Ambulatory
Conservative Hemodynamic Management of Varicose Veins: Critical Analysis
of Results at 3 Years
Massimo Cappelli, MD, Raffaello Molino Lova, MD, Stefano Ermini, MD,
Adolfo Turchi, MD, Giuseppe Bono, MD, Amine Bahnini, MD, and Claude
Franceschi, MD, Florence, Italy, and Paris, France
This report describes the results of our 3-year experience using
ambulatory conservative hemodynamic management (ACHM) for lower extremity
venous insufficiency involving the greater saphenous vein (GSV), with
specific analysis of recurrence due to neoformation of vessels. We
performed 289 ACHM procedures in 259 consecutive patients with GSV-related
varicose veins. Follow-up clinical examination and Doppler ultrasound
imaging was carried out at 3, 6, 12, 24, and 36 months in all cases to
assess formation of neovessels supplied either by the superficial (A) or
deep (B) venous system. Our data showed that ACHM achieved excellent
improvement, with complete disappearance of varicose veins in 41.2% of
cases, good improvement in 43%, fair improvement in 14.1%, and no
improvement in 1.7%. The only predictor of outcome was the quality of
drainage from the GSV vein. Poor drainage leads to neoformation of vessels
supplied by the superficial (A) venous system. In about 50% of cases,
drainage appeared spontaneously within 1 year, with a subsequent reduction
in formation of neovessels. Neoformation of vessels supplied by the deep
(B) venous system (10%) was independent of the quality drainage. This
finding suggests that formation of these neovesseis is unrelated to the
surgical method used to treat varicose veins. In patients with poor
drainage of the saphenous network, neoformation of vessels supplied by the
superficial (A) venous system is predictable with regard to both
topography and delay. ACHM is a good tool for treatment of varicose veins,
as reliable statistical prediction of mid-term results is possible using
available models. DOI: 10.1007/s100169910064
INTRODUCTION
For many years, saphenous vein stripping was considered to be the
method of choice for treatment of varicose veins of the lower
extremities.1-4 In 1988, Francheschi 5 described a new method called
ambulatory conservative hemodynamic management (ACHM), which consists of
minimally invasive surgical procedures under local anesthesia that are
based on the findings of careful hemodynamic analysis of the venous
network of the lower limb using pulsed Doppler ultrasound. We have
performed over 600 ACHM procedures. In the present study, we describe the
outcome of 289 of these procedures in 259 consecutive patients. Outcome is
based on assessment of neoformation of vessels by clinical examination and
Doppler ultrasonography.
PATIENTS AND METHODS Principles of ACHM
The goal of ACHM for superficial venous insufficiency (SVI) is to
relieve the hydrostatic pressure
|
Fig. 1. Drawing representing the
four venous networks of the lower extremities. R1, deep venous
network, including veins located beneath the fascia. R2, superficial
venous network, including veins located between superficial fascia
layers (saphenous veins, Giacomini vein). R3, saphenous vein
collaterals located above the superficial fascia with no connection
to any vessel in the R2 network. R4, saphenous vein collaterals
located above the superficial fascia with connection to a vessel in
the R2 network, either at the origin (longitudinal R4L) or otherwise
(transverse R4T). | column by deleting
venovenous shunts without removal of the saphenous vein or disruption of
drainage of superficial tissue. Hemodynamic studies of patients with SVI
have demosntrated four main shunt patterns, depending on communication
between four venous networks: R1 (deep vein), R2 (subfascial saphenous
veins and Giacomini vein), R3 (branches of the suprafascial saphenous
veins), and R4 (saphenous branches between saphenous veins) (Fig. 1). As a
result of muscle contraction, many incompetent saphenous veins empty in
anterograde fashion via the saphenofemoral junction. When muscles relax,
these saphenous veins refill by reflux via the saphenofemoral junction and
empty in a retrograde fashion into one or more distal perforators, which
act as reentry points. These reentry points can be located on the
saphenous vein (P/PR2) or its collaterals (P/PR3). Both anterograde and
retrograde flow drain into the deep venous network. Thus flow can be
stopped by suppressing the drainage route. Since the saphenofemoral
junction usually constitutes the point of reentry of anterograde flow,
crossectomy leads to disappearance of anterograde flow but does not affect
retrograde flow. Conversely, since the distal perforating veins constitute
the point of reentry for retrograde flow, their disruption leads to
disappearance of retrograde flow without affecting anterograde flow. In
both cases, flow continues in the saphenous vein during either muscle
relaxation or contraction, thus ensuring drainage into the deep venous
system. By preventing reentry of either anterograde or retrograde flow, we
obtain a draining saphenous system, i.e., a system able to empty in either
the retrograde or anterograde direction, respectively. Conversely, if both
anterograde and retrograde flow are prevented, we obtain a non-draining
saphenous system in which no emptying occurs at velocities detectable by
Doppler ultrasound.
|
Fig. 2. Different venovenous
shunts that may be ob-served during Doppler ultrasound examination
as defined by Franceschi. 5 Type I, reflux from the saphenous vein
with reentry through a perforating vein located on the saphenous
vein (P/R2). Type II, reflux from a saphenous vein collateral (R3)
with a competent saphenous vein. Type III, reflux from the saphenous
vein with reentering perforating vein from the collateral vein
(P/R3). There can be several types, depending mainly on the length
of the refluxing saphenous segment. The shared feature is the
disappearance of saphenous reflux during diastole when the origin of
the collateral giving rise to the reentry vein is compressed. Type
IV, any type of shunt other than those described above.
|
|
Fig. 3. Example illustrating the
principles of ACHM for type I venovenous shunts. The internal and
external saphenous veins show reflux through junctions A and D,
respectively, and through perforating vein B with reentry points
through distal perforating veins (terminals) C and E. Crossectomy of
junction A eliminates saphenofemoral reflux and relieves the
hydrostatic pressure column. Termination may (as here) or may not be
associated with division/ligation of the saphenous vein below the
refluxing perforating vein which thus becomes the new reentry vein.
This type of termination should be used only if the perforating vein
can accommodate sufficient flow for efficient drainage. Crossectomy
of junction D (preferentially below the origin of the Giacomini
vein) has the same effect. |
Thus saphenous vein hemodynamics can be manipulated by performing one
or more surgical procedures to adjust reentry of anterograde flow, which
is usually also the point of reflux and/or reentry of retrograde flow,
depending on the type of venovenous shunt 6 (Fig. 2). A variety of
procedures are possible and together constitute the basis for ACHM of
varicose veins (Figs. 3 and 4). The characteristic feature of ACHM is to
be not only conservative but also hemodynamic.
|
Fig. 4. Examples illustrating the
principles of ACHM for type III venovenous shunts and analysis of
recurrences due to formation of type A or type B neovessels,
depending on whether a draining saphenous system was achieved. a
Type III shunt, b Stage I of ACHM-2 preventing reflux at point B and
preserving drainage through junction A. c Progression to a type III
shunt after development of the reentering perforating vein D. d
Stage II of ACHM-2 with crossectomy of junction B. e Development of
neovessels supplied by the deep network (type B) is not correlated
with the procedure itself. Development of type B neovessels is
probably related to either the presence of a undetected perforating
vein or unexplained development of a secondary opening. f ACHM-1+2
with division/ligation at point B and crossectomy of junction A.
This procedure cannot be considered a true ACHM procedure since it
results in a nondraining saphenous system with stasis between A and
B. However, this non-draining ACHM can be transformed into a
draining ACHM (d) secondarily by development of a perforating vein
under the effect of residual pressure. g If this transformation does
not occur, residual pressure in the nondraining segment will lead to
development of a type A neovessel bridging the division ligation at
point B, causing recurrence without reflux from the deep venous
system. h Isolated crossectomy of junction A achieves a draining
system without deep reflux. This system meets the hemodynamic
requirements of management but leaves a superficial type II shunt
that may cause a small but uncosmetic R3 network.
| Assuming that any treatment for varicose
veins must eliminate venovenous shunting, preservation of the saphenous
vein becomes a necessary but insufficient criterion for ACHM. Two other
criteria are required to qualify as an ACHM procedure. The first is that
the preserved saphenous system must empty in one direction at a sufficient
velocity to allow drainage of cutaneous and subcutaneous circulation into
the deep vein network. The emptying direction depends on the therapeutic
procedure used and emptying velocity depends on the choice of reentry
points. The second requirement for qualification as an ACHM procedure is
reduction in filling pressure. This depends on both prevention of reflux
and proper adjustment of emptying velocity. It would be illogical to
define ACHM as a procedure resulting in a nondraining saphenous system in
which anterograde flow has been stopped but no retrograde flow is
detectable. Absence of retrograde saphenous flow is not related to
reestablishment of valve competence due to reduction in the
diameter of the saphenous vein lumen, as reported by several authors,7 but
rather to inadequate reentry flow due to poor preoperative evaluation;
retrograde flow was always observed in draining saphenous systems despite
the same reduction in GSV diameter as in nondraining systems. In our
experience, we were not always able to obtain draining saphenous systems
for two reasons. The first was poor hemodynamic significance of the
perforating veins used for reentry. The second in-volves special
anatomophysiological features of the varicose venous system, which will be
discussed below. The purpose of this study was to determine if the course
of varicose disease was influenced more favorably by a draining saphenous
system than a nondraining saphenous system.
Patients
All patients with incompetence of the greater sa-phenous vein (GSV)
were considered candidates for ACHM. From January 1990 to July 1994, we
per-formed 289 ACHM procedures on 259 consecutive patients, including 60
men and 199 women, pre-senting varices in the region of the GSV. Mean age
was 49.1 ± 12.4 years (range, 20 to 79 years). Pulsed Doppler ultrasound
was performed in all cases for careful preoperative evaluation of the
whole venous network of the lower extremities. Unilateral
or bilateral incompetance of the GSV was documented in all cases.
Preoperative diameter of the GSV, which was measured in 254 cases at a
distance of 15 cm below the junction with femoral veins, varied from 4 to
13 mm (mean, 6.8 ± 1.8 mm). Thirty patients presented with primary deep
valve insufficiency (DVI) and four presented with post-thrombotic
secondary DVI. Thirty-eight patients were obese. In 26 lower extremities,
ACHM was associated with phlebectomy of saphenous branches.
Methods
In all cases veins in the lower extremity were carefully marked during
preoperative Doppler ultra-sound examination to identify the shunt pattern
5 (Fig. 2) and to determine vessels to ligate or remove. Surgery was
performed under local anestheisa and lasted approximately 1 hr in all
cases. Patients were allowed to walk immediately and to leave the
institution about 30 min after the procedure. All patients were asked to
return for clinical examination and Doppler ultrasound at 3, 6, and 12
months and then every year after the procedure. A minimum follow-up period
of 36 months was re-quired for inclusion in this study. For analysis of
outcome, patients were divided into two groups, depending on whether the
resulting saphenous system was draining or nondraining. The draining ACHM
group (D.ACHM) included cases in which good anterograde or retrograde flow
was observed throughout follow-up. The nondraining ACHM group (ND.ACHM)
included cases in which anterograde or retrograde flow was unde-tectable
at any one time during follow-up. Within the second group, we also
analyzed the difference in outcome in cases in which a P/R2 perforating
vein eventually developed so that the nondraining saphenous system was
spontaneously transformed into a draining saphenous
system. Neoformation of vessels appeared to be a good criterion for
evaluating the outcome of ACHM, as we took into account not only
clinically visible new vessels but also new vessels detectable by Doppler
ultrasound. Careful mapping by Doppler ultrasound at each scheduled
follow-up allowed monitoring of neoformation. Neovessels were classified
into the following two categories:
- 1. Type A neovessels: varices without reflux from the deep venous
system characterized by a nega-tive response to the Valsalva maneuver,
i.e., neovessels bridging the R2-R2 or R3-R3 ligature or the R2-R3 or
R2-R4 compartment (Fig. 2).
- 2. Type B neovessels: varices with reflux from the deep venous
system characterized by a positive response to the Valsalva maneuver,
i.e., neoves-sels bridging the R1-R2 or R1-R3 compartments. Improvement
at 3 years was graded as excellent if varices disappeared completely,
good if residual or new varices were minimal, fair if residual or new
varices persisted but the situation was better than before, and poor if
there was no improvement or the varicose network reappeared during
follow-up. Any patient who underwent further surgical treatment or
sclerotherapy at any time during follow-up was classified in the poor or
fair result group. Statistical analysis was performed using the
Student’s t-test for independent parametric values and the Pearson and
McNemar test for nonparametric values. When necessary, the Bonferroni
difference theory was applied as described by Glantz.8
RESULTS Overall Results
No death or major complication was observed in this series. Partial
thrombosis of the GSV occurred in 72 cases (24.9%). It spontaneously
recanalized in 68 cases, at a mean follow-up of 5 months. Secondary
surgical treatment or sclerotherapy of collateral saphenous veins was
performed for cosmetic reasons in 27 cases. Almost all these cases
involved collateral veins in the thigh with low reentry points, and hence
partially visible after the procedure. All secondary procedures were
performed using the same technique after marking by means of Doppler
ultrasound. Excellent improvement was obtained in 119 cases (41.2%); no
visible varice was observed at any time during follow-up. Good improvement
was obtained in 124 cases (43%), with residual varices and neoformation of
vessels being minimal. Fair improvement was obtained in 41 cases (14.1%);
the situation was better compared to the preoperative status but residual
varices and/or neovessels were observed. Poor improvement was obtained in
five cases (1.7%) in which the situation did not change or
worsened. Recurrences involved type A neovessels that were clinically
visible in 42 cases (14.5%) and detectable by Doppler ultrasound in 72
cases (24.9%), and type B neovessles that were clinically visible in 21
cases (7.2%) and detectable by Doppler ultrasound in 30 cases (10.3%).
Table I. Comparison of patients in the
D.ACHM AND ND.ACHM groups |
|
D.ACHM |
ND.ACHM |
p |
Procedures (n) |
198 |
91 |
|
Gender |
145 F |
65 F |
NS |
Mean age (years) |
48.4 ± 11.7 |
50.8 ± 13.6 |
NS |
Size of varices |
0 |
2 |
0 |
< 0.001 |
1 |
66 |
17 |
2 |
108 |
48 |
3 |
22 |
26 |
Saphenous vein diameter |
Patients (n) |
177 |
77 |
NS |
Mean diameter |
6.7 ± 1.7 |
7.1 ± 2 |
|
Obese patients |
25 |
13 |
NS |
PDVI |
19 |
11 |
NS |
SDVI |
2 |
2 |
NS |
Phlebectomy |
19 |
2 |
NS |
|
NS, not significant; PDVI, primary deep
vein insufficiency; SDVI, secondary deep vein
insufficiency. |
Table II. Comparison of outcome after
D.ACHM and ND.ACHM groups |
|
D.ACHM (198 procedures) |
ND.ACHM (91 procedures) |
p |
GSV thrombosis |
20 |
52 |
<0.001 |
Improvement |
|
|
<0.001 |
Excellent |
93 |
26 |
|
Good |
89 |
35 |
|
Fair |
13 |
28 |
|
Poor |
3 |
2 |
|
Recurrences |
Type A neovessels |
Clinically visible |
10 |
32 |
<0.001 |
Detectable by
ultrasound |
18 |
54 |
<0.001 |
Type B neovessels |
Clinically visible |
13 |
8 |
NS |
Clinically visible |
13 |
8 |
NS |
|
NS, not
significant. |
Results in the D.ACHM and ND.ACHM Subgroups
The D.ACHM group identified by Doppler ultrasound included 198
procedures and the ND.ACHM group included 91 procedures. These two groups
were comparable with regard to age, gender, incidence of valve
incompetence in the deep venous network, and incidence of obesity (Table
I). Comparison of the mean preoperative diameter of the greater saphenous
vein showed no significant difference between the D.ACHM and ND.ACHM
groups. Nor was there any significant difference between the two groups
with regard to the number of secondary phlebectomies carried out on
collateral sapheous veins (R3) for cosmetic reasons. The incidence of
thrombosis was 10.1% (20 cases) in the D.ACHM group versus 59% (52 cases)
in the ND.ACHM group (p < 0.001). As shown in Table II, there was a
highly significant correlation between saphenous vein drainage and
neoformation of clinically visible or ultrasound-detectable vessels.
Qualitative analysis showed no statistical difference between the D.ACHM
and ND.ACHM groups with regard to formation of clinically visible or
ultrasound-detectable type B neovessels.
Table III. Comparison of size of
varices and diameter of GSV in patients with or without recurrence
in D.ACHM and ND.ACHM groups |
|
|
D.ACHM |
|
|
D.ACHM |
|
|
|
No recurrence |
Recurrence |
|
No recurrence |
Recurrence |
|
|
Procedures |
175 |
23 |
|
33 |
58 |
|
Size of varices |
0 |
2 |
0 |
|
0 |
0 |
|
1 |
60 |
6 |
|
10 |
7 |
|
2 |
95 |
13 |
NS |
14 |
34 |
NS |
3 |
18 |
4 |
|
9 |
17 |
|
GSV diameter |
n |
158 |
19 |
|
31 |
46 |
|
Diameter |
6.6 ± 1.7 |
6.9 ± 19 |
NS |
6.8 ± 1.6 |
7.6 ± 2.1 |
NS |
|
NS, not
significant |
Conversely, there was a significant difference (p <
0.001) between the two groups with regard to formation of clinically
visible or ultrasound-detectable type A neovessels. Within the D.ACHM and
ND.ACHM groups, comparison of patients in whom recurrence was or was not
observed showed no significant difference with regard to the size of
varices or diameter of the GSV (Table III). In 49 cases in the ND.ACHM
group, development of a perforating reentry vein along the distal GSV
(P/PR2) led to saphenous vein drainage spontaneously within a period of 6
to 24 months after the procedure. In 15 of these cases, formation of type
A vessels was observed before develoment of the reentry perforating vein.
In contrast, formation of type A vessels was observed after development of
the reentry perforating vein in only two cases. This difference was
statistically significant (p < 0.005; McNemar test).
DISCUSSION
The findings of this study show that the determinant factor for outcome
of ACHM is the quality of drainage of the saphenous vein system. The
incidence of recurrence due to formation of type B neovessels was the same
in the D.ACHM and ND.ACHM groups. Conversely, the incidence of recurrence
due to formation of type A neovessels was significantly higher in the
ND.ACHM group. This finding demonstrates that outcome depends on the
quality of drainage of the saphenous vein system. This study also showed
that secondary development of a reentering perforating vein can transform
a nondraining system into a draining system, thereby greatly reducing the
likelihood of formation of type A neovessels. To obtain a draining
saphenous system, ACHM strategy must take into account the hemodynamic
pattern of the venous network. The original procedure proposed by
Francheschi 5 for all types of venovenous shunts was, in fact, only one
possible ACHM technique (ACHM-1) (Fig. 3). After identification of the
perforating vein most likely to provide the best reentry point, the
saphenous vein was divided and tied at the saphenofemoral junction to
prevent reflux at the most proximal level. Collateral veins from the
junction to the saphenous vein were left patent so as to insure optimal
retrograde flow (at low pressure and low flow). At the same time, the
vessel giving rise to the reentering perforating vein was interrupted
about 2 cm below the mouth of the perforating vein. In this way, the
reentering perforating veins was “terminalized” and the hydrostatic
pressure column of the superficial venous system was relieved (Fig. 3). In
cases involving nonterminal, refluxing perforating veins,9 terminalization
included elimination of secondary venovenous shunts generated by the
perforating veins. This technique (ACHM-1) achieved good results for
patients with type I shunts (Fig. 3), which account for about 33% of the
total population with varicose veins. Conversely, results were poor in
patients with type 3 shunts, which account for about 60% of the total
population (Fig. 4a). The drawback of ACHM-1 in patients with type III
venovenous shunts was the preesence of secondary shunts gen-erated by
R2-R3 reflux from the collateral that was not disconnected from the
saphenous vein (Fig. 4h). This cause of failure was obvious in patients in
whom this collateral was superficial (R3) and thus visible after the
procedure. This problem led Franceschi and Bailly 6 to develop a
two-stage technique (ACHM-2) for type III shunts. The first
stage was designed to modulate venous hemodynamics by disconnecting the
origin of the collaterals giving rise to the reentering perforating vein
that allowed retrograde reflux (P/R3). The goal of this step was to
transform a refluxing saphenous system into a saphenous system with
anterograde reflux in which the point of reentry was the junction (Fig.
4b). Following the first step, reflux should no longer be detected in the
junction by Doppler ultrasound after compression and release (Fig. 4b).
The second stage was carried out after formation of a functional reentry
vein, thanks to the development of a P/R2 perforating vein. At this time,
the system can be considered a refluxing system similar to that of a type
I shunt (Fig. 4c) that can be treated by crossectomy (Fig.
4d). However, ACHM-2 is not safe in patients presenting with type 3
short saphenous vein insufficiency, i.e., confined to the upper half of
the thigh. In these cases, in fact, ACHM-2 carries the risk of extension
of thrombosis from the upper saphenous vein into the common femoral vein.
To prevent this complication, Franceschi and Bailly 6 proposed use of a
hybrid technique (ACHM-1+2) involving simultaneous ligation of the origin
of the collateral vein giving rise to the reentry perforating vein and the
saphenofemoral junction (Fig. 4f). This procedure results in a saphenous
vein system with practically no drainage presenting a high risk of
thrombosis of the saphenous vein. Subsequently, the vessel can be
recanalized by either formation of P/R2 perforating vein (Fig. 4d) or
neoformation of vessels (Fig. 4g) at the level of the ligation of the
collateral vein giving rise to the reentry perforating vein (ligature
“bridging”). Recanalization by formation of a P/R2 perforating vein leads
to a spontaneously draining saphenous system with a low propensity for
formation of neovessels. Conversely, recanaliation by ligature bridging
creates the need to empty the system and thus leads to formation of type A
neovessles that may connect with the previous net-work or a new P/R3
perforating vein. In any case, since it results in a nondraining system,
ACHM-1+2 is a conservative but nonhemodynamic technique and hence does not
qualify as a true ACHM procedure. The main difference between ACHM and
other conservative treatment techniques is thus clear. In over 50% of
cases, crossectomy in association with interruption or phlebectomy of
collaterals leads to a nondraining saphenous system with a higher
incidence of neoformation of vessels. Conversely, like valvuloplasty of
the saphenofemoral junction, successful crossectomy or isolated ligation
of the saphenous vein at the saphenofemoral junction leads to a draining
saphenous system but only treats the point of reflux in patients with
primary shunts (R1- R2). Secondary shunts (R2-R3 and R2-R4) resulting from
incompetent collaterals or refluxing perforating veins remain patent.2
Stripping of the saphenous vein is a good surgical procedure in terms
of simplicity, rapidity, and safety. It does not require long hemodynamic
evaluation or complicated mapping and the operative technique is well
defined. By definition, however, stripping prevents drainge from the
territory of the GSV. We thus sought to determine if the benefits of ACHM
outweighed the long period of time required for hemodynamic mapping and
the high investment needed for equipment. Previous authors reporting on
the results of stripping only took into account clinically visible
neo-vessels. Examinations for detection of infraclinical neovessels were
not performed. In our series, post-operative follow-up included both
clinical examination and Doppler ultrasound, so we were able to monitor
total neoformation, including both clinically visible and infraclinical
neovessels. In the past three decades, only a few authors 4,10-14 have
described 3-year results of stripping of the saphenous vein. Comparison of
these results with our overall results, i.e., including those from both
the D.ACHM and ND.ACHM groups, indicate that ACHM compares favorably with
stripping. It is likely that this comparison would probably have been even
more conclusive for ACHM if only D.ACHM had been taken into
account.15 These findings demonstrate that hemodynamic study, which is
the basis for ACHM, is an effective method for evaluation of varicose
veins. The validity of current models is confirmed by the fact that
statistical methods can predict certain potential events, e.g., formation
of type A neovessels. The major findings of this study can be summarized
as follows:
- The preoperative diameter of the GSV is not correlated with
formation of neovessels and thus with outcome.
- Secondary procedures carried out on R3 for cosmetic reasons do not
affect the outcome of ACHM.
- The quality of drainage from the treated GSV is the only factor
correlated with outcome of ACHM.
- Formation of type A neovessels in nondraining saphenous systems can
be predicted in terms of topography and delay.
- Formation of type A neovessels transforming a ND.ACHM into a D.ACHM
and leading to a reduction in neoformation can be
predicted by statistical methods.
- Formation of type B neovessels is not correlated with the quality of
drainage of the treated GSV. The incidence of type B neovessels is about
10% regardless of whether the saphenous vein system is draining or
nondraining. Although this type of neoformation probably has a strong
influence on the outcome of any type of surgical treatment, it has not
been described in the literature. The most likely reason for this
oversight is that postoperative Doppler ultrasound has not been widely
used to detect infraclinical neovessels.
- Results of ACHM at 3 years are at least as good as those reported
with the same follow-up for stripping of the saphenous vein.
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