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Avoiding Complications is Sclerotherapy
Sonja Stiller Martin, MD
Disclosures: none
“ A clever person solves a problem.
A wise person avoids it.”
- Albert Einstein
Avoiding Complications is Sclerotherapy
Objectives
• The learner will be able to describe the most common complications
of sclerotherapy
• The learner will be able to describe the complications of
sclerotherapy with higher morbidity/mortality risks
• The learner will be able to identify strategies to minimize
complications associated with foam sclerotherapy
Most common complications of sclerotherapy:
• Pain/inflammation
• Transient bruising
• Intravascular coagulum/hematoma
• Post treatment pigmentation: 10-30% *
• Telangiectatic Matting: 15-20% *
*Cavezzi, A, and K. Parsi. “Complications of Foam Sclerotherapy.” Phebology 27. Supplement 1 (2012): 46-51.
Fortunately, most serious complications of
Sclerotherapy are rare:
DVT
1-2%
SVT
4.4%]
Edema
0.5%
Nerve Damage
0.2%
Tissue Necrosis – variable frequency
Anaphylactic/anaphylactoid reactions – very rare
Cavezzi, A, and K. Parsi. “Complications of Foam Sclerotherapy.” Phebology 27. Supplement 1 (2012): 46-51.
A multicenter, prospective, controlled study using foam sclerotherapy
for truncal vein incompetence (small saphenous vein and large
saphenous vein) with:
• 1,025 patients
• 99% done using ultrasound guidance
• 818 GSV treated
• 207 SSV treated
Gillet, J-L, J. Guedes M., J-J Guex, C. Hamel-Desnos, M. Schadeck, M. Luseker, and F. Allaert A. “Side-effects and Complications of Foam
Sclerotherapy of the Great and Small Saphenous Veins: A Controlled Multicentre Prospective Study including 1025 Patients.” Phlebology
24.3(2009):131-38.Print.
Reported side-effects/complications:
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•
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Migraine: 8 episodes, 4 with visual disturbances
Visual disturbance alone: 7
Chest pressure alone: 7
Chest pressure with visual disturbance: 5
VTE: total of 11
• DVT: 10, only 5 were symptomatic
• PE: 1 – identified 19 days post treatment, without U/S evidence of DVT
• TIA: 1 – complete recovery in 30 minutes
• Infection/septicemia: 1
Gillet, J-L, J. Guedes M., J-J Guex, C. Hamel-Desnos, M. Schadeck, M. Luseker, and F. Allaert A. “Side-effects and Complications of Foam Sclerotherapy of the Great and
Small Saphenous Veins: A Controlled Multicentre Prospective Study including 1025 Patients.” Phlebology 24.3(2009):131-38.Print.
A Prospective Multicenter Registry of 12,173 sclerotherapy sessions:
• 5,434 with liquid sclerotherapy
• 6,395 with foam
• 344 with both
• Only 49 adverse events reported during the study and follow up
period
• Visual disturbances reported in 20
• Only 1 severe adverse event: femoral vein DVT
Guex, JJ, F.A.Allaert, J.L.Gillet, F.Chleir. “Immediate and Midterm complications of sclerotherapy: report of a prospective multicenter registry of
12,173 sclerotherapy sessions.”Dermatol Surg. 2005 Feb:31(2)123-8. web
Prospective five year study of ultra-sounded guided foam sclerotherapy
for GSV reflux, using tessari microfoam method and sodium tetradecyl
sulfate:
• Foam Sclerotherapy was the SOLE treatment in all cases
• 146 patients, 203 limbs.
•
•
•
•
•
NO serious adverse outcomes observed
No VTE
No arterial injection
No anaphylaxis
No nerve damage
Chapman-Smith, P., and A. Browne. “Prospective Five-year Study of Ultrasound-guided Foam Sclerotherapy in the Treatment of Great
Saphenous Vein Reflux.” Phlebology 24.4(2009):183-88.
Sclerotherapy is characterized by a
high degree of safety.
Numerous Case Reports of Serious Complications in the
literature:
• TIA – recent case of transient episode of dense hemiplegia in an otherwise
healthy individual after receiving foamed polidocanol
Malvehy, M.A., and C. Asbjornsen. “Transient Neurologic Event following Administration of Foam Sclerotherapy.” Phebology. The Journal of
Venous Disease (2016)n.pag.Web.
• MI - 61 year old female with non-ST elevation MI
Stephens, R., and S. Dunn. “Non-ST-elevation Myocardial Infarction following Foam Ultrasound-guided Sclerotherapy.” Phlebology: The Journal
of Venous Disease 29.7(2013): 488-90.
• PE – recent case of a 52 year old female with fatal PE
Bruijninckx, C. “Fatal pulmonary embolism following ultrasound-guided foam sclerotherapy combined with multiple microphlebectomies.”
Phlebology:31.7(2016):449-455.
“If you haven’t seen a complication, you
haven’t been doing it long enough.”
David Wagner
Pediatric Surgeon and Emergency Medicine Specialist
“Success does not consist in never
making mistakes but in never making the
same one a second time.”
-George Bernard Shaw
Basic initial steps in AVOIDING COMPLICATIONS with
sclerotherapy:
• Prepare YOURSELF
• Know your patient
• Pre-procedure preparation
Prepare YOURSELF
• Training – for yourself and staff members who are going to be
performing sclerotherapy.
• Know your medications
• Know your ‘tools’ and equipment
• Ensure that you are prepared for the ‘worst case scenario’
Know the Indications and Contraindications for
sclerotherapy in vein care:
Indications for sclerotherapy in vein care include:
• Treatment of spider and reticular veins
• Treatment of larger (>3mm) residual refluxing veins following previous thermal or surgical
treatment of saphenous truncal veins or incompetent perforators
• Treatment of refluxing saphenous veins
• Treatment of incompetent perforators
• Treatment of bleeding varicosities
• Treatment of veins associated with venous ulcers
Contraindications for sclerotherapy in vein care include:
Absolute Contraindications:
Previous anaphylactic reaction to proposed sclerosant
Acute DVT
Relative contraindications:
- Deep vein obstruction
- Pregnancy/breastfeeding
- Peripheral vascular disease
- OCP/HRT use
- Documented thrombophilia
- Skin disease (systemic disease)
- Inability to mobilize
- Uncontrolled asthma
- Poor tolerance of compression
- Uncontrolled migraine
- Acute superficial venous thrombosis (SVT)
Other contraindications that can be found in literature include:
-
Obesity
Incompetence of deep veins
Advanced age
Anticoagulation
Acute infections/fever
Tamoxifen use
Patent Foramen Ovale/known Right to Left shunt
Recent immobilization (long travel, lower extremity cast, enforced bed rest)
Know your PATIENT:
• Thorough and current patient history
• Medical history: history of PFO (or RLS), VTE’s, known thrombophilia,
migraine, asthma, PVD, cancer history
• Allergy history
• Current Medications
• Previous vein treatment and response to treatment
• Pertinent family history
• VTE, thrombophilia, vein disease
Physical assessment and exam:
• Looking for contraindications: PVD, acute SVT/DVT, wheezing (asthma)
• Looking for indications
Ultra-sound evaluation:
• Looking for indications: Reflux/incompetence of superficial veins
• identify most proximal source of reflux/incompetence
• Looking for potential contraindications or indications for further evaluation:
DVT/SVT, atypical anatomy(?AVM, deep vein system abnormalities), deep vein
reflux.
Pre-procedure Preparation:
• ‘Before’ Photos
• Consent form
• Manage patient expectations!
Avoiding specific complications:
• Infection
• Arterial injection
• Allergic reaction
• VTE
• Neurologic events
• Nerve injury
Avoiding infection
Considerations in sources of infection in vein care:
1) person to person contact
- practice good hygiene and follow universal precautions (wear gloves while treating)
2) equipment
- ensure re-usable equipment is covered with appropriate barrier during use and
cleaned between each patient (i.e.ultrasound probe)
- use new sterile disposable equipment/supplies when able
3) skin
- cleanse patient’s skin prior to injection (with alcohol, chlorhexidine, hibiclens, etc.)
4) air
- use closed system for injection as much as possible
5) injected solution/medication
- use pre-prepared solutions/medications as much as feasible
- use sterile technique in medication preparation if it is necessary
Avoiding arterial injection
Signs and Symptoms of Arterial injection include:
• Five P’s: Pain, polar sensation (cold), parlor, pulseless, paresthesia
• Note: Polidocanol has a local anesthetic effect, pain may not be
appreciated immediately
• Pain (and other symptoms) can occur immediately or progress
over several hours
Avoiding arterial injection
If there is any question of a possible inadvertent intra-arterial
injection of sclerosant:
1)Stop injection Immediately
2)Treatment needs to be administered quickly and effectively to salvage
tissue. If available, consider:
• topical nitrates
• unfractionated heparin infusion
• phosphodiesterase inhibitors (i.e. sildenafil,tadalafil, vardenafil,
pentoifylline or cilostazol)
• prostacyclins (lloprost, alprostadil)
3) Transfer to hospital immediately
Fibrinolytic therapy/catheter-directed thrombolysis/mechanical
thrombectomy
Avoiding arterial injection
Prevention:
• Ultrasound guidance
• Use extra care in areas identified in literature as ‘HIGH RISK’ areas*
• Near the ankle
• Distal medial calf
• Aspirate prior to injection (confirm venous blood)
*Hafner,F.,H. Froehlich,T.Gary,and M.Brodmann. “Intra-arterial injection, a Rare but Serious Complication of Sclerotherapy.”Phlebology:The
Journal of Venous Disease 28.2(2013):64-73.
Avoiding Allergic Reactions
Very RARE – but potentially life-threatening.
Be aware that exposure to sclerosant in either liquid or foam form can
precipitate an allergic reaction particularly in atopic individuals and/or those
previously exposed to sclerosants.
If using local anesthetics during the procedure, consider the anesthetic
and/or preservatives/preparation solutions as well when investigating allergy
risk for your patient.
Scurr, J.r.h., R.K.Fisher,S.b.Wallace, and G.I.Gilling-Smith. “Anaphylaxis Following Foam Sclerotherapy: A Life Threatening Complication of Non Invasive
Treatment for Varicose Veins.” EJVES Extra 13.6(2007):87-89. Web
Avoiding VTE/DVT/SVT
Know your patient
• History/past history/risk factors
• Consider using a Venous Thromboembolism Risk Factor Assessment tool*
• No tool that is specific for Sclerotherapy
During Procedure:
• Avoid injection of large volumes of sclerosant*
• Foot and/or ankle 'pumping'**
* Rabe, E., et al. “European guidelines for sclerotherapy in chronic venous disorders.” Phlebology:The Journal of Venous Disease 29.6(2013):338-54.Web
**"Chapter 15: Sclerotherapy for Venous Disease." American Venous Forum. N.p., n.d. Web. 24 Sept. 2016.
Avoiding VTE/DVT/SVT
• Compression
• Ambulation
• Use of pharmacological prophylaxis not generally
recommended. May choose to use for patients
considered High Risk (i.e. history of unprovoked VTE
or known thrombophilia)*
* Rabe, E., et al. “European guidelines for sclerotherapy in chronic venous disorders.” Phlebology:The Journal of Venous Disease
29.6(2013):338-54.Web
Avoiding Neurologic Events
Variety of Reported Neurologic Events with sclerotherapy:
Migraine with/without aura
Visual disturbances
Transient Ischemic Attack
Cerebral Vascular Accident
Avoiding Neurologic Events
• Occur with both liquid and foam sclerotherapy
• Most often occurs with foam sclerotherapy*
• Etiology: ? Multifactorial*
• Gas bubbles
• Endothelin
• Right to Left Shunt
• Other?
*D.A.Hill."Neurological and chest symptoms following sclerotherapy:A single centre experience."Phlebology29.9(2014):619-627.
*T.Willenberg,et.al."Visual disturbance following sclerotherapy for varicose veins,reticular veins and telangiectasias: a sytematic literatury
review."Phlebology 28.3(2013):123-131
Avoiding Neurologic Events
• Supine position during/post injection*
• Leg elevation during/after procedure?**
•
•
•
•
Avoid injection of large volumes of foam*
Avoid valsalva maneuver during/immediately after*
Ensure foaming technique/equipment adequately creates microbubbles
Possible role for use of physiologic gases for foam mixture:
• jury still out on this one*
*M.Wong "Should foam made with physiologic gases be standard in sclerotherapy?."Phlebology30.9(2014):580-586.
**" Chapter 15: Sclerotherapy for Venous Disease." American Venous Forum. N.p., n.d. Web. 24 Sept. 2016.
Avoiding Nerve Injury
• Very rare complication complication
• Remember your anatomy:
• Sural nerve runs with the small saphenous vein on the posterior aspect of the leg,
lateral to the Achilles
• Saphenous nerve typically runs along the medial aspect of the leg
• Cutaneous branches of larger nerve
• Irritation or injury of a nerve during sclerotherapy:'numbness'
• May be able to visualize nerve during ultrasound guidance
• If you see it, avoid it!
• Usually self limiting
• Document location, size and description of sensation
• Consider anti-inflammatory(NSAID)use
Now this is not the end. It is not even the
beginning of the end. But it is, perhaps, the end
of the beginning.
Winston Churchill