Durability of treatment effect with polidocanol endovenous microfoam on varicose vein symptoms and appearance (VANISH-2)

Todd, Kenneth L.; Wright, David; Gibson, Kathleen; Goldman, Mitchel P.; Hertzman, Phillip A.; Hirsch, Stanley; Hye, Robert J.; Plaza-Ponte, M; Rathbun, Suman; Rosenberg, G; Schul, Marlin; Stanbro, Marcus; Weiss, RA

doi:10.1016/j.jvsv.2015.03.003

Cited by 27 publications

(17 citation statements)

References 13 publications

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“…17 The U.S. FDA has indicated that PROMs on symptoms and appearance is of greater importance that duplex ultrasound in the assessment of success in the treatment of varicose veins. 16 In the end, the potential of PROMs can be extended to optimize clinical effectiveness in deciding which patients should be offered a follow-up visit and which not. Patients with persistent problems or complications should be the only ones offered clinical follow-up.…”

Section: Discussionmentioning

confidence: 99%

Patients and physicians agree only partially in symptoms and clinical findings before and after treatment for varicose veins

2017

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Objective Quality improvement in surgery has mainly been based on clinical database outcomes. This study compared variables from the patient-reported Aberdeen Varicose Vein Questionnaire with the Danish Clinical Vein Database, in order to reveal agreements and differences in symptoms and clinical findings. Methods In the period January-March 2011, 379 legs in 287 patients treated for varicose veins were registered in the Danish Clinical Vein Database and compared to the Aberdeen Varicose Vein Questionnaire. Results Patients and physicians agreed in reduction of symptoms after intervention with one or more complaints still present in 128 (93%) patients according to Aberdeen Varicose Vein Questionnaire compared to the Danish Clinical Vein Database with only 64 (47%) patients. Patients reported cosmetic complaints and teleangiectasies both before and after treatment (p < 0.001) more often than doctors. Conclusion The Aberdeen Varicose Vein Questionnaire has added valuable information to the dialogue between the doctor and patient on which symptoms expecting to improve and which not.

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Section: Discussionmentioning

confidence: 99%

Patients and physicians agree only partially in symptoms and clinical findings before and after treatment for varicose veins

2017

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“…One-year efficacy data showed that although the product demonstrates sustained efficacy in terms of PROs, there was a reduction in sustained ultrasound response to treatment as measured by elimination of reflux through SFJ or complete occlusion of target incompetent vein. 54 Seventy-three per cent of patients demonstrated a sustained ultrasound response at one year compared to 89% at week 8.…”

Section: Clinical Trialsmentioning

confidence: 92%

“…Efficacy: BTGs have demonstrated that the product is efficacious and this is confirmed in one-year follow-up. 54 However, POL has previously been shown to be efficacious. BTG has effectively reconfirmed the established benefits of POL for varicose vein management.…”

Section: Clinical Trialsmentioning

confidence: 99%

Novel developments in foam sclerotherapy: Focus on Varithena® (polidocanol endovenous microfoam) in the management of varicose veins

2017

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Scope Varithena® is a recently approved commercially available drug/delivery unit that produces foam using 1% polidocanol for the management of varicose veins. The purpose of this review is to examine the benefits of foam sclerotherapy, features of the ideal foam sclerosant and the strengths and limitations of Varithena® in the context of current foam sclerotherapy practices. Method Electronic databases including PubMed, Medline (Ovid) SP as well as trial registries and product information sheets were searched using the keywords, 'Varithena', 'Varisolve', 'polidocanol endovenous microfoam', 'polidocanol' and/or 'foam sclerotherapy/sclerosant'. Articles published prior to 20 September 2016 were identified. Results Foam sclerosants have effectively replaced liquid agents due to their physiochemical properties resulting in better clinical outcomes. Medical practitioners commonly prepare sclerosant foam at the bedside by agitating liquid sclerosant with a gas such as room air, using techniques as described by Tessari or the double syringe method. Such physician-compounded foams are highly operator dependent producing inconsistent foams of different gas/liquid compositions, bubble size, foam behaviour and varied safety profiles. Varithena® overcomes the variability and inconsistencies of physician-compounded foam. However, Varithena® has limited applications due to its fixed sclerosant type and concentration, cost and lack of worldwide availability. Clinical trials of Varithena® have demonstrated efficacy and safety outcomes equivalent or better than physician-compounded foam but only in comparison to placebo alone. Conclusion Varithena® is a promising step towards the creation of an ideal sclerosant foam. Further assessment in independent randomised controlled clinical trials is required to establish the advantages of Varithena® over and above the current best practice physician-compounded foam.

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“…There is also a 1% polidocanol formulation named Varithena (BTG International, West Conshohocken, PA, USA) [ 63 ]. Varithena is FDA approved (since 2013) for the closure of visible varicose veins, as well as truncal incompetent veins.…”

Section: Non-thermal Techniquesmentioning

confidence: 99%

Latest Innovations in the Treatment of Venous Disease

Attaran

2018

JCM

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Durability of treatment effect with polidocanol endovenous microfoam on varicose vein symptoms and appearance (VANISH-2)

Cited by 27 publications

References 13 publications

Patients and physicians agree only partially in symptoms and clinical findings before and after treatment for varicose veins

Patients and physicians agree only partially in symptoms and clinical findings before and after treatment for varicose veins

Novel developments in foam sclerotherapy: Focus on Varithena® (polidocanol endovenous microfoam) in the management of varicose veins

Latest Innovations in the Treatment of Venous Disease

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