ultrasound-guided sclerotherapy: when, how and for what? · a) twenty patients, 16 women and four...

27
Ultrasound-guided sclerotherapy: When, how and for what? 2nd Venous Symposium in New York 8 April, 2011

Upload: others

Post on 26-Jun-2020

0 views

Category:

Documents


0 download

TRANSCRIPT

Page 1: Ultrasound-guided sclerotherapy: When, how and for what? · a) Twenty patients, 16 women and four men, in 11 phlebology clinics b) VDs average 7 minutes after FS c) All pts VDs characteristic

Ultrasound-guided sclerotherapy:

When, how and for what?

2nd Venous Symposium

in New York8 April, 2011

Page 2: Ultrasound-guided sclerotherapy: When, how and for what? · a) Twenty patients, 16 women and four men, in 11 phlebology clinics b) VDs average 7 minutes after FS c) All pts VDs characteristic

Disclosures

Research Grant

BTG Varisolve

Medical Director

Morrison Vein/Training Institute

Scientific Advisory Board

Vascular Insights

VenX

Minor Stockholder

Covidien

Page 3: Ultrasound-guided sclerotherapy: When, how and for what? · a) Twenty patients, 16 women and four men, in 11 phlebology clinics b) VDs average 7 minutes after FS c) All pts VDs characteristic

Off label and/or Non-FDAApproved Drugs

Polidocanol and STS foam, as referred to in this presentation, may be considered “off-label” or

not approved by FDA

Disclosures

Page 4: Ultrasound-guided sclerotherapy: When, how and for what? · a) Twenty patients, 16 women and four men, in 11 phlebology clinics b) VDs average 7 minutes after FS c) All pts VDs characteristic

Liquid vs Foam

Needle vs Catheter-directed

If catheter-directed, angiocath

(20-guage, 4mm Teflon device)

Seldinger with 5Fr infusion

catheter

Ultrasound guided sclerotherapy

Page 5: Ultrasound-guided sclerotherapy: When, how and for what? · a) Twenty patients, 16 women and four men, in 11 phlebology clinics b) VDs average 7 minutes after FS c) All pts VDs characteristic

Any detergent can be foamed

Foaming increases effectiveness by

increasing the surface area of the

solution on the vein wall and

displacing the blood for a longer

time

Hamel-Desnos C, Desnos P, Wollman JC, Ouvry P,

Mako S, Allaert FA. Dermatol Surg 2003;

29:1170e1175.Allaert

Sclerotherapy with Foam

Page 6: Ultrasound-guided sclerotherapy: When, how and for what? · a) Twenty patients, 16 women and four men, in 11 phlebology clinics b) VDs average 7 minutes after FS c) All pts VDs characteristic

Bonn StudyMulticenter RCT

Liquid vs Foam Sclerotherapy

106 patients

Elimination of Reflux:

Liquid: 29%

Foam: 69% ( p < 0.0001)

Rabe E, Pannier-Fischer F, et al. Eur J Vasc Endovasc Surg 35, 238-245 (2008)

Ultrasound guided sclerotherapy

Page 7: Ultrasound-guided sclerotherapy: When, how and for what? · a) Twenty patients, 16 women and four men, in 11 phlebology clinics b) VDs average 7 minutes after FS c) All pts VDs characteristic

Macrofoam (>500microns) and microfoam(preferably <100 microns)

Variables in foam sclerosants¹Type of sclerosant

Concentration

Type of gas

Ratio of gas to liquid

Method of preparation (e.g., Tessari)

Time between foam preparation and use

Bubble size of foam

Sadick N. Advances in Dermatology 2006; 22:139–156.

Ultrasound guided sclerotherapy

Page 8: Ultrasound-guided sclerotherapy: When, how and for what? · a) Twenty patients, 16 women and four men, in 11 phlebology clinics b) VDs average 7 minutes after FS c) All pts VDs characteristic

Advanced skill level required

Excellent ultrasound contrast medium,

enhancing accuracy and extent of treatment

Foam is not generally indicated for use on

veins <2 mm

Commonly used for reticular veins or veins

using ultrasound- guidance

Early results not quite as good as surgery or endovenous thermal ablation

Reimbursement?

NO sclerosing agent FDA approved as foam

Sclerotherapy with Foam

Page 9: Ultrasound-guided sclerotherapy: When, how and for what? · a) Twenty patients, 16 women and four men, in 11 phlebology clinics b) VDs average 7 minutes after FS c) All pts VDs characteristic

Indications:Primary Rx of incompetent

GSV/SSV

(Not commonly in U.S.)

Recurrence following GSV

ligation/stripping

Venous malformations

Sciatic nerve varices

Saphenous or non-saphenous

perforating veins

Sclerotherapy with Foam

Page 10: Ultrasound-guided sclerotherapy: When, how and for what? · a) Twenty patients, 16 women and four men, in 11 phlebology clinics b) VDs average 7 minutes after FS c) All pts VDs characteristic

IndicationsAdjunctive treatment following

endovenous thermoablation or

surgical excision for:

Incompetent Distal Great Saphenous Vein

Incompetent distal Small Saphenous Vein

Major Tributaries with Reflux

Incompletely ablated veins

Sclerotherapy with Foam

Page 11: Ultrasound-guided sclerotherapy: When, how and for what? · a) Twenty patients, 16 women and four men, in 11 phlebology clinics b) VDs average 7 minutes after FS c) All pts VDs characteristic

*

*Concept Courtesy L. Tessari

Sclerotherapy with Foam

Foam production

Page 12: Ultrasound-guided sclerotherapy: When, how and for what? · a) Twenty patients, 16 women and four men, in 11 phlebology clinics b) VDs average 7 minutes after FS c) All pts VDs characteristic

Sclerotherapy with Foam

Ultrasound guided sclerotherapy set up

Start distally work proximally

Page 13: Ultrasound-guided sclerotherapy: When, how and for what? · a) Twenty patients, 16 women and four men, in 11 phlebology clinics b) VDs average 7 minutes after FS c) All pts VDs characteristic

Sclerotherapy with Foam

Page 14: Ultrasound-guided sclerotherapy: When, how and for what? · a) Twenty patients, 16 women and four men, in 11 phlebology clinics b) VDs average 7 minutes after FS c) All pts VDs characteristic

Foam injection distal GSV

Sclerotherapy with Foam

Page 15: Ultrasound-guided sclerotherapy: When, how and for what? · a) Twenty patients, 16 women and four men, in 11 phlebology clinics b) VDs average 7 minutes after FS c) All pts VDs characteristic

Following foam up distal GSV

Sclerotherapy with Foam

Page 16: Ultrasound-guided sclerotherapy: When, how and for what? · a) Twenty patients, 16 women and four men, in 11 phlebology clinics b) VDs average 7 minutes after FS c) All pts VDs characteristic

Small Saphenous Vein injection

(patient prone)

Sclerotherapy with Foam

Page 17: Ultrasound-guided sclerotherapy: When, how and for what? · a) Twenty patients, 16 women and four men, in 11 phlebology clinics b) VDs average 7 minutes after FS c) All pts VDs characteristic

Side EffectsDry cough

Migraine

Chest tightness

Circumoral paresthesia

Metallic taste

Nausea

Dizziness

Hyperpigmentation

Adverse Events Occular migraine

Visual disturbance

Panic attack

Neurasthenia

Respiratory difficulty

Cutaneous necrosis

DVT

STP

Neurologic event

Sclerotherapy with Foam

Page 18: Ultrasound-guided sclerotherapy: When, how and for what? · a) Twenty patients, 16 women and four men, in 11 phlebology clinics b) VDs average 7 minutes after FS c) All pts VDs characteristic

Jean-Luc Gillet, et al.

multicentre, prospective, controlled

study

1025 pts

818 GSVs, 207 SSVs in 20 centers

27 (2.6%) side effects

migraine,visual disturbance, chest

pressureGillet JL, et al. Phlebology 2009;24:131–138

Sclerotherapy with Foam

Page 19: Ultrasound-guided sclerotherapy: When, how and for what? · a) Twenty patients, 16 women and four men, in 11 phlebology clinics b) VDs average 7 minutes after FS c) All pts VDs characteristic

Lower risk of chest tightness, dry

cough, dizziness with CO2/O2-

based foam compared to air-

based foam

(p < 0.05)

Incidence of visual disturbance

with CO2/O2-based foam (2%)

trended less than with air-based

foam (8%)

Morrison N, et al. Eur J Vasc Endovasc Surg 2010

Sclerotherapy with Foam

Page 20: Ultrasound-guided sclerotherapy: When, how and for what? · a) Twenty patients, 16 women and four men, in 11 phlebology clinics b) VDs average 7 minutes after FS c) All pts VDs characteristic

Intra-arterial injection

FREAKING DISASTER!!!

1-2cm Skin necrosis/ulcer

Tissue/limb loss

Stop if painful!

Sclerotherapy with Foam

Adverse Events

Page 21: Ultrasound-guided sclerotherapy: When, how and for what? · a) Twenty patients, 16 women and four men, in 11 phlebology clinics b) VDs average 7 minutes after FS c) All pts VDs characteristic

Background

Reports:

rare neurologic symptoms or events

following ultrasound guided foam

sclerotherapy (UGFS) 1,2,3

1Forlee MV, Moore DJ, Shanik G, et al. Stroke after varicose

vein foam injection sclerotherapy.J Vasc Surg 2006;43:162-4.

2Bush RG, et al. Major neurological events following

foam sclerotherapy. Phlebology 2008;23:189-92

3Ceulen R. Microembolism during Foam Sclerotherapy of

Varicose Veins. N Engl J Med 2008;358:14

Page 22: Ultrasound-guided sclerotherapy: When, how and for what? · a) Twenty patients, 16 women and four men, in 11 phlebology clinics b) VDs average 7 minutes after FS c) All pts VDs characteristic

What is the fate of injected foam?

Sclerotherapy with Foam

Page 23: Ultrasound-guided sclerotherapy: When, how and for what? · a) Twenty patients, 16 women and four men, in 11 phlebology clinics b) VDs average 7 minutes after FS c) All pts VDs characteristic

Foam Migration

Page 24: Ultrasound-guided sclerotherapy: When, how and for what? · a) Twenty patients, 16 women and four men, in 11 phlebology clinics b) VDs average 7 minutes after FS c) All pts VDs characteristic

Vasoactive CompoundsProspective multicentre study

Patients with visual disturbances (VD) after foam sclerotherapy (air –based foam, 10mL max)

Patient assessment:

a) Clinically – description of procedure and neurological symptoms

analysis method by neurologist specialized in migraine

b) Brain diffusion-weighted MRI - within two weeks – neuroradiologist analysed

Results:

a) Twenty patients, 16 women and four men, in 11 phlebology clinics

b) VDs average 7 minutes after FS

c) All pts VDs characteristic of migraine with aura

1) with headache in 10 , without in 10.

2) Paresthesia in 5

3) Dysphasic speech in 1

d) 15 pts (75%) Hx of migraine

e) 18/20 MRI – ALL NORMAL

Conclusion:

a) VDs after FS correspond to MA and not transient ischaemic cerebro-vascular events

b) Pathophysiological hypothesis : endothelin release to cerebral cortex via patent

foramen ovale Gillet, Guex, et al. Phlebology 2010;25:261–266

Page 25: Ultrasound-guided sclerotherapy: When, how and for what? · a) Twenty patients, 16 women and four men, in 11 phlebology clinics b) VDs average 7 minutes after FS c) All pts VDs characteristic

Conclusions

Ultrasound-guided foam

sclerotherapy appears to be

effective, safe, associated with few

mild, short-lived side effects, and

infrequent (rare) significant

complications

Page 26: Ultrasound-guided sclerotherapy: When, how and for what? · a) Twenty patients, 16 women and four men, in 11 phlebology clinics b) VDs average 7 minutes after FS c) All pts VDs characteristic

Proximal truncal ablation alone will

ultimately fail

Unless one is committed to careful

follow up and adjunctive

treatment, the practitioner and

the patient will be left with

unsatisfactory results

Conclusions

Page 27: Ultrasound-guided sclerotherapy: When, how and for what? · a) Twenty patients, 16 women and four men, in 11 phlebology clinics b) VDs average 7 minutes after FS c) All pts VDs characteristic

Antelope Canyon, [email protected]

Thank you for your

kind attention

Antelope Canyon, AZ