230 likes | 626 Views
2. Ultrasound-guided Foam Sclerotherapy (FS) has becomea common treatment for patients with varicose veins.As all treatments, sclerotherapy is associated with a numberof side effects and complications.The expansion of FS has changed the features of the sideeffects and some seem to occur specifi
E N D
1. 1 Side Effectsof Foam Sclerotherapy J L GILLET, France
2. 2 Ultrasound-guided Foam Sclerotherapy (FS) has become
a common treatment for patients with varicose veins.
As all treatments, sclerotherapy is associated with a number
of side effects and complications.
The expansion of FS has changed the features of the side
effects and some seem to occur specifically with FS.
We will not discuss local effects (pigmentation, inflammatory
reactions, matting) ? technical or tactical problems.
To focus on the main controversial and serious complications:
Thromboembolic
Neurological Complications
3. 3 Jia X: Systematic review of foam sclerotherapy for varicose veins, BJS 2007
< 1% serious complications including DVT and PE
Bradbury AW. J Vasc Surg 2010 977 patients
3 symptomatic DVT (0.3%) – 1 (0.01%) PE
Coleridge Smith P, EJVES 2006 :
808 patients with saphenous insuf. : 13 (13 / 808 = 1.6 %)
10 distal DVT, treated without AC
1 thrombosis of the CFV : AC for 6 months
1 Non-occlusive thr. of the CVF and PV: no AC.
Bergan J, J Cardiovasc Surg 2006 : 6 / 332 (1.8 %), distal.
Cavezzi A, Phlebology 2002 : 2 / 194 (1%)
Guex jj , Dermatol Surg 2005 : 9 / 6395 = 0.3 %
4. 4 Personal study A multicentre, prospective and controlled study was carried
out in which GSV and SSV trunks were treated with FS.
Inclusion criteria
- Terminal or preterminal valve and truncal reflux of the GSV or a truncal reflux of the SSV starting at the terminal valve.
Systematic DUS examination between D8 and D30
5. 5 Results Population
1025 Patients 20 Phlebology Clinics
GSV : 818 (79.8%) SSV : 207 (20.2%)
Follow up
99 % of patients were checked with DUS (median : 20 days)
and the non-checked patients (n=11) were all called :
? no patient was completely lost to follow-up
6. 6 Results Thrombo-Embolic Events
11 events (11/ 1025 = 1.07%)
* 5 symptomatic DVT (5/1025 = 0.5%) - all distal
- 4 muscular vein (MGV) - 1 Post Tibial Vein
* 5 asymptomatic DVT (0.5 %), all not completely occlusive
- 3 distal, with 1 controlateral
- 2 Femoral Common Vein
* 1 PE, but its association with FS was not certain :
D + 19 - DUS (repeated) : no DVT
Satisfactory outcome
7. 7 Discussion
Surgery : only 1 study with systematic control of patients :
Van Rij AM, B J Surg 2004 : 5 % DVT
Radiofrequency : 0 – 16 %
Weiss RA, Dermatol Surg 2002 - Merchant RF, Dermatol Surg 2005
Kistner RL, JJP 2002 - Hingorani AP, J Vasc Surg 2004
Endovenous Laser : 0 – 8 %
Min RJ, JVIR 2001 - Anatasie B, Phlébologie 2002
Proebstle TM, Der. Surg 2003 - Mozes G, J Vasc Surg 2005
? FS does not lead to more Thrombo-Embolic Complications
than the other methods
8. 8 Neurological Complications
9. 9 1)The issues can be summarized :
What are the neurological risks of FS?
2) Among the neurological disturbances :
- Visual disturbances
- Cerebro-vascular events
10. 10 Cerebro-vascular events While millions of FS sessions have been performed
* No death or stroke with significant after-effects
* 2 cases of stroke (with minimal after-effects – D15)
Forlee MV, J Vasc Surg 2006
Bush RG, Phlebology 2008
* A few cases of TIA
Bush RG, Phlebology 2008
Gillet JL Phlebology 2009
Hartmann K, EJVES 2009
Leslie-Mazwi TM, Neurocrit Care 2009
Hahn M, Vasa 2010
Picard C, J N P 2010
11. 11 Foam volume or quality or both may be involved in most
cases of stroke occuring after FS.
All patients had an undiagnosed PFO.
Considering the high prevalence of PFO in the adult population
(# 30%), the risk of stroke following FS appears to be very low.
According to the opinion of experts, screening for FPO is not
necessary before FS Consensus of Tegernsee , Breu FX, Vasa 2008
Symptomatic PFO: CI for FS
We must remember that strokes have complicated liquid
sclerotherapy and endovenous laser as has been reported.
12. 12 Though strokes are exceptional, their prevention must
be our main concern.
? Quality
Volume
Injection of large volume of foam remains controversial
Most physicians recommend limiting the volume :
Maximum volume of foam per session
10 ml : Tegernsee Consensus
12 ml : Venous Forum of the Royal Society of Medicine
15 ml : Australasian College of Phlebology
13. 13 Prevention
We recommend patients avoid the Valsalva manśuvre
(they should not put compression stockings on by themselves)
Additional measures have been suggested:
- elevating the leg 30° during injection and remaining
supine for 5 min
- compression of the SF junction
? Efficiency is not established
14. 14 Visual Disturbances (ViD)
15. 15 Visual Disturbances (ViD) : reversible symptoms
* Positive features
(Flickering lights, spots, lines or scotoma)
* Negative features (loss of vision)
One or both eyes
The frequency of occurrence : 0% - 14 %
average rate : 1.4% Jia X: Systematic review of foam sclerotherapy for varicose veins, BJS 2007
Some clues indicated that they could correspond to
migraine with aura (MA) and were not TIA
Ratinahirana H et al. Cephalalgia 2003
Coleridge Smith P. EJVES 2006
16. 16 Demonstrating that ViD corresponds to MA and is not a
cerebro-vascular event is a crucial issue in the assessment
of the safety of FS.
We carried out a prospective muticentre study :
- Collaboration with the Neurology Department of the
Marseille University Hospital
(Specialist of migraine : Dr A Donnet)
- Clinical assessment combined with a brain MRI
(T1, T2, T2*, diffusion)
17. 17 Results 20 patients were included in 11 phlebology clinics
Clinical assessment : ViDs presented characteristics of
MA in all patients
15 MRIs were performed within 2 weeks (average: 8 days)
? All the MRIs were normal
18. 18 2 pathophysiological mechanismscould be involved in MA after FS I – Release of endothelin
that could reach the cerebral cortex through a PFO.
* Endothelin has been demonstrated as being a trigger
factor for MA Dreier JP et al. Brain 2002
* Significant increase of endothelin 1 level was identified
after FS in rats Frulini et al. ACP meeting 2010
19. 19 2 pathophysiological mechanismscould be involved in MA after FS II – Microemboli
Moskowitz et al. Ann Neurol 2010
Mice : microemboli of microbubbles of air, polystyrene
micropheres or cholesterol crystals into the carotid artery
could trigger a cortical spreading depression (CSD)
(pathophysiological correlate with MA)
without requisite tissue damage.
CSDs were preceded by local or regional hypoperfusion.
Histopathological evaluation: no ischemic infarct
in mice brains after microemboli of air.
20. 20 2 pathophysiological mechanismscould be involved in MA after FS II – Microemboli
Caputi et al. Headache 2010
Performed contrast-enhanced transcranial Doppler with
air-mixed saline in 159 patients with MA.
A typical MA attack was observed in 12 patients,
only in PFO positive ones (12/ 79 = 15.2%)
21. 21 2 pathophysiological mechanismscould be involved in MA after FS These data reinforce the hypothesis that ViDs occuring
after FS correspond to MA and are not TIA.
Two pathophysiological mechanisms are possible and
might coexist:
- Release of Endothelin
- Microembolization with a decrease in cerebral oxygen
saturation,
Both triggering CSD and Migraine with Aura.
22. 22 CONCLUSION
23. 23 Ultrasound-guided FS is a safe and effective treatment
for varicose veins.
Most side effects and complications are benign.
However, the eventuality of exceptional but more serious
complications has to be taken into account in the
management of patients.
As in all treatments, it is necessary to evaluate the ratio
benefit / risk before treating a patient.
24. 24 We insist on:
- The necessary preliminary training in this method
should be done by expert for practitioners and the
educational process should be ongoing.
- We must remember that the physicians have to provide
accurate, documented information to the patients and
the physicians have to obtain the patient’s consent.
Thank you for your Attention