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- W3204071104 abstract "Numerous devices are available for the treatment of venous insufficiency. Until recently, only one radiofrequency ablation (RFA) catheter (ClosureFast; Medtronic, Dublin, Ireland) has been widely available for clinical use in the United States. To date, no investigators have described their experience with a new RFA catheter, Venclose (Venclose Inc, San Jose, Calif), in clinical practice. We assessed the short-term success of great saphenous vein (GSV) ablation with the Venclose catheter compared with the ClosureFast catheter, according to the treatment times, number of RFA cycles, duplex ultrasound results, and morbidity. We performed a retrospective matched cohort study of patients who had undergone RFA for symptomatic GSV insufficiency at a vascular surgery practice (three surgeons) from 2019 to 2020. We included the first 48 consecutive patients treated with the Venclose catheter and matched them 1:1 with patients treated with ClosureFast catheter by age and sex. We excluded patients who had not had the GSV treated or had not undergone follow-up ultrasound within 1 week after treatment. We tested for significant differences in outcomes using the Fisher exact test if the outcome was rare (fewer than five events). Finally, we assessed for differences in treatment times and RFA cycles using multivariable linear and Poisson regression, respectively. We controlled for potential confounders established a priori (ie, vein length, surgeon, body mass index) and defined as α = 0.05. We included 96 patients. Descriptive statistics are presented in the Table. The treatment time and number of RFA cycles were significantly shorter and fewer (P < .01) for the patients treated with the Venclose catheter, after controlling for confounders. All GSVs were closed at the first ultrasound examination and none had recanalized at the second (∼1-6 months). No statistically significant differences were found in the incidence of complications, including thermal injury, nerve injury, superficial vein thrombosis, deep vein thrombosis, and pulmonary embolism. The providers achieved equal numbers of successful GSV ablation with both devices. The procedure times and number of treatment cycles were significantly less with the Venclose catheter, and adverse events were rare with both catheters. These findings have practical implications for patients and vascular surgeons, with enhanced procedure room efficiency and without increased morbidity.TableDescriptive statistics for retrospective matched cohort study of two radiofrequency ablation catheters used for great saphenous vein closure at a vascular surgery practice, 2019 to 2020VariableClosureFastVencloseP valueaTotal sample48 (50)48 (50)Age, years57.0 ± 16.456.9 ± 16.8.99BMI, kg/m231.5 ± 6.029.4 ± 6.1.10Sex1.00 Male20 (41.7)20 (41.7) Female28 (58.3)28 (58.3)Race/ethnicity.50 White39 (81.3)33 (68.8) Black1 (2.1)2 (4.2) Hispanic4 (8.3)9 (18.8) Other/did not disclose4 (8.3)4 (8.3)Length of vein, mm43.3 ± 16.948.7 ± 15.8.11Procedure duration, minutes3.2 ± 1.32.3 ± 0.7<.01RFA cycles, No.10 (7-13)7 (6-8)<.01GSV closureb48 (100.0)48 (100.0)NARecanalization of closed veinc0 (0.0)0 (0.0)NABMI, body mass index; GSV, great saphenous vein; NA, not applicable; RFA, radiofrequency ablation.Data presented as number (%), mean ± standard deviation, or median (interquartile range [25th percentile to 75th percentile]).Boldface P values represent statistical significance.aCrude analysis of group differences using the independent Student t test for continuous variables, the χ2 or Fisher exact for categorical variables, and the nonparametric K-sample test of equality for the median for count variables.bDefined as no reflux or the appearance of a closed vein at the first postprocedure duplex ultrasound.cAt second consecutive postprocedure duplex ultrasound. Open table in a new tab" @default.
- W3204071104 created "2021-10-11" @default.
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- W3204071104 date "2021-10-01" @default.
- W3204071104 modified "2023-10-18" @default.
- W3204071104 title "Practical Efficacy of a New Radiofrequency Ablation Catheter: A First Experience, Comparative Study" @default.
- W3204071104 doi "https://doi.org/10.1016/j.jvs.2021.07.048" @default.
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