Endovenous Thermal vs. Endovenous Chemical Ablation What ... · Endovenous Thermal vs. Endovenous...
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T. Noppeney, J. Noppeney
Center for Vascular Diseases:
Outpatient Dept. Obere Turnstrasse,
Dept. for Vascular Surgery Martha-Maria Hospital
(Academic Teaching Hospital Erlangen University)
Nuremberg, Germany
Endovenous Thermal vs. Endovenous
Chemical Ablation – What is the Best for the
Patient
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Disclosures
TN Consultant Medi Bayreuth,
Germany
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Development of Varicose Vein Therapy
• 1998 CE mark for Radiofrequencyablation (RFA)
• 1999 CE mark for endovenous laserablation (ELA)
• 1998 CHIVA
• 2004 Renaissance of foam sclerotherapy
• 2007 Stripping without ligation of the SFJ (ASFAL)
• 2009 Steam ablation
• 2011 Mechano-chemical ablation (Clarivein™)
• 2012 Closing the vein with Cyanoacrylat glue
(Sapheon™)
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RFA – Perioperative Complications
Deep Vein Thrombosis, Pulmonary Embolism
• DVT Closure Plus™ 0% (Lübke 2008)
• DVT Closure Plus™ 0,2% (Noppeney 2008)
• DVT Closure Fast™ 0% (Pröbstle 2008)
• PE Closure Plus™ 0,2% (Noppeney 2008)
• PE Closure Fast™ 0% (Pröbstle 2008)
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Perioperative Complications and Side Effects
follow-up 1 week 1 year 3 years 4 years
ecchymosis 5.8% 0.0% 0.0% 0.0%
erythema 2.0% 0.0% 0.0% 0.0%
hematomas 1.4% 0.0% 0.0% 0.0%
paresthesias 3.4% 0.4% 0.4% 0.4%
phlebitis 1.0% 0.0% 0.0% 0.0%
pigmentation 2.4% 1.0% 0.4% 0.4%
thrombus
extension, DVT
0.0% 0.0% 0.0% 0.0%
5 years
0.0%
0.0%
0.0%
0.4%
0.0%
0.4%
0.0%
T.M. Pröbstle, B. J. Alm, O. Göckeritz, C. Wentzel, T. Noppeney, C. Lebard, C. Sessa,
D. Creton, O. Pichot
Five year results from the prospective European multicenter cohort study on
radiofrequency segmental thermal ablation for incompetent great saphenous veins
Br J Surg 2015; 102: 212-218
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ELA- Perioperative Complications
Analysis of 1020 procedures from
11 European and US centers
DVT 0,6%
Hyp- und paresthesias 2,7%
Skin burn 0,9%
Spreafico G, et al Laser saphenous ablations in more than 1,000 limbs with long-
term duplex examination follow-up.
Ann Vasc Surg 2011; 25: 71-78
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ELA – Perioperative Complications
ELA with bare fibers has a higher perioperative
complication rate and produces more perioperative
pain due to perforations
(Doganci S, 2010; Schwarz T, 2010)
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RFA – Return to Work
● Return to work after RFA significant faster in comparison
to stripping
Luebke T, Gawenda M, Heckenkamp J et al. Metaanalysis of endovenous radiofrequency
obliteration of the great saphenous vein in primary varicosis
J Endovasc Ther 2008; 15: 213-223
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Rasmussen LH et al: Randomized clinical trial comparing endovonus laser ablation,
radiofrequency ablation, foam sclerotherapy and surgical stripping for great
saphenous veins
Br J Surg 2011; 96: 1079-1087
• RCT with 580 legs stripping, ELA, RFA and FS
Reflux in the GSV after 1 year
STR 4,8%
ELA 5,8%
RFA 4,8%
FS 16,3% (p<0,001)
Results
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Occlusion Rate of the GSV
91,9 ±
1,8%
T.M. Pröbstle, B. J. Alm, O. Göckeritz, C. Wentzel, T. Noppeney, C. Lebard, C. Sessa,
D. Creton, O. Pichot
Five year results from the prospective European multicenter cohort study on
radiofrequency segmental thermal ablation for incompetent great saphenous veins
Br J Surg 2015; 102: 212-218
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ELA – Results
Occlusion Rates
Author Study type Follow up months Occlusion
Rasmussen 2011 RCT 12 94,2%
Rasmussen 2010 RCT 24 99%
Christenson 2010 RCT 24 95,6%
Rasmussen 2012 RCT 24 82,2%
Disselhof 2011 RCT 60 91%
Van den Bos 2009 Metanalysis 60 95,4%
Rasmussen 2013 RCT 60 82,1%
Ravi 2009 Case Series 66 86%
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Development of the VCSS Score
after 5 years 1.3 ± 1.7 (p<0.0001)
T.M. Pröbstle, B. J. Alm, O. Göckeritz, C. Wentzel, T. Noppeney, C. Lebard, C. Sessa,
D. Creton, O. Pichot
Five year results from the prospective European multicenter cohort study on
radiofrequency segmental thermal ablation for incompetent great saphenous veins
Br J Surg 2015; 102: 212-218
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ELA – Venous Disorders, Qualitiy of Life
RCT´s
• Significant improvement of VCSS and AVVSS after ELA
up to 24 months postoperatively (Darwood 2008, Kalteis
2008, Disselhoff 2008, Almeida 2009)
• Improvement of quality of life up to 16 months
postoperatively (Kalteis 2008, Almeida 2009)
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Summary RFA and ELA
• RFA has a standardised procedure protocol, simple to
perform, ELA different wave lenghts
• Perioperative complication rates are very low
• Pathological reflux can be eliminated securely
• Fast return to work, significant improvement of venous
disorders and QoL
• Mid- and long term results are good and well
documented in the literature
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MOCA
Prospective observational study with 68 patients presenting
insufficiency of the GSV, MOCA vs. RFA
• After MOCA significant less pain 14 d postoperatively
(VAS 4,8±9,7 mm vs 18,6±17,0mm; p<0,001)
• Shorter return to daily activities and to work after MOCA
(p=0,02)
• In both groups significant improvement of quality of life
(SF36) and venous disorders (AVVQ)
van Eekeren RR et al., Postoperative pain and early quality of life after radiofrequency
ablation and mechanochemical endovenous ablation of incompetent great saphenous veins
J Vasc Surg 2013; 57: 445-450.
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MOCA
RCT MOCA vs RFA in 170 patients
• Significant less pain in the MOCA group (p=0.003)
• Improvement of VCSS, QoL similar in both groups
• Occlusion rates similar in both groups at 1 and 6 m
Lane T, Bootun R, Dhamarajiah B Lim CS, Najem M, Renton S, Sritan K, Davies AH
A multi-center randomised controlled trial comparing radiofrequency and mechanical
occlusion chemically assisted ablation of varicose veins – Final results of the
Venefit vs Clarivein for varicose veins trial
Phlebology 2016; epub ahead
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Studies Almeida E-scope Lawson Zierau Total %
GSV or SSV Procedures
38 69 8 65 180
Occluded 3 months 35/36 65/69 8/8 64/65 96.6
Occluded 12 months 33/36 91.7
Paraesthesia 0 0 0 0 0
DVT 0 0 0 0 0
Other SAEs 0 0 0 0 0
Superficial phlebitis 6 6 4 10 26 14.4
J Lawson, S Gauw, C van Vlijmen, P Pronk, M Gaastra, M Mooij, C H A Wittens
Sapheon: the solution?
Phlebology 2013; 28 Suppl 1:2–9
Glue - Cyanoacrylat
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Tekin AI, Tuncer ON, Memetoglu ME et al
Nonthermal, nontumescent endovenous treatment of varicose veins
Ann Vasc Surg 2016; 36: 231-235
Single center prospective study, n=62 patients
with incompetence of GSV
● Occlusion at 6 m 90.3 %, subtotal occlusion 3.2 %,
no occlusion 6.5 %, diameter > 11 mm
● No compression stockings
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Bozkurt AK, Yilmaz MF
A prospective comparison of a new cyanoacrylate glue and laser ablation for the
treatment of venous insufficiency
Phlebology 2016; 31: Suppl 1, 106-113
RCT with 310 patients glue vs. ELA
● Significant less pain for patients treated with glue (p<0.001)
● Significant less ecchymosis with glue (p<0.001)
● Less paresthesias in the glue group (p<0.015)
● Both groups significant improvement of the VCSS and
in the AVVQ
● Both groups similar occlusion rates at 12 m
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Comparison Between Different Ablation
Techniques
Compl.
Side
effects
Pain Effort Occl
usion
Limita
tions
Long
term
results
QoL
VCSS
RFA ↓↓↓ ↓↓ ↑↑↑ ↑↑↑ + ↑↑ ↑↑↑
ELA ↓↓ ↓↓ ↑↑↑ ↑↑↑ + ↑↑ ↑↑↑
MOCA ↓↓↓ ↓↓↓ ↑↑ ↑↑↑ + ? ↑↑↑
GLUE ↓↓ ↓↓↓ ↑ ↑↑↑ ++ ? ↑↑↑
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Summary
• No final conclusion possible for MOCA and glue,
because we dont have sufficient and long term data
• MOCA and glue seem to be associated with less pain in
comparison to other endovenous procedures
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Meisner MH
What is effective care for varicose veins?
Phlebology 2016; 31: Suppl 1, 80-87
Which form of intervention is superior to another?
„ … This (question) has largely been driven by patient
and physician preferences in the
absence of robust evidence
that one therapy is truely superior to another …“
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Thank You Very Much for Your
Attention
Center for Vascular Diseases:
Outpatient Dept. Obere Turnstrasse,
Dept. for Vascular Surgery Martha-Maria Hospital
(Academic Teaching Hospital Erlangen University)
Nürnberg, Germany
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T. Noppeney, J. Noppeney
Center for Vascular Diseases:
Outpatient Dept. Obere Turnstrasse,
Dept. for Vascular Surgery Martha-Maria Hospital
(Academic Teaching Hospital Erlangen University)
Nuremberg, Germany
Endovenous Thermal vs. Endovenous
Chemical Ablation – What is the Best for the
Patient