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Acta Phlebologica 2002 August;3(2):101-6


language: English

External valve-support (EVS) for saphenofemoral junction incompetence. Randomized trial at 3 years follow-up

Agus G. B., Bavera P. M., Mondani P., Santuari D.

Chair of Vascular Surgery, Igea Clinic, University of Milan, Milan, Italy


BACKGROUND: Times for use of saph­e­nof­e­mo­ral junc­tion val­vu­lo­plas­ty in the treat­ment of var­i­cose ­veins, ­after a ­long experi­men­tal peri­od devel­oped in Italy, are now ­ready. By the end of 1998, an international multicenter trial start­ed: the ­IMES (international multicenter EVS Study). The aim of ­this ­trial was to eval­u­ate the ­effects of a new sur­gi­cal ­device, external valve support (EVS), and tech­nique for exter­nal val­vu­lo­plas­ty of the ­long saph­e­nous ­vein (LSV). The pur­pose of the cur­rent ­brief ­study car­ried out with­in the ­IMES was to exam­ine our ­results of EVP pro­ce­dure ver­sus stan­dard sur­gery at 3 ­years fol­low-up ­with clin­i­cal, hae­mod­y­nam­ic and qual­ity of ­life assess­ment as out­comes.
METHODS: Our ­group ­enrolled 24 select­ed ­patients, 18 ­females and 6 ­males, ­between January and December 1999 affect­ed by incom­pe­tence of the saphe­no-femo­ral junc­tion (SFJ) and con­se­quent uncom­pli­cat­ed ­venous dis­ease. The age of the ­patients was ­between 26 and 57 ­years (­mean age 48). All the ­patients under­went oper­a­tion ­with the ­same sur­geon so to ­receive the near­est pos­sible sur­gi­cal uni­for­mity. Patients ­with super­fi­cial ­venous dis­ease and ­venous incom­pe­tence ­were ran­dom­ized ­into 2 treat­ment ­groups. According to ­CEAP clas­sifi­ca­tion all ­patients ­were Cs2,3 – Ep – A2,3p17, 18 – Pr. The ­first ­group (Group 1) was ­cured ­with a stan­dard treat­ment (sim­ple liga­ton or strip­ping, accord­ing to the dif­fer­ent pat­terns of ­reflux) ­plus ­stab-avul­sions, ­when nec­es­sary. The oth­er ­group (Group 2) was treat­ed ­with exter­nal val­vu­lo­plas­ty ­with the EVS. For ­each ­patient iden­ti­fied as a can­di­date for ­venous ­repair sur­gery, col­or ­flow ­duplex imag­ing, air-ple­tis­mog­ra­phy (APG) or ambu­la­to­ry ­venous pres­sure (AVP), and Trendelemburg test­ing ­were per­formed pre­op­er­a­tive­ly to ­assess the num­ber, con­di­tion and orien­ta­tion of the ­valve leaf­lets and the diam­e­ter of the LSV. The ­effect of var­i­cose ­veins sur­gery to ­affect qual­ity of ­life (QoL) was exam­ined. In ­this ­study we ­used the Italian version dis­ease-spe­cif­ic Aberdeen Varicose Vein Questionnaire (­AVVQ).
RESULTS: Twelve ­patients had a “tail­ored” ­PTFE ­patch cho­sen ­from 1 of the 3 avail­able siz­es, ­placed ­around the preter­mi­nal SFJ so to cor­rect the cal­i­per and ­vein ­cusp func­tion. The remain­ing 12 ­were sub­mit­ted to a “clas­sic” SFL liga­tion. One ­month, 6 ­months, 1-­year, 2-­years and final­ly 42 ­months fol­low-ups ­have ­been con­duct­ed ­after sur­gi­cal pro­ce­dures. The ­check had ­been sub­jec­tive and objec­tive, con­sid­er­ing the res­o­lu­tion of the pri­mary var­i­cose ­veins dis­ease and recur­rence of var­i­cos­ity. In all ­that ­times, ­there ­were no evi­dence of ­device relat­ed com­pli­ca­tions and ­above all the ­repaired ­valves ­remained com­pe­tent at the duplex ­scan con­trols: ­only 1 ­patient ­showed a ­reflux in the ­site of ­valve ­repair. All the ­patients ­reached ­very ­good ­results ­almost com­par­able in ­each of the 2 ­groups, ­either if treat­ed ­with exter­nal val­vu­lo­plas­ty (Group 2) or ­with clas­si­cal pro­ce­dures (Group 1).
CONCLUSIONS: If now­a­days ­some excel­lent 5 to 10 ­years fol­low-up stud­ies are avail­able, we con­sid­er our ­small ran­dom­ized ­group to be of cer­tain inter­est. Our ­study, ­despite its imper­fec­tions pri­mar­ly ­because the ­series is too ­small for sta­tis­ti­cal anal­y­sis expect­ed for the com­plete mul­ti­cen­ter RCT, clear­ly ­shows the ben­e­fi­cial ­effect for the ­patients in ­terms of QoL ­even if ­there was no dif­fer­ence in ­this out­come ­between the two ­groups. In our opin­ion, at ­this ­point, the exter­nal val­vu­lo­plas­ty is a use­ful meth­od of restor­ing ­form and func­tion to the incom­pe­tent LSV in a high­ly select­ed ­group of ­patients (­about 5-8%).

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