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Файл:Ординатура / Хирургия / Библиотека им академика М.И. Перельмана / Книга_3953_Библиотеки_им_академика_М_И_Перельмана
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into the subfascial plane. The “two-port” technique uses one port for the camera and a
separate port for instruments, providing improved visualization of subfascial perforators.
The authors use a balloon technique using the Spacemaker
w
surgical balloon dissector
(General Surgical Innovations, Cupertino, CA, U.S.A.) described below.
Technique
With a thigh tourniquet inflated, a 10 mm endoscopic port is inserted into the subfascial
medial compartment of the calf 10 cm distal to the tibial tuberosity, but away from any
diseased skin. Balloon dissection is used to separate the subfascial space, which
facilitates port placement. CO
2
insufflation is used to enhance visibility and a second
5 mm operator port is then inserted under direct vision, distal and posterior to the
camera port. Medial perforators encountered are divided using clips and sharp
dissection, a harmonic scalpel, or electrocautery. Cockett II and III perforators and the
paratibial perforators are accessed via a separate paratibial fasciotomy and are usually
found within an intermuscular septum, which must be incised before the perforators can
be divided. In order to visualize proximal paratibial perforators, the medial insertion of
the soleus on the tibial may have to be exposed.
After all incompetent perforators have been treated, the ports are removed, the
subfascial space is manually deflated, and the tourniquet is released. Any additional
treatment, such as stab avulsions or high ligation and stripping, is then carried out
and the subfascial compartment can be instilled with local anesthetic to reduce post-
operative pain. The wounds are closed and the limb is wrapped with an elastic
compression bandage.
Comparison of SEPS and Open Perforator Surgery
The main advantage of SEPS over the traditional open surgical techniques is a lower
wound complication rate (45,47). In a review by the North American SEPS registry
(NASEPS) of 155 SEPS procedures with concomitant venous procedures in 72%
of patients, the one-year cumulative ulcer-healing rate was 88% following SEPS and
superficial venous surgery with a median time to healing of 54 days (47,48). The
cumulative rate of ulcer recurrence was 16% at one year and 28% at two years.
In a systematic review of the outcomes after surgical management including
SEPS for perforator reflux (49,50), 20 studies comprising 19 case series and one
randomized trial were identified. One thousand thirty-one patients with 1140 treated
limbs were reviewed, and of those limbs that underwent SEPS, the ulcer-healing rate
ranged from 56% to 100%, with a combined healing rate in 88% of limbs at a mean
follow-up of 10 months. The reported median time to healing was 30 to 60 days
and significant risk factors for non-healing and ulcer recurrence, as well as the early
complication rates, are shown in Table 3. The overall probability of ulcer recurrence
during follow-up is 16%.
Sybrandy et al. compared SEPS to open perforator surgery in a randomized study
of 39 patients with perforator vein incompetence using duplex sonography (50), which
revealed that both the ulcer healing rates and the recurrence rates were similar following
both procedures. It was also found that deep venous incompetence, superficial venous
incompetence, and the number of perforating veins had no influence on recurrence rates in
either group. The complication rates were, however, significantly different. In the Linton
group, 53% of patients developed wound infections while there were no reported
complications in the SEPS group.
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Ablation of the LSV
There has been a resurgence of interest in endovenous closure of the LSV since the
concept was first explored over 40 years ago. Two techniques that are presently in use are
radiofrequency and laser ablation.
Radiofrequency Ablation (RFA)
RFA uses radiofrequency energy supplied via a catheter electrode inserted into to the
LSV. This is coupled with compression of the vein around the catheter. The result is
resistive heating of the vein wall, which is maintained at a constant temperature by a
thermocouple, inducing vein wall thickening, contraction of the lumen, and formation of
a fibrotic seal of the vein’s lumen. The Closure
w
radiofrequency catheter (VNUS
Medical Technologies Inc, Sunnyvale, CA, U.S.A.) was first introduced in Europe in
1998 and was granted Australian and U.S. FDA approval in March 1999 (51). The system
consists of a microprocessor-controlled bipolar generator and sheathable electrode
catheters that are introduced intravenously. Two catheters measuring 1.7 mm (6F) and
2.7 mm (8F) are available (Fig. 1) and allow radiofrequency obliteration of veins
measuring between 2 and 12 mm in diameter. Direct heating of the vein to a depth of
1 mm occurs in rings 6 to 8 mm in length during withdrawal of the catheter along
the vein.
Patients with confirmed primary or secondary SFJ and LSV incompetence on duplex
sonography are suitable for the procedure. The authors consider the following conditions
unsuitable for RFA:
1. Vein diameter !2mmorO12 mm. If less than 2 mm the vein is too small to
cannulate, while vein diameters O12 mm give poor impedance when the patient
is supine.
2. Very tortuous veins above the knee (curves O908). This makes advancement of
the catheter very difficult.
3. Thrombus in the LSV.
4. Any patient with a pacemaker or internal defibrillator.
The treatment of the SSV by ablation is not advocated by the authors due to the
potential risk of sural nerve injury. The National Institute for Clinical Excellence
Table 3 Risk Factors and Early Complications of SEPS
Significant risk factors for non-healing Persistent postoperative incompetent
perforators
Ulcer diameter O2cm
Secondary etiology
Significant risk factors for ulcer recurrence Obstructive pathophysiology
Secondary etiology
Postoperative incompetent perforators
Early complications (!30 days) Infection (6%)
Hematoma (9%)
Neuralgia (7%)
DVT (1%)
Abbreviation: DVT, deep vein thrombosis.
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(NICE) published guidelines for the procedure in September 2003 and they can be
found at www.nice.org.uk/pdf/ip/ipg008guidance.pdf.
Technique
Ablation can be performed under general, regional or local (tumescent) anesthetic, with
or without sedation (52,53). After adequate skin preparation, duplex ultrasound is used
to map the course of the LSV from the SFJ to the knee, where it is accessed either
percutaneously or via a cut-down procedure. Access can be achieved at the ankle,
however passage of the catheter from this level can sometimes be difficult and the
authors now favor access at the knee level (54). Access to the lumen of the LSV is
established using ultrasound control and a seven or nine French sheath (dependent on
the size of the catheter to be used) is inserted. The ablation catheter is then fed through
the sheath and passed along the LSV into the common femoral vein under ultrasound
control. Infiltration of the tissue surrounding the LSV with 0.9% saline and local
anesthetic helps to achieve vein wall compression and reduces the risks of skin burns
and paraesthesia from saphenous nerve injury. Following infiltration, the leg is
exsanguinated by tilting the patient to 308 Trendelenberg position, elevating the limb to
be treated and wrapping the thigh with an Esmark
w
bandage to compress the vein
around the catheter. Manual compression is applied between the upper limit of the
bandage and the SFJ. The catheter is withdrawn to a position just below the SFJ
(usually below the inferior epigastric vein) (Fig. 2), and the catheter electrodes are
unsheathed. At this stage, wall contact is assessed by measuring the impedance and the
power level, and maximum temperature and duration of treatment are also recorded.
With the target temperature set at 858 C, ablation is performed from just below the SFJ
Figure 1 Closure
w
catheters with unsheathed electrodes. Arrows indicate the microthermocouple
that continuously measures vein wall temperature and provides feedback to the radiofrequency
generator. Source: VNUS
w
Medical Technologies, Inc.
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Catheter in LSV
CFV
CFA
IEV
Figure 2 Positioning the Closure
w
catheter under ultrasound guidance. The electrodes are
sheathed as the catheter is positioned in the long saphenous vein just below the saphenofemoral
junction. Abbrevations: CFV, common femoral vein; CFA, common femoral artery; IEV, inferior
epigastric vein. Source: Courtesy of Olivier Pichot, MD. (See color insert.)
Figure 3 Schematic diagram of long saphenous endovenous ablation with Closure
w
catheter. The
catheter is inserted up to the saphenofemoral junction with the electrodes sheathed. The electrodes
are unsheathed with the catheter withdrawn to just below the saphenofemoral junction and the vein is
compressed. The electrodes are then activated and the temperature allowed to reach 858C. The
catheter is gradually withdrawn as radiofrequency energy heats and contracts the vein wall. (See
color insert.)
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to the knee, by withdrawing the catheter at a rate of 2.5 to 3 cm/min and maintaining
the temperature at 858CG38C (Fig. 3). Heparinized saline is infused continuously into
the catheter via a central lumen to avoid thrombus formation on the electrodes.
Following completion, there will be minimal flow in the vein lumen before complete
occlusion occurs. A duplex scan is performed to assess adequacy of the procedure and
any residual patent segments are re-treated until satisfactory vein treatment is achieved.
Local varicosities can be treated either by avulsions at the same operation or by
subsequent sclerotherapy.
Results Following RFA
The vein occlusion rate following RFA is between 88% to 100% at one week and 85%
to 90% remain occluded at two years (54). To date, two randomized controlled trials
comparing the outcome of radiofrequency ablation with conventional surgery have been
reported (55,56). Both trials have shown that endovenous obliteration resulted in less
postoperative pain, shorter sick leaves, and faster recovery of physical function than
following conventional surgery; however, both VNUS and conventional surgery have
been shown to be equally effective in elimination of reflux in the treated LSV
segments.
Complication rates were similar after both procedures, though the types of compli-
cations differed, with hematoma formation more likely in the conventional group, while
thrombophlebitis and thermal skin injury occurred in the RFA group. In one case series
only, a high incidence of DVT following RFA was reported (16%) requiring
anticoagulation therapy and, in some cases, insertion of an IVC filter (57).
Overall operating times were longer in the RFA groups, but this was thought to
reflect the associated learning curve as the studies were performed soon after the introduc-
tion of the technique.
Neither RCT assessed the long-term recurrence rate of varicose veins, but other
follow-up studies have reported 10% persistent reflux and 5–13% recurrence at two years
(55,56). There was no neovascularization reported after two years in limbs that underwent
RFA (58), whereas neovascularization following conventional surgery at two years post-
procedure has been reported to be as high as 52% (26). This is thought to be due to the lack
of hematoma formation in the groin with RFA and preservation of the superficial
epigastric and superficial pudendal venous drainage via the SFJ tributaries.
The treatment cost of RFA is higher than conventional surgery due to the cost of the
generator, the radiofrequency catheter, use of intraoperative duplex, and possibly longer
operating time. One RCT compared the cost of RFA to that of conventional surgery (56).
Though the direct operative cost of RFA is greater than conventional surgery, the earlier
return to work following RFA in employed patients influences the overall cost to society.
The sensitivity analysis in one RCT showed that if 60% to 75% of patients are employed,
RFA could be economically cost minimizing due to the earlier return to work following
the procedure compared with that following conventional surgery.
Endovenous Laser Treatment (EVLT
TM
)
The use of laser energy delivered endovenously via fiberoptic laser fibers was first reported
in 1999 in Spain and soon after in New York (59). Laser ablation involves insertion of an
optical fiber with a bare tip into the LSV. Partial compression is applied to the vein with a
modified tumescent anesthesia technique. Some intravascular blood is necessary for
heating of the vein as the chromophore for 810 nm laser is hemoglobin. Pulses of energy
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are delivered in 0.5–1 sec bursts, with a total power of 8–12 W for each pulse. Intravascular
coagulation therefore occurs with this method.
Patients with confirmed primary or secondary SFJ and LSV incompetence on duplex
sonography are suitable for the procedure. Based on preliminary reports on the technique
from New York and Spain (59), there are no limitations based on the vein diameter.
Contraindications for the procedure are as follows:
1. History of deep venous thrombosis
2. Hypercoagulability
3. Arterial occlusive disease
4. Poor general health
5. Pregnancy
NICE published guidelines on this procedure in March 2004. These guidelines can
be found at www.nice.org.uk/pdf/ipg052uidance.pdf.
Technique
The following technique is a summary of that described by Navarro, Min, and Bone
´
(59). Using duplex ultrasound, the site of the SFJ and the course of the LSV and
varicose branches in the thigh are marked in the upright position. These markings are
verified with the patient in the supine position and the skin is prepared for surgery with
appropriate solution. The procedure can be performed under general anesthetic or local
anesthetic, with or without sedation. Under ultrasound control, the LSV is entered on
the lower thigh or at the knee, either via percutaneous needle puncture with a 7 cm, 19-
gauge needle or a stab wound using a Mu
¨
eller hook approach. A 0.035 inch J-tip guide
wire is fed into the LSV through the needle and the needle removed. A 45 cm, 5 or 5.5
French catheter is placed over the guidewire and advanced to the SFJ. The position is
confirmed by visualization on ultrasound and aspiration of non-pulsatile venous blood.
A bare-tipped laser fiber measuring 400–750 mm in diameter is introduced into
the vein via the catheter and advanced to the SFJ. The patient and all staff in the
treatment room must wear 810 nm laser safety glasses. The sheath is withdrawn by
3 cm leaving the distal tip of the laser fiber positioned 1–2 cm below the SFJ. The
position can be confirmed in three ways: (1) by direct visualization of the red aiming
beam of the laser fiber through the skin, (2) by ultrasound imaging, (3) and by
previous marking of the distance from the point of entry to the SFJ on the catheter
and fiber with Steri-strips. By observing the aiming beam, any inadvertent slippage of
the laser fiber into the common femoral vein or the sheath can be immediately
detected, as the beam would suddenly disappear. The fiber and catheter should be
taped to reduce the risk of them moving independently. Tumescent anesthesia is
provided with local anesthetic (lignocaine 0.5%–1%Gadrenaline) infiltrated to form a
cuff along the LSV under direct ultrasound guidance and vein emptying is facilitated
by Trendelenberg position. Manual finger pressure is applied to oppose the vein walls
around the tip of the laser fiber. A wavelength of 810 nm diode laser energy is then
delivered to the LSV 1–2 cm below the SFJ and along the course of the LSV as the
fiber and catheter are withdrawn in increments of 1–2 mm. The parameters used
depend on the operating surgeon and vary from 3–12 W in continuous mode with
0.8–2.0 sec pulse duration of 15–20 J of energy with an interval of 1 sec. The fiber is
slowly withdrawn between pulses at a rate of 2–3 mm per pulse of laser energy
delivered. A duplex scan is performed after completion of the procedure to assess the
adequacy of treatment. If warranted additional treatments such as stab avulsions or
sclerotherapy are carried out.
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Class II graduated compression stockings are applied and worn for one week
after surgery and patients are encouraged to start walking immediately after
the procedure.
Results Following EVLT
There are currently no randomized controlled trials of laser treatment compared to
conventional surgery in the treatment of varicose veins. Case studies report that the vein
occlusion rate following EVLT was between 97%–100% at 1 week in two clinical studies
totaling 130 treated limbs (59,60). Those that were not successfully treated at 1-week
follow-up were re-treated with 100% of treated LSV remaining closed at nine months. The
recurrence rate after two year follow-up is 7%, with the majority of recurrences occurring
within the first three months (61).
Complication rates following EVLT are low. In reported series, there were no
complications related to cannulation of the LSV such as hematoma or infection.
Ecchymoses and induration around the site of local anesthetic infiltration have been
reported. In addition, the procedure has been associated with no heat-related complications
such as thermal skin injury and paraesthesia. There are also no reported cases of superficial
phlebitis or deep vein thrombosis.
The equipment required for EVLT is expensive. The set-up cost amounts to
approximately UK$27000 plus the cost of the ultrasound equipment, with a consumable
cost of UK$250 per treatment. No published studies have compared the overall operative
cost of EVLT with that of any other treatment for varicose veins. However, as with RFA,
the overall comparative cost may be lower that expected as the procedure can be
undertaken under local anesthetic, recovery and return to work is quick, and the
consumable cost is relatively low.
One possible advantage of EVLT over RFA is larger vessels can be treated, as the
largest diameter vein successfully treated with EVLT was 32 mm although long-term
results still need to be assessed.
Transilluminated Powered Phlebectomy (TIPP)
This has been advocated as a minimally invasive treatment of non-truncal superficial
varices. The TriVexe system (Smith & Nephew, Andover, MA, U.S.A.) consists of an
illuminator device, a powered vein resector, a system control unit, and a light source (62).
The TriVexe illuminator combines an irrigator device connected to a tumescent solution
that is placed in a pressure cuff at 400 mmHg. Tumescent irrigation hydrodissects the
tissue surrounding the vein clusters, which assists in their resection. The resector
consists of a rotating inner blade with a speed ranging from 700 to 3000 rpm (forward
and reverse).
Technique
The procedure is performed with the patient in the Trendelenberg position. After LSV
stripping is completed, the irrigated illuminator and resector devices are inserted
via two separate 2–3 mm incisions made just around the previously marked varicose
cluster to be treated. Hydrodissection of the venous cluster is performed with a
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solution of 1000 ml of 0.9% normal saline with 50 ml of lignocaine 1% with
adrenaline 1:200,000, which helps to reduce postoperative pain and hematoma. With
the veins transilluminated, the resector is inserted via the second incision and
the veins avulsed and aspirated with this device (Fig. 4). Once the procedure is
completed, the devices are removed and the wounds closed with Steri-Stripse.
Results Following TIPP
One reported case series of 15 patients with varicose vein classification CEAP C2 to
C4 (chap. 6), found that postoperative pain is limited as the number of skin incisions
is less than with conventional phlebectomies. All patients reported significantly
improved symptoms with very good cosmetic results (62). There was one report of
paraesthesia, which was thought to result from concomitant ankle to groin LSV
stripping. These findings were not supported, however, in a randomized controlled
study by Aremu et al. (63), who found that although there are fewer incisions in the
TIPP procedure compared with hook phlebectomy (ratio: 1:7), overall cosmesis was
similar in both groups. They also found no significant difference in postoperative
pain, cutaneous nerve injury, or operating time. Other authors, however, noted
significantly greater incidences of postoperative hematoma (64) but this was not
evident in the RCT. NICE guidelines were published in January 2004 and can be
found at www.nice.org.uk/pdf/ip/IPG037guidance.pdf. These guidelines have high-
lighted that current evidence on the efficacy and safety of the procedure is of limited
Figure 4 TriVex
w
system. (A) The surgeon makes incisions—as few as 2 per cluster. (B) The
illumination device is inserted through one incision, allowing surgeon to highlight the veins. (C) The
resection device is inserted through the other incision to remove the vein. Source: Courtesy of
Smith & Nephew. (See color insert.)
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value due to the small number of patients and limited quality of reported data. It is
recommended that clinicians wishing to undertake the procedure in the UK should
have appropriate systems in place to cover adequate patient consent and to perform
surgical audit.
Foam Sclerotherapy
Orbach first described the use of a foam sclerosant in 1950 (65). He suggested that
vigorously shaking a 3% sodium tetradecyl sulphate solution improved the thrombogenic
effect. Initial sclerosant foams were produced by shaking the sclerosant in the vial or
syringe, producing bubbles with a high air:liquid ratio, with increased efficacy in smaller
veins only. With larger veins, the air would position itself along the upper side of the vein,
impeding contact with endothelium. Several surgeons have since proposed different
methods of producing sclerosing foam for the treatment of varicose veins with the aim of
increasing the efficacy and safety of the treatment (Table 4). By definition “sclerosing foam
(SF) is a mixture of gas and liquid sclerosing solution with tensio-active properties (66).”
The gas should be well tolerated or physiologic and the bubble sizes less than 100 m.
Table 4 Techniques Employed to Produce Foam
Name/year described Method Foam quality Duration
Orbach 1950 (65) Shaking syringe/vial
manually
Poor; of use only in
small veins
Short lasting
Monfreux 1995 (78)
a
Spigotted glass
syringe with
0.3–0.5 ml liquid;
piston effect of
plunger to create
2–3 ml foam
Poor; low
consistency,
large bubbles
Long lasting (3 h
in vivo, 20 min
in vitro)
Cabrera 1997 (79) CO
2
used in place of
air
Medium quality Unknown
Benigni–Sadoun 1999
(80,81)
Plastic syringes with
fast pulling and
release of piston
Medium quality Short lasting
Mingo–Garcia 1999 (82)
(minimal data
available)
Device producing
compressed air
Low to medium
quality
Unknown
Tessari 1999 (83) Two disposable
syringes and a
3–way tap (sterile,
dedicated kit)
High quality using
STS
Reconstitution
possible
b
Frullini 2000 (84) Similar to Tessari;
different quantities
of sclerosant and air
used
High quality Reconstitution
possible
b
a
Dizziness and confusion are recognized self-limited side effects of treatment.
b
System allows reconstitution of foam if treatment takes a long time.
Abbreviation:STS, sodium tetradecylsulfate.
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Sclerosing foam displaces the blood in the vein, which enhances the sclerosant power ofthe
agent. By using the foam technique it is possible to reduce the volume of the necessary
sclerosing liquid and its concentration.
The authors advocate the use of the Tessari method, which produces a high-
quality foam that is very compact with a small bubble diameter in a kit that includes
two syringes and three-way tap. One syringe is pre-filled with air, which avoids the
problem of using “nonsterile air” for injections. The foam lasts for at least two min and
if injections take longer, new foam can be reconstituted easily. Following the European
Consensus Meeting on Foam Sclerotherapy in 2003 (67), the following recommen-
dations (Table 5) on the maximum safe volumes for use in foam sclerotherapy were
prepared for different vein calibers taking into consideration the CEAP classification
(chap. 6).
Results Following Foam Sclerotherapy
Foam sclerotherapy allows treatment of large truncal varices, which would otherwise not
be amenable to treatment with conventional sclerotherapy. The success rate varies from
88.1% with the Monfreux technique to 93.3% with the Tessari technique at six months
follow-up (66). Frullini et al. found that air sclerosing foam is as safe as liquid solution in
terms of major complications such as DVT’s pulmonary embolism, allergies and skin
necrosis. The types of complications are similar to those occurring with conventional
sclerotherapy (Table 6).
Table 6 Advantages and Complications of Foam Sclerotherapy
Advantages Complications
There is no need for general anesthetic Superficial thrombophlebitis
Can be performed as an out-patient procedure Skin staining
The procedure can be easily repeated Skin ulceration
Normal activity can be resumed almost immediately DVT
Scotoma (temporary)
Abbreviation: DVT, deep vein thrombosis.
Table 5 Recommendations on Safe Volumes of Foam
Vein Caliber Volume of foam
per single injection
Volume of foam
per session
Telangiectasia and reticular
veins
!0.5 mL with the Tessari
and Monfreux techniques
Tessari technique: 6–8 mL
Monfreux technique: 4 mL
CEAP C2–C6 No consensus reached Tessari technique: 6–8 mL
Monfreux technique: 4 mL
Small caliber saphenous veins No consensus reached Less than 3mL
Source: European Consensus Meeting on Foam Sclerotherapy, 2003.
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