Author + information
- Received May 24, 2018
- Revision received November 20, 2018
- Accepted November 28, 2018
- Published online February 18, 2019.
- Ralf Langhoff, MDa,∗ (, )
- Joachim Schofer, MDb,
- Dierk Scheinert, MDc,
- Andrej Schmidt, MDc,
- Gerald Sedgewick, BAd,
- Elizabeth Saylors, MSce,
- Ravish Sachar, MDf,
- Horst Sievert, MDg,h and
- Thomas Zeller, MDi
- aDepartment of Angiology, Sankt Gertrauden Krankenhaus GmbH, Berlin, Germany
- bDepartment of Cardiology, Medical Care Center Prof. Mathey, Prof. Schofer, Hamburg, Germany
- cClinic for Angiology, University Hospital Leipzig, Leipzig, Germany
- dImaging and Analysis, LLC, St. Paul, Minnesota
- eContego Medical, LLC, Raleigh, North Carolina
- fHeart and Vascular Services, UNC REX Healthcare, Raleigh, North Carolina
- gCardioVascular Center Frankfurt, Frankfurt am Main, Germany
- hAnglia Ruskin University, Chelmsford, United Kingdom
- iDepartment of Angiology, Universitats Herzzentrum Freiburg–Bad Krozingen, Bad Krozingen, Germany
- ↵∗Address for correspondence:
Dr. Ralf Langhoff, Sankt Gertrauden Krankenhaus GmbH, Paretzer Straße 12, 10713 Berlin, Germany.
Objectives This study evaluated the safety and performance of the Paladin System, a novel angioplasty balloon with an integrated embolic protection filter designed to increase embolic protection during post-dilation.
Background The risk of major adverse events during carotid artery stenting (CAS) is equivalent to carotid endarterectomy. However, the risk of minor stroke remains higher with CAS. Much of this risk occurs during post-stent dilation.
Methods A total of 106 patients were enrolled in 5 centers in Germany. The study’s primary endpoint was all-cause death, myocardial infarction, and stroke at 30 days post-procedure. Pre- and post-procedural diffusion-weighted magnetic resonance imaging evaluated new ischemic lesions in 30 subjects. Filter histomorphometric analysis was performed in 23 patients. Retrospective analyses compared outcome rates to historical controls.
Results Device and procedural success rates were 100%. The combined major adverse event rate (death, myocardial infarction, and stroke) at discharge and at 30 days was 0% and 1.0%, respectively. The single adverse event was a stroke, which occurred at day 12 and was believed unrelated to the device or procedure. New ischemic lesions were found in 11 (36.7%) patients in the diffusion-weighted magnetic resonance imaging subset. New ipsilateral lesions were seen in 9 (30.0%) patients. Mean lesion volume per patient was 0.010 cm3. Debris was present in all filters, and approximately 90% of captured particles were <100 μm.
Conclusions Use of the Paladin System for post–stent dilation during CAS appears safe, and it may effectively decrease the number of embolic particles reaching the brain, which may help reduce the risk of procedure-related stroke. (A Multi-Center Study to Evaluate Acute Safety and Clinical Performance of Paladin® Carotid Post-Dilation Balloon System With Integrated Embolic Protection; NCT02501148)
The work was funded by Contego Medical, LLC (Raleigh, North Carolina). Dr. Langhoff has served as a consultant for Biotronik, B. Braun, Kardionet, and Contego Medical; has served on the Speakers Bureau for Boston Scientific, Terumo, and Medtronic; and has received speaking honoraria from Contego Medical. Prof. Scheinert has served on advisory boards and/or as a consultant for Abbott, Bayer, Boston Scientific, Cook Medical, Cardionovum, CR Bard, Gardia Medical/Allium, Medtronic, Philips, and Upstream Peripheral Technologies. Dr. Schmidt has received consulting or speaker honoraria from Abbott Vascular, Cordis, Cook Medical, and Medtronic. Ms. Saylors is an employee of Contego Medical. Dr. Sachar is the founder and a significant shareholder of Contego Medical; has served as a consultant for Boston Scientific and Medtronic; has received research support from Medtronic, Boston Scientific, Microvention, Gore, Surmodics, and Abbott Vascular; and has served on the Speakers Bureau for Spectranetics. Prof. Sievert has received consulting fees from Abbott Vascular, Ablative Solutions, Ancona Heart, Bioventrix, Boston Scientific, Carag, Cardiac Dimensions, Celenova, Cibiem, CGuard, Comed BV, Contego Medical, CVRx, Edwards, Hemoteq, Inspire MD, Kona Medical, Lifetech, Maquet Getinge Group, Medtronic, Occlutech, pfm Medical, Recor, St. Jude Medical, Terumo, Trivascular, Vascular Dynamics, Venus, and Veryan Medical. Prof. Zeller has received honoraria from Abbott Vascular, Bard Peripheral Vascular, Biotronik, Boston Scientific, Cook Medical, Gore & Associates, Medtronic, Spectranetics, Straub Medical, TriReme, VIVA Physicians GLG, Philips, and Veryan Medical; and he is a consultant for Abbott Vascular, Boston Scientific, Cook Medical, Gore & Associates, Medtronic, Spectranetics, and Veryan Medical. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
- Received May 24, 2018.
- Revision received November 20, 2018.
- Accepted November 28, 2018.
- 2019 American College of Cardiology Foundation
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