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ITALIAN JOURNAL OF VASCULAR AND ENDOVASCULAR SURGERY
A Journal on Vascular and Endovascular Surgery
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.