The BASILICA Trial Prospective Multicenter Investigation of Intentional Leaflet Laceration to Prevent TAVR Coronary Obstruction

• Type of Material: Article
• Authors: Jaffar Khan, Emory University; Adam Greenbaum, Emory University; Vasilis Babaliaros, Emory University; Toby Rogers, National Heart, Lung, and Blood Institute; Marvin H. Eng, Henry Ford Health System; Gaetano Paone, Emory University; Bradley Leshnower, Emory University; Mark Reisman, University of Washington; Lowell Satler, Medstar Washington Hospital Center; Ron Waksman, Medstar Washington Hospital Center; Marcus Y. Chen, National Heart, Lung, and Blood Institute; Annette M. Stine, National Heart, Lung, and Blood Institute; Xin Tian, National Heart, Lung, and Blood Institute; Danny Dvir, Henry Ford Health System; Robert Lederman, Emory University
• Language: English
• Date: 2019-07-08
• Publisher: Elsevier: 12 months
• Publication Version: Author Accepted Manuscript (After Peer Review)
• Copyright Statement: Published by Elsevier on behalf of the American College of Cardiology Foundation
• License: Creative Commons Attribution-NonCommercial-NoDerivs 4.0 International
• Final Published Version (URL): http://dx.doi.org/10.1016/j.jcin.2019.03.035
• Title of Journal or Parent Work: JACC: Cardiovascular Interventions
• ISSN: 1936-8798
• Volume: 12
• Issue: 13
• Start Page: 1240
• End Page: 1252
• Grant/Funding Information: This work was supported by the Division of Intramural Research, National Heart Lung and Blood Institute, National Institutes of Health (Z01-HL006040–7); and by the intramural programs of the participating centers.
• Keywords: coronary artery obstruction; transcatheter aortic valve replacement; Science & Technology; transcatheter electrosurgery; IMPLANTATION; Cardiac & Cardiovascular Systems; CLINICAL-OUTCOMES; THROMBOSIS; TRANSCATHETER AORTIC-VALVE; Cardiovascular System & Cardiology; RISK; TRANSCAVAL ACCESS; Life Sciences & Biomedicine; structural heart disease; bioprosthetic heart valve failure; PROTECTION; REPLACEMENT; INSIGHTS
• Research Categories: Health Sciences, Medicine and Surgery

Abstract

Objectives: The BASILICA (Bioprosthetic or native Aortic Scallop Intentional Laceration to prevent Iatrogenic Coronary Artery obstruction during TAVR) investigational device exemption trial was a prospective, multicenter, single-arm safety and feasibility study. Background: Coronary artery obstruction is a rare but devastating complication of transcatheter aortic valve replacement (TAVR). Current stent-based preventative strategies are suboptimal. Bioprosthetic or native aortic scallop intentional laceration to prevent iatrogenic coronary artery obstruction during TAVR (BASILICA) is a novel transcatheter technique performed immediately before TAVR to prevent coronary artery obstruction. Methods: Subjects with severe native or bioprosthetic aortic valve disease at high or extreme risk for surgery, and at high risk of coronary artery obstruction, were included. The primary success endpoint was successful BASILICA and TAVR without coronary obstruction or reintervention. The primary safety endpoint was freedom from major adverse cardiovascular events. Data were independently monitored. Endpoints were independently adjudicated. A core laboratory analyzed computed tomography images. Results: Between February 2018 and July 2018, 30 subjects were enrolled. Primary success was met in 28 (93%) subjects. BASILICA traversal and laceration was successful in 35 of 37 (95%) attempted leaflets. There was 100% freedom from coronary obstruction and reintervention. Primary safety was met in 21 (70%), driven by 6 (20%) major vascular complications related to TAVR but not BASILICA. There was 1 death at 30 days. There was 1 (3%) disabling stroke and 2 (7%) nondisabling strokes. Transient hemodynamic compromise was rare (7%) and resolved promptly with TAVR. Conclusions: BASILICA was feasible in both native and bioprosthetic valves. Hemodynamic compromise was uncommon. Safety was acceptable and needs confirmation in larger studies. BASILICA appears effective in preventing coronary artery obstruction from TAVR in subjects at high risk.