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

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

System Components: ClosureFast Catheter

!  3 catheter sections: !  Handle !  Shaft !  Heating element

2. Shaft

Heating Element

Lubricious outer jacket covers heating element and thermocouple

Thermocouple

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

ClosureFast ablation - Method of Action

!  Vein wall heated via

!  RF energy delivery to catheter heating element, resulting in: !  Endothelial denaturation !  Collagen contraction !  Fibrotic sealing

Covidien | Februar 2, 2016 | Confidential 7 |

ClosureFast segmental ablation procedure

Covidien | Februar 2, 2016 | Confidential 8 |

ClosureFast full vessel wall fibrosis induction

Goat saphenous vein 12 wks post-ablation

EVLA vs. ClosureFast: Continuous Pullback vs. Segmental Ablation

Endovenous Laser Ablation

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

ClosureFast™ Catheter

Segmental Ablation !  Used by the VenefitTM procedure

delivered by the ClosureFastTM 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.

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

CEAP at 36 months

Overall 74.1% (189 limbs) showed an improvement when compared to pre-treatment (P< .001)

C3 & C4 8%, a reduction from 46% at pre-treatment

C4 (skin changes) 4%, a reduction from 15% at pre-treatment

C2 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

Secondary Endpoints: CEAP and VCSS

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 2015

VCSS at 60 months

Pre-treatment 3.9 ± 2.1

3-60 months 1.3 ± 1.7; P<0.0001

295 limbs enrolled

3 Months 6 Months 1 year 2 Year 3 Year 5 Year 235 limbs @

5 yr f/u

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%

Conclusion

•  Safe and effective treatment •  Straightforward •  Good long term data •  May be challenged by the NTNT

techniques

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