Author + information
- Received June 11, 2019
- Revision received October 31, 2019
- Accepted November 5, 2019
- Published online April 6, 2020.
- Azeem Latib, MDa,b,c,∗∗ (, )@azeemlatib,
- Antonio Mangieri, MDd,∗,
- Paolo Vezzulli, MDe,
- Pietro Spagnolo, MDf,
- Francesco Sardanelli, MDf,
- Giovanni Fellegara, MDg,
- Matteo Pagnesi, MDa,
- Francesco Giannini, MDd,
- Andrea Falini, MDe,
- Riccardo Gorla, MDh,
- Matteo Montorfano, MDa,
- Francesco Bedogni, MDh,
- Antonio Colombo, MDa,
- Jeffrey Popma, MDi,
- William M. Merhi, DOj and
- Federico De Marco, MDh
- aInterventional Cardiology Unit, San Raffaele Scientific Institute, Milan, Italy
- bDivision of Cardiology, Department of Medicine, University of Cape Town, Cape Town, South Africa
- cDepartment of Cardiology, Montefiore Medical Center, New York, New York
- dInterventional Cardiology Unit, GVM Care and Research Maria Cecilia Hospital, Cotignola, Italy
- eDepartment of Neuroradiology, San Raffaele Scientific Institute, Milan, Italy
- fUnit of Radiology, IRCCS Policlinico San Donato, Milan, Italy
- gDepartment of Surgical Pathology, Centro Diagnostico Italiano, Milan, Italy
- hDepartment of Clinical and Interventional Cardiology, IRCCS Policlinico San Donato, Milan, Italy
- iDepartment of Cardiology, Beth Israel Deaconess Medical Center, Boston, Massachusetts
- jDepartment of Cardiology, Spectrum Health Hospital, Grand Rapids, Michigan
- ↵∗Address for correspondence:
Dr. Azeem Latib, Department of Cardiology, Montefiore Medical Center, 111 East 210th Street, Bronx, New York 10467.
Objectives This study sought to evaluate the feasibility of complete cerebral protection during transcatheter aortic valve replacement (TAVR) with a novel embolic protection device.
Background Evidences and data about new cerebral embolic protection devices are lacking and scarce.
Methods A prospective, nonrandomized, multicenter, first-in-man pilot study designed to evaluate the efficacy and safety of cerebral embolic protection utilizing the Emblok embolic protection system (Innovative Cardiovascular Solutions, Grand Rapids, Michigan) during TAVR. The Emblok is a transfemoral aortic filter that provide full coverage of the epiaortic vessels. Brain diffusion-weighted magnetic resonance imaging (DW-MRI) was performed at baseline and 2 to 5 days after TAVR. Primary endpoints were technical success and immediate cerebral embolic burden after TAVR, defined as number and volume of new brain lesions detected with DW-MRI at days 2 to 5 post-TAVR compared with baseline.
Results A total of 20 subjects were enrolled. The Emblok system was successfully positioned in all the cases. At 30-day follow-up, no major adverse cardiovascular and cerebrovascular events occurred. Nineteen (95%) patients had new ischemic defects at post-procedural DW-MRI. The median number of new lesions per patient was 10.00 (interquartile range [IQR]: 4.75 to 15.25). The total new lesion volume was 199.9 mm3 (IQR: 83.9 to 447.5 mm3) and the mean lesion volume per lesion was 42.5 mm3 (IQR: 21.5 to 75.6 mm3). Histopathologic analysis showed evidence of significant debris in 18 (90%) filters.
Conclusions The Emblok embolic protection system appears to be feasible and safe during TAVR. The device was successfully placed and retrieved in all cases and no neurological events were observed. Cerebral total new lesion volume was similar to other trials on cerebral protection during TAVR, thus warranting a larger study. (European Study Evaluating the Emblok Embolic Protection System During TAVR; NCT03130491)
↵∗ Drs. Latib and Mangieri contributed equally to this work.
Dr. Latib has served on Advisory Boards for Medtronic and Abbott; and has served as a consultant for Edwards Lifesciences and Innovative Catheter Solution. Dr. Mangieri has received institutional research grant support from Boston Scientific. Dr. Giannini has served as proctor for Neovasc. Dr. Montorfano has served as proctor for Edwards Lifesciences, Abbott, and Kardia. Dr. Popma has received institutional research grant support from Medtronic, Boston Scientific, Abbott Vascular, and Edwards Lifesciences; and has served on medical Advisory Boards for Boston Scientific and Edwards Lifesciences. Dr. Merhi is the Chief Science Officer for Innovative Cardiovascular Solutions. Dr. De Marco has served as proctor for Boston Scientific and Kardia; and is part of the scientific Advisory Board for Innovative Catheter Solution. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
- Received June 11, 2019.
- Revision received October 31, 2019.
- Accepted November 5, 2019.
- 2020 American College of Cardiology Foundation
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