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Author Notes:

Dr. Robert J. Lederman, Cardiovascular Branch, Division of Intramural Research, National Heart, Lung, and Blood Institute, National Institutes of Health, Building 10, Room 2C713, MSC 1538, Bethesda, Maryland 20892-1538. lederman@nih.gov.

The authors thank clinical and research staff at University of Washington (Christopher Rumer, Data Manager; Ikki Komatsu, MD; Gabriel Aldea, MD; G. Burkhard Mackensen, MD, PhD; James M. McCabe, MD); Emory University (Lauren Wheeler; James Lee, RN; Patricia Keegan, DNP; Elizabeth Charles, Research Coordinator; Kristy Pitts, Research Coordinator; Kimberly McWhorter, Research Coordinator; Hima Patel, Research Coordinator; Jennifer James, Research Coordinator); Medstar Washington Hospital Center (Petros Okubagzi, Clinical Research Director; Dorion Hoffmeister, Research Coordinator); Henry Ford Hospital (Ashish Solanki, Research Coordinator); and independent Data Monitors (Olha Katynska; Valeriy Matveev; Artur Karapetyan).

We thank the Medstar Clinical Events Adjudication Committee (Hector Garcia-Garcia, Soloman Beyene, Kayode Kuku, and Viana Azizi); and the National Heart, Lung, and Blood Institute Computed Tomography Core Laboratory.

Dr. Greenbaum has served as a proctor for Edwards Lifesdences, Medtronic, and Abbott Vascular; and a consultant for Transmural Systems.

Dr. Babaliaros has served as a consultant for Edwards Lifesdences and Abbott Vascular; and his employer has research contracts for clinical investigation of transcatheter aortic and mitral devices from Edwards Lifesdences, Abbott Vascular, Medtronic, St. Jude Medical, and Boston Scientific.

Complete list of disclosures available in full text.

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Research Funding:

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:

  • Science & Technology
  • Life Sciences & Biomedicine
  • Cardiac & Cardiovascular Systems
  • Cardiovascular System & Cardiology
  • bioprosthetic heart valve failure
  • coronary artery obstruction
  • structural heart disease
  • transcatheter aortic valve replacement
  • transcatheter electrosurgery
  • TRANSCATHETER AORTIC-VALVE
  • CLINICAL-OUTCOMES
  • TRANSCAVAL ACCESS
  • REPLACEMENT
  • IMPLANTATION
  • THROMBOSIS
  • RISK
  • PROTECTION
  • INSIGHTS

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

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Journal Title:

JACC: Cardiovascular Interventions

Volume:

Volume 12, Number 13

Publisher:

, Pages 1240-1252

Type of Work:

Article | Post-print: After Peer Review

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.

Copyright information:

Published by Elsevier on behalf of the American College of Cardiology Foundation

This is an Open Access work distributed under the terms of the Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License (http://creativecommons.org/licenses/by-nc-nd/4.0/).

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