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March 10, 2020

Medtronic’s VenaSeal Closure System Compared With Other Therapies for Chronic Venous Insufficiency

March 10, 2020—Findings from a network meta-analysis evaluating the VenaSeal closure system (Medtronic) for chronic venous insufficiency (CVI) management were recently published online by Raghu Kolluri, MD, et al in Journal of Vascular Surgery: Venous and Lymphatic Disorders (JVS–VL).

The aim of the study was to compare the VenaSeal with endovenous laser ablation (EVLA), radiofrequency ablation (RFA), mechanochemical ablation, sclerotherapy, and surgery for management of CVI. Achieving anatomic success (complete closure of treated vein within 6 months of intervention) was the primary outcome and health-related quality of life (HRQoL) (including EuroQoL five dimensions [EQ-5D] and Aberdeen Varicose Vein Questionnaire [AVVQ]), Venous Clinical Severity Score (VCSS), pain scores, and adverse events were secondary outcomes.

As summarized in JVS:VL, the investigators conducted a systematic review of journal databases, which included RCTs between January 1996 and September 2018, and compared different treatment options. They assessed risk of bias and quality of publications using the Cochrane bias tool. Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines were used for study selection and reporting.

Twenty RCTs comprising 4,570 patients were analyzed. Data for anatomic success, VCSS, HRQoL, pain score, and adverse events were extracted and analyzed using mixed treatment comparison in a network meta-analysis.

A Bayesian fixed or random effects model was selected for analysis. Rank probability graphs were generated for various treatments and corresponding ranks obtained to estimate their probability of being best. Relative treatment effects were calculated in terms of log odds ratios for anatomic success and adverse events. Mean difference was calculated for VCSS, HRQoL, and pain score.

The investigators reported the following:

  • For primary outcome measure (anatomic success), VenaSeal had the highest probability of being ranked first (P = .98); RFA was ranked second (P = .365), EVLA third (P = .397), surgery fourth (P = .29), mechanochemical ablation fifth (P = .695), and sclerotherapy sixth (P = .982).
  • For secondary outcome measures, VenaSeal ranked third for VCSS (P = .332), fifth for EQ-5D (P = .42), and third for AVVQ (P = .3).
  • VenaSeal was slightly inferior to some of the other interventions for HRQoL; however, the 95% credible interval of log odds ratio indicated insufficient evidence for any concrete conclusion to be drawn.
  • VenaSeal ranked first in reduction of postoperative pain score from baseline (P = .69) and was lowest in occurrence of adverse events (P = .65).
  • The odds of occurrence of adverse events was 3.3 times in the sclerotherapy arm, 2.7 times in the EVLA arm, 1.6 times with surgery, and 1.1 times with RFA versus the VenaSeal system arm.

In JVS:VL, the study investigators concluded, “VenaSeal system is a promising therapeutic option for anatomic success at 6 months, with fewer occurrences of adverse events (wound and groin infection, pulmonary embolism) in CVI patients compared with other interventions in this study.” Furthermore, they advised, “Additional economic analysis including cost-effectiveness analysis would provide interesting perspectives on real-world insights to patients, payers, and providers.”

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Prevalence and Predictors of Elevated Central Venous Pressure and Obstructive Sleep Apnea Evaluated in Patients With Lower Extremity Chronic Venous Disease

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