Predictors of Cerebral Embolic Debris During Transcatheter Aortic Valve Replacement: The SafePass 2 First-in-Human Study.

Autor: Grubman D; Division of Cardiovascular Medicine, Department of Internal Medicine, Yale School of Medicine, New Haven, Connecticut; Yale Cardiovascular Research Group, Yale School of Medicine, New Haven, Connecticut., Ahmad Y; Division of Cardiovascular Medicine, Department of Internal Medicine, Yale School of Medicine, New Haven, Connecticut., Leipsic JA; Department of Radiology, Centre for Cardiovascular Innovation, University of British Columbia, Vancouver, Canada., Blanke P; Department of Radiology, Centre for Cardiovascular Innovation, University of British Columbia, Vancouver, Canada., Pasupati S; Department of Cardiology, Waikato Hospital, Hamilton, New Zealand., Webster M; Department of Cardiology, Auckland City Hospital, Auckland, New Zealand., Nazif TM; Division of Cardiology, Department of Medicine, NewYork-Presbyterian Hospital/Columbia University Irving Medical Center, New York, New York., Parise H; Division of Cardiovascular Medicine, Department of Internal Medicine, Yale School of Medicine, New Haven, Connecticut; Yale Cardiovascular Research Group, Yale School of Medicine, New Haven, Connecticut., Lansky AJ; Division of Cardiovascular Medicine, Department of Internal Medicine, Yale School of Medicine, New Haven, Connecticut; Yale Cardiovascular Research Group, Yale School of Medicine, New Haven, Connecticut. Electronic address: alexandra.lansky@yale.edu.
Jazyk: angličtina
Zdroj: The American journal of cardiology [Am J Cardiol] 2023 Nov 15; Vol. 207, pp. 28-34. Date of Electronic Publication: 2023 Sep 16.
DOI: 10.1016/j.amjcard.2023.08.137
Abstrakt: Transcatheter aortic valve replacement (TAVR) generates significant debris, and strategies to mitigate cerebral embolization are needed. The novel Emboliner embolic protection catheter (Emboline, Inc., Santa Cruz, California) is designed to capture all particles generated during TAVR. This first-in-human study sought to assess the safety and feasibility of the device and to characterize the distribution and histopathology of the debris generated during TAVR. The SafePass 2 study was a prospective, nonrandomized, multicenter, single-arm investigation of the Emboliner device. Primary end points included 30-day major adverse cardiac and cerebrovascular events (MACCE) and technical performance. Computed tomography angiography was analyzed by an independent core laboratory, and filters were sent for histopathology of captured debris. Predictors of particle number were identified using >150 µm and >500 µm size thresholds. Of 31 subjects enrolled, technical success was 100%, and 30-day MACCE was 6.5% (2 cerebrovascular accidents, with 1 attributed to subtherapeutic dosing of rivaroxaban along with atrial fibrillation and the other to possible previous small ischemic strokes on magnetic resonance imaging; neither MACCE event had a causal relation to the Emboliner). All filters contained debris, with a median of 191.0 particles >150 µm and 14.0 particles >500 µm. Histopathology revealed mostly acute thrombus and valve or arterial tissue with lesser amounts of calcified tissue. A history of atrial fibrillation predicted a greater number of particles >500 µm (p = 0.0259) and its presence on admission was associated with 4.1 times more particles >150 µm (p = 0.0130) and 8.1 times more particles >500 µm (p = 0.0086). Self-expanding valves were associated with twice the number of particles >150 µm (p = 0.0281). TASK score was positively correlated with number of particles >500 µm (p = 0.0337). The Emboliner device was safe and feasible. Emboli after TAVR appear more numerous than previously documented. Atrial fibrillation, higher TASK score, and self-expanding valve use conferred higher embolic burden. Notably, none of the tested computed tomography angiography features were able to identify with higher embolic risk. Larger-scale studies are needed to identify high-risk patients for selective embolic protection device use.
Competing Interests: Declaration of Competing Interest Dr. Ahmad is a consultant for Cardiovascular Systems Inc and Shockwave; and serves on the medical advisory board of Boston Scientific. Dr. Leipsic serves at Institutional Core Lab - Edwards, Medtronic, Boston Scientific, Abbott, and Pi-Cardia. Dr. Blanke is a consultant to Edwards Lifesciences and LARALAB; Institutional Core Lab – Edwards Lifesciences, Medtronic, Boston Scientific, Abbott, and Pi-Cardia. Dr. Webster receives institutional research funding – Emboline Inc. Dr. Nazif receives consulting fees or honoraria from Medtronic, Boston Scientific, and EnCompass Technologies. Dr. Parise receives consulting fees – Intact Vascular, Inc. (now Philips Image Guided Therapy), TriReme Medical LLC, and Veryan Medical Ltd. Dr. Lansky receives consulting fees from Med Alliance. The remaining authors have no competing interests to declare.
(Copyright © 2023 Elsevier Inc. All rights reserved.)
Databáze: MEDLINE
Externí odkaz: