1. April 20, 2018
Comparison of Monopolar vs Segmental Radiofrequency Ablation in Endovenous Treatment of Lower Limb Chronic Venous Insufficiency
Good morning all, I’m Ryan, a final year medical student presenting our study on behalf of the team.
We would like to thank the organisers of the Charing Cross Symposium and the scientific community for accepting our study on the the comparison of Monopolar and Segmental Radiofrequency Ablation in Endovenous treatment of Lower Limb Chronic Venous Insufficiency
JYR TAN, P LINGAM, Z J LO, QT HONG, S CHANDRASEKAR, S NARAYANAN, GWL TAN
Vascular Surgery Service,
Department of General Surgery, Tan Tock Seng Hospital, Singapore
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2. I do not have any potential conflict of interest
April 20, 2018
Disclosure
Speaker name:
Tan Jun-Yi Ryan
I do not have any potential conflict of interest
No conflict of interests to declare
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3. Radiofrequency Ablation (RFA)
April 20, 2018
Surgical Intervention for Chronic Venous Insufficiency at Our Institution
The field of surgical intervention for lower limb chronic insufficiency has progressed greatly since the traditional methods of ligation and stripping, the most recent development being that of endovenous treatment by radiofrequency ablations, of which 3 main systems/catheters are available – VNUS, EVRF and RFiTT
Only VNUS and EVRF available locally
Radiofrequency Ablation (RFA)
Ligation and Stripping
Endovenous Laser Therapy (EVLT)
Sclerotherapy
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4. EVRF® (F Care Systems, Belgium) VNUS® ClosureFast ™ (Medtronic, USA)
April 20, 2018
EVRF® (F Care Systems, Belgium)
Monopolar RFA
VNUS® ClosureFast ™ (Medtronic, USA)
Segmental RFA
The field of surgical intervention for lower limb chronic insufficiency has progressed greatly since the traditional methods of ligation and stripping, the most recent development being that of endovenous treatment by radiofrequency ablations, of which 3 main systems/catheters are available – VNUS, EVRF and RFiTT
Only VNUS and EVRF available locally
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5. April 20, 2018
Literature Review
EVLT and RFA have better post-procedure outcomes and better occlusion rates than traditional surgery
Van den Bos, R., Arends, L., Kockaert, M., Neumann, M., & Nijsten, T. (2009). Endovenous therapies of lower extremity varicosities: A meta-analysis. Journal of Vascular Surgery, 49(1), 230–239.
VNUS® ClosureFast ™ (Medtronic, USA) is feasible, safe and well tolerated
Proebstle, T. et al. (2008). Treatment of the incompetent great saphenous vein by endovenous radiofrequency powered segmental thermal ablation: First clinical experience. Journal of Vascular Surgery., 47(1), 151–156.
Current literature shows that RFA is superior to traditional surgery, and that VNUS -- a Segmental RFA application is a feasible, safe and well tolerated system
The EVRF system yields
satisfactory clinical and anatomical midterm outcomes with very low complication rates
However, contemporary studies of the radiofrequency-induced thermal therapy device (RFiTT®), show that in experienced hands, clinical equivalence to the Venefit™ procedure can be achieved. The evidence base for EVRF® and VeinCLEAR™ devices is currently weak and absent, respectively.
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6. April 20, 2018
Literature Review
EVRF® (F Care Systems, Belgium) has satisfactory clinical anatomical midterm outcomes with very low complication rates
Spiliopoulos, S., Theodosiadou, V., Sotiriadi, A., & Karnabatidis, D. (2014). Endovenous ablation of incompetent truncal veins and their perforators with a new radiofrequency system. Mid-term outcomes. Vascular, 23(6), 592–598.
Meta-analysis: Smaller body of publications on EVRF ®
Goodyear, S., & Nyamekye, I. (2015). Radiofrequency ablation of varicose veins: Best practice techniques and evidence. Phlebology / Venous Forum of the Royal Society of Medicine., 30, 9–17.
Similar literature has established the satisfactory efficacy and safety of the EVRF system, a monopolar RFA system
However, a 2015 meta-analysis on various RFA systems revealed far fewer publications on EVRF data as compared to VNUS
The EVRF system yields
satisfactory clinical and anatomical midterm outcomes with very low complication rates
However, contemporary studies of the radiofrequency-induced thermal therapy device (RFiTT®), show that in experienced hands, clinical equivalence to the Venefit™ procedure can be achieved. The evidence base for EVRF® and VeinCLEAR™ devices is currently weak and absent, respectively.
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7. April 20, 2018
Study Objectives
Compare outcomes in patients with lower limb Chronic Venous Insufficiency (CVI) who underwent Monopolar (EVRF®, F Care Systems, Belgium) vs Segmental (VNUS® ClosureFast™, Medtronic, USA) Radiofrequency Ablation therapy
As both EVRF and VNUS RFAs are carried out at our institution, we used the opportunity to bridge this gap in existing knowledge
by comparing the Monopolar EVRF and Segmental VNUS Closurefast RFA systems in the treatment of lower limb chronic venous insufficiency,
with regards particularly to the number of short vein ablations and their respective post-operative outcomes
VNUS Closurefast now Venefit?
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8. Methodology Single Centre, Retrospective Study January 2014 – May 2015
April 20, 2018
Methodology
Single Centre, Retrospective Study
January 2014 – May 2015
The study was done retrospectively at our centre -- Tan Tock Seng Hospital, a 1,500 bed tertiary hospital in Singapore over a 1 year period from Jan 2014 – May 2015
189 patients with 288 limbs were treated with RFA ,with 146 limbs treated with EVRF (Monopolar) and 142 with VNUS (Segmental)
Multiple surgeons
Singapore
189 Patients
288 Limbs
Monopolar (EVRF®) – 146 Limbs
Segmental (VNUS® ClosureFast™) – 142 Limbs
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9. April 20, 2018
Results
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10. Patient Demographics Monopolar RFA (N=146 limbs) (N=91 patients)
April 20, 2018
Patient Demographics
Monopolar RFA
(N=146 limbs)
(N=91 patients)
Segmental RFA
(N=142 limbs)
(N=98 patients)
p Value
Male : Female
64 (44%) : 82 (56%)
50 (35%) : 92 (65%)
0.15
Average Age (Range)
57.9 (27 – 78) years
58.6 (37 – 83) years
0.62
Average BMI (Range)
26.0 (17.3 – 45.1) kg/m2
26.6 ( 16.6 – 41.9) kg/m2
0.34
Treated Limbs:
Right : Left
72 (49%) : 74 (51%)
71 (50%) : 71 (50%)
1.00
Bilateral
111 (76%)
89 (63%)
0.02
In general, our patient demographics were similar between the two groups
In both groups, there were more female patients and the average age of patients was 58 years and an average BMI of 26.3 kg/m^2
There were also more patients with bilateral chronic venous insufficiency in the monopolar group as opposed to the segmental group
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11. Patient Comorbidities
April 20, 2018
Patient Comorbidities
Monopolar RFA
(N=146 limbs)
(N=91 patients)
Segmental RFA
(N=142 limbs)
(N=98 patients)
p Value
ASA Class I
12 (8%)
20 (14%)
0.13
ASA Class II
122 (84%)
98 (69%)
0.01
ASA Class III
24 (17%)
0.03
Smoker
40 (27%)
26 (18%)
0.07
Type II DM
15 (10%)
0.06
Good DM Control
(HbA1c ≤ 7.0%)
7/15 (47%)
21/26 (81%)
0.04
Peripheral Artery Disease NA
Previous Venous Surgery
8 (5%)
4 (3%)
0.38
Most of our patients were of ASA Class I and II, and we had a low prevalence of (smokers?) and Type II Diabetics, and significantly no patients with mixed arterio-venous disease. 3-5% of our patients have had previous venous interventions (Stress the point – patients are mostly first time interventions)
Point of the slide – to stress that our patient population are healthy patients with minimal comorbidities
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12. Venous Disease Clinical Manifestation (CEAP)
April 20, 2018
Venous Disease Clinical Manifestation (CEAP)
Percentage of Limbs/% 52 46 43 37 32
Regarding venous disease manifestation, a majority (70%) of our patients who underwent radiofrequency ablation in both groups were grade C4 and above and among these patients there was an equal distribution between both systems
Majority C4 and C5 33 18 5 9 3
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13. Pre-Operative Venous Duplex
April 20, 2018
Pre-Operative Venous Duplex
Percentage of Limbs/%
114
138
129
114
As for pre-operative venous duplex scans, almost all our patients had Great Saphenous Vein reflux and SFJ incompetence, whereas half had short saphenous vein reflux and a third had concomitant deep venous reflux
Only SSV reflux w concomitant SPJ incompetence are for ablation (14% and 8% respectively for SSV ablations)
Why do we treat deep venous reflux?
Offered if symptoms do not improve with graduated compression stockings
Will be on lifelong stockings s/p surgery 74 69 48
p = 0.01 42 27 6
GSV reflux
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14. April 20, 2018
Surgical Procedure
Percentage of Limbs/%
144
139
Intra-operatively, with the shorter active catheter tip of the EVRF system, we were able to treat significantly more Anterior Accessory Saphenous Veins by radiofrequency ablation, with 20% of the EVRF group being treated as compared to only 3% in the VNUS group, and this was found to be statistically significant by fischer’s chi squared analysis
A similar trend can be seen in the SSV ablations, with 14% being treated in the EVRF group as compared to only 8% in the VNUS group
p = 0.01 29 21 12 4
AASV Ablation
Phlebectomy
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15. Post-Operative Outcomes
April 20, 2018
Post-Operative Outcomes
Percentage of Limbs/%
No incidents of:
Deep Vein Thrombosis
Recurrences
Both systems were similar in their post-operative outcomes, with similarly low rates of transient superficial neuropathy, of which none were permanent, and phlebitis. There were also no serious complications of DVT and recurrences
This is in concordance with previous literature, underscoring RFA’s safety and low complication rates
Both are SIMILAR in post-operative outcomes
Low rates of complications, no serious complications (Safe and efficacious)
Definition of Recurrences
How long did you watch patients post op for? 11 12 6 2
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16. April 20, 2018
Conclusion
Both EVRF and VNUS are feasible and safe endovenous modalities for the treatment of Lower Limb CVI
Low complication rates
Similar clinical outcomes
EVRF (Monopolar RFA) advantageous
Shorter active catheter tip
Treatment of shorter vein segments
Anterior Accessory Saphenous Vein and Short Saphenous Vein
As such, from our results we were able to conclude that while both systems were similarly feasible and safe to use in treating chronic venous insufficiency, the EVRF Monopolar system was advantageous in the ability to treat shorter vein segments such as the AASV and SSV, due to its shorter active catheter tip (5mm vs 7cm)
For asian population?
Similar clinical outcomes? (But no CEAP comparison)
Efficacy, safety similar; technical aspects advantageous in EVRF
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17. Questions Thank you for your time, I will now take any questions
April 20, 2018
Questions
Thank you for your time, I will now take any questions
Why use both in your centre? – diff surgeons using each, each well versed in it –
Why EVRF > VNUS – EVRF cheaper, shorter active catheter tip
Why are C6 patients being operated on?
These are patients usually been treated with 4 layer compression bandages – however ulcers recurring, lack of healing – therefore Sx when C6 ulcers are healing (almost C5) – to decrease venous hypertension
Large amount of our patients are C4, C5
Why more phlebitis?
Slightly more in EVRF group, but not statistically significant and small numbers
How are the AASV and SSV ablations done in VNUS then?
– 3cm catheter for VNUS – but increases cost for the patient – 2 catheter sets then need to be opened
How are your phlebectomies done – standard Stab Avulsions (don’t use EVRF device due to cost)
How do you decide on AASV ablations – mapped out by our Vascular Scientists pre-operative and reassessed intraoperative; if incompetent, planned for S x
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18. Surgical Procedure p = 0.68 p = 0.01 p = 0.14 n = 29 n = 4
April 20, 2018
Surgical Procedure
p = 0.68
p = 0.01
n = 29
p = 0.14
n = 4
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19. Patient Demographics Monopolar RFA (n=146 limbs) (n=91 patients)
April 20, 2018
Patient Demographics
Monopolar RFA
(n=146 limbs)
(n=91 patients)
Segmental RFA
(n=142 limbs)
(n=98 patients)
P Value
Male : Female
64 (44%) : 82 (56%)
50 (35%) : 92 (65%)
0.15
Average Age (Range)
57.9 (27 – 78) years
58.6 (37 – 83) years
0.62
Average BMI (Range)
26.0 (17.3 – 45.1) kg/m2
26.6 ( 16.6 – 41.9) kg/m2
0.34
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20. Investigated Variables
April 20, 2018
Investigated Variables
Patient Demographics
Age, Sex, Ethnicity, Body Mass Index (BMI)
Comorbidities
American Society of Anesthesiologists (ASA) Classification, Smoking, Type 2 Diabetes Mellitus (DM) and Control, Peripheral Arterial Disease
Venous Disease Clinical Manifestation (CEAP)
Pre-Operative Duplex Studies
Surgical Procedure
Post-Operative Outcomes
Transient Neuropathy, Phlebitis, Deep Vein Thrombosis, Recurrence
Based on our literature review, we devised the following variables
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21. Patient Demographics (Ethnicity)
April 20, 2018
Patient Demographics (Ethnicity)
Monopolar RFA
(n=146 limbs)
(n=91 patients)
Segmental RFA
(n=142 limbs)
(n=98 patients)
P Value
Chinese
105 (72%)
100 (71%)
0.79
Indian
25 (18%)
24 (17%)
1.00
Malay
8 (5%)
9 (6%)
0.81
Others
There was also no statistical significance between the ethnicity of the patients in the 2 groups
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