| BackgroundOver the last decade, the advent of foam sclerotherapy has been one of the most important developments in the field of phlebology. Foam sclerotherapy is quick, efficient, safe, easy to use and cheap, and is widely believed to become the dominant form of therapy for venous disorders. In the published literature, the vast majority of foam sclerotherapy is performed under ultrasound guidance, in particular colour duplex ultrasound. Although the safety of ultrasound-guided foam sclerotherapy is acceptable, major complications such as local cutaneous necrosis, extravascular injection and inadvertent intra-arterial injection have been reported. It is also reported that neurologic, pulmonary and thrombotic complications occurred because the foam sclerosant flowed into the deep venous system, even pulmonary circulation or cerebral circulation. Ultrasound has the disadvantage of a narrow field of view that often does not encompass the entire lesion or a long segment of vein, so it is evident that ultrasound guidance cannot comprehensively surveil the injection procedures of foam sclerosant; furthermore, low spitial resolution and operator dependency is the common limitation of ultrasonography. Therefore, ultrasound guidance is not a perfect method to monitor the flow of foam sclerosant in the treated vein. Interventional radiologists have accumulated a wealth of experience in endovascular embolization of tumor disorders and scleroembolization of vascular disorders using liquid sclerosants under fluoroscopic guidance. Fluoroscopic guidance has a particular value in real-time monitoring of the distribution of the sclerosing agent during injection. Foam sclerotherapy of male varicoceles, ovarian varices and peripheral venous malformations under fluoroscopic guidance have been fewly reported. It does not, however, give a detailed description on how to monitor the injection procedures of foam sclerosant. Polidocanol and sodium tetradecyl sulfate are the most widely used detergen sclerosants for foam sclerotherapy in the world today, but commercially unavailable in our country. Sodium morrhuate is the oldest representative of the detergent sclerosants, and can be used to produce foam sclerosant. Reunderstanding the safety of sodium morrhuate should be of value to promote the development of foam sclerotherapy.ObjectiveThe purpose of this study is to describe a new monitoring technique of the standardized sclerosing foam produced from sodium morrhuate under fluoroscopic guidance, to evaluate the technical feasibility of fluoroscopy-guided foam sclerotherapy, and assess the safety and the early outcomes of fluoroscopy-guided foam sclerotherapy for the treatment of varicoceles, peripheral venous malformations and lower extremity varicosities.Materials and Methods1. Fluoroscopy-guided foam sclerotherapy of varicocelesNinety-seven cases of gradeⅡandⅢmale varicocele patients (mean age 21.9 years, range 15-38 years) with abnormal semen parameters between May 2007 and June 2009 underwent clinical assessment, Doppler ultrasonography, and semen analysis. Clinical varicoceles were diagnosed by physical examination and were graded based on physical findings according to the Dubin-Amelar classification. The ultrasonographic criteria for identifying a varicocele were an internal spermatic vein which had a luminal diameter greater than 0.27cm and/or reflux. The semen specimens were collected and evaluated according to the WHO criteria.In all 97 cases,86 cases were left varicocele and 11 cases were bilateral; GradeⅡleft varicocele was noted in 64 patients, and gradeⅢleft varicocele in 33 patients, and gradeⅡright varicocele in 11 patients. At least one of the parameters of the semen analysis was abnormal before procedure in all patients.Sclerosing foam was prepared using Tessari's method to mix room air with 5% sodium morrhuate in a 4:1 ratio. After the catheter was advanced into the preconcerted location of scleroembolization, the foam sclerosant was injected under fluoroscopic guidance (58 patients) or digital subtraction fluoroscopy (DSA) guidance (39 patients), the sclerosing foam pushed inferiorly the previously injected contrast media and appeared as radiolucent filling-defects (arrow) in the vein filled with contrast media.If the flow of the sclerosing foam arrived near the external inguinal ring occurred (equivalent to the superior boundary of pecten pubis), the procedure could be stopped immediately. The same technique was performed on right-sided varicoceles.Technical success was defined as completion of the procedure with occlusion of the varicocele. Clinical success was defined as disappearance of the varicocele and symptoms at the clinical follow-up visit and/or absence of refluxing veins greater than 3 mm on follow-up US examination. Varicocele was considered persistent if the procedure failed to produce any beneficial effects, and recurrent if, although absent at the first follow up, it reappeared after the fifth month. Follow-up was performed using a questionnaire to evaluate the success rate of the procedure, complications, and symptomatic relief the patients. The clinical outcome was graded as excellent, good, fair or poor. Specific complications were classified as major or minor. 2. Fluoroscopy-guided Foam Sclerotherapy of peripheral venous malformationsThirty-seven patients with peripheral venous malformations (mean age 21.5 years, range 5 months-31 years) were treated with foam sclerotherapy between January 2007 and October 2008. Diagnosis of venous malformations was made by clinical examination according to guidelines for the diagnosis and therapy of the vein and lymphatic disorders. Lesion locations included the craniofacial regions in 18 patients, extremities in sixteen, and trunks in three.According to the Puig's classification system based on anatomical and haemodynamic features of lesion and adjacent veins under direct puncture venography, we divided all patients into 4 categories:Type I, isolated malformation without peripheral drainage (n=11); TypeⅡ, malformation that drains into normal veins (n=15); TypeⅢ, malformation that drains into dysplastic veins (n=7); Type IV, malformation that represents a dysplastic venous ectasia (n=4). Sclerosing foam was prepared using Tessari's method to mix room air with 5%sodium morrhuate in a 4:1 ratio. Percutaneous foam sclerotherapy of venous malformations under digital subtraction angiography guidance was performed using a combined technique modified with the double-needle technique and the filling-defects technique. The injection of the foam sclerosant was stopped immediately once contrast medium in the lesion was completely displaced, the sclerosing foam flowed out through the second needle, or the sclerosing foam was visualized in the draining vein.Technical success was defined as the distribution of injected foam corresponding to previous direct puncture venography of vascular malformations. The primary efficacy end point was defined as a reduction in size of the lesion after completion of the treatment. Follow-up clinical, radiologic assessment and patient satisfaction were performed to evaluate the end result. The end results obtained by relatively short-term follow-up were classified as excellent, good, moderate, unchanged, or worse. Specific complications were classified as major or minor.3. Fluoroscopy-guided foam sclerotherapy of lower extremity varicosities with preservation of the saphenous veinA retrospective review of a prospectively collected data was performed for 21 limbs of 16 patients (median age 44 years, range 19-61 years) with lower extremity varicosities treated with fluoroscopy-guided foam sclerotherapy who were referred from August 2008 to December 2009. Clinical symptoms were evaluated according to the Venous Disability Score. The CEAP classification system was used for clinical staging. A reflux was considered to be pathologic if the reflux duration was more than 0.5 seconds for the superficial veins and 1.0 second for the deep veins with duplex ultrasound examination; 8 legs presented reflux along the great saphenous vein, whereas 13 legs had isolated varices with no saphenous reflux. The extent of varices was evaluated according to the scoring grids in question 1 of Aberdeen Varicose Veins Questionnaire.Foam sclerosant was made by the Tessari's method using 5%sodium morrhuate solutions to air in a 1:4 ratio. After direct puncture phlebography of the varicosities, foam sclerotherapy was performed by the filling-defects technique under DSA guidance. The treated limb was wrapped with an elastic bandag for 24 hours, and then changed to wear the class 2 elastic stockings for 14 days post-treatment, day and night for the first 7 days.Technical success was defined as injected foam being distributed over varicosities rather than saphenous vein trunk. Symptom relief was assessed using the Venous Disability Score. Reflux was deemed nonsignificant if the reflux duration was<0.5 seconds; considerably reduced if the postoperative reflux duration was reduced by< 50%compared with the preoperative reflux duration, and unchanged in the other cases. The changes in the size and number of varicosities were evaluated according to the scoring grids in question 1 of Aberdeen Varicose Veins Questionnaire. The presence of recurrent varicose veins included the Recurrent Varices After Surgery (REVAS) criteria. Clinical outcome was assessed as full success, partial success and no success according to the clinical criteria recommended by 2nd European Consensus Meeting on Foam Sclerotherapy. Specific complications were classified as major or minor.Results1. Fluoroscopy-guided foam sclerotherapy of varicocelesThe procedure was technically successful in all patients. The dosage of foam sclerosant ranged from 2 to 10 ml (0.4 to 2.0 ml of liquid sclerosant) per patient with an average dosage of 5.6 ml (approximate 1.1 ml of liquid sclerosant). No major complications were encountered in our series. In majority of patients, the injection of the foam sclerosant caused transient discomfort that lasted only a few minutes in left flank or low abdomen. One patient developed edema of the left scrotum, witch ceased without further treatment after 2 days of bed rest. Within 6 months after the procedure, Ninety-two of 97 patients (94.8%) reported disappearance or only a slight, asymptomatic residual varicocele (n=5). There have been no testes lost and no recurrent/persistent varicoceles. Patients reported the overall outcome as excellent in 53 (91.4%), good in 5 (8.6%). At 6 months follow-up, statistically significant improvement was noted in seminal parameters in terms of sperm concentration, viability, progressive motility and grade a+b motility (P<0.001).No major complications occurred. In the majority of patients, the injection of the foam sclerosant caused transient discomfort lasting only a few minutes in left flank or low abdomen. Only one patient (1.0%) developed edema of the left scrotum. This dissipated without further treatment after 2 days of bed rest.2. Fluoroscopy-guided Foam Sclerotherapy of peripheral venous malformationsA total of 109 treatment sessions were performed (mean,3 sessions per patient; range,1～7 sessions); of these patients,15 needed only one session, and 4 patient required more than five sessions. Sessions took place at a median interval of 4.5 weeks (range,2 weeks-4 months). The average dosage of the sodium morrhuate foam per session was 8.0 ml (2.0 ml of solution) per patient (range,2～50ml; 0.4～10ml of solution). The total treatment dose per patient averaged 4.8 ml of solution (range, 0.2-35 ml of solution). At the 6-month follow-up,15 patients (40.5%) showed a total disappearance of treated malformations, seventeen (45.9%) showed a reduction in malformation size of>50%, and five (13.5%) showed a reduction in malformation size of<50%. Minor complications included swelling and inflammatory reaction per session, mild pain in 17 sessions (62.4%), and skin blister at the injection site in two sessions (1.8%), which resolved spontaneously within several days to 2 weeks. No major complication occurred.3. Fluoroscopy-guided foam sclerotherapy of lower extremity varicosities with preservation of the saphenous veinThe procedure was technically successful in all 21 limbs, and a single sclerotherapy session was adequate in all limbs. The dosage of foam sclerosant ranged from 5 to 18 ml (1.0 to 3.6 ml of liquid sclerosant) per patient with an average dosage of 10.0 ml (2.0 ml of liquid sclerosant). For 8 legs with the great saphenous vein reflux in preoperative venous duplex ultrasound, the reflux was non-significant in 4 legs and considerably reduced in 4 legs at the first month following completion of treatment; and all 8 legs showed a non-significant reflux at 4 month after treatment. At median 6.0 months (ranged from 3 to 17 months) follow-up, the clinical outcome was full success (no visible varicosities or incompressibility of the treated vein segment, and absent or improved symptoms) in 17 limbs (81.0%), and partial success (smaller visible varicosities or partial incompressibility of the treated vein segment, and absent or improved symptoms) in 4 limbs (19.0%). Minor complications included cordlike subcutaneous indurations along the treated veins per limb (21/21,100%), skin pigmentation in 8 limbs (8/21,38.1%), local pain in 7 limbs (7/21,33.3%) and superficial thrombophlebitits (1/21, 4.8%) in one limb. No major complications or systemic disorders occurred.Conclusions1. Foam sclerosant, composed of more gas and less liquid, is visualized clearly as radiolucent filling defects in the vein filled with iodic contrast media during injection under fluoroscopic guidance. The extent of scleroembolization could be controlled accurately by showing clearly the flow of foam sclerosant under radiologic guidance. This method can be named as "the filling-defects technique under radiologic guidance".2. It is efficient and safe that radiologic-guided foam sclerotherapy for the treatment of varicoceles, peripheral venous malformations and lower extremity varices. Minor local complications were self-limiting, and no major complications or systemic disorders occurred.3. Foam sclerosant produced by sodium morrhuate using Tessari's method, could be used safely and effectively for percutaneous sclerotherapy of venous disorders. No anaphylaxis or any drug-related complications occurred. |
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