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Chapter
Hub
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9
FloLock port
FloLock release button
Infusion port
Proximal
marker
Balloon inflation port
Figure 9.19 Diagrammatic representation of the VeinRx catheter. (Courtesy VeinRx, Inc., Miami, Fla.)
Clinical Methods for Sclerotherapy of Varicose Veins
Infusion length Balloon
Distal
marker
Figure 9.20 Photograph of the proximal end of the VeinRx catheter
showing the infusion ports. (Courtesy VeinRx, Inc., Miami, Fla.)
body with infusion holes, and trifurcated hub. Figure 9.19 is a line drawing that further illustrates the catheter design. The FloLock trifurcated hub is designed to connect the following three main systems of the device (Fig. 9.20). A tubing extension incorporating a stopcock on one side of the hub is the port used to inflate and deflate the occlusion balloon. The Luer connection in the center of the hub is used to mount the syringe loaded with the desired sclerosant. Opposite the balloon port and nearest the blue button is a port for control­ling the FloLock channel. The FloLock channel allows the physician to determine accurately whether the infusion ports are open or closed (Fig. 9.21), a feature previously unavail­able in standard infusion catheters. This channel uses an inflatable elastomeric bladder to either close or open the infusion ports.
This feature is used to eliminate port obstruction before and during catheter placement, support pre-purging and holding the purge in the catheter before and during place­ment, and precise control of sclerosant during infusion. The device is provided in sterile packaging for single-patient use. The infusion catheter is manufactured with well-known and commonly used medical-grade materials.
The distal end of the catheter incorporates a compliant latex occlusion balloon. The balloon eliminates communi­cation between the GSV and the SFJ and enables the sclero­sant to produce maximal therapeutic action in the target vein. With the balloon inflated, the physician can deliver a predetermined amount of sclerosant through the catheter and into the GSV, with subsequent flow of sclerosant into incom­petent perforators and tributaries. The sclerosant chemically
254
Figure 9.21 Diagram illustrating the effusion of solution from the distal
ports on the VeinRx catheter. (Courtesy VeinRx, Inc., Miami, Fla.)
ablates the targeted segment of the vein and has the poten­tial for providing a complete treatment within a single procedure.
There is also the possibility of a small amount of the scle­rosant entering the deep venous system through communicat­ing perforator veins. However, this potential is relatively insignificant when compared to femoral vein intrusion of scle­rosants in the setting of direct-injection/ultrasound-guided sclerotherapy.
The importance of having a series of infusion ports along the lumen length is to optimize the treatment of the GSV by localized delivery of the sclerosant. Sclerosant is uniformly delivered when all infusion ports are patent. This design also reduces the possibility of having excess sclerosant flow into large communicating veins near the target vein.
Device Preparation
The VeinRx infusion catheter comes in multiple infusion lengths. The catheter selected for a procedure is a function of the required vessel treatment length. This is determined pre­operatively during ultrasound examination. Ultrasound exam­ination is also required to determine the amount of sclerosant to be injected and the proper occlusion balloon inflation volume, which is a function of the vein diameter at the desired occlusion site, usually just distal to the SFJ. Prior to surgery, the balloon is inflated with sterile saline using a 10-mL syringe and inspected for leakage or damage.
The infusion lumen is prepared by purging the catheter using foam sclerosant constituted by passing the sclerosant back and forth between two 10-mL syringes for 10 or more times, using a ratio of one part sclerosant to four parts air. During proper functioning of the device, foam will exit from all of the holes in the infusion lumen.
The infusion ports are sealed by pressurizing the FloLock
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channel with a 1-mL syringe filled with approximately 0.75 mL of sterile saline. To insure that the bladder is properly inflated, the operator applies low-level pressure to the infusion syringe and visually confirms that no flow exits the infusion ports along the marked infusion length.
Delivery of Sclerosant
After the preparation described above and percutaneous access, the device should be introduced and advanced through the patient’s vasculature with the leg in the horizontal and straight position. Using ultrasound guidance, the balloon is advanced to the most proximal treatment point, which is marked in advance. With the leg remaining horizontal and straight, the balloon is inflated. At this point, the foam sclerosant is injected through the device into the patient’s target vein. The infusion rate should be approximately 5 mL over 10 seconds.
Upon completion of the infusion, the patient’s leg should remain horizontal and straight with the balloon inflated for 4 minutes. This is known as the ‘dwell time’. After the 4-minute dwell time, the balloon should be deflated and the device removed. After removal of the device, the introducer is removed and the entry site is manually compressed for 2 minutes and dressed using traditional wound closure tech­niques. Proper and constant pressure during this period is important to reduce the potential of ecchymosis at the entry site. This is followed by compression. This technique turned out not to yield any better results than standard foam sclero­therapy and is no longer manufactured.
Treatment of specific problems
Treatment of large-diameter great saphenous veins
The treatment of the GSV with foam sclerotherapy has been discussed and found to be effective depending on the method of foam injection and the concentration and volume of solu­tion. However, almost all of the previously cited studies set an upper limit for the diameter of the GSV to be no more than
164
8 mm. since non-detergent) to inject 500 GSVs with diameters of between 6 and 12 mm measured 3 cm distal to the SFJ. authors reported a 22% failure rate irrespective of vein diam­eter. Barrett et al90 reported outstanding efficacy in GSV with diameters greater than 10 mm injected with foamed STS. This was also found by Valsamis. and the use of an appropriate concentration and/or type of sclerosing solution can allow successful treatment of large­diameter GSVs, although length of follow-up must be a critical factors in all of these studies.
cannulated GSV with tumescent anesthesia placed in the sur­rounding facial sheath which may also lead to improved effi­cacy and reduce recurrences (Fig. 13).
Treatment of vulvar varicosities
Vulvar varicosities can be treated effectively with sclerotherapy. Two problems in their treatment are sclerosis of the proximal point of reflux and compression of the treated vein. Since vulvar veins may arise from the internal iliac (hypogastric), pudendal, obturator, uterine, or ovarian veins deep within the pelvis, treatment directed at the most proximal point of reflux cannot be attempted directly. Instead, the most proximal visible varicosity is cannulated and sclerosing solution injected in a proximal manner. With this technique, 1 to 2 mL of liquid
0.5% to 1.0% STS is injected slowly. Distal varicosities are then treated. Alternatively, foamed 0.25 to 0.5% STS may be injected.
the vulvar veins (V2-supporter, Prenatal Cradle Inc, Hamburg, Mich.). This device is worn until veins have resolved. Five
One study used Variglobin 8%–12% (non-foamed
165
The
166
Therefore, proper technique
Thibault
89
has described a technique for compressing the
A pelvic support device has been developed to compress
patients treated in this manner showed no evidence of recur­rence in a 1-year follow-up.
167
Adverse sequelae have not been noted. A 2-year follow-up of these five patients (and two others) also demonstrated no adverse sequelae and resolution of the varicose veins.
168
Treatment of venous malformations (liquid sclerosant)
Venous malformations (VM), as described in Chapter 4, consist of variably sized vessels. Sclerotherapy has proven to be very useful in their treatment. In a study by Yamaki et al,
169
28 patients with a variety of VM on the face, neck, extremity, and elsewhere were treated with duplex-guided sclerotherapy with POL 3%. Eighty-two percent of the patients had effective resolution. Pain on injection in 82%, marked swelling in 75%, hemoglobinuria in 14%, and superficial epidermal necrosis in
10.7% were the reported adverse sequelae.
Lee et al
170
reported a 92% efficacy in treating 30 patients with a variety of VM with absolute ethanol. Multiple sessions were required and 24 total adverse effects occurred in the 92 sessions given. Adverse effects consisted of nerve palsy in five, ischemic bullae in nine, tissue necrosis in two, tissue fibrosis in two, and DVT in one. The authors proposed that this treat­ment helps to debulk and stabilize the VM, permitting simpler surgical correction. An additional report on 399 sessions in 87 patients by Lee and colleagues
171
showed similar results
with long-term efficacy.
Foam sclerotherapy using the Cabrera foam on 50 patients with VM was beneficial in 92% after an average of 12 sessions with a mean of 30 months’ follow-up.
172
Of the 46 responders, 18 showed complete disappearance of the VM and 15 showed a reduction of over 50% in size of the VM. Of the 39 patients who reported pain, it disappeared in 25 and was reduced in
14. Three cases of skin ulceration occurred. For more informa­tion on foam sclerotherapy in venous malformations, please see the above foam sclerotherapy section.
Treatment of other venous conditions
A variety of other venous conditions have been reported to resolve with sclerotherapy. A report of complete resolution of a venous lake of the lip after two treatments with POL 1%, without adverse effects, has been reported.
173
Hemangioma showing late involution was successfully shrunk with an injection of 5% ethanolamine oleate, allowing surgical excision.
Multiple hereditary glomangiomas were treated with 0.2% to 3% STS, depending on the size of the lesion.
174
175
An average of two treatments where the lesions were injected with 0.5 to 1 mL of solution was required for lesion improvement.
Treatment of pyogenic granuloma with 5% monoeth­anolamine oleate in nine patients, who were all injected once, resulted in complete resolution of the lesion within 2 weeks.
176
An additional study on 15 lesions in 14 patients treated with
0.5% STS (0.15–2 mL) one to five times (mean, 2.2) showed complete resolution in 12 lesions.
177
No adverse effects were
seen in any patient.
Treatment of recurrences
When unsuccessful or in case of recurrence, sclerotherapy does not modify the initial, pretherapeutic varicose pattern, which reappears as it was before or smaller. This is not the case with surgery, and, very often, recurrent varices after surgery (REVAS) are extremely difficult to manage. be, in certain selected cases, considered as an alternative treat­ment after sclerotherapy failure, sclerotherapy is the usual and most appropriate recourse for recurrence after surgery of vari­cose veins. The progress in ultrasound guidance and, most of all, the use of foam sclerosing agents have revolutionized the approach to this difficult problem.
178
Therefore, if surgery can
Injection Technique
255
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9
256
Severity and extent of varices
With initial
Initial status
0
Sclerosing injection sessions
Figure 9.22 Evolution of varicose veins. Although we do not have a simple
and accurate criterion of evaluation of varicose veins’ severity and extent, the concept is simple enough and patients can understand it easily. This diagram represents the evolution of the varicose status and the influence of
Clinical Methods for Sclerotherapy of Varicose Veins
active management. If it is true that there is some spontaneous trend toward worsening, the status is always better when patients are appropriately treated by sclerotherapy, especially with maintenance treatments (theoretical approach).
sclerosing and no
maintenance
treatment
Without any
With initial
sclerosing treatment
and maintenance
sclerotherapy
As stated in the REVAS consensus document, rences must be completely assessed by duplex in order to map all leaks and refluxes. After surgery of junctions, two types of recurrence can be observed:
Neovascularization, where very small veins have grown
through the hard connective tissue and lymph nodes and reinject lower varicose veins
Inappropriate ligation, where an important saphenous
stump has been left in place and where macro veins connect the femoral or popliteal vein to the varicose network.
Before onset of UGFS, both types were issues. Since, in the first case, direct injection was rendered difficult by the small diameters, and, in the second case, appropriate long­term control of reflux was doubtful. Now, both types of recur­rence can be easily treated either by direct echo-guided puncture and foam injection or by remote access through more superficial tributaries. REVAS veins are usually prone to sclerose since the venous wall remodeling has been severe and since dysplasia allows easier sclerosis. Anyway, in all these cases, attention must be paid to an annual check-up of veins in order to take care of new recurrences as soon as possible.
For most patients, the difference between ‘new veins’ and ‘recurrent veins’ is not obvious at all and this misunder­standing is likely to create some difficulties in doctor–patient relationships. A simple diagram explaining evolution of varicose veins with or without treatment can be extremely useful (Fig. 9.22; also see Case Study 13 later in this chapter).
Does the Menstrual Cycle Influence Sclerotherapy?
The actions of estrogens and progestins on venous distensi­bility were discussed previously (see Chapters 3 and 4). Theoretically, sclerotherapy should be performed when the venous system is in its most contracted state so that post­treatment thrombosis is minimized. Since limb volume and
treatment
178
all recur-
Time
Figure 9.23 Turbulent flow is produced with injection of solution at the
point of discharge of sclerosant from the needle cannula. (From Green D: Semin
Dermatol 12:88, 1993.)
venous distensibility are at their least during and just after menses and at their highest during ovulation, the optimal window for sclerotherapy treatment is when estrogen levels are lowest.
179
However, until appropriate studies are per­formed to test this hypothesis, no absolute recommendation can be made.
Recommended Sclerosing Solution Amounts and Concentrations for Non-Foam Sclerotherapy
Although the exact concentration of sclerosing solution depends on the caliber and location of the varicose vein, the following suggestions can serve as an initial guide to therapy. Dilution of nonosmotic sclerosing solutions with sterile water will cause the sclerosing agent to sting with injection. Thus, dilutions should be performed with bacteriostatic normal saline solution, which will not impart an additional sting.
The first principle of determining solution amounts and concentrations is that the concentrations should be strongest at the highest point of reflux. With saphenofemoral reflux, the concentration should be strongest at the upper thigh and weakest at the ankle. With ankle or calf perforating veins, the concentration should be highest at the perforator. For example,
180
Vin
recommends that 1 mL of STS 1.0% be used at the proximal thigh, 0.5 mL of STS 1.0% be used at the medial thigh, and 0.3 mL of STS 0.5% be used at the medial knee to treat a moderately sized varicose vein.
The second principle, as described by Tournay in 1949, is: ‘It is not the concentration of the sclerosing agent in the syringe that matters, but the concentration within the vein.’ importance of this statement was discussed in Chapter 7. In short, for sclerotherapy to be effective, the entire vein wall must be damaged and the entire intraluminal volume of the segment of the vein must be destroyed. This is important because the smooth muscle portion of the vein wall theoreti­cally can regenerate endothelium, and endothelial cells can migrate long distances to re-establish a functional conduit. Sackmann
182
expanded on this principle by demonstrating in polyvinyl tubes the local conditions of ‘time and space’ regarding contact of the sclerosing solution with the vessel wall were also important. He showed the zone of contact diminishes as the caliber of the vessel increases. In tubes with a diameter of less than or equal to 4 mm, the liquid flowed in a laminar fashion. In tubes with a diameter of greater than or equal to 8 mm, turbulent flow was produced. In tubes 6 mm in diameter, a mixed flow occurred, with a transition between a laminar and turbulent appearance (Fig. 9.23). In contrast, the caliber and position of the needle, the speed of injection, and the viscosity of the solution did not seem to influence the time of contact of the sclerosing solution with the tube.
181
The
Ci
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A
B
Figure 9.24 Nonlaminar flow occurs distal to the point of injection in an
empty vein. A, Needle inserted into empty vein. B, The force of the advancing injected solution dilates the vein and produces turbulent flow.
(From Green D: Semin Dermatol 12:88, 1993.)
183
Green
used Poiseuille’s formula to describe resistance to
fluid flow in a varicose vein:
Rl= 8 πn r
9.3
where
R = resistance κn = viscosity of the solution
l = length of the vein r = radius of the vein.
From this formula it is apparent that the most important factor in determining resistance of flow is the vessel diameter (radius). At the point of injection into an empty vein, expected flow of sclerosing solution would be nonlaminar (Fig. 9.23). This may account (along with increased localized concentra­tion; see the following paragraph) for a greater incidence of vessel damage and blowout at the point of injection (see Chapter 8). Nonlaminar flow also occurs downstream of injection in an empty vein in which resistance is still high, since the pressure generated by the physician on the syringe plunger is much greater than intravascular pressure, which would approach zero in an empty vein, especially if the limb were elevated (Fig. 9.24).
184
Guex
has worked out that the concentration of sclerosing
184
solution can be calculated based on the diameter of the vein by the following formula:
Cm = × ×v C n rπ
2
9.4
Cs
Aggressive concentration
Effective concentration
Ineffective concentration
0
Injection site
Figure 9.25 Injection at one site with a high concentration but low
volume of sclerosing solution. Note localized excessive concentration.
(From Guex JJ: J Dermatol Surg Oncol 19:959, 1993.)
Ci
Cs
0
Figure 9.26 Injection at one site with large volume of a dilute
concentration of sclerosing solution. Note that a longer segment of vein is sclerosed without any one point of excessive concentration.
Dermatol Surg Oncol 19:959, 1993.)
Sclerosis
Inflammatory reaction
Injection site
Varicose vein
Aggressive concentration
Effective concentration
Ineffective concentration
Sclerosis
Varicose vein
x
x
(From Guex JJ: J
Recommended Sclerosing Solution Amounts and Concentrations for Non-Foam Sclerotherapy
where Cm = mean concentration of solution
v = volume of injected sclerosing solution C = concentration of sclerosing solution n = number of injections r = radius of the injected vein.
Thus, if 0.5 mL is injected into a varicose vein 2 mm in diameter, the sclerosing solution will fill a 16-cm length of vein. In reality, the concentration of sclerosing solution at the injection site is maximal and decreases with distance from each point when small volumes of solution are injected (Fig.
9.25). The concentration of sclerosing solution along the
entire course of the vein can be equalized either by injecting a larger volume in a single site or by injecting small volumes
A study by Cornu-Thenard ing concentrations for varicosities of various diameters:
4 mm = STS 0.25%
5 mm = STS 0.5%
6 mm = STS 1.0%.
185
suggests the following scleros-
Ci
Aggressive concentration
Cs
0
Injection site
Figure 9.27 Multiple injections with low volumes of low concentrations of
sclerosing solution. This technique theoretically provides the safest method for treating long lengths of vein.
1993.)
Injection site Injection site
Effective concentration
Ineffective concentration
Sclerosis
(From Guex JJ: J Dermatol Surg Oncol 19:959,
x
257
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9
Clinical Methods for Sclerotherapy of Varicose Veins
258
Table 9.7 Indicative concentrations and volumes for polidocanol foam
First
Vein
Thigh GSV 1.5 3 Up to 8
GSV main tributary 0.5 1 Up to 4
SSV 1.5 3 Up to 4
Perforators 1 2 Up to 2
Nonsaphenous 0.5 1 2 per site
GSV, great saphenous vein; SSS, small saphenous vein.
Session (%)
Second
Session (%)
Volume
(cm3)
He recommends 0.5-ml injections be placed every 6 to 10 cm along the varicose vein. Additional recommended concentrations for injection of other sclerosing solutions into various types and diameters of vein can be found in Chapter 7.
The third principle is the amount of sclerosing solution injected into a single site should not be more than 1.0 mL (usually 0.5 mL). Venographic studies of direct injections into varicosities of the leg have demonstrated that if more than
1.5 mL of solution is injected at a single site, it is likely to spill over into the deep veins.
49,186
In addition, the patient should not move the leg for a few minutes so that the sclerosing solu­tion can remain in contact with the varicose vein, because any movement of the leg will rapidly move the sclerosing solution into the deep venous system.
Some physicians do not limit the volume of sclerosing
solution at a single site.
187
Green
187
reports infusing from 3 to 12 mL of STS into each injection site. Concentrations ranged from 0.75% to 3.0% depending on vein size. He reports treat­ing more than 3000 patients in this manner without encoun­tering a single case of DVT. He also reports enhanced efficacy with this technique, having near 100% efficacy with follow­ups of up to 5 years. He uses class II compression for 2 to 8 weeks. Other details of his technique are not specified. Green claims that ‘the widely varying success rates reported in the literature are usually a reflection of the technique of the prac­titioner and not any inherent limitation of the procedure.’ The authors believe that this statement is somewhat correct but still caution against the use of excessive volumes of sclerosing solution in a single site, since many cases of DVT have been reported by other reputable physicians (see Chapter 8).
Histologic examination of peripheral veins may provide assistance in determining the optimal concentration of sclero­sing solution. Corcos et al
188
have determined through biopsy of the dorsal pedal vein that the degree of intimal thickening, ectasia, muscular hyperplasia, medial fibrosis, fragmentation, and dissociation of the internal elastic membrane and intimal fibrous plaques correlate with the concentration of sclerosing solution necessary to effect endosclerosis of varicose veins. This finding is supported by the theory that varicosis is a sys­temic disease (see Chapter 3).
The use of foam has very much simplified the approach of concentration and the current trend is to decrease the concen­tration in half when using foam as opposed to liquid scleros­ing solution. Guex
62
has suggested the values shown in Table
9.7, which remain open to adaptation and discussion.
Postsclerotherapy Compression
After injection of varicose or telangiectatic veins, the treated veins are immediately compressed to minimize significant thrombosis. The patient is instructed to walk immediately
after the injection session to help prevent DVT and reduce venous reflux into the treated veins. Calf muscle movement produces a rapid blood flow in the deep venous system, which dilutes any sclerosing solution that may have migrated into the area.
Postsclerosis compression is perhaps the most important advance in sclerotherapy treatment of varicose veins since the introduction of relatively safe synthetic sclerosing agents in the 1940s. Primarily, compression eliminates a throm­bophlebitic reaction and substitutes a ‘sclerophlebitis’ with the production of a firm fibrous cord.
12
The advantages of postsclerotherapy compression are discussed in detail in Chapter 6.
In addition to providing external compression to the treated vessel, one should try to minimize forces that act to distend the vessel. Since taking hot baths or saunas dilates the cutane­ous venous network, they should be avoided for 2 to 6 weeks after sclerotherapy or until such time as the treated vessel is fully sclerosed. In addition, any activity that increases abdomi­nal pressure may act to force blood in a retrograde manner through the SFJ or IPVs, producing venous dilation. Heavy weight lifting therefore must be discouraged, along with any exercises that use the abdominal musculature, unless the legs are elevated during abdominal exercise. One such activity that increases abdominal pressure by approximately 22 mmHg is running, with pressure apparently being produced to splint the trunk and pelvis.
189
Therefore, aerobic exercises, jogging,
and running should be limited for 1 to 2 weeks.
Patients should be examined 2 weeks after injection so any area of thrombosis can be evacuated early.
190
Each individual area should not be treated again sooner than 6 to 8 weeks after initial injection in order to allow adequate healing between treatments.
Contraindications to Treatment
Knowing and applying contraindications to sclerotherapy is an important part of phlebological practice. The principle of precaution is increasingly applied when using a treatment or a drug – when its use has not been specifically determined, registered, and officially approved, its use is unlawful. Official contraindications are very often unclear, false or inaccurate, outdated, or worse. Contraindications should remain under medical control and managed by specialists.
Pregnancy
Besides the risk of absorption of the sclerosing solution by the fetus, pregnancy is associated with dilation of the entire venous system through multiple mechanisms that do not nor­malize until 3 months postpartum (see Chapter 3). Therefore, although sclerotherapy can be and has been performed successfully by many physicians on pregnant women, the desired contraction of the treated varicose vein (see Chapters 3, 4, and 8). Finally, varicose veins may decrease in size and disappear after delivery (see Chapters 3 and 4). Thus, waiting may eliminate the need for the procedure.
nancy is the presence of significant and painful vulvar vari­cosities, which develop in approximately 2% of pregnant women. more likely in multiparous women. Although they rarely thrombose, they are painful, especially with walking. Bed rest, leg elevation, and localized compression are usually effective in alleviating symptoms, but sclerotherapy may be necessary in severe cases.
any combination of the following: obturator vein; internal
194–198
the increase in venous distensibility counteracts
One situation that may justify sclerotherapy during preg-
200
They usually occur by the second trimester and are
Venography has shown that vulvar varices arise from
191
192,193
199
pudendal vein; inferior gluteal vein; external iliac, uterine, and
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ovarian veins; obturator vein; presacral veins; common femoral vein; and the GSV.
201,202
Because of this variable and extensive system of reflux and the thin-walled, fragile nature of these veins, sclerotherapy is preferred over surgical excision or avulsion (see Case Study 7 later in this chapter).
Inability to ambulate
Walking after treatment is very important because it ensures rapid dilution of the sclerosing solution, which may enter normal deep veins. In addition, stagnation of blood flow is avoided, and the possibility of excessive thrombosis lessened, by the liberation of thrombolytic factors during muscle con­traction when walking. Walking also decreases physical dis­tention of the vein caused by reflux.
A corollary to the contraindication just mentioned is the performance of sclerotherapy during surgical ligation. Although this procedure has been performed by many sur­geons and was advocated by de Takats in 1930,
203
it was usually limited to a point distal to the SFJ on the GSV and therefore was performed on an ambulatory basis. In 1934,
204
Faxon
modified this technique to include ligation at the SFJ with retrograde injection of the GSV. He achieved good results (although follow-up was poor) in his series of 117 cases except for one case of fatal PE, which was attributed to faulty tech­nique by a resident surgeon. In more recent times, Conrad reports great success with this technique when used in con­junction with ligation at the SFJ. Hubner
206
reported similar
205
success without mention of complications in 413 patients fol­lowed for more than 1 year. Patients treated with POL 4% had an 83% success rate, whereas patients treated with Variglobin 4% had a 94% success rate. However, Hubner separates the two procedures by a few hours to a day because his patients had the ligation performed by a surgeon in a separate office and return to him for sclerotherapy. This latter scenario ensures that the patient is ambulatory for both procedures.
In spite of the above-mentioned successful results, there are potential complications that call for separating the two proce­dures. First, many varicose veins will resolve after surgical treatment of the high-pressure reflux points, so subsequent sclerotherapy is minimized or not necessary.
207
Secondly, the surgical period is often one of minimal ambulation because of postoperative pain and the use of general or regional anesthesia. The delay in adequate ambulation may allow the sclerosing solution to migrate to the deep venous system where unwanted damage could occur (see Chapter 8).
200
The authors recommend postoperative sclerotherapy be delayed for 2 to 3 weeks.
History of thrombophlebitis and deep vein thrombosis
Patients with a history of certain venous diseases may be pre­disposed to the development of excessive thrombosis with injection of a sclerosing agent (that is, development of an excessive phlebitic reaction; see Chapter 8).
Patients with low-risk thrombophilia (activated protein C resistance, hyperhomocysteinemia especially, factor II, factor V Leiden) can be treated with sclerotherapy. A prospective study in progress will determine the best prophylaxis (see Chapter 8).
Regarding patients already treated with oral anticoagula­tion, the contraindication is more dependent on the disease treated by anticoagulation than on anticoagulation itself. Patients treated for atrial fibrillation can be sclerosed without inconvenience; most of the time, the course of their treatment is simpler than for normal patients.
Also, in rare patients, the dilated superficial system may serve as a conduit for carrying blood to the heart. Interruption
of the superficial system may then increase venous insuffi­ciency. Therefore, PPG, both with and without application of a superficial tourniquet or a trial of 30- to 40-mmHg gradu­ated compression stockings, helps determine which patients will benefit and which may be harmed by sclerotherapy treatment.
Another simple test to determine if the varicosity resulting from DVT is a necessary conduit is a modification of the Perthes’ test (see Chapter 5). A tensiometer cuff is inflated to 110 mmHg, and the patient is asked to walk quickly for 5 minutes. If the patient complains of heavy pain, or if the leg becomes livid, or both, the varicosity is necessary as a collat­eral channel. This test has allowed, without complication, surgery on 53 limbs with varicose veins in 52 patients with prior DVT.
208
Allergic reaction
Patients are rarely allergic to a sclerosing solution, but a dif­ferent solution can usually be substituted. If the allergic reac­tion consists of generalized urticaria, with or without an erythematous papulosquamous appearance, French authors advocate continuing treatment with the offending sclerosing solution with the addition of antihistamines before and after treatment (see Chapter 8).
Infrequently, patients develop periorbital edema and a maculopapular cutaneous eruption even with the use of
209
unadulterated hypertonic saline solutions. In this case, ‘aller­gic reaction’ may be the result of histamine release by intravascular basophils or perivascular mast cells that are directly damaged by the sclerosing solution (see Chapter 7). Under this circumstance, administration of antihistamines before and after the procedure appears safe while therapy is continued.
Patients taking disulfiram
Patients taking disulfiram (Antabuse) should not be treated with POL or Sclerodex, since these sclerosing solutions contain ethyl alcohol.
Patients taking tamoxifen
As described in Chapter 8, tamoxifen is often responsible for extensive superficial phlebitis in patients treated by sclero­therapy, even of reticular or spider veins. We consider it to be a relative contraindication.
Patients taking hormones
Hormonal replacement as discussed previously is not consid­ered a contraindication to sclerotherapy. If a patient is at risk for venous thrombosis they should not be on hormonal replacement in the first place.
Other contraindications
Warm Weather
Treating patients in summer is not a contraindication, pro­vided they can wear compression and do not sunbathe during the treatment.
Travel
Administering sclerosing injections immediately prior to a long flight or trip (more than 4 hours) is not recommended as the patient is at slightly increased risk for thromboembolic events from the inactivity in flight. Additionally, it is not very prudent for a patient to be unavailable for examination imme­diately after treatment.
210
Contraindications to Treatment
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Clinical Methods for Sclerotherapy of Varicose Veins
Age
Many venous malformations are currently treated with sclerosing foam; young age does not forbid sclerotherapy. Conversely, the elderly are good candidates for sclerotherapy since they are often not candidates for surgery. Since their veins are especially dysplastic, they usually respond better to injections. We do not limit our treatments in these patients, except when life expectancy is short.
Case Histories
The following case histories demonstrate the authors’ tech­nique of sclerotherapy for different varicose veins (Box 9.1).
Case Study 1
Incompetent perforator veins treated with Fegan’s technique
A 35-year-old woman developed varicose veins during the second trimester of her second pregnancy and wore an over-the-counter light compression stocking during the remainder of her pregnancy. At delivery she developed thrombophlebitis that was treated with hot packs only. She came for evaluation and treatment 6 months after delivery. Physical examination showed a 4- to 6-mm varicose tributary of the GSV originating at the medial midthigh and extending to the medial calf with continuation across the anterior tibia (Fig. 9.28A and B). Venous Doppler examination revealed a continuous venous sound with distal augmentation at the level of the posterior tibial vein at the left ankle. There was no evidence of saphenofemoral reflux or other abnormalities. Photoplethysmography revealed a normal venous refilling time in the right leg and an abnormal refilling time in the left leg (20 seconds). The venous refilling time normalized with placement of a tourniquet at the level of the left upper calf and left lower thigh. Therefore, the physical and noninvasive examinations were consistent, showing incompetence of the midthigh (Hunterian) perforator.
Because of the localized abnormality (IPVs) producing the varicose vein, Fegan’s technique of perforator interruption was used. Sclerotherapy was performed with the injection of 0.5 to
1.0 mL of STS 1.0% at the midthigh, medial superior calf, and anterior distal tibial point of fascial depression. The needles
were inserted with the patient standing, and the patient then assumed the supine position with the leg elevated to 45 degrees. After aspiration to confirm proper needle placement, the sclerosing solution was injected while proximal pressure was maintained. STD E-foam pads were placed over the entire course of the varicose vein and secured with Microfoam tape. A 30- to 40-mmHg graduated compression stocking was applied and worn continuously for 7 days, after which it was worn for an additional week only while the patient was ambulatory.
The patient was seen 2 weeks later, at which time physical examination revealed total resolution of the varicosity at the midthigh (Fig. 9.28C) and persistence of a thrombosed varicosity at the anterior tibial level (Fig. 9.28D). It was drained, and the pressure stocking was prescribed for use while the patient was ambulatory for another week. On follow-up examination 6 weeks later, the vessel had resolved (Fig. 9.28E). One-year follow-up demonstrated total obliteration of the varicosity and post-treatment hyperpigmentation (Fig. 9.28F
and G). This case illustrates Fegan’s principle that interruption
of the IPVs alone causes normalization of the entire varicose vein.
One year later (2 years after her initial sclerotherapy), the patient became pregnant with her third child and noted the development of new varicose and telangiectatic leg veins during her first trimester. Despite wearing 30- to 40-mmHg graduated support stockings for much of her pregnancy, she developed incompetence of the SFJ bilaterally, with new incompetent GSV bilaterally and new vulvar varicosities. Interestingly, the previously sclerosed veins just above the medial knee and on the anterior tibial surface did not reappear (Fig. 9.28H and I). Ligation and stripping were performed 18 months postpartum when breastfeeding was discontinued, followed 2 weeks later with sclerotherapy of reticular veins, with excellent results (Fig. 9.28J).
This patient illustrates many important points. Sclerotherapy is very effective in treating large varicose veins when the SFJs are competent. However, varicose veins represent a disease of the venous system that is often progressive. So, initial success may be met with new disease over time, especially if additional aggravating events (pregnancy) occur. Fortunately, treatment is both effective and cosmetic.
Case Study 2
Box 9.1 Sclerotherapy of varicose veins
Sequence of events
1. Physical examination
2. Noninvasive diagnostic examination
3. If findings are abnormal, consider duplex scanning, varicography, or photoplethysmography
4. Eliminate the high-pressure inflow points
5. Saphenofemoral-saphenopopliteal junction
6. Incompetent perforators
7. Sclerotherapy of the largest diameter varicose veins
8. Sclerotherapy of perforator or reticular veins that feed ‘spider’ telangiectasia
9. Sclerotherapy of ‘spider’ telangiectasia
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Incompetent perforator vein at the midcalf treated with modified Fegan technique
A 40-year-old woman noticed the gradual development of a varicose vein over 4 years without any predisposing factors. Physical examination showed a varicose tributary of the GSV 3 to 5 mm in diameter extending from the midanterior tibial surface to the medial calf and thigh and ending in the lower anterior thigh (Fig. 9.29A and B). Venous Doppler xamination was remarkable only for an IPV at the right midmedial calf.
Since fascial depressions could not be felt, the classic Fegan technique could not be performed. Therefore, 25-gauge butterfly catheters were placed randomly into the varicosity at the level of the anterior midtibia, medial superior tibia, and the lateral knee with the patient standing. After the patient
Figure 9.28 Case Study 1. A, Varicose
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tributary of the great saphenous vein originating at medial midthigh and, B, extending to medial calf and continuing across the anterior tibia. C, Two weeks after sclerotherapy, total resolution of varicosity is shown at midthigh, but, D, persistence of thrombosed varicosity is visible at anterior tibial level. E, Complete resolution 6 weeks after sclerotherapy. F, Lateral views of vein normalization 1 year after treatment.
Case Histories
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C
B
D
E
F
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Chapter
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9
Clinical Methods for Sclerotherapy of Varicose Veins
G
I J
Figure 9.28, cont’d Case Study 1
an incompetent saphenofemoral junction. Note that previously treated veins remain sclerosed. J, Clinical appearance, 6 months after ligation and stripping of GSV followed by sclerotherapy of reticular veins.
G, Anterior views of vein normalization 1 year after treatment. H and I, New varicose great saphenous vein (GSV) from
H
assumed the supine position, STS 0.5% was injected into these sites after proper needle placement was confirmed with blood aspiration. A total of 0.5 mL was injected at the anterior midtibia, 1 mL at the medial superior tibia, and 2 mL at the lateral knee while pressure was maintained on the vein proximally. STD E-foam pads were placed over the entire vessel and were secured with Coban tape applied with moderate pressure. A 30- to 40-mmHg graduated compression stocking was applied, with two stockings worn on top of each other while the patient was ambulatory and one stocking worn at night for 1 week. During the second week, the dressing was removed, and the graduated support stocking was worn for another week only while the patient was ambulatory. The
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varicosity was completely resolved on follow-up examination at 2 weeks, and a few thrombi were drained. The photographs in
Figuse 9.29C and D were taken 11 months after treatment.
The latter technique used the principles of Fegan, except the entire area of presumed perforator incompetence was sclerosed. If Sigg’s technique had been used, the sclerosing solution would have been more randomly injected throughout the entire course of the varicose veins. The classic Fegan technique could have been performed if the sites of IPVs were localized with duplex imaging. Duplex-controlled injections may have limited the quantity of sclerosing solution injection to very specific sites but probably would not have affected the clinical outcome.
Figure 9.29 Case Study 2. A, Varicose tributary
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of great saphenous vein extending from midanterior tibial surface to, B, medial calf and thigh ending in lower anterior thigh. C, Midanterior tibial surface and medial calf and thigh and, D, lower anterior thigh views of vein normalization 11 months after treatment.
Case Histories
A
C D
B
Case Study 3
Reticular varicosities without perforator vein reflux treated with total-vein sclerotherapy (Sigg’s technique)
A 34-year-old woman first noticed the appearance of varicose veins with her second pregnancy, 3 years before treatment. The veins were symptomatic after prolonged standing and were thought to have enlarged over the past year. Physical examination showed a set of 3- to 4-mm varicose reticular veins coursing from the posterior midthigh to the posterior midcalf bilaterally (Fig. 9.30A and B). There was no evidence of incompetence in either the perforator veins or the SFJs on venous Doppler examination.
While the patient was lying horizontal on her abdomen, multiple injections of STS 0.5% were made into the varicose veins. Approximately 0.5 mL was injected into each site every 4 to 6 cm for a total of 8 mL of solution per leg. Continuous compression was maintained for 7 days only with 30- to 40-mmHg graduated compression stockings overlying STD E-foam pads over the varicose veins. Follow-up examination did not disclose excessive bruising or pigmentation. No thrombosis occurred. Figure 9.30C and D, shows the appearance of the treated vessels at 1-year follow-up.
Since points of venous reflux could not be found either at the SFJ or in perforator veins, it was assumed that the varicose vein was essential in nature. As it was serving no useful function, it was obliterated in its entirety. This forms the rationale for Sigg’s technique.
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