Keywords
valvuloplasty - varicose veins - vein reflux - venous insufficiency - vessel repair
- vein patch - venous ulcer
Chronic venous insufficiency (CVI) is an extremely common disease in the adult population
and, in particular, in female population.
The underlying pathogenesis of this disease is not clear. There are different hypotheses,
such as the descending, ascending, and microangiopathic theory. Nowadays, none of
these pathogenetic theories, relies on a scientific demonstration. In most cases of
CVI, the presence of reflux on venous vessels with a profound reversal of normal and
physiological vein circulation at the level of the extra fascial vein of the lower
limb is observed.[1]
[2]
The main symptoms of CVI are lower limb heaviness, pain, and skin imperfections. In
the most severe cases, cutaneous ulcers, venous thrombosis, and pulmonary embolism
may occur.
The gold standard of medical therapy are compression and lifestyle improvement in
addition to phlebotonic drugs.[3] Unfortunately, such therapies do not provide any long-lasting healing.
Surgical techniques, used to treat this pathology, can be divided into two main categories:
reconstructive and ablative techniques. The ablative techniques include the following:
(1) the binding and stripping of the GSV, and (2) the ablation either by endovascular
radiofrequency or by laser. Reconstructive techniques consist of hemodynamic reflux
correction (ASVAL-CHIVA) and reconstruction of the physiological continence of venous
valves by valvuloplasty. The latter technique can be performed both at superficial
venous circulation (saphenous vein) level and at deep venous circulation (femoral
vein) level.[4]
[5] The main limitation of the devices, currently in use, is the need of ligation of
collateral veins at the saphenofemoral junction.
The present study shows the preliminary results of valvuloplasty performed by the
use of OSES (oval shaped external support) device.
We found that OSES device allows to restore the physiological valve continence, allowing
a better alignment of the valvular cusps, and to preserve the drainage of collateral
veins at the same time.
Materials and Methods
Study Design
This is a retrospective clinical study, the main endpoints are the improvement of
clinical conditions stated by the individual patient, the change in the CEAP score[6] ([Table 1]), recurrence of varicose veins, and need for redo surgery.
Table 1
Definitions for CEAP clinical grade
|
CEAP clinical grade
|
|
C0
|
No visible or palpable varicose veins
|
|
C1
|
|
Teleangectasia (thread veins/spider veins/broken veins)
|
|
C2
|
C2A
|
Varicose veins without any symptoms (asymptomatic)
|
|
C2B
|
Varicose veins with symptoms
|
|
C3
|
|
Swollen ankle (edema) due to varicose veins or hidden varicose veins (venous reflux)
|
|
C4
|
|
Skin damage due to varicose veins of hidden varicose veins (venous reflux)
|
|
C5
|
|
Healed venous leg ulcer
|
|
C6
|
|
Venous leg ulcer
|
Abbreviation: CEAP, clinical-etiological-anatomical-pathophysiological.
Statistical Analyses
Statistical analyses were performed using InStat and SPSS 20 stat software. Student's
t-test was used to compare the data collected. A p-value < 0.05 was considered as a significant difference.
Enrollment Criteria
In this study we included patients with reflux on the terminal or preterminal valve
documented by ultrasound examination with morphologic study (valves visible, mobile,
and not prolapsed) and with measures of the saphenofemoral junction ([Fig. 1]); all patients underwent a follow-up at 36 months; age: young adult.
Fig. 1 Preoperative morphologic and measure record. CFV, common femoral vein; D1, TV diameter;
D2, PTV diameter; GSV, great saphenous vein; L1, distance from GSV origin and TV;
L2, distance from GSV origin and PTV; PTV, preterminal valve; SEV, superficial eipgastric
vein; TV, terrminal valve.
Exclusion Criteria
We excluded patients without saphenous reflux or without terminal o preterminal valve
(valve's flaps were nonvisible at the ultrasound examination), with segmental reflux
of the GSV or with reflux only on collaterals/tributary branches, and with low life
expectancy.
Patients Data
Between 2012 and 2015, 30 patients underwent external valvuloplasty of the great saphenous
vein for a total of 32 limbs.
CEAP score was used to assess the severity of the pathology before and after the operation.
UltraSoundcolor Flow was used to assess the competence of the valves. All patients
were evaluated by ultrasound examination before the operation to analyze the hemodynamic
asset and to measure the vein diameter to select the device size.
The presence of a reflux more than 0.5 seconds at the level of the valve was considered
pathologic and an indication for surgical intervention.
All patients underwent clinical and ultrasound examination follow-up at every 6 months
for a mean time of 36 months. At the end of the study, all patients filled in a questionnaire
for the clinical outcome evaluation.
Procedural Data
Intervention was performed under local anesthesia in selected cases under pharmacological
sedation. The saphenofemoral junction was isolated together with the affluent collateral
veins. The OSES ([Fig. 2]) device has been positioned around the GSV and sutured with prolene 6.0 at the level
of the valve ([Fig. 3]). Exact position of the valve cusps can be located visually by the operator according
to the preoperative distance from the common femoral vein measured with the ultrasound.
The procedure was completed by flebectomy of the tributary veins according to preoperative
hemodynamic strategy. Patients were discharged with elastic bandage that was removed
after 7 days. The use of an elastic sock (compression class 1) was suggested for at
least 6 months.
Fig. 2 OSES device working principle. Left: Great saphenous vein section before (A) and after (B) the position of the OSES device; a'
[1] and a"
[2]
: prolene stitches. Right: the OSES device: (A) proximal stent; (C) and C1 holes to suture the device at the level of the terminal valve; (B) distal stent; (D) and D1 holes to suture the device at the level of the preterminal valve. e, support
stent; f, strings used to help the positioning of the device and then removed; OSES,
oval-shaped external support.
Fig. 3 OSES device in situ (arrow); GSV, great saphenous vein; OSES, oval-shaped external
support; PTV, preterminal; TV, terrminal valve.
Results
Among 30 patients enrolled, 24 were female (80%) and 6 were male (20%), with a mean
age of 43.5 years (minimum, 28 years and maximum, 65 years). Dyslipidemia, hypertension,
and dysthyroidism were the most common comorbidities.
There were no intraoperative or postoperative complications.
No cases of deep venous thrombosis were observed, and no one complained about any
symptom related to the device implanted (neither rejection syndrome nor pain at the
groin were observed).
At the end of the study (36 months), 26 (81.25%) limbs showed a complete restoration
of the valvular competence with the abolition of the reflux and no visible varices.
Two (6.25%) limbs showed a low reflux (> 0.5 and < 1 seconds) and four (12.5%) showed
the presence of long reflux (> 1 second). In two (6.25%) cases, it was necessary to
remove the device and perform GSV stripping, at 12 and 18 months after the intervention,
respectively, because of the presence of reflux and worsening of symptoms ([Table 2]).
Table 2
Clinical results on 32 limbs' ultrasound evaluation of anatomical modifications
|
Clinical results on 32 limbs
|
Preoperative
|
Follow-up
|
|
n
|
%
|
1 month
|
%
|
1 year
|
%
|
3 year
|
%
|
|
Terminal valve reflux (no varices)
|
0
|
0,00
|
10
|
31.3
|
4
|
12.50
|
4
|
12.50
|
|
Terminal valve reflux (and varices)
|
32
|
100.00
|
0
|
0.0
|
1
|
3.13
|
2
|
6.25
|
|
Preterminal valve reflux
|
0
|
0.00
|
0
|
0.0
|
0
|
0.00
|
0
|
0.00
|
|
Tributaries
|
32
|
100.00
|
4
|
12.5
|
6
|
18.75
|
6
|
18.75
|
|
CEAP C2a
|
0
|
0.00
|
4
|
12.5
|
4
|
12.50
|
4
|
12.50
|
|
CEAP C2s
|
32
|
100.00
|
0
|
0.0
|
1
|
3.13
|
1
|
3.13
|
|
CEAP C4
|
0
|
0.00
|
0
|
0.0
|
0
|
0.00
|
0
|
0.00
|
|
VCSS (mean)
|
6.5
|
|
1.22
|
|
1.96
|
|
1.96
|
|
|
Deep venous thrombosis
|
0
|
0.00
|
0
|
0.0
|
0
|
0.00
|
0
|
0.00
|
|
Superficial venous thrombosis
|
1
|
3.13
|
0
|
0.0
|
0
|
0.00
|
0
|
0.00
|
|
Further surgery
|
0
|
0.00
|
0
|
0.0
|
1
|
3.13
|
2
|
6.25
|
Abbreviations: VCSS, venous clinical severity score; CEAP, Clinical-Etiological-Anatomical-Pathophysiological
score.
The patient-standing GSV mean diameter decreased from 8.32 to 6.80 mm at terminal
valve level and from 7.34 to 5.71mm at the preterminal valve level. A lower difference
was observed when GSV mean diameter was measured with the patient supine (6.85–5.72 mm
at terminal valve level; 5.97–4.69 mm at preterminal valve level). In three cases,
there was no significant change in diameter before and after the operation. In two
cases, no comparison was possible due to the removal of the device ([Table 3]).
Table 3
UltraSound evaluation of anatomical modifications (mean values in mm and SD)
|
Preoperative (mm and SD)
|
Follow-up (mm and SD)
|
Difference (mm)
|
p
|
|
Mean distance from GSV origin and terminal valve (mm)
|
3.95 ± 2.60
|
4.82 ± 1.60
|
0.87
|
0.30
|
|
Mean distance from GSV origin and preterminal valve (mm)
|
19.74 ± 7.10
|
16.66 ± 6.80
|
− 3.08
|
0.30
|
|
Mean terminal valve diameter: patient upright (mm)
|
8.32 ± 3.70
|
6.80 ± 1.70
|
− 1.52
|
0.20
|
|
Mean terminal valve diameter: patient supine (mm)
|
6.85 ± 3.20
|
5.72 ± 1.70
|
− 1.13
|
0.40
|
|
Mean preterminal valve diameter: patient upright (mm)
|
7.34 ± 3.00
|
5.71 ± 2.00
|
− 1.63
|
0.10
|
|
Mean preterminal valve diameter: patient supine (mm)
|
5.97 ± 3.20
|
4.69 ± 1.60
|
1.28
|
0.30
|
Abbreviations: GSV, great saphenous vein; SD, standard deviation.
All patients were classified as CEAP C2s preoperatively. At the end of follow-up,
seven (23.3%) patients had recurrence varices but didn't necessitate a second surgery
(CEAP C2a). The mean venous clinical severity score (VCSS)[6] was 6.52 ± 0.58 preoperatively and 1.9 ± 0.88 at the end of the follow-up.
Discussion
Varicose disease is a frequent cause of ulcerative disease in the lower limbs,[2]
[7] phlebitis, or deep thrombosis and it affects quality of life. The main problem of
the current therapeutic approach is the high number of recurrences following traditional
ablative surgery (stripping or endovascular surgery). Hemodynamic treatment with saphenous
trunk was shown to have a lower percentage of long-term recurrence.[8]
[9]
The reasons of recurrences are not fully understood. Often there is neovascularization
following surgery at the groin level. In other cases, there is evidence of varicose
recurrences at the leg level that show chaotic circulation without a clear hemodynamic
rationale.
Some authors have suggested that one of the causes of this recurrence is due to the
lack of a drainage vessel (the GSV) that, when correctly continent, decreases the
blood volume drained by the deep venous circulation.[10] The absence of this drainage pathway could lead to femoral venous hypertension and
to the need to establish low flow channels able to support the function of the femoral
vein. In many cases, the amount of blood volume exceeds the drainage capacity of the
deep venous system and burdens on the superficial venous circulation. Such blood flow,
without a drainage pathway, would result in venous wall changes and, ultimately, venous
dilation visible as varices.
Following these observations, reconstitution of physiological valve continence would
be a valid therapeutic approach to decrease the rate of varicose recurrence. Preserving
the main superficial drainage vessel (the GSV) shortens, the volume of blood that
is directed to the level of the deep venous circulation. The presence of competent
valves also reduce the weight of the hydrostatic column and produce a drainage effect
on the tributary collateral vessels.
Hemodynamic effects of valve competence restoration are current subject of study,
but clinical results suggest that the presence of auxiliary drainage pathway to the
femoral vein is a protective element and can reduce the risk of varicose recurrences.
The OSES device, unlike other devices or valvuloplasty techniques (plication, trapdoor
internal valvuloplasty,[11] etc.), acts by stretching on the valve cusps and not by generating pressure from
the outside (e.g., “Gore” external valve support[12]). In our opinion, this type of mechanism allows a better efficacy and a better result
in terms of valve competence, as evidenced by the ultrasound control when traction
is performed exactly at the level of the valve joint.
The structure of the device also saves all the drainage vessels at the level of the
femoral artery (epigastric, circonflex, pudenda vein, etc.), helping the femoral vein
drainage. The ultimate goal is to “rebuild” the original, physiological, and sophisticated
design of the saphenofemoral junction, directing the stream in the right way toward
the iliac circulation and, finally, reducing the hemodynamic pressure on the superficial
venous compartment.
Short-term results were good. In 81.25% of cases, terminal valve was continent at
1 year follow-up, the amount of reinterventions was low (6.25%) with a low-recurrence
rate (18.75%). Only in two cases, the GSV stripping was performed that even after
valvuloplasty remains a therapeutic opportunity that may, if necessary, still be performed.
Randomized studies showed that hemodynamic treatment (CHIVA) has better long-term
results than stripping. Stripping and endovascular ablation give comparable results
but the rate of recurrences or reinterventions is still not negligible. According
to these studies, hemodynamic treatment associated with reconstruction of valve continence
may be a valid strategy for achieving the best long-term outcome.
Conclusion
Valvular incompetence is a frequent occurrence in patients with chronic venous insufficiency.
In many studies, it has been highlighted that valvuloplasty is an effective technique
in correcting this situation by reconstructing the normal and physiological valve
function. In the case of young patients with mobile valve cusps, this type of approach
can be a valid alternative to traditional ablation surgery that causes complete subversion
of physiological venous hemodynamics of the lower limb. Reconstruction of normal venous
circulation could reduce or reset the tendency to distance relapse. The OSES device
has been proved to be technically easy to use, restores the valve competence, and
saves the drainage given by the tributaries at the saphenofemoral junction. Midterm
results were positive in terms of reflux elimination and of clinical condition improvement.
The results of varicose relapse reduction are currently being studied and will be
evaluated over time.
