Author + information
- Received March 22, 2018
- Revision received May 8, 2018
- Accepted May 15, 2018
- Published online October 1, 2018.
- Nicolas W. Shammas, MD, MSa,∗ (, )
- Anthony Pucillo, MDb,
- J. Stephen Jenkins, MDc,
- Lawrence A. Garcia, MDd,
- Tom Davis, MDe,
- Herbert D. Aronow, MD, MPHf,
- Ehrin J. Armstrong, MD, MScg,
- Thomas Zeller, MDh,
- Dierk Scheinert, MDi,
- Uri Rosenschein, MDj and
- William Gray, MDk
- aMidwest Cardiovascular Research Foundation, Davenport, Iowa
- bDivision of Cardiology, Columbia Presbyterian, New York, New York
- cDivision of Cardiology, Ochsner Medical Center, New Orleans, Louisiana
- dDivision of Cardiology, St. Elizabeth’s Medical Center, Steward Health Care, Boston, Massachusetts
- eDivision of Cardiology, St. John Hospital and Medical Center, Detroit, Michigan
- fDivision of Cardiology, Lifespan Cardiovascular Institute, Providence, Rhode Island
- gDivision of Cardiology, University of Colorado, Aurora, Colorado
- hDivision of Cardiology, Universitaets-Herzzentrum Freiburg – Bad Krozingen, Bad Krozingen, Germany
- iDivision of Cardiology, Leipzig University Hospital, Leipzig, Germany
- jDivision of Cardiology, Bnai Zion Medical Center, Haifa, Israel
- kDivision of Cardiology, Lankenau Heart Institute, Wynnewood, Pennsylvania
- ↵∗Address for correspondence:
Dr. Nicolas W. Shammas, Midwest Cardiovascular Research Foundation, 1622 East Lombard Street, Davenport, Iowa 52803.
Objectives The WISE LE (WIRION™ EPS in Lower Extremities Arteries) study was designed to assess the clinical performance of the WIRION Embolic Protection System (EPS) in subjects undergoing lower extremity atherectomy for the treatment of peripheral artery disease.
Background Embolization is ubiquitous during endovascular procedures for lower extremity peripheral artery disease.
Methods The WISE LE was a multicenter study, performed in the United States and Germany. The primary endpoint was freedom from major adverse events (MAEs) occurring within 30 days post-procedure and was compared with an objective performance goal derived from historical atherectomy trials. MAE was defined as a serious adverse event that resulted in death, acute myocardial infarction, thrombosis, pseudoaneurysm, dissection (grade C or greater), or clinical perforation at the filter location, clinically relevant distal embolism, unplanned amputation, or clinically driven target vessel revascularization. The study also included a histopathological analysis of debris captured by the filter during the procedures.
Results The study protocol specified enrollment of 153 patients with the primary endpoint successfully met if 18 (12.0%) or fewer MAEs occurred. A pre-specified interim analysis performed after 103 patients revealed only 2 MAEs, and the study was stopped because it had met its pre-determined metric for success. Lesion deemed not accessible by the WIRION EPS occurred in 7 patients. Debris of <1-mm, 1- to 2-mm, and >2-mm diameter were found in 98%, 22%, and 9% of patients, respectively.
Conclusions The WIRION EPS is safe and noninferior to the pre-specified performance goal in capturing debris in the vast majority of patients and with the use of a broad range of atherectomy systems.
- arterial interventions
- distal embolization
- embolic filter
- embolic protection
- lower extremity
- peripheral arterial disease
This study was sponsored by Gardia Medical. Dr. Shammas has received research and educational grants from Boston Scientific and Bard; and has served on Speaker Bureau for Novartis, Boehringer Ingelheim, and Janssen. Dr. Jenkins has served on the Speakers Bureau of Abbott Vascular; and has proctored for Endologix and St. Jude Medical. Dr. Garcia has equity interest with Scion CV; has received research funding from Abbott and Medtronic; has served as an advisor to Medtronic, Abbott, and Boston Scientific; has equity in Syntervention, Essential Medical, CV Ingenuity, Spirox, Tissue Gen, Primacea, and Arsenal; and is founder of Innovation Vascular Partners Consulting. Dr. Davis is a stockholder in Avinger; and has served on scientific advisory boards for Volcano, Boston Scientific, Medtronic, Avinger, and Roxwood Medical. Dr. Armstrong has been a consultant to Abbott Vascular, Boston Scientific, Cardiovascular Systems, Medtronic, and Philips. Dr. Zeller has received honoraria from Abbott Vascular, Veryan, Biotronik, Boston Scientific, Cook Medical, Gore & Associates, Medtronic, Philips-Spectranetics, TriReme, Veryan, Shockwave, Bayer, B. Braun, and Vesper Medical; has consulted for Boston Scientific, Cook Medical, Gore & Associates, Medtronic, Spectranetics, Veryan, B. Braun, Shockwave, Bayer, Vesper Medical, and Intact Vascular; and holds common stock in Veryan Medical and QT 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. Rosenschein is the inventor of the WIRION EPS device; and has been a consultant to Abbott, Bayer, Boston Scientific, Cook Medical, Cardionovum, CR Bard, Gardia Medical/Allium, Medtronic, Philips, and Upstream Medical Technologies. Dr. Gray has equity in Allium Medical; and has been a consultant to Gardia Medical. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
- Received March 22, 2018.
- Revision received May 8, 2018.
- Accepted May 15, 2018.
- 2018 American College of Cardiology Foundation
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