PolytetraOuoroethylene patch saphenoplasty: Is it effective against recurrent varicose veins?

PolytetraOuoroethylene patch saphenoplasty: Is it effective against recurrent varicose veins?

Hosam Roshdy,a MD; Khaled El Alfy,a MD; Tallal Amer,b MD

a) Department of  General & vascular Surgery, Faculty of Medicine, Mansoura

University, Egypt.

b)Department of Radiology, Faculty of Medicine, Mansoura University, Egypt.

Co"espondence:e-mail: hosam.roshdi@yahoo.com

Abstract

Background: Recurrent varicose veins after surgery (REVAS) are a common, complex and costly problem. The possibilities for recurrent varicose veins after correctly ligated SFJ may be due to: dilatation of preexisting venous tributaries from the common femoral vein (CFV) or formation of new  veins  as a result  of angiogenic stimulation termed  neovascularisation. Interposition of a prosthetic implant  covering  the saphenous  stump  has been called ''patch saphenoplasty." The aim of the present study is to evaluate the use of polytetrajluroethylene (PTFE) patch sutured over the saphenofemoraljunction (PTFE saphenoplasty) to reduce the incidence of recurrent varicose veins.

Patients and methods: This study was conducted in General and Vascular Surgery Unit at

Mansoura University hospital between March 2007 and November 2010.Patients were included

ifthey had varicose veins from the CEAP clinical classification: C 2-5; recurrent varicose veins

and isolated  short saphenous  vein varicosity  were excluded.  320 patients  (368 limbs) were eligible for the study; The patients were randomized into two groups; group L flush ligation of the GSV was performed at the SFJ without using any technique to contain possible postoperative neovasculorization; group IL underwent  PTFE saphenoplasty (rectangular piece (2 x 3cm) of PTFE was sutured on the saphenous stump).

Results: Both groups were comparable as regard patients' characteristics.The global incidence of early postoperative complications was higher in-group  II than group I    (9.4% vs. 3.8%) (PO.OOJ). Two months  postoperative clinical  and duplex  examination revealed  no clinical recurrence or neovascularization at the site of SFJ ligation in both groups.One-year  postoperative clinical examination revealed recurrent thigh varicosities in 15/187 limbs in-group I (8 %) and in 8/181 limbs (4.4 %) in-group  II.  By duplex examination neovascularization occurred  in

37/187  (19.7%) limbs in-group I (22  limbs  grade  2 & 15 limbs  grade  3) but  in-group  II

neovascularization occurred  in 19/181(10.5%) limbs (11 limbs  grade 2 & 8 limbs grade).

(P 0.001)

Conclusion: Interposition of PTFE implant at the level of the ligated saphenofemoral stump significally  reduces the  incidences of  clinical recurrence and  neovascularization.

Key  words: Polytetrajluoroethylene, saphenoplasty, varicose veins  after  surgery, neovascularization.

Introduction:

The saphenous venous system is the most commonly affected by varicose. Removal of diseased veins  is still  the standard surgical method. Great saphenous vein (GSV) stripping and ligation of the saphenofemoral junction

(SFJ) has been the most commonly performed operation  for   varicose  veins (VV).l,2

Recurrent varicose veins  after  surgery (REVAS) are a common, complex and costly problem. The incidence lies between 20% and

80% depending  on the definition  of REVAS

and the time to recurrence.3 This extremely wide range of prevalence underscores the need for a better  definition  of this condition. An international consensus meeting held  on REVAS in Paris (July 1998) agreed to adopt a clinical defmition of it,4 i.e. the existence of varicose veins  in a lower  limb  previously operated  on for varicosities, with or without adjuvant  therapies, which  includes true re­ currences, residual veins and new varicose, as a result of disease progression.

REVAS are a great problem for both patients and physicians. Operations for recurrence are more difficult and time consuming; complications  are more common and can be

serious.4

Surgery in the form of saphenofemoral ligation (SFL), great saphenous vein (GSV) stripping and multiple phlebectomies remains the gold standard treatment for primary great saphenous varicose veins.  Unfortunately, recurrence rates remain high, despite attempts to improve outcomes by ensuring that appropriately trained surgeons perform procedures.5

REVAS of the great saphenous vein (GSV) cannot always be attributed to technical inadequacy. Recent  clinical studies have indicated that postoperative neovascularization may occur  and can  be detected on duplex ultrasound scans 6,7 Tiny new venous vessels developing in the granulation  tissue around the saphenofemoraljunction (SFJ) may enlarge and  connect to superficial veins, causing clinically obvious recurrence after  a few years.8,9

Surgical failure at  the  saphenofemoral junction- (SFJ) remains an important  cause of  recurrent varicose  veins.  It is generally agreed that recurrence is minimized by flush ligation of the great saphenous vein (GSV) at its junction  with the femoral  vein, together with ligation of all tributaries of the SFJ and any  tributaries of  the femoral vein  in the region.6

Three potential mechanisms for  re­ connecting the deep and superficial venous systems after a correct  SFJ ligation, with or without GSV  stripping are;  transnodal lymphovenous connections, enlargement of tiny femoral venules, and several variants of

stump-related neovascularity.All of these occur on a background of the wound-healing process, in which angiogenesis is an important component, potentially  giving rise to a more generalized, field-related neovascularity.1o,11

The possibilities for recurrent varicose veins after  correctly ligated SFJ may  be due  to: dilatation of preexisting venous  tributaries from the common femoral vein (CFV);9,12 or formation of new veins because of angiogenic stimulation termed neovascularisation (NV). Many authors favour the neovascularisation4,13.

It seems that apart from correctly performed

preoperative diagnosis and adequate surgery (including flush  saphenous ligation), other measures are  necessary in  order  to  avoid recurrence.These measures should be directed towards prevention or at least limitation of the extent of neovascularisation.14

Multiple surgical techniques were  used aiming to create a physical barrier between the ligated  stump  on the common  femoral  vein (CFV) and the surrounding superficial veins. Over the years, several techniques have been tested with varying results. Closure of the cribriform fascia and covering the saphenous stump with an artificial implant was apparently associated - with good results at clinical follow

up.6,7

Interposition of a prosthetic implant covering the saphenous stump is called "patch saphenoplasty". Various patch materials have been used for this purpose: Mersilene mesh, reinforced silicone sheeting, polytetrafluoroethylene  (PTFE), and Dacron.15,16

The aim of the present study is to evaluate the use of polytetrafluro ethylene (PTFE) patch sutured  over  the  saphenofemoral junction (PTFE saphenoplasty) to reduce the incidence of recurrent varicose veins.

Patients and methods:

This study was conducted  in General and Vascular Surgery Unit at Mansoura University hospital between March 2007 and November

2010

Patients were included if they had varicose veins from the CEAP clinical classification: C2-5.

Recurrent varicose veins,  isolated short

saphenous vein varicosity and active ulceration

(C6) were excluded.

320 patients (368 limbs) were eligible for the study; informed written consent was obtained from all patients.

The patients were thenrandomized into two groups: Group(I), flush ligation of the GSV

was performed at the SFJ without using any technique to contain possible postoperative neovasculorization; group(ll) underwentPTFE saphenoplasty.

Randomization was performed using sealed envelopes and the random number generator

with varying block sizes in SPSS. Envelopes were opened on the day of surgery, patients rather than individual legs were randomized; thereforet those with bilateral varicose veins had the same procedure performed on both legs.

All patients underwent assessment preoperatively with clinical examination and duplex imaging.

A single surgical team performed all operations.

All operation were performed under spinal

anesthesia (safe to the patients and avoid complication of general anesthesia) except 17 patients done under general anesthesia either due to failure of spinal anesthesia or the patients refused spinal anesthesia.

Surgical procedures:

Group(I):After incision in the skin crease

of the groint the GSV was exposed and all tributaries divided between ligatures. When

the termination of the GSV in the common femoral vein bad been identified with ce.rfllinty, the main trunk of the GSV was divided and the SFJ was exposed through the opening in the cribriform fascia, without enlarging it. Tributaries ending - directly into the common femoral vein within 1 em above or below the SFJ were separately ligated Flush ligation of the GSV was performed at the SFJ with Silk

2/0 followed by stripping of the GSV to the level   of   the  knee   and  stab   avulsion phlebectomies of established varicose clusters. The groin incision was closed with redivac

drain without using any technique to contain

possible postoperative neovasculoriza.tion.l7,18

Group(II): The  same  operation  was performed as a part from the procedure in the groin but before closing the groin incision, a rectangular piece (2 x 3cm) of PTFE was

sutured on the saphenous stump. The PTFE implant was tucked under the cribriform fascia, inorder to cover the anterior half of the deep vein in the neighborhood of the saphenous stump. The opening in the cribriform fascia was closed by vicryl 3/0 in separate stitches to maintain the patch inapposition to the deep vein.

Our usual practice when treating patients with bilateral varicose veins is to treat one limb at a time,leaving a periodof three months between the first and the second operation. In this way, we allow complete recovery of the patient and resolution of symptoms and signs following surgical treatment.

(A) Flush ligation at saphenofemoral junction, with ligation of all tributaries

-&iiihl!*iil!ffNtiWf*ii*

(B) Polytetrajlouroethylene patch

(C) FixationofPTFE patch at saphenofemoral ligation on the femoral vein

Follow up:

Follow up period range from 6 to 36 months

(median 21 months) post operation; all patients

underwent postoperative clinical and duplex

examination 2 and 12 months postoperatively

(after 12 months 23 patients (27limbs) were

lost to follow up).

At clinical examination patients were

checked for the presence of recurrent varicose

veins i.e. recurrent varicose veins were defined

as any new visible varicosity on clinical

examination  one  year  post  operatively

(palpable, dilated subcutaneous veins larger than4mm).

Post operative duplex scanning for the presence or absence of neovascularization.

Neovascularisation was defined as the presence of serpentine venous tributaries entering the common femoral vein at the site of the old saphenofemoral junction after calf compression or Valsalva's maneuver.A clinical gradingsystem was used to describe the degree of neovascularisation.19,20

Grade 0: no neovascularisation Gradel:<3  mm  diameter  vessels Grade 2: >3 mm diameter vessels with

visible reflux.

(D) Closureof cribriform fascia over the patch

Statistical analysis:

The statistical analysis of data was done by using excel program and SPSS  program statistical package for social science version

16.

The description of the data was done in the

form of mean(+/-) SD for quantitative data; and Frequency & proportion for Qualitative data.

The analysis of the data was done to test

statistical significant difference between groups. For quantitative data, independent sample t­ test was used to compare between two groups.

Chi square test was used for qualitative

data.

N.B: P is significant if < or  = 0.05  at

confidence interval 95%.

Results:

Three hundreds and twenty patients (368

limbs) were included in the study.Their mean

ages in-groupi and Groupll were (40 ± 18.)

and (39 ± 18.7) years respectively. There is

no significant difference regarding age and sex

between the two groups. Both groups were comparable regarding patients' characteristics Table(l).

Table (1): Patients' characteristics.

There is no significant difference as regard  clinical  classification of the

Table (2): C of CEAP classification.

patients by  CEAP   classification

Table (2).

The global incidence of early postoperative complication was higher in-group IT than group I (9.4% vs. 3.8%) (P0.001) Table(3).

Wound infection occurred in six limbs in­

group IT and in two limbs in-group I allresolved by antibiotics except in one limb that hadPTFE patch in which the patch had to be removed.

Lymphatic problems in the form  of lymphocele & lymphoedema occurred in ten limbs (8 Lymphocele & 2 lymphoedema) in­ group II. However, in-group I lymphatic problems occurred in four limbs (2 lymphocele

Table (3):Complication.

& 2 lymphoedema). Lymphocele disappeared after  evacuation of the lymphatic fluid lymphoedema, which  was transient and resolved during follow up.

Asymptomatic deep venous thrombosis (DVT), at the level of common femoral vein in 2 patients (one in groupI and one in group II) which was discovered by Duplex scan 2 months after the operation on these patients was treated by oral anticoagulants for 6 months and resulted in complete recanalization of the vern.

- Two months  postoperative clinical  and duplex examination revealed no clinical recurrence or neovascularization at the site of SFJ ligation in both groups.

-After one year clinical examination revealed recurrent thigh varicosities in 15 limbs in group  I (8 %) and in 8 limbs  (4.4 %) in

Group 1

group II. And  by  duplex examination neovascularization occurred in 37/187 (19.7%) limbs in group I (22 limbs grade 2 & 15 limbs grade 3) but in group II neovascularization occurred  in 19/181(10.5%) limbs (11 limbs grade 2 & 8 limbs grade).

(P 0.001)

Neovascularization

Oclinical recurrence

Group 2

Figure (2): Total incidence of clinical recurrence and  neovascularization by in both groups one year Postoperatively.

Discussion:

The management of venous disease of the lower extremities was greatly improved with the advent of the hand - held Doppler and was again substantially enhanced by color-coded duplex imaging_lO

The surgical treatment  of varicose veins has changed very little over the last century. Many studies have explored the importance of stripping the GSV with a wide range of reported recurrence rates (7- 65 %).21

The surgical treatment of primary varicose veins associated with GSV reflux  should include flush  SFJ  ligationt  excision of all tributaries entering the terminal portion of the GSVt stripping the thigh portion of the GSV, and stab avulsion phlebotomies of established varicose clusters.ll

Inappropriate use of the term recurrence might partly explain the considerable variation between different studies. VV after a previous operation may  be  residual varicose, true recurrences or progression of the disease - in new vein segments.22

There are - three major sources of recurrence following varicose vein surgery.The first group

of  causes  is  attributable to  inadequate or incomplete initial treatment. These arise either due to a tactical  error resulting  in failure  to identify all incompetent veins or due to failure to  carry  out  technically adequate primary treatment (despite a correct preoperative diagnosis). The second group of causes arises from the progression of venous disease resulting in  development of  varicose in  previously normal veins.  The third cause of recurrence is neovascularisation where varicose arise in the track  of previously stripped or ligated veins.23

Recurrent varicose  veins after ligation of

the SFJ can  be divided in those  caused  by technical inadequacy or those without operative error.24.25 Botht in our study and in the studies of Creton  15 and De Maeseneer17 operative mistakes could be excluded by early postoperative duplex imaging. When the first operation had been performed correctly, there are two potential pathogenic mechanisms for new reflux have been postulated.Dilatation of pre-existing veins or true angiogenesis.Firstlyt dilatation  of pre-existing  veins may occur in venules in a lymph node venous network, or

it may follow  dilatation  of small adventitial vessels in the vasa vasorum of the femoral vein.25 Alternatively, it may be the result of collaterals. Any of these dilated - tributaries may create  a new connection between the femoral vein and any residual superficial veins left  in  the  thigh. The  second pathogenic mechanism neovascularisation-might  be stimulated  by the free endothelium  left after simple saphenofemoral ligation by vascularisation of residual thrombus or by disturbed venous drainage of the ligated branches of the SFJ.9,26

The fact that there are recurrent VV does not mean  that the patient  suffers from any discomfort, i.e. the  recurrent VV may  be without clinical significance; this also makes figures  about  recurrence rates  difficult to interpret. Nevertheless, re-operations for VV are common, and the increased knowledge from  various  duplex-based studies on  the anatomy  of VV and patterns  of recurrences has so far not improved the operative results.27

A significant amount of research has been aimed at decreasing recurrent groin  reflux. Barrier techniques have been used by a number

- of authors. Sheppard was the first to describe the use of an anatomical barrier, in the form of  a reflected flap  of  pectineus  fascia.28

Gibbs used a reflected flap  of pectineus fascia and  showed no difference in re­ recurrence rates  inpatients with  recurrent varicose veins.29

Glass pioneered the use of a synthetic barrier in the form of a synthetic  mesh (Mersilene, Ethicon Ltd). He showed a SFJ recurrence rate of 1% at a mean of 5 years following surgery.6

A number of different synthetic materials have been used including silicone patches and polytetrafluoroethylene (PTFE) patches. De Maeseneer showed lower rates of neovascularisation in  patients who  had  a silicone patch inserted over the ligated SFJ.16,18

Creton between April1992 and June 1994 first used PTFE. Patients with recurrent varicose veins underwent redo saphenofemoralligation followed by insertion of a PTFE patch (1 x 1.5 em), which was glued, to the CFV. Follow up at  a  mean of  4.9 years showed a neovascularisation rate of 4 %.15

In our study, we have used PTFE patches.

The preliminary results ofPTFE patch sapheno­ plasty reported by Earnshaw were  less promising than the results of the present study. In 14 (21 %) of 66 limbs- (51 primary  VV and 15 recurrences)  operated upon with this barrier technique recurrent VV were visible after one year. On  duplex scan neovascularisation at the  SFJ  ligation site accounted for 10 of 14 recurrences. Although PTFE  is an ideal  impervious material, the design of the quite small PTFE patch (1 x 2 em) seemed to be unsatisfying  and therefore the size of the patch was increased to 3 x 2 cm.6,7

A pilot study done by Jones et al, involving patients with  primary and  recurrent veins showed that use of the patch was safe. Those undergoing surgery for recurrence had disappointing results with a recurrence rate of

47% (7 of 15 legs) and neovascularisation rate of 40% (6 of 15legs). A further 80 legs with recurrence veins underwent  patch insertion and the recurrence rates and neovascularisation rates at a median of 19 months following surgery were  23%  and  37%  respectively. Neovascularisation remained the commonest source of recurrence.l9

In our study PTFE patch was tailored to 2 x 3 em in order to cover the anterior  half of the common  femoral  vein. The PTFE patch was tucked underneath  the cribriform  fascia then  covering the  patch by  suturing the cribriform fascia  over  it creating a double barrier, which may be an explanation for our improved results.

In our study, neovascularisation occurred

in (19.7%) in group I and (10.5%) in group II. These results were compared with a previously reported study using silicone patch saphenoplasty and another group without any barrier technique. The  incidence of  neo­ vascularisation at one year follow-up  in the anatomical barrier group (6.7%) was significantly lower than in the group without barrier (14.8  %;  P 0.001) similar to  the incidence reported after patch saphenoplasty (5.2%: P=0.45)  (17,18).

As regard complication  De maesseneer et

al.,16 reported the incidence of complications after silicone patch  saphenoplasty in which wound infection occurred in 2% lymphocele

or lymyhoedema in 3.2%,  asymptomatic venous thromboembolism in 1% & these results were nearly equal to the results in our study and nearly equal to that reported by Winterbom et al.JO

Conclusion:

Interposition of PTFE implant at the level of the ligated saphinofemoral stump significally reduces the incidence  of clinical  recurrence and neovascularization.

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