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Embolic Protection Devices: No Room for Standardization
Eur J Vasc Endovasc Surg (2010) 39, 667
INVITED COMMENTARY
Embolic Protection Devices: No Room for Standardization C. Setacci* Vascular and Endovascular Surgery Unit, University of Siena, Viale Bracci 1, 53100, Siena, Italy Submitted 11 March 2010; accepted 12 March 2010 Available online 8 April 2010 I read with interest the paper by Leal et al.1 The technique proposed [transcervical carotid stenting (TCS) þ carotid flow reversal] was associated with a low incidence of new ischemic brain lesions (12.5%) when checked by DW-MRI. The aim of the study was to prove the safety of this hybrid procedure (neck surgery þ CAS) in preventing stroke and silent brain infarctions. We know that the real role of CAS is still the subject of debate and no randomized trial has yet proved the superiority of CAS over CEA.2 From this point of view the paper lacks a comparison with CEA, which is the gold standard for carotid lesions. As a second point, the device used to protect the brain in this study may also be questionable. For best results, the embolic protection device needs to be matched to each patient and lesion: this means that there is no room for standardization as the same device cannot be suitable for all different patients and lesions. CAS could be considered as an alternative to CEA and I strongly believe that there are precise indications for such a hybrid technique. The critical steps of CAS that are most likely to produce emboli are during engagement of the CCA, advancement of the guiding catheter or sheath into the CCA, crossing of the stenotic lesion with the guide wire, stent deployment and balloon dilatation. The hybrid procedure could reduce the embolic load by removing one of these critical steps. As reported by many other Authors, the crucial aspects of CAS (as for every vascular intervention) are the interventionist’s/surgeon’s learning curve, combined with full DOI of original article: 10.1016/j.ejvs.2010.02.006. * Tel.: þ39 0577 585123; fax: þ39 0577 233426. E-mail address: [email protected]
knowledge of materials. This hybrid technique needs to be restricted to subgroups of patients with a particularly difficult arch anatomy or shaggy aorta, in order to overcome possible preventable access problems. Moreover, as the operator’s skill and materials improve, the trans-femoral approach may be considered more appropriate due to the mini-invasiveness of access (cutdown vs. percutaneous approach), the duration of the procedure, the LOS and possibly lower expense. The clinical significance of new post-procedural silent ischemic cerebral lesions is still unknown; the only certainty is that to date, CEA is the procedure with the lowest embolic risk. I wondered when I first read about this technique some years ago, why I shouldn’t make a slightly longer incision and perform a gold standard CEA. Papers such as this by Leal et al.1 are essential to gradually improve our knowledge of CAS, while the real role of CAS needs to be investigated by the scientific world through randomized studies, so the role of this hybrid procedure can be tailored. The best technique must in any case be that with the lowest risk of debris-related embolization.
References 1 Leal JI, Orgaz A, Fontcuberta J, Flores A, Doblas M, GarciaBenassi JM, et al. A prospective evaluation of cerebral infarction following transcervical carotid stenting with carotid flow reversal. Eur J Vasc Endovasc Surg 2010;39:661e6. 2 Ederle J, Featherstone RL, Brown MM. Randomized controlled trials comparing endarterectomy and endovascular treatment for carotid artery stenosis: a Cochrane systematic review. Stroke 2009;40:1373e80.
1078-5884/$36 ª 2010 European Society for Vascular Surgery. Published by Elsevier Ltd. All rights reserved. doi:10.1016/j.ejvs.2010.03.016
INVITED COMMENTARY
Embolic Protection Devices: No Room for Standardization C. Setacci* Vascular and Endovascular Surgery Unit, University of Siena, Viale Bracci 1, 53100, Siena, Italy Submitted 11 March 2010; accepted 12 March 2010 Available online 8 April 2010 I read with interest the paper by Leal et al.1 The technique proposed [transcervical carotid stenting (TCS) þ carotid flow reversal] was associated with a low incidence of new ischemic brain lesions (12.5%) when checked by DW-MRI. The aim of the study was to prove the safety of this hybrid procedure (neck surgery þ CAS) in preventing stroke and silent brain infarctions. We know that the real role of CAS is still the subject of debate and no randomized trial has yet proved the superiority of CAS over CEA.2 From this point of view the paper lacks a comparison with CEA, which is the gold standard for carotid lesions. As a second point, the device used to protect the brain in this study may also be questionable. For best results, the embolic protection device needs to be matched to each patient and lesion: this means that there is no room for standardization as the same device cannot be suitable for all different patients and lesions. CAS could be considered as an alternative to CEA and I strongly believe that there are precise indications for such a hybrid technique. The critical steps of CAS that are most likely to produce emboli are during engagement of the CCA, advancement of the guiding catheter or sheath into the CCA, crossing of the stenotic lesion with the guide wire, stent deployment and balloon dilatation. The hybrid procedure could reduce the embolic load by removing one of these critical steps. As reported by many other Authors, the crucial aspects of CAS (as for every vascular intervention) are the interventionist’s/surgeon’s learning curve, combined with full DOI of original article: 10.1016/j.ejvs.2010.02.006. * Tel.: þ39 0577 585123; fax: þ39 0577 233426. E-mail address: [email protected]
knowledge of materials. This hybrid technique needs to be restricted to subgroups of patients with a particularly difficult arch anatomy or shaggy aorta, in order to overcome possible preventable access problems. Moreover, as the operator’s skill and materials improve, the trans-femoral approach may be considered more appropriate due to the mini-invasiveness of access (cutdown vs. percutaneous approach), the duration of the procedure, the LOS and possibly lower expense. The clinical significance of new post-procedural silent ischemic cerebral lesions is still unknown; the only certainty is that to date, CEA is the procedure with the lowest embolic risk. I wondered when I first read about this technique some years ago, why I shouldn’t make a slightly longer incision and perform a gold standard CEA. Papers such as this by Leal et al.1 are essential to gradually improve our knowledge of CAS, while the real role of CAS needs to be investigated by the scientific world through randomized studies, so the role of this hybrid procedure can be tailored. The best technique must in any case be that with the lowest risk of debris-related embolization.
References 1 Leal JI, Orgaz A, Fontcuberta J, Flores A, Doblas M, GarciaBenassi JM, et al. A prospective evaluation of cerebral infarction following transcervical carotid stenting with carotid flow reversal. Eur J Vasc Endovasc Surg 2010;39:661e6. 2 Ederle J, Featherstone RL, Brown MM. Randomized controlled trials comparing endarterectomy and endovascular treatment for carotid artery stenosis: a Cochrane systematic review. Stroke 2009;40:1373e80.
1078-5884/$36 ª 2010 European Society for Vascular Surgery. Published by Elsevier Ltd. All rights reserved. doi:10.1016/j.ejvs.2010.03.016