, throbbing, itching) score, incidence of follow-up complications, and recanalization of treated veins. The change in the VCSS and HASTI score were analyzed using Student t tests, and complications and recanalization were assessed using the Fisher exact test. Significant outcomes were confirmed by multiple variable logistic regression. The remaining significant variables were then analyzed, with obesity categorized using the World Health Organization classification system to analyze how increasing obesity levels affect outcomes. RESULTS: There were 8146 limbs that met the inclusion criteria, of which 5183 (63.6%) were classified as nonobese and 2963 (36.4%) as obese. Obesity showed no impact on improvement in the VCSS (-3.29 vs -3.35; P = .408). Obesity was found to be associated with a larger improvement in overall symptoms, as evidence by a greater improvement in the HASTI score (-7.24 vs -6.62; P < .001). Obese limbs showed a higher incidence of superficial phlebitis (1.5% vs 0.7%; P = .001), but no difference was found in recanalization or any other complication. CONCLUSIONS: These data suggest that obese patients with CEAP clinical class C2 or C3 experience greater improvement in their perceived symptoms after EVTA with little difference in clinical improvement and complications compared with nonobese patients. Although obesity has been associated with increased severity of venous disease symptoms, obese patients are able to derive significant relief after treatment during the short term and may experience greater relief of symptoms than nonobese patients when treated at more mild disease presentations.
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Procedimientos Endovasculares , Obesidad , Índice de Severidad de la Enfermedad , Insuficiencia Venosa , Humanos , Masculino , Femenino , Estudios Retrospectivos , Persona de Mediana Edad , Insuficiencia Venosa/cirugía , Insuficiencia Venosa/fisiopatología , Insuficiencia Venosa/diagnóstico por imagen , Obesidad/fisiopatología , Obesidad/complicaciones , Procedimientos Endovasculares/efectos adversos , Resultado del Tratamiento , Anciano , Bases de Datos Factuales , Adulto , Factores de Tiempo , Factores de Riesgo , Medición de Resultados Informados por el Paciente , Recuperación de la Función , Técnicas de Ablación/efectos adversosRESUMEN
BACKGROUND: Recanalization of target veins after treatment of superficial venous incompetence has clinical implications and may depend on the type of intervention. The aim of this study was to evaluate patient and procedural factors associated with truncal vein recanalization in a large study cohort using the Vascular Quality Initiative (VQI) Varicose Vein Registry. METHODS: We performed a retrospective review using the VQI Varicose Vein Registry from 2014 to 2018. We evaluated all procedures performed for truncal venous insufficiency. Demographic data and information about treatment modality were collected. Patients were separated into recanalization and nonrecanalization groups based on the status of the treated vein at follow-up ultrasound examination. The vein was only considered recanalized if the VQI noted complete recanalization of the target vein. Univariate and multivariate comparisons were performed as appropriate. RESULTS: A total of 10,604 procedures were performed in 7403 patients. The average age was 55.9 years and 70.3% of the patients were female. Patients with recanalization were more likely to have a history of phlebitis (P < .001) and had a higher mean body mass index (30.5 vs 32., kg/m2 ; P = .006) compared with those without recanalization. There was no difference in the use of compression therapy, anticoagulation, deep venous reflux, number of pregnancies, prior deep vein thrombosis, Venous Clinical Severity Score, and clinical-etiology-anatomy-pathophysiology between patients with and without recanalization. The number of truncal veins treated per procedure was higher in the recanalization group compared with the nonrecanalization group (2.36 vs 1.88; P = .001). After multivariate logistic regression, laser ablation was associated with higher rate of recanalization compared with radiofrequency ablation (P = .017). CONCLUSIONS: This study is the first to use VQI based data to describe risk factors for recanalization following treatment of truncal venous reflux. The use of laser ablation for truncal veins is associated with a higher risk for recanalization compared with radiofrequency ablation. Obesity, prior phlebitis, and number of veins treated were independently associated with increased rate of recanalization.
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Sistema de Registros , Várices , Insuficiencia Venosa , Humanos , Femenino , Masculino , Estudios Retrospectivos , Persona de Mediana Edad , Factores de Riesgo , Insuficiencia Venosa/diagnóstico por imagen , Insuficiencia Venosa/cirugía , Insuficiencia Venosa/fisiopatología , Insuficiencia Venosa/terapia , Resultado del Tratamiento , Várices/diagnóstico por imagen , Várices/cirugía , Várices/fisiopatología , Anciano , Medición de Riesgo , Procedimientos Endovasculares/efectos adversos , Adulto , Factores de Tiempo , Ablación por Catéter/efectos adversosRESUMEN
BACKGROUND: The optimal treatment approach for patients with active venous leg ulcers (VLUs) and post-thrombotic syndrome (PTS) associated with great saphenous vein (GSV) reflux remains unclear. To address this gap, we retrospectively compared the outcomes of patients with post-thrombotic VLU with an intact GSV vs those with a stripped or ablated GSV. METHODS: We retrospectively analyzed data from 48 patients with active VLUs and documented PTS, who were treated at a single center between January 2018 and December 2022. Clinical information, including ulcer photographs, was recorded in a prospectively maintained digital database at the initial and follow-up visits. Two patient groups-group A (with an intact GSV) and group B (with a stripped or ablated GSV)-were compared in terms of time to complete healing, proportion of ulcers achieving complete healing, and ulcer recurrence during the follow-up period. RESULTS: There were no significant differences in age, gender, initial ulcer size, or ulcer duration between the two groups. All included patients had femoropopliteal post-thrombotic changes. Group A had significantly more completely healed ulcers (33 of 34 ulcers, 97%) compared with group B (10 of 14 ulcers, 71%) (P = .008). Group A also exhibited a significantly shorter time to complete ulcer healing (median: 42.5 days, interquartile range [IQR]: 65) compared with group B (median: 161 days, IQR: 530.5) (P = .0177), with a greater probability of ulcer healing (P = .0084). Long-term follow-up data were available for 45 of 48 patients (93.7%), with a mean duration of 39.6 months (range: 5.7-67.4 months). The proportion of ulcers that failed to heal or recurred during the follow-up period was significantly lower in group A (9 of 32 ulcers, 27%) compared with group B (11 of 13 ulcers, 85%) (P = .0009). In addition, in a subgroup analysis, patients with an intact but refluxing GSV (12 of 34) had a significantly shorter time to heal (median: 34 days, IQR: 57.25) (P = .0242), with a greater probability of ulcer healing (P = .0091) and significantly fewer recurrences (2 of 12, 16%) (P = .006) compared with group B. CONCLUSIONS: Our findings suggest that removal of the GSV through stripping or ablation in patients with post-thrombotic deep venous systems affecting the femoropopliteal segment may result in delayed ulcer healing and increased ulcer recurrence. Patients with an intact GSV had better outcomes, even when the refluxing GSV was left untreated. These findings emphasize the potential impact of GSV treatment on the management of VLUs in individuals with PTS. Further investigation is needed to validate these results and explore alternative therapeutic strategies to optimize outcomes for this patient population.
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Síndrome Postrombótico , Úlcera Varicosa , Insuficiencia Venosa , Humanos , Úlcera , Estudios Retrospectivos , Vena Safena/cirugía , Resultado del Tratamiento , Úlcera Varicosa/terapia , Insuficiencia Venosa/cirugía , RecurrenciaRESUMEN
Obstruction and/or reflux compromise during venous emptying can facilitate different pathophysiologies in chronic venous insufficiency (CVI). We present a patient with persistent lower limb CVI edema caused by post-thrombotic syndrome (PTS), who responded well to femoral vein valve therapy via axillary vein bypass after unsuccessful valvuloplasty, and led a normal life. During a 12 month observation period, bridging vessels completely restored original anatomical structures. In a literature study, no similar surgeries were reported, but we show that this operation may be feasible in selected patients.
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Insuficiencia Venosa , Humanos , Insuficiencia Venosa/cirugía , Vena Femoral/cirugía , Extremidad Inferior/irrigación sanguínea , Edema/etiologíaRESUMEN
OBJECTIVE: Superficial venous incompetence (SVI) is a common disease that causes significant quality of life (QoL) impairment. There is a need for more health economic evaluations of SVI treatment. The aim of this study was to perform a cost effectiveness analysis in patients with great saphenous vein (GSV) incompetence comparing radiofrequency ablation (RFA), high ligation and stripping (HL/S), and no treatment or conservative treatment with one year follow up. METHODS: Randomised controlled trial economic analysis from an ongoing trial; 143 patients (156 limbs) with GSV incompetence (CEAP clinical class 2 - 6) were included. Treatment was performed with RFA or HL/S. Follow up was performed up to one year using duplex ultrasound, revised venous clinical severity score (r-VCSS), Aberdeen Varicose Vein Questionnaire (AVVQ), and EuroQol-5D-3L (EQ-5D-3L). RESULTS: Seventy-eight limbs were treated with RFA and HL/S respectively. No treatment or conservative treatment was assumed to have zero in treatment cost and no treatment benefit. In the RFA group, one limb had reflux in the GSV after one month and three limbs after one year. In HL/S, two limbs had remaining reflux in the treated area at one month and one year. Both disease severity (r-VCSS, p = .004) and QoL (AVVQ, p = .021 and EQ-5D-3L, p = .028) were significantly improved over time. The QALY gain was 0.21 for RFA and 0.17 for HL/S. The cost per patient was calculated as 1 292 for RFA and 2 303 for HL/S. The cost per QALY (compared with no treatment or conservative treatment) was 6 155 for RFA and 13 549 for HL/S. With added cost for days absent from work the cost per QALY was 7 358 for RFA and 24 197 for HL/S. The cost per QALY for both methods was well below the threshold suggested by Swedish National Board of Health. CONCLUSION: RFA is more cost effective than HL/S and no treatment or conservative treatment at one year follow up.
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Análisis Costo-Beneficio , Calidad de Vida , Ablación por Radiofrecuencia , Vena Safena , Insuficiencia Venosa , Humanos , Ligadura/economía , Vena Safena/cirugía , Vena Safena/diagnóstico por imagen , Insuficiencia Venosa/cirugía , Insuficiencia Venosa/economía , Insuficiencia Venosa/diagnóstico por imagen , Femenino , Masculino , Persona de Mediana Edad , Resultado del Tratamiento , Ablación por Radiofrecuencia/economía , Ablación por Radiofrecuencia/efectos adversos , Años de Vida Ajustados por Calidad de Vida , Factores de Tiempo , Procedimientos Quirúrgicos Vasculares/economía , Procedimientos Quirúrgicos Vasculares/efectos adversos , Procedimientos Quirúrgicos Vasculares/métodos , Anciano , Ablación por Catéter/economía , Ablación por Catéter/efectos adversos , Ablación por Catéter/métodos , Adulto , Costos de la Atención en Salud , Várices/cirugía , Várices/economía , Várices/diagnóstico por imagen , Análisis de Costo-EfectividadRESUMEN
BACKGROUND: To compare radiofrequency ablation (RFA) and cyanoacrylate closure (CAC) for large-diameter great saphenous vein (GSV) insufficiency between diameters of 12 and 16 mm. METHODS: This study is a single-center retrospective study. Subjects who underwent endovenous treatment with RFA (Group A) or CAC (Group B) for GSV insufficiency between June 2015 and June 2021 who were followed up for at least 2 years were included in the study. Subjects who had a 12-mm to 16-mm target vessel diameter and subjects with grade 3 and grade 4 reflux were included. Subjects' demographic data (age, sex), body mass indices, clinical, etiological, anatomic, pathophysiologic classification, GSV diameter, reflux grade, target vessel length, preoperative venous clinical severity score (VCSS), procedural time, postoperative first-day pain scores, postoperative 14th-day patient satisfaction scale, and postoperative complications were noted. In follow-up, subjects were evaluated with duplex ultrasonography and VCSS at 1, 6, 12, and 24 months. RESULTS: In total, 142 subjects were included (n = 71 for both groups). The mean GSV diameter was 13.21 ± 1.00 for Group A and 13.51 ± 0.97 for Group B. The groups did not differ in terms of age, sex, body mass index, clinical, etiological, anatomic, pathophysiologic classification, GSV diameter, reflux grade, target GSV length, preoperative VCSS, complications, postoperative 24-hr pain status or postoperative 14-day patient satisfaction scale (P > 0.05 for all comparisons). The procedure time was significantly shorter in Group B (34.68 ± 4.22 min for Group A vs. 22.59 ± 4.5 min for Group B, P = 0.001). In the 1-month and 6-month Duplex ultrasonography of the subjects, partial closure and patency rates in Group B were significantly higher than those in Group A (P = 0.003 and P = 0.025, respectively). At the 12-month and 24-month evaluation, closure rates did not show a statistically significant difference between the groups (P = 0.056 and P = 0.090, respectively). Preoperative and 1-month VCSS measurements did not show a statistically significant difference between groups (P > 0.05 for all comparisons). The 6-month, 12-month, and 24-month VCSS measurements of Group A were significantly higher than those in Group B. (P = 0.043, P = 0.009 and P = 0.002, respectively). CONCLUSIONS: Both RFA and CAC were found to be effective in the treatment of large-diameter GSV incompetency. The complication rates were similar between the 2 techniques. CAC had a shorter procedure time. Although the closure rates in the early postoperative period were better in the RFA group, long-term follow-up demonstrated similar patency rates. The functional results in the long-term follow-up were better in the RFA group.
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Cianoacrilatos , Vena Safena , Insuficiencia Venosa , Humanos , Vena Safena/diagnóstico por imagen , Vena Safena/fisiopatología , Vena Safena/cirugía , Estudios Retrospectivos , Femenino , Masculino , Insuficiencia Venosa/diagnóstico por imagen , Insuficiencia Venosa/cirugía , Insuficiencia Venosa/fisiopatología , Insuficiencia Venosa/terapia , Persona de Mediana Edad , Resultado del Tratamiento , Cianoacrilatos/efectos adversos , Cianoacrilatos/administración & dosificación , Factores de Tiempo , Adulto , Anciano , Ablación por Radiofrecuencia/efectos adversos , Procedimientos Endovasculares/efectos adversos , Adhesivos Tisulares/uso terapéutico , Adhesivos Tisulares/efectos adversosAsunto(s)
Vena Safena , Humanos , Vena Safena/cirugía , Vena Safena/trasplante , Vena Safena/diagnóstico por imagen , Várices/cirugía , Várices/diagnóstico por imagen , Resultado del Tratamiento , Ablación por Catéter/efectos adversos , Insuficiencia Venosa/cirugía , Insuficiencia Venosa/diagnóstico por imagen , Insuficiencia Venosa/fisiopatologíaRESUMEN
Objective: To compare the application effect of domestic and imported intravenous radiofrequency closure system in the treatment of primary varicose veins of lower extremities. Methods: This single-center prospective, non-inferiority randomized controlled trial was performed in the Department of Vascular Surgery, the Fourth Affiliated Hospital, Zhejiang University School of Medicine from January 2021 to January 2022. Patients with primary varicose veins of lower extremities who met the ataxation criteria were randomly assigned to the experimental group(domestic novel venous radiofrequency closure system) or the control group(imported venous radiofrequency closure system) in a ratio of 1â¶1. The two groups of subjects were compared in terms of target vein closure rate, technical success rate, system operation performance, incidence of adverse events and incidence of serious adverse events(SAE) within 6 months after surgery. Quantitative data were compared by Mann-Whitney U test, and categorical data were compared by χ2 test and non-inferiority test. Results: A total of 80 subjects were included in the trial (41 in the experimental group and 39 in the control group), including 27 males and 53 females, aged (M(IQR)) 55(23) years (range:40 to 78 years). There were 48 cases of left lower limb and 32 cases of right lower limb. The technical success rate and system control performance between the groups were 100%.The incidence of adverse events (58.5% (24/41) vs. 61.5% (24/39), χ2=0.075, P=0.784), and the incidence of SAE (7.3% (3/41) vs. 5.1% (2/39), χ2=0.163, P=0.686) within 6 months after surgery in experimental group and control group had no statistical significance. There was one device-related adverse event in each of the two groups. In the experimental group, one patient developed endovenous heat-induced thrombosis after surgery and recovered after taking rivaroxaban tablets. One patient in the control group had pain in the upper right thigh for more than 1 day after operation, which was cured after using analgesic cream. No device-related SAE occurred. The venous closure rate of the experimental group was 100% (38/38) at 6 months after surgery, and that of the control group was 97.4% (37/38). The difference between the two groups was 2.63% (95%CI:-3.19 to 8.45, Z=4.865, P<0.01), and the 95%CI lower limit of the difference in target venous closure rate between two groups was greater than the non-inferiority threshold of -10.00%. Conclusion: The early application effect of the new domestic intravenous radiofrequency closure system in patients with primary varicose veins of lower extremities is in line with expectations, it is not inferior to the imported system.
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Várices , Insuficiencia Venosa , Femenino , Humanos , Masculino , China , Estudios Prospectivos , Vena Safena/cirugía , Resultado del Tratamiento , Várices/cirugía , Insuficiencia Venosa/cirugía , Adulto , Persona de Mediana Edad , AncianoRESUMEN
An updated report on the five-year results in the treatment of great saphenous vein incompetence with mechanochemical ablation (MOCA) provides additional evidence for higher rates of anatomic recanalization compared to other treatment modalities and progressive worsening of symptoms with time.
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Várices , Insuficiencia Venosa , Humanos , Insuficiencia Venosa/cirugía , Insuficiencia Venosa/diagnóstico , Resultado del Tratamiento , Factores de Tiempo , Escleroterapia , Vena Safena/cirugía , Várices/cirugíaRESUMEN
OBJECTIVE: We aim to report on the Laser-Sclerosing Foam Hybrid Treatment (LSFHT) and its outcomes when used on patients with great saphenous vein (GSV) insufficiency. METHODS: This was a single center retrospective cohort study on patients with GSV insufficiency that were treated with the LSFHT technique, a surgical procedure that comprises the use of both sclerosing foam and endovenous ablation and avoids the use of tumescent anesthesia. Occlusion rates and complications were reported. RESULTS: 139 legs from 106 patients were operated, achieving a 100% occlusion rate, while only a small burn and 2 popliteal vein thrombosis cases occurred. CONCLUSION: The study suggests that the LSFHT is a feasible fast procedure that proved both effective and safe for the treatment of GSV insufficiency.
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Terapia por Láser , Várices , Insuficiencia Venosa , Humanos , Várices/cirugía , Escleroterapia/métodos , Insuficiencia Venosa/diagnóstico por imagen , Insuficiencia Venosa/cirugía , Vena Safena/cirugía , Estudios Retrospectivos , Terapia por Láser/efectos adversos , Resultado del TratamientoRESUMEN
BACKGROUND: Endovenous thermal ablation (EVTA) of the lower extremity veins has risen to become the main treatment modality for symptomatic venous reflux disease. One of the main reported side effects of EVTA is recanalization. As of today, there is no clear protocol as to when follow-up duplex ultrasound scans should be performed. However, the standard for postoperative duplex after truncal ablation is within 1 week of the procedure. Our aim is to try to find whether there is a particular time period when postoperative duplex ultrasound scans should be performed to allow us to best diagnose recanalization. METHODS: We retrospectively analyzed 9799 procedures in 3237 patients with chronic venous insufficiency owing to great, small, and anterior accessory saphenous vein insufficiency from 2012 to 2018. We excluded 466 perforator veins. All 9799 procedures were performed using EVTA in patients who failed to respond to conservative management initially. Postoperative duplex ultrasound scans were performed within 1 week (3-7 days postoperatively). We defined a successful obliteration as lack of color flow on postoperative scan. We defined symptomatic recanalization as presence of reflux on duplex ultrasound examination in the targeted vessel at follow-up with symptom recurrence. Follow-ups were performed every 3 months in the first year and every 6 months thereafter. RESULTS: Patient ages ranged from 15 to 99 years. The median patient age at the time of the procedures was 63 years (interquartile range [IQR], 51-73 years). The median overall follow-up was 25 months (IQR, 4-56 months). The Clinical, Etiology, Anatomy, and Pathophysiology (CEAP) class of all the procedures were: C1, 21; C2, 208; C3, 3585; C4, 4680; C5, 188; and C6, 1117. There were 145 redo procedures performed after symptomatic recanalization was diagnosed in patients. CEAP class of the redo patients were: C1, 0; C2, 2; C3, 49; C4, 70; C5, 5; and C6, 19. CONCLUSIONS: Most patients underwent a redo procedure performed within the first year after the initial procedure. Conversely, there was great variability as to when redo procedures were performed. Because there is no defined pattern as to when these symptomatic occurrences arise, it may not be required to perform postoperative duplex ultrasound scans after EVTA routinely, but instead when a patient comes back with symptoms such as swelling.
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Ablación por Catéter , Terapia por Láser , Várices , Insuficiencia Venosa , Humanos , Adolescente , Adulto Joven , Adulto , Persona de Mediana Edad , Anciano , Anciano de 80 o más Años , Estudios Retrospectivos , Resultado del Tratamiento , Insuficiencia Venosa/diagnóstico por imagen , Insuficiencia Venosa/cirugía , Insuficiencia Venosa/etiología , Extremidad Inferior/irrigación sanguínea , Vena Safena/diagnóstico por imagen , Vena Safena/cirugía , Várices/cirugía , Terapia por Láser/efectos adversosRESUMEN
INTRODUCTION: The objective of this study is to evaluate and compare the effectiveness of endovenous microwave ablation (EMA) and high ligation and strippingn (HLS) of the great saphenous vein (GSV) in the treatment of varicose veins. METHODS: We included 182 patients in each EMA and HLS groups. Follow-up outcomes included AVVQ, VCSS, chronic venous insufficiency questionnaire-14 (CIVIQ14) score, clinical recurrence rate of varicose vein treatment, and patient satisfaction during the 1-year follow-up period. RESULTS: At the 1-year follow-up, no significant difference was found in the clinical recurrence rate of varicose veins between the EMA and HLS groups (p = .75). The duration of the operation and the length of hospital stay for patients in the EMA group was shorter than that for the HLS group (p < .01). The Aberdeen Varicose Vein Questionnaire (AVVQ), Venous Clinical Severity Score (VCSS) score, and ecchymosis were lower for patients who underwent EMA surgery (p < .01). CONCLUSION: Our research results confirm that EMA improves patients' quality of life with lower limb varicose veins, with EMA showing higher patient satisfaction.
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Terapia por Láser , Várices , Insuficiencia Venosa , Humanos , Vena Safena/cirugía , Calidad de Vida , Microondas/uso terapéutico , Resultado del Tratamiento , Várices/cirugía , Ligadura , Insuficiencia Venosa/cirugía , Terapia por Láser/métodosRESUMEN
OBJECTIVE: Recanalization of the saphenous vein trunk after endovenous radiofrequency ablation (RFA) is often associated with recurrent varicose veins (RVVs) or recanalization. This study aimed to assess the long-term results of RFA of the great saphenous vein (GSV) and identify the risk factors for GSV recanalization and RVVs during follow-up for patients presenting to dedicated outpatient vein centers. METHODS: All consecutive patients with incompetent GSVs who underwent RFA between 2009 and 2019 were retrospectively analyzed. The primary study end points were freedom from GSV recanalization and the RVV rate during follow-up. The secondary study end points were the postoperative complication rate and the risk factors for GSV recanalization and RVVs. Univariate and multivariate analyses were performed to identify the potential risk factors for GSV recanalization and RVVs. RESULTS: During the study period, 1568 limbs were treated in 1300 consecutive patients (mean age, 53.5 ± 12.9 years; 71.9% women; CEAP [clinical, etiology, anatomy, pathophysiology] C2-C6; venous clinical severity score >5). Technical success was achieved in 99.7% of cases. At a mean follow-up of 57.2 ± 25.4 months, the GSV occlusion and freedom from reintervention rates were 100% and 100% within 1 week, 97% and 95.7% at 1 year, 95.2% and 93.1% at 3 years, and 92.4% and 92.8% at 5 years, respectively. The recurrence rate was 10% (n = 158) during the follow-up period. On multivariate analysis, a direct confluence of the accessory saphenous vein into the saphenofemoral junction (odds ratio [OR], 1.561; 95% confidence interval [CI], 1.0-7.04; P = .032), a history of pregnancy >2 (OR, 3.68; 95% CI, 1.19-11.36; P = .023), C4 (OR, 6.41; 95% CI, 1.36-30.28; P = .019), and preoperative GSV diameter >10 mm (OR, 1.82; 95% CI, 1.65-4.03; P = .043) were risk factors for GSV recanalization. Moreover, age >70 years (OR, 1.04; 95% CI, 1.01-1.06; P = .014) and incompetent perforator veins (OR, 1.17; 95% CI, 0.65-2.03; P = .018) were also risk factors for RVVs. CONCLUSIONS: RFA is a safe technique to ablate the GSV with a low complication rate and durability during 5 years of follow-up. However, patients with a high clinical score and those with direct confluence of the accessory saphenous vein into the saphenofemoral junction experienced higher long-term GSV recanalization and RVV rates.
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Ablación por Catéter , Ablación por Radiofrecuencia , Várices , Insuficiencia Venosa , Humanos , Femenino , Adulto , Persona de Mediana Edad , Anciano , Masculino , Estudios Retrospectivos , Ablación por Catéter/efectos adversos , Várices/diagnóstico por imagen , Várices/cirugía , Várices/etiología , Ablación por Radiofrecuencia/efectos adversos , Vena Safena/diagnóstico por imagen , Vena Safena/cirugía , Insuficiencia Venosa/diagnóstico por imagen , Insuficiencia Venosa/cirugía , Insuficiencia Venosa/etiología , Resultado del TratamientoRESUMEN
OBJECTIVE: The aim of this study was to summarize the existing evidence for the treatment of saphenous veins >10 mm in diameter, to determine whether there were vein size limits for treatment modalities, and to determine if there are specific technical considerations for treatment of large veins. METHODS: We searched the literature for reports of treatment methods and outcomes for patients with large-diameter saphenous veins treated with various ablation methods between 1993 and 2023. These studies were evaluated for the size of the vein determined as "large diameter," type of ablation method, study type, outcomes, adverse events, and any technical considerations noted. A systematic review was conducted and reported according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) methodology. The COVIDENCE software was used for full-text screening and data extraction. Three reviewers reviewed the data, and the content expert served as the tiebreaker. RESULTS: Seventy-one records were identified, of which 24 studies were deemed appropriate for extraction. Most of the studies identified reported outcomes of endovenous thermal ablation modalities. There were fewer studies on non-thermal, non-tumescent techniques, and these studies reported an overall lower occlusion rate compared with endovenous thermal ablation techniques. CONCLUSIONS: Large head-to-head trials or randomized controlled that compare all the modalities over a long follow-up duration are yet to be performed. In the existing literature, there is considerable heterogeneity in terms of the study size, design, definition of large veins, site of vein measurement, and follow-up periods, making it challenging to make fair comparisons and draw firm conclusions. Currently available evidence supports the use of endothermal ablation techniques for the treatment of veins >10 mm in diameter as they have a more favorable efficacy and safety profile and have a larger body of evidence available compared with non-thermal, non-tumescent techniques or surgery.
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Técnicas de Ablación , Várices , Insuficiencia Venosa , Humanos , Vena Safena/diagnóstico por imagen , Vena Safena/cirugía , Técnicas de Ablación/efectos adversos , Técnicas de Ablación/métodos , Várices/diagnóstico por imagen , Várices/cirugía , Insuficiencia Venosa/diagnóstico por imagen , Insuficiencia Venosa/cirugía , Vena Femoral , Resultado del TratamientoRESUMEN
BACKGROUND: Vein ablation is a common and effective treatment for patients with chronic venous insufficiency. The overuse of vein ablation despite the existence of evidence-based guidelines has resulted in insurance companies developing restrictive policies for coverage that create barriers to appropriate care. This study compares the insurance coverage by single-state carriers (SSCs) and multistate carriers (MSCs), highlighting the variations and inconsistencies in the various policies. METHODS: The American Venous Forum Venous Policy Navigator was reviewed for the various policies available in the United States. The policies were divided into SSCs and MSCs. The characteristics of the policies, including the anatomic and hemodynamic criteria for specific veins, duration of conservative treatment, disease severity, symptoms, and types of procedures covered, were compared between the two groups. SAS, version 9.4 (SAS Institute Inc) was used for statistical analysis. RESULTS: A total of 122 policies were analyzed and divided between SSCs (n = 85; 69.7%) and MSCs (n = 37; 30.3%). A significant variation was found in the size requirement for great saphenous vein ablation. Although 48% of the policies did not specify a size criterion, the remaining policies indicated a minimal size, ranging from 3 to 5.5 mm. However, no significant differences were found between SSCs and MSCs. Similar findings were encountered for the small and anterior accessory saphenous veins. MSCs were more likely to define a saphenous reflux time >500 ms compared with SSCs (81.1% vs 58.8%; P = .04). A significant difference was found between the SSCs and MSCs in the criteria for perforator ablation in terms of size and reflux time. MSCs were significantly more likely to provide coverage for mechanochemical ablation than were SSCs (24.3% vs 8.2%; P = .03). SSCs were more likely to require ≥12 weeks of compression stocking therapy than were MSCs (76.5% vs 48.7%; P = .01). No significant differences were found in the clinical indications between the two groups; however, MSCs were more likely to mention major hemorrhage than were SSCs. CONCLUSIONS: The results of this study highlight the variations in policies for venous ablation, in particular, the striking inconsistencies in size criteria. MSCs were more likely to cover mechanochemical ablation and require a shorter duration of conservative therapy before intervention compared with SSCs. Evidence-based guidance is needed to develop more coherent policies for venous ablation coverage.