According to a network meta-analysis, the VenaSeal system by Medtronic is “a promising therapeutic option for anatomic success at six months.” The study, published in the Journal of Vascular Surgery: Venous and Lymphatic Disorders, also highlighted the lower number of adverse events with VenaSeal in patients with chronic venous insufficiency (CVI) compared to other interventions studied.
Although “several randomized controlled trials (RCTs) have compared different interventions for CVI management,” as first author Raghu Kolluri, MD, of Ohio Health and Riverside Methodist Hospital in Columbus, Ohio, and colleagues write, there is a lack of studies offering a mixed comparison of these available options.
Summarizing the current landscape of CVI management, Kolluri et al highlight that there are number of strategies being used to treat this kind of disease, including conservative care with compression stockings, surgery, foam sclerotherapy, endovenous laser ablation (EVLA), mechanochemical ablation (MOCA), radiofrequency ablation (RFA) and cyanoacrylate embolization (CAE).
VenaSeal can be used for CAE, and is employed globally for the treatment of CVI patients. In order to assess the effectiveness and safety of this system compared with other treatment methods previously listed, investigators performed a systematic review of journal databases, analyzing data from RCTs published between January 1996 and September 2018.
In total, 20 trials comprising 4,570 patients were examined, with Kolluri et al extracting data pertaining to anatomic success, Venous Clinical Severity Score (VCSS), health-related quality of life (HRQoL), pain score, and adverse events.
“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 authors explain.
Regarding the primary outcome measure of anatomic success, it was found that VenaSeal had the highest probability of being ranked first (p=0.980), followed in order by RFA (p=0.365), EVLA (p=0.397), surgery (p=0.290), MOCA (p=0.695) and sclerotherapy (p=0.982). “For secondary outcome measures,” Kolluri et al continue, “VenaSeal system ranked third for VCSS (p=0.332), fifth for EuroQol-5 Dimension (p=0.420), and third for Aberdeen Varicose Vein Questionnaire (p=0.300).”
Commenting on these results, the investigators note that while VenaSeal was slightly inferior to some interventions in terms of HRQoL, “the 95% credible interval of log odds ratio indicated insufficient evidence for any concrete conclusion to be drawn.”
Moreover, VenaSeal ranked first in reduction of postoperative pain score from baseline (p=0.690) and demonstrated the lowest occurrence of adverse events (p=0.650). Odds of occurrence of adverse events—including wound and ground infection, pulmonary embolism and deep vein thrombosis—was 3.3 times higher in the sclerotherapy arm, 2.7 times higher in the EVLA arm, 1.6 times higher with surgery, and 1.1 times higher with RFA, as compared to the arm of patients treated with VenaSeal.
“Limitations of this analysis include restricted data availability in terms of time points and pooling of data. Thus, the analysis could be performed only at the available time points. Another limitation with this analysis is that it compared the methods for the first six months after treatment, which is a relatively short period. Results were reported in different manners in the included studies; hence, fewer data points could not be pooled and used in this analysis,” acknowledged the authors.
Concluding, Kolluri et al write: “Previous studies have already reported that the use of CAE for CVI may reduce the time to return to work or normal activity, minimizing pain and improving the patient’s comfort. In total, the current level of clinical data shows the unique benefits of this non-thermal, non-tumescent, non-sclerosant treatment in management of CVI.
“The existing evidence is robust to demonstrate the safety and effectiveness of CAE in treating these patients; additional economic analysis including a cost-effectiveness analysis would provide interesting perspectives to the real-world insights to patients, payers, and providers.”
SOURCE: doi.org/10.1016/j.jvsv.2019.12.061
