Eur J Vasc Endovasc Surg xx, 1e7 (xxxx)doi:10.1016/j.ejvs.2006.04.033, available online on
Chronic Venous Disease Treated by Ultrasound Guided
Aim. To report the outcome of a series of patients with chronic venous disease due to incompetence of saphenous trunksmanaged by ultrasound guided foam sclerotherapy (UFS). Patients and methods. A group of 808 patients comprise this series. CEAP clinical class for limbs was C1: 15%, C2:81%, C3: 0.5%, C4: 2%, C5: 0.2%, C6: 0.4%. UFS using 1% polidocanol (107 limbs), 1% sodium tetradecyl (102 limbs),3% sodium tetradecyl (900 limbs) was employed to treat incompetent saphenous trunks. In patients with unilateral varices1 treatment was required in 43% of patients and 2 treatments in 48% of patients to obliterate incompetent saphenoustrunks and varices. For bilateral varices 2 treatments were required in 40% of patients and 3 treatments in 46% of cases.
The clinical outcome and patency of treated veins on duplex ultrasonography was assessed at a mean follow-up interval of
11 months. Results. A total of 459 limbs were available for assessment at a follow-up interval of 6 months or greater. The CEAP clin-ical stage was C0:182 limbs, C1: 241, C2: 22, C3: 0, C4: 11, C5: 2, C6:1. The GSV had remained obliterated in 88% oflimbs and the SSV in 82% of limbs. Recurrent venous incompetence following previous surgery was as effectively treatedby UFS as primary incompetence. Conclusions. This technique is useful in the management of chronic venous disease as an alternative to surgery.
Keywords: Varicose veins; Foam sclerotherapy; Duplex ultrasonography; Clinical outcome.
Subsequently a number of authors have publishedclinical series using this treatment including Frullini
Surgery for varicose veins is widely used in the UK
and Cavezzi who reported a series of 453 patien
but recurrence may be expected in 25e50% of patients
and Barrett who reported a series of 100 limbs.
at 5 Surgery leaves scars and may result in
Cavezzi has subsequently reported a good outcome
damage to adjacent structures including nerves, lym-
in 93% of 194 patients.This technique has become
phatics, major arteries and veins.Deep vein throm-
widely used in southern Europe, Australia, New
bosis and pulmonary embolism occur.Saphenous
Zealand, South America and the USA.In the UK
trunks, but not superficial varices, may be obliterated
one series has been recently reported involving 60
by radiofrequency obliteration (RF obliteration)or
patients comparing surgical treatment with foam scle-
endovenous laser treatment (EVLT).Phlebectomy or
rotherapy combined with sapheno-femoral ligation.
sclerotherapy are used to manage the residual varices.
The aim of this paper is to report the author’s own
The advantage of using these methods is more rapid
series of patients treated by ultrasound guided foam
post-operative recovery compared to surgery.
(UFS) sclerotherapy for the management of chronic
In 1995 Cabrera reported that foam created using
‘physiological gases’ mixed with polidocanol (a deter-gent sclerosant) was effective in the management oftruncal saphenous incompetence.He used ultra-
sound guided injection into saphenous trunks.
A total of 808 patients (666 women, 142 men) weremanaged by ultrasound guided foam sclerotherapy
*Corresponding author. Philip Coleridge Smith, DM, FRCS, Depart-
for chronic venous disease due to truncal saphenous
ment of Surgery, Thames Valley Nuffield Hospital, Wexham Street,
incompetence. Patients without truncal incompetence
Wexham SL3 6NH, UK. Tel.: þ44 1753 665449; fax: þ44 1753 663964. E-mail address:
have been excluded from this series.
1078–5884/000001 + 07 $35.00/0 Ó 2006 Elsevier Ltd. All rights reserved.
All patients were referred to the author for man-
trunks and STD was used as either a 1% or 3% solu-
agement of varices in private practice (Thames Valley
tion for saphenous trunks. Foam was prepared in a
Nuffield Hospital, Wexham, Bucks, UK). Patients
ratio of 0.5 ml of sclerosant to 1.5 ml of air in keeping
were assessed by clinical examination during which
the CEAP clinical stage was recorded and all under-went colour duplex ultrasonography (Sonoline, Sie-mens, Germany) using a 5e9 MHz linear transducer. The author or an assistant trained in venous duplex
ultrasound examination undertook all investigations. Patients stood during ultrasound examination and
The author’s preparation for this clinical series in-
venous reflux was assessed by manual compression
cluded treating 50 patients in clinical trials under
of the calf followed by release. Reverse flow in the
the supervision of an experienced practitioner of ul-
vein under examination exceeding 0.5 seconds indi-
trasound guided foam sclerotherapy. The author also
cated venous incompetence.The diameter of incom-
has 20 years of experience of vascular duplex ultraso-
petent saphenous veins and perforating veins was
nography. Patients lay supine during canulation of the
recorded in a computer database. The extent of previ-
veins and during treatment to minimise the amount of
ous varicose vein surgery and recurrent varices
blood in the vein and to avoid syncope. With all can-
shown by duplex ultrasound was also recorded. The
nulae and Butterflies in place the limb to be treated
definition of ‘recurrent’ used here is a saphenous
was elevated to an angle of about 30 to empty the
trunk or system where previous junction ligation or
veins and foam was injected. The progress of foam
stripping had been carried out. Limbs in which sur-
was monitored using ultrasound imaging. No specific
gery had been carried out to another vein e.g. previ-
measures were taken to avoid foam entering the deep
ous SSV surgery in a patient with GSV reflux, were
veins but only 2 ml of foam per injection was given at
classified as ‘primary GSV reflux’. Incompetence of
a time. The total amount of foam injected in one treat-
the anterior accessory saphenous vein (AASV) in
ment session was limited to 20 ml in order to avoid
limbs where previous GSV surgery had been per-
local or systemic complications. Saphenous trunks
formed was considered to be recurrent reflux accord-
were injected first and any residual varices treated
ing to recent anatomical definitions.
in subsequent sessions. Blood flow in the deep veins
All treatments were carried out in a consulting
was encouraged after each injection by asking the
room without sedation or general anaesthesia using
patient to perform as series of dorsiflexions at the
ankle in order to minimise the risk of DVT.
The great saphenous vein (GSV) was canulated with
Prophylactic heparin was not given routinely in
an 18g IV cannula (Optiva 2, Medex Medical Ltd,
this series. A small number of patients with duplex
Rossendale, UK) at the level of the knee or just above
ultrasound evidence of post-thrombotic deep vein
with ultrasound guidance. The GSV below the knee
damage was treated. All received a 5 day course of
was injected via a 23 g Butterfly needle (Abbot
prophylactic LMWH and none developed a DVT.
Ireland, Sligo, Eire). In the small saphenous vein the
Short stretch compression bandaging was applied
cannula was placed in the proximal part of the calf
to limbs where saphenous trunks and varices had
10e15 cm from the sapheno-popliteal junction. The
been injected. Pehahaft cohesive bandage (PehahaftÒ,
distal SSV was injected using a 23 g Butterfly. Correct
positioning of the cannula or Butterfly was confirmed
(VelbandÒ, Johnson & Johnson Medical, Ascot, Berk-
by the injection of 0.9% saline solution. Saphenous
shire, UK) cotton wool padding applied over the saphe-
varices (3 mm diameter or greater) were injected
nous trunks to increase compression. A class 2 medical
through either a 23 g Butterfly or 30 g needle attached
compression stocking was measured and applied over
to a 2 ml syringe. Transverse ultrasound images of the
the bandage to secure the bandage (CredelastÒ,
veins were used to guide injections.
Credenhill, Ilkeston, Derbyshire, UK). Initially bandag-
The Tessari method of preparing foam was used in
ing was left in place for 3e5 days but later in the series
which sclerosant and air was mixed in two syringes
this was increased to 10e14 days to minimise the inci-
dence of thrombophlebitis. Treatment sessions were
used were either polidocanol (POL e ScleroveinÒ,
carried out at intervals of 2 weeks. Duplex ultrasonog-
Resinag AG, Zurich, Switzerland) and purified so-
raphy was used to check the treated veins for complete-
dium tetradecyl sulphate (STD e FibroveinÒ, STD
ness of occlusion. Veins containing a substantial
Pharmaceuticals Ltd, Hereford, UK). POL was used
amount of residual thrombus after sclerotherapy were
as a 1% solution to create the foam to treat saphenous
managed by aspiration using a 19 g needle.
Eur J Vasc Endovasc Surg Vol xx, Month xxxx
Chronic Venous Disease Treated by Foam Sclerotherapy
Patients were invited to return for follow up visits 6
reflux but patients from all CEAP clinical stages are
months after treatment. The patients were asked
included. Some saphenous trunks shown to be incom-
about symptoms and recurrence of varices. The
petent on duplex ultrasound were not treated since
CEAP clinical stage was recorded at each visit and du-
they gave rise to few or no varices. In all 1109 limbs
plex ultrasonography used to assess the state of occlu-
were managed by foam sclerotherapy. A surprisingly
sion of saphenous trunks and varices. In addition, the
high proportion of patients had undergone previous
competence of all other saphenous trunks and deep
surgery for varicose veins in the vessel being treated,
veins of the thigh and calf were assessed.
30% of GSVs and 17% of SSVs. Four limbs were
Where recurrent or residual reflux was found in
treated in which post-thrombotic deep vein incompe-
tributaries or trunks, further UFS was used. The diam-
tence was found in association with GSV or SSV
eter of recurrent incompetent saphenous trunks fol-
lowing earlier foam sclerotherapy was much smaller
than at the initial treatment. Subsequent foam sclero-
were performed in all 808 patients to obliterate incom-
therapy was no more technically complex than at
petence trunks and varices. In 99% of patients with
the first treatment and usually resulted in obliteration
unilateral varices and 92% of bilateral varices 3 treat-
of the re-treated saphenous trunk. Longer term
ments were sufficient to obliterate all veins. The me-
follow-up in retreated saphenous trunks has not been
dian volume of sclerosant foam required to achieve
completed. No patient required surgical treatment.
this outcome over all sessions was 14 ml (inter-quartile range, IQR 9e21 ml, range 1 mle72 ml). Themedian volume of foam used per limb over all
sessions was 10 ml (IQR 6e14 ml). In treating theGSV the median volume of foam used was 10 ml
Data are represented by the mean and range for the
age and median and interquartile range for all other
e14 ml) and for the SSV 6 ml (IQR 5e10 ml).
Initially in this series, 1% POL foam was used to
data, which were not normally distributed. Tests of
treat saphenous trunks. Later 1% and 3% STD were
statistical significance have not been used. These
employed. The aim of using stronger sclerosants
were not considered appropriate in a clinical series
was to minimise the risk of recanalisation of saphe-
where differences may have arisen as a consequence
nous trunks. 1% POL was used in 13% of saphenous
veins, 1% STD in 9% and 3% STD in 78%.
Thrombophlebitis occurred in a small number of
patients (5%) and was managed by analgesia, com-pression and aspiration of thrombus. Calf vein throm-
A total of 808 patients are included in this series in
bosis was confined to isolated gastrocnemius veins or
whom 1411 limbs were affected by venous disease.
to part of the posterior tibial vein (10 cases). All re-
The clinical and duplex ultrasound findings are sum-
solved with compression by stocking or bandage
and exercise without use of anticoagulants. In one
limbs were affected by uncomplicated varicose veins
case a short occlusive thrombus arose in the common
(CEAP C2, n ¼ 1154, 81%) attributable to GSV or SSV
femoral vein 2 weeks following treatment of the GSV
Table 1. Patients included in study e clinical data
CEAP stage e limbs with venous disease considered for treatment, total 1411C1
Duplex ultrasound findings in 1109 limbs which were treated by UFSGSV reflux, alone
Eur J Vasc Endovasc Surg Vol xx, Month xxxx
Table 2. Number of treatments received per patient
Outcome of treatment of GSV
probably due to direct extension of thrombus from the
Number of limbs 100
GSV into the femoral vein. This case was managed byanticoagulation using low molecular weight heparin
and warfarin continued for six months. The occluded
femoral vein recanalised within 4 weeks and at six
months of follow-up no residual scarring or valve
CEAP Clinical class
damage could be demonstrated on duplex ultraso-
Fig. 1. CEAP clinical stage before and at an average of 11
nography. In two further cases non-occlusive throm-
months after UFS carried out to the GSV.
bus extended from the SFJ and SPJ (one case each)into the femoral and popliteal vein. The extent ofthe thrombus was limited and firmly adherent to the
The data in has been subdivided to assess fac-
vein wall. This was managed by compression stock-
tors which might influence the outcome including
ings and exercise whilst monitoring the extent of the
diameter of the vein, type of sclerosant and whether
thrombus by duplex ultrasonography. In these cases
primary or recurrent varices were treated. A greater
the thrombus resolved without further intervention.
incidence of recanalisation was seen in GSVs and
No major systemic complication such as anaphy-
SSVs larger than 5 mm in diameter. The recurrence
laxis, stroke or transient ischaemic attack occurred in
rates are similar with both sclerosants used in the
this series. A number of patients (14, 2% of all patients
treatment. A substantial proportion (30%) of patients
treated) reported visual disturbance following treat-
were treated for recurrent varices of the GSV follow-
ment. Patients with a previous history of migraine
ing previous surgery. The outcome for this group
with visual aura were especially at risk of this prob-
was similar to that for patients with primary varices.
lem. The visual aura was precipitated by sclerother-
Residual skin pigmentation and palpable lumps
apy and resolved in most cases within 30 minutes.
were sometimes seen at follow-up. Skin pigmentation
Patients experiencing one episode of visual distur-
was seen in 115 of 459 limbs at 6 months and palpable
bance were prone to further episodes. These patients
lumps were present in 21 limbs. The skin pigmenta-
were managed by inviting them to rest supine for
tion was almost always of a minor extent and contin-
ued to fade with time. 1 year or more following
Although all patients were invited for follow-up
examinations at 6 months following treatment, by nomeans all patients returned despite reminders. In all459 limbs have been reviewed at 6 months or more
Outcome of treatment of SSV
following treatment, average 11 months, range 6e46
months. This includes 363 of 886 GSVs and 141 of
before and after sclerotherapy in these limbs. A sub-
stantial improvement in clinical venous disease wasobtained. Duplex examination of the GSVs showed
occlusion had been obtained in 318 of 363 (88%). In
the SSVs occlusion was present in 116 of 141 (83%).
The data in show the outcome of treatment
for the GSV and SSV. Where incompetence or varices
arose in a major tributary of the GSV or SSV this
was also considered to comprise treatment failure.
In 4 cases reviewed after 6 months the anterior acces-
sory saphenous vein developed reflux and in one case
Fig. 2. CEAP clinical stage before and at an average of
a medial thigh tributary of the GSV was incompetent.
11 months after UFS carried out to the SSV.
Eur J Vasc Endovasc Surg Vol xx, Month xxxx
Chronic Venous Disease Treated by Foam Sclerotherapy
Table 3. Outcome in 363 (of 886) GSVs and 141 (of 263) SSVs where follow-up had been completed at 6 months or more (mean11 months following treatment)
treatment skin pigmentation was present in 11 of 115
Varicose vein surgery is imperfect. Neurological
limbs. Small palpable lumps were sometimes detect-
injury and an unsatisfactory outcome are common
able in the calf and comprised residual elements
causes for litigation, damage to the femoral artery
of treated veins. In contrast to surgical series, no
and vein also occurs.Rautio found that patients un-
scars, neurological damage or lymphatic injuries
dergoing varicose vein surgery required on average
16 days off work compared to 6.5 days following RFclosure of the saphenous trunk.Recurrence ofvaricose veins following surgery is a common event
and is often attributable to neovascularisation.Fischer reviewed 125 limbs in 77 patients after an
The publication of a clinical series cannot replace
average of 34 years following SFJ ligation and
a randomised controlled trial (RCT) in the evaluation
GSV stripping and found recurrence in 60%.Wood
of a new treatment. The author acknowledges one
et al. reported that neurological injury may be present
RCT has been published, however both groups of pa-
in 27% of patients treated surgically six weeks post-
tients underwent surgical ligation of the SFJ with scle-
operatively.Ouvry reports an 8.7% rate of lymphatic
rosant foam or stripping being used to manage the
complications amongst 30 surgeons surveyed.
saphenous trunA further randomised clinical trial
Surgical treatment which is widely regarded as the
of VarisolveÒ, a polidocanol foam, compared against
reference standard, carries the risk of significant
surgery in 650 patients has been completed and re-
post-operative complications, necessitates significant
ported at a scientific meeting (UIP Chapter meeting,
time off work and despite this does not prevent
San Diego, USA, 2003) but not yet published. The final
endpoint is the efficacy with which a treatment elim-
In my series foam sclerotherapy required 30 min-
inates varicose veins after an extended period of
utes per treatment session, patients could walk from
follow-up. Hobbs found that a follow-up period of
the room afterwards and in most cases patients only
10 years was required fully to distinguish the failures
took time off on the days in which treatment was
of injection-compression treatment from surgery
given. Discomfort at the time of treatment was mini-
Such long studies are difficult to complete and
mal and in the majority of patients, symptoms in the
many authors now base their conclusions on the use
2 weeks following treatment were few, although
of duplex ultrasound imaging as a surrogate end-
thrombophlebitis was seen in 5%. Patients main com-
point. There is a good correlation between duplex re-
plaints related to the compression bandage applied
currence at the SFJ 1 year after treatment and clinical
after each session. Few other problems were encoun-
recurrence 5 years after treatment.Duplex ultraso-
tered with skin pigmentation at follow-up being the
nography has been used as a predictor of the final out-
most frequent. This was usually mild and continued
to resolve with the passage of time.
Eur J Vasc Endovasc Surg Vol xx, Month xxxx
Patients followed up for more than 6 months repre-
assistance of the following members of my team for assis-
sent only 40% of the overall group. This is a potential
tance in completing this work: Paola Buresta MD, Maria
disadvantage since it might lead to bias in the overall
Cork RGN, Frances Devine RGN, Sue Topp RGN. I am
assessment. Patients were all invited to attend at an in-
also indebted to the many experts in venous disease who
terval of 6 months following initial treatment but
have provided advice in the preparation of this manuscript.
many defaulted. In some instances patients returnedwith residual or recurrent varices due to recanalisationof the treated vein. Further invitations for review havenow been sent to those who have not attended so far at
Examination of shows that the main factor
VAN RIJ AM, JIANG P, SOLOMON C, CHRISTIE RA, HILL GB. Re-currence after varicose vein surgery: a prospective long-term
influencing recurrence was the size of the vein prior
clinical study with duplex ultrasound scanning and air plethys-
to treatment. Both GSVs and SSVs of 6 mm dia or
mography. J Vasc Surg 2003;38:935e943.
greater were more likely to recur than those of 5 mm
INTERBORN RJ, FOY C, EARNSHAW JJ. Causes of varicose vein re-
currence: late results of a randomized controlled trial of strip-
dia and below. For the GSV, treatment of recurrent
ping the long saphenous vein. J Vasc Surg 2004;40:634e639.
varicose veins was as successful as for primary vari-
3 FISCHER R, LINDE N, DUFF C, JEANNERET C, CHANDLER JG, SEEBER P.
Late recurrent saphenofemoral junction reflux after ligation
ces. Operations for recurrent varicose veins are usu-
and stripping of the greater saphenous vein. J Vasc Surg 2001;
ally technically more difficult and prone to a high
complication rate compared to that for primary vari-
4 PERRIN MR, GUEX JJ, RUCKLEY CV, DEPALMA RG, ROYLE JP, EKLOF B
et al. Recurrent varices after surgery (REVAS), a consensus doc-
ces.Foam sclerotherapy carries little risk and may
ument. REVAS group. Cardiovasc Surg 2000;8:233e245.
be a satisfactory solution in patients with recurrence
5 CAMPBELL WB, FRANCE F, GOODWIN HM, Research and Audit Com-
mittee of the Vascular Surgical Society of Great Britain andIreland. Medicolegal claims in vascular surgery. Ann R Coll
In the series of patients presented here, no case of
neovascularisation was seen at the SFJ or SPJ although
6 VAN RIJ AM, CHAI J, HILL GB, CHRISTIE RA. Incidence of deep vein
this would have been expected following surgical
thrombosis after varicose vein surgery. Br J Surg 2004;91:1582e1585.
treatment. The mode of recurrence following UFS
7 SRILEKHA A, KARUNANITHY N, CORBETT CRR. Informed consent:
was recanalisation of previously treated veins. It is
what do we tell patients about the risk of fatal pulmonary embo-
likely that surgical treatment itself promotes neovas-
lism after varicose vein surgery? Phlebology 2005;20:175e176.
cularisation. If varicose veins can be closed without
ERCHANT RF, PICHOT O, Closure Study Group. Long-term out-
comes of endovenous radiofrequency obliteration of saphenous
surgical intervention then the risk of neovascularisa-
reflux as a treatment for superficial venous insufficiency. J Vasc
Comparison of UFS to other endovenous techniques
UNDY L, MERLIN TL, FITRIDGE RA, HILLER JE. Systematic review
of endovenous laser treatment for varicose veins. Br J Surg
reveals similar outcomes. In a series of 1006 patients
treated by RF obliteration with follow-up to 5 years
the occlusion rate for saphenous trunks was 88% at
OMINGUEZ GARCIA OLMEDO. Nuevo metododel de esclerosis en
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reviewed recentlyIn 13 clinical series 88
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and complications. Dermatol Surg 2002;28:11
treated saphenous trunks were obliterated. Reported
12 BARRETT JM, ALLEN B, OCKELFORD A, GOLDMAN MP. Microfoam
complications of both techniques include skin burns,
ultrasound-guided sclerotherapy of varicose veins in 100 legs.
thrombosis, ecchymosis, paraesthesia, induration and
AVEZZI A, FRULLINI A, RICCI S, TESSARI L. Treatment of varicose
veins by foam sclerotherapy: two clinical series. Phlebology
This clinical series demonstrates that ultrasound
guided foam sclerotherapy can be used effectively to
14 BREU FX, GUGGENBICHLER S. European consensus meeting on foam
sclerotherapy [April, 4-6, 2003, Tegernsee, Germany]. Dermatol
manage a wide range of chronic venous disease on
an outpatient basis without the need to resort to sur-
15 BOUNTOUROGLOU DG, AZZAM M, KAKKOS SK, PATHMARAJAH M,
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RAMSEY DE, FAUGHT WE et al. Does air plethysmography correlate
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I am grateful to Attilio Cavezzi MD for introducing me to
AGGIATI A, BERGAN JJ, GLOVICZKI P, EKLOF B, ALLEGRA C, PARTSCH H
et al. Nomenclature of the veins of the lower limb: extensions,
foam sclerotherapy and to David Wright FRCS for guidance
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concerning the technique. I acknowledge the valuable
Eur J Vasc Endovasc Surg Vol xx, Month xxxx
Chronic Venous Disease Treated by Foam Sclerotherapy
18 CABRERA J, CABRERA Jr J, GARCIA-OLMEDO MA. Treatment of vari-
24 VAN RIJ AM, JONES GT, HILL GB, JIANG P. Neovascularization and
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28 MERCHANT RF, PICHOT O, Closure Study Group. Long-term out-
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22 PERALA J, RAUTIO T, BIANCARI F, OHTONEN P, WIIK H, HEIKKINEN T
reflux as a treatment for superficial venous insufficiency. J Vasc
et al. Radiofrequency endovenous obliteration versus stripping
of the long saphenous vein in the management of primary vari-
29 MUNDY L, MERLIN TL, FITRIDGE RA, HILLER JE. Systematic review
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23 SARIN S, SCURR JH, COLERIDGE SMITH PD. Assessment of stripping
the long saphenous vein in the treatment of primary varicose
Eur J Vasc Endovasc Surg Vol xx, Month xxxx
MENTIONS LEGALES ACULAR 0,5 pour cent COLLYRE COMPOSITION POUR 100 g Kétorolac trométhamine ………………………………………………………………0,50g Excipients: Chlorure de sodium, Edétate de sodium, Octosinol, Chlorure de benzalkonium (solution à 50 pour cent) Hydroxyde de sodium 1N ou Acide Chloridrique 1N, Eau purifiée INDICATIONS THERAPEUTIQUE
BRIAN S. KAHAN, D.O. CURRICULUM VITAE Business Address: Business Phone: BOARD CERTIFICATION American Board of Physical Medicine and Rehabilitation American Board of Physical Medicine and Rehabilitation- Pain Subspecialty Fellow Interventional Pain Physicians American Osteopathic Board of Physical Medicine and Rehabilitation American Board of Pain Med