Hrev_master Veins and Lymphatics 2014; volume 3:717 [Veins and Lymphatics 2014; 3:717] [page 15] The sapheno-femoral junction valvuloplasty in the post-thrombotic syndrome: a proposal with the use of a new device Sante Camilli,1 Daniele Camilli2 1Vascular Surgery, Private Office; 2Vascular Surgery, Policlinico Di Liegro, Roma, Italy Abstract Before developing deep venous thrombosis (DVT), most patients suffering from post- thrombotic syndrome (PTS) have a normal great saphenous vein (GSV). After DVT, the GSV plays a vicarious function, but many patients develop secondary varicose veins (VVs) and the previous positive contribution of the GSV vanishes. In these cases the ablative strategy is generally implemented with positive results in the short-term, but commonly with late varicose recurrences. In two cases the authors preferred a different approach to pre- serve and recover the GSV vicarious function by sapheno-femoral junction (SFJ) valvuloplasty. Out of 43 cases we treated with SFJ stretching valvuloplasty performed with the new OSES device (V-OSES), we proposed this operation to two patients (A and B) suffering from PTS and secondary VVs at an early stage, classified as C3 and C4 (Clinical-Etiology-Anatomy- Pathophysiology classification, CEAP). In the V- OSES operation a gentle stretching force is applied onto the apex of the opposite valve com- misures so that the valve cross-section becomes oval and the cusp’s length excess is retrieved. The operation was performed on the SFJ valve having incompetent, but floating cusps visible on ultrasound (US) scan. This reparative technique was undertaken under local anesthesia and was combined with dis- connection of the incompetent tributaries and/or perforators. The US-duplex scanning showed that the SFJ valves were competent at month 16 (B) and 20 (A) follow-up after sur- gery and the GSV vicarious function was pre- served. The stretching valvuloplasty operation is intended to repair the SFJ valve incompe- tence and preserve the GSV vicarious function. This approach may be useful in primary VVs, but especially in PTS when superficial reflux appears and secondary VVs are at early stage. The SFJ reparative operation may be combined with the conventional GSV conservative strate- gies, including incompetent tributaries abla- tion/disconnection. This approach does not seem to have been already reported in the liter- ature and needs further confirmation. Introduction Since the post-thrombotic syndrome (PTS) is a consequence of a deep venous thrombosis (DVT), we cannot neglect that these patients may be suffering from thrombophilia, but, more often, they may have developed DVT as a result of trauma or surgery. In general they have not the stigmata (genetic, hormonal, etc.) of patients with primary varicose veins (VVs). Before developing a DVT, these patients usually have a normal great saphenous vein (GSV). However it is a fact that most patients suffering from PTS develop secondary VVs. In these cases the ablative strategy is generally implemented with positive results in the short- term, but commonly with late varicose recur- rences, regardless of the type of ablative treat- ment performed. The GSV system acts anatomically and func- tionally in parallel to the deep system and therefore plays a vicarious function in case of deep venous hypertension, which leads to the diversion of blood towards the superficial sys- tem. The vicarious function of the saphenous system plays a positive role in the early phase of PTS, however - sooner or later - the overload accumulating into the saphenous system caus- es a progressive dilatation of the vicarious cir- cuit and leads to valve incompetence with a resulting backward flow. Then secondary VVs appear and decrease the previous GSV vicari- ous function with an overall clinical and hemo- dynamic deterioration. The surgical correction of deep reflux in PTS (by valvuloplasty, transposition, bypass, neo- valve) involves rather complex procedures, mostly with uncertain or poor results, and has therefore been limited to special cases and per- formed in highly specialized surgical centres.1 On the contrary the correction of the superficial reflux in PTS, in secondary VVs, is commonly treated by ablative techniques (stripping, endovenous thermal or chemical ablation, etc.) to ablate or destroy the GSV and its tributaries. Others techniques [stab avulsion, phlebectomy, ablation selective des varices sous anesthesie locale (ASVAL), i.e. selective varicose vein abla- tion under local anesthesia] aim to reduce the VVs reservoir. Others disconnect the sapheno- femoral junction (SFJ) trying to spare the GSV trunk as a backward draining conduit [cure con- servatrice et hémodynamique de l’insuffisance veineuse en ambulatoire (CHIVA), i.e. outpa- tient conservative hemodynamic management of varicose veins], etc. (Figure 1). All ablative conservative techniques show positive clinical results at short-term follow-up, but in the mid- or long-term the varicose veins still tend to relapse in many cases. The authors propose a different approach to PTS, which envisages SFJ stretching valvulo- plasty in combination with incompetent tribu- taries disconnection or ablation to preserve or recover as much- and as long as possible the GSV vicarious function. Materials and Methods In the case of SFJ incompetence with free- floating valve cusps visible on ultrasound (US) scan, the valve may be eligible for repair. The oval-shaped external support (OSES - a med- ical device manufactured by Assut Europe SpA, Rome, Italy) is a new and innovative medical device, especially intended for venous valve repair by a stretching movement (Figure 2). Being purposely oversized (large diameter about 30 percent greater than the native valve diameter), it is placed outside the vein and sutured at the apex of the opposite valve com- missures (Figure 3). Consequently, the OSES device applies an external and gentle stretch- ing force onto the valve’s walls, thus extending the inter-commissural diameter and reducing the cusps excessive length (stretching valvulo- plasty), consequently restoring the valve com- petence in most cases.2,3 Out of 43 cases we treated personally with SFJ external stretching valvuloplasty with the placement of the OSES device (V-OSES) to repair the junctional reflux, two patients had PTS and secondary VVs. A 36-year-old woman (A) had acute DVT of Correspondence: Sante Camilli, via Lombardia 30, 00187 Roma, Italy. Tel. +39.06.482.1244. E-mail: sante.camilli@gmail.com Key words: valvuloplasty, valve repair, post-throm- botic syndrome, varicose veins, valve incompe- tence. Contributions: the main contribution is from Sante Camilli (SC). Conflict of interests: the authors declare poten- tial conflict of interests: SC is the inventor of the stretching valvuloplasty technique and the oval- shaped external support (Assut Europe SpA, Rome, Italy) device. Conference presentation: XVII UIP meeting 2013, Boston (USA). Received for publication: 6 June 2013. Revision received: 26 February 2014. Accepted for publication: 26 February 2014. This work is licensed under a Creative Commons Attribution 3.0 License (by-nc 3.0). ©Copyright S. Camilli and D. Camilli, 2014 Licensee PAGEPress, Italy Veins and Lymphatics 2014; 3:717 doi:10.4081/vl.2014.717 No n- co mm er cia l u se on ly Article [page 16] [Veins and Lymphatics 2014; 3:717] the right limb, two years before, with femoral- popliteal involvement. The treatment with low- molecular-weight heparin, oral anticoagulants and elastic stockings offered an initial clinical improvement, but then she started to develop secondary VVs, heaviness and foot edema, and was classified as CEAP-C3 (Clinical-Etiology- Anatomy-Pathophysiology classification). The ultrasound investigation revealed a femoral- popliteal recanalization with deep reflux, SFJ and saphenous trunk incompetence, medial accessory saphenous competence, and incom- petence of a perforator in the lower part of the thigh. The other patient was a 45-year-old man (B), who had a femoral-iliac DVT on the right side following a trauma in a car accident and limb immobilization. Medical therapy and elas- tic stockings did not prevent the PTS. After 3.5 years, he had skin discoloration, foot edema and secondary infra-genicular VVs classified as CEAP-C4. The ultrasound revealed a satis- factory recanalization of the iliac tract, an almost complete obstruction of the femoral vein, SFJ and saphenous trunk incompetence in the upper third of the leg. In these two cases, the laboratory tests detected no throm- bophilia or hormonal abnormalities; no venous hemodynamic tests [e.g., venous refilling time, ambulatory venous pressure (AVP), air plethysmography (APG)] were performed. The two patients agreed with the proposal of intervening on the SFJ with the V-OSES tech- nique, along with a disconnection of incompe- tent tributaries and perforators in the same session. They also agreed to undergo US-guid- ed foam sclerosis or stab avulsion of residual incompetent tributaries in a later session, if need be. The surgery was performed under local anesthesia and general sedation in an outpatient setting. The patients were dis- charged with an elastic stockings prescription with no additional therapy. The postoperative course was simple and uneventful. Results After one month, the two patients had relieved symptoms, a better quality of life and were satisfied with the procedure. The SFJ was competent at duplex evaluation. Some residual varicose veins were reduced in size and some were treated with foam sclerotherapy as planned. During the follow-up, at month 20 (A) and 16 (B), the clinical improvement was evi- dent, both subjectively and objectively. The SFJ valves proved to be competent at duplex scan- ning, while the GSV trunks were incompetent and draining backward as expected. Instrumental evaluation tests were not per- formed. The patients continued to wear elastic stockings, when needed, and tolerated them bet- ter than before. Figure 1. Algorhythm of surgical therapies that can be applied in post-thrombotic syn- drome (PTS). In advanced-stage PTS, a combination of superficial and deep reflux can be detected along with deep obstruction/recanalization. In this case, the superficial one is commonly treated first. The conventional ablative techniques are useful, but they also eliminate the positive vicarious function previously played by the greater saphenous vein (GSV). A strategy for preserving this vicarious function should consider the sapheno- femoral junction (SFJ) valvuloplasty and the GSV conservative technique at an early stage of superficial reflux. This strategy may be combined with other conservative tech- niques, such as the cure conservatrice et hémodynamique de l’insuffisance veineuse en ambulatoire (CHIVA) and ablation selective des varices sous anesthesie locale (ASVAL). Indeed, it is a proposal … to be confirmed. Figure 2. A picture of the oval-shaped external support (OSES) device. It looks like a vas- cular stent in Nitinol alloy submitted to a treatment for biocompatible and super-elastic performance. It comprises two oval arches (A-B), which are active elements, to treat 2 near valves with different diameters. They are provided with multiple eyelets (c,c’ and d,d’) intended for stitching and securing the device to the vein wall. The multiple eyelets, as well as the different device sizes, are intended to achieve a correct stretching action and compliance. The two oval arches (A-B) are connected by a long element (e) giving stabil- ity and also elastic flexibility in any direction. For easy positioning of the device, it is equipped with handles (f) to be removed after placement. No n- co mm er cia l u se on ly Article [Veins and Lymphatics 2014; 3:717] [page 17] Discussion On the basis of the introductory remarks, the authors proposed and then performed the stretching V-OSES operation on the incompe- tent SFJ in two cases of young adults suffering from PTS and recent secondary VVs with SFJ and truncal reflux. The aim was to preserve the GSV vicarious function by SFJ repair and refluxive tributaries disconnection or ablation, to restore the GSV positive hemodynamic con- tribution. Although we found a limited number of previous reports concerning primary VVs 4,5 in the medical literature, we couldn’t find any about secondary VVs in PTS. In general, the only pre-requisite to perform the V-OSES operation is the presence of free- floating valve cusps that are visible at ultra- sound investigation. The correct eligibility cri- teria for valve repair are important, because a positive outcome can be more easily achieved in the case of young adult patients with valve incompetence at an early stage (Table 1). For this reason a thorough pre-operative US inves- tigation is mandatory for an accurate evalua- tion of mobility, consistency, and also symme- try of the valve cusps. This surgical procedure is generally feasible in all eligible cases, is technically simple, is not time consuming (15-30 min in most cases), can be performed under local anesthesia and, if need be, general sedation. A great deal of attention must be paid to the placement of sutures that secure the stretching device to the apex of the opposite commissures, because this is a crucial step that affects the anatomical, hemodynamic and clinical results. These apices are not always easily identifiable, as a reversed V shaped line on the vein wall, and also due to venous spasm induced by usual and even gentle surgical manip- ulation or to the thickness of the wall. In these cases the surgeon can rely on the images and the measures from the pre-operative duplex scan- ning that need to be accurately transferred on a paper sketch of the SFJ. The learning curve is short for experienced surgeons. The most impor- tant requirement is to have a forward-looking mentality and culture and be willing to achieve new goals and use innovative methods. In comparison with the conventional external valvuloplasty techniques, the V-OSES operation entails a new and unique approach. We gained extensive experience with the conventional external banding/wrapping techniques,6,7 as well as the SFJ plication,8 which are narrowing tech- niques, thus involving the opposite of the stretch- ing technique. However all of these techniques aim to reduce the vessel area with cusp bundling and implicitly unpredictable erratic or uncertain cusp apposition. This drawback can be overcome by performing the correct stretching operation, which does not involve a cross-sectional area reduction and applies a calibrated, elastic and Figure 3. The working concept of the stretching valvuloplasty technique with the oval shaped external support (V-OSES) device. The cross-section of the incompetent valve bulb (A) shows circular shape and slackened cusps/leaflets, causing valve incompetence and reflux. A proper OSES device should be over-sized by about 30% compared with to the native valve diameter. A correct positioning of the device and its fixation by sutures onto the vein walls (a’, a”) acts like a spring performing a gentle action and modifies the valve bulb that acquires an oval shaped cross-section (B). The stretching action onto the inter-commissural diameter retrieves the slackened cusps and restores the valve compe- tence. Figure 4. Chart showing a duplex scanning pattern at 1-24-48-month follow-up, after sapheno-femoral junction stretching valvuloplasty by using the oval shaped external sup- port device. Among a cohort of 38 consecutive cases of primary varicose veins, 18 were checked at 48 months by ultrasound duplex scanning: 14 (78%) showed a repaired incompetence, 3 (17%) had a reduced incompetence and 1 (5%) was a failure. Table 1. Inclusion/exclusion criteria for venous valvuloplasty eligibility, in particular for stretching valvuloplasty by using the oval shaped external support device. More extensive experience is needed on the topic to refine criteria and match the best valvuloplasty results. Inclusion criteria Exclusion criteria Valve pattern (US) Visibility Undetectable Free floating cusps Frozen cusps Symmetrical (substantially) Asymmetrical (markedly) Varicose disease Early stage Late stage Patient age Young-adult Short life expectancy US, ultrasound. No n- co mm er cia l u se on ly Article [page 18] [Veins and Lymphatics 2014; 3:717] gentle stretching action onto the ideal site, i.e. the opposite commissural apices. The Gore- external valve support9 is also an oval-shaped device, but it has a compressive action as well, acting along the anterior-posterior plane. Moreover, depending on its configuration, it could not be used onto the GSV terminal valve and even requires the ligation of the first tribu- tary (the superficial inferior epigastric vein) that is generally competent, while the OSES device is adaptive and can spare it. The OSES device con- sists of a slender thread-like material and has a compliant and adaptive behavior and is therefore better than previous devices that might kink in the sitting or crouching position. As to the band- ing techniques, they have been used by a few groups, mainly in deep venous system, common- ly in small groups of patients.8-12 Among them, one of the Authors obtained deep valve compe- tence in 78 percent of cases at long-term follow- up,10 but inferior results for SFJ valves. Others compared air- or photo-plethysmography (APG/ PPG) instrumental findings after SFJ valvuloplas- ty vs stripping or VNUS ablation (VNUS Medical Techn., Inc., San Jose, CA, USA), showing an hemodynamic improvement in all cases at a 1 month follow-up.11 The same results after SFJ valvuloplasty were found also at a 10 year follow- up.12 The Authors have a cumulative personal experience on 43 patients treated with stretching V-OSES operation for primary VVs and on one with bilateral primary deep venous insufficiency. Among the patients treated for primary VVs, 18 out of 38 have a 4-year follow-up: 14 (78%) show an excellent valve competence, 3 (17%) have a reduced incompetence and 1 was a failure (Figure 4).3 The two patients treated for second- ary VVs in PTS, described in this report, showed SFJ competence at US-duplex evaluation after 20 and 16 months and a SFJ forward drainage as well as a preserved GSV vicarious function. Indeed, in similar cases we commonly adopt a combination of a reparative operation (SFJ valvuloplasty) together with disconnection (like in the CHIVA strategy) or ablation (like in the ASVAL technique) of the incompetent tributar- ies. In our opinion this is a reasonable approach, because in some randomized controlled trials (RCT) and Cochrane reviews, the CHIVA strate- gy showed to have better long-term results than stripping.13-18 Moreover, the stripping or endovas- cular techniques give comparable long-term results.19 Although these reports may be criti- cized for some aspects, more RCTs should be car- ried out and give an opposite result, before they can be declared inconsistent. In conclusion, we can reasonably expect that the combination of SFJ repair and GSV conserva- tive strategy will have a better mid-term outcome than the individual strategies applied separately. However, in order to assess the actual benefits and the overall strategy to be adopted in these cases, we need to rely on a larger clinical experi- ence, deeper instrumental monitoring (e.g., AVP, PPG, APG, etc.) and a longer clinical follow-up. Conclusions In case of venous valve incompetence with free-floating US-visible valve cusps, the SFJ stretching valvuloplasty by OSES device (V- OSES) is technically feasible, simple and safe. It aims to repair the SFJ incompetence and pre- serve the GSV forward flow. In a personal short series of eligible cases in primary VVs, the V- OSES operation has shown clinical and function- al effectiveness and good long-term results in most cases.3 If applied in PTS, at a relatively early stage or when secondary VVs appear, it may restore the vicarious function of the saphenous system. It may be combined with the convention- al conservative strategies for the GSV (e.g. CHIVA and ASVAL, and also sclerotherapy) with a rea- sonable expectation that the combination may have a better mid-term outcome than the use of the ablative or conservative strategy applied sep- arately. This proposal does not seem to have been described in previous reports in the medical liter- ature. Moreover two clinical positive cases have no statistical significance. Therefore it still needs to be validated by a larger clinical experi- ence and instrumental investigation. However, since it is a reconstructive rather than an abla- tive surgery, it does not preclude the patient from any other therapeutic chance, especially in case of PTS. Even in case of failure, any other ablative option can still be implemented. Furthermore if the effectiveness of SFJ valvuloplasty is con- firmed, this intervention can be considered the first-choice option in PTS, when secondary VVs appear. References 1. 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CHIVA method for the treatment of chronic venous insufficiency. Cochrane Database Syst Rev 2012;(2): CD009648. 19. Rasmussen L, Lawaets M, Bioern L, et al. Randomized clinical trial comparing endovenous laser ablation and stripping of the great saphenous vein with clinical and duplex outcome after 5 years. J Vasc Surg 2013;58:421-6. No n- co mm er cia l u se on ly