Independent Modular Filter for Embolic Protection in Carotid Stenting

Dierk Scheinert, Bernhard Reimers, Alberto Cremonesi, Andrej Schmidt, Horst Sievert, Stefan Rohde, Joachim Schofer, Harald G. Mudra, Marc Bosiers, Thomas Zeller, Andrea Pacchioni, Uri Rosenschein

Research output: Contribution to journalReview article

Abstract

Background - Embolic protection during carotid artery stenting reduces the rate of thromboembolic events. The Wirion Embolic Protection System is used to deploy an independent distal filter using any 0.014″ guidewire. WISE study (Wirion Study Europe) evaluated the safety and performance of Wirion Embolic Protection System in patients undergoing carotid artery stenting. Methods and Results - A prospective, multicenter, nonrandomized, open-label, single-arm study of carotid artery stenting in high surgical risk patients was performed. The primary end point, a composite of death, stroke, and myocardial infarction at 30 days, was compared with performance goal derived from historical controls. Secondary end points were components of the primary end point and the device, angiographic, procedural, and clinical success rates. Preplanned interim analysis was performed on the first 120 patients. At interim analysis, the primary end point was significantly lower for the Wirion Embolic Protection System group, compared with historical data (3.3% versus 6.3%, respectively; P value =0.0008). Analysis of primary end point components in the WISE group, compared with the historical control group, shows numerically lower mortality (0% versus 1.7%, respectively; P=0.21), stroke (2.5% versus 4.6%, respectively; P=0.18), and myocardial infarction (0.8% versus 1.5%, respectively; P=0.50). Device, angiographic, procedural, and clinical success was achieved in 99.2%, 99.1%, 98.3%, and 96.6% of cases, respectively. Conclusions - The data suggest that independent modular filter use in carotid artery stenting in high surgical risk patients is safe and effective. The outcomes suggest that use of an independent modular filter may be associated with a lower rate of embolic complications associated with carotid stent placement.

Original languageEnglish
Article numbere004244
JournalCirculation: Cardiovascular Interventions
Volume10
Issue number3
DOIs
Publication statusPublished - Mar 1 2017
Externally publishedYes

Fingerprint

Embolic Protection Devices
Carotid Arteries
Stroke
Myocardial Infarction
Equipment and Supplies
Stents
Safety
Control Groups
Mortality

Keywords

  • carotid artery
  • embolic protection
  • embolic stroke
  • myocardial infarction
  • stenting

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

Cite this

Scheinert, D., Reimers, B., Cremonesi, A., Schmidt, A., Sievert, H., Rohde, S., ... Rosenschein, U. (2017). Independent Modular Filter for Embolic Protection in Carotid Stenting. Circulation: Cardiovascular Interventions, 10(3), [e004244]. https://doi.org/10.1161/CIRCINTERVENTIONS.116.004244

Independent Modular Filter for Embolic Protection in Carotid Stenting. / Scheinert, Dierk; Reimers, Bernhard; Cremonesi, Alberto; Schmidt, Andrej; Sievert, Horst; Rohde, Stefan; Schofer, Joachim; Mudra, Harald G.; Bosiers, Marc; Zeller, Thomas; Pacchioni, Andrea; Rosenschein, Uri.

In: Circulation: Cardiovascular Interventions, Vol. 10, No. 3, e004244, 01.03.2017.

Research output: Contribution to journalReview article

Scheinert, D, Reimers, B, Cremonesi, A, Schmidt, A, Sievert, H, Rohde, S, Schofer, J, Mudra, HG, Bosiers, M, Zeller, T, Pacchioni, A & Rosenschein, U 2017, 'Independent Modular Filter for Embolic Protection in Carotid Stenting', Circulation: Cardiovascular Interventions, vol. 10, no. 3, e004244. https://doi.org/10.1161/CIRCINTERVENTIONS.116.004244
Scheinert, Dierk ; Reimers, Bernhard ; Cremonesi, Alberto ; Schmidt, Andrej ; Sievert, Horst ; Rohde, Stefan ; Schofer, Joachim ; Mudra, Harald G. ; Bosiers, Marc ; Zeller, Thomas ; Pacchioni, Andrea ; Rosenschein, Uri. / Independent Modular Filter for Embolic Protection in Carotid Stenting. In: Circulation: Cardiovascular Interventions. 2017 ; Vol. 10, No. 3.
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AU - Rohde, Stefan

AU - Schofer, Joachim

AU - Mudra, Harald G.

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