Author + information
- Received February 3, 2015
- Accepted April 8, 2015
- Published online August 17, 2015.
- Joachim Schofer, MD∗∗ (, )
- Piotr Musiałek, MD, DPhil†,
- Klaudija Bijuklic, MD∗,
- Ralf Kolvenbach, MD‡,
- Mariusz Trystula, MD†,
- Zbigniew Siudak, MD†,§ and
- Horst Sievert, MD‖
- ∗Medical Care Center, Hamburg University Cardiovascular Center, Hamburg, Germany
- †Jagiellonian University Department of Cardiac and Vascular Diseases, John Paul II Hospital, Krakow, Poland
- ‡Augusta Hospital, Dusseldorf, Germany
- §Krakow Cardiovascular Research Institute, Krakow, Poland
- ‖CardioVascular Center, Frankfurt, Germany
- ↵∗Reprint requests and correspondence:
Prof. Joachim Schofer, Medical Care Center, Hamburg University Cardiovascular Center, Wördemanns Weg 25-27, 22527 Hamburg, Germany.
Objectives This study sought to evaluate the feasibility of the CGuard Carotid Embolic Protective Stent system—a novel thin strut nitinol stent combined with a polyethylene terephthalate mesh covering designed to prevent embolic events from the target lesion in the treatment of carotid artery lesions in consecutive patients suitable for carotid artery stenting.
Background The risk of cerebral embolization persists throughout the carotid artery stenting procedure and remains during the stent healing period.
Methods A total of 30 consecutive patients (age 71.6 ± 7.6 years, 63% male) meeting the conventional carotid artery stenting inclusion criteria were enrolled in 4 centers in Germany and Poland.
Results The primary combined endpoint was the procedure success of the CGuard system and the number and volume of new lesions on the ipsilateral side assessed by diffusion-weighted magnetic resonance imaging at 48 h post-procedure and at 30 days. The secondary endpoint was 30-day major adverse cardiac or cerebrovascular events (death, stroke, or myocardial infarction). Protection devices were used in all procedures. Procedure success was 100%, with 0% procedural complications. The 30-day major adverse cardiac or cerebrovascular events rate was 0%. New ipsilateral ischemic lesions at 48 h occurred in 37.0% of patients and the average lesion volume was 0.039 ± 0.08 cm3. The 30-day diffusion-weighted magnetic resonance imaging showed complete resolution of all but 1 periprocedural lesion and only 1 new minor (0.116 cm3) lesion in relation to the 48-h scan.
Conclusions The use of the CGuard system in patients undergoing carotid artery stenting is feasible. In addition, the benefit of using CGuard may extend throughout the stent healing period.
Dr. Sievert has received study honoraria, travel expenses, or consulting fees from Abbott, Aptus, Atrium, Biosense Webster, Boston Scientific, Carag, Cardia Dimensions, CardioKinetix, CardioMEMS, Cardiox, Celonova, CGuard, Coherex, Comed B.V., Contego, Covidien, CSI, CVRx, ev3, FlowCardia, Gardia, Gore, GTIMD Medical, Lumen Biomedical, Lifetech, Lutonix, Maya Medical, Medtronic, Occlutech, pfm Medical, Recor, ResMed, SentreHeart, Spectranetics, Svelte Medical Systems, Tendyne, Trireme, Trivascular, Valtech, Vascular Dynamics, Venus Medical, Veryan, and Vessix; and has stock options in CardioKinetix, Access Closure, Coherex, and SMT. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
- Received February 3, 2015.
- Accepted April 8, 2015.
- 2015 American College of Cardiology Foundation