Article

Strategies and Outcomes for Proximal and Distal Embolic Protection Devices - A Review

Register or Login to View PDF Permissions
Permissions× For commercial reprint enquiries please contact Springer Healthcare: ReprintsWarehouse@springernature.com.

For permissions and non-commercial reprint enquiries, please visit Copyright.com to start a request.

For author reprints, please email rob.barclay@radcliffe-group.com.
Average (ratings)
No ratings
Your rating

Disclosure:Sumaira Macdonald has received research grants from Abbott Vascular, AGA Medical, CR Bard, Biotronik, Boston Scientific, Cordis (J&J), ev3, LeMaitre, Medtronic/Invatec, Silk Road Medical, St Jude, Spectranetics, Tryton Medical, Pyramed and WL Gore and consultancy fees from ev3, Medtronic and WL Gore. Flora Kovacs has no conflicts of interest to declare.

Received:

Accepted:

Correspondence Details:Sumaira Macdonald, Interventional Radiology, Freeman Hospital, Freeman Road, High Heaton, Newcastle Upon Tyne, NE7 7DN, UK. E: Sumaira.Macdonald@nuth.nhs.uk

Copyright Statement:

The copyright in this work belongs to Radcliffe Medical Media. Only articles clearly marked with the CC BY-NC logo are published with the Creative Commons by Attribution Licence. The CC BY-NC option was not available for Radcliffe journals before 1 January 2019. Articles marked ‘Open Access’ but not marked ‘CC BY-NC’ are made freely accessible at the time of publication but are subject to standard copyright law regarding reproduction and distribution. Permission is required for reuse of this content.

Abstract

Both carotid endarterectomy (CEA) and carotid artery stenting (CAS) are associated with small, but clinically important and discrepant, rates of procedural complications, including cerebral and myocardial ischaemic events, cranial nerve injury and access site haematoma. Embolic protection devices (EPDs) may lower the rate of ipsilateral ischaemic events during CAS and are considered by the majority of interventionists to be mandatory during CAS, although there are no available data from randomised trials based on clinical outcomes to support this practice (perhaps because many thousands of patients would be required to adequately power a trial based on stroke and death endpoints). A recent systematic review of non-randomised data supports the use of EPDs. Worldwide experience demonstrates that all available protection strategies will capture macroemboli generated during endovascular manipulation of carotid bifurcation plaque, thus clearly implying an added level of protection for the brain when these systems are employed, but different philosophies of protection manage the microembolic burden of CAS (i.e. those particles less than 1 mm in diameter) in very different ways. These differences may be assessed by the evaluation of microembolic signals (MES) on transcranial Doppler (TCD) and of new hyperintensities ('new white lesions') on diffusion-weighted magnetic resonance imaging (DWMRI) of the brain. Differences between proximal and distal systems may assume clinical relevance, but further work is required before definitive conclusions can be drawn. This article focuses on the clinical and subclinical differences between protection strategies and provides a pragmatic treatment paradigm to support clinical decision-making.

To view the full article, please click on the PDF icon.

References

  1. Carotid artery stent placement for symptomatic extracranial carotid stenosis, NICE guideline, 2011.
  2. Brott TG, Halperin JL, Abbara S, et al., 2011 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, J Am Coll Cardiol , 2011;57(8):1002–44.
    Crossref | PubMed
  3. Liapis CD, Bell PR, Mikhailidis D, et al., ESVS Guidelines. Invasive Treatment for Carotid Stenosis: Indications, Techniques, Eur J Vasc Endovasc Surg , 2009;37(4 Suppl.):1–19.
    Crossref | PubMed
  4. Naggara O, Touzé E, Beyssen B, EVA-3S Investigators, Anatomical and technical factors associated with stroke or death during carotid angioplasty and stenting: results from the endarterectomy versus angioplasty in patients with symptomatic severe carotid stenosis (EVA-3S) trial and systematic review, Stroke , 2011;42(2):380–8.
    Crossref | PubMed
  5. Bates ER, Babb JD, Casey DE Jr, et al., ACCF/SCAI/SVMB/SIR/ ASITN 2007 clinical expert consensus document on carotid stenting: a report of the American College of Cardiology Foundation Task Force on Clinical Expert Consensus Documents (ACCF/SCAI/SVMB/SIR/ASITN Clinical Expert Consensus Document Committee on Carotid Stenting), J Am Coll Cardiol , 2007;49:126–70.
    Crossref | PubMed
  6. Bijuklic K, PROFI: A Prospective, Randomized Trial of Proximal Balloon Occlusion vs. Distal Filter Embolic Protection in Patients Undergoing Carotid Stenting, Presented at: Late Breaking Trials TCT, San Francisco, CA, 11 November 2011.
  7. Montorsi P, Caputi L, Galli S, et al., Microembolization during carotid artery stenting in patients with high-risk, lipid-rich plaque. A randomized trial of proximal versus distal cerebral protection, J Am Coll Cardiol , 2011;58(16):1656–63.
    Crossref | PubMed
  8. Schmidt A, Diederich KW, Scheinert S, et al., Effect of two different neuroprotection systems on microembolization during carotid artery stenting, J Am Coll Cardiol , 2004;44:1966–9.
    Crossref | PubMed
  9. Rubino P, DESERVE study: diffusion weighted - magnetic resonance imaging based evaluation of the effectiveness of endovascular clamping during carotid artery stenting with the Mo.Ma device. Results from a prospective, multicentre study, Presented at: EuroPCR, Paris, 17 May 2011.
  10. Gupta N, Corriere MA, Dodson TF, et al., The incidence of microemboli to the brain is less with endarterectomy than with percutaneous revascularization with distal filters or flow reversal, J Vasc Surg , 2011;53:316–22.
    Crossref | PubMed
  11. Pinter L, Ribo M, Loh C, et al., Safety and feasibility of a novel transcervical access neuroprotection system for carotid artery stenting in the PROOF Study, J Vasc Surg , 2011;54(5):1317–23.
    Crossref | PubMed
  12. North American Symptomatic Carotid Endarterectomy Trial, Methods, patient characteristics, and progress, North American Symptomatic Carotid Endarterectomy Trial (NASCET) Steering Committee, Stroke , 1991;22:711–20.
    Crossref
  13. Clair DG, Hopkins LN, Mehta M, et al., for the EMPiRE Clinical Study Investigators, Neuroprotection During Carotid Artery Stenting Using the GORE Flow Reversal System: 30-Day Outcomes in the EMPiRE clinical Study, Catheter Cardiovasc Interv , 2011;77:420–9.
    Crossref | PubMed
  14. Ansel GM, Hopkins NL, Jaff MR, et al., and the Investigators for the ARMOUR Pivotal Trial, Safety and Effectiveness of the Ivatec MOMA Proximal Cerebral Protection Device During Carotid Artery Stenting Results From the ARMOUR Pivotal Trial, Catheter Cardiovasc Interv , 2010;76:1–8.
    Crossref
  15. Myla S, Bacharach M, Ansel GM, et al., Carotid Artery Stenting in High Surgical Risk Patients Using The FiberNet Embolic Protection System. The EPIC Trial Results, Catheter Cardiovasc Interv , 2010;75:817–22.
    Crossref | PubMed
  16. Theron J, Venturi C, Reul J, et al., Immediate and 30 day Clinical Outcomes of Patients treated with the TwinOne Cerebral Protection System: Multicenter Experience in 217 Cases, Cardiovasc Intervent Radiol , 2009;32:1139–45.
    Crossref | PubMed
  17. Stabile E, Salemme L, Sorropago G, et al., Proximal endovascular occlusion for carotid artery stenting, J Am Coll Cardiol , 2010;55:1661–7.
    Crossref | PubMed
  18. Cremonesi A, Setacci C, Bignamini A, et al., Carotid artery stenting. First Consensus Document of the ICCS-SPREAD Joint Committee, Stroke , 2006;37:2400–9.
    Crossref | PubMed
  19. Bonati LH, Jongen LM, Haller S, et al., 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.
    Crossref | PubMed
  20. Altinbas A, van Zandvoort MJ, van den Berg J, et al., Cognition after carotid endarterectomy or stenting: a randomised comparison, Neurology , 2011;77:1084–90.
    Crossref | PubMed
  21. Palombo G, Faraglia V, Stella N, et al., Late evaluation of silent cerebral ischemia detected by diffusion-weighted MR imaging after filter-protected carotid artery stenting, AJNR Am J Neuroradiol , 2008;29:1340–3.
    Crossref | PubMed