X线透视引导下精索静脉曲张的泡沫硬化治疗 李龙

Safety and Effectiveness of Transcatheter Foam Sclerotherapy for Testicular Varicocele with a Fluoroscopic Tracing Technique

Long Li,MD,1Xin-Qiao Zeng,MD,and Yan-Hao Li,MD

PURPOSE:To evaluate the safety and effectiveness of percutaneous sodium morrhuate foam sclerotherapy of varicoceles with the use of fluoroscopic tracing technique.

MATERIALS AND METHODS:At baseline and at6-month follow-up,58patients with grade II/III left varicocele (mean age,21.1years;range,19–25y)with abnormal semen parameters underwent clinical assessment,Doppler ultrasonography,and semen analysis between September2002and January2007.In all58cases,selective catheter-ization of the spermatic vein was performed with a right transfemoral approach.The standardized sclerosing foam was prepared with the Tessari method.Foam sclerotherapy was performed by the“filling-defects technique”under fluoroscopic guidance,with the sclerosing foam visualized as translucent filling defects in the internal spermatic vein filled with contrast medium during injection of the foam.

RESULTS:Technical success was achieved in all patients.Sodium morrhuate foam dose ranged from2mL to8mL (0.4–1.6mL of solution)per patient,with an average dose of5.3mL(approximately1.1mL of solution).There were no major side effects or complications of the procedure.At6-month follow-up,53of58patients(91.4%)reported disappearance of previous varicoceles and five had slight,asymptomatic residual varicoceles.Seminal parameters showed significant increases after treatment.No major complications occurred,and no recurrent/persistent varicoceles were found.

CONCLUSIONS:Fluoroscopy-guided transcatheter foam sclerotherapy is a safe and effective approach for varicoce-les,and the filling-defects technique under fluoroscopy is a feasible method for tracing the sclerosing foam.

J Vasc Interv Radiol2010;21:824–828

TRADITIONAL sclerotherapy with liquid sclerosant agents has been used for many years in the treatment of var-icose veins and vascular malforma-

tions.The use of liquid sclerosant

agents has the limitations of their di-

lution and progressive inactivation in

the circulation and the irregular distri-

bution of the liquid sclerosant on the

endothelium(1).

The use of foam sclerotherapy tech-

nique has become increasingly popu-

lar in the treatment of lower-extremity

varicose veins and reticular veins,tel-

angiectasias,and venous malforma-

tions and Klippel–Trenaunay syn-

drome(2).These advantages include

increase in contact between the scle-

rosing liquid and the vessel wall,de-

crease in dilution of the sclerosing

agent secondary to displacement of

blood by the foam as opposed to mix-

ing with the blood,and increase in the

amount of contact time between the

sclerosant and the vein.Foam also has

the benefit of creating a more uniform

distribution of sclerosing liquid within

the venous system with decreased side

effects(3).Studies of the foam tech-

nique have suggested greater efficacy

with lower total amount of sclerosant

agent compared with liquid sclerosant

agents(1–3).

Since the late1970s and early1980s,

percutaneous transcatheter sclerother-

apy has been used successfully to treat

male varicoceles(4,5).Various liquid

sclerosant agents have been used to oc-

clude the internal spermatic vein,in-

cluding concentrated dextrose,sodium

morrhuate,sodium tetradecyl sulfate,

polidocanol(hydroxypolyethoxydode-

cane),ethanolamine,hot(boiling)con-

trast medium,and alcohol(6,7).

Foam sclerotherapy has become

From the Department of Interventional Radiology (L.L.,Y.H.L.),Nanfang Hospital,Southern Medical University,No.1838Guangzhou Ave.N.,Guang-zhou,Guangdong510515,China;and Department of Radiology(X.Q.Z.),Guangdong Provincial Corps Hospital,Chinese People’s Armed Police Forces, Guangzhou,China.Received July30,2008;final re-vision received February10,2010;accepted Febru-ary18,2010.Address correspondence to Y.H.L.; E-mail:liyanhao@https://www.360docs.net/doc/0213234827.html,

1Current address:Department of Radiology,Guang-dong Provincial Corps Hospital,Chinese People’s Armed Police Forces,Guangzhou,China.

None of the authors have identified a conflict of interest.

?SIR,2010

DOI:10.1016/j.jvir.2010.02.026

824

useful in all types of venous disorders, and it is proven to be safe,simple, inexpensive,reliable,and repeatable (2,3,8).However,few studies have fo-cused on the use of foam sclerosant for the treatment of varicoceles(9,10).The purposes of the present study are to (i)evaluate the safety and effective-ness of percutaneous foam sclerother-apy with the standardized sodium morrhuate foam in left-sided varico-cele with abnormal semen,and(ii)de-scribe a new tracing technique of the standardized sclerosing foam under fluoroscopy(the“filling-defects tech-nique”).

MATERIALS AND METHODS Patients

The study design was a retrospec-tive review of prospectively collected data.The study was approved by our local ethics committee,and informed consent was obtained from all pa-tients.

The records of58patients from two institutions aged19–25years(mean age,21.1y)who underwent percuta-neous foam sclerotherapy for left var-icocele between September2002and January2007were reviewed through the hospital information support sys-tem and patient medical records.All patients underwent clinical evalua-tion,including a detailed history,com-plete physical examination,Doppler ultrasonography(US),and sperm analyses.Patients commonly presented reporting symptoms of(i)swelling of scrotum,especially after long periods of standing;and(ii)scrotal discomfort.In all patients,at least one of the parame-ters of the semen analysis was abnormal before the procedure was undertaken.

Clinical varicoceles were diagnosed by physical examination and graded based on physical findings according to Dubin–Amelar classification(11). All patients were given a complete physical examination by a single in-vestigator(L.L.).Palpation of the pam-piniform plexus were done with and without the patients performing a Valsalva maneuver.Directly visible varicoceles were graded as class III. Directly palpable varicoceles were graded as class II.Varicoceles palpa-ble only during Valsalva maneuver were graded as class I.Grade II vari-coceles were noted in39patients (67.2%)and grade III varicoceles in19

patients(32.8%).

Color Doppler US scrotal examina-

tions were carried out by an experi-

enced radiologist(X.Q.Z.)with the use

of a Logic400US machine(GE Medi-

cal Systems,Milwaukee,Wisconsin)

equipped with a7.5-MHz high-resolu-

tion linear-array transducer.The US

criteria used to identify a varicocele

were internal spermatic vein luminal

diameter greater than0.27cm and/or

the presence of reflux(12).

A minimum of three preoperative

semen samples were submitted.The

semen specimens were collected and

evaluated according to World Health

Organization criteria(13).The refer-

ence values for semen and sperm pa-

rameters are as follows:volume of2.0

mL or greater;pH7.2or greater;

sperm concentration of20?106/mL

or greater;total sperm count of40?

106or greater;motility of50%or

greater(ie,grade A/B)or25%or

greater with progressive motility(ie,

grade A)within60minutes after col-

lection;and vitality of75%or greater.

Sclerosing Foam

The foam sclerosant was produced

by Tessari technique with two sy-

ringes and one three-way connector

with an air–to–liquid sclerosant ratio

of4:1(14,15).This procedure was

achieved by mixing1mL of5%so-

dium morrhuate solution(Donghai,

Shanghai,China)and4mL of room air

in20passages between two5-mL sy-

ringes and a three-way stopcock,

which had a30°hub rotation to nar-

row the aperture through which the

foam passed.The maximum dose per

treatment session was limited to10

mL sodium morrhuate foam(16).

Technique

Sclerotherapy was performed on an

outpatient basis.A rubber-coated lead

cover was placed over the testes.The

right common femoral vein was punc-

tured under local anesthesia and a5-F,

25-cm-long introducer sheath(Intro-

ducer II;Terumo,Tokyo,Japan)was

placed to avoid venous damage dur-

ing subsequent manipulations of the

diagnostic catheter.A5-F Cobra cath-

eter(Radifocus;Terumo)was inserted

with fluoroscopic guidance(Axiom

Artis dFA;Siemens,Erlangen,Ger-

many)into the inferior vena cava to

the second lumbar vertebral body.The

left renal vein was selectively catheter-

ized and,if possible,the origin of the

testicular vein was engaged and selec-

tive venography was performed.If

this was not immediately possible,left

renal venography was performed dur-

ing a Valsalva maneuver to locate and

demonstrate the origin of the refluxing

vein,facilitating subsequent selective

catheterization.Sclerotherapy was per-

formed through a catheter placed in

the spermatic vein below the origin

of the lowest collateral vessel,usually at

the level of the upper half of the sacro-

iliac joint,assuring complete thrombo-

sis of the internal spermatic vein and

avoiding distal embolization of the

pampiniform plexus.With a0.035-inch

J-tipped180-cm-long hydrophilic guide

wire(Radifocus;Terumo),the catheter

was advanced into the spermatic vein

until the tip reached at the level of the

upper half of the sacroiliac joint.Addi-

tional venography was performed at

this level to confirm the position and

demonstrate any other collateral veins.

The internal spermatic vein was

filled with contrast medium before the

foam sclerosant was injected.When

the correct position and abdominal

pressure was found with a Valsalva

maneuver,sclerotherapy was per-

formed by injecting5mL of the so-

dium morrhuate foam under constant

fluoroscopic guidance until complete

filling with the foam sclerosant within

the target vessel was observed.The

foam sclerosant appeared as beaded or

strip-shaped translucent filling defects

in the internal spermatic vein filled

with contrast medium.The catheter

was then withdrawn approximately2

cm and rinsed with contrast medium.

Under constant fluoroscopic guidance,

a small amount of contrast medium

was slowly injected until it came out of

the tip of the catheter to ensure that

the foam sclerosant would not be

pushed ahead into the pampiniform

plexus(Figure).Therefore,it was quite

easy to control the flow of the scleros-

ing foam and,if flow near the external

inguinal ring occurred(equivalent to

the superior boundary of pecten pu-

bis),the procedure could be stopped

https://www.360docs.net/doc/0213234827.html,pression of the

spermatic cord at the level of the in-

guinal canal was not performed in this

series.

After15minutes,repeated sper-

Li et al?825

Volume21Number6

matic phlebography was performed to check the result.After the internal spermatic vein was obstructed satis-factorily,the catheter and the sheath were withdrawn in turn,and the puncture site was briefly compressed.Patients were ordered to stay in bed for 2hours and to avoid intense exer-cise and heavy lifting for 7days.Tele-phone follow-up was performed the next day.Patients could return to school or work the next day.Follow-up

To determine symptomatic relief,the patients were interviewed at 6months after the procedure.Follow-up was performed with use of a question-naire to evaluate the success rate of the procedure,complications,and any treatment for infertility undergone by the patient after the procedure.The patient was asked to report the end result as excellent (ie,clinical oblitera-tion and asymptomatic),good (ie,sub-stantial improvement in size and symptoms of ?50%),moderately im-proved (ie,significant decrease in size and symptoms of ?50%),unchanged,or worse.At 6months after the proce-dure,repeated physical examination and semen analysis were also per-formed.Patients underwent follow-up US examination only when physical examination revealed suspected recur-rent or residual varicocele.

Technical success was defined as completion of the procedure with oc-clusion of the varicocele.Clinical suc-cess was defined as disappearance of the varicocele and symptoms at the clinical follow-up visit and/or absence of refluxing veins greater than 3mm on follow-up US examination.In ac-cordance with the definition of com-plications established by the Society of Interventional Radiology (17),specific complications were classified as major or minor.Major complications were defined as those that,if left untreated,might threaten a patient’s life,lead to substantial morbidity and disability,or result in hospital admission or a substantially lengthened hospital stay.Minor complications were defined as events that did not require interven-tion or prolonged hospitalization,or that resulted in transient self-limit-ing sequelae or required nominal therapy.

Statistical Analyses

The two-sample paired Student t test was used for statistical analysis.Values were expressed as means ?SD.P values of less than .05were con-sidered significant.

RESULTS

The procedure was technically suc-cessful in all patients.Foam sclerosant doses ranged from 2mL to 8mL (0.4–1.6mL of liquid sclerosant)per pa-tient,with an average dose of 5.3mL (approximately 1.1mL of liquid scle-rosant).No major complications were encountered in our series.In the ma-jority of patients,injection of the foam sclerosant caused transient discomfort that lasted only a few minutes in the left flank or low abdomen.Spasm of the spermatic vein occurred in one pa-tient and subsided within a few min-utes.One patient developed edema of the left scrotum.This ceased without further treatment after 2days of bed-rest.Within 6months after the proce-dure,53of 58patients (91.4%)re-ported disappearance or only a slight,asymptomatic residual varicocele (n ?5).There have been no testes lost

and

Figure.Percutaneous foam sclerotherapy in varicocele by the filling-defects technique under fluoroscopy.(a)Selective spermatic venograms obtained in a 19-year-old man show the vein originated from the pampiniform plexus with two branches,and gathered together one trunk near the superior border of sacroiliac joint.(b)The catheter was inserted into the superior margin of the venous bifurcation,and the internal spermatic vein is filled with contrast medium.(c)As the foam sclerosant is being injecting under constant fluoroscopic guidance,the sclerosing foam is visualized as strip-shaped translucent filling defects (arrow)in the vein filled with contrast medium.(d)When residual sclerosant agent in the lumen of the catheter is rinsed with contrast medium,the injection procedure should be stopped immediately only if the contrast medium (arrow)comes out of the tip of the catheter.(e)After 15minutes,repeat spermatic phlebography shows that the left spermatic vein has been occluded completely.

826

?

Foam Sclerotherapy with Fluoroscopy for Testicular Varicocele

June 2010JVIR

no recurrence or persistence of varico-celes.Patients reported the overall outcome as a excellent in53cases (91.4%)and good in five(8.6%).No major complications occurred.

The Table shows the changes in seminal parameters for all58patients. At6-month follow-up,statistically sig-nificant improvement was noted in seminal parameters in terms of sperm concentration,viability,progressive motility,and grade A/B motility. Mean sperm concentration increased from14.37?106/mL?8.61before

treatment to50.56?106/mL?20.16 after treatment(P?.01),mean sperm motility increased from44.02%?9.86%before treatment to70.14%?8.67%after treatment(P?.01),pro-gressive motility increased from 61.45%?11.93%before treatment to 80.79%?5.20%after treatment(P?.01),and grade A/B motility increased from18.05%before treatment?3.83% to37.13%?7.21%after treatment (P?.01).

In five of the17patients who had suspected recurrent or residual varico-celes based on physical examination, follow-up Doppler US detected a brief reflux that lasted less than1second.

DISCUSSION

The percutaneous treatment of var-icocele is a minimally invasive inter-ventional procedure that requires only local anesthesia at the puncture site and moderate sedation,thereby avoid-ing complications associated with surgery and general anesthesia.The methods currently used for percutane-ous varicocele treatment are mechani-cal occlusion with metallic coils or de-tachable balloons and sclerosis by means of chemical agents.The detach-able balloon and metallic coil are more expensive than sclerosing agent and are associated with the potential risk of pulmonary embolism from possible migration of embolization material into the systemic circulation.Also,bal-loon or coil embolization can be asso-ciated with early recurrence of varico-cele because of endogenous lysis of the thrombus and opening of collateral veins,and late recurrence of varicocele because of coil erosion.Therefore,per-cutaneous sclerotherapy of varicocele is widely available as a reliable,effec-tive,minimally invasive,and econom-ically viable technique(18).

Foam sclerotherapy has become

popular worldwide in the past decade.

Much has been published on the effi-

cacy and safety of foam sclerotherapy,

and it has been recognized to hold

several advantages over traditional

liquid sclerotherapy(2,3,8,19).How-

ever,there are few studies regarding

percutaneous transcatheter varicocele

sclerotherapy with sclerosing foam.

Seyferth et al in1981(20),Sigmund

et al in1987(21),Lenz et al in1996

(22),and Wunsch and Efinger in2005

(6)described an“air-block”technique

with the foamy air during percutane-

ous sclerotherapy for the treatment of

varicoceles,in which a small amount

of air was injected before the injection

of sclerosant to avoid dilution of the

liquid.However,the methods of use

of the air were different in all these

articles,and it was not a true foam

sclerotherapy in the strict significa-

tion.Moreover,the disadvantage of

the air-block technique in large vessels

was that the air bubble floating on the

blood column protected the vessel

from contact with the sclerosant at the

upper circumference,so it was effec-

tive only partially(23).The air-block

technique is basically no longer used

today.Lord et al(9)in2003mentioned

the method of sodium tetradecyl sul-

fate foam(air-to-liquid ratio,3:1)

scleroembolization for pediatric vari-

cocele.Nevertheless,these articles

have not attached enough importance

to the clinical value of foam sclerother-

apy of varicocele.

The most popular foam sclerosant

agents used in the literature include

sodium tetradecyl sulfate and poli-

docanol(1–3,8,15,16,19,23);however,

these are not obtainable in China.So-

dium morrhuate is the only commer-

cially available to make the foam scle-

rosant in China.Sodium morrhuate

was introduced in the1920s,was first

applied in the treatment of varicose

veins in1930(24),and is still available

today.Because it was in general use

before there was any requirement to

demonstrate safety or efficacy,it has

been exempted from the need for ap-

proval by the Food and Drug Admin-

istration for sale in the United States.

The early adopters have found that

sodium morrhuate could form bubbles

when agitated.However,there is little

information available concerning the

use of the standardized foam form of

sodium morrhuate(16,25)in foam

sclerotherapy,even though foam scle-

rotherapy has become widely used in

recent years in Europe,the United

States,Australia,and some other

countries.In traditionally percutane-

ous liquid sclerotherapy of varicocele,

the dosage of5%sodium morrhuate

solution ranged from1mL to9mL,

with an average dose of3mL(26);one

report(27)even claimed the usual

dose was6–9mL.In the present

study,5%sodium morrhuate solution

was used to produce the standardized

foam sclerosant(air-to-liquid ratio,

4:1)by the Tessari technique.The dose

of sodium morrhuate foam ranged

from2mL to8mL(0.4–1.6mL of

liquid sclerosant)per patient,with an

average dose of5.3mL(approximate

1.1mL of liquid sclerosant).Therefore,

foam sclerotherapy requires a lower

dose of sclerosant compared with liq-

uid sclerotherapy.

In the vast majority of literature re-

garding foam sclerotherapy,US guid-

ance has been used to identify treated

veins and monitor foam injection

and/or foam flow(1–3,8,15,16,19,23).

However,duplex US machines are ex-

pensive and examination requires ex-

perience,and US guidance is not avail-

able for transcatheter treatment of Changes in Seminal Parameters and Hormonal Levels before and after

Treatment(N?58)

Seminal Parameter Baseline6-Month Follow-up P Value Concentration(?106/mL)14.37?8.6150.56?20.16?.01 Viability(%)44.02?9.8670.14?8.67?.01 Progressive motility(%)61.45?11.9380.79?5.20?.01 Grade A/B motility(%)18.05?3.8337.13?7.21?.01 Volume(mL) 3.44?1.12 3.71?1.22?.05 pH7.45?0.447.41?0.58?.05 Note.—Values presented as means?SD.

Li et al?827

Volume21Number6

varicocele.Recently,Gandini et al(10) published the results of a study of244 consecutive patients with a total of280 varicoceles who were treated with transcatheter foam sclerotherapy with sodium tetradecyl sulfate.Although this study is the true first report on the subject of percutaneous foam sclero-therapy in varicoceles(10),their meth-ods were actually a repeat of the air-block technique,and the authors were incapable of monitoring sclerosing foam flow.In traditional liquid sclero-therapy,the liquid sclerosant can be visualized under fluoroscopy by mix-ing with moderate doses of contrast media.Lord and Burrows(9),in2003, suggested that the foam sclerosant was opacified under fluoroscopy by addition of Ethiodol.It is well known that liquid sclerosant mixed with a small amount of contrast medium only produces pastel shades in fluoro-scopic images.Moreover,we do not know whether peculiar properties of the sclerosing foam mentioned by Frullini(28)would be changed by mixing with contrast medium or Lipi-odol,and whether the chemical reac-tion would be set off by mixing the liquid sclerosant with contrast media. Regardless,there is currently no clear evidence to support it.Therefore,we propose a tracing technique of the sclerosing foam under fluoroscopy, which we called the filling-defects technique.

According to our methods of per-cutaneous foam sclerotherapy in vari-coceles,we obtained durable results with no major side effects or compli-cations.

The main limitations of the present study were the relatively small study group,the lack of a control group,and the absence of analysis of pregnancy rate.Multicenter studies including larger patient populations with longer follow-up periods are necessary to confirm our data.

In summary,fluoroscopy-guided transcatheter foam sclerotherapy is a safe and effective approach for varico-celes,and the filling-defects technique under fluoroscopy is a feasible method for tracing the sclerosing foam.References

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828?Foam Sclerotherapy with Fluoroscopy for Testicular Varicocele June2010JVIR