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Giornale Italiano di Chirurgia Vascolare 2002 June;9(2):115-23


language: English, Italian

Early thrombogenicity and preliminary results following FDP patch application after carotid endarterectomy

Pedrini L., Dondi M., Cirelli M. R., Magagnoli A., Magnoni F., Santoro M., Pisano E.

From the Ospedale Maggiore C. A. Pizzardi - Bologna Unità Operativa di Chirurgia Vascolare Dipartimento Chirurgico * Unità Operativa di Medicina Nucleare Dipartimento di Diagnostica per Immagini


Background. The appli­ca­tion of an expand­ed ­patch ­after carot­id endar­te­rec­to­my (CEA) is rec­om­mend­ed to ­reduce the inci­dence of resten­o­sis. Most stud­ies ­report treat­ment ­with saph­e­nous or poly­tet­ra­flu­o­roe­thy­lene patch­es (­PTFE) ­because of throm­bo­gen­ic ­response to poly­es­ter. This ­study eval­u­ates the throm­bog­e­nic­ity of a poly­es­ter ­patch (FPD) pas­si­vat­ed by flu­o­rop­o­lym­er sur­face treat­ment ­which experi­men­tal stud­ies ­have dem­on­strat­ed as ­being ­less throm­bo­gen­ic ­than oth­er ­types of patch­es.
Methods. In ­this pros­pec­tive and ran­dom­ized ­study, 22 ­patients under­went CEA. Eleven ­received ­direct ­suture of the arter­i­ot­o­my, and 11 ­received an FPD ­patch. The ­patient’s 111Indium-­oxine ­labeled plate­lets ­were re-inject­ed on the ­first post­op­er­a­tive day and scin­tig­ra­phies ­were per­formed ­after 4, 24, and 48 ­hours.
Results. The ­results are report­ed as ­count ­ratio (CR) ­between the treat­ed and the con­tra­lat­er­al carot­id ­artery at 4, 24 and 48 ­hours. In the ­direct ­suture ­group, the CR was 1.07±0.09, 1.2±0.27, and 1.197±0.50, respec­tive­ly, where­as in the FPD-­patch ­group the CR was 0.96±0.04, 1.08±0.09 and 1.216±0.24, respec­tive­ly. A sta­tis­ti­cal­ly sig­nif­i­cant dif­fer­ence in plate­let adhe­sive­ness was ­found ­only on eval­u­a­tion at 4 ­hours. The rela­tion­ship ­between CR and pre­op­er­a­tive bleed­ing ­time was the ­only sta­tis­ti­cal­ly sig­nif­i­cant param­e­ter (r=0.5), ­which indi­cat­ed a cer­tain asso­ci­a­tion ­with the phar­mac­o­log­i­cal activ­ity of the ­antiplate­let ­drug admin­is­tered to the ­patients. At 6 ­months fol­low-up, 1 ­patient pre­sent­ed ­with resten­o­sis great­er ­than 60% and 1 ­patient ­with inti­mal hyper­pla­sia 2 mm ­thick. The ­patients had abnor­mal ­blood coag­u­la­tion val­ues, but no rela­tion­ship ­with com­mon ­risk fac­tors was ­found.
Conclusions. This ­study con­firmed ­that the FPD ­patch is no ­more throm­bo­gen­ic ­than a sim­ple CEA; there­fore, appli­ca­tion of the ­patch can be rec­om­mend­ed to ­reduce resten­o­sis with­out any add­ed throm­boem­bol­ic ­risk. The fea­sibil­ity of a mul­ti­cen­ter ­trial was con­firmed to ­show hypo­thet­i­cal dif­fer­enc­es ­between FPD-­induced carot­id throm­bog­e­nic­ity and ­long-­term ­results.

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