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

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          Abstract

          Background:

          Coronary artery obstruction is a rare but fatal complication of transcatheter aortic valve replacement (TAVR).

          Objectives:

          We developed a novel technique called BASILICA ( Bioprosthetic or native Aortic Scallop Intentional Laceration to prevent Coronary Artery obstruction).

          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 centreline. 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 one patient with native disease, three had severe aortic regurgitation, and two 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.

          Graphical Abstract

          CONDENSED ABSTRACT

          Bioprosthetic or native Aortic Scallop Intentional Laceration to prevent Iatrogenic Coronary Artery obstruction (BASILICA) is a technique to prevent coronary artery obstruction complicating transcatheter aortic valve replacement (TAVR). BASILICA uses catheter electrosurgery to split aortic valve leaflets lengthwise immediately prior to TAVR. We describe the technique on the benchtop and in animals. We also report the first-in-human application in seven patients, including both aortic stenosis and regurgitation, in both bioprosthetic and native aortic valves. All patients had high predicted risk of coronary artery obstruction. All patients had successful BASILICA and TAVR, with no coronary obstruction, stroke or 30-day mortality.

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          Author and article information

          Journal
          101467004
          35678
          JACC Cardiovasc Interv
          JACC Cardiovasc Interv
          JACC. Cardiovascular interventions
          1936-8798
          1876-7605
          27 July 2018
          09 April 2018
          09 April 2019
          : 11
          : 7
          : 677-689
          Affiliations
          [* ]Cardiovascular Branch, Division of Intramural Research, National Heart Lung and Blood Institute, National Institutes of Health, Bethesda, MD, USA
          []University of Washington, Seattle, WA, USA
          []Center for Structural Heart Disease, Division of Cardiology, and Division of Cardiac Surgery, Henry Ford Health System, Detroit, Michigan, USA
          [§ ]Structural Heart and Valve Center, Emory University Hospital, Atlanta, Georgia, USA
          Author notes
          Correspondence to: 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@ 123456nih.gov
          Article
          PMC6309616 PMC6309616 6309616 nihpa949385
          10.1016/j.jcin.2018.01.247
          6309616
          29622147
          1e65f21f-5911-400c-ac82-b1d5a77f8908
          History
          Categories
          Article

          Structural heart disease,Transcatheter electrosurgery,Coronary artery obstruction,Transcatheter aortic valve replacement,Bioprosthetic heart valve failure

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