Varicose vein surgery in lower limbs with preservation of the great saphenous vein

Abstracts

The autologous great saphenous vein is the most effective bypass choice for lower limb revascularization, playing an important role in myocardial revascularization, and can be used in venous system surgeries and extremity traumas. Stripping increases the risk of lymphatic lesions and nerve damage. Therefore, when surgery or other techniques are used to treat primary varicose veins in the lower limbs, preservation of the saphenous vein is a desirable objective whenever the vein remains healthy or with alterations that still allow preservation by correcting the cause. Such corrections can be performed surgically. Among the methods currently used, the ambulatory conservative hemodynamic correction of venous insufficiency has yielded good results. A randomized controlled trial confirming the efficacy of this procedure has been recently published. Another largely used technique is flush ligation of the saphenofemoral junction plus saphenous veins stripping and ligation of its tributaries at the groin, which has yielded conflicting results. Finally, there are techniques that correct saphenofemoral reflux by external valvuloplasty of the saphenofemoral junction. An international multicenter, randomized, controlled trial, testing a new device, is currently in progress with favorable preliminary results. This study aimed to review the techniques employed to preserve the great saphenous vein in varicose vein surgery.

Varicose veins; great saphenous vein; ultrasound; surgery

A veia safena magna autóloga é o melhor substituto arterial nas revascularizações dos membros inferiores, importante na revascularização do miocárdio e pode ser utilizada nas cirurgias do sistema venoso e nos traumas das extremidades. A fleboextração aumenta os riscos de lesões linfáticas e neurológicas. Assim, no tratamento das varizes primárias dos membros inferiores por meio da cirurgia ou de outras técnicas, a preservação da safena é recomendável se ela for normal ou apresentar alterações que ainda permitam sua preservação pela correção da causa desencadeante. Tal correção pode ser feita por técnicas cirúrgicas. Entre elas, a cura hemodinâmica da insuficiência venosa em ambulatório (CHIVA) tem mostrado bons resultados. Recentemente, um ensaio clínico randomizado e controlado foi publicado comprovando sua eficácia. Outra técnica bastante utilizada é a da ligadura rasante da junção safenofemoral + crossectomia + ligadura das tributárias de crossa, com a qual se tem obtido resultados contraditórios. Finalmente, as técnicas que corrigem a insuficiência da safena reparando as valvas ostial e pré-ostial (valvoplastia externa) são mais fisiológicas. Um ensaio clínico internacional multicêntrico, randomizado e controlado, testando um novo dispositivo, está sendo realizado, com resultados iniciais favoráveis. Este estudo pretende fazer uma revisão sobre as técnicas utilizadas na preservação da safena magna.

Varizes; veia safena magna; ultrassom; cirurgia

REVIEW ARTICLE

Varicose vein surgery in lower limbs with preservation of the great saphenous vein

Hamilton Almeida Rollo^I; Mariângela Giannini^II; Winston Bonetti Yoshida^I

^ILivre-docente. Professor adjunto, Disciplina de Cirurgia Vascular, Departamento de Cirurgia e Ortopedia, Faculdade de Medicina, Universidade Estadual Paulista Júlio de Mesquita Filho (UNESP), Campus de Botucatu, Botucatu, SP, Brazil

^IIDoutora. Professora assistente, Disciplina de Cirurgia Vascular, Departamento de Cirurgia e Ortopedia, Faculdade de Medicina, UNESP, Campus de Botucatu, Botucatu, SP, Brazil

Correspondence

ABSTRACT

The autologous great saphenous vein is the most effective bypass choice for lower limb revascularization, playing an important role in myocardial revascularization, and can be used in venous system surgeries and extremity traumas. Stripping increases the risk of lymphatic lesions and nerve damage. Therefore, when surgery or other techniques are used to treat primary varicose veins in the lower limbs, preservation of the saphenous vein is a desirable objective whenever the vein remains healthy or with alterations that still allow preservation by correcting the cause. Such corrections can be performed surgically. Among the methods currently used, the ambulatory conservative hemodynamic correction of venous insufficiency has yielded good results. A randomized controlled trial confirming the efficacy of this procedure has been recently published. Another largely used technique is flush ligation of the saphenofemoral junction + high ligation of the saphenofemoral junction ("crossectomia")+ ligation of tributaries in the groin, which has yielded conflicting results. Finally, techniques that correct saphenous insufficiency by ostial and subostial valve repair (external valvuloplasty) are more physiological approaches. An international multicenter, randomized, controlled trial, testing a new device, is currently in progress with favorable preliminary results. This study aimed to review the techniques employed to preserve the great saphenous vein.

Keywords: Varicose veins, great saphenous vein, ultrasound, surgery.

INTRODUCTION

Over the past 3 decades, surgical treatment of primary varicose veins of the lower limbs has received great attention, concerned with the preservation of the great saphenous vein (GSV) whenever possible, for its use as a bypass choice at some future time. Increased longevity has led to an increased number of elderly persons and, consequently, to an increased occurrence of complications resulting from degenerative diseases such as coronary or extremity arterial atherosclerosis.

GSV is widely recognized as the most effective bypass choice for lower limb infrainguinal revascularization.¹ In myocardial revascularization, after mammary artery, GSV remains as the best choice for cardiac surgery.^2,4 GSV can also be used as a shunt in deep venous system obstructions (Palma-Dale procedure),⁴ as an arterial or venous bypass in extremity vascular traumas with deep arterial or venous injuries in the femoropopliteal and brachial-axillary segment,⁵ and, occasionaly, as a vascular access for hemodialysis.

Another aspect to be considered is that non-stripping of the GSV may reduce lymphatic lesions and saphenous nerve damage, resulting in lower risk of alterations in the lymphatic network and nervous system following varicose vein surgery.⁶ Non-ablation of the GSV may also reduce the occurrence of hematoma.

Taking into consideration the above-mentioned facts, preservation of the GSV has been recommended whenever a surgical intervention is indicated in the treatment of primary varicose veins of the lower limbs. In the clinical practice of varicose vein surgery, preservation of the GSV is a desirable objective whenever the vein remains healthy at clinical examination. With the development of noninvasive diagnostic methods, preoperative evaluation enabled a clear identification of GSV alterations. In Brazil, Luccas et al.,⁷ after observation of the GSV using continuous wave Doppler ultrasound through a technique developed by the authors, indicated successful preservation of the GSV without any procedures in patients with healthy or little altered saphenous vein, only by avulsing varicosities and ligating perforators. The authors obtained good results (87.69%) in the short and medium term (2 to 7-year follow-up period).⁸

Over the last 30 years, several techniques have been proposed aiming at preservation of GSV,^9-15 even when the vein shows some alterations. In general, varicose alterations affecting the GSV are caused by venous reflux at the saphenofemoral junction (SFJ) due to ostial valve failure, extending into the saphenous trunk and often through its superficial collateral veins, which become varicose, keeping the GSV itself little altered.¹⁶

Therefore, techniques for GSV preservation aim to block reflux at the SFJ or repair ostial valve incompetence. In other situations, SFJ valve is competent and saphenous vein alterations are caused by reflux from other sources, such as insufficient perforators ligated to the vein, particularly Hunter's perforator, located in the middle third of the thigh, or saphenous reflux through collateral veins that connect the GSV to the small saphenous vein, due to insufficiency of the saphenopopliteal junction (SPJ).^17-19

The saphenofemoral reflux may also come from pelvic veins or from the abdominal wall through the tributaries in the groin (superficial circumflex iliac, superficial epigastric or superficial external pudendal veins). In most cases, venous flow in these veins drains into the common femoral vein, which occurs due to the presence of GSV subostial valve.²⁰ When ostial valve is competent and subostial valve is not, reverse flow may occur, and if the reflux is important and there is no reentry perforator to the deep venous system, GSV is likely to undergo changes. Stehling et al.²¹ found this alteration in 10% of GSV with some trunk reflux, i.e., reflux at the level of the groin, but due to subostial rather than ostial valve incompetence. Such authors submitted 41 patients with this type of alteration to surgery, performing ligation and ablation of tributaries in the groin to the fullest possible extent, with good results in most patients (92%), in a short-term follow-up (2 to 18 months).

In order to identify the above-mentioned alterations and determine the best repair technique (preserving the GSV), appropriate diagnostic methods are important and necessary to enable the evaluation of patients with varicose veins in the lower limbs and to reveal anatomical and functional abnormalities of the deep venous system (DVS) and superficial venous system. Among the complementary diagnostic methods currently used, mapping with color-flow duplex ultrasound (CDU) scanning is considered the most sensitive examination, in addition to being a noninvasive procedure. This method enables to characterize the normality or not of DVS and sites of reflux from deep to superficial veins (SFJ, SPJ and perforating veins), as well as the anatomical distribution of varicose alterations within the superficial system.^22-29 It also enables to assess GSV diameters and whether the vein is straight or tortuous. Recently, some authors^30,31 have even correlated diameter alterations in GSV found by CDU scanning with reflux volume and severity of clinical status, parameters which are also calculated by CDU or by air plethysmography (APG). Thus, it seems possible to predict the degree of alteration in the GSV and whether the vein can still be preserved or extracted. Therefore, CDU scanning provides an appropriate evaluation of the pathophysiology of varicose disease, confirming whether varicose veins are primary (normal DVS) and whether the degree of alteration still allows the GSV to be preserved.

The main surgical techniques proposed for the treatment of primary varicose veins with preservation of GSV and with results published in the literature are: high ligation of the saphenofemoral junction (SFJ), with no ligation of tributary veins in the groin;^11,32 section of the SFJ ("crossectomia") + ligation of tributaries in the groin;^10,12,33-39 valvuloplasty of ostial and subostial valves of the GSV, with no SFJ ligation;¹³ placement of polytetrafluoroethylene (PTFE) or teflon cuff involving ostial and subostial valves, with no SFJ ligation.^14,15,40

In view of the foregoing, the present study aimed to review the main techniques employed to preserve the great saphenous vein.

REVIEW OF THE LITERATURE

Among the techniques that preserve the GSV with SFJ ligation and no ligation of tributaries in the groin, the so-called ambulatory conservative hemodynamic correction of venous insufficiency (CHIVA) has been often employed, mainly in Europe (France, Italy, and Spain) (Table 1). Such technique was designed by Franceschi,¹¹ in 1988, and consists basically of ligation of the GSV with reflux close to the femoral vein. In order to allow blood to reenter the DVS, one should avoid to perform ligation of tributaries in the groin and of insufficient perforators connecting to the GSV. To fractionate the blood pressure column, other ligations are performed in the GSV trunk with reflux, using staggered tecnhique, immediately distal to the connection of insufficient perforators. In addition, disconnection of the venous shunts linked to the GSV is performed.

In 1990, Mandolesi et al.³² published a multicenter, prospective, nonrandomized study, conducted in Italy, with 430 patients who underwent surgical intervention using the CHIVA procedure, with a mean follow-up of 14 months. Good results were obtained in 85% of cases with occurrence of postoperative GSV thrombophlebitis in 9% of them. In the end of the 1990s, Cappelli et al.,⁴¹ in a nonrandomized study, with a 3-year follow-up period, compared the results of the CHIVA procedure (148 patients) with those of saphenectomy reported by other authors, with the same follow-up period. They verified good results, with no differences from the published case series on patients who underwent saphenectomy. Zamboni et al.,⁴² in a prospective nonrandomized study, analyzed 357 patients submitted to the CHIVA procedure for a mean period of 49 months, the patients being evaluated pre and postoperatively by CDU scanning, photoplethysmography (PPG), and clinical examination. In 94% of cases, GSV was preserved appropriately to be used as a bypass choice and with 11% of recurrence of varicose veins.

Maeso et al.⁴³ published a retrospective nonrandomized study comparing patients submitted to the CHIVA procedure with patients submitted to saphenectomy, with a 3-year follow-up and clinical examination. The authors obtained better results among CHIVA patients, including lower recurrence rates. More recently, Escribano et al.⁴⁴ used the CHIVA technique in two steps: the first step consisting of ligation or disconnection of the origin of the insufficient collateral (venous shunt), which contained the reentry perforator of the GSV. If the GSV reflux was not resolved, the second step would consist of flush ligation of the SFJ. Good results were obtained in 89.6% of cases with GSV diameter reduction in most patients.

The above-mentioned studies using the CHIVA technique are short- or medium-term, nonrandomized, noncontrolled studies. However, Carandina et al.⁴⁵ have recently published a randomized controlled clinical trial comparing the CHIVA procedure with varicose vein surgery followed by saphenectomy. The study included 150 patients, over a 10-year period, with 75 patients being randomly assigned to CHIVA and 75 to saphenectomy. Patients submitted to the CHIVA procedure had lower recurrence rates than those submitted to saphenectomy (p < 0.04). Clinical outcomes were similar in both groups.

In our service at Hospital das Clínicas of Faculdade de Medicina de Botucatu we have employed a modified CHIVA procedure.^46,47 Staggered ligations along the GSV trunk above the perforators are not performed, and varicosities are avulsed by mini-incisions using the crochet hook technique. If there is a connection of varicosities to the GSV, they are ligated close to the vein, thus totally preserving the GSV. Insufficient perforators connected to the GSV are also ligated. The results were obtained from a nonrandomized case series, with patients evaluated preoperatively by clinical examination and CDU, repeated after 1, 3, 6, and 12 months and annually in the follow-up postoperative period. Preliminary results (up to 2 years)⁴⁶ of 20 limbs of 18 patients were good, with 77% of patients showing improvement of clinical symptoms. GSV was preserved to the fullest extent in 18 limbs (90%) and the vein mean diameters decreased significantly (p < 0.05) in relation to preoperative values, but still suitable for future use as arterial conduits. Two limbs exhibited GSV occlusion at the level of the thigh due to thrombophlebitis (10%), yet 50% of the vein could be preserved. In the medium-term assessment (4 to 6 years)⁴⁷ of 19 limbs of 16 patients, 63% still showed clinical improvement and 89% showed a GSV patent and appropriate for grafting to its longest extent. Recurrence of varicosities was more frequent at the level of the leg (47% of limbs) and not related to the GSV, but to insufficient perforators.

The surgical procedure suggesting flush ligation of the SFJ, high ligation and section of the SFJ ("crossectomia"), ligation of all tributaries in the groin and insufficient perforators, followed by avulsion of all varicosities using staggered incisions, has been proposed and used by several authors^10,12,33-39 (Tabela 2).

In 1979, Jakobsen⁹ used a modified version of this technique (associated with sclerotherapy) in a randomized controlled clinical trial investigating 516 patients with primary varicose veins, with GSV insufficiency, who had not undergone any previous treatment. Patients were divided into 3 groups: group 1 underwent saphenectomy, ligation of perforators and avulsion of varicosities by staggered incisions (radical surgery); group 2 underwent high ligation of the SFJ and section of the SFJ ("crossectomia") and ligation of tributaries + sclerotherapy of varicosities; and group 3 underwent sclerotherapy alone. Patients were evaluated in the short and medium term (3 months and 3 years). The group submitted to radical surgery showed better clinical improvement and lower recurrence rates (10.2%), when compared to the preservation group (34.8%).

The first prospective, randomized, double-blind study using this technique was conducted by Munn et al..¹⁰ The authors argued that, since the technique proposed by Rivlin⁵² was being used in the treatment of varicose veins in the 1970s, they intended to compared this technique to that involving saphenectomy. The results were evaluated clinically, by observers who did not belong to the surgical team, with medium-term follow-up (2.5 to 3.5 years). The authors observed 57 patients with bilateral and symmetrical varicose veins, a total of 114 lower limbs, and, of these, 57 were randomly assigned to GSV preservation and 57 to saphenectomy. Recurrence of varicose veins was more frequent in limbs undergoing GSV preservation (59.6%) in relation to those undergoing saphenectomy (36.8%). However, the presence of paresthesia was higher in patients submitted to saphenectomy, so that patients who underwent GSV preservation reported clinical improvement. Although it was a randomized double-blind study, only clinical evaluation was performed in the operated limbs, both in the pre and postoperative period. Therefore, no objective method was used in the evaluation of the GSV, such as CDU, that could determine the severity and extension of saphenous alterations, in order to obtain a criterion to indicate whether the GSV was preserved. The lack of such a criterion might have led to a higher incidence of recurrence in the limbs in which the vein was preserved, since several preserved GSV could show severe alterations, which would not indicate preservation. On the other hand, Large³³ obtained better results with this preservation technique, with only 10.5% of recurrence in a 3-year follow-up. However, this was a retrospective study.

Hammarsten et al.¹² conducted a randomized controlled study, in which patients, after evaluation by ascending and descending phlebography and strain-gauge plethysmography, were operated and submitted to ligation + section of the SFJ and tributaries in the groin. Patients were then randomly assigned to saphenectomy or GSV preservation. In both groups, varicosities were avulsed and all insufficient perforators were ligated. Patients were reevaluated after 4 to 5 years, by clinical examination, strain-gauge plethysmography, and CDU, to verify diameters and patency of the GSV. Most patients improved clinical symptoms, recurrence of varicose veins was similar in both groups, and plethysmography returned to normal values. There was no statistical difference between groups. In the preserved GSV group, 78% of the veins were appropriate to be used for arterial grafting.

McMullin et al.,³⁴ in a prospective, nonrandomized, non-controlled case series (54 lower limbs), used PPG and CDU before and after (6 and 12 months) varicose vein surgery, in which GSV was preserved with the technique of high ligation of the SFJ and section of the SFJ ("crossectomia") and ligation of tributaries. After surgery, CDU revealed that in 2 of the 54 limbs studied, SFJ remained open and with reflux, and in the remaining 52, GSV was not identified in 28 (53.8%) and patent vein was observed in 24 limbs (46.2%). In the 28 limbs in which GSV could not be identified, the authors considered that venous thrombosis or inadvertent surgical removal might have occurred. The 24 veins identified by CDU were patent and showed retrograde reflux. Therefore, this technique enabled to preserve only 50% of GSV, an unsatisfactory rate considering the objective to obtain GSV at proper conditions for future use as an arterial bypass.

Sarin et al.,³⁵ with the aim to compare the technique used by McMullin et al.³⁴ for GSV preservation and the technique performing partial saphenectomy at the level of the thigh to the upper third of the leg, conducted a prospective randomized study in 105 lower limbs of 69 patients with GSV insufficiency induced by reflux of the SFJ, extending to the saphenous trunk. The authors verified the frequency of neurological complications and presence of residual reflux in the preserved GSV at the level of the leg. After random assignment, 49 limbs were submitted to partial saphenectomy and 56 to total GSV preservation. Patients were evaluated clinically, by CDU and PPG, before and after 3 months of surgery. PPG showed improvement after surgery and there was no statistical difference between groups. CDU revealed the presence of retrograde flow in the preserved GSV at the level of the leg, being more frequent in the limbs with total preservation. The authors did not report aspects related to patency or suitability for use as arterial conduits. There was no difference between groups regarding neurological complications; however, follow-up time was short, hindering the observation of recurrences. Thus, the primary interest of this study lies in the objective evaluation performed by CDU and PPG before and after surgery.

Fligelstone et al.,³⁶ as the above-mentioned authors, studied short-term progression in 44 patients, a total of 75 limbs, who underwent the technique described by Hammarsten et al. for GSV preservation. In a noncontrolled case series, patients were evaluated clinically by an independent observer and by CDU. CDU verified extension, diameters and patency of preserved GSV, patients being studied from 6 to 14 months, after surgery. The authors found GSV suitable for use as an artery bypass to the fullest extent in 68% of limbs and in the leg region in 82%. There was no association between presence of retrograde flow in the preserved saphenous vein and clinical worsening. Afterward, Fligelstone et al.⁵⁰ further evaluated 72 limbs of these patients (3 to 5 years) and verified that 65% of GSV were suitable for arterial grafting use. In addition, most patients showed clinical improvement.

Neglen et al.⁴⁸ compared in a prospective nonrandomized study the technique developed by Hammarsten et al.¹² associated with sclerotherapy of varicosities, through a group of patients submitted to radical surgery (saphenectomy) and another group treated with sclerotherapy alone. Patients were followed up for 5 years, being observed clinically and by PPG, but not by CDU. The group submitted to radical surgery had better results both in the clinical evaluation and by PPG.

Rutgers & Kitslaar,⁴⁹ in a prospective randomized study, compared patients with primary varicose veins with GSV insufficiency submitted to radical surgery with patients with the same diagnosis and treated by the technique developed by Hammarsten et al. associated with compressive sclerotherapy of varicosities. Patients were evaluated 3 months postoperatively, and after 1, 2 and 3 years, by clinical evaluation + continuous wave Doppler ultrasound. If during examination any residual or recurrent varicosities were observed, patients underwent sclerotherapy. After the 3-year follow-up period, the group treated with radical surgery had better cosmetic results, but there was no difference between groups regarding patient satisfaction with treatment.

Dwerryhouse et al.³⁸ conducted a randomized study comparing the technique of flush ligation and section of the SFJ + ligation of GSV tributaries associated or not with saphenectomy (Hammarsten et al.¹²), the patients being randomly assigned after ligation of the SFJ. Seventy-eight patients underwent surgical intervention in a total of 110 limbs; of these, 52 were submitted to GSV saphenectomy to the knee, and in 58 the saphenous vein was preserved. Patients were reassessed 5 years after surgery by clinical examination and CDU. Most patients showed clinical improvement (83%) and there was no statistical difference between groups. There was no statistical difference between groups in relation to recurrence of varicose veins (34% in the saphenectomy group and 40% in the preserved GSV group). However, the number of reoperations was higher in the preservation group due to recurrence of insufficiency of the SFJ. Recently, in 2004, 51 patients of that study were reassessed in a long-term follow-up (11 years). Results revealed that there was no difference between groups regarding recurrence of varicose veins.⁵¹

In Brazil, Fonseca et al.³⁷ and more recently Pitta et al. (2002)³⁹ used the technique described by Hammarsten et al.,¹² but Pitta et al.³⁹ modified the technique, since, in addition to ligation of tributaries in the groin, tributaries were also avulsed. As Hammarsten et al.,¹² such authors demonstrated favorable short-term results, but observed in the early evaluation (from 1 to 3 months), occurrence of GSV thrombosis in the thigh segment in 30 to 50% of cases. Although the authors reported late recanalization of these segments (6 to 12 months), there is doubt whether these veins were suitable for future arterial grafting.

Belcaro et al.⁵³ conducted a prospective randomized study of patients with varicose veins in the lower limbs who showed GSV insufficiency by reflux of the SFJ, employing two different techniques of GSV preservation. One group (369 patients) was submitted to the technique of flush ligation and section of the SFJ + ligation of tributaries in the groin, and the other group (377 patients) was submitted to ligation and section of the GSV alone, 3 to 5 cm below the SFJ, with no ligation of tributaries in the groin. Patients were evaluated pre and postoperatively (10 years after surgery), by ambulatory venous pressure (AVP), venous filling time (VFT), and CDU. In addition, in the postoperative period, clinical examination and CDU scanning were performed annually. If patients had residual or recurrent varicose veins, they were submitted to sclerotherapy. At the end of a 10-year follow-up, the groups showed similar results, suggesting that ligation + section of the GSV distal to the SFJ is a good alternative to preserve the GSV, although, theoretically, this procedure does not seem appropriate to correct SFJ reflux, which could enable dilatation of tributaries in the groin.

Finally, there are techniques that preserve the GSV with no need for ligation of the SFJ; however, correcting SFJ valve insufficiency by means of some valvuloplasty technique that enables to normalize venous reflux through the GSV without blockade at the level of the junction. These techniques appear as a more physiological alternative to the repair of SFJ valve insufficiency. It is important to consider whether the SFJ valves can still be repaired. Such confirmation may be obtained through ultrasound scanning. Two techniques have been proposed to repair valve dysfunction: in one of them, we perform external valvuloplasty of the ostial valve in the SFJ through a longitudinal suture or plication to reduce the vein lumen to 60-70%, thus enabling that cusps are closed completely restoring valvular competence. In the other one, external valvuloplasty of the SFJ is performed through the placement of a PTFE or teflon cuff in the valves, in order to reduce the lumen and restore their competence. Table 3 describes the main studies employing these techniques and, subsequently, these studies are analyzed.

Belcaro, in 1993,¹³ published a prospective randomized study, in which 54 patients with GSV insufficiency due to reflux in the SFJ extending into the saphenous trunk were randomly assigned to two groups. The first group was submitted to the plication technique for repair of the SFJ valve and the other group (control group) did not undergo treatment. Patients were examined pre and postoperatively by CDU and AVP + VFT. After 5 years, 43 patients (22 in the treatment group and 21 in the control) were evaluated. All patients in the control group failed to show improvement, whereas in the treatment group, 68.25% of patients who had SFJ reflux corrected, improved the parameters obtained and most of them showed clinical improvement. In this group, in 31.8% of patients, in whom reflux was not repaired, the parameters did not improve and all of them showed unsatisfactory clinical improvement.

Concerning the valvuloplasty technique with cuff, Schanzer & Skladany⁴⁰ compared two nonrandomized case series with GSV insufficiency due to SFJ and trunk reflux, but in the first case series (12 patients, 15 limbs) external valvuloplasty of the SFJ was performed with a small dacron-reinforced silicone cuff. In the second case series, 14 patients (16 limbs) were submitted to flush ligation of the SFJ. In both series, GSV tributaries in the groin were ligated and sectioned, all varicosities were avulsed by staggered incisions, and GSV were preserved. Patients were evaluated before and after surgery, and after 1 and 6 months by CDU and also by clinical evaluation. Afterward, patients were followed up for 1 year by clinical examination alone. During this period, no recurrences were observed and both groups showed clinical improvement. CDU showed total patency of saphenous vein in 87% of limbs in the group treated with external valvuloplasty and of only 12.5% in the group with ligation of the SFJ. Thus, thrombophlebitis occurred in 13% in the valvuloplasty group and 87.5% in the ligation group. Of the 13 patients submitted to valvuloplasty, without thrombophlebitis occurrence, in 1 case valvuloplasty failed and did not repair reflux.

Zamboni et al.¹⁴ studied a series of 35 patients with primary varicose veins who were selected because they presented reflux in the SFJ and ostial and preostial valves with preserved cusps, when verified by CDU. This was a noncontrolled study, in which patients were followed for up to 42 months with a pre and postoperative evaluation by CDU. In 15 patients AVP and VFT were performed by means of photoplethysmography before and after surgery (one week). In most patients, reflux in the SFJ was repaired by external valvuloplasty with PTFE cuff on the ostial and preostial valves. Patients showed clinical improvement, GSV was totally patent in 33 (94.3%); thrombophlebitis occurred in two (5.71%) and in other two patients recurrence of reflux in the SFJ was observed. In the 15 patients examined by AVP and VFT, altered values in the preoperative examination returned to normal after surgery with statistical difference between them. In 1998, Zamboni et al.⁴² published the results of a prospective case series in which the authors performed 64 external valvuloplasties in the SFJ that presented insufficient valves, but with preserved cusps. Of these, 42 were performed by external suture or plicaton technique and 22 with PTFE cuff and mean patient follow-up was 52 months. The authors observed 94% of totally patent saphenous veins and recurrence of varicose veins in 12%.

Incandela et al.⁵⁴ published preliminary and partial results of an international multicenter, prospective, randomized study aiming to test a new device (Gore External Vein Support-EVS) for valvuloplasty of the SFJ. The study is conducted in 10 European centers (20 patients per center) and the main inclusion criterion is insufficiency of the SFJ and GSV + presence of SFJ valve with normal and functioning cusps. Patients with mild or moderate primary varicose veins are randomly assigned to the EVS group or control group (flush ligation of the SFJ, tributaries and with or without saphenectomy). Varicose veins are avulsed by staggered incisions and insufficient perforators are ligated. Patients are evaluated clinically, by CDU and PPG or air plethysmography in the pre- and postoperative period with 1 and 6 months, and annually up to 3 years. The authors published the results from the first 30 patients, 14 from the EVS group and 16 controls. In the EVS group, all saphenous veins were patent, there was no reflux in the SFJ, with clinical improvement and no complications (no thrombophlebitis or device infection). Therefore, preliminary results with EVS are considered efficient and safe.

Lane et al. developed an external valvular stent (Venocuff)¹⁵ for the repair of insufficient ostial and subostial valves of the SFJ, being later improved (Venocuff II).⁵⁵ The authors showed short- and medium-term results of the application of this device in 2002: They verified that in the evaluation, 3 months after implantation, 94% of the SFJs were competent and after 4.8 years 90% remained competent. Patients were studied pre and postoperatively by CDU, photoplethysmography and also clinically, in a prospective, but nonrandomized, study. GSV diameters decreased significantly, patients showed clinical improvement, and recurrence rates were low. More recently, these authors published long-term results of this technique, which remained favorable.⁵⁶

FINAL CONSIDERATIONS

When surgery or other procedures are used to treat primary varicose veins in the lower limbs, such as compressive sclerotherapy, preservation of the GSV is a desirable objective whenever possible, that is, whenever the vein remains healthy or with alterations that still allow preservation by correcting or eliminating the cause of dysfuntion. This correction has been performed through surgical procedures, among which, the so-called CHIVA¹¹ used by some surgeons.^32,41-44,47 This procedure has yielded good short- and medium-term results, and recently a randomized controlled study has confirmed the efficacy of this technique.⁴⁵

Among the techniques that preserve the GSV, correcting the reflux in the SFJ by flush ligation + section of the SFJ ("crossectomia") and ligation of tributaries in the groin, studies (most of them randomized and controlled studies, and other ones with evaluation by objective diagnostic methods) have yielded controversial results.^10,12,33-39 In these studies, GSV preservation is not always achieved to an extent suitable for arterial grafting, or medium- and long-term recurrence rates are not satisfactory. More recently, regarding recurrence, it has been proposed^57,58 that patients be followed up more closely, including adjuvant procedures to control recurrent varicosities, such as outpatient surgical treatment for avulsion of varicosities by staggered mini-incisions or compressive sclerotherapy, but maintaining the GSV preserved.

Techniques that correct insufficiency of the GSV by repairing SFJ valves (external valvuloplasty) seem to be more physiological because they do not block venous drainage through SFJ, which according to some authors ⁵⁵ would stimulate the development of collateral avalvular veins that could trigger recurrence of varicose veins. A multicenter, randomized, controlled clinical trial, testing a device for SFJ valvuloplasties, is currently in progress in Europe ⁵⁴ with favorable preliminary results.

Similar to the treatment of varicose veins in the lower limbs, to which there is no level of evidence, the techniques for correction of GSV insufficiency, aiming at vein preservation, also require further evidence on their efficacy. However, ethical issues should be taken into consideration, that is, if GSV preservation is important for future arterial bypass or grafting, how could a patient be submitted to a random assignment that might result in the loss of a GSV which can still be preserved?

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Publication Dates

• Publication in this collection
  02 Oct 2009
• Date of issue
  June 2009

History

• Accepted
  06 Mar 2009
• Received
  16 May 2008