Closurefast radiofrequency ablation for the treatment of GSV: Technique and outcome results
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1 Closurefast radiofrequency ablation for the treatment of GSV: Technique and outcome results Stephen Black Consultant Vascular Surgeon Clinical Lead for Venous and Lymphoedema Surgery Guy s and St Thomas Hospital London
2 Disclosure Speaker name: Stephen Black I have the following potential conflicts of interest to report: Consulting : Medtronic, Cook, Optimed, Volcano, Veniti Employment in industry Stockholder of a healthcare company Owner of a healthcare company Other(s) I do not have any potential conflict of interest
3 System Components: ClosureFast Catheter! 3 catheter sections:! Handle! Shaft! Heating element 2. Shaft
4 Heating Element Thermocouple Lubricious outer jacket covers heating element and thermocouple
5 Closurefast Treatment Parameter Overview! 20-second treatment cycles! Generator timer counts down from 20 to 0! Energy delivery automatically stops at end of cycle! Device temperature: 120 C! Maximum power: 40 Watts! Impedance monitored internally by generator! Indicate uniformity of heating along coli! User prompted to make adjustments to external compression if necessary
6 ClosureFast ablation - Method of Action! Vein wall heated via! RF energy delivery to catheter heating element, resulting in:! Endothelial denaturation! Collagen contraction! Fibrotic sealing
7 ClosureFast segmental ablation procedure Covidien Februar 2, 2016 Confidential 7
8 ClosureFast full vessel wall fibrosis induction Covidien Februar 2, 2016 Confidential Goat saphenous vein 12 wks post-ablation 8
9 EVLA vs. ClosureFast: Continuous Pullback vs. Segmental Ablation Endovenous Laser Ablation ClosureFast Catheter Continuous Pullback! Used by endovenous lasers and some RF ablation systems (F-Care Systems)! Energy source is on throughout treatment! Energy delivery varies by pullback speed as well as other factors! Small area treated at any given time Segmental Ablation! Used by the Venefit TM procedure delivered by the ClosureFast TM catheter! Vein segment treated at one time! No energy delivered during catheter pullback! Energy delivery does not vary by pullback speed Image source: Covidien R&D dept.
10 Title: Randomized clinical trial comparing endovenous laser ablation, radiofrequency ablation, foam sclerotherapy, and surgical stripping for great saphenous varicose veins with 3 year follow up. Author: Rasmussen L, Lawaetz M, Serup J et al. Journal: Journal of Vascular Surgery: Venous and Lymphatic Disorders; published online August 5, 2013 RESULTS 500 patients (580 limbs) were randomized. All groups were similar in regards to baseline characteristics. Kaplan Meier estimates showing the percent of patients who were free from the following endpoints at 3 yrs *P<.0001 difference across all 4 groups RFA EVLA UGFS Stripping Reflux-free* 93% 93.2% 73.6% 93.5% Free of Recurrent Varicose Veins 85.1% 80% 80.9% 79.8% Free of Reoperations* 88.9% 87.5% 68.4% 84.5% CONCLUSIONS The author concluded that all treatment modalities were efficacious and resulted in a similar improvement in VCSS and QOL. However, more recanalization and reoperations were seen after UGFS
11 Title: The 5-year Final Results from the Prospective European Multicentre Cohort Study on Radiofrequency Segmental Thermal Ablation of Incompetent Great Saphenous Veins Authors: Proebstle TM, Alm BJ, Göckeritz O, Wenzel C, Noppeney T, Lebard C, Sessa C, Creton D, Pichot O Journal: British Journal of Surgery limbs enrolled yr f/u 3 Months 6 Months 1 year 2 Year 3 Year 5 Year Vein Occlusion 99.7% 98.6% 96.3% 94.5% 92.6% 91.9% No Reflux 99.7% 99.3% 99.0% 97.2% 95.7% 94.9% Secondary Endpoints: CEAP and VCSS CEAP at 36 months Overall 74.1% (189 limbs) showed an improvement when compared to pre-treatment (P<.001) C3 & C4 C4 (skin changes) C2 8%, a reduction from 46% at pre-treatment 4%, a reduction from 15% at pre-treatment 33.3% an increase from 12.5% at 12 months This may be due to the normal course of the disease or related to the study protocol prohibiting the treatment of thigh varicosities VCSS at 60 months Pre-treatment 3.9 ± months 1.3 ± 1.7; P<0.0001
12 Conclusion Safe and effective treatment Straightforward Good long term data May be challenged by the NTNT techniques
13 Closurefast radiofrequency ablation for the treatment of GSV: Technique and outcome results Stephen Black Consultant Vascular Surgeon Clinical Lead for Venous and Lymphoedema Surgery Guy s and St Thomas Hospital London
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A one stop vein shop: the ideal option? Professor Alun H Davies Section of Vascular Surgery Imperial College, Charing Cross & St Mary s Hospitals London Conflicts of Interest None to declare Which treatment?
Compression after sclerotherapy and endovenous ablations, the Italian point of view
Compression after sclerotherapy and endovenous ablations, the Italian point of view Fabrizio Mariani Siena (Italy) General Secretary "Multidisciplinary Joint Committee in Phlebology" - UEMS (EU) General
Great saphenous vein patency and endovenous heat-induced thrombosis after endovenous thermal ablation with modified catheter tip positioning
Great saphenous vein patency and endovenous heat-induced thrombosis after endovenous thermal ablation with modified catheter tip positioning Omar P. Haqqani, MD, Calin Vasiliu, MD, Thomas F. O Donnell,
Treatment of Varicose Veins/Venous Insufficiency. Description
Page: 1 of 24 Last Review Status/Date: March 2015 Description A variety of treatment modalities are available to treat varicose veins/venous insufficiency, including surgical approaches, thermal ablation,
Introduction to Saphenous Vein Ablations: When/Why/How?
John Ligush, MD SMJH Vascular and Vein Center Introduction to Saphenous Vein Ablations: When/Why/How? Saphenous Vein Ablations: When/Why/How? Venous disease is easy Treatment is straightforward The patients
Phlebectomy vs sclerotherapy ALESSANDRO FRULLINI MD FLORENCE - ITALY
Phlebectomy vs sclerotherapy ALESSANDRO FRULLINI MD FLORENCE - ITALY DISCLOSURE Consultant for: GloriaMed Personal background General and vascular surgeon More than 3500 stripping performed 33 years of