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Author Notes:

Robert J. Lederman, MD, Cardiovascular Branch, Division of Intramural Research, National Heart Lung and Blood Institute, National Institutes of Health, Building 10, Room 2c713, MSC 1538, Bethesda, MD 20892-1538, USA., Telephone: +1-301-402-6769., lederman@nih.gov.

We thank Alan Hoofring for medical illustrations; Katherine Lucas for animal care; Daniel Herzka, Merdim Sonmez, and Dmitri Levin for technical assistance; Norihiko Kamioka, Lauren Wheeler, and Patricia Keegan for data assistance; and Elena Grant and James McCabe for thoughtful advice.

We thank Richard Olson of Abbott for supplying a sample Trifecta valve in anticipation of helping the first patient.

Full list of disclosures available in full text.

Subject:

Research Funding:

Supported by the National Heart Lung and Blood Institute; National Institutes of Health, USA (Z01-HL006040-7); and by the intramural programs of the participating centres.

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
  • BIOPROSTHETIC SURGICAL VALVES
  • INTERMEDIATE-RISK PATIENTS
  • CLINICAL-OUTCOMES
  • IMPLANTATION
  • REGISTRY
  • PROTECTION
  • INSIGHTS
  • IMPACT

Transcatheter Laceration of Aortic Leaflets to Prevent Coronary Obstruction During Transcatheter Aortic Valve Replacement Concept to First-in-Human

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Journal Title:

JACC: Cardiovascular Interventions

Volume:

Volume 11, Number 7

Publisher:

, Pages 677-689

Type of Work:

Article | Post-print: After Peer Review

Abstract:

Objectives: This study sought to develop a novel technique called bioprosthetic or native aortic scallop intentional laceration to prevent coronary artery obstruction (BASILICA). Background: Coronary artery obstruction is a rare but fatal complication of transcatheter aortic valve replacement (TAVR). Methods: We lacerated pericardial leaflets in vitro using catheter electrosurgery, and tested leaflet splaying after benchtop TAVR. The procedure was tested in swine. BASILICA was then offered to patients at high risk of coronary obstruction from TAVR and ineligible for surgical aortic valve replacement. BASILICA used marketed devices. Catheters directed an electrified guidewire to traverse and lacerate the aortic leaflet down the center line. TAVR was performed as usual. Results: TAVR splayed lacerated bovine pericardial leaflets. BASILICA was successful in pigs, both to left and right cusps. Necropsy revealed full length lacerations with no collateral thermal injury. Seven patients underwent BASILICA on a compassionate basis. Six had failed bioprosthetic valves, both stented and stent-less. Two had severe aortic stenosis, including 1 patient with native disease, 3 had severe aortic regurgitation, and 2 had mixed aortic valve disease. One patient required laceration of both left and right coronary cusps. There was no hemodynamic compromise in any patient following BASILICA. All patients had successful TAVR, with no coronary obstruction, stroke, or any major complications. All patients survived to 30 days. Conclusions: BASILICA may durably prevent coronary obstruction from TAVR. The procedure was successful across a range of presentations, and requires further evaluation in a prospective trial. Its role in treatment of degenerated TAVR devices remains untested.

Copyright information:

Copyright © 2019 Elsevier B.V. or its licensors or contributors.

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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