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The Journal of Cardiovascular Surgery 2001 August;42(4):543-9

lingua: Inglese

Fibrin sealant coated stents compared with non-coated stents in a porcine carotid artery model. Preliminary study report

Byer A., Peters S. *, Settepani F. **, Pagliaro M. **, Galletti G. **

From the Depart­ment of Sur­gery and *­Pathology Hack­en­sack Uni­ver­sity Med­ical ­Center and UMDNJ - New ­Jersey Med­ical ­School Hack­en­sack, NJ, USA
**Depart­ment of Sur­gery Faculty of Med­i­cine and Sur­gery Uni­ver­sity of ­Bologna, Bologna, ­Italy


Back­ground. Bal­loon expand­able ­metal ­stents (­BEMS) are ­used to ­treat resten­osis fol­lowing per­cut­aneous trans­lu­minal angio­plasty (PTA) and as pri­mary treat­ment. ­Intimal pro­life­ra­tion (IP) and resul­tant resten­osis ­occurs in 25-50% of ­patients ­despite all pre­ven­tive meas­ures. Objec­tive: to ­test the ­intra-arte­rial ­response to the inser­tion of a ­fibrin ­sealant (FS) ­coated ­BEMS vs an ­uncoated ­BEMS by meas­uring endo­thel­iza­tion and IP. Hypoth­esis: ­that a ­BEMS ­coated ­with FS ­will ­lead to ­rapid endo­thel­iza­tion and pre­vent or ­reduce IP. Ratio­nale: FS con­sists of ­fibrinogen and ­thrombin. ­Thrombin ­affects endo­the­lial ­cell pro­life­ra­tion and ­reduces ­smooth ­muscle pro­life­ra­tion, the fore­runner of IP and resten­osis. ­Normal endo­the­lium ­also ­releases sub­stances ­that pro­mote vas­cular relax­a­tion and ­normal ­smooth ­muscle ­tone reg­u­la­tion.
Methods. Thirty-40 kg ­pigs (EA), ­Palmaz-­Shatz ­BEMS *(­Cordis), FS Tis­sucol* (Baxter Immuno). ­Stents ­were uni­formly ­coated ­with FS in a spe­cial ­mold. ­Both ­coated and ­uncoated ­stents ­were ­mounted on bal­loon cath­e­ters and ­deployed ­caudad in the ­carotid ­arteries via an arter­i­otomy. Angio­grams ­were ­obtained ­postdeploy­ment. All spec­i­mens ­were exam­ined ­grossly, pho­to­graphed ­then ­fixed for his­tology and in ­some ­cases, scan­ning elec­tron micros­copy (SEM).
­Results. Fif­teen ani­mals ­form ­this pre­lim­i­nary ­report. Sac­ri­fice at ­five ­days as per orig­inal pro­tocol ­showed insuf­fi­cient ­stent incor­po­ra­tion. There­after 1/2 of the ani­mals ­were sac­ri­ficed at 15 ­days and 1/2 at 30 ­days. ­Patency: ­coated ­stents: 6 ­patent, 9 throm­bosed. ­Uncoated: 7 ­patent, 8 throm­bosed. Of ­five EA ­given post­op­er­a­tively ­low molecular weight heparin (LMWH) 4 ani­mals had ­patent ­stents 80%. His­tology: var­ying ­degrees of IP ­were ­seen in all spec­i­mens. In gen­eral the ­coated ­stents ­showed a ­greater ­degree ­than the ­uncoated. Sten­osis: presac­ri­fice angio­graphy ­revealed ­that ­where the ­stents ­were ­patent no sten­osis was ­present, in ­fact, ­some dem­on­strated ­mild dil­a­ta­tion. ­This was par­tic­u­larly the ­case ­with the ­coated ­stents.
Con­clu­sions. ­Coating ­stents ­with FS is not det­ri­mental. IP in ­these EA at 30 ­days did not pro­duce sten­osis. Post­op­er­a­tive ­LMWH ­appears ­helpful in main­taining ­patency in a throm­bo­genic experi­mental ­animal. Fur­ther ­study main­taining EA for 6-12 ­months ­should ­resolve ­whether the IP ­seen had ­achieved its max­imum expres­sion or ­would ­progress and pro­duce sten­osis.

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