Hrev_master Veins and Lymphatics 2015; volume 4:5141 [Veins and Lymphatics 2015; 4:5141] [page 31] Sclerofoam assisted laser therapy for saphenous refluxes: an innovative tumescence-free technique Francesco Zini,1 Lorenzo Tessari,2 Renato Torre3 1Surgical Department, Casa di Cura Città di Parma, Parma; 2Glauco Bassi Foundation, Trieste; 3Casa di Cura Privata, Piacenza, Italy Abstract Endovenous laser (EL) and radiofrequency devices have continuously increased their appealing in the last decade. Even if mini- invasive, such procedure still requires multiple high volume injections of tumescent anesthe- sia: a medical act that is not totally complica- tions-free. Aim of the present investigation is to evaluate the feasibility of a hybrid technique (so called sclerofoam assisted laser therapy, SFALT) combining foam sclerotherapy (FS) and EL in a tumescence free approach. Fourty primary chronic venous disease patients (8 males, 32 females, C2-4EpAsPr) presenting a sapheno-femoral reflux both at the Valsalva and compression/relaxation maneuver under- went a SFALT procedure. Diameters were measured at mid-thigh in supine. It consists in a EL fiber introduction into the great saphe- nous vein (GSV), shrinking it for a single cm at 200 J/cm. After a shrunk plug is created, keep- ing the fiber stuck in it, 5 cc of foam sclerother- apy [Tessari method, 1% polidocanol (POL) or 1% sodium tetradecyl sulfate (STS)] are injected through the same 6 Fr EL introducer. The consequent spasm allows a following EL mediated shrinkage by means of a significant- ly reduced fluence. Clinical and sonographic follow up were performed at one and three weeks. At 3 weeks follow up all the 40 cases presented a shrunk GSV, without recanaliza- tion signs. Neither major nor minor complica- tions were reported. At the mid-thigh the standing GSV caliber decreased from a pre- operative mean value of 0.6±0.2 cm to a post FS injection 0.3±0.1 cm value (P<0.05), show- ing no statistical difference among STS and POL. SFALT approach is feasible, safe and with potentially interesting outcomes. More investi- gations are needed in order to define the prop- er fluence parameters and the chance of elim- inating the even mild sedation. This technique offers the chance of a possible tumescence free GSV treatment, even in case of major cal- ibers vessels. Introduction Endovenous laser (EL) and radiofrequency (RF) devices have continuously increased their appealing in the last decade, so much to be recommended with a 1B grade in the most recent guidelines.1 Thanks to its ease of use, fast procedural time, safety and effectiveness profiles, endovenous procedures have been progressively substituting in most counties the traditional surgical stripping.2 Even if mini-invasive, such a procedure still requires multiple high volume injections of tumescent anesthesia (TA). TA represents a relatively safe act. Nevertheless it is not only responsible for quite easily observed painful and not aesthetic hematomas along the saphe- nous area, but is also not free from potential complications.3-5 At the same time, foam scle- rotherapy (FS) has proved to represent an extremely valid alternative therapeutic tool, since the diffusion of a powerful, cost-effective and easily reproducible extemporary produc- tion method.6,7 A brand new holmium laser device has been developed and combined with FS in order to avoid TA and being effective even in a large diameter great saphenous vein (GSV), demon- strating preliminary promising outcomes.7 Objectives Aim of the present investigation is to explore the feasibility of a FS assisted-tradi- tional EL use in absence of TA exploiting the spasm effect that is caused by the sclerosing drug. Secondary endpoint is the exploration of new EL energy deliver settings, eventually sig- nificantly reduced thanks to the synergic FS action, thus leading the procedure to a simpli- fied office-based scenario. Materials and Methods Forty chronic venous disease patients with a symptomatic GSV incompetence (8 males; 32 females; C2-4EpAsPr C2(17), C3(20), C4(3); mean age was 51±8 years old; body mass index 22±4) underwent a standing-up pre-operative ultrasound (US) scanning demonstrating the homogeneity in the reflux pattern (sapheno- femoral junction incompetence placing the sample volume at the femoral side of terminal valve detected by both positive Valsalva and compression/relaxation maneuver, single or multiple incompetent saphenous tributaries along the lower limb). A normally developed incompetent saphenous trunk (anatomically found always in between the fascia splitting, according to the so called saphenous eye)8 was present all the way from the sapheno-femoral junction to below the knee. No pelvic varicose veins were reported. Diameters were measured at mid-thigh in supine to evaluate the foam injection-induced spasm. A second scanning was repeated imme- diately before the procedure, GSV diameters were recorded below the superficial epigastric vein and at the middle thigh, in supine. After a mild intra-venous sedation with dosages relat- ed to the short procedural time and limited pain trigger (midazolam 3+1 cc), the proce- dure included a percutaneous GSV access without local anesthesia at the distal third of the thigh or below the knee, depending on the incompetent tributary localization, a 0.0035-in guide-wire insertion, placement of a 6 Fr intro- ducer, insertion of 1470 nm diode laser radial fiber 600 µm up to 1 cm below the superficial epigastric vein confluence. Particular care was used in detecting the anterior accessory saphenous vein confluence with the GSV and its eventual incompetence that potentially could be treated in the same procedural ses- sion. All patients were accurately informed about the procedure, according to internation- al rules. The EL was then activated (6-8W, 30-50 J/cm), shrinking the GSV by a 200 J fluence for the first cm in order to create a shrunk plug, completely obliterating the vessel in that limit- ed segment. Keeping the fiber tip tucked into the shrunk plug, 5 cc of FS 1:4 (drug/air ratio according to the Tessari method, using two 5 mL silicone- free syringes), were then injected directly by the 3-way introducer using 1% polidocanol (POL) (30 cases of whom 5 males, 25 females) or 1% sodium tetradecyl sulfate (STS) (10 cases of whom 3 males and 7 females) (Figure 1). A finger compression below the introducer insertion point guaranteed the FS upward flow. The injected foam was clearly detected echo- graphically getting up to the shrunk plug and then filling up the minor GSV tributaries (Figure 2). Correspondence: Francesco Zini, Surgical Department, Casa di Cura Città di Parma, p.zza A. Maestri 5, 43123 Parma, Italy Tel.: +39.0521.284472. E-mail: fzflebo@tin.it Key words: Tumescense; laser; foam. Received for publication: 7 March 2015. Revision received: 17 April 2015. Accepted for publication: 17 April 2015. This work is licensed under a Creative Commons Attribution 3.0 License (by-nc 3.0). ©Copyright F. Zini et al., 2015 Licensee PAGEPress, Italy Veins and Lymphatics 2015; 4:5141 doi:10.4081/vl.2015.5141 No n c om me rci al us e o nly Article [page 32] [Veins and Lymphatics 2015; 4:5141] A sudden venous spasm is obtained, opti- mizing the subsequent EL shrinkage that was performed all the way down to the knee GSV region with a significant reduction of the usual fluence. Varicose veins that were not previously reached by the injected foam can than be treated both by phebectomies or FS itself, as occurred in 3 patients of our study population. An above-knee 20-30 mmHg elastic stocking compression was prescribed to all the patients for one week 24 h a day, then just dur- ing the daytime for the following two weeks. All the patients underwent an immediately post-operative US and clinical follow-up, that was repeated by the same assessor at 7 and 21 days. Results In supine at the mid-thigh the GSV caliber decreased from a pre-operative mean value of 0.6±0.2 cm to a post FS injection 0.3±0.1 cm value (P<0.05), showing no statistical differ- ence among STS and POL (P=0.7). At the two follow-up visits (7 and 21 days after the procedure) all the patients presented a GSV shrinkage with reflux suppression. Neither major nor minor complications were reported. In particular neither ecchymosis nor hematoma were detected at the thigh. No significant pain was reported by the patients, clearly demonstrating the feasibility of the herein presented tumescence-free tech- nique. Discussion and Conclusions EL and RF have progressively gathered a major role in therapeutic international indica- tions for varicose veins treatment.1 Nevertheless, the same guidelines point out the need of a smaller than 15 mm caliber GSV for a RF approach, while stating that, even if there are no absolute contraindicated GSV cal- ibers for EL,9 an association among larger than 8 mm GSV and femoral thrombus extension was reported.10,11 EL is scarless, aesthetically satisfying and considered as a mini-invasive effective thera- peutic approach. Nevertheless, up to now, EL is strictly related to TA. This last one has four main aims: cooling and protecting the perivascular tissue from heating and burns, pain control, guaranteeing at least 1 cm of depth from the skin surface, reducing the GSV caliber in order to remove blood and improving surface contact. On the other side, eve if minimally, TA is an invasive act that can be related to unpleasant consequences such as perivenous ecchymosis and hematoma, up to 52% of patients, all along the treated GSV tract.12,13 This fact is responsible for a temporarily aesthetic impact, involving the patient dissat- isfaction. Rare but extremely severe TA complications have also been described in the literature.2-4 At the same time the same TA injection technique can present some difficulties lead- ing to complications. In the same way, if the injecting needle remains too far away from the vein the perivenous tissue will remain attached to the vein, so suffering of heat dam- age.5 Nowadays, technological innovations are developing in order to eliminate the TA need. In particular, a holmium laser assisted foam sclerotherapy (LAFOS) has been introduced with definitely promising outcomes.7 Thanks to the low temperature generated by LAFOS a GSV caliber reduction is made possible even at the lowest energy delivery, so avoiding the need of any kind of TA. A following foam scle- rotherapy injection completes the venous shrinkage. The herein reported absence of peri-opera- tive and early post-operative complications points out how our strategic proposal produces preliminary evidences regarding the feasibility of a new EL use without the need of both any TA and of any new laser device. The FS introduction in a previously partially shrunk GSV induces a venous spasm around the fiber, creating an endothelial damage, so allowing a lower EL energy delivery. Moreover, the creation of a shrinkage plug on the cranial saphenous side, limit the diffu- sion of FS derived cathabolites (like endothe- lin and histamin), maximizing the same drug local effect, while minimizing the systemic possible even if extremely rare side effects.14 The synergic EL 1470 nm and FS effect, thanks to the more available water cromophore (water is specific target of 1470 nm laser fre- quency), may be that paves the way for a brand new definition of the energy delivery parame- ters in endovenous techniques, with hypothet- ical consequent smaller side effects and higher patient satisfaction, providing a TA-free strate- gy to be performed in the future in an office- setting. Further investigations to this feasibil- ity study are ongoing regarding the EL energy delivery settings and the spasm effect induced by different concentrations of POL vs STS in a wider and thus more significant patient popu- lation, in absence we hope also of any kind of sedation. Further investigations are needed for the proposed strategy application both in larger GSV calibers and with the use also of RF devices. This study is a feasibility study. Number of patients and, in particular, follow-up time are clearly insufficient to draw conclusions. A more complex and accurate study is in progress. Figure 1. Foam sclerotherapy preparation and injection through the same laser fiber introducer. Laser fiber remains endove- nous, blocked by the initially performed shrunk plug. Figure 2. A) Laser fiber into the great saphenous vein (GSV) after a shrunk plug was cre- ated just below the superficial epigastric vein confluence, sparing the remaining GSV trunk. B) Foam injection into the GSV with the laser fiber still inside the vein. A conse- quent significant caliber decrease is detected after the injection. Foam easily reaches the GSV tributaries along the thigh thanks to the block caused by the shrunk plug. 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