Author + information
- Received January 22, 2018
- Revision received February 28, 2018
- Accepted March 1, 2018
- Published online July 2, 2018.
- Tobias Schmidt, MDa,∗ (, )
- Martin B. Leon, MDb,
- Roxana Mehran, MDc,
- Karl-Heinz Kuck, MDa,
- Maria C. Alu, MSb,
- Ryan E. Braumann, BSd,
- Susheel Kodali, MDb,
- Samir R. Kapadia, MDe,
- Axel Linke, MDf,
- Raj Makkar, MDg,
- Christoph Naber, MDh,
- Maria E. Romero, MDd,
- Renu Virmani, MDd and
- Christian Frerker, MDa
- aDepartment of Cardiology, Asklepios Klinik St. Georg, Hamburg, Germany
- bColumbia University Irving Medical Center, New York, New York
- cMount Sinai School of Medicine, New York, New York
- dCVPath Institute, Inc., Gaithersburg, Maryland
- eCleveland Clinic, Cleveland, Ohio
- fHerzzentrum Leipzig GmbH–Universitätsklinik, Leipzig, Germany
- gCedars-Sinai Medical Center, Los Angeles, California
- hUniversity Hospital of Essen, Essen, Germany
- ↵∗Address for correspondence:
Dr. Tobias Schmidt, Department of Cardiology, Asklepios Klinik St. Georg, Lohmühlenstrasse 5, 20099 Hamburg, Germany.
Objectives This study investigated differences between transcatheter heart valve (THV) types and regarding debris captured by a cerebral embolic protection system (Claret Medical Sentinel, Santa Rosa, California).
Background Differences of THV types and cerebral injury after transcatheter aortic valve replacement (TAVR) are not well understood.
Methods A total of 246 patients pooled from 2 prospective studies (SENTINEL [Cerebral Protection in Transcatheter Aortic Valve Replacement] trial, N = 100; SENTINEL-H [Histopathology of Embolic Debris Captured During Transcatheter Aortic Valve Replacement] trial, N = 146) were included in the analysis. Histopathologic assessment and histomorphometric analyses of debris were compared with THV types. Analyses were differentiated by particle size (≥150, ≥500, and ≥1,000 μm), particle count, total particle area, and maximum of largest dimension. Only commercially available THVs were included: 16% Evolut R (EvR), 15% Lotus, 59% SAPIEN 3 (S3), and 10% SAPIEN XT (XT).
Results Particles were captured in 99% of patients. There was a significantly higher amount of debris related to the vascular bed (valve tissue, arterial wall, calcification) in EvR patients compared with S3 patients; 53% of all patients irrespective of valve type had at least 1 particle ≥1 mm. Larger particles (≥500 and ≥1,000 μm) were significantly more frequent in EvR than XT and S3 patients. Lotus patients with particles ≥1,000 μm were significantly more frequent than in S3 patients. Particle count, total particle area, and maximum of largest dimension were significantly higher in both Lotus and EvR patients compared with S3 and XT.
Conclusions Debris was captured in 99% of patients, of whom 53% had at least 1 particle of debris >1 mm. The number and size of particles captured during a procedure in which EvR or Lotus THV was used were higher and larger than with a Sapien THV. Regardless, embolic debris, including large particles, is universal across valve types and provides mechanistic support for the potential benefit of using cerebral embolic protection in all TAVR procedures.
The SENTINEL trial and the SENTINEL H registry were funded by Claret Medical, Inc. Dr. Schmidt has received speakers honoraria from Medtronic and Claret Medical; and has received travel expenses from Medtronic, Edwards Lifesciences, and Boston Scientific. Dr. Mehran has received institutional grant support from AstraZeneca, Bayer, Beth Israel Deaconess, Bristol-Myers Squibb/Sanofi, CSL Behring, Eli Lilly/Daiichi-Sankyo, Medtronic, Novartis, and OrbusNeich; has received consultant fees to her institution from Abbott Vascular, Boston Scientific, CardioKinetix, Cardiovascular Systems, Medscape, Shanghai BraccoSine Pharmaceutical, and Spectranetics; has received executive committee fees from Janssen Pharmaceuticals and Osprey Medical; has received advisory board fees to her institution from Bristol-Myers Squibb; has received data and safety monitoring board membership fees to her institution from Watermark Research Partners; and her spouse is a consultant for Abiomed and The Medicines Company. Dr. Kuck has received research grants from Medtronic; has been a consultant for Edwards Lifesciences, Medtronic, Abbott, and Boston Scientific; and has received lecture honoraria from Medtronic, Edwards Lifesciences, and Boston Scientific. Ms. Alu has received consulting fees from Claret Medical. Dr. Kodali has received consulting fees from Claret Medical and Merrill Lifesciences; has served on the scientific advisory boards of Thubrikar Aortic Valve, Abbott Vascular, Biotrace Medical, Dura Biotech, Microinterventional Devices, and VS Medtech; is an unpaid member of the steering committee for the PARTNER trial for Edwards Lifesciences; honorarium from Abbott Vascular, Claret Medical, and Merrill Lifesciences; and has received equity from Thubrikar Aortic Valve, Dura Biotech, and Biotrace Medical. Dr. Linke has received speaker honoraria or served as a consultant for Medtronic, St. Jude Medical, Abbott Vascular, Claret Medical, Boston Scientific, Edwards Lifesciences, Symetis, and Bard; owns stock options from Claret Medical; and has received grant support to his institution from Medtronic, St. Jude Medical, Abbott, Claret Medical, Boston Scientific, Edwards Lifesciences, Symetis, and Bard. Dr. Makkar has received consulting fees from Edwards Lifesciences, Medtronic, and Abbott Vascular. Dr. Naber has received minor stock options from Claret Medical. Dr. Virmani has received institutional research support from 480 Biomedical, Abbott Vascular, BioSensors International, Boston Scientific, Celonova, Claret Medical, Cook Medical, Edwards Lifesciences, Medtronic, MicroPort, MicroVention, Terumo Corporation, W.L. Gore, and Xeltis; has received honoraria from 480 Biomedical, Abbott Vascular, Boston Scientific, Cook Medical, Claret Medical, Lutonix, Medtronic, Terumo Corporation, and W.L. Gore; and has been a consultant for 480 Biomedical, Abbott Vascular, Medtronic, and W.L. Gore. Dr. Frerker has worked as a proctor for Medtronic and Boston Scientific; and has received lecture honoraria from Edwards Lifesciences. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
- Received January 22, 2018.
- Revision received February 28, 2018.
- Accepted March 1, 2018.
- 2018 American College of Cardiology Foundation