Alexandra J Lansky1, Joachim Schofer2, Didier Tchetche3, Pieter Stella4, Cody G Pietras5, Helen Parise5, Kevin Abrams6, John K Forrest7, Michael Cleman7, Jochen Reinöhl8, Thomas Cuisset9, Daniel Blackman10, Gil Bolotin11, Stefan Spitzer12, Utz Kappert13, Martine Gilard14, Thomas Modine15, David Hildick-Smith16, Michael Haude16, Pauliina Margolis17, Adam M Brickman18, Szilard Voros19, Andreas Baumbach20. 1. Division of Cardiology, Yale School of Medicine, New Haven, CT, USA Yale Cardiovascular Research Group, New Haven, CT, USA alexandra.lansky@yale.edu alexandralansky@gmail.com. 2. Cardiovascular Center, Hamburg University, Hamburg, Germany. 3. Department of Interventional Cardiology, Clinique Pasteur, Toulouse, France. 4. Department of Cardiology, University Medical Center Utrecht, Utrecht, The Netherlands. 5. Division of Cardiology, Yale School of Medicine, New Haven, CT, USA Yale Cardiovascular Research Group, New Haven, CT, USA. 6. Department of Radiology, Baptist Hospital of Miami, Miami, FL, USA. 7. Division of Cardiology, Yale School of Medicine, New Haven, CT, USA. 8. Department of Cardiology and Angiology I, Heart Center, University of Freiburg, Freiburg, Germany. 9. Department of Cardiology, CHU Timone, Marseille, France. 10. Department of Cardiology, Leeds Teaching Hospitals NHS Trust, Leeds General Infirmary, Leeds, UK. 11. Department of Cardiac Surgery, Rambam Health Care Campus, Haifa, Israel. 12. Praxisklinik Herz und Gefäße, Dresden, Germany. 13. Herzzentrum Dresden GmbH, Universitätsklinik, Dresden, Germany. 14. Department of Cardiology, Brest University, Brest, France. 15. Department of Cardiovascular Surgery, Hôpital Cardiologique, Lille, France. 16. Sussex Cardiac Centre, Brighton and Sussex University Hospital NHS Trust, Brighton, UK. 17. Keystone Heart Ltd., Caesarea, Israel. 18. Department of Neurology, College of Physicians and Surgeons, Columbia University, New York, NY, USA Taub Institute for Research on Alzheimer's Disease and the Aging Brain, College of Physicians and Surgeons, Columbia University, New York, NY, USA. 19. Global Institute for Research, Richmond, VA, USA. 20. Bristol Heart Institute, University Hospitals Bristol NHS Foundation Trust, Bristol, UK.
Abstract
AIMS: To evaluate the safety, efficacy, and performance of the TriGuard™ HDH Embolic Deflection Device (TriGuard) compared with no cerebral protection in patients undergoing transcatheter aortic valve implantation (TAVI). METHODS AND RESULTS:From February 2014 to March 2015, 85 subjects undergoing TAVI at 13 centres in Europe and Israel were randomized to TriGuard protection vs. no protection. Subjects underwent neurologic and cognitive evaluation at baseline, pre-discharge and 30 days; cerebral diffusion-weighted magnetic resonance imaging was performed at 4 ± 2 days post-procedure and at 30 days. Technical success, which included complete 3-vessel cerebral coverage, was achieved in 88.9% (40/45) of cases. The primary in-hospital procedural safety endpoint (death, stroke, life-threatening or disabling bleeding, stage 2 or 3 acute kidney injury, or major vascular complications) occurred in 21.7% of TriGuard and 30.8% of control subjects (P = 0.34). In the Per Treatment population (subjects with complete three-vessel cerebral coverage), TriGuard use was associated with greater freedom from new ischaemic brain lesions (26.9 vs. 11.5%), fewer new neurologic deficits detected by the National Institutes of Health Stroke Scale (3.1 vs. 15.4%), improved Montreal Cognitive Assessment (MoCA) scores, better performance on a delayed memory task (P = 0.028) at discharge, and a >2-fold increase in recovery of normal cognitive function (MoCA score >26) at 30 days. CONCLUSION: TriGuard cerebral protection during TAVI is safe and complete cerebral vessel coverage was achieved in 89% of subjects. In this exploratory study, subjects undergoing protected TAVI had more freedom from ischaemic brain lesions, fewer neurologic deficits, and improved cognitive function in some domains at discharge and 30 days compared with controls. Published on behalf of the European Society of Cardiology. All rights reserved.
RCT Entities:
AIMS: To evaluate the safety, efficacy, and performance of the TriGuard™ HDH Embolic Deflection Device (TriGuard) compared with no cerebral protection in patients undergoing transcatheter aortic valve implantation (TAVI). METHODS AND RESULTS: From February 2014 to March 2015, 85 subjects undergoing TAVI at 13 centres in Europe and Israel were randomized to TriGuard protection vs. no protection. Subjects underwent neurologic and cognitive evaluation at baseline, pre-discharge and 30 days; cerebral diffusion-weighted magnetic resonance imaging was performed at 4 ± 2 days post-procedure and at 30 days. Technical success, which included complete 3-vessel cerebral coverage, was achieved in 88.9% (40/45) of cases. The primary in-hospital procedural safety endpoint (death, stroke, life-threatening or disabling bleeding, stage 2 or 3 acute kidney injury, or major vascular complications) occurred in 21.7% of TriGuard and 30.8% of control subjects (P = 0.34). In the Per Treatment population (subjects with complete three-vessel cerebral coverage), TriGuard use was associated with greater freedom from new ischaemic brain lesions (26.9 vs. 11.5%), fewer new neurologic deficits detected by the National Institutes of Health Stroke Scale (3.1 vs. 15.4%), improved Montreal Cognitive Assessment (MoCA) scores, better performance on a delayed memory task (P = 0.028) at discharge, and a >2-fold increase in recovery of normal cognitive function (MoCA score >26) at 30 days. CONCLUSION: TriGuard cerebral protection during TAVI is safe and complete cerebral vessel coverage was achieved in 89% of subjects. In this exploratory study, subjects undergoing protected TAVI had more freedom from ischaemic brain lesions, fewer neurologic deficits, and improved cognitive function in some domains at discharge and 30 days compared with controls. Published on behalf of the European Society of Cardiology. All rights reserved.
Authors: Alexandra J Lansky; Steven R Messé; Adam M Brickman; Michael Dwyer; H Bart van der Worp; Ronald M Lazar; Cody G Pietras; Kevin J Abrams; Eugene McFadden; Nils H Petersen; Jeffrey Browndyke; Bernard Prendergast; Vivian G Ng; Donald E Cutlip; Samir Kapadia; Mitchell W Krucoff; Axel Linke; Claudia Scala Moy; Joachim Schofer; Gerrit-Anne van Es; Renu Virmani; Jeffrey Popma; Michael K Parides; Susheel Kodali; Michel Bilello; Robert Zivadinov; Joseph Akar; Karen L Furie; Daryl Gress; Szilard Voros; Jeffrey Moses; David Greer; John K Forrest; David Holmes; Arie P Kappetein; Michael Mack; Andreas Baumbach Journal: Eur Heart J Date: 2018-05-14 Impact factor: 29.983
Authors: Hector Cubero-Gallego; Isaac Pascual; José Rozado; Ana Ayesta; Daniel Hernandez-Vaquero; Rocio Diaz; Alberto Alperi; Pablo Avanzas; Cesar Moris Journal: Ann Transl Med Date: 2019-10