Author + information
- Received January 30, 2019
- Revision received June 3, 2019
- Accepted June 6, 2019
- Published online December 2, 2019.
- Christopher U. Meduri, MD, MPHa,
- Michael J. Reardon, MDb,
- D. Scott Lim, MDc,
- Elliot Howard, PhDd,
- Gan Dunnington, MDe,
- David P. Lee, MDf,
- David Liang, MDf,
- Robert Gooley, MBBS, PhDg,
- Daniel O’Hair, MDh,∗,
- Martin K. Ng, MBBS, PhDi,
- Antony Walton, MDj,
- Konstantinos Spargias, MDk,
- Daniel Blackman, MDl,
- Augustin Coisne, MD, PhDm,
- David Hildick-Smith, MDn,
- Marine De Gouy, MSd,
- Sharla Chenoweth, MSo,
- Saibal Kar, MDp,†,
- Patrick M. McCarthy, MDq,
- Nicolo Piazza, MDr,
- Atif Qasam, MDs,
- Randolph P. Martin, MDt,
- Martin B. Leon, MDu,
- Michael J. Mack, MDv,
- David H. Adams, MDw and
- Vinayak Bapat, MBBS, MS, MChx,y,∗ (, )@chrismeduri
- aMarcus Heart Valve Center, Piedmont Heart Institute, Atlanta, Georgia
- bDepartment of Cardiothoracic Surgery, Houston Methodist DeBakey Heart and Vascular Center, Houston, Texas
- cDivision of Cardiology, Bon Secours, Richmond, Virginia
- dCoronary and Structural Heart Research and Innovation, Medtronic, Redwood City, California
- eDepartment of Cardiothoracic Surgery, St. Helena Hospital, St. Helena, California
- fDepartment of Cardiovascular Medicine, Stanford University, Stanford, California
- gMonash Cardiovascular Research Centre and MonashHeart, Melbourne, Australia
- hDepartment of Cardiothoracic Surgery, Aurora Health Center, Milwaukee, Wisconsin
- iDepartment of Cardiology, Royal Prince Alfred Hospital, Sydney, Australia
- jDepartment of Cardiology, The Alfred Hospital, Melbourne, Australia
- kDepartment of Transcatheter Heart Valves, Hygeia Hospital, Athens, Greece
- lDepartment of Cardiology, Leeds Teaching Hospitals NHS Trust, Leeds, United Kingdom
- mHeart Valve Center, Lille University Hospital, Lille, France
- nDepartment of Interventional Cardiology, Sussex Cardiac Centre, Brighton and Sussex University Hospitals, United Kingdom
- oCoronary and Structural Heart, Department of Biostatistics, Medtronic, Mounds View, Minnesota
- pSmidt Heart Institute, Cedars Sinai Medical Center, Los Angeles, California
- qBluhm Cardiovascular Institute and Division of Cardiac Surgery, Northwestern University, Chicago, Illinois
- rDepartment of Medicine, Division of Cardiology, McGill University Health Centre, Montreal, Canada
- sDivision of Cardiology, University of California, San Francisco, San Francisco, California
- tDivision of Cardiology, Emory University, Atlanta, Georgia
- uDivision of Cardiology, Columbia University Medical Center, New York, New York
- vDepartment of Cardiothoracic Surgery, Baylor Scott and White Health, Plano, Texas
- wDepartment of Cardiovascular Surgery, Mount Sinai Medical Center, New York, New York
- xSt Thomas’ Hospital, London, United Kingdom
- yDepartment of Surgery, New York Presbyterian/Columbia University Medical Center, New York, New York
- ↵∗Address for correspondence:
Dr. Vinayak Bapat, CUMC/Milstein Hospital Building, 177 Fort Washington Avenue, Floor: MHB 7-435, New York, New York 10032.
Objectives This study proposes a physiologic assessment of left ventricular outflow tract obstruction (LVOTO) that accommodates changes in systolic flow and accounts for the dynamic neo–left ventricular outflow tract (LVOT).
Background Patients considered for transcatheter mitral valve replacement trials often screen-fail because of the perceived risk of LVOTO. In the Intrepid Global Pilot Study, assumed risk of LVOTO was based on computed tomography estimates of the neo-LVOT area computed at end-systole. However, this may overestimate actual risk.
Methods Retrospective analyses were performed for screen-failed patients for potential LVOTO (n = 33) and treated patients (n = 29) with available dynamic computed tomography. A multiphase assessment of the neo-LVOT area was performed and represented as: 1) multiphase average; and 2) early systolic value. Prospective evaluation was performed in 9 patients approved for enrollment with multiphase and early systole methods that would have previously screen-failed with the end-systolic approach.
Results Of 166 patients screened for possible inclusion; 32 were screen-failed for nonanatomical reasons. Screen failure for assumed LVOTO risk occurred in 37 of 134 (27.6%) patients. Retrospective analysis indicated a potential enrollment increase of 11 of 33 (33.3%) and 18 of 33 (54.5%) patients using multiphase and early systolic assessment methods. In the prospective cohort, there were no clinical observations of LVOTO 30 days post-procedure, despite assumed risk based on end-systolic estimates.
Conclusions Multiphase, and specifically early systolic, assessment of the neo-LVOT may better determine risk of LVOTO with transcatheter mitral valve replacement compared with end-systolic estimates. This novel approach has the potential to significantly increase patient eligibility, with over one-half of patients previously screen-failed now eligible for treatment.
↵∗ Dr. O'Hair is currently at Boulder Heart, Boulder, Colorado.
↵† Dr. Kar is currently at the Center for Advanced Cardiac and Vascular Interventions, Los Angeles, California.
The study was supported by Medtronic. Dr. Meduri has served as a consultant for Medtronic and Boston Scientific; and on the advisory board for Boston Scientific. Dr. Reardon has received personal fees from Medtronic and Boston Scientific outside the submitted work. Dr. Lim has received institutional grant support from Medtronic. Dr. Howard, Ms. De Gouy, and Ms. Chenoweth are employees and shareholders of Medtronic. Dr. Dunnington has received research support and consulting honoraria and served on a medical review panel for Medtronic. Dr. Liang has served as consultant for and received consulting honoraria from Medtronic and Twelve. Dr. Gooley has received proctoring fees from Medtronic and Boston Scientific; and has received consulting fees from Boston Scientific. Dr. O’Hair has served as a consultant to Medtronic. Dr. Ng has served as an advisor to Medtronic and Edwards Lifesciences; and has received research grant support from Edwards Lifesciences; and has served as a consultant and proctor for Medtronic, HighLife, and Microport. Dr. Walton has served as a proctor and advisor for Medtronic. Dr. Spargias has served as consultant and proctor for Medtronic. Dr. Blackman has served as a consultant and proctor for Medtronic and Boston Scientific. Dr. Hildick-Smith has served as a proctor and advisor for Medtronic, Boston Scientific, and Edwards Lifesciences. Dr. Kar has received consulting honoraria from Abbott Vascular, Boston Scientific, Medtronic, and W.L. Gore. Dr. McCarthy has served as a consultant for and received royalties from Edwards Lifesciences; has received consulting honoraria from AtriCare; has received speaker fees from Medtronic; and has served on an advisory board for Abbott Vascular. Dr. Piazza has served as a proctor for HighLife, Microport, and Medtronic. Dr. Qasim has received grant support from Abbott Vascular, Siemens, and Medtronic; and has served as a consultant for Siemens and Biotelemetry. Dr. Martin has served on the executive committee for Medtronic. Dr. Mack has served on the executive board for the Medtronic APOLLO trial; and has served on the Speakers Bureau and as a principal investigator for Medtronic and Edwards Lifesciences. Dr. Adams has served as the national co-principal investigator of the Medtronic APOLLO Pivotal Trial, Medtronic CoreValve US Pivotal Trial, NeoChord ReChord FDA Trial, and the Abbott TRILUMINATE Trial. In addition, The Icahn School of Medicine at Mount Sinai receives royalty payments from Edwards Lifesciences and Medtronic for intellectual property related to development of valve repair rings. Dr. Bapat has served as a consultant for Medtronic, Edwards Lifesciences, 4C, and Boston Scientific. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
- Received January 30, 2019.
- Revision received June 3, 2019.
- Accepted June 6, 2019.
- 2019 American College of Cardiology Foundation
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