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Giornale Italiano di Chirurgia Vascolare 2002 December;9(4):357-67


language: English, Italian

Prospective comparative study of two cerebral protection devices in angioplasty and carotid stenting

Grego F. 1, Frigatti P. 1, Amistà P. 2, Lepidi S. 1, Antonello M. 1, Carollo C. 2, Deriu G. P. 1

1 Vascular Surgery Clinic, Padua University, Padua 2 Neuroradiology Service, Padua Hospital, Padua


Back­ground. Cere­bral pro­tec­tion ­during endo­vas­cular treat­ment of ­carotid ste­noses ­appears to be a ­valid way to pre­vent neu­ro­log­ical com­pli­ca­tions due to ­micro-embo­lism. The ­study com­pares two of the avail­able cere­bral pro­tec­tion ­devices, Per­cu­Surge, of the bal­loon ­type (­Group A) and Angio­guard, of the ­filter ­type (­Group B), ­used in angio­plasty and ­carotid ­stenting (ACS).
­Methods. ­From Sep­tember 1999 to Feb­ruary 2001, 26 ­patients ­were sub­jected to ACS for symp­to­matic or non-symp­to­matic ­carotid sten­osis at the Vas­cular Sur­gery ­Clinic, ­Padua Uni­ver­sity, fol­lowing pre­cise indi­ca­tions. The cere­bral pro­tec­tion ­device (CPD) was ­chosen alter­na­tively, ­thus 13 ­patients ­were ­enrolled in ­Group A (Per­cu­surge) and 13 in ­Group B (Angio­gard). Imme­diate ­results ­were ana­lysed in ­terms of neu­ro­log­ical and non-neu­ro­log­ical mor­tality and mor­bidity, elec­tro­en­ce­phal­o­graphic and elec­tro­car­di­o­graphic alter­a­tions ­during ACS, vari­a­tions in ­size of the ­distal ­internal ­carotid ­artery (ICA) ­during and ­after ACS, micro­scopic and his­to­log­ical char­ac­ter­is­tics of the frag­ments cap­tured by the CPD. ­Lastly, the two ­devices ­were eval­u­ated qual­ita­tively; fac­tors for ­which ana­lyt­ical eval­u­a­tion was not pos­sible ­were clas­si­fied on a ­quality ­scale ­with ­scores ­from 0 to 5.
­Results. ­With ­regard to imme­diate ­results, ­RNCR (rel­e­vant neu­ro­logic com­pli­ca­tion ­rate = ­stroke, TIA) was = 0. ­Four ­patients, 3 in ­Group A and 1 in ­Group B, under­went sen­sory obnu­bi­la­tion char­ac­ter­ised by a con­fused ­state ­that ­lasted for approx­i­mately 3-4 ­hours imme­di­ately ­postoper­a­tive. The pro­tec­tion ­systems ena­bled ­micro-­embolic mate­rial to be cap­tured in 7 ­patients (­4 in ­Group A, 3 in ­Group B). ­Mean ­time for util­isa­tion of the CPD ­from the begin­ning of the pro­ce­dure to ­removal of the ­system was 46 min for ­Group A ­versus 36 min for ­Group B. In the ­first ­patient in ­Group A, the ­internal ­carotid ­artery was com­pletely ­occluded ­after posi­tioning the ­stent, ­thus the pro­ce­dure was imme­di­ately con­verted, ­with ­full suc­cess, to ­carotid endar­te­rec­tomy (CE) (­shunting + ­patch).
Con­clu­sions. The ­results ­show ­that the pro­tec­tion ­systems are ­safe and effec­tive in ­blocking ­embolic mate­rial ­released ­during ACS. Spe­cific neg­a­tive ­aspects ­were ­detected for ­each ­system, and ­others ­common to ­both. The ­devices exam­ined ­cannot yet be con­sid­ered ­ideal ­systems, espe­cially ­with ­regard to sim­plicity, effi­cacy, reli­ability and not ­least ­ease of use. It is to be ­hoped ­that tech­no­log­ical devel­op­ments ­will pro­duce pro­tec­tion ­systems suit­able for rou­tine use ­during ACS.

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