Safety and feasibility of a novel transcervical access neuroprotection system for carotid artery stenting in the PROOF Study

Journal of Vascular Surgery

Volumn 54, Issue 5, 2011, Pages 1317-1323

  Pinter, Laszlo ^a   Ribo, Marc ^b   Loh, Christopher ^c   Lane, Barton ^d   Roberts, Tracy ^e   Chou, Tony M ^e,f   Kolvenbach, Ralf R ^a  

^a Augusta Hospital   (Germany)

^b UNIVERSITAT AUTÒNOMA DE BARCELONA   (Spain)

^c UNIVERSITY OF CALIFORNIA   (United States)

^d STANFORD UNIVERSITY SCHOOL OF MEDICINE   (United States)

^e Silk Road Medical Inc ^*  (United States)

^f UNIVERSITY OF CALIFORNIA   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ADULT; AGED; ARTERY BLOOD FLOW; ARTICLE; BRAIN EMBOLISM; BRAIN ISCHEMIA; CAROTID ARTERY OBSTRUCTION; CAROTID ARTERY STENTING; CAROTID ENDARTERECTOMY; CLINICAL ARTICLE; DEVICE SAFETY; DIFFUSION WEIGHTED IMAGING; EMBOLIC PROTECTION DEVICE; FEMALE; FLOW ALTERED SHORT TRANSCERVICAL CAROTID ARTERY STENTING; FOLLOW UP; HEART INFARCTION; HUMAN; MALE; MICHI NEUROPROTECTION SYSTEM; NEUROPROTECTION; PRIORITY JOURNAL; STROKE; TRANSIENT ISCHEMIC ATTACK; TRANSITIONAL BLINDNESS;

AGED; AGED, 80 AND OVER; ANGIOPLASTY; CAROTID STENOSIS; CEREBROVASCULAR CIRCULATION; DIFFUSION MAGNETIC RESONANCE IMAGING; EMBOLIC PROTECTION DEVICES; FEASIBILITY STUDIES; FEMALE; GERMANY; HUMANS; INTRACRANIAL EMBOLISM; MAGNETIC RESONANCE ANGIOGRAPHY; MALE; MIDDLE AGED; MYOCARDIAL INFARCTION; PREDICTIVE VALUE OF TESTS; PROSPECTIVE STUDIES; PROSTHESIS DESIGN; SEVERITY OF ILLNESS INDEX; STENTS; STROKE; TIME FACTORS; TOMOGRAPHY, X-RAY COMPUTED; TREATMENT OUTCOME; ULTRASONOGRAPHY, DOPPLER, DUPLEX;

EID: 80054875927     PISSN: 07415214     EISSN: 10976809     Source Type: Journal    
DOI: 10.1016/j.jvs.2011.04.040     Document Type: Article

References (18)

1. Brott TG, Halperin JL, Abbara S, Bacharach JM, Barr JD, Bush RL, et al. ASA/ACCF/AHA/AANN/AANS/ACR/ASNR/CNS/SAIP/ SCAI/SIR/SNIS/SVM/SVS Guideline on the Management of Patients with Extracranial Carotid and Vertebral Artery Disease: A Report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines, and the American Stroke Association, American Association of Neuroscience nurses, American Association of Neurological Surgeons, American College of Radiology, American Society of Neuroradiology, Congress of Neurological Surgeons, Society of Atherosclerosis Imaging and Prevention, Society for Cardiovascular Angiography and Interventions, Society of Interventional Radiology, Society of NeuroInterventional Surgery, Society for Vascular Medicine, and Society for Vascular Surgery. J Am Coll Cardiol 2011;57:1002-44.
2. Liapis CD, Bell PR, Mikhailidis D, Sivenius J, Nicolaides A, Fernandes e Fernandes J, et al. for the ESVS Guidelines Collaborators. ESVS guidelines: invasive treatment for carotid stenosis: indications, techniques. Eur J Vasc Endovasc Surg 2009;37 (Suppl):1-19.
3. Carotid Stenting Trialists' Collaboration; Bonati LH, Dobson J, Algra A, Branchereau A, Chatellier G, Fraedrich G, et al. Short-term outcome after stenting versus endarterectomy for symptomatic carotid stenosis: a preplanned meta-analysis of individual patient data. Lancet 2010;376: 1062-73.
4. Bangalore S, Kumar S, Wettersley J, Bavry AA, Gluud C, Cutlip DE, et al. Carotid artery stenting vs carotid endarterectomy: meta-analysis and diversity-adjusted trial sequential analysis of randomized trials. Arch Neurol 2011;68:172-84.
5. Brott TG, Hobson RW 2nd, Howard G, Roubin GS, Clark WM, Brooks W, et al., for the CREST investigators. Stenting versus endarterectomy for treatment of carotid-artery stenosis. N Engl J Med 2010; 363:11-23.
6. International Carotid Stenting Study investigators; Ederle J, Dobson J, Featherstone RL, Bonati LH, van der Worp HB, de Borst GJ, et al. Carotid artery stenting compared with endarterectomy in patients with symptomatic carotid stenosis (International Carotid Stenting Study): an interim analysis of a randomised controlled trial. Lancet 2010;375:985-97.
7. Bendszus M, Koltzenburg M, Burger R, Warmuth-Metz M, Hofmann E, Solymosi L, et al. Silent embolism in diagnostic cerebral angiography and neurointerventional procedures: a prospective study. Lancet 1999; 354:1594-7. (Pubitemid 29515951)
8. Schnaudigel S, Groschel K, Pilgram SM, Kastrup A. New brain lesions after carotid stenting versus carotid endarterectomy: a systematic review of the literature. Stroke 2008;39:1911-9.
9. Parodi JC, La Mura R, Ferreira LM, Mendez MV, Cersósimo H, Schönholz C, et al. Initial evaluation of carotid angioplasty and stenting with three different cerebral protection devices. J Vasc Surg 2000;32:7-36.
10. Hammer FD, Lacroix V, Duprez T, Grandin C, Verhelst R, Peeters A, et al. Cerebral microembolization after protected carotid artery stenting in surgical high-risk patients: results of a 2-year prospective study. J Vasc Surg 2005;42:847-53. (Pubitemid 41571945)
11. Bonati LH, Jongen LM, Haller S, Flach HZ, Dobson J, Nederkoorn PJ, et al., for the ICSS-MRI Study Group. New ischaemic brain lesions on MRI after stenting or endarterectomy for symptomatic carotid stenosis: a substudy of the International Carotid Stenting Study (ICSS). Lancet Neurol 2010;9:353-62.
12. Instruction for Use, Flow Reversal System (May 2009). Flagstaff, AZ: W. L. Gore & Associates, Inc.
13. Chang DW, Schubart PJ, Veith FJ, Zarins CK. A new approach to carotid angioplasty and stenting with transcervical occlusion and protective shunting: why it may be a better carotid artery intervention. J Vasc Surg 2004;39:994-1002. (Pubitemid 38581629)
14. Criado E, Doblas M, Fontcuberta J, Orgaz A, Flores A. Transcervical carotid artery angioplasty and stenting with carotid flow reversal: surgical technique. Ann Vasc Surg 2004;18:257-61. (Pubitemid 38509665)
15. Lin JC, Kolvenbach RR, Pinter L. Protected carotid artery stenting and angioplasty via transfemoral versus transcervical approaches. Vasc Endovasc Surg 2005;39:499-503. (Pubitemid 41790141)
16. Criado E, Fontcuberta J, Orgaz A, Flores A, Doblas M. Transcervical carotid stenting with carotid artery flow reversal: 3-year follow-up of 103 stents. J Vasc Surg 2007;46:864-9. (Pubitemid 350007994)
17. Alvarez B, Ribo M, Maeso J, Quintana M, Alvarez-Sabin J, Matas M, et al. Transcervical carotid stenting with flow reversal is safe in octogenarians: a preliminary safety study. J Vasc Surg 2008;47:96-100.
18. Ribo M, Molina CA, Alvarez B, Rubiera M, Alvarez-Sabin J, Matas M, et al. Transcranial Doppler monitoring of transcervical carotid stenting with flow reversal protection: a novel carotid revascularization technique. Stroke 2006;37:2846-9. (Pubitemid 44922551)