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138 RCCAVC and Surgery in Treating Venous Ulceration
Consecutively targeted patients
(three vascular centers in UK)
Inclusion criteria
CEAP class C5 & C6
ABPI >0.85
Duplex proven superficial venous reflux
*
Consent to inclusion
Venous hemodynamic assessment
(PPG)
Compression
†
alone
Compression
†
plus
surgery
Regular follow-up in specialist clinic
At 1 year
Repeat color venous duplex
Repeat PPG hemodynamic assessment
Randomization
*
Legs classified into those with isolated superficial reflux, superficial plus segmental deep reflux,
and superficial plus total deep reflux.
†
Multilayer compression for open ulcers, Class II elastic stockin
g
s for healed le
g
s.
FIGURE 11-1 ESCHAR study design.
stratifi ed by pattern of venous refl ux (Figure 11-2). It should be noted that
most patients did not receive immediate surgery, and any benefi ts from
operative intervention were therefore delayed. A study by Bello and col-
leagues demonstrated that superfi cial venous surgery improved venous
ulcer healing when compared to legs treated without compression.
17
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RCCAVC and Surgery in Treating Venous Ulceration 139
100
60
20
100
60
20
100
60
20
Numbers
at risk
Healed
legs (%)
Time
(years)
sn = p sn = p sn = p
39 8 4 2 20 1 0 0
40 10 0 0 28 9 6 5
1230
0
1
23 0123
AB C
3915102Compression
plus surgery
2714114Compression
alone
FIGURE 11-2 Ulcer healing rates in ESCHAR study. A. Isolated superfi cial refl ux. B. Superfi cial with segmental deep refl ux. C. superfi cial
with total deep refl ux.
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140 RCCAVC and Surgery in Treating Venous Ulceration
However, other studies comparing surgery to compression have echoed the
fi ndings from ESCHAR and failed to demonstrate a healing benefi t with
surgery.
18,19
These fi ndings confi rm that the most effective strategy for rapid
healing of venous ulcers is likely to be effective multilayered graduated
compression applied by appropriately trained staff.
Impact of Surgery on Ulcer Recurrence
The ESCHAR study confi rmed the fi ndings of previous, smaller studies
and demonstrated that superfi cial venous surgery reduces ulcer recurrence
in legs with isolated superfi cial refl ux. Three-year recurrence rates were
21% for patients randomized to surgery, compared to 51% for legs treated
with compression alone (p < 0.001, Figure 11-3).
16
A signifi cant benefi t was
also seen for legs with segmental deep refl ux, suggesting that the presence
of coexistent deep refl ux should not be considered a contraindication to
superfi cial venous surgery (Figure 11-3). For legs with total deep refl ux, a
signifi cant benefi t for surgery was not demonstrated, although patient
numbers in this subgroup were small. Interestingly, some legs with total
deep refl ux did derive a hemodynamic benefi t from surgery (see following
section). Legs randomized to surgery experienced greater ulcer free time
over 3 years compared to patients in the compression group (mean 100 vs.
85 weeks respectively, p < 0.001) and suffered signifi cantly fewer episodes
of recurrent ulceration.
16
These results reproduced the high rates of venous ulcer recurrence
reported by other authors (>50% at 3 years) despite advice to wear class
II hosiery.
20
Even for legs randomized to surgery, 3-year ulcer recurrence
rates were over 20%. Although it is reasonable to assume that surgery may
not be successful in all cases, this does suggest that simply correcting ana-
tomic venous incompetence does not cure the leg of chronic venous hyper-
tension. In cases of recurrent ulceration after surgery, factors such as calf
muscle pump failure, obesity, and immobility may be signifi cant in indi-
vidual patients. The use of long-term class II elastic stockings after super-
fi cial venous surgery may therefore be advisable to counter the causes of
venous hypertension not addressed by saphenous surgery.
OTHER FINDINGS
Anatomic Changes with Surgery
Color venous duplex assessment in the ESCHAR study revealed that
residual incompetence in greater or lesser saphenous veins was a common
fi nding after venous surgery. In a report of 84 patients treated for greater
saphenous refl ux, only 22/84 (26%) were free of greater saphenous incom-
petence after 1 year.
21
In 30/84 (36%) patients, there was refl ux in the
above-knee segment of the greater saphenous vein after 1 year, including
six patients in which the saphenofemoral junction was incompetent (Figure
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RCCAVC and Surgery in Treating Venous Ulceration 141
100
60
20
100
60
20
100
60
20
0123 0123 0123
Numbers
at risk
Compression
plus surgery
133 107 83 46
Legs
remaining
healed
(%)
Time
(years)
sn = p 440.0 = p 100.0 < p
54 38 27 13 29 21 14 9
Compression
alone
140 90 63 27
56 32 25 12 30 18 10 7
AB C
FIGURE 11-3 Ulcer recurrence rates in the ESCHAR study. A. Isolated superfi cial refl ux. B. Superfi cial with segmental deep refl ux.
C. Superfi cial with total deep refl ux.
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142 RCCAVC and Surgery in Treating Venous Ulceration
11-4). Disappointing surgical results following saphenous vein surgery have
been reported previously and neovascularization, incomplete surgery, or
anatomic anomalies (such as bifi d greater saphenous vein) may have con-
tributed to residual refl ux. Interestingly, in a subgroup analysis, the pres-
ence of residual superfi cial incompetence after surgery was not associated
with reduced hemodynamic status, inferior ulcer healing, or higher recur-
rence rates (unpublished data). This observation questions the signifi cance
of residual refl ux after venous surgery and suggests that repeat surgery to
Greater saphenous vein (GSV) surgery (n = 84)
Lesser saphenous vein (LSV) surgery (n = 33)
No reflux SFJ reflux
AK-GSV
reflux
22
(26%)
32
(38%)
24
(29%)
6
(7%)
No reflux SPJ reflux LSV reflux
15
(46%
)
6
(18%)
12
(36%)
BK-GSV
reflux
FIGURE 11-4 Residual superfi cial venous refl ux 1 year after saphenous surgery.
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RCCAVC and Surgery in Treating Venous Ulceration 143
cure venous refl ux may not confer any hemodynamic or clinical benefi t.
Perhaps more detailed assessment of the duration of venous incompetence
and size of refl uxing vein may help identify clinically signifi cant anatomic
refl ux.
Previous authors have commented that deep venous refl ux may be
reversed following superfi cial venous surgery.
22
A similar effect was seen
in this study, particularly for patients with segmental deep refl ux, which
was abolished in 45% of patients after surgery.
21
Interestingly, reversal of
deep and superfi cial venous incompetence was seen in some patients
treated with compression alone. The temporal variation of venous incom-
petence and infl uence of simple measures such as elevation, exercise, and
compression remain poorly understood, and these limitations must be
considered when interpreting duplex changes.
The signifi cance of incompetent calf perforating veins in patients with
venous ulcers is poorly understood and continues to be widely debated.
Duplex examination revealed that incompetent perforators were present
in 51% of patients prior to surgery, which reduced to 42% of legs 1 year
after surgery (p = 0.001). This effect was seen in legs with and without deep
venous refl ux.
21
The reversal of calf perforator incompetence after saphe-
nous vein surgery is well reported but widely considered to be a short-term
phenomenon and less well recognized in the presence of coexistent deep
refl ux.
Hemodynamic Changes with Surgery
Venous refi ll time (VRT) refl ects the time taken for a limb to return to
its resting venous pressure following calf muscle pump contraction. Long
VRT demonstrates normal venous function, whereas very short VRT may
indicate a greater severity of venous disease. Digital photoplethysmogra-
phy (PPG) is a minimally invasive procedure for the measurement of VRT,
validated against invasive pressure measurements, and was used for func-
tional limb assessment in the ESCHAR study. PPG was performed with
and without a narrow below-knee tourniquet to occlude superfi cial veins
(to simulate surgery) and repeated 1 year after recruitment. VRT >20
seconds was considered normal.
The initial median VRT in the ESCHAR population was 11 seconds
(range 3–48), demonstrating signifi cant venous dysfunction. No improve-
ment in VRT was seen in the legs treated with compression alone. However,
in the surgical group, initial VRTs of median 10 seconds (range 3–48)
improved to median 15 seconds (range 4–48) 1 year after surgery (p <
0.001).
21
Some legs gained a hemodynamic benefi t from superfi cial venous
surgery, whereas others did not regardless of the initial pattern of venous
refl ux.
Hemodynamic data also demonstrated that VRT measured with a
below-knee tourniquet correlated with both ulcer healing and recurrence,
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144 RCCAVC and Surgery in Treating Venous Ulceration
implying that PPG assessment accurately refl ects actual venous dysfunc-
tion. Poor initial VRT measurements were associated with delayed ulcer
healing, and using this predictive value, a prognostic scoring system for
venous ulcer healing has been developed from the ESCHAR results.
23
Interestingly, a normal VRT with a tourniquet (>2 0 sec onds) before s urge ry
was associated with a 1-year recurrence rate of only 3% compared to 24%
in legs with a poor preoperative VRT (<11 seconds) (Figure 11-5).
24
These
fi ndings strongly suggest that VRT measurement using PPG could be a
useful adjunct to duplex scanning to identify good operative candidates
and potentially avoid unnecessary surgery.
CRITIQUE OF THE ESCHAR STUDY
The ESCHAR study is the largest published randomized study to evalu-
ate the role of surgery in addition to compression for treating venous ulcers.
A great attribute of the study is that inclusion criteria were deliberately
wide, and the study design aimed to emulate standard clinical practice to
ensure that results could be widely applicable. The trial was set within an
* Lo
g
-rank test
VRT with tourniquet
<11s 11–20s >20s
1 year recurrence
(n)
24%
(31)
10%
(40)
3%
(62)
0 6 12
Time (months)
VRT
>20s
11–20s
100
80
60
p=0.033 *
Healed
legs (%)
FIGURE 11-5 Kaplan-Meier curve for ulcer recurrence demonstrating the predictive
value of preoperative hemodynamic assessment using PPG with below-knee tourniquet.
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RCCAVC and Surgery in Treating Venous Ulceration 145
established leg ulcer service and detailed anatomic and hemodynamic
assessments have augmented the clinical results and improved understand-
ing of the overall infl uence of surgery.
A large number of patients refused to attend for surgery despite consent-
ing to inclusion. Moreover, a quarter of patients were treated with local
anesthetic procedures, and the median time to surgery was nearly 2 months.
As the clinical outcomes were analyzed on intention to treat, it is likely
that the actual benefi t of superfi cial venous surgery may have been under-
estimated. It is regretful that quality of life and economic data are not
available to support the clinical fi ndings, as these are powerful drivers for
changes in modern clinical practice.
RESULTS FROM OTHER STUDIES
In a small study published in 2003, Zamboni and colleagues randomized
47 legs (45 patients) to either compression alone or compression plus mini-
mally invasive hemodynamic venous surgery performed under local anes-
thetic.
18
Greater saphenous stripping was not performed, and patients over
80 years with a history of deep venous thrombosis or evidence of deep
refl ux were excluded. The authors reported that healing rates were similar
in the two groups, but the legs treated with surgery had a recurrence rate
of only 9% at 3 years compared to 38% for patients in compression only.
The USABLE multicenter study aimed to randomize 1,000 patients to
compression alone or compression plus surgery, but was abandoned after
18 months due to poor recruitment.
25
The early results for 76 recruited
patients showed no difference in healing rates or quality of life scores.
19
The trial organizers concluded that as a large proportion of screened
patients were not suitable for superfi cial venous surgery, the role of surgery
in venous ulceration may have been overestimated. However, these obser-
vations differed from the ESCHAR study, where the proportion of screened
patients suitable for surgery was far greater. Differences in the study setting
and target populations may have contributed to these observations.
CONCLUSIONS
Chronic venous ulceration is widely accepted as a common, debilitating,
and expensive health problem. Although most patients have superfi cial
venous incompetence potentially amenable to surgical correction, evidence
to support operative intervention has been scarce. The fi ndings from the
ESCHAR study and other research strongly suggest that superfi cial venous
surgery reduces venous ulcer recurrence and should be considered for all
patients with chronic venous ulceration. Patients deemed suitable for surgi-
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146 RCCAVC and Surgery in Treating Venous Ulceration
cal treatment should undergo color duplex venous mapping in order to
identify superfi cial venous incompetence potentially suitable for surgical
correction. Although the advantage appears greatest for legs with isolated
superfi cial refl ux, surgery may also reduce ulcer recurrence for some
patients with deep venous incompetence, and hemodynamic assessment
may be a useful selection tool.
Despite any proven clinical benefi t, it must be acknowledged that elderly
patients with leg ulcers may be unfi t for surgical intervention or unwilling
to accept it. Local anesthetic surgery was performed in a quarter of patients,
but long-term effectiveness is unlikely to match general anesthetic proce-
dures. In keeping with previous studies, residual venous refl ux after venous
surgery was common, although this was not associated with reduced hemo-
dynamic function or clinical outcomes.
Foam sclerotherapy may be used for the treatment of superfi cial venous
incompetence and has the advantage of being performed using local anes-
thesia as an outpatient procedure. The early experience of foam sclero-
therapy in chronic venous ulceration both in our unit and other units has
been promising.
26
More studies are needed to evaluate the effi cacy of foam
sclerotherapy and other endovenous procedures, including radiofrequency
ablation and endovenous laser therapy. Patient acceptance of such proce-
dures may be greater than traditional surgery.
Selection of patients for surgery has been largely based on duplex fi nd-
ings, although results from the ESCHAR study suggest that measurement
of venous refi ll time may also be benefi cial. Further refi nement of selection
pathways may improve the identifi cation of patients most likely to benefi t
from surgery.
REFERENCES
1. Baker SR, Stacey MC, Singh G, Hoskin SE, Thompson PJ. Aetiology of chronic leg
ulcers. Eur J Vas c Surg. 1992;6:245–251.
2. Nelzen O, Bergqvist D, Lindhagen A. Leg ulcer etiology—A cross sectional population
study. J Va sc Surg. 1991;14:557–564.
3. Lawrence PF, Gazak CE. In: Gloviczki P, Bergan JJ, eds., Atlas of Endoscopic Perfora-
tor Vein Surgery. London: Springer-Verlag, 1998:31–44.
4. Phillips T, Stanton B, Provan A, Lew R. A study of the impact of leg ulcers on quality
of life: Financial, social and psychological implications. J Am Acad Dermatol.
1994;31:49–53.
5. Nelzen O, Bergqvist D, Lindhagen A. The prevalence of lower-limb ulceration has been
underestimated: Results of a validated population questionnaire. Br J Surg. 1996;
83:255–258.
6. Callam MJ. Epidemiology of varicose veins. Br J Surg. 1994;81:167–170.
7. Magnusson MB, Nelzen O, Risberg B, Sivertsson R. A colour doppler ultrasound study
of venous refl ux in patients with chronic leg ulcers. Eur J Vas c Endovasc Surg.
2001;21:353–360.
https://t.me/med1917
RCCAVC and Surgery in Treating Venous Ulceration 147
8. Hanrahan LM, Araki CT, Rodriguez AA, Kechejian GJ, LaMorte WW, Menzoian JO.
Distribution of valvular incompetence in patients with venous stasis ulceration. J Vasc
Surg. 1991;13:805–811.
9. Grabs AJ, Wakely MC, Nyamekye I, Ghauri AS, Poskitt KR. Colour duplex ultraso-
nography in the rational management of chronic venous leg ulcers. Br J Surg.
1996;83:1380 –1382.
10. Nicolaides AN, Hussein MK, Szendro G, Christopoulos D, Vasdekis S, Clarke H. The
relation of venous ulceration with ambulatory venous pressure measurements. J Vasc
Surg. 1993;17:414–419.
11. Hardy SC, Riding G, Abidia A. Surgery for deep venous incompetence. Cochrane
Database Syst Rev. 2004;CD001097.
12. Darke SG, Penfold C. Venous ulceration and saphenous ligation. Eur J Vasc Surg.
1992;6:4–9.
13. Barwell JR, Taylor M, Deacon J, et al. Surgical correction of isolated superfi cial venous
refl ux reduces long-term recurrence rate in chronic venous leg ulcers. Eur J Vasc Endo-
vasc Surg. 2000;20:363–368.
14. Barwell JR, Davies CE, Deacon J, et al. Comparison of surgery and compression with
compression alone in chronic venous ulceration (ESCHAR study): Randomised con-
trolled trial. Lancet. 2004;363:1854–1859.
15. Ghauri AS, Taylor MC, Deacon JE, et al. Infl uence of a specialised leg ulcer service on
management and outcome. Br J Surg. 2000;87:1048–1056.
16. Gohel MS, Barwell JR, Taylor M, et al. Superfi cial venous surgery reduces venous ulcer
recurrence: 3 year results from the ESCHAR trial. Br J Surg. 2005;92:506.
17. Bello MSM, Hartshorne T, Bell PR, Naylor AR, London NJ. Role of superfi cial venous
surgery in the treatment of venous ulceration. Br J Surg. 1999;86:755–759.
18. Zamboni P, Cisno C, Marchetti F, et al. Minimally invasive surgical management of
primary venous ulcers vs. compression treatment: A randomised clinical trial. Eur J
Vasc Endovasc Surg. 2003;25:313–318.
19. Guest M, Smith JJ, Tripuraneni G, et al. Randomized clinical trial of varicose vein
surgery with compression versus compression alone for the treatment of venous ulcer-
ation. Phlebology. 2003;18,130–136.
20. Franks P, Oldroyd M, Dickson D, Sharp E, Moffatt C. Risk factors for leg ulcer
recurrence: A randomised trial of two types of compression stocking. Age Ageing.
1995;240:440– 494.
21. Gohel MS, Barwell JR, Earnshaw JJ, et al. Randomized clinical trial of compression
plus surgery versus compression alone in chronic venous ulceration (ESCHAR study)—
Haemodynamic and anatomical changes. Br J Surg. 2005;92:291–297.
22. Walsh JC, Bergan JJ, Beeman S, Comer TP. Femoral vein refl ux abolished by greater
saphenous vein stripping. Ann Va sc Surg. 1994;8:566–570.
23. Kulkarni SA, Gohel MS, Poskitt KR, Whyman MR. Ulcerated Leg Severity Assessment
(ULSA): A new scoring tool to predict healing in venous leg ulceration. Br J Surg.
2007;94:189–193.
24. Gohel MS, Barwell JR, Wakely C, et al. Haemodynamic assessment is predictive of
healing and recurrence in chronic venous leg ulceration. Phlebology. 2004;19:157–158.
25. Davies AH, Hawdon AJ, Greenhalgh RM, Thompson S. Failure of a trial evaluating
the effect of surgery on healing and recurrence rates in venous ulcers? The USABLE
trial: Rationale, design and methodology, and reasons for failure. Phlebology.
2004;19:137–142.
26. Pascarella L, Bergan JJ, Mekenas LV. Severe chronic venous insuffi ciency treated by
foamed sclerosant. Ann Va sc Surg. 2006;20:83–91.
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