Author + information
- Received October 1, 2016
- Revision received October 21, 2016
- Accepted October 22, 2016
- Published online November 1, 2016.
- Samir R. Kapadia, MDa,∗∗ (, )
- Susheel Kodali, MDb,∗,
- Raj Makkar, MDc,
- Roxana Mehran, MDd,
- Ronald M. Lazar, PhDb,
- Robert Zivadinov, MD, PhDe,
- Michael G. Dwyer, MDe,
- Hasan Jilaihawi, MDf,
- Renu Virmani, MDg,
- Saif Anwaruddin, MDh,
- Vinod H. Thourani, MDi,
- Tamim Nazif, MDb,
- Norman Mangner, MDj,
- Felix Woitek, MDj,
- Amar Krishnaswamy, MDa,
- Stephanie Mick, MDa,
- Tarun Chakravarty, MDc,
- Mamoo Nakamura, MDc,
- James M. McCabe, MDk,
- Lowell Satler, MDl,
- Alan Zajarias, MDm,
- Wilson Y. Szeto, MDh,
- Lars Svensson, MD, PhDa,
- Maria C. Alu, MSb,
- Roseann M. White, MSn,
- Carlye Kraemer, MSo,
- Azin Parhizgar, PhDp,
- Martin B. Leon, MDb and
- Axel Linke, MDj,q
- aCleveland Clinic, Cleveland, OH
- bColumbia University Medical Center, New York, NY
- cCedars-Sinai Medical Center, Los Angeles, CA
- dMount Sinai School of Medicine, New York, NY
- eBuffalo Neuroimaging Analysis Center, Buffalo, NY
- fNYU Langone Medical Center, New York, NY
- gCV Path Institute, Gaithersburg, MD
- hUniversity of Pennsylvania, Philadelphia, PA
- iEmory University, Atlanta, GA
- jHerzzentrum Leipzig GmbH –Universitätsklinik, Leipzig, Germany
- kUniversity of Washington, Seattle, WA
- lMedstar Washington Hospital Center, Washington, DC
- mWashington University School of Medicine, St. Louis, MO
- nDuke Clinical Research Institute, Durham, NC
- oNAMSA, Minneapolis, MN
- pClaret Medical Inc, Santa Rosa, CA
- qLeipzig Heart Institute, Leipzig, Germany
- ↵∗Address for Correspondence: Samir Kapadia, MD Cleveland Clinic 9500 Euclid Avenue, Desk J2-3 Cleveland, OH 44195 Tel: 216-444-6697.
Background Neurological events and brain infarction after transcatheter aortic valve replacement (TAVR) are concerns which may be reduced with transcatheter embolic protection (TEP).
Objective Evaluate the safety and efficacy of TEP during TAVR.
Methods Nineteen centers randomized 363 patients undergoing TAVR to safety (n=123), device imaging (n=121), and control imaging (n=119). The primary safety endpoint was major adverse cardiac and cerebrovascular events (MACCE) at 30 days and the primary efficacy endpoint was reduction in new lesion volume in protected brain territories on MRI scans at 2-7 days. Patients underwent neurocognitive assessments and the debris captured was analyzed.
Results MACCE (7.3%) was non-inferior to the performance goal (18.3%, pnoninferior<0.001) and not statistically different from control (9.9%, p=0.41). New lesion volume was 178.0 mm3 in controls and 102.8 mm3 in the device arm (p=0.33). A post hoc multivariable analysis identified preexisting lesion volume and valve type to be predictors of new lesion volume. Strokes at 30d were 9.1% in controls and 5.6% in device patients (p=0.25). Although neurocognitive function was similar in control and device patients, there was correlation between lesion volume and neurocognitive decline (p=0.0022). Histopathologic debris, found within filters in 99% of patients, included thrombus, calcification, valve tissue, artery wall and foreign material.
Conclusions TEP was safe, captured embolic debris 99% patients, and did not change neurocognitive function. Reduction in new lesion volume on MR scans was not statistically significant.
↵∗ co-first authors
Sources of Funding: The SENTINEL Trial was funded by Claret Medical, Inc.
Relationships with Industry: Authors disclose the following relationships with industry:Dr. Kodali is a consultant for Edwards Lifesciences. Dr. Makkar has received research support from Edwards Lifesciences and St. Jude Medical and is a consultant for Abbott Vascular, Cordis, and Medtronic. He also holds equity in Entourage Medical. Dr. Mehran receives research grant support from Eli Lilly/DSI, BMS, AstraZeneca, The Medicines Company, OrbusNeich, Bayer, and CSL Behring; is a consultant for Janssen Pharmaceuticals, Osprey Medical, Watermark Research Partners, and Medscape, a member of the Scientific Advisory Board of Abbott Laboratories, and holds Equity or Stock Options in Claret Medical Inc. and Elixir Medical Corporation. Dr. Zivadinov has received personal compensation from Teva Pharmaceuticals, Biogen Idec, EMD Serono, Genzyme-Sanofi, Claret Medical, IMS Health and Novartis for speaking and consultant fees. He received financial support for research activities from Teva Pharmaceuticals, Genzyme-Sanofi, Novartis, Claret Medical, Intekrin and IMS Health. Dr. Zivadinov serves on editorial board of J Alzh Dis, BMC Med, BMC Neurol, Vein and Lymphatics and Clinical CNS Drugs. He is Executive Director and Treasurer of International Society for Neurovascular Disease. Dr. Jilaihawi is a consultant for Edwards Lifesciences, St. Jude Medical, and Venus Medtech. Dr. Anwaruddin is a speaker, consultant, and proctor for Edwards Lifesciences and Medtronic and a consultant for the American College of Radiology. Dr. Thourani is a consultant for Edwards Lifesciences, Sorin Medical, St. Jude Medical, and DirectFlow. Dr. Nazif is a consultant for Edwards Lifesciences. Dr. Nakamura is a consultant for Edwards Lifesciences. Dr. McCabe is a consultant for Edwards Lifesciences. Dr. Zajarias is a consultant for Edwards Lifesciences. Dr. Szeto is a consultant for MicroInterventional Devices. Dr. Svensson holds equite in Cardiosolutions and ValvXchange and Intellectual Property Rights for Posthorax. Ms. Alu is a consultant for Claret Medical. Ms. White is a consultant for Claret Medical through Duke Clinical Research Institute. Ms. Kraemer is a consultant for Claret Medical. Dr. Parhizgar is an employee of Claret Medical. The other authors report no relevant relationships with industry.
- Received October 1, 2016.
- Revision received October 21, 2016.
- Accepted October 22, 2016.