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Saphenous vein sparing surgery: principles, techniques and results P. ZAMBONI, M. G. MARCELLINO, M. CAPPELLI, C.
V. FEO, V. BRESADOLA, G. VASQUEZ. A. LIBONI
Objective. Evaluation of saphenous vein sparing surgical
procedures alternative to high ligation and distal stab avulsion, in terms
of effectiveness and suit-ability for eventual bypass
surgery. Saphenous vein sparing surgery for varicose vein disease is still
controversial in the literature. Many groups note the increased risk of
varicose vein recurrence if the long saphenous vein is not excised at the
time of initial surgery. On the other hand, some comparative studies show
no significant differences in recurrence rate between stripped and
non-stripped limbs, especially if the preoperative assessment allows
mapping of the insufficient veins. Alternative long saphenous vein sparing
surgical procedures such as the external valve-plasty of the
sapheno-femoral junction (EV-SFJ) and the hemo-dynamic correction of
varices (French acronym is CHIVA), seem to be effective for varicose
treatment and, maintaining a high saphenous vein patency rate more useful
for future grafting as compared to high ligation and distal stab avulsion.
This paper shows a prospective long-term evaluation of these treatments
defining precisely the patients' population by means of CEAP
classification and ultrasonographic criteria: moreover, the rate of long
saphenous vein suitable as an arterial conduit following these new
procedures is evaluated by means of duplex, scanning the preserved vein.
Materials and methods
Four hundred and twency-one cases of primary varicose veins disease
with epical sapheno-femoral reflux have been selected for alternative
saphenous vein sparing surgery at the Vascular Laboratory of our
Institute.
EV-SFJ
Patients' selection and preoperative assessment.-64 patients (15 men,
49 women, 20-70 years old. mean age 41 years old, were selected for EV-SFJ
using the following criteria:
Clinical.-Primary varices, symptoms of venous insufficiency,
absence of prior thrombophlebites or sclerotherapy.
Duplex scanning (Ansaldo AU 530, 7.5-10 MHz probe,
Italy).-Evidence of mobile valve leaflets of uniform length at the
sapheno-femoral junction (SFJ). Sapheno-femoral reflux and competence of
the deep venous system. Long saphenous vein (LSV) diameter at the mid
thigh was measured both preoperatively and 6 months later.
CEAP classification.-52 patients were retrospectively and 12
prospectively classified according to the new CEAP classification
criteria. Regarding the clinical class, C, all the patients were
symptomatic and affected by simple varicose veins without oedema, skin
changes and/or ulcerations. The etiology, E, was always primary. The
anatomical distribution of cases, A, was in the LSV above the knee in 27
cases, above and below the knee in 35. Perforators were found to be
incompetent at the thigh in 34 cases and at the calf in 42. Finally the
pathophysiology of the disease, P, was due to reflux in all cases. The
following algorithm describes the selected patients: C2s, Ep, As2-3 p
17-18. Pr.
Venous function assessment.-32 patients underwent preoperatively
and 6 months postoperatively ambulatory venous pressure (AVP) and light
reflection rheography-refilling time (LRR-RT) measurements.
Operations.-Under local anaesthesia, the saplieno-femoral
junction was exposed and the terminal valve encircled by an external
prosthesis, using the hand-sewn technique previously reported. In 42 cases
the valve-plasly was performed using a PTFEe sleeve (Gore-Tex, USA) 0.4 mm
thick. 1-1.5 cm long to surround an average circumference of 1.7 cm. The
graft was fixed around the vein with a 7/0 PTFEe interrupted suture. In 22
cases the valve- plasly was performed using the Veno-cuff device (Vaso
Inc., USA) surrounding the valve site with a Dacron reinforced silicone
cuff. Intraoperative valve competence tests.-Intraoperative detection
of the restored valve function was made: CHIVA
Patients' selection and preoperative assessment.-Other 357 patients
with primary varicose veins syndrome with typical sapheno-femoral reflux
were treated by hemodynamic correction, using the following selection
criteria:
Clinical.-Primary and symptomatic chronic venous insufficiency
(CVI) of all clinical classes, absence of prior chrombophlebites and/or
surgical and sclerotherapic treatment.
Duplex scanning (Ansaldo AU 530. 7.5-10 MHz probe.
Italy).-Preoperative duplex detected patients with typical sapheno-femoral
reflux. excluding patients affected by varicose veins fed by different
primary reflux points. In addition duplex made it possible to outline on
the skin the points where the superficial veins should be interrupted (see
Preoperative duplex mapping). The LSV diameter at mid thigh was measured
boch preoperatively and 6 months later.
CEAP classification.-188 patients were retrospectively and 169
prospectively classified according to the new CEAP classification
criteria. The clinical class. C, ranged from C2 to C6 (267 with simple
varicose veins (C2), 60 with oedema (C3). 11 wich lipodermatosclerosis
and/or other skin changes (C4). 16 with healed (C5) and 3 with active
ulcer (C6): all the selected patients presented with classic symptoms of
CVI. of different severity. The etiology was, obviously, primary. The
anatomical distribution of cases was in the LSV above the knee in 104
cases, above and below the knee in 253 cases, perforators were found to be
incompetent at the thigh in 134 cases and at the leg in 283.. Finally the
pathophysiology was due to reflux in all cases. The following algorithm
describes the selected patients C2-6. EP. As2-3, p 17-18, Pr.
Venous function assessment.-73 patients underwent preoperacively
and 6 months postoperatively AVT and LRR-RT measurements.
Preoperative duplex mapping.-A preoperative skin map was
obtained by duplex in order to identifv the points where the superficial
veins had to be interrupted. Operations.-All operations were performed under local
anaesthesia. The SFJ was exposed in the usual way, maintaining the
tributaries. The SFJ was clipped or disconnected (flush ligation). The
preserved tributaries allow the superficial and pelvic venous systems to
drain into the LSV, where the blood flow will be reversed toward the
re-entry perforators. In Type I Shunt, we ligated all the incompetent TVs
from their origin on the LSV. If the TV is particurarly dilated cosmetic
avulsion of its proximal tract can be performed, while the PV on the LSV
main trunk allows blood re-entry into the deep veins without
sapheno-femoral reflux overload. Moreover, in Type I Shunt a secondary
reflux from an incompetent PV proximal to the re-entry PV was detected in
31 cases (9% of the operated cases). (Fig. 6). In such a case we
interrupted the LSV just below the origin of the proximal PV. The ligature
transforms a secondary reflux point into a re-entry point, with a Doppler
detectable inward flow and preserves at least two LSV segments (Fig. 6).
In contrast, in Type III Shunt, the original technique proposed by
Franceschi in 1988, the so-called "CHIVA 1", consists of disconnecting
either the SFJ (the proximal reflux point) and all the incompetent TVs
from the LSV (the secondary reflux points), except chat containing the
re-entry PV (Fig. 2). Such a lactic allows us to maintain the LSV patency
and the drainage function, and was attempted in 72 cases (20% of ehe
operated cases); in addition the TV was ligated just below the outlet of
the re-entry PV (Fig. 2). Clinical assessment of the results.-The assessment was performed
by an independent assessor who had not been involved in previous surgical
decision making and operative procedure (MGM) according to the following
criteria previously proposed in the literature:
Objective assessment: Subjective assessment: The four classes, both subjectively and objectively assessed, were
divided in accord with the preoperative hemodynamic pattern (Shunt I or
III) and cesced for significance by the x2 test.
Selection criteria adopted in a sub-group of patients.-After 4
years of mean follow-up we selected other 27 patients for the so called
CHIVA in 2 steps treatment, proposed to avoid treatment failures chat both
the first part of the present study and the literature had shown to
coincide with the hemodynamic patterns of Type III Shunt. In this way a
sub-group of patients affected by superficial incompetence of all stages,
not previously treated, was selected according to the following
ultrasonographic criteria: CEAP classification.-Patients were prospectively classified in
accord with CEAP. The clinical class, C, ranged to C2 to C5 (12 C2, 10 C3.
4 C4, 1 C5) and all the patients were symptomatic. The etiology, E, was
primary. The anatomical distribution of cases, A, was in the LSV above the
knee in 9 cases, above and below the knee in 18 cases; perforators were
always incompetent at the leg. Finally the pachophysiology, P, was due to
reflux in all cases. The following algorithm describes the selected
patients C2-5, Ep, As2-3 p 18. Pr.
Preoperative duplex mapping.-In all the selected patients duplex
examination allowed the identification of the superficial branch of the PC
represented by the LSV from its junction to the origin of the TV on which
the outlet of the re-entry PV is located (Fig. 5).
Operations.-The treatment is performed in two steps. The first
step is represented by the disconnection of the origin of the TV
containing the "reentry" PV from the main trunk of the LSV, thus
transforming the refluent LSV into an LSV with a forward flow during
muscular contraction, but no Doppler-detectable reverse flow during
muscular relaxation (Fig. 5). However, Doppler-detectable reverse flow
could be demonstrated under Valsalva manoeuvre. The second step,
represented by the section-ligature of the SFJ, is performed when the LSV
again shows a reverse flow due to the development of a new re-entry PV
situated on the LSV itself (transformation into a Shunt type 1) or on a
new insufficient TV.
Results
Of the 421 selected patients who entered the study 2 of the EV-SFJ and
17 of the CHIVA group did not finish it. We have divided the results
evaluation into three sections.
EV-SFJ
For these 62 patients follow-up lasted 52 months, ranging from 12 to
84. The outcome evaluation consisted of clinical and duplex scanning
examinations for all the patients every 3 months for the First three years
and then every year. 12 patients underwent descending and 4 ascending
venography. Clinical results are summarized in Table 1. In the early
postoperative period we had 2 saphenous thrombophlebites due to a
technical error, requiring emergency short stripping. Both cases had been
operated on with the hand sewn technique above described and were lost for
further follow-up. All patients were discharged at the day of surgery.
Total varices recurrence race was 12% (7/60). Ultrasonographic follow-up
showed the long saphenous vein completely preserved in 58 cases (94%).
Mean preoperative diameter at middle thigh was 5.6 mm versus 4 mm recorded
after surgery.
Venous function assessment.-AVP and LRR/RT measurements were
performed in 32 cases preoperatively and 6 months postoperatively. AVP and
LRR/RT modifications after surgery evaluated both by Student's "t" and
Wilcoxon tests, demonstrated a highly significant variation (p<0.001)).
(Table II).
CHIVA 1
In this patients' group the mean follow-up lasted 49 months, ranging
from 72 to 12. Clinical and duplex evaluations were made every 6 months
for the first 3 years and then every year. Operations were well tolerated
under local anesthesia. Postoperative analgesic administration was not
necessary. Patients resumed working activity within 3-7 days after
surgery.
Ultrasonographic findings and clinical correlation.-Results are
summarized in Table III, dividing the cases into four sub-groups, Type I
Shunt (186 cases. Fig. 1), Type III Shunt operated on maintaining the
reverse flow from the LSV to a long and superficial TV containing the
re-entry PV(27 cases, Type III Shunt with re-entry in Table III, Fig. 2);
Shunt III operated on without preserving the LSV drainage function (92
cases, Type III Shunt without re-encry in Table III, Fig. 3) and finally,
Type III Shunt with a short or deep TV containing the reentry PV (35
cases, Type III Shunt short or deep in Table III, Fig. 4). Overall
saphenous vein patency recorded was 94%, with a mean diameter measured at
mid thigh of 4.6 mm as compared to 6.2 mm recorded preoperatively. When
patency was demonstrated the saphenous flow was reversed and with low
velocity. Two patent segments of LSV were demonstrated in 29 cases of the
31 LSV interrupted (94%), whereas in 2 cases we ligated the main trunk
above the re-entry perforator causing a symptomatic LSV thrombosis for
technical error. Total recurrences/residual varicose veins registered were
11%, 8% for Shunt I and 16 % for Shunt III, respectively. Symptoms
improved in 97% of cases, no-ulcer recurrences were observed in the
outcome of the 19 patients in pre-operative clinical class 5 or 6.
Subjective and objective assessment of the results.- These
results are also summarized in Table III. Better results obtained with
this technique in patients with Type I Shunt as compared to those
objectively and subjectively assessed in Type III Shunt are statistically
significant (x2=22.144, p<0.0001). However, overall evaluation of the
technique demonstrated 84% of patients in class A, 11% in class B, 4% in
class C and 1% in D (x2 p<0.0001),
Hemodynamic results.-AVP and LRR/RT postoperative evaluations
were done 6 months after surgery. The difference between pre and
postoperative measurements was statistically significant using both
Student's "t" and Wilcoxon's tests (p<0.001), (Table 1).
CHIVA in two steps/or Type III Shunt
The last group of 27 patients with Type III Shunt was operated on using
the two steps CHIVA strategy (Figs. 5, 7). Although the SFJ is not treated
in the first operation LSV reflux and symptomatology disappeared
immediately after. When a new re-entry point-was developed LSV reflux was
newly detected and symptoms worsened. This occurred in 33% of cases after
3 months, in 70% after 6 but in 15°/o of cases after 12/18 months
follow-up neither reflux nor re-entry was detected. The new re-entry
perforator was detected in the LSV main trunk in 37% of cases (Type III
Shunt transformed in Type 1 Shunt) and in 48% newly in a TV, but deep,
short or still not varicose and visible (Shunt type III transformed in
Type III Shunt short and/or deep). The follow-up lasted on average 18
months, ranging from 14 to 24. Clinical and ultrasonographic evaluations
were made every 3 months. Discussion
Long saphenous vein sparing surgical procedures have two main
end-points: to perform an ambulatory and effective varicose veins
treatment and to save the long saphenous vein for an eventual future
grafting. This paper also introduces the concept of differentiating the
surgical treatment on the basis of the ultrasonographic features of
patients with varicose veins. We will discuss these three concepts in
regard to the two operations evaluated.
EV-SFJ
Edwards and other authors showed that in early varicose stages valve
incompetence is due to a parietal dilatation with normal valve leaflets.
Hallberg and other authors showed the effectiveness of the external valve
repair both in the deep and in the superficial venous system when this
early pathologic condition has been identified. Current duplex scanning
images can demonstrate the presence of mobile valve flaps at the
sapheno-femoral junction. This examination is crucial in order to plan
external surgical repair. CHIVA
We consider the application of CHIVA in patients with the outlet of the
re-entry perforator on the LSV (Shunt I) to he successful in our long term
follow-up (Table III): 92% of disappearance of varicose veins, 99% of
saphenous vein patency and when the functional and cosmetic results were
subjectively and objectively assessed, we registered excellent and good
results (Class A and B of the scale) in 98% and 94% of the cases,
respectively. This finding is not surprising and previous clinical reports
of CHIVA technique showed satisfactory results for Type I Shunt but
disappointing cosmetic results for persistent or recurrent varicose veins
in the Type III Shunt, the Achille's heel of the CHIVA theory. Conclusions
Long saphenous vein sparing surgical procedure alternatives to high
ligation and distal stab avulsion seem to be advantageous for future
grafting because a higher rate of long saphenous vein paiencv was found.
All the illustrated techniques suppress reflux while maintaining a
saphenous flow. Following CHIVA I and the second step of CHIVA 2
procedures the LSV drains blood with a reverse flow toward the re-entry
PV, whereas after EV-SFJ and the first step of CHIVA 2 with the
physiological flow through the junction. Further studies are warranted in
order to verify the association between draining and patent LSV and
successful outcome of varicose vein treatment on one hand, and with the
suitability of the vein for arterial reconstruction
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